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Intelect Neo
User Manual
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Chattanooga Intelect Neo User Manual

Intelect® Neo Clinical
Therapy System
User Manual
Operator and
Installation
Instructions
TABLE OF CONTENTS
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
PRECAUTIONARY INSTRUCTIONS . . . . . . . . . . . . . . . . 2
SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
COMPONENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
HEAD TO CART ASSEMBLY . . . . . . . . . . . . . . . . . . . . . . . . 5
NEO LEG TO CART ASSEMBLY/ADJUSTMENT . . . . . 6
MODULE INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . 7
MODULE-SPECIFIC INFORMATION . . . . . . . . . . . . . . . . 8
MODULE KIT CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . 9
THERAPY SYSTEM START-UP . . . . . . . . . . . . . . . . . . . . . 10
NOMENCLATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
OPERATOR INTERFACE. . . . . . . . . . . . . . . . . . . . . . . . . . . 11
MODULE SLOTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
ULTRASOUND APPLICATOR. . . . . . . . . . . . . . . . . . . . . . 12
LASER APPLICATOR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
PATIENT REMOTE/LASER INTERRUPT SWITCH . . . . 14
PATIENT REMOTE/LASER INTERRUPT SWITCH
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
INSTALLING THE LASER INTERLOCK . . . . . . . . . . . . . 15
GENERAL TERMINOLOGY . . . . . . . . . . . . . . . . . . . . . . . . 16
SYSTEM SOFTWARE SYMBOLS . . . . . . . . . . . . . . . . . . 16
SCREEN DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . 17
PRECAUTIONARY INSTRUCTIONS . . . . . . . . . . . . . . . 18
INDICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
ELECTROTHERAPY INDICATIONS. . . . . . . . . . . . . . . . . 21
SEMG & STIM INDICATIONS . . . . . . . . . . . . . . . . . . . . . . 23
ULTRASOUND INDICATIONS . . . . . . . . . . . . . . . . . . . . . 24
LASER INDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
SYSTEM SPECIFICATIONS AND DIMENSIONS . . . . 26
POWER COMBINATION AND ELECTROTHERAPY. . 26
VACUUM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
ULTRASOUND SPECIFICATIONS. . . . . . . . . . . . . . . . . . 27
LASER SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 27
LASER APPLICATOR TECHNICAL
SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
LASER PROTECTIVE EYEWEAR SPECIFICATIONS . . 31
LASER LABELS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
WAVEFORMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
UTILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
UTILITIES AND OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . 39
PATIENT PREPARATION . . . . . . . . . . . . . . . . . . . . . . . . . 41
ELECTRODE PLACEMENT . . . . . . . . . . . . . . . . . . . . . . . . 41
DURA-STICK™ ELECTRODES . . . . . . . . . . . . . . . . . . . . . 41
ELECTROTHERAPY PATIENT PREPARATION . . . . . . . 41
IONTOPHORESIS PATIENT PREPARATION. . . . . . . . . 42
VACUUM ELECTRODE PATIENT PREPARATION. . . . 43
SEMG & STIM PATIENT PREPARATION . . . . . . . . . . . . 45
LASER PATIENT PREPARATION . . . . . . . . . . . . . . . . . . . 46
ULTRASOUND PATIENT PREPARATION . . . . . . . . . . . 47
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
HOME SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
TREATMENT SCREENS . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
CPS (CLINICAL PROTOCOL SETUP) . . . . . . . . . . . . . . . 50
ELECTROTHERAPY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
VACUUM OPERATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
SEQUENCING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
STRENGTH/DURATION (S/D) CURVE. . . . . . . . . . . . . . 54
IONTOPHORESIS OPERATION . . . . . . . . . . . . . . . . . . . . 55
ULTRASOUND OPERATION. . . . . . . . . . . . . . . . . . . . . . . 56
COMBINATION OPERATION . . . . . . . . . . . . . . . . . . . . . . 57
SEMG OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
LASER OPERATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
DATA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
SAVING TO USB FLASH DRIVE/PATIENT DATA. . . . . 63
CUSTOM PROTOCOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
ANATOMICAL LIBRARY . . . . . . . . . . . . . . . . . . . . . . . . . . 66
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
TROUBLESHOOTING CODES . . . . . . . . . . . . . . . . . . . . . 67
ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
REPLACEMENT ACCESSORIES . . . . . . . . . . . . . . . . . . . . 70
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
FUSE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
INSTRUCTION FOR SOFTWARE UPGRADE . . . . . . . 73
COPY OF MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
