chattanooga Neo 6000 Clinical Therapy System User Manual

chattanooga Neo 6000 Clinical Therapy System

Product Information:

The device is designed for various therapeutic indications including electrotherapy, SEMG & STIM, ultrasound, and laser therapy. It is equipped with an operator interface for ease of use.

Specifications

• Power: Combination and Electrotherapy Units – 28
• General System Operating and Storage Temperature: 28
• Ultrasound Specifications: 29
• Laser Specifications: 30
• Laser Applicator Technical Specifications: 31
• Laser Protective Eyewear Specifications: 33
• Laser Labels: 34
• Waveforms: 35

Product Usage Instructions

1. General Warnings and Precautions:

Before using the device, read all caution notices, warning notices, and danger notices provided in the manual.

2. System Specifications:

Ensure the device operates within the specified power and temperature ranges as outlined in the manual. Refer to specific sections for ultrasound and laser specifications.

3. Troubleshooting:

If you encounter any issues, refer to the troubleshooting section and make note of the troubleshooting codes for assistance in resolving problems.

4. Accessories:

Refer to the accessories section for information on compatible accessories and replacement parts.

5. Service and Warranty:

For warranty repairs or out-of-warranty repairs, follow the instructions provided in the manual. Familiarize yourself with the warranty terms.

FAQs

• Q: What should I do if the device displays a troubleshooting code?
  • A: Refer to the troubleshooting section of the manual to identify the issue and follow the recommended steps to resolve it.
• Q: Can I use any accessories with the device?
  • A: Only use accessories recommended by the manufacturer to ensure compatibility and safe operation of the device.

Vectra® Neo Clinical Therapy System User Manual
Operator and Installation Instructions
Rx Only

Vectra® Neo Clinical Therapy System

INTRODUCTION

FOREWORD
This manual is intended for users of Vectra® Neo Clinical Therapy System. It contains general information on operation, precautionary practices, and maintenance. In order to maximize use, efficiency, and the life of the system, please read this manual thoroughly and become familiar with the controls, as well as the accessories before operating the system.
In addition to the above information, this manual contains care and installation instructions for the optional Cart, Channel 1/2 Electrotherapy module, Channel 1/2 Electrotherapy module + sEMGmodule, Channel 3/4 Electrotherapy module, Laser module, and Ultrasound module for the users of the Vectra® Neo Clinical Therapy System.
Specifications put forth in this manual were in effect at the time of publication. However, owing to DJO’s policy of continual improvement, changes to these specifications may be made at any time without notification on the part of DJO.
Before administering any treatment to a patient, the users of this equipment should read, understand, and follow the information contained in this manual for each mode of treatment available, as well as the indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the application of electrotherapy, ultrasound, and laser.

Vectra® Neo Clinical Therapy System
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:
CAUTION
Text with a “CAUTION” indicator explains possible safety infractions that have potential to cause minor or moderate injury or damage to the equipment.
WARNING
Text with a “WARNING” indicator explains possible safety infractions that will potentially cause serious injury and equipment damage.
DANGER
Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury.
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 possible safety infractions if this equipment is used in the presence of flammable anesthetics, mixture with air, oxygen, or nitrous oxide.
Wear eye protection

NOTE: Throughout this manual, “NOTE” indicators provide helpful information regarding the particular area of function being described.

4

Vectra® Neo Clinical Therapy System

INTRODUCTION

GENERAL TERMINOLOGY

The following are definitions for the terminology used throughout this manual. Study these terms to become familiar with them for ease of system operation and control functionality of the Vectra® Neo Clinical Therapy System.
SYSTEM SOFTWARE SYMBOLS

Back Arrow

Stim

Home

Electrode Placement

Increase/Decrease Parameter

Ultrasound

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 inserted Patient Remote/Laser Shut Off Icon
Indicates the Remote is plugged in

Combo sEMG Laser CPS Custom Protocols Patient Data Anatomical Library

5

INTRODUCTION
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: Refer to Instructional Manual Booklet . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equipment capable of delivering output values in excess of 10 mA r.m.s. or 10V r.m.s. averaged over any period of 5s . . . . . . . . . . . . . . . . . . . . . . .
Testing Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dangerous Voltage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical Type B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical Type 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 indicates the active radiant surface (the area on the applicator that emits infrared laser energy and the direction of the beam of light) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MRI Unsafe (device, its components, and accessories are not to be present in an MRI or CT environment) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vectra® Neo Clinical Therapy System

6

Vectra® Neo Clinical Therapy System

INDICATIONS FOR USE

ELECTROTHERAPY INDICATIONS

Indications
For VMS (Pulsed Mode, Burst Mode, or FR Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential, and Premodulated (IFS):
· Relaxation of muscle spasms · Prevention or retardation of disuse atrophy · Increasing local blood circulation · Muscle re-education · Maintaining or increasing range of motion · Immediate postsurgical stimulation of calf muscles to
prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS (Pulsed Mode, Burst Mode, or FR Mode), Asymmetrical Biphasic (TENS), and HANS:
· Symptomatic relief or management of chronic, intractable pain
· Post-traumatic acute pain · Post-surgical acute pain
For DC (Direct Current) Continuous Mode:
· Relaxation of muscle spasm
For FES:
· Stimulation of the muscles of the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient’s gait.
Contraindications
The Vectra® Neo Clinical Therapy System should NOT be used under the following conditions:
· Do not use for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed.
· Do not use when cancerous lesions are present in the treatment area.
· Do not apply stimulation over swollen, infected, inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.).
· Do not use when patient is suspected or known to have infectious disease and/or disease where it is advisable, for general medical purposes, to suppress heat or fevers.
· Do not place electrode placements to the carotid sinus region (anterior neck) or transcerebrally (through the head).
· Do not use on pregnant women. Safety has not been established for the use of therapeutic electrical stimulation during pregnancy.

· Do not use powered muscle stimulators or TENS waveforms 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 Vectra® Neo Clinical Therapy System, its components, and accessories are not to be present in an MRI or CT environment.
Additional Precautions
· Use caution for patients with suspected or diagnosed heart problems.
· Use caution for patients with suspected or diagnosed epilepsy.
· Use caution in the presence of the following: – When there is a tendency to hemorrhage following acute trauma or fracture – Following recent surgical procedures when muscle contraction may disrupt the healing process – Over a menstruating or pregnant uterus – Over areas of the skin that lack normal sensation
· Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternative conductive medium or an alternative electrode placement.
· Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
· Powered muscle stimulators should be used only with the lead wires and electrodes recommended for use by the manufacturer.
· With TENS waveforms, isolated cases of skin irritation may occur at the site of electrode placement following long-term application.
· The effective management of pain by TENS waveforms is highly dependent upon patient selection by a person qualified in pain management.
Adverse Effects
· Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.
· Potential adverse effects with TENS are skin irritation and electrode burns.

7

INDICATIONS FOR USE

Vectra® Neo Clinical Therapy System

SEMG & STIM INDICATIONS
Indications
For EMG triggered Stim:
· Stroke rehab by muscle re-education · Relaxation of muscle spasms · Prevention or retardation of disuse atrophy · Increase local blood circulation · Muscle re-education · Maintaining or increasing range of motion
For EMG:
· To determine the activation timing of muscles for: – Retraining of muscle activation – Coordinating of muscle activation
· Any indication of the force produced by muscle for control and maintenance of muscle contractions – Relaxation muscle training – Muscle re-education
Contraindications
The Vectra® Neo Clinical Therapy System should not be used under the following conditions:
· Do not use for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed.
· Do not use when cancerous lesions are present in the treatment area.
· Do not apply stimulation over swollen, infected, inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.).
· Other contraindications are patients suspected of carrying serious infectious disease and/or disease where it is advisable, for general medical purposes, to suppress heat or fevers.
· Do not place electrode placements to the carotid sinus region (anterior neck) or transcerebrally (through the head).
· Safety has not been established for the use of therapeutic electrical stimulation during pregnancy.
· Do not use powered muscle stimulators or TENS waveforms 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 Vectra® Neo Clinical Therapy System, its components, and accessories are not to be present in an MRI or CT environment.
Additional Precautions
· Use caution for patients with suspected or diagnosed heart problems.
· Use caution for patients with suspected or diagnosed epilepsy.
· Use caution in the presence of the following: – When there is a tendency to hemorrhage following acute trauma or fracture – Following recent surgical procedures when muscle contraction may disrupt the healing process – Over a menstruating or pregnant uterus – Over areas of the skin that lack normal sensation
· Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternative conductive medium or an alternative electrode placement.
· Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.
· Powered muscle stimulators should be used only with the lead wires and electrodes recommended for use by the manufacturer.
· With TENS waveforms, isolated cases of skin irritation may occur at the site of electrode placement following long term application.
· The effective management of pain by TENS waveforms is highly dependent upon patient selection by a person qualified in the management of pain patients.
Adverse Effects
· Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.
· Potential adverse effects with TENS are skin irritation and electrode burns.

