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Vectra® Neo Clinical Therapy System

LASER LABELS

This serial decal label is affi

xed at the

rear of the system.

DJO, LLC
1430 Decision Street
Vista, CA 92081
USA

Complies with
21CFR 1040.10
21CFR 1040.11
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-22
IEC 60601-2-57
IEC 62471
IEC 60825-1:2007

13-7687-5_C

Rx Only

The device is labeled with the date of
manufacture.

The Laser Applicator handle label
includes important safety information.

The LED Applicator handle label includes
important safety information.

SYSTEM SPECIFICATIONS

Содержание Vectra Neo

Страница 1: ...Vectra Neo Clinical Therapy System User Manual Operator and Installation Instructions Rx Only ...

Страница 2: ......

Страница 3: ...ND ELECTROTHERAPY UNITS 28 GENERAL SYSTEM OPERATING AND STORAGE TEMPERATURE 28 ULTRASOUND SPECIFICATIONS 29 ULTRASOUND SPATIAL PATTERN 29 SYSTEM SPECIFICATIONS 30 LASER SPECIFICATIONS 30 LASER APPLICATOR TECHNICAL SPECIFICATIONS 31 LASER PROTECTIVE EYEWEAR SPECIFICATIONS 33 LASER LABELS 34 WAVEFORMS 35 PATIENT PREPARATION 38 ELECTRODE PLACEMENT 38 DURA STICK ELECTRODES 38 ELECTROTHERAPY PATIENT PR...

Страница 4: ...RMS 72 APPENDIX 2 73 ELECTROMAGNETIC COMPATIBILITY EMC 73 ELECTROMAGNETIC COMPATIBILITY EMC TABLES 74 APPENDIX 3 78 CALCULATIONS FOR OUTPUT CURRENT 78 MAXIMUM CURRENT OUTPUT CALCULATIONS BASED ON 250 MW CM2 POWER DENSITY LIMIT 80 CURRENT DENSITY CALCULATIONS FOR DJO ELECTRODES 81 ELECTRODE SIZE SELECTION 82 ...

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Страница 6: ...ces for additional information regarding the application of electrotherapy ultrasound and laser FOREWORD Text with a DANGEROUS VOLTAGE indicator serves to inform the user of possible hazards resulting in the electrical charge delivered to the patient in certain treatment configurations of TENS waveforms Warning Laser beam Explosion Hazard Text with an Explosion Hazard indicator will explain possib...

Страница 7: ...Therapy System SYSTEM SOFTWARE SYMBOLS Stim Electrode Placement Ultrasound Combo sEMG Laser CPS Custom Protocols Patient Data Anatomical Library Back Arrow Home Increase Decrease Parameter Scroll Up or Down in a text box Select Page Up Page Down Customize Save Data When pressed will print the screen contents or Patient Treatment Results Report to the USB flash drive Indicates a USB flash drive is ...

Страница 8: ...ver any period of 5s Testing Agency DangerousVoltage ElectricalType B ElectricalType BF Laser Ultrasound Stim Start Stop Pause Intensity Lock Unlock ON OFF Laser Stop Switch 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 beam The symbol to the right is located on the back of the applicator and in...

Страница 9: ...on patients with cardiac demand pacemakers Do not use Vectra Neo Clinical Therapy System on patients who have or have had implantable neurostimulating cardiac demand pacemakers ICD or other implantable electronic devices Do not use Vectra Neo Clinical Therapy System on patients with body worn electro mechanical medical devices i e insulin pump Do not use this system in an MRI or CT environment The...

Страница 10: ...ostimulating cardiac demand pacemakers ICD or other implantable electronic devices Do not use Vectra Neo Clinical Therapy System on patients with body worn electro mechanical medical devices i e insulin pump Do not use this system in an MRI or CT environment The Vectra Neo Clinical Therapy System its components and accessories are not to be present in an MRI or CT environment Additional Precaution...

Страница 11: ... until bone growth is complete This device should not be used over the thoracic area if the patient is using a cardiac pacemaker This device should not be used over a healing fracture This device should not be used over or applied to the eye This device should not be used over a pregnant uterus Tissue necrosis might result if the device is used on ischemic tissues in individuals with vascular dise...