CLEANING THE INTELECT® NEO CLINICAL
THERAPY SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
VACUUM MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . 74
CALIBRATION REQUIREMENTS . . . . . . . . . . . . . . . . . . . 74
SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
WARRANTY REPAIR/OUT OF WARRANTY REPAIR . 75
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
APPENDIX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
OVERVIEW OF LASER THERAPY . . . . . . . . . . . . . . . . . . 77
TREATMENT TIPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
COMMON TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
ELECTROMAGNETIC COMPATABILITY TABLES . . . . 79
1
FOREWORD
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, e ciency, 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 + sEMG module, Channel 3/4 Electrotherapy module, Vacuum module, Laser module, and Ultrasound module for the users of the Intelect® Neo Clinical Therapy System.
Speci cations put forth in this manual were in e ect at the time of publication. However, owing to DJO’s policy of continual improvement, changes to these speci cations may be made at any time without noti cation 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, contra indications, warnings and precautions. Consult other resources for additional information regarding the application of electrotherapy, ultrasound, and laser.
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.
PRECAUTIONARY INSTRUCTIONS
The precautionary instructions found in this section and throughout this manual are indicated by speci c symbols. Understand these symbols and their de nitions before operating this equipment. The de nition of these symbols are as follows:
!"#$%&'
Text with a “CAUTION” indicator explains possible safety infractions that have potential to cause minor or moderate injury or damage to the equipment.
(")'%'*
Text with a “WARNING” indicator explains possible safety infractions that will potentially cause serious injury and equipment damage.
+"'*,)
Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury.
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 con gurations of TENS waveforms.
Warning; Corrosive substance
Warning; Laser beam
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.
Explosion Hazard - Text with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of  ammable 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.
2
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 Intelect® Neo Clinical Therapy System allows installation of optional modality modules (except Vacuum module) by the user. Speci cally designed for use with the Intelect® Neo Clinical Therapy System, these modules con gure 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 on page 7. Installation of the Vacuum module is required by DJO-Authorized Service Persons.
Cart
SETUP
Cart with Vacuum Module
installed
Head
Base
Modules
• Stimulation Channel 1/2
• Stimulation Channel 1/2 + sEMG
• Stimulation Channel 3/4
• Laser
• Ultrasound
• Vacuum (Shown in Cart above)
3
SETUP
COMPONENTS (CONTINUED)
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.
Powercord
Leadwire Holders
4
HEAD TO CART ASSEMBLY
SETUP
The optional Therapy System Cart, PN 70001, is designed for use with the Intelect® 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 Intelect® Neo Clinical Therapy System from the shipping carton. Visually inspect for damage. Report any damage to the carrier immediately.
To assemble the Intelect® 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.
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 first 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.
Screws
5. If desired, replace the closed Handles with the open Handles. Each Handle is attached with four screws as shown.
6. Reinstall the drawer
5
SETUP
NEO LEG TO CART ASSEMBLY/ADJUSTMENT
The Neo Cart is shipped without the legs attached. To install or adjust the leg assemblies onto the Neo Cart, follow these steps:
Neo Leg to Cart assembly/Adjustment
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)
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.
6
MODULE INSTALLATION
SETUP
All modules (except vacuum module) are installed on 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. Module­speci c Installation instructions are shown after the generic instructions. To install the modules in the Intelect® Neo Clinical Therapy System, follow the steps shown.
NOTE: 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.
UltrasoundLaser
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).
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).
Stimulation 3/4 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 (2x16) in first. Secure the module in place with gentle pressure until you feel the module is seated.