8

Vectra® Neo Clinical Therapy System

INDICATIONS FOR USE

ULTRASOUND INDICATIONS
Indications
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
· Relief of pain, muscle spasms, and joint contractures · Relief of pain, muscle spasms, and joint contractures
that may be associated with: – Adhesive capsulitis – Bursitis with slight calcification – Myositis – Soft tissue injuries – Shortened tendons due to past injuries and scar tissues
· Relief of sub-chronic and chronic pain and joint contractures resulting from: – Capsular tightness – Capsular scarring
Contraindications
· This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed.
· This device should not be used when cancerous lesions are present in the treatment area.
· Other contraindications are patients suspected of carrying serious infectious disease and disease where it is advisable for general medical purposes to suppress heat or fevers.
· This device should not be used over or near bone growth centers 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 disease, where the blood supply would not keep up with the metabolic demand. · 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 Vectra® Neo Clinical Therapy System, its components, and accessories are not to be present in an MRI or CT environment.
Additional Precautions
Additional precautions should be used when ultrasound is used on patients with the following conditions:
· Over an area of the spinal cord following a laminectomy, i.e., when major covering tissues have been removed
· Over anesthetic areas · On patients with hemorrhagic diatheses

9

INDICATIONS FOR USE

Vectra® Neo Clinical Therapy System

LASER INDICATIONS
Indications
To provide topical heating for the following:
· Temporary increase in local blood circulation · Temporary relief of minor muscle and joint aches,
pains, and stiffness · Relaxation of muscles · Temporary relief of muscle spasms · Temporarty relief of minor pain and stiffness
associated with arthritis
Contraindications
The Vectra® Neo Clinical Therapy System Laser 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 over areas injected with steroids in the past 2-3 weeks
· Over areas that are suspicious or contain potentially cancerous tissue
· Over areas of active hemorrhage · Over a pregnant uterus · Over the neck (thyroid or carotid sinus region) or chest
(vagus nerve or cardiac region of the thorax) · Directly over areas with open wounds, unless covered
with a clear protective barrier · Treatment over sympathetic ganglia · For symptomatic local pain relief unless etiology
is established or unless a pain syndrome has been diagnosed · On patients suspected of carrying serious infectious disease and/or disease where it is advisable, for general medical purposes, to suppress heat or fevers · Over or near bone growth centers until bone growth is complete · Over the thoracic area if the patient 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 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 Precautions
Additional precaution should be used when the Laser is used on patients with the following conditions:
· Over an area of the spinal cord following a laminectomy, i.e., when major covering tissues have been removed
· Over anesthetic areas · On patients with hemorrhagic diatheses
Preventing Adverse Effects
Perform the following procedures to avoid the negative effects of Laser therapy:
· Inspect the treatment area during and following treatment, and discontinue if an adverse reaction does occur.
· 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.
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

10

Vectra® Neo Clinical Therapy System

PRODUCT DESCRIPTION

The Vectra® Neo Clinical Therapy System is a modular system used with or without an optional Cart, allowing for the inclusion of Channel 1/2 Electrotherapy module with or without sEMG, Channel 3/4 Electrotherapy module, Laser module, and Ultrasound module.
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 to be used only under the prescription and supervision of a licensed medical practitioner.

DEVICE DESCRIPTION

11

DEVICE DESCRIPTION

OPERATOR INTERFACE
The Vectra® Neo Clinical Therapy System Operator Interface contains all the functions and controls necessary for operator access to all operator utilities, modalities, and parameters for modification and system set up.

Front Controls

1. Color Display 2. Intensity Dial (Gray outer ring) 3. Start/Pause button 4. Stop button 5. ON/OFF switch 6. Ultrasound Applicator holder, left and right sides 7. Laser Applicator holder, left and right sides 8. Patient Remote/Laser Interrupt Switch 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
Side Holders

4
Rear Access Panel 12
11

Vectra® Neo Clinical Therapy System
1 2 3
5 6,7

10 8
6,7

45º

13

90º 14

15

16

9

12

Vectra® Neo Clinical Therapy System

GENERAL WARNINGS AND PRECAUTIONS

CAUTION
· Read, understand, and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any electrical stimulation, Laser device, or ultrasound device. Observe the precautionary and operational decals placed on the unit.
· All modalities should be routinely checked before each use to determine that all controls function normally, especially that the intensity control does properly adjust the intensity of the ultrasonic power output in a stable manner. Also, determine that the treatment time control does actually terminate ultrasonic power output when the timer reaches zero.
· DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel.
· This unit should be operated at 10°C to 45°C and 0% to 90% relative humidity. The unit should be transported and stored at 0°C to 60°C and 0% to 95% relative humidity.
· Handle Ultrasound Applicator and Laser Applicator with care. Inappropriate handling may adversely affect its characteristics.
· Before each use, inspect Ultrasound Applicator for cracks, which may allow the ingress of conductive fluid.
· Inspect Applicator cables and associated connectors before each use.
· Device is designed to comply with electromagnetic safety standards. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with 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 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 a different circuit from that to which the other device(s) are connected and consult the factory field service technician for help.
– Consult your authorized DJO dealer for help.
· Do not operate this unit when connected to any unit other than DJO devices or accessories specifically described in user or service manuals.
· Use of controls, adjustments or performance of procedures other than those specified herein may result in hazardous exposure to Laser energy.
· DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury.

CAUTION
· Failure to use and maintain the Vectra® Neo Clinical Therapy System, its modules, and its accessories in accordance with the instructions outlined in this manual will invalidate the warranty.
· DO NOT permit foreign materials, liquids, or cleaning agents (including, but not limited to, inflammables, water, and metallic objects) to enter the unit to prevent unit damage, malfunction, electrical shock, fire, or personal injury.
· If you have difficulty operating the unit after carefully reviewing this user manual, contact your DJO dealer for assistance.
· DO NOT remove the cover. Doing so 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 dealer for repair service.
· Use of parts or materials other than DJO’s can degrade minimum safety.
· The Vectra® Neo Clinical Therapy System 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.
· DO NOT operate the Vectra® Neo Clinical Therapy System within the vicinity or environment as any microware and RF shortwave diathermy system.
· DO NOT operate the Vectra® Neo Clinical Therapy System within the vicinity or environment as an ultrasonic diathermy system. The Ultrasound (diathermy) Module of the Vectra® Neo Clinical Therapy System does not require separation distance.
· DO NOT use electrodes with an active area less than 7.92 cm2, as there will be a risk of suffering a burn injury. Always exercise caution with current densities more than 2mA/cm2. Refer to the CURRENT DENSIT CALCULATIONS FOR DJO ELECTRODES table in Appendix 3.

13

GENERAL WARNINGS AND PRECAUTIONS

Vectra® Neo Clinical Therapy System

WARNING
· U.S.A. Federal Law restricts these devices to sale by, or on the order of, a physician or licensed practitioner. This device should be used only under the continued supervision of a physician or licensed practitioner.
· Be sure to read all instructions for operation before treating patient.
· Make certain the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes.
· Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it.
· The safety of TENS waveforms for use during pregnancy or birth has not been established.
· TENS is not effective for pain of central origin. (This includes headache.)
· TENS waveforms have no curative value.
· Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is in use.
· TENS is a symptomatic treatment, and as such, suppresses the sensation of pain which would otherwise serve as a protective mechanism.
· Inspect the plastic lens of the laser head for blemishes, deformation, pitting, scratches, discoloration, and cleanliness before each use.
· Do not drop the applicator or unit on hard surfaces or submerge in water. These actions 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 procedures other than those specified herein may result in hazardous exposure to Laser energy.
· This device should be kept out of the reach of children.
· Use of other accessories other than those specified in this User Manual may increase electrical emissions and decrease electrical immunity of the device.
· Contaminated sponges, electrodes, lead wires, and gel can lead to infection.
· Use of electrode with degraded hydrogel can result in burn to the skin.
· DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner.
· Use of electrode on multiple patients can lead to infection.
· Clean applicators after each use, otherwise it can lead to cross contamination and infection.
· When the Laser Module is not in use, it should be protected against unqualified use.

WARNING
· 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 laser on or over a tattoo.
· 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 no liquids enter into the laser head while cleaning. Do not use any chlorine-based cleaners on the laser head.
· The color of skin, age of lesion, depth of lesion, sensitivity of the patient, tissue type, and medications that increase sensitivity to light may affect therapy.
· Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.
· In the event of all 300-Level or a 200-Level error message that cannot be resolved, immediately stop all use of the system, and contact the dealer or DJO for service. Errors and Warnings in these categories indicate an internal problem with the system that must be tested by DJO or a Trained Technician before any further operation or use of the system.
– Use of a system that indicates an Error or Warning in these categories may pose a risk of injury to the patient, user, or extensive internal damage to the system.
· Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.
· Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the application of each mode of treatment.
· Disconnect the system from the power source before attempting any maintenance, installation, removal, or replacement procedures to prevent electrical shock and possible damage to system.
· Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns.

14

Vectra® Neo Clinical Therapy System

GENERAL WARNINGS AND PRECAUTIONS

WARNING
· The Vectra® Neo Clinical Therapy System may be susceptible to ElectroStatic Discharge (ESD) at greater than ±4 kV when first grasping either the Ultrasound or Laser Applicator. In the event of such a discharge, the Vectra® Neo Clinical Therapy System may experience communication loss with the installed modules. The Vectra® Neo Clinical Therapy System will terminate all active outputs (stim, ultrasound, laser), automatically place the unit in a safe state, and issue an error message 301 or 307.
– To recover from an error message 301 or 307, turn the unit off and on using the ON/OFF switch located at the top of the display. Once the system restarts, re-initiate all treatments that were interrupted.
· To prevent Electro-Static Discharge (ESD) at greater than ±4 kV:
– Grasp and hold the Ultrasound or Laser Applicator prior to starting treatment. If the applicator must be put down prior to completion of treatment, stop the current treatment first and then place the applicator 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.
· Long term effects of chronic electrical stimulation are unknown.
· Stimulation should not be applied over the anterior neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.
· Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmia.
· Stimulation should not be applied over swollen, infected, and inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
· Stimulation should not be applied over, or in proximity to, cancerous lesions.
· Electrotherapy output current density is related to electrode size. Improper application may result in patient injury. If any question arises as to the proper electrode size, consult a licensed practitioner prior to therapy session.
· The Vectra® Neo Clinical Therapy System optional modules and associated accessories are designed for use only with the Vectra® Neo Clinical Therapy System.
· Remove the Ultrasound or Laser Applicator by pulling the cable connector only. DO NOT remove by pulling the cable.

