Intelect Neo Clinical Therapy System User Manual Rev H Aug 2020

Intelect® Neo Clinical Therapy System

TABLE OF CONTENTS INTRODUCTION... 4 FOREWORD... 4 USER PROFILE... 4 PRECAUTIONARY INSTRUCTIONS... 4 GENERAL TERMINOLOGY... 5 SYSTEM SOFTWARE SYMBOLS... 5 DESCRIPTION OF DEVICE MARKINGS... 6 INDICATIONS FOR USE... 7 ELECTROTHERAPY INDICATIONS... 7 SEMG & STIM INDICATIONS... 9 ULTRASOUND INDICATIONS... 10 LASER INDICATIONS... 11 DEVICE DESCRIPTION... 12 PRODUCT DESCRIPTION... 12 OPERATOR INTERFACE... 13 GENERAL WARNINGS AND PRECAUTIONS... 14 CAUTION NOTICES... 14 WARNING NOTICES... 15 DANGER NOTICES... 17 DETAIL DEVICE DESCRIPTION... 18 COMPONENTS... 18 MODULE SLOTS... 19 MODULE KIT CONTENTS... 19 ULTRASOUND APPLICATOR... 20 LASER APPLICATOR... 20 PATIENT REMOTE/LASER INTERRUPT SWITCH... 21 SETUP INSTRUCTIONS... 22 HEAD TO CART ASSEMBLY... 22 NEO LEG TO CART ASSEMBLY/ADJUSTMENT... 23 MODULE INSTALLATION... 24 MODULE-SPECIFIC INFORMATION... 25 INSERTING PLUGS... 25 PATIENT REMOTE/LASER INTERRUPT SWITCH INSTALLATION... 26 INSTALLING THE LASER INTERLOCK (DOOR INTERRUPT SWITCH)... 27 THERAPY SYSTEM START-UP... 28 SYSTEM SPECIFICATIONS... 29 SYSTEM SPECIFICATIONS AND DIMENSIONS... 29 POWER (COMBINATION AND ELECTROTHERAPY UNITS)... 29 VACUUM SPECIFICATIONS... 29 GENERAL SYSTEM OPERATING AND STORAGE TEMPERATURE... 29 ULTRASOUND SPECIFICATIONS... 30

LASER SPECIFICATIONS... 30 LASER APPLICATOR TECHNICAL SPECIFICATIONS . 31 LASER PROTECTIVE EYEWEAR SPECIFICATIONS . . . 33 LASER LABELS... 34 WAVEFORMS... 35 ELECTRODE PLACEMENT... 40 DURA-STICK® ELECTRODES... 40 ELECTROTHERAPY PATIENT PREPARATION... 40 PATIENT PREPARATION... 41 VACUUM ELECTRODE PATIENT PREPARATION... 41 SEMG & STIM PATIENT PREPARATION... 43 LASER PATIENT PREPARATION... 45 ULTRASOUND PATIENT PREPARATION... 45 DEVICE USER INTERFACE... 46 SCREEN DESCRIPTION... 46 HOME SCREEN... 47 UTILITIES AND OPTIONS... 48 TREATMENT SCREENS... 50 CPS (CLINICAL PROTOCOL SETUP)... 51 ELECTROTHERAPY OPERATION... 52 VACUUM OPERATION... 54 SEQUENCING OPERATION... 55 STRENGTH/DURATION (S/D) CURVE... 56 ULTRASOUND OPERATION... 57 COMBINATION OPERATION... 59 sEMG OPERATION... 61 LASER OPERATION... 62 SAVING TO USB FLASH DRIVE/PATIENT DATA... 64 CUSTOM PROTOCOLS... 65 ANATOMICAL LIBRARY... 68 TROUBLESHOOTING... 69 TROUBLESHOOTING CODES... 69 ACCESSORIES... 72 REPLACEMENT ACCESSORIES... 72 MAINTENANCE... 75 CLEANING THE INTELECT® NEO CLINICAL THERAPY SYSTEM... 75 VACUUM MAINTENANCE... 75 CALIBRATION REQUIREMENTS... 75 DEVICE DISPOSAL... 75 FUSE INFORMATION... 76 INSTRUCTION FOR SOFTWARE UPGRADE... 76 COPY OF MANUAL... 76

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Intelect® Neo Clinical Therapy System

SERVICE AND WARRANTY... 77 WARRANTY REPAIR/OUT OF WARRANTY REPAIR . . . 77 WARRANTY... 78 APPENDIX 1...79 OVERVIEW OF LASER THERAPY... 79 TREATMENT TIPS... 79 COMMON TERMS... 80 APPENDIX 2...81 ELECTROMAGNETIC COMPATIBILITY (EMC)... 81 ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES... 82 APPENDIX 3...86 WAVEFORM FORMULAS... 86

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INTRODUCTION

Intelect® Neo Clinical Therapy System

FOREWORD

PRECAUTIONARY INSTRUCTIONS

This manual is intended for users of Intelect® 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.