Страница 12: ...t is using a cardiac pacemaker Over or applied to the eye 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 Do not use Vectra Neo Clinical Therapy System on patients who have or have had implantable neurostimulating cardiac demand pacemakers ICD or other implantable electronic ...

Страница 13: ...le To maximize functionality and life of Vectra Neo be sure to Stay current with the latest clinical developments in the field of electrotherapy ultrasound laser therapy sEMG and sEMG electrotherapy Observe all applicable precautionary measures for treatment Keep informed of appropriate indications and contraindications for the use of the Vectra Neo Clinical Therapy System NOTE This equipment is t...

Страница 14: ...h port 9 Mains Power Cord 10 Rear Access Panel 11 Serial Label 12 USB Flash Drive Port USB flash drive not included 13 Tilt Screen 14 Swivel function 15 Laser Interlock Port and Icon 16 Lead wire holders 45º Front Controls Side Holders Rear Access Panel The Vectra Neo Clinical Therapy System Operator Interface contains all the functions and controls necessary for operator access to all operator ut...

Страница 15: ...vicetechnicianforhelp ConsultyourauthorizedDJOdealerforhelp DonotoperatethisunitwhenconnectedtoanyunitotherthanDJO devicesoraccessoriesspecificallydescribedinuserorservicemanuals Useofcontrols adjustmentsorperformanceofproceduresotherthan thosespecifiedhereinmayresultinhazardousexposuretoLaser energy DONOTdisassemble modify orremodeltheunitoraccessories This maycauseunitdamage malfunction electric...

Страница 16: ...atintentionallyradiateelectromagneticenergyinan unshieldedmanner Useofelectrodeonmultiplepatientscanleadtoinfection Cleanapplicatorsaftereachuse otherwiseitcanleadtocross contaminationandinfection WhentheLaserModuleisnotinuse itshouldbeprotectedagainst unqualifieduse WARNING WARNING Donottreatthroughclothing Stoptreatmentimmediatelyifpatientexperiencesdiscomfortorpain Donotapplylaseronanareaofskin...

Страница 17: ...s varicoseveins etc Stimulationshouldnotbeappliedover orinproximity to cancerouslesions Electrotherapyoutputcurrentdensityisrelatedtoelectrodesize Improperapplicationmayresultinpatientinjury Ifanyquestion arisesastotheproperelectrodesize consultalicensedpractitioner priortotherapysession TheVectra NeoClinicalTherapySystemoptionalmodulesand associatedaccessoriesaredesignedforuseonlywiththeVectra Ne...

Страница 18: ...osuretotheLaserbeam Thesymboltothe leftislocatedonthebackoftheapplicatorandindicates theactiveradiantsurface theareaontheapplicatorthat emitsinfraredLaserenergyandthedirectionofthebeam oflight Whentheunitison notallwavelengthsare visibletothenakedeye Therefore whenperformingany operationalorfunctionalcheck alwayswearChattanooga laserprotectiveeyewear Thesolventsofadhesivesandflammablesolutionsused...

Страница 19: ...he Vectra Neo Clinical Therapy System when ordered as a Tabletop System without cart is assembled with Base shown below The only assembly required is the installation of the desired Modules described in the MODULE INSTALLATION section on page 23 Head Cart COMPONENTS Base Modules Stimulation Channel 1 2 Stimulation Channel 1 2 sEMG Stimulation Channel 3 4 Laser Ultrasound Lead Wires The available l...

Страница 20: ...rasound Module PN 70002 Ultrasound module Faceplates to cover module after inserted into main unit Electrotherapy Module Channels 3 4 PN 70003 Stimulation module Lead wires DURA STICK 2 in 5 cm Round Disposable Electrodes 1 pack of 4 Faceplates to cover module after inserted into main unit Electrotherapy Module Channels 1 2 sEMG PN 70004 Stimulation module 2 channel Stimulation with sEMG sEMG Lead...

Страница 21: ...3 LED The component of the applicator that indicates if the Applicator is coupled or uncoupled on the treatment area Coupling is not available on the 1 cm2 applicator LED Indicator Output Power LED Indicator Output Power This orange light illuminates when Laser energy is being distributed by the applicator Pause Resume Button Laser Head LASER APPLICATOR LED s SLD s Laser Diode Aperture Laser Head ...