WARNING
· Output current density is related to electrode size. Improper application may result in patient injury. If any question arises as to the proper electrode size, consult a licensed practitioner prior to therapy session.
· Do not apply the Ultrasound Applicator to the patient during the Head Warming period. Applicator must remain in Applicator Hook during the Head Warming 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.
· Before each Laser use, clean the plastic lens with a clean cloth. 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.
· Medical electrical equipment needs special precautions regarding EMC. Portable and mobile RF communication equipment can be affected by other medical electrical devices. If you believe interference is occurring, please consult the ELECTROMAGNETIC COMPATIBILITY (EMC) section on page 73, to assist in removing the interference.
· Common RF emitting devices (e.g., RFID) and electromagnetic security systems (e.g., metal detectors) may interfere with the operation of the Vectra® Neo Clinical Therapy System. The Vectra® Neo Clinical Therapy System has been tested in the presence of these types of devices and while no adverse event occurred, the device should not be operated within the vicinity or environment as another RF emitting device.

15

GENERAL WARNINGS AND PRECAUTIONS
DANGER
· Stimulus delivered by the TENS waveforms of this device, in certain configurations, will deliver a charge of 25 microcoulombs (C) or greater per pulse and may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia.
· Patients with an implanted neurostimulation device must not be treated with or be in close proximity to any shortwave diathermy, therapeutic ultrasound 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.
· Handle, clean, and dispose of components and accessories that have come in contact with bodily fluids according to National, Local, and Facility rules, regulations, and procedures.
· 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 left 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 light). 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 laser protective eyewear.
· The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the unit is used.
· 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 DJO dealer if the unit is not properly rated.
· Laser protective eyewear should be worn during laser treatment by the operator and patient to block infrared light energy from the eyes during treatment.
· DO NOT point the Laser beam directly into human or animal eyes. The lens of the eye does not detect the invisible, coherent Laser beams, potentially resulting in permanent retinal damage.
· Device is not designed to be used in oxygen rich environment. Explosion hazard if the device is used in the presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.
16

Vectra® Neo Clinical Therapy System

Vectra® Neo Clinical Therapy System

DETAIL DEVICE DESCRIPTION

COMPONENTS
Throughout these instructions the terms “left” and “right” referring to the machine sides are from the perspective of a user standing in front of the unit.
The Vectra® Neo Clinical Therapy System allows installation of optional modality modules by the user. Specifically designed for use with the Vectra® Neo Clinical Therapy System, these modules configure the system to meet virtually every therapeutic need that a clinician may have. The components of the Vectra® Neo Clinical Therapy System are shown below.
NOTE: The 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

Modules · Stimulation Channel 1/2 · Stimulation Channel 1/2 + sEMG · Stimulation Channel 3/4 · Laser · Ultrasound
Lead Wires The available lead wires are shown below. If the user orders Stimulation Channel 1/2 module, the box will include the blue and green lead wires. Stimulation Channel 3/4 is the cranberry and orange lead wires. If both modules are ordered, the box contains all four colored lead wires. Stimulation modules channel 1/2 with sEMG includes blue and green sEMG lead wires.

Base

Lead Wire Holders

Cart

Powercord

17

DETAIL DEVICE DESCRIPTION MODULE SLOTS 1. Laser 2. Stimulation (1 & 2) / Stimulation (1 & 2) + sEMG 3. Ultrasound 4. Stimulation (3 & 4) ­ opposite side Side Module Slots ­ Left Side
1 2 3
Side Module Slots ­ Right Side
4
To remove module, take right side off face plate and push module from right side.

Vectra® Neo Clinical Therapy System
MODULE KIT CONTENTS
Electrotherapy Module Channels 1/2 ­ PN 70000
· 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)
Ultrasound 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 Wires · DURA-STICK® 2 in (5 cm) Round Disposable Electrodes
(2 packs of 4) · Faceplates (to cover module after inserted into main
unit)
Laser Module ­ PN 70005
· Laser module · Protective Eyewear, 2 Pair · Interlock · Patient Remote/Laser Interrupt Switch · Faceplates (to cover module after inserted into main
unit)

18

Vectra® Neo Clinical Therapy System

ULTRASOUND APPLICATOR

1. Applicator Head

The component of the applicator that makes

contact with the patient during Ultrasound or

1

Combination therapy.

2. Applicator The assembly that connects to the system and incorporates the Applicator.

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.
2

LASER APPLICATOR Aperture

Laser Diode

DETAIL DEVICE DESCRIPTION 3

Laser Head

LED’s/SLD’s

Pause/Resume Button

Laser Head

LED Indicator (Output Power) LED Indicator (Output Power) This orange light illuminates when Laser energy is being distributed by the applicator.
19

DETAIL DEVICE DESCRIPTION

PATIENT REMOTE/LASER INTERRUPT SWITCH
The Vectra® Neo Patient Remote/Laser Interrupt Switch buttons are described in the table below. By default, the remote is not assigned to any treatment. When assigned, the buttons function as follows:

STOP M

Increase Intensity (1) Decrease Intensity (2) STOP/Pause Treatment (3) Manual Stimulation (4)

Increase Intensity (1) (Electrical Stimulation Treatments Only) – Increases 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.
Decrease Intensity (2) (Electrical Stimulation Treatments 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 mode on the base unit (head). This mode is clinician monitored and is not for use when the patient is unattended. Button is not active and has no function for Ultrasound or Laser treatments.

Stop (3) Increase (1) Decrease (2) Manual (4)

Vectra® Neo Clinical Therapy System

20

Vectra® Neo Clinical Therapy System
HEAD TO CART ASSEMBLY
The optional Therapy System Cart, PN 70001, is designed for use with the Vectra® Neo Clinical Therapy System only and allows the user to easily transport the System from patient to patient within the clinic as well as store all necessary accessories, 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 the drawer
open. Press the plastic tabs on both drawer slides simultaneously in opposite directions, as shown. Pull the drawer completely out.

SETUP INSTRUCTIONS 3. Place the Neo Head on the cart facing toward the
drawers.
4. Fasten the Neo Head to the cart using four screws to connect the base to the Neo Head.

2. Remove the base from the head unit prior to placing it on the cart. Do this by removing the four screws from the underside of the base where they secure to the Neo Head. Retain for use when attaching the Neo Head to the Cart.

5. If desired, replace the closed Handles with the open Handles. Each Handle is attached with four screws as shown.

6. Reinstall the drawer. 21

SETUP INSTRUCTIONS

Vectra® Neo Clinical Therapy System

NEO LEG TO CART ASSEMBLY/ADJUSTMENT
The Neo Cart is shipped without the legs attached.
Tools Required:
· 3/16″ Hex Key Wrench (provided) · Flat Washer ¼” Internal diameter, quantity 6 (provided) · Socket Head Cap Screw ¼-20 x 1-1/4″, quantity 6
(provided)
To install or adjust the leg assemblies onto the Neo Cart, follow these steps:
1. Remove the bottom drawer from the Cart. Pull the drawer open. Press 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 secure the legs.
NOTE: To adjust height at a later time, simply remove the Allen-style bolts, re-position the legs, and re-insert the bolts.

3. Reinstall the Bottom Drawer. 22

Vectra® Neo Clinical Therapy System
MODULE INSTALLATION
All modules are installed from the left side (when facing the screen) of the Neo Head unit and are each installed in the same manner. Each has color-coded lead wires that correspond to the appropriate colored labeling on the modules. Module-specific installation instructions are shown after the generic instructions. To install the modules in the Vectra® Neo Clinical Therapy System, follow the steps shown.
Tools required (not included): #2 Phillips screwdriver and standard slotted screwdriver.
The System is programmed to automatically recognize the new Module(s), therefore, no software installation is required.

SETUP INSTRUCTIONS
3. Insert a standard slotted screwdriver (not provided) into the top slot, pressing down with slight pressure. Pull the faceplate off (in this example showing Electrotherapy Channel 3/4).

Laser

Ultrasound

4. The module is inserted on the left side of the Neo Head in the slot as shown in this example (with the Ultrasound module).

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.)

5. Carefully insert the module into the slot, with 32 pins (2×16) in first. Secure the module in place with gentle pressure until you feel the module is seated.

23

SETUP INSTRUCTIONS
MODULE INSTALLATION (CONTINUED) 6. Secure the module with a screw provided at the
bottom as shown (using channel 3/4 as example).

Vectra® Neo Clinical Therapy System
MODULE-SPECIFIC INFORMATION Ultrasound Cable Insertion Shown below is the Ultrasound Cable Insertion location.

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.)

INSERTING PLUGS
When inserting the plugs for the Ultrasound and Laser modules, be sure to align the flat side of the plug with the flat side of the slot and push in gently. This is to avoid bending the pins in the plug

8. Plug in the unit and press the power button. Allow the unit to initialize, and then verify that the newly installed module is shown as available on the Home screen.