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:

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, Vacuum module, Laser module, and Ultrasound module for the users of the Intelect® Neo Clinical Therapy System.

Text with a “CAUTION” indicator explains possible safety infractions that have potential to cause minor or moderate injury or damage to the equipment.

CAUTION

WARNING Text with a “WARNING” indicator explains possible safety infractions that will potentially cause serious injury and equipment damage.

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.

DANGER Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury.

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.

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.

USER PROFILE

Warning; Laser beam

The intended user of this device is a licensed medical professional. The user should be able to: 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.

• Read and understand the operator’s manual, warnings, cautions and dangers. • Sense auditory and visual signals.

Wear eye protection

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

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INTRODUCTION

Intelect® Neo Clinical Therapy System

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 Intelect® Neo Clinical Therapy System.

SYSTEM SOFTWARE SYMBOLS Back Arrow

Stim

Home

Guideline

Increase/Decrease Parameter

Ultrasound

Combo Scroll Up or Down in a text box sEMG Select

Laser

Page up

CPS

Page down

Custom Protocols

Customize

Patient Data

Save Data

Anatomical Library

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

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INTRODUCTION

Intelect® Neo Clinical Therapy System

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:

CE Mark of conformity with notified body number ... CE Mark of conformity...

Refer to Instructional Manual Booklet...

Manufacturer...

Warning, Caution, or Danger...

Date of manufacture...

Testing Agency ...

Catalogue number ...

Dangerous Voltage...

Serial number...

Electrical Type B Equipment...

Authorized representative in the European Community...

Electrical Type BF Equipment...

Federal law (U.S.A.) restricts this device to sale by or on the order or a licensed

Laser...

health care professional...

Ultrasound...

Fragile, handle with care ...

Stim ...

This end up...

Start...

Keep dry...

Stop...

Temperature Range ...

Pause ...

Relative Humidity Range...

Intensity...

Atmospheric Pressure Range...

Lock/Unlock... ON/OFF... Laser Stop Switch... This unit is considered to be a Class IIIB 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)...

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INDICATIONS FOR USE

Intelect® Neo Clinical Therapy System

ELECTROTHERAPY INDICATIONS Indications

Contraindications

EStim • TENS: Symptomatic relief of chronic pain, Management of post-operative pain • NMES: Muscle re-education, increasing local blood supply, relaxation of muscle spasms • Maintaining/Increasing range of motion.

The Intelect® 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 Intelect® 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 Intelect® 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 Intelect® Neo Clinical Therapy System, its components, and accessories are not to be present in an MRI or CT environment.

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INDICATIONS FOR USE

Intelect® Neo Clinical Therapy System

ELECTROTHERAPY INDICATIONS (CONTINUED) 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.

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INDICATIONS FOR USE

Intelect® Neo Clinical Therapy System

SEMG & STIM INDICATIONS Indications • • • • • •

• Do not use Intelect® 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 Intelect® Neo Clinical Therapy System, its components, and accessories are not to be present in an MRI or CT environment.

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

Additional Precautions

Indications for EMG alone:

• 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.

• 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 Indications for incontinence: • Provide biofeedback for the purpose of rehabilitation of pelvic floor muscles for the treatment of urinary Incontinence. Contraindications The Intelect® 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 Intelect® Neo Clinical Therapy System on patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD, or other implantable electronic devices.

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.

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INDICATIONS FOR USE

Intelect® Neo Clinical Therapy System

ULTRASOUND INDICATIONS Indications

• Do not use Intelect® 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 Intelect® Neo Clinical Therapy System, its components, and accessories are not to be present in an MRI or CT environment.

• Relief of pain from muscle spasm • Relief of pain from joint contracture • Relief of pain associated with ligament sprains, tendinitis and muscle sprain 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 Intelect® Neo Clinical Therapy System on patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD, or other implantable electronic devices.

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

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INDICATIONS FOR USE

Intelect® Neo Clinical Therapy System

LASER INDICATIONS Indications

• Do not use Intelect® 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 Intelect® Neo Clinical Therapy System, its components and accessories, are not to be present in an MRI or CT environment.

To provide topical heating for the following: • Increasing local blood circulation • Relieving minor muscle and joint aches, pains, and stiffness • Relaxing muscles • Relieving muscle spasms • Relieving minor pain and stiffness associated with arthritis • Promoting nerve regeneration, bone growth, and ligament repair • Healing wounds

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

Contraindications The Intelect® Neo Clinical Therapy System Laser should NOT be used:

Preventing Adverse Effects Perform the following procedures to avoid the negative effects of Laser therapy:

• Where analgesia may mask progressive pathology, and where the practitioner would normally avoid the use of any other analgesia in order to retain the beneficial aspects of pain • For direct aim into the eyes of humans or animals over areas injected with steroids in the past 2-3 weeks • Over areas that are suspicious or contain potentially cancerous tissue • Over 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 Intelect® Neo Clinical Therapy System on patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD, or other implantable electronic devices.