Страница 22: ...ents Only Decreases the intensity of the assigned stim treatment button is not active if stim treatment is unassigned Button is not active and has no function for Ultrasound or Laser treatments STOP Pause Treatment 3 All Treatments Pauses treatment M Manual Stimulation 4 Electrical Stimulation Treatments Only Provides one cycle of stimulation Can only be operated when the clinician enables manual ...

Страница 23: ...s supplies and applicators used for the various modalities of the System Tools required not included 2 Phillips screwdriver and standard slotted screwdriver Remove the Vectra Neo Clinical Therapy System from the shipping carton Visually inspect for damage Report any damage to the carrier immediately To assemble the Neo Head to the Cart follow these steps 1 Remove the top drawer from the Cart Pull ...

Страница 24: ...s the plastic tabs on both drawer slides simultaneously in opposite directions as shown Completely pull the drawer out 2 There are two Cart height adjustments Standard shown on the left and lowered shown on the right For initial installation determine the desired height Locate three Allen style bolts for each leg left and right and insert by hand in their respective slots Use the Allen wrench to s...

Страница 25: ...recognize the new Module s therefore no software installation is required Ultrasound Laser Stimulation3 4 Stimulation 1 2 1 Ensure that the power cord is removed from the device 2 Remove the blank faceplate over the slot from the left and right sides of the Neo head The example displays the Ultrasound module 3 Insert a standard slotted screwdriver not provided into the top slot pressing down with ...

Страница 26: ...his is to avoid bending the pins in the plug 6 Secure the module with a screw provided at the bottom as shown using channel 3 4 as example 7 In this example showing the Laser faceplate insert the faceplate at the bottom and snap into place at the top as shown on the left and right sides Vectra Neo Clinical Therapy System allows Laser access on the left and right sides 8 Plug in the unit and press ...

Страница 27: ...clips in the same manner as lead wires and cables shown below Complete the following steps to assign the remote to a treatment 1 When the remote is plugged into the unit a Remote ON OFF toggle icon is displayed on the Treatment review screen in the upper right corner shown below PATIENT REMOTE LASER INTERRUPT SWITCH INSTALLATION To operate the Patient Remote Laser Interrupt Switch plug the remote ...

Страница 28: ... resistor and a jack Customers must supply the necessary cable that complies with local and international codes Use only qualified electricians to install the Laser Interlock Kit The diagrams to the right provide installation guidelines for therapy room with single and multiple doors Operation of the Laser Interlock Laser Interlock works as an interrupt switch once it is installed and connected to...

Страница 29: ... the Power cord into the back of device Plug the other end of the cord into an electrical outlet NOTE The Power Cord may be unplugged from the back of the cart in an emergency situation 2 Press the Power button located on the top left portion of the LCD casing shown below THERAPY SYSTEM START UP 3 Select desired function on the Home screen shown below ...

Страница 30: ...16 1036 cm 1 43 3 6322 cm 1lb 0 453592 kg Head 45 degree with Base Tabletop 15 89 40 3606 cm 15 89 40 3606 cm 22 05 56 007 cm 20 7lb 9 389362 kg Cart Lowered with casters 23 94 60 8076 cm 26 19 66 5226 cm 27 41 69 6214 cm 29 4lb 13 33562 kg Cart Raised with casters 23 94 60 8076 cm 26 19 66 5226 cm 30 15 76 581 cm Head and raised cart with screen 90deg 23 94 60 8076 cm 26 19 66 5226 cm 52 85 134 2...

Страница 31: ...2 Crystal 4 5 25 3 25 2 cm2 Crystal 1 8 2 11 1 4 22 1 cm2 Crystal 0 9 1 11 0 4 55 Head Warming Feature The HeadWarming feature of anVectra Neo ClinicalTherapy System utilizes Ultrasound output resulting in warming of the Applicator to increase patient comfort With HeadWarming enabled ultrasound is emitted without pressing the Start button while an ultrasound treatment is being set up The Applicato...

Страница 32: ... OutputType Infrared Lamp Laser Laser Class 3B Laser Technical Specifications Pulse Frequencies 8 Hz 10000 Hz and continuous Wavelengths 670 950 nm dependent on applicator Output 100 1440 mW dependent on applicator Output accuracy 20 of nominal SYSTEM SPECIFICATIONS ...