Flat side of plug Flat side of slot

24

Vectra® Neo Clinical Therapy System
PATIENT REMOTE/LASER INTERRUPT SWITCH INSTALLATION To operate the Patient Remote/Laser Interrupt Switch, plug the remote into the device on the Rear Access Panel receptacle, as shown below:

SETUP INSTRUCTIONS
2. Press the Remote ON/OFF toggle icon to assign or unassign the remote to the selected treatment. The remote can be assigned to only one treatment at a time, however the remote can be reassigned as needed. When not in use, the Patient Remote/Laser Interrupt Switch can be stored by hooking it onto the lead wire holder clips in the same manner as lead wires and cables (shown below).

CAUTION
· Patient Remote/Laser Interrupt Switch is to be used under supervision of a physician or licensed practitioner only.
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).

25

SETUP INSTRUCTIONS
INSTALLING THE LASER INTERLOCK (DOOR INTERRUPT SWITCH)
The Laser Interlock is an optional safety device designed to interrupt Laser therapy if the door to the therapy room is opened. The Laser Interlock Kit consists of a switch 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 the Vectra® Neo Clinical Therapy System with Laser module.
Laser Interlock monitors the state of the door(s) of the therapy room and only allows start of Laser treatment if all of the doors are closed.
If any door is open, it will not allow user to start the Laser treatment; and if treatment is already started and someone opens the door, it interrupts the system to stop the Laser treatment.
WARNING
· Disconnect the system from the power source before attempting any maintenance, installation, removal, or replacement procedures to prevent electrical shock and possible damage to system.
· 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.

Vectra® Neo Clinical Therapy System Diagram for Therapy Room with One Door
Diagram for Therapy Room with Multiple Doors

26

Vectra® Neo Clinical Therapy System
THERAPY SYSTEM START-UP
Complete the following steps for initial setup of the Vectra® Neo Clinical Therapy System: 1. Plug 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.

SETUP INSTRUCTIONS
3. Select desired function on the Home screen (shown below).

2. Press the Power button located on the top left portion of the LCD casing (shown below):

27

SYSTEM SPECIFICATIONS

SYSTEM SPECIFICATIONS AND DIMENSIONS

Module Head @ 45 degree with Base (Tabletop) Cart Lowered (with casters) Cart Raised (with casters) Head and raised cart with screen @ 90deg

Width 11.12″ (28.2448 cm) 15.89″ (40.3606 cm) 23.94″ (60.8076 cm) 23.94″ (60.8076 cm) 23.94″ (60.8076 cm)

Depth 6.34″ (16.1036 cm) 15.89″ (40.3606 cm) 26.19″ (66.5226 cm) 26.19″ (66.5226 cm) 26.19″ (66.5226 cm)

Vectra® Neo Clinical Therapy System

Height 1.43″ (3.6322 cm) 22.05″ (56.007 cm) 27.41″ (69.6214 cm) 30.15″ (76.581 cm) 52.85″ (134.239 cm)

Weight 1lb (0.453592 kg) 20.7lb (9.389362 kg)
29.4lb (13.33562 kg)
48.9lb (22.18067 kg)

POWER (COMBINATION AND ELECTROTHERAPY UNITS)
Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 – 240 V AC, 2.5A to 1.25A, 50/60 Hz Electrical Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CLASS I Mode of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous
Electrical Type (Degree of Protection)
Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .TYPE B
Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .TYPE B
Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .TYPE BF
Electrotherapy & sEMG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .TYPE BF
Ultrasound & Electrotherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .TYPE B
NOTE: All waveforms except High Voltage Pulsed Current (HVPC) have been designed with a 200 mA current limit. VMSTM, VMSTM Burst ,and all TENS waveform output intensities are measured, specified, and listed to peak, not peak to peak.

GENERAL SYSTEM OPERATING AND STORAGE TEMPERATURE
Operating Conditions
The device will meet its requirement under the following conditions: Temperature: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10° C to 45° C Relative Humidity: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0% to 90% Atmospheric Pressure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 700hPa to 1060hPa
Transport and Storage Conditions
The device will remain in proper condition under the following conditions: Temperature: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Above 0° C freezing to +60°C Relative Humidity: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . max 95% Atmospheric Pressure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 700hPa to 1060hPa

28

Vectra® Neo Clinical Therapy System
ULTRASOUND SPECIFICATIONS
Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 MHz, ±5%; 3.3 Mhz, ±5% Duty Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10%, 20%, 50%, Continuous Pulse Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Hz ±20% Pulse Duration . . . . . . . . . . . . . . . . . .1mSec,±20%;2mSec,±20%;5mSec,±20%
Output Power
10 cm2 Crystal. . . . . . . . . . . . . . . . . . . . . . . 0-15 W at 1 MHz, 0-10 W at 3.3 MHz 5 cm2 Crystal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-6W @ 1 and 3.3 MHz 2 cm2 Crystal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-3 W @ 1 and 3.3 MHz 1 cm2 Crystal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-1.5 W @ 3.3 MHz

SYSTEM SPECIFICATIONS
ULTRASOUND SPATIAL PATTERN
The following charts represent the distribution of the ultrasonic radiation field and the orientation of the field with respect to each applicator (Y-plane represents voltage in Vrms and X-plane represents applicator head surface in 1mm resolution).
1 cm2 Crystal (model 27333)

Amplitude. . . . . . . . . . . . . . . . . . .0-2.5 W/cm2 in continuous and pulsed modes Output accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ±20%, 10% of maximum Temporal Peak to Average Ratio: . . . . . . . . . . . . . 2:1, ±20%, at 50% Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:1, ±20%, at 20% Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:1, ±20%, at 10% Duty Cycle Beam Nonuniformity Ratio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:1 maximum Beam Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Collimating IPXX Rating for Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IPX0 IPXX Rating for Applicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IPX7 Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 to 30 min

Effective Radiating Areas (ERA)

ERA High

ERA Low

Description ERA (cm2) cm2

%

cm2

%

10 cm2 Crystal 8.5

10

+18% 7

-18%

5 cm2 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 Head Warming feature of an Vectra® Neo Clinical Therapy System utilizes Ultrasound output, resulting in warming of the Applicator to increase patient comfort.
With Head Warming enabled, ultrasound is emitted without pressing the Start button while an ultrasound treatment is being set up. The Applicator LED will not illuminate during the Head Warming period. US Channel will indicate “Head Warming”.
Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-50% Cycling of maximum power Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 Mhz Applicator Temperature. . . . . . . . . . . . . . . . . . . 29.4 °C – 43.3 °C (85 °F – 110 °F)

2 cm2 Crystal (model 27334) 5 cm2 Crystal (model 27335) 10cm2 Crystal (model 27336)

29

SYSTEM SPECIFICATIONS
LASER SPECIFICATIONS
Power
Output Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

Vectra® Neo Clinical Therapy System

30

Vectra® Neo Clinical Therapy System

SYSTEM SPECIFICATIONS

LASER APPLICATOR TECHNICAL 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 software incorporates a cooling function that forces the user to cool the laser cluster 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 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.

Model # 27799 27802 27803

Description
Single 670nm
LED
33-Diode cluster Laser/LED
Single 850nm Laser

Diode Type

Wavelength(s) (nm)

Output Power (mW)

LED

670

10

670 nm (10mW) LED x12

GaAIAs LED

880 nm (25mW) LED x8 950 nm (15mW) LED x8

690

850 nm (50mW) Laser x5

GaAIAs

850

40

Single

27804

850nm

GaAIAs

850

150

Laser

Single

27805

820nm

GaAIAs

820

300

Laser

27807

33-Diode cluster Laser/LED

GaAIAs LED

670 nm (10mW) LED x12 880 nm (25mW) LED x8 950 nm (15mW) LED x8 850 nm (100mW) Laser x5

940

27808

33-Diode cluster Laser/LED

670 nm (10mW) LED x12

GaAIAs LED

880 nm (25mW) LED x8 950 nm (15mW) LED x8

1440

850 nm (200mW) Laser x5

27809

33-Diode cluster LED

670 nm (10mW) LED x12

LED

880 nm (25mW) LED x13 950 nm (15mW) LED x8

565

Power Density (W/cm2)

Treatment Area (Spot Size) (cm2)

Nominal Ocular Hazard Distance (NOHD-in meters)

Divergence a1 (rad)

0.012

0.785

0.386

0.698

0.022

31.2

3.110

0.097

0.05

0.785

2.488

0.097

0.191

0.785

8.800

0.097

0.382

0.785

15.240

0.097

0.03

31.2

6.221

0.097

0.045

31.2

12.443

0.097

0.018

31.2

0.386

0.698

Divergence a1 (rad) N/A
0.543
0.543
0.543
0.543
0.543
0.543
N/A

31

SYSTEM SPECIFICATIONS LASER APPLICATOR TECHNICAL SPECIFICATIONS (CONTINUED)

Vectra® Neo Clinical Therapy System

Model #

Description

Diode Type

Wavelength(s) (nm)

Output Power (mW)