7
SETUP
5. Secure the module with a screw provided at the bottom as shown (using stimulation channel 3/4 as example).
MODULE-SPECIFIC INFORMATIONMODULE INSTALLATION (CONTINUED)
Ultrasound Cable Insertion
Shown below is the Ultrasound Cable Insertion location.
6. 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 (Neo allows Laser access on the left and right sides).
7. 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.
NOTE: Installation of the Intelect® Neo Vacuum Module into the Cart must be performed by the Selling Dealer’s Trained Technician.
8
MODULE KIT CONTENTS
Electrotherapy Module Channels 1/2 – PN 70000
• Stimulation module
• Lead wires
• Dura-Stick® 5 cm (2 in) 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® 5 cm (2 in) Round Disposable Electrodes (1 pack of 4)
• Faceplates (to cover module after inserted into main unit)
SETUP
Electrotherapy Module Channels 1/2 + sEMG – PN 70004
• Stimulation module (2 channel Stimulation with sEMG)
• sEMG Leadwires
• Dura-Stick® plus 5 cm (2 in) (1 pack of 4) and Dura-Stick® plus 3 cm (1.25 in) Round Disposable Electrodes
• 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)
Vacuum Module – PN 70006
• Vacuum module
• Vacuum hoses 1&2
• Vacuum hoses 3&4
• 60mm electrodes
• Sponges
9
SETUP
THERAPY SYSTEM START-UP
Complete the following steps for initial setup of the Intelect® 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.
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, as shown below:
10
OPERATOR INTERFACE
NOMENCLATURE
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 modi cation and system set up.
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 (Flash Drive not included)
13. Tilt Screen
14. Swivel function
Front Controls
Rear Access Panel
12
1
2
4
3
5
15. Laser Interlock Port and Icon
16. Leadwire holders
Side Holders
45
11
10
6, 7
6, 7
14
8
º
13
º
90
15
16
9
11
NOMENCLATURE
MODULE SLOTS ULTRASOUND APPLICATOR
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
1. Applicator Head
The component of the applicator that makes contact with the patient during Ultrasound or 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.
1
3
2
Side Module Slots – Right Side
Add 2nd shot of right side
looking from front
for US, CH3/4, Laser
4
To remove module, take right side o face plate and push module from right side
12
LASER APPLICATOR
Aperture
NOMENCLATURE
NOTE: When inserting the plugs for the Ultrasound and
Laser modules, be sure to align the  at side of the plug with the  at side of the slot and push in gently. This is to avoid bending the pins in the plug.
Laser Diode
Flat side of slotFlat side of plug
Laser Head
Pause/Resume
Button
LED’s/SLD’s
Laser Head
LED Indicator (Output Power)
LED Indicator (Output Power) This orange light illuminates when Laser energy is being distributed by the applicator.
13
NOMENCLATURE
PATIENT REMOTE/LASER INTERRUPT SWITCH PATIENT REMOTE/LASER INTERRUPT SWITCH
INSTALLATION
The Intelect® Neo Patient Remote/Laser Interrupt Switch buttons are described below. By default, the remote is not assigned to any treatment. When assigned, the buttons function as follows:
Increase Intensity (1)
Decrease Intensity (2)
STOP STOP/Pause Treatment (3)
M Manual Stimulation (4)
Intensity Up - Operates the same as turning the Intensity
Dial clockwise for the assigned treatment.
To operate the Patient Remote/Laser Interrupt Switch, plug the remote into the device on the Rear Access Panel receptacle, as shown below:
!"#$%&'
Intensity Down - Operates the same as turning the Intensity Knob counter-clockwise for the assigned treatment.
STOP - Operates as a toggle switch between stopping and resuming the assigned treatment.
• Operate as pause switch when assign to laser treatment.
• Operates as pause switch when not assigned to any treatment, it pauses all treatment.
• Operates as a toggle switch between pause and resume if assigned to stim treatment.
M (Manual Stimulation) (Electrical Stimulation treatments only)
When pressed for the  rst time, will pause the treatment. After the  rst press, will ramp up and stimulate at desired output if held down or will pause treatment if released.