Страница 33: ...wn mode After the cool down period is complete a message displays that informs the user that the unit is ready for use LASER APPLICATOR TECHNICAL SPECIFICATIONS SYSTEM SPECIFICATIONS Model Description Diode Type Wavelength s nm Output Power mW Power Density W cm2 Treatment Area Spot Size cm2 Nominal Ocular Hazard Distance NOHD in meters Divergence a1 rad Divergence a1 rad 27799 Single 670nm LED LE...

Страница 34: ...GaAIAs LED 670 nm 10mW LED x4 850 nm 200mW Laser x5 1040 0 137 7 55 12 443 0 097 0 543 27813 13 Diode cluster Laser LED GaAIAs LED 670 nm 10mW LED x7 950 nm 15mW LED x3 850 nm 50mW Laser x3 265 0 035 7 55 3 110 0 097 0 543 27814 13 Diode cluster Laser LED GaAIAs LED 670 nm 10mW LED x7 950 nm 15mW LED x3 850 nm 100mW Laser x3 415 0 054 7 55 6 221 0 097 0 543 27815 19 Diode cluster Laser LED GaAIAs ...

Страница 35: ...y in relation to wavelength Each unit is shipped with laser protective eyewear that is L3 rated and approved as well as EN207 compliant Optical Density Wavelength Useful Range Optical Density 5 190 400 nm Optical Density 3 625 830 nm Optical Density 3 815 1050 nm LASER PROTECTIVE EYEWEAR SPECIFICATIONS ...

Страница 36: ... Complies with 21CFR 1040 10 21CFR 1040 11 IEC 60601 1 IEC 60601 1 2 IEC 60601 2 22 IEC 60601 2 57 IEC 62471 IEC 60825 1 2007 13 7687 5_C Rx Only The device is labeled with the date of manufacture The Laser Applicator handle label includes important safety information The LED Applicator handle label includes important safety information SYSTEM SPECIFICATIONS ...

Страница 37: ...tion CC or CV Burst Frequency 0 31 bps Frequency Modulation 0 250 Hz Amplitude Modulation Off 40 60 80 and 100 TreatmentTime 1 60 min Ramp 0 5 sec TENS Asymmetrical Biphasic The Asymmetrical Biphasic waveform has a short pulse duration It is capable of strong stimulation of the nerve fibers in the skin as well as of muscle tissue This waveform is often used inTENS devices Because of its short puls...

Страница 38: ...Ramp 0 5 sec TreatmentTime 1 60 min Available on Channels 1 2 3 or 4 VMS FR TheVMS FR version of theVMS waveform is a physiologically based channel interaction in which one channel stimulates the agonist and the other the antagonist of the muscle group that is being exercised VMS is a symmetrical biphasic waveform with a 100 μsec interphase interval Because the pulse is relatively short the wavefo...

Страница 39: ...st Frequency Anti Fatigue Off 20 100 bps Ramp 0 5 sec TreatmentTime 1 60 min Available on Channels 1 2 3 or 4 High Voltage Pulsed Current HVPC The HighVoltage Pulsed Current HVPC has a very brief pulse duration characterized by two distinct peaks delivered at high voltage The waveform is monophasic current flows in one direction only Output Mode Electrodes Output Intensity 0 500V Polarity Positive...

Страница 40: ...e good contact between each electrode and the skin Check the electrode contact regularly during the treatment Examine the skin again after the treatment Choose electrodes that fit the anatomy View the Electrode Placement recommendations in the Treatment Review screen for the particular modality being used for treatment as a reference point only prior to administering treatment Follow electrode man...

Страница 41: ...2 Choose one of the following modalities sEMG Ch 1 sEMG Ch 2 sEMG Ch 1 2 sEMG Stim VMS sEMG Stim Sym Biph Connect the sEMG Lead Wires 1 Connect the sEMG Lead wires to the channel s desired for use with the selected modality connect SEMG lead wires 2 Select the Customize icon 3 Select the Electrode Placement icon to view electrode placement according to body area 4 Touch the body part you wish to t...

Страница 42: ... sEMG and sEMG Stim therapy Electrode Placement 1 Using DURA STICK 2 in 5 cm electrodes place the Active red and black lead electrodes in the center of the muscle belly and parallel with the muscle fibers 2 Position the Reference electrode green lead in close proximity to the treatment area Using small electrodes and placing them closer together will render a more specific reading of muscle activi...