27810

9-Diode cluster Laser/LED

GaAIAs 670 nm (10mW) LED x4 LED 850 nm (50mW) Laser x5

290

27811

9-Diode cluster Laser/LED

GaAIAs 670 nm (10mW) LED x4 LED 850 nm (100mW) Laser x5

540

27812

9-Diode cluster Laser/LED

GaAIAs 670 nm (10mW) LED x4 LED 850 nm (200mW) Laser x5

1040

27813

13-Diode cluster Laser/LED

GaAIAs LED

670 nm (10mW) LED x7 950 nm (15mW) LED x3 850 nm (50mW) Laser x3

265

27814

13-Diode cluster Laser/LED

GaAIAs LED

670 nm (10mW) LED x7 950 nm (15mW) LED x3 850 nm (100mW) Laser x3

415

27815

19-Diode cluster Laser/LED

GaAIAs LED

670 nm (10mW) LED x6 880 nm (25mW) LED x7 950 nm (15mW) LED x6

325

27816

13-Diode cluster Laser/LED

GaAIAs LED

670 nm (10mW) LED x7 950 nm (15mW) LED x3 850 nm (200mW) Laser x3

715

Single

27840

850nm

GaAIAs

850

100

Laser

Single

27841

85 nm

GaAIAs

850

200

Laser

Power Density (W/cm2)

Treatment Area (Spot Size) (cm2)

Nominal Ocular Hazard Distance (NOHD-in meters)

Divergence a1 (rad)

0.038

7.55

3.110

0.097

0.071

7.55

6.221

0.097

0.137

7.55

12.443

0.097

0.035

7.55

3.110

0.097

0.054

7.55

6.221

0.097

0.043

7.55

0.386

0.698

0.094

7.55

12.443

0.097

0.127

0.785

6.221

0.097

0.254

0.785

12.440

0.097

Divergence a1 (rad)
0.543 0.543 0.543 0.543 0.543 N/A 0.543 0.543 0.543

32

Vectra® Neo Clinical Therapy System

SYSTEM SPECIFICATIONS

LASER PROTECTIVE EYEWEAR SPECIFICATIONS
The graph below illustrates optical density 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

33

SYSTEM SPECIFICATIONS
LASER LABELS
This serial decal label is affixed at the rear of the system.

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

The device is labeled with the date of manufacture.

DJO, LLC 1430 Decision Street Vista, CA 92081 USA
Rx Only

Vectra® Neo Clinical Therapy System
13-7687-5_C

The Laser Applicator handle label includes important safety information.
The LED Applicator handle label includes important safety information.

34

Vectra® Neo Clinical Therapy System
WAVEFORMS
For additional information on Waveforms and output energy, refer to APPENDIX 3 on page 78.
CC: Constant Current CV: Constant Voltage
IFC (Interferential) Traditional (4 Pole)
Interferential Current is a medium frequency waveform. Current is distributed through two channels (four electrodes). The currents cross each other in the body at the area requiring treatment. The two currents interfere with each other at this crossing point, resulting in a modulation of the intensity (the current intensity increases and decreases at a regular frequency).
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Carrier Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2000-10,000 Hz Beat Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 Hz Sweep Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 sec Sweep Low Beat Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 Hz Sweep High Beat Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 Hz Scan Percentage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Static, 40%, 100%, Manual Amplitude. . . . . . . . . . . . . . . . . . . . 0-100 mA (CC with carrier freq 5000 kHz) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-90 mA (CC with carrier freq > 5000 kHz) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-64 V (CC with carrier freq 5000 kHz) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-45 V (CC with carrier freq > 5000 kHz) Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-60 Minutes Available on Channel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1&2, 3&4 Option Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV
TENS- Symmetrical Biphasic
The Symmetrical Biphasic waveform has a short pulse duration and is capable of strong stimulation of nerve fibers in the skin and in muscle. This waveform is often used in portable muscle stimulation units, and some TENS devices.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-80 mA (CC) 0-80 V (CV) Phase Duration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-1,000 sec Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-250 Hz Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV Burst Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-31 bps Frequency Modulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-250 Hz Amplitude Modulation . . . . . . . . . . . . . . . . . . . .Off, 40%, 60%, 80%, and 100% Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 min Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-5 sec

SYSTEM SPECIFICATIONS
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 in TENS devices.Because of its short pulse, the patient typically tolerates the current well, even at relatively high intensities.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-110 mA (CC) 0-110 V (CV) Phase Duration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-1,000 sec Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-250 Hz Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV Burst Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-31 Hz Frequency Modulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-250 Hz Amplitude Modulation . . . . . . . . . . . . . . . . . . . .Off, 40%, 60%, 80%, and 100% Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 minutes Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-5 sec
TENS – HAN
The HAN Waveform provides optimal parameters with a precisely controlled sequence of Dense-and-Disperse (DD) modes of stimulation where 2 Hz is alternating with 15 or 70 Hz, each lasting for 3 seconds..
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-100 mA Phase Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .180 sec Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC Burst Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-2 Hz Frequency Modulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Hz Cycle Time . . Burst of 8 pulses at 80 Hz(at a frequency of 2 Hz) for 3 seconds to . . . . . . . . . . . . . . . . . . . . . . .80 Hz continuous (no burst) for 3 seconds, repeated Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 min Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4
DANGER
· Stimulus delivered by the TENS waveforms of this device, in certain configurations, will deliver a charge of 25 microcoulombs (C) or greater per pulse and may be sufficient to cause electrocution. Electrical current of this magnitude must not flow through the thorax because it may cause a cardiac arrhythmia.

35

SYSTEM SPECIFICATIONS WAVEFORMS (CONTINUED)

Vectra® Neo Clinical Therapy System

VMSTM
VMSTM is a symmetrical biphasic waveform with a 100 sec interphase interval. Because the pulse is relatively short, the waveform has a low skin load, making it suitable for applications requiring high intensities, such as in muscle strengthening protocols.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-200 mA (CC) 0-200 V (CV) Channel Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .Single, Reciprocal, Co- Contract Phase Duration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-1,000 sec Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV Anti-Fatigue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Off or On Set Intensity . . . . . . . . . . . . . . . . . . . . . . .Individual Channel Intensity Setting in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reciprocal and Co- Contract modes Cycle Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous or User Defined Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 pps Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-5 sec Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 min Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4

VMSTM FR
The VMSTM FR version of the VMS TM 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 sec interphase interval. Because the pulse is relatively short, the waveform has a low skin load, making it suitable for applications requiring high intensities, such as in muscle strengthening protocols.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-150 mA (CC) 0-150 V (CV) Burst Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .200 – 5000 ms Phase Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20-400 sec Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV Channel Intensity. . . . . . . . . . . . . Setting in Reciprocal and Co- Contract modes Cycle Time . . . . . . . . . . . . . . . Continuous, 5/5, 4/12,10/10, 10/20, 10/30, 10/50 Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-80 pps Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 min Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1&2, 3&4

VMSTM Burst
VMS TM Burst is a symmetrical biphasic waveform delivered in a burst format. Because the pulse is relatively short, the waveform has a low skin load, making it suitable for applications requiring high intensities, such as muscle strengthening protocols.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-200 mA (CC) 0-200 V (CV) Channel Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .Single, Reciprocal, Co- Contract Phase Duration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20-700 sec Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV Anti-Fatigue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Off or On Set Intensity . . . . . . . . . . . . . . . . . . . . . . .Individual Channel Intensity Setting in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reciprocal and Co- Contract modes Cycle Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous or User Defined Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 bps Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-5 sec Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 min Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4

IFC Premodulated (Traditional 2 Pole)
Premodulated Current is a medium frequency waveform. Current comes out of one channel (two electrodes). The current intensity is modulated: it increases and decreases at a regular frequency (the Amplitude Modulation Frequency).
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-100 mA (CC) 0-96 V (CV) (with Carrier Frequency 5,000 kHz) . . . . . . . . . . . .0-100 mA (CC) 0-68 V (CV) (with Carrier Frequency > 5,000 kHz) Carrier Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2,000-10,000 Hz Beat Fixed (Sweep Off) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 Hz Sweep Low Beat Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-200 Hz Sweep High Beat Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-200 Hz Cycle Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous or User Defined Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 Min Available on Channel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4

36

Vectra® Neo Clinical Therapy System
WAVEFORMS (CONTINUED)

SYSTEM SPECIFICATIONS

DC (Direct Current)
DC Current is a direct current flowing in one direction only. The current can be continuous or interrupted.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-72 mA Polarity Reversal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . On or Off . . . . . . . . . . . . With Polarity Reversal On, Polarity will change every 5 minutes. Cycle Time . . . . . . . . . . . . . . .Continuous, 5/5, 4/12, 10/10, 10/20, 10/30, 10/50 Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 min Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4
Russian
Russian Current is a sinusoidal waveform, delivered in bursts or series of pulses. This method was claimed by its author (Kots) to produce maximal muscle strengthening effects without significant discomfort to the patient.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-100 mA (CC) 0-90 V (CV) Channel Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . .Single, Reciprocal, Co- Contract Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10%, 20%, 30%, 40%, 50% Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC or CV Anti- Fatigue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Off or On Cycle Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous or User Defined Carrier Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2,500 Hz Burst Frequency (Anti-Fatigue Off) . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-100 bps Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-5 sec Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 min Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4

High Voltage Pulsed Current (HVPC)
The High Voltage 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-500 V Polarity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Positive or Negative Ramp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5-5 sec Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Peak Current or Volts Sweep High Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20-120 pps Sweep Low Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-110 pps Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-120 pps Cycle Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Continuous or User Defined Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 Min Available on Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4 Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CV
Microcurrent
Microcurrent is a monophasic waveform of very low intensity. The physiological working mechanism of this effect is as yet not clearly understood. It is thought to stimulate tissue healing by stimulating the`current of injury’, a current which naturally occurs in healing tissue.
Output Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrodes Output Intensity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-1,000 A Polarity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Positive, Negative, or Alternating Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 Min Available on channels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 3, or 4 Duty Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50% Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.1-1,000 Hz Mode Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CC

37

PATIENT PREPARATION

Vectra® Neo Clinical Therapy System

ELECTRODE PLACEMENT
· Examine the skin for any wounds and clean the skin. · Apply the electrodes to the treatment area. · Ensure the electrodes are applied securely to the skin. · Ensure 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 manufacturer instructions. · DO NOT use electrodes with an active area less than 7.92 cm2, as there will be a risk of suffering a burn injury. Always exercise caution with current densities more than 2mA/cm2. Refer to CURRENT DENSITY CALCULATIONS FOR DJO ELECTRODES table in Appendix 3.