Stop (3) Increase (1) Decrease (2) Manual (4)
• Patient Remote/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 icon is displayed on the screen. Shown below:
14
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 leadwire holder clips in the same manner as leadwires and cables, as demonstrated. Shown below.
NOMENCLATURE
(")'%'*
• 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.
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 quali ed electricians to install the Laser Interlock Kit.
Diagram for Therapy Room with One Door:
Diagram for Therapy Room with Multiple Doors:
15
NOMENCLATURE
GENERAL TERMINOLOGY
The following are de nitions 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
Home
Increase/Decrease Parameter
Stim
Ultrasound
Combo
sEMG
Scroll Up or Down in a text box
Laser
Select
Page up
Custom Protocols
CPS
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 O Icon
Indicates the Remote is plugged in
Patient Data
Anatomical Library
16
SCREEN DESCRIPTION
NOMENCLATURE
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 Shut O , when installed, and a USB connectivity icon when 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
Setup: Indicates a treatment for the channel is
currently being setup 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
Electrode Contact Quality Indicator
Active Channels Indicator
17
PRECAUTIONARY INSTRUCTIONS
!"#$%&' !"#$%&'
• 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 and touchscreen 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.
• Failure to use and maintain the Intelect® Neo 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.
• 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.
• Use of parts or materials other than DJO’s can degrade minimum safety.
• 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.
• 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.
• The Intelect® Neo Vacuum Electrode Module is designed to operate only when properly installed in the Intelect® Neo Clinical Therapy System Cart.
• DO NOT operate the system in an environment of shortwave diathermy use.
• 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 of this manual for proper instructions.
• DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury.
18
PRECAUTIONARY INSTRUCTIONS
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• 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.
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• Clean applicators after each use, otherwise it can lead to cross contamination and infection.
• Clean vacuum electrodes, sponges and hoses before each use. Lack of proper cleaning and maintenance may lead to cross-contamination and infection.
• When the laser module is not in use, it should be protected against unqualified use.
• 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.
• 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 accessories other than those specified in this User Manual may increase electrical emissions and decrease electrical immunity of the device.
• DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner.
• Contaminated sponges, electrodes, leadwires, and gel can lead to infection.
• Use of contaminated sponge or electrodes with corrosion with vacuum system can result in possible infection or skin irritation.
• Use of electrode with degraded hydro-gel can result in infection to the skin burn.
• 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.
• Use of electrode on multiple patients can lead to infection.
19
PRECAUTIONARY INSTRUCTIONS
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• Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns.
• 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.
• 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.
• 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.
+"'*,)
• 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.
• 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.
20
ELECTROTHERAPY INDICATIONS
INDICATIONS
Indications
The Intelect® Neo Clinical Therapy System o ers VMS, VMS Burst, VMS-FR, Russian, TENS, TENS HAN, High Voltage Pulsed Current (HVPC), Interferential, and Premodulated Waveforms, providing the following bene ts:
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombists
Additional Indications for Microcurrent, Interferential, Premodulated, VMS™, VMS™ Burst, VMS™ FR, TENS, TENS HAN Waveforms:
• Symptomatic relief and management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain
Indications for DC (Direct Current) Mode:
• Relaxation of muscle spasm
Indications for Iontophoresis
• Calcium deposits, calcific tendinitis
• Edema
• Myofascial trigger points (chronic)
• Scar tissue, adhesions
• Scleroderma
• Gouty arthritis
• Wounds, ulcers
• Inflammation
• Pain management
• Achilles Tendinopathy
• Carpal Tunnel Syndrome
• Epicondylitis
• Gouty arthritis
• Plantar Fasciitis
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.)
• 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
Indications 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.
21
INDICATIONS
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 E ects
• 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.
22
SEMG & STIM INDICATIONS
INDICATIONS
Indications
• 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
Indications for EMG alone:
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 weak 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
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 E ects
• 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
23
INDICATIONS
ULTRASOUND INDICATIONS LASER 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, 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
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
Indications
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
Contraindications
The Intelect® 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 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
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