Страница 43: ... of the Applicator 3 If US Coupling is On the Applicator is properly coupled to the patient and administering ultrasound when the LED is constantly illuminated Coupling is not available on the 1 cm2 applicator For ULTRASOUND OPERATION refer to page 51 Preparing the Patient s Skin for Laser Therapy Before applying Laser therapy to the patient you must first prepare the patient s skin By properly pr...

Страница 44: ...each screen this screen displays the following status information about each channel Not Installed Indicates the associated module is not installed in the unit Available Indicates the channel is available for use Setup Indicates a treatment for the channel is currently being set up but treatment has not yet begun Running Indicates a treatment for the channel is currently running Paused Indicates a...

Страница 45: ...ides access to all of the system modalities and functions The Home screen has the following information 1 Utilities Modality Icons 2 Electrotherapy 3 Ultrasound 4 Combo 5 sEMG 6 Laser 7 Clinical Protocol Set up CPS 8 Custom Protocols 9 Assign Shortcut Options 10 Patient Data Storage 11 Anatomical Library 1 2 3 4 5 6 11 10 8 7 9 ...

Страница 46: ...uncoupled Coupling is not available on the 1cm2 applicator The default is set to Off The following preferences are available Off Nothing happens when applicator becomes uncoupled Pause and Beep When applicator becomes uncoupled treatment timer will pause unit will beep and channel area indicates uncoupled state Pause and No Beep When applicator becomes uncoupled treatment timer will pause unit wil...

Страница 47: ...rsion of software for each module that is on the USB flash drive is displayed NOTE USB flash drive version is displayed in yellow if it is newer than the current software version for the applicable module 10 Export Protocols to USB flash drive Select the Export Protocols to USB flash drive icon to export all protocols both default and custom to a valid USB flash drive UTILITIES AND OPTIONS CONTINU...

Страница 48: ...mote Control feature 6 Time Icon Press the Time icon to adjust therapy time duration 7 Intensity Icon Set intensity by rotating the Intensity Control Knob to the prescribed level Clockwise Increases Intensity Counterclockwise Decreases Intensity 8 Therapy Information Window View selected Therapy information such as Waveform Electrode Size CC CV Carrier Frequency Cycle Time Frequency and Vector Sca...

Страница 49: ...rom the Home screen 2 Touch the body part you wish to treat 3 Using the Up and Down Arrows scroll to the appropriate indication and select by pressing the icon 4 Using the Up and Down Arrows scroll to the appropriate condition you wish to treat and select by pressing the icon 5 Select the modality desired 6 Begin therapy by pressing the Start button or make setting changes pressing the Customize i...

Страница 50: ...view additional text Press the Back Arrow icon to return to the previous screen or the Home icon to return to the Home screen To view the most commonly used electrode placement for the selected waveform press the Electrode Placement icon A picture will appear prompting you to select the body part you wish to treat Press the Down icon to scroll through text Press the Back icon to return to the prev...

Страница 51: ...eatment NOTE To make setting adjustments during therapy press the Customize icon or adjust intensity using the intensity knob 8 When treatment has completed the Treatment Summary screen will appear with the following options Save therapy information to a USB flash drive by inserting a USB flash drive into the device and pressing the Save to USB Flash Drive icon Repeat the treatment by pressing the...

Страница 52: ...N 4 Make any desired changes to the existing sequences by using the Up and Down arrows to find the desired sequence and press the Edit icon This screen also allows you to Delete a sequence from the protocol by pressing the Delete icon Add a new sequence to the protocol by pressing the New icon and using the Up and Down arrows to find the desired protocol in the list box Press the icon to add the n...

Страница 53: ...ity Floorsshouldbewood concrete orceramictile Iffloorsare coveredwithsyntheticmaterial DJOrecommendsimplementing additionalcontrolstomaintainrelativehumiditytoatleast50 CommunicatetheseESD precautionaryprocedurestohealthcare staff contractors visitors andpatients NOTE Prior to starting treatment replace the ultrasound faceplate on the side of the module not being used with a blank faceplate ULTRAS...

Страница 54: ...een will appear with the following options Save therapy information to a USB flash drive by inserting a USB flash drive into the device and pressing the Save to USB Flash Drive icon Repeat the treatment by pressing the Run this Treatment icon Save the treatment protocol by pressing the Save Protocol icon Refer to the CUSTOM PROTOCOLS section on page 59 for detailed instructions for saving customiz...