ELECTROTHERAPY PATIENT PREPARATION
DURA-STICK® Electrode Instructions
Connecting Lead Wires
1. Insert the lead with the Red (+) electrode connector into one DURA-STICK® Electrode.
2. Insert the lead with the Black (-) electrode connector into the other electrode.
3. Make certain the lead wires are seated completely into the electrodes. NOTE: Use of conductive medium or sponges is not required or recommended. DURA-STICK® Electrodes are manufactured to ensure the optimum conductivity during therapy when properly applied.

DURA-STICK® ELECTRODES
DURA-STICK® Electrodes are a self adhesive, disposable product designed specifically for use with Vectra® Neo Clinical Therapy System.
It is recommended that DURA-STICK® Electrodes be used whenever possible to ensure the highest level of contact with the treatment area and most uniform delivery of the prescribed electrotherapy treatment.

Securing Electrodes
1. Remove the DURA-STICK® Electrodes from the protective backing.
2. Apply to the treatment area as prescribed.
3. Ensure the entire electrode surface is in contact with patient skin by pressing into place.

For ELECTROTHERAPY OPERATION, refer to page 48. 38

Vectra® Neo Clinical Therapy System
SEMG & STIM PATIENT PREPARATION
Install DURA-STICK® Electrodes 1. Connect a DURA-STICK® 2 in (5 cm) disposable
electrode to each lead. These electrodes are designed for use with DJO equipment and will provide an accurate reading of sEMG activity. Active (Red) Lead, Active (Black) Lead, and Reference (Green) Lead are shown below.

PATIENT PREPARATION
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 treat. 5. View the electrode placement(s) for desired body area
and press the Up and Down icons to scroll through text relating to specific electrode placement and typical conditions of the area.

2. Leave protective backing on electrodes until treatment area has been prepared.
Electrode Placement by Body Area 1. From the Home screen, select sEMG. 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

6. Press the Back Arrow icon to return to desired screen. 7. Examine the skin for any wounds.

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PATIENT PREPARATION

Vectra® Neo Clinical Therapy System

sEMG & STIM PATIENT PREPARATION (CONTINUED)

8. Thoroughly cleanse the skin treating area.

3. Review the specific Electrode Placement graphic for positioning of the Reference (green lead) electrode.

NOTE: Thorough and proper cleaning of the treatment area to remove any topical medication and cream film as well as loose skin particles from the treatment area is critical to the skin contact and reception of the Electrodes during 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 activity during sEMG and sEMG + Stim therapy.
· The Active electrodes may be placed farther apart to obtain a general reading of a muscle or muscle group activity during the session.
· DJO recommends using only DURA-STICK® electrodes to obtain the most accurate sEMG feedback.
· Follow the electrode manufacturer instructions.
· Trimming or cutting electrodes may interfere with the reception of sEMG data and may affect the delivery of electrical stimulation in the sEMG + Stim Modality.

NOTE: The electrodes may be placed for specific, general, and quasi-specific biofeedback muscle or muscle group activity.
For sEMG and sEMG + Electrical Stimulation operation, refer to page 55.

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Vectra® Neo Clinical Therapy System
LASER PATIENT PREPARATION
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 preparing the patient’s skin for Laser therapy, you will allow more Laser energy to reach the targeted areas and reduce the risk of skin irritation.
To prepare the patient’s skin for Laser 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.
For LASER OPERATION, refer to page 56.

PATIENT PREPARATION
ULTRASOUND PATIENT PREPARATION
1. Examine the skin for any wounds and clean the skin. 2. View the Applicator recommendation in the
treatment. 3. Review screen for Ultrasound (as a reference point
only) prior to administering treatment. NOTE: Applicators are available in the sizes shown below:
1 cm2 2 cm2 5 cm2 10 cm2 Applicator Preparation and Use 1. Clean applicator before each therapy session with
warm soapy water. 2. Liberally apply ConductorTM Transmission Gel to the
treatment area on the patient. · Move the Applicator during therapy session in a
circular motion. The area treated should be twice the diameter 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.

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DEVICE USER INTERFACE

SCREEN DESCRIPTION
Each screen contains the following areas:
Title Bar
Located at the top of each screen and lists the current screen and previous screens back to the Home screen. It also contains a Print Screen icon at the top right, Patient Remote/Laser Interrupt Switch, when installed, and a USB connectivity icon when a USB flash drive is inserted.
Main Area · Located under the Title bar, this area displays icons unique to the current screen. · All screens (except the Home screen) will contain the Back Arrow icon to scroll to the previous screen and the Home icon to return to the Home screen.
Channel Area
Located at the bottom of 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

Vectra® Neo Clinical Therapy System
· 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 treatment for the channel is currently paused
· Completed: Indicates a treatment for the channel has completed
· No applicator: Indicates there is not a valid applicator plugged into the channel’s module (only valid for Ultrasound and Laser)
Electrode Contact Quality Indicator
(Electrotherapy Channels Only)
Active Channels Indicator
The image below shows the Home screen with modality and resource icons.

Title Bar

Main Area Channels

Active Channels Indicator 42

Electrode Contact Quality Indicator

Vectra® Neo Clinical Therapy System
HOME SCREEN
The Vectra® Neo Clinical Therapy System Home screen provides 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

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234567

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DEVICE USER INTERFACE

43

DEVICE USER INTERFACE

Vectra® Neo Clinical Therapy System

UTILITIES AND OPTIONS The Utilities icon on the Home screen offers users the opportunity to set the following preferences::

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1. Print Screen Select the Printer icon in the top right corner to capture screen shots of current screen. Screen shots are saved to the USB flash drive plugged into the unit and are saved in Windows bitmap (.bmp) format. Note that a screen cannot be printed while a treatment is in process.
2. Volume Select the Volume icon to set desired audio volume. The volume range is 0% (off ) to 100% (loudest) and is measured in 20% increments. The default setting is 60%.
3. LCD Brightness Select the Brightness icon to set the brightness of the LCD screen. The brightness ranges from 50% (dimmest) to 100% (brightest) in 10% increments. The default setting is 100%.

4. US Coupling Select the US Coupling icon to set the functionality of an ultrasound treatment when unit detects that the ultrasound applicator is 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 will not beep, and channel area indicates “uncoupled” state.
· Beep: When applicator becomes uncoupled, treatment timer will continue to run, unit will beep, and channel area indicates “uncoupled” state.
· No Beep: When applicator becomes uncoupled, treatment timer will continue to run, unit will not beep, and channel area indicates “uncoupled” state.
NOTE: Ultrasound output will continue to be emitted in all US Coupling modes even if the applicator is uncoupled.

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Vectra® Neo Clinical Therapy System

DEVICE USER INTERFACE

UTILITIES AND OPTIONS (CONTINUED)
5. US Head Warming Select the US Head Warming icon to turn on or off the ultrasound warming feature during ultrasound treatment setup. The available choices are either On or Off. The default setting is Off.
6. E-Stim Contact Quality Select the E-Stim Contact Quality icon to turn on or off the electrotherapy contact quality monitoring function. The available choices are either On or Off. The default setting is On, and in the On position, the unit will monitor the contact quality of the electrodes on all waveforms, excluding High Voltage Pulsed Current (HVPC) and Microcurrent.
NOTE: If the impedance feedback exceeds 5000 ohms (tolerance ±20%) and the set intensity is 10 mA CC or 10 V CV, then the unit will display an information message and set the intensity to zero for all channels associated with this treatment.
7. Restore Default Unit Settings Select the Restore Default Unit Settings icon to reset all of the following settings back to their factory defaults:
· Volume
· LCD Brightness
· US Coupling
· US Head Warming
8. Restore Default Protocols Select the Restore Default Protocols icon to reset all protocols (factory, custom, and the 5 custom protocol shortcuts) to their factory defaults.
9. Display Unit Version Information Select the Display Unit Version Information icon to view the install status of each module. For all installed modules, the PCB information and the Software version for that module are displayed.
If a valid software upgrade USB flash drive is inserted into the unit, the version 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.

11. Import Protocols from USB Flash Drive Select the Import Protocols from USB Flash Drive icon to import all protocols from a valid USB flash drive. Any protocols with the same name as an existing unit protocol will be overwritten by the imported protocol, and any protocols of a different name on the unit will remain intact.
12. Date and Time Select the Date and Time icon to set the date and time on the unit.
13. Clinic Name Select the Clinic Name icon to enter the name of your clinic. The clinic displays on the Home screen and on the patient treatment reports saved to the USB flash drive. The following icons will perform the functions listed:
· Left: Moves the cursor to the left one space per instance pressed.
· Right: Moves the cursor to the right one space per instance pressed.
· Space: Inserts one space per instance pressed.
· Clear: Clears the entire entry.
· Delete: Once the cursor has been moved using the Left or Right icons, press the Delete icon to delete the character.
· Caps: Press the Caps icon to capitalize the letters or to make letters lowercase.
· Cancel: Press the Cancel icon to cancel the clinic name entry function and return to the Utilities screen.
· Accept: Press the Accept icon once entry of the clinic name is complete. The clinic name should now appear in the title bar area of the screen.