• 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: • • • • • •

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Color of skin (light or dark) Age of lesion Depth of lesion Sensitivity of patient Type of tissue Medications that increase sensitivity to light

DEVICE DESCRIPTION

Intelect® Neo Clinical Therapy System

PRODUCT DESCRIPTION The Intelect® 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, Vacuum module, Laser module, and Ultrasound module. To maximize functionality and life of Intelect® 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 Intelect® Neo Clinical Therapy System. NOTE: This equipment is to be used only under the prescription and supervision of a licensed medical practitioner.

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DEVICE DESCRIPTION

Intelect® Neo Clinical Therapy System

OPERATOR INTERFACE Front Controls

The Intelect® 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.

1

1. Color Display 2. Intensity Dial (Gray outer ring) 3. Start/Pause button 4. Stop button 5. ON/OFF switch

2

4

6. Ultrasound Applicator holder, left and right sides

3

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

Rear Access Panel

12. USB Flash Drive Port (Flash Drive not included) 13. Tilt Screen

12

14. Swivel function

5

15. Laser Interlock Port and Icon 16. Leadwire holders

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6,7

Side Holders

10

8

6,7 90º 45º

13

14 15

16

9

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GENERAL WARNINGS AND PRECAUTIONS

Intelect® Neo Clinical Therapy System

CAUTION

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.

• Failure to use and maintain the Intelect® 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 to enter the unit, including, but not limited to, inflammables, water, and metallic objects from entering the unit, to prevent unit damage, malfunction, electrical shock, fire, or personal injury.

• 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.

• If you have difficulty operating the unit after carefully reviewing this user manual, contact your DJO dealer for assistance. • DO NOT remove the front and back covers. 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.

• 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.

• Use of parts or materials other than DJO’s can degrade minimum safety.

• Handle Ultrasound Applicator and Laser Applicator with care. Inappropriate handling may adversely affect its characteristics.

• The Intelect® 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.

• 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.

• The Intelect® Neo Vacuum Electrode Module is designed to operate only when properly installed in the Intelect® Neo Clinical Therapy System Cart.

• 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:

• Before each use, inspect Vacuum Electrode Cups and Lead Hoses for cracks and damage which may not allow the vacuum to properly secure the electrodes. • Drain the Vacuum Electrode Module water reservoir regularly to prevent excessive accumulation from electrode sponge water. • Periodic flushing of the Vacuum system and the Vacuum reservoir are required to maintain factory functionality of the Vacuum Electrode Module. Refer to the MAINTENANCE section on page 75 for proper instructions.

- 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.

• DO NOT operate the Intelect® Neo Clinical Therapy System within the vicinity or environment as any microware and RF shortwave diathermy system.

- Consult your authorized DJO dealer for help.

• DO NOT operate the Intelect® Neo Clinical Therapy System within the vicinity or environment as an ultrasonic diathermy system. The Ultrasound (diathermy) Module of the Intelect® Neo Clinical Therapy System does not require separation distance.

• 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.

• Caution should always be exercised with current densities more than 2mA/cm2.

• DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury.

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GENERAL WARNINGS AND PRECAUTIONS

Intelect® Neo Clinical Therapy System

WARNING

WARNING

• This device should be used only under the continued supervision of a physician or licensed practitioner.

• Clean applicators after each use, otherwise it can lead to cross contamination and infection.

• Be sure to read all instructions for operation before treating patient.

• Clean vacuum electrodes, sponges, and hoses before each use. Lack of proper cleaning and maintenance may lead to cross-contamination and infection.

• 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.

• When the Laser Module is not in use, it should be protected against unqualified use.

• 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.

• 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.

• The safety of TENS waveforms for use during pregnancy or birth has not been established.

• Do not use laser on or over a tattoo.

• TENS is not effective for pain of central origin. (This includes headache.) • Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is in use.

• The laser head must be cleaned with a disinfectant cleaner (i.e. Virex® II 256) or germicidal cloth (i.e. PDI Sani-Cloth® Plus/Hb) between each therapy session. Ensure no liquids enter into the laser head while cleaning. Do not use any chlorine-based cleaners on the laser head.

• TENS is a symptomatic treatment, and as such, suppresses the sensation of pain which would otherwise serve as a protective mechanism.

• 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.

• Inspect the plastic lens of the laser head for blemishes, deformation, pitting, scratches, discoloration, and cleanliness before each use.

• Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.

• 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.

• 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.

• TENS waveforms have no curative value.

• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to Laser energy.

- 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.

• 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.

• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.

• Contaminated sponges, electrodes, leadwires, and gel can lead to infection.

• 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.

• 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 contaminated sponge or electrodes with corrosion with vacuum system can result in possible infection or skin irritation.

• 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.

• Use of electrode with degraded hydro-gel can result in infection to the skin burn.

• Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns.

• Use of electrode on multiple patients can lead to infection.

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GENERAL WARNINGS AND PRECAUTIONS

Intelect® Neo Clinical Therapy System

WARNING

WARNING

• The Intelect® Neo Clinical Therapy System may be susceptible to Electro-Static Discharge (ESD) at greater than ±4 kV when first grasping either the Ultrasound or Laser applicator. In the event of such a discharge, the Intelect® Neo Clinical Therapy System may experience communication loss with the installed modules. The Intelect® 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.

• Vacuum electrodes are not suitable for patients who are taking steroids, due to the likelihood of bruising. • 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.

- 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.

• 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.

• 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.

• 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.

- Maintain humidity in the use environment to at least 50% relative humidity.

• 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 81, to assist in removing the interference.

- 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%.

• Common RF emitting devices (e.g., RFID) and electromagnetic security systems (e.g., metal detectors) may interfere with the operation of the Intelect® Neo Clinical Therapy System. The Intelect® 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.

- 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 Intelect® Neo Clinical Therapy System optional modules and associated accessories are designed for use only with the Intelect® Neo Clinical Therapy System. • Remove the Ultrasound or Laser Applicator by pulling the cable connector only. DO NOT remove by pulling the cable. • Vacuum electrodes should not be used on patients with thin, papery skin. Vacuum may lead to contact difficulty and bruising. 16

GENERAL WARNINGS AND PRECAUTIONS

Intelect® Neo Clinical Therapy System

DANGER • Stimulus delivered by the TENS waveforms of this device, in certain configurations, will deliver a charge of 25 microcoulombs (µC) 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. 17

DETAIL DEVICE DESCRIPTION

Intelect® Neo Clinical Therapy System

COMPONENTS Modules

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.

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The Intelect® Neo Clinical Therapy System allows installation of optional modality modules (except Vacuum module) by the user. Specifically designed for use with the Intelect® Neo Clinical Therapy System, these modules configure the system to meet virtually every therapeutic need that a clinician may have. The components of the Intelect® Neo Clinical Therapy System are shown below. NOTE: The Intelect® Neo Clinical Therapy System, when ordered as a Tabletop System, without cart, is assembled with Base, as shown below. The only user assembly required is the installation of the desired Modules described in the MODULE INSTALLATION section on page 24. Installation of the Vacuum module is required by DJO-Authorized Service Persons.

Stimulation Channel 1/2 Stimulation Channel 1/2 + sEMG Stimulation Channel 3/4 Laser Ultrasound Vacuum (Shown in Cart previous)

Leadwires The available leadwires are shown below. If the user orders Stimulation Channel 1/2 module, the box will include the blue and green leadwires. Stimulation Channel 3/4 is the cranberry and orange leadwires. If both modules are ordered, the box contains all four colored leadwires. Stimulation modules channel 1/2 with sEMG includes blue and green sEMG leadwires.

Head

Leadwire Holders Base

Cart

Cart with Vacuum Module Installed

Powercord

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DETAIL DEVICE DESCRIPTION

Intelect® Neo Clinical Therapy System

MODULE SLOTS

MODULE KIT CONTENTS

1. Laser

Electrotherapy Module Channels 1/2 – PN 70000

2. Stimulation (1 & 2) / Stimulation (1 & 2) + sEMG

• 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)

3. Ultrasound 4. Stimulation (3 & 4) – opposite side Side Module Slots – Left Side

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)

1 2 3

Electrotherapy Module Channels 1/2 + sEMG – PN 70004

Side Module Slots – Right Side

• Stimulation module (2 channel Stimulation with sEMG) • sEMG Leadwires • Dura-Stick® plus 2 in (5 cm) (2 packs of 4) • Faceplates (to cover module after inserted into main unit)

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Laser Module – PN 70005 • • • • •

To remove module, take right side off face plate and push module from right side.

Laser module Protective Eyewear, 2 Pair Interlock Patient Remote, Laser Interrupt Switch Faceplates (to cover module after inserted into main unit)

Vacuum Module – PN 70006 • • • • •

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Vacuum module Vacuum hoses 1 & 2 Vacuum hoses 3 & 4 60 mm electrodes Sponges

DETAIL DEVICE DESCRIPTION

Intelect® Neo Clinical Therapy System

ULTRASOUND APPLICATOR 1. Applicator Head The component of the applicator that makes contact with the patient during Ultrasound or Combination therapy.

1

3

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 Laser Diode

Aperture

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.

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