Страница 55: ...atient and securing electrodes For ULTRASOUND PATIENT PREPARATION refer to page 41 3 Connect the Black lead wire from Channel 2 to the electrode Make certain the lead wire is completely seated in the electrode The Red lead wire is not used The Ultrasound Applicator completes the circuit for Combination Therapy 4 From the Home screen select the Combo icon COMBINATION OPERATION 5 Select the ultrasou...

Страница 56: ...t or right arrows to reach desired treatment time Use the Intensity dial to set therapy intensity Clockwise Increases Intensity Counterclockwise Decreases Intensity 6 Press the Start button to begin therapy the Pause button to pause treatment or the Stop button to terminate the treatment 7 When treatment has completed the Treatment Summary screen will appear with the following options Save therapy...

Страница 57: ...r to the PATIENT PREPARATION section on page 38 for electrode selection preparing the patient and securing electrodes 3 Select sEMG icon from the Home screen 4 Select the prescribed channel icon see previous for the available choices The treatment screen will appear the screen shown below illustrates the sEMG Channel 1 selection To set the Target Threshold either Automatically or Manually touch th...

Страница 58: ...etheseESD precautionaryprocedurestohealthcare staff contractors visitors andpatients 6 The following options are available under the Customize Treatment screen and accessed by pressing the appropriate icon To view information explaining the waveform press the Modality Description icon Press the Up and Down icons to view additional text Press the Back Arrow icon to return to the previous screen or ...

Страница 59: ...stomized settings Complete the following steps to begin Laser therapy treatment 1 Touch the screen to activate the system Read and carefully follow the instructions on the screen 2 Select the Laser icon from the Home screen 3 Type in a four digit PIN and press the Accept icon to accept the entry or choose from the following options The Cancel icon to return to the Home screen The Clear icon to cle...

Страница 60: ...he treatment date desired from the list box by using the Up and Down arrows or Previous Page Next Page icons to locate the treatment date information Select the treatment date you wish to view and access by pressing the icon 4 The Treatment Summary list box will appear with detailed information about the specific treatment DEVICE USER INTERFACE SAVING TO USB FLASH DRIVE PATIENT DATA 5 Choose one o...

Страница 61: ... to the protocol using the Up and Down arrow icons Press the Save icon when finished typing in the protocol name A yellow text box will appear confirming the newly saved protocol and name 3 After saving the protocol you will return to the Treatment Summary screen Complete one of the following actions listed on the Treatment Summary screen Return to Home screen by pressing the Home icon Scroll back...

Страница 62: ...4 Return to Home screen by pressing the Home icon or press the Back Arrow icon to scroll back one screen at a time Complete the following steps to assign a Home screen shortcut for a customized protocol 1 Press one of the 5 Assign Shortcut icons on the Home screen 2 Find the previously saved protocol in the list box by using the Up and Down arrows or Previous Page Next Page icons to locate the pro...

Страница 63: ... screen The previously assigned shortcut will no longer appear on the Home screen Complete the following steps to view and access patient data 1 Press the Patient Data icon on the Home screen 2 Select the patient ID from the list box by using the Up and Down arrows or Previous Page Next Page icons to locate the patient ID information Select the patient ID you wish to view and access by pressing th...

Страница 64: ... Library 1 Press the Anatomical Library icon on the Home screen 2 Touch the body part for which you wish to view information Choose either anterior on left of screen or posterior on right of screen 3 Select an image from either the Anatomical Image list box or the Pathological Image list box by using the Up and Down arrows or Previous Page Next Page icons to locate the desired image Select the ima...

Страница 65: ...e currently in use Complete existing treatment before attempting to start another treatment on the same channel 114 Information Attempting to select an sEMG treatment but no sEMG is installed on the Stim 1 2 module 1 If sEMG is installed on the Stim 1 2 module reset theTherapy System by turning theTherapy System Off then back On via the Power button 2 If sEMG is installed on the Stim 1 2 module an...

Страница 66: ...tempting to perform a Print Screen to the USB flash drive while a treatment is running The Print Screen function is not allowed while a treatment is running Wait for treatment to complete and then try again 133 Information Attempting to import protocols from the USB flash drive while a treatment is running The Protocol Import function is not allowed while a treatment is running Wait for treatment ...