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DEVICE USER INTERFACE

Vectra® Neo Clinical Therapy System

TREATMENT SCREENS

The Vectra® Neo Clinical Therapy System Treatment screens for Electrotherapy and Ultrasound include the following information:

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1. Modality Description Icon Press the Modality Description Icon to view the text explaining the rationale for the modality associated with the specific Clinical Protocol selected.
2. Electrode Placement Icon Press the Electrode Placement Icon to view the specific electrode placement for the Clinical Protocol selected.
3. Home Icon Press the Home Icon to return to the Home screen at any time.
4. Back Arrow Icon Press the Back Arrow Icon to return to the previously viewed screen.
5. Remote Icon Press either Off/On to deactivate or activate the Remote 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 Scan on the Therapy Information Window.
9. Customize Icon Press the Customize icon to edit the Therapy information.
10. 4 Channel Icons This icon shows the modalities in use. Channels are automatically assigned to the next available channel. Manual selection is done by touching the desired channel.
11. Ultrasound Icon This icon shows the Ultrasound information when in use.
12. Laser Icon This icon shows the Laser module information when in use.
13. Remote Icon This is how the Remote Icon is viewed from the main screen.

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Vectra® Neo Clinical Therapy System

DEVICE USER INTERFACE

CPS (CLINICAL PROTOCOL SETUP)
The Vectra® Neo Clinical Therapy System has a Clinical Protocol Setup (CPS) icon that is a series of protocol presets where the Body Area, Clinical Indication, Pathological Condition, and Pathological Severity are selected by the user to assist in selecting the parameter setting. These Clinical Protocols are to be used only as guidelines. Each patient should be individually assessed to determine the appropriateness of the protocol parameters prior to use.
The following information gives general instructions to access, select, and set up Clinical Protocols. Each Clinical Protocol is set up and edited in the same basic manner.
1. Select CPS from the Home screen.
2. Touch the body part you wish to treat.

9. Overwrite a previously saved protocol by using the Up and Down arrows or Previous Page/Next Page icons to select the protocol to overwrite. Press the Save icon to save the overwritten icon.
10. Return to Home screen by pressing the Home icon. Press the Back arrow to scroll back one screen.

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 icon. 7. To save the customized protocol, press the Save icon. 8. Save a new protocol by pressing the Save as a New
Name icon and typing in a name for the protocol. Press the Save icon when finished.
47

DEVICE USER INTERFACE
ELECTROTHERAPY OPERATION
All waveforms in the Vectra® Neo Clinical Therapy System are set up and edited in the same basic fashion. The Vectra® Neo Clinical Therapy System has an Electrotherapy Icon with the following waveforms: IFC (Interferential) Traditional (4 Pole), TENS- Asymmetrical Biphasic, TENS- Symmetrical Biphasic, TENS HAN, High Voltage Pulsed Current (HVPC), VMSTM, VMSTMBurst, VMSTM FR, IFC Premodulated (Traditional 2 Pole), Russian, and Microcurrent.
Complete the following steps to begin Electrotherapy treatment:
1. Prepare patient and therapy system for Electrotherapy. Refer to the ELECTROTHERAPY PATIENT PREPARATION section on page 38 for electrode selection, preparing the patient, and securing electrodes.
2. Touch the screen to activate the system. Read and carefully follow the instructions on the screen.
3. From the Home screen, press the Electrotherapy icon.
4. Select desired waveform from the listing on the screen by pressing the appropriate icon. Refer to the SYSTEM SPECIFICATIONS section on page 28 for all waveform specifications for the Vectra® Neo Clinical Therapy System. The screen shown below will appear.

Vectra® Neo Clinical Therapy System
· 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 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 previous screen or the Home icon to return to the Home screen.
· To customize waveform settings shown in the list box, press the Customize icon located in the list box, and the screen shown below will appear. Make the desired changes and press the Back icon to return to the previous screen, the Home icon to return to the home screen, or the Save icon to save the customized settings. Refer to the CUSTOM PROTOCOLS section on page 59 for detailed instructions for saving customized settings.

· To set pain information for the treatment, press the Pain Information icon. At this screen, you can do the following:
– Map electrode placement by dragging the electrodes to their appropriate locations on the body and selecting either front, back, left, or right side.
– Map pain information by touching the body area in the list box.
– Edit pain scale information by pressing the Edit Pain Scale icon. Press the Up and Down arrows until pain is properly gauged. Press the Back Arrow icon to return to the previous screen or the Home icon to return to the Home screen.
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Vectra® Neo Clinical Therapy System
ELECTROTHERAPY OPERATION (CONTINUED)
5. If desired, connect optional Remote Control to device.
6. Use the Intensity dial to set therapy intensity:
· Clockwise – Increases Intensity · Counterclockwise – Decreases Intensity 7. Press the Start button to begin therapy, the Pause button to pause treatment, or the Stop button to terminate the treatment.
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 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 on customized settings.

DEVICE USER INTERFACE

49

DEVICE USER INTERFACE

Vectra® Neo Clinical Therapy System

SEQUENCING OPERATION
The Vectra® Neo Clinical Therapy System offers sequencing for special electrotherapy waveform treatment purposes and stores these protocols in the system memory for recall and use. Sequencing allows you to link up to 3 electrotherapy protocols together to encompass one treatment session. Each sequence can have up to 3 protocols. The Vectra® Neo Clinical Therapy System memory will accommodate up to 200 user-defined protocols, including all user protocols, sequences, and system default protocols. The Vectra® Neo Clinical Therapy System denotes default protocols with an asterisk (*) before the named sequence.
Complete the following steps to create and access customized sequences:
1. Press the Electrotherapy icon from the Home screen.
2. Press the Sequencing icon.
3. Select a sequence from the list box by pressing the Up and Down arrows to find the desired sequence and press the “” icon. The screen shown below will appear.

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 new sequence.
· Save the newly created sequence by pressing the Save icon and following the saving a treatment protocol instructions listed in the ELECTROTHERAPY OPERATION section on page 48.
5. Set the intensity for each protocol by using the Up and Down arrows for each sequence and press the Start button to begin treatment.
6. When treatment is 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 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 customized settings.

50

Vectra® Neo Clinical Therapy System
ULTRASOUND OPERATION
The Vectra® Neo Clinical Therapy System Ultrasound modality allows the user to select specific Applicator recommendations and edit treatment parameters for various syndromes requiring the use of ultrasound therapy. The following information gives general instructions for the setup of Ultrasound Therapy when selecting Ultrasound from the Home screen.
WARNING
· The Vectra® Neo Clinical Therapy System may be susceptible to Electrostatic Discharge (ESD) at greater than ±4 kV when first grasping either the Ultrasound or Laser Applicator. In the event of such a discharge, the Vectra® Neo Clinical Therapy System may experience communication loss with the installed modules. The Vectra® Neo Clinical Therapy System will terminate all active outputs (stim, ultrasound, laser), automatically place the unit in a safe state, and issue an error message 301 or 307.
– To recover from an error message 301 or 307, turn the unit off and on using the ON/OFF switch located at the top of the display. Once the system restarts, re-initiate all treatments that were interrupted.
· To prevent Electrostatic Discharge (ESD) at greater than ±4 kV:
– Grasp and hold the Ultrasound or Laser Applicator prior to starting treatment. If the applicator must be put down prior to completion of treatment, stop the current treatment first and then place the applicator 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.
NOTE: Prior to starting treatment, replace the ultrasound faceplate on the side of the module not being used with a blank faceplate.

DEVICE USER INTERFACE
Complete the following steps to begin Ultrasound treatment: 1. Touch the screen to activate the system. Read and
carefully follow the instructions on the screen. · To prepare the patient’s skin for Ultrasound Therapy,
prepare patient as described in the ULTRASOUND PATIENT PREPARATION section on page 41. 2. From the Home screen, select the Ultrasound icon. The screen shown below will appear:
· To view information explaining the modality, select 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 the Home icon to return to the Home screen.
· To view applicator information, press the Applicator Information icon: – Touch the body part you wish to treat. – Information about applicator sizes, frequency, and treatment directions will appear as seen on the screen above. Press the Down icon to scroll through the information. – Press the Back Arrow icon to return to the previous screen or the Home icon to return to the Home screen.
· Use the Intensity dial to set therapy intensity: – Clockwise ­ Increases Intensity – Counterclockwise ­ Decreases Intensity

51

DEVICE USER INTERFACE
ULTRASOUND OPERATION (CONTINUED)
3. Press the Start button to begin therapy, the Pause button to pause treatment, or the Stop button to terminate the treatment.
4. 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 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 customized settings.

Vectra® Neo Clinical Therapy System

52

Vectra® Neo Clinical Therapy System

COMBINATION OPERATION
The Vectra® Neo Clinical Therapy System Combination modality allows the user to select and use Ultrasound therapy in combination with electrical muscle stimulation.
Combination therapy utilizes the Ultrasound modality in conjunction with High Voltage Pulsed Current (HVPC), IFC (4 pole), IFC Premodulated (2 pole), Asymmetrical Biphasic, Symmetrical Biphasic, or VMSTM to generate a therapeutic effect. In this mode of therapy, the Applicator of the Ultrasound Applicator becomes one-half of the electrical circuit. An electrode attached to the Black (-) lead wire completes the circuit.
Complete the following steps to begin Combination treatment:
1. Touch the screen to activate the system. Read and carefully follow the instructions on the screen.
2. Prepare patient and therapy system. Refer to the PATIENT PREPARATION section on page 38 for electrode selection, preparing the patient, 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.

5. Select the ultrasound combination therapy desired, and press the corresponding icon. The Treatment Review screen shown below will appear:
· To view information explaining the waveform, select 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 the Home icon to return to the Home screen.
· To view the most commonly used electrode placement for the selected waveform, select 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 Arrow icon to return to the previous screen or the Home icon to return to the Home screen.

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DEVICE USER INTERFACE
COMBINATION OPERATION (CONTINUED)
· To customize settings shown in the list boxes, press the Customize icon located in the list box, and the screen shown below will appear.
Electrotherapy Customization Screen

Vectra® Neo Clinical Therapy System
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 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 customized setting.

Ultrasound Customization Screen

· Make the desired changes and press the Back Arrow icon to return to the previous screen, the Home icon to return to the home screen, or the Save icon to save the customized settings. Refer to the CUSTOM PROTOCOLS section on page 59 for detailed instructions for saving customized settings.
· To adjust treatment time, press the left or right arrows to reach desired treatment time.
· Use the Intensity dial to set therapy intensity: – Clockwise ­ Increases Intensity – Counterclockwise ­ Decreases Intensity
54

Vectra® Neo Clinical Therapy System

DEVICE USER INTERFACE

sEMG OPERATION
The Vectra® Neo Clinical Therapy System sEMG + Stim modality utilizes sEMG biofeedback activity coupled with triggered electrical muscle stimulation using selected electrotherapy waveforms for the maximum benefit in muscle retraining. The following options are available: sEMG (Channel 1), sEMG (Channel 2), sEMG (Channels 1 & 2), sEMG + Stim VMS, and sEMG + Stim Sym Biphasic.
The Electrical Muscle Stimulation is triggered when the muscle contraction (sEMG portion of the therapy) reaches the target, sEMG stops, and the muscle is then electrically stimulated for the pre-set period. After stimulation, the patient is given a short rest period and then repeats the muscle contraction, attempting to reach the target to again trigger the electrical stimulation. This is repeated throughout the therapy session.
Session parameters can be stored on a USB storage drive and accessed on the Home screen under the Patient Data icon. The sEMG portion of sEMG + Stim modality is used to force the patient to contract the muscle to a prescribed target. The data cannot be recorded or stored on the Patient Data Card or the sEMG Data Card.
NOTE: This section applies when Stimulation Channels and sEMG module is installed.
Complete the following steps to begin sEMG treatment:
1. Touch the screen to activate the system.
2. Prepare patient and therapy system. Refer 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 the CUSTOMIZE Icon.
· Use the Intensity dial to set therapy intensity: – Clockwise ­ Increases Intensity – Counterclockwise ­ Decreases Intensity
5. Press Start/Pause button.to begin therapy. Screen prompts willl appear: · Contract: Instructs the patient to attempt reaching the Target Threshold. “Contract” and a green vertical line appear on the screen, indicating the patient should attempt to contract the selected muscle(s). “Contract” remains on the screen until the patient’s sEMG output reaches the Target Threshold, at which time Electrical Stimulation is delivered. · Hold: Instructs the patient to contract the selected muscle(s). When the Target Threshold is reached, the “Hold” prompt appears, instructing the patient to continue to contract the selected muscle(s) until the pre-set time for the Stimulation ends. A yellow vertical line appears at the end of the Hold period. · Relax: Instructs the patient to relax. “Relax” appears, indicating the patient should relax, stopping the contraction. Relax continues for the pre-set time. The cycle repeats when “Contract” re-appears, again indicating the patient should attempt to contract the selected muscle(s).

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DEVICE USER INTERFACEsEMG OPERATION (CONTINUED)
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 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 Arrow icon to return to the previous screen or the Home icon to return to the Home screen.
NOTE:When using sEMG + Stim, the Customization screen adds two icons to edit Stimulation settings and to set the stimulation intensity.
· Use the Intensity dial to set therapy intensity:
– Clockwise – Increases Intensity – Counterclockwise – Decreases Intensity 7. Make the desired changes and press the Back Arrow icon to return to the previous screen and begin treatment, the Home icon to return to the home screen, or the Save icon to save the customized settings. Refer to the CUSTOM PROTOCOLS section on page 59 for detailed instructions for saving customized settings.
8. Press the Start button to begin therapy, the Pause button to pause treatment, or the Stop button to terminate the treatment.
9. 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 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 customized settings.

Vectra® Neo Clinical Therapy System
LASER OPERATION
Before applying Laser therapy to the patient, you must first prepare the patient’s skin as described in the PATIENT PREPARATION section on page 38. By properly preparing the patient’s skin for Laser therapy, you will allow more Laser energy to reach the targeted areas and reduce the risk of skin irritation.
DANGER
· Laser protective eyewear should be worn during laser treatment by the operator and patient to block infrared light energy from the eyes during treatment.
WARNING
· The Vectra® Neo Clinical Therapy System may be susceptible to Electrostatic Discharge (ESD) at greater than ±4 kV when first grasping either the Ultrasound or Laser Applicator. In the event of such a discharge, the Vectra® Neo Clinical Therapy System may experience communication loss with the installed modules. The Vectra® Neo Clinical Therapy System will terminate all active outputs (stim, ultrasound, laser), automatically place the unit in a safe state, and issue an error message 301 or 307.
· To recover from an error message 301 or 307, turn the unit off and on using the ON/OFF switch located at the top of the display. Once the system restarts, re-initiate all treatments that were interrupted.
· To prevent Electrostatic Discharge (ESD) at greater than ±4 kV:
· Grasp and hold the Ultrasound or Laser Applicator prior to starting treatment. If the applicator must be put down prior to completion of treatment, stop the current treatment first and then place the applicator 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.
**Refer to the TREATMENT TIPS section on page 71.
NOTE: Prior to starting treatment, replace the laser faceplate on the side of the module not being used with a blank faceplate.

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Vectra® Neo Clinical Therapy System
LASER OPERATION (CONTINUED)
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 clear the numbers entered · The Left and Right arrows to scroll through the
numbers entered · The Delete icon to delete numbers entered one at a
time 4. After successfully entering your PIN, the screen shown
below will appear:

DEVICE USER INTERFACE

· To customize settings shown in the list boxes, press the Customize icon located in the list box, and the screen shown below will appear.

· To view information explaining the modality, 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 the Home icon to return to the Home screen.
5. Verify that the Patient Remote/Laser Interrupt Switch is connected and provided to the patient.
· To view applicator information, press the Applicator Information icon:
– Touch the body part you wish to treat. – Information about applicator sizes, frequency,
and treatment directions will display. Press the Down icon to scroll through the information. – Press the Back Arrow icon to return to the previous screen or the Home icon to return to the Home screen.

– Make the desired changes and press the Back Arrow icon to return to the previous screen, the Home icon to return to the Home screen, or the Save icon to save the customized settings. Refer to the CUSTOM PROTOCOLS section on page 59 for detailed instructions for saving customized settings.
6. Use the Intensity dial to set therapy duration:
· Clockwise ­ Increases duration
· Counterclockwise ­ Decreases duration
7. Press the Start button to begin therapy, the Pause button to pause treatment, or the Stop button to terminate the treatment.
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 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 customized settings.

57

DEVICE USER INTERFACE
SAVING TO USB FLASH DRIVE/PATIENT DATA
Patient treatment data can be saved to the USB flash drive for viewing/printing on a PC, as well as for retrieving for later use on the unit or multiple units.
Complete the following steps to view and access patient data:
1. Press the Patient Data icon on the Home screen. The screen will display a list box of all previously saved patient data sessions found on the USB flash drive connected to the unit.
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 the “” icon.
3. Select the 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.

Vectra® Neo Clinical Therapy System
5. Choose one of the following options from the Treatment Summary screen: · Run 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 customized settings. · View the pain information by pressing the View Pain Information icon. · Save therapy information to USB flash drive by inserting a USB flash drive and pressing the Save Protocol icon.

58

Vectra® Neo Clinical Therapy System
CUSTOM PROTOCOLS
A new custom protocol may be saved at either the Treatment Edit or Treatment Complete screen. The Vectra® Neo Clinical Therapy System will allow a maximum of 200 custom protocols to be defined, and the Home screen will allow for 5 custom protocol shortcut assignments.
Complete the following steps to save a customized protocol created from a Treatment Summary screen: 1. Press the Save Protocol icon from either the Treatment
Edit or the Treatment Complete screen.

DEVICE USER INTERFACE
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 one screen at a time by pressing the Back Arrow icon. · Run the treatment again by pressing the Run this Treatment icon. · 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. · Clear the treatment from “Completed” to “Available” on the involved channel by pressing the Clear this Treatment icon. NOTE: The treatment protocol cannot be saved or run once Clear the Treatment is selected.

2. Save the new protocol by pressing the Save as a New Name icon and typing in a name for the protocol, or overwrite a currently saved protocol by scrolling 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.

59

DEVICE USER INTERFACE

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