Страница 67: ...em that indicates aWarning in these categories may pose a risk of injury to the patient user or extensive internal damage to the system Any 300 level code Error Immediately stop all use of the system and contact the dealer or DJO for service Errors in these categories indicate an internal problem with the system that must be tested and corrected by DJO or aTrainedTechnician before any further oper...

Страница 68: ... PREM 2 SQ 40 CASE 42175 DURA STICK P 2 X3 5 REC 40 CASE 42176 DURA STICK BG 2 SQ 40 CA 42177 DURA STICK BG 1 5 X3 5 REC 40 CASE 42178 DURA STICK 2 SQ 40 CASE 42179 DURA STICK 2 X3 5 REC 40 CASE 42181 DURA STICK 2 X3 5 REC 40 CASE 42182 DURA STICK 2 RND 40 CASE 42183 DURA STICK 2 SQ 40 CASE GENERAL ACCESSORIES Model Number Description 70000 Electrotherapy Module Channels 1 2 70001 Neo Cart 70002 U...

Страница 69: ... 50mW laser diodes 10 LED s 27814 13 Diode cluster 3 100mW laser diodes 10 LED s 27816 13 Diode cluster 3 200mW laser diodes 10 LED s 27802 33 Diode cluster 5 50mW laser diodes 28 LED s 27807 33 Diode cluster 5 100mW laser diodes 28 LED s 27808 33 Diode cluster 5 200mW laser diodes 28 LED s 27799 Single 670nm LED 10mW 27815 19 Diode LED cluster no laser 27809 33 Diode LED cluster no laser 27525 La...

Страница 70: ...d be sent to the factory or a Trained Technician for this procedure NOTE The unit was calibrated during the manufacturing process and is ready to be placed into service upon delivery DEVICE DISPOSAL Council Directive 2012 19 EU concerning Waste Electrical and Electronic Equipment WEEE requires not to dispose of WEEE as municipal waste Contact your local distributor for information regarding dispos...

Страница 71: ... at purchase of the Therapy System or Module 3 Ship the unit to address specified by an authorized Service Technician Service to these units should be performed only by a service technician certified by the Company Ultrasound Applicators require annual calibration from the date placed in service by the Factory or a Trained Technician Through the purchase of a Service Manual DJO LLC has made availa...

Страница 72: ...ver Replacement parts or labor furnished by anyone other than the Company the selling dealer or a Company service technician Defects or damage caused by labor furnished by someone other than Company the selling dealer or a Company service technician Any malfunction or failure in the Product caused by product misuse including but not limited to the failure to provide reasonable and required mainten...

Страница 73: ...lt NOTE Some laser applicators may cause a noticeable heat sensation particularly in hairy areas and on sensitive tissues such as lips 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 the angle at which the light enters the patient s skin is very important Therefore the ap...

Страница 74: ...d penetration of the Laser energy High powered diodes will reduce patients treatment times 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 the Total time of the cycle expressed as a percentage The lower the percentage the lower temporal average...

Страница 75: ...idance document for EMC in healthcare facilities developed with FDA participation by the Association for the Advancement of Medical Instrumentation AAMI Technical Information Report TIR 18 Guidance on Electromagnetic Compatibility of Medical Devices for Clinical Biomedical Engineers AAMI TIR 18 1997 Arlington Virginia Association for the Advancement of Medical Instrumentation 1997 Caution Medical ...

Страница 76: ... emissions CISPR 11 Group 1 The Vectra Neo Clinical Therapy System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The Vectra Neo Clinical Therapy System is suitable for use in all establishments other than domestic and those directly connected to the publ...

Страница 77: ...r in the holder Maintain humidity in the use environment to at least 50 relative humidity Floors should be wood concrete or ceramic tile If floors are covered with synthetic material DJO recommends implementing additional controls to maintain relative humidity to at least 50 Communicate these ESD precautionary procedures to healthcare staff contractors visitors and patients Electrical fast transie...

Страница 78: ...om fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 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...

Страница 79: ...f transmitter P W Separation distance according to frequency of transmitter d m 150 kHz to 80 MHz d 3 5 P V1 where V1 3V 80 MHz to 800 MHz d 3 5 P E1 where E1 3V m 800 MHz to 2 5 GHz d 7 P E1 where E1 3V m 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters...

Страница 80: ...Interferential F 5 kHz CC 100 ܫ כ ܽܿܿ ݕܿܽݎݑ ξʹ 0 100 50 250 2000 10000 100 N A Interferential F 5 kHz CC 100 ܫ כ ܽܿܿ ݕܿܽݎݑ 0 90 50 250 2000 10000 100 N A Interferential F 5 kHz CV 100 ሺ ܫ Ȁܴሻ כ ܽܿܿ ݕܿܽݎݑ ξʹ 0 64 50 250 2000 10000 100 N A Interferential F 5 kHz CV 100 ሺ ܫ Ȁܴሻ כ ܽܿܿ ݕܿܽݎݑ 0 45 50 250 2000 10000 100 N A Premodulated F 5 kHz CC 100 ܫ כ ܽܿܿ ݕܿܽݎݑ ʹ 0 100 50 250 2000 10000 66 N A Premod...

Страница 81: ...rrent CC 80 N A 0 1 500 500000 0 1 1000 50 N A TENS Asymmetrical Biphasic CC 50 ܫ כ ܽܿܿ ݕܿܽݎݑ כ ඥ ܨ כ ሺܶ ʹͷͲሻ ͳͲͲͲ 0 110 20 1000 1 250 100 N A TENS Asymmetrical Biphasic CV 50 ሺ ܫ Ȁܴሻ כ ܽܿܿ ݕܿܽݎݑ כ ඥ ܨ כ ሺܶ ʹͷͲሻ ͳͲͲͲ 0 110 20 1000 1 250 100 N A TENS Symmetrical Biphasic CC 50 ܫ כ ܽܿܿ ݕܿܽݎݑ כ ξܰ כ ξ ܨ כ ξܶ ͳͲͲͲ 0 80 20 1000 1 250 100 2 TENS Symmetrical Biphasic CV 50 ሺ ܫ Ȁܴሻ כ ܽܿܿ ݕܿܽݎݑ כ ξܰ כ ξ ܨ ...

Страница 82: ...47 90 5 42160 4 2 ellipse 40 54 250 142 37 90 5 42170 1 25 circle 7 92 250 62 92 62 92 42171 2 circle 20 27 250 100 67 90 5 42172 2 5 1 5 ellipse 19 00 250 97 47 90 5 42173 5 3 ellipse 76 01 250 194 95 90 5 42174 2 2 square 25 81 250 113 60 90 5 42175 3 5 2 rectangle 45 16 250 150 27 90 5 42176 2 2 square 25 81 250 113 60 90 5 42177 3 5 2 rectangle 33 87 250 130 13 90 5 42178 2 2 square 25 81 250 ...

Страница 83: ... 1 2 5 1 9 50 0 0 6 Russian CV 90 0 1 0 4 7 2 2 4 4 4 7 1 2 3 5 2 0 3 5 2 7 3 5 2 0 2 0 4 4 3 5 62 9 0 7 VMS CC 45 6 0 5 2 4 1 1 2 2 2 4 0 6 1 8 1 0 1 8 1 3 1 8 1 0 1 0 2 2 1 8 45 6 0 5 VMS CV 45 6 0 5 2 4 1 1 2 2 2 4 0 6 1 8 1 0 1 8 1 3 1 8 1 0 1 0 2 2 1 8 45 6 0 5 VMS Burst CC 45 6 0 5 2 4 1 1 2 2 2 4 0 6 1 8 1 0 1 8 1 3 1 8 1 0 1 0 2 2 1 8 45 6 0 5 VMS Burst CV 45 6 0 5 2 4 1 1 2 2 2 4 0 6 1 8 ...

Страница 84: ...trode part numbers Device Electrode Selection DJO Electrode Part Number 1 25 round 42170 2 round 42159 42171 42172 42182 2 square 42045 42160 42173 42174 42175 42176 42177 42178 42179 42181 42183 The maximum output current is limited by the System to a value lower than what the electrode can deliver and therefore for the purposes of electrode selection in modality setup all elliptical electrodes a...

Страница 85: ......

Страница 86: ...DJO Global Company 1430 Decision Street Vista CA 92081 8553 USA T 1 800 592 7329 USA F 1 760 734 5608 DJOGlobal com 2014 DJO LLC All rights reserved Vectra Neo ClinicalTherapy System Manual 13 7646 Rev E 11 2014 ...

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