Intelect Legend 2
2 CHANNEL COMBO (12-5010), 4
CHANNEL COMBO (12-5011)
User Manual

INTRODUCTION

FOREWORD
This manual is intended for users of the Intelect Legend 2 COMBO 2 CHANNEL (12-5010) and Intelect Legend 2 COMBO 4 CHANNEL (12-5011). 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.
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, cautions, warnings, and dangers.
INTENDED PURPOSE
The Intelect® Legend 2 devices comprise of a range of multimodality (TENS; NMES, Ultrasound) therapies intended to be used by healthcare professionals using TENS, NMES and Therapeutic Ultrasound for the treatment of various musculoskeletal and skeletal muscle deficit disorders.
The Intelect® Legend 2 product range offers the following models:
The Intelect® Legend 2 2 Channel Combo device delivering both 2 Channel Electrotherapy (TENS and NMES) and Therapeutic Ultrasound either simultaneously or independently.
The Intelect® Legend 2 4 Channel Combo device delivering both 4 Channel Electrotherapy (TENS and NMES) and Therapeutic Ultrasound either simultaneously or independently.
INTENDED USER
The intended user of this device is a licensed healthcare professional. The user should be able to:

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

INTENDED ENVIRONMENT FOR USE
The device is intended to be operated in a professional healthcare environment.
INTENDED PATIENT POPULATION
The Intelect® Legend 2 Devices are suitable for adult patients requiring symptomatic treatment of musculoskeletal conditions mentioned under “indications” and to whom none of the contraindications apply.
PRECAUTIONARY INSTRUCTIONS
The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows:
CAUTION
Text with a “CAUTION” indicator explains possible safety infractions that have potential to cause minor or moderate injury or damage to the equipment.
WARNING
Text with a “WARNING” indicator explains possible safety infractions that will potentially cause serious injury and equipment damage.
DANGER
Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury.
NOTE: Throughout this manual, “NOTE” indicators provide helpful information  regarding the particular area of function being described.

ELECTROTHERAPY INDICATIONS

INDICATIONS
For VMS (Pulsed Mode, Burst Mode, or FR Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential, and Premodulated (IFS):

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS (Pulsed Mode, Burst Mode, or FR Mode), Asymmetrical Biphasic (TENS), and HANS:
Symptomatic relief or management of chronic, intractable pain

• Post-traumatic acute pain
• Post-surgical acute pain

For DC (Direct Current) Continuous Mode:

• Relaxation of muscle spasms

CONTRAINDICATIONS
The Intelect® Legend 2 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
• There should not be any use of TENS waveforms on patients with cardiac demand pacemakers
• Do not use device on patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD, or other implantable electronic devices
• Do not use device on patients with body worn electro mechanical medical devices, i.e. insulin pump
• Do not use this system in an MRI or CT environment. Device, its components, and accessories are not to be present in an MRI or CT environment

ADDITIONAL PRECAUTIONS

• Use caution for patients with suspected or diagnosed heart problems
• Use caution for patients with suspected or diagnosed epilepsy
• Use caution in the presence of the following:
  » When there is a tendency to hemorrhage following acute trauma or fracture
  » Following recent surgical procedures when muscle contraction may disrupt the healing process
  » Over a menstruating or pregnant uterus
  » Over areas of the skin that lack normal sensation
• Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternative conductive medium or an alternative electrode placement
• Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner
• Powered muscle stimulators should be used only with the lead wires and electrodes recommended for use by the manufacturer
• With TENS waveforms, isolated cases of skin irritation may occur at the site of electrode placement following long-term application
• The effective management of pain by TENS waveforms is highly dependent upon patient selection by a person qualified in pain management

ADVERSE EFFECTS

• Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.
• Potential adverse effects with TENS are skin irritation and electrode burns

ULTRASOUND INDICATIONS INDICATIONS
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

• Relief of pain, muscle spasms, and joint contractures
• Relief of pain, muscle spasms, and joint contractures that may be associated with:
  » Adhesive capsulitis
  » Bursitis with slight calcification
  » Myositis
  » Soft tissue injuries
  » Shortened tendons due to past injuries and scar tissues
• Relief of sub-chronic and chronic pain and joint contractures resulting from:
  » Capsular tightness
  » Capsular scarring

CONTRAINDICATIONS

• 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 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
• 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 device on patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD, or other implantable electronic devices
• Do not use device 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 device, its components, and accessories are not to be present in an MRI or CT environment

ADDITIONAL PRECAUTIONS
Additional precautions should be used when ultrasound is used on patients with the following conditions:

• Over an area of the spinal cord following a laminectomy, i.e. when major covering tissues have been removed
• Over anesthetic areas
• On patients with hemorrhagic diatheses

GENERAL WARNINGS AND PRECAUTIONS

CAUTION

• Read, understand, and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any electrical stimulation, or ultrasound device. Observe the precautionary and operational decals placed on the unit.
• All modalities should be routinely checked before each use to determine that all controls function normally, especially that the intensity control does properly adjust the intensity of the ultrasonic power output in a stable manner. Also, determine that the treatment time control does actually terminate ultrasonic power output when the timer reaches zero.
• DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel.
• This unit should be operated at 10°C to 40°C and 30% to 75% relative humidity The unit should be transported and stored at -20°C to 60°C and 10°C to 90°C relative humidity
• Handle Ultrasound Applicator with care. Inappropriate handling may adversely affect its characteristics
• Before each use, inspect Ultrasound Applicator for cracks, which may allow the ingress of conductive fluid
• Inspect Applicator cables and associated connectors before each use
• Device is designed to comply with electromagnetic safety standards. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off. Try to correct the interference using one or more of the following:
  » Reorient or relocate the receiving device
  » Increase the separation between the equipment
  » Connect the equipment to an outlet on a different circuit from that to which the other device(s) are connected
  » 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
• DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury.
• Failure to use and maintain the device, its modules, and its accessories in accordance with the instructions outlined in this manual will invalidate the warranty.
• DO NOT permit foreign materials, liquids, or cleaning agents (including, but not limited to, inflammables, water, and metallic objects) to enter the unit to prevent unit damage, malfunction, electrical shock, fire, or personal injury.
• If you have difficulty operating the unit after carefully reviewing this user manual, contact your DJO dealer for assistance
• DO NOT remove the cover. Doing so may cause unit damage, malfunction, electrical shock, fire, or personal injury. There are no user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately and consult dealer for repair service.
• Use of parts or materials other than DJO’s can degrade minimum safety
• The device is not designed to prevent the ingress of water or liquids. Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient
• DO NOT operate the device within the vicinity or environment as any microware and RF shortwave diathermy system
• DO NOT operate the device within the vicinity or environment as an ultrasonic diathermy system. The Ultrasound (diathermy) Module of the device does not require separation distance
• DO NOT use electrodes with an active area less than 7.92 cm2 , as there will be a risk of suffering a burn injury. Always exercise caution with current densities more than 2mA/cm2.
• Ultrasound applied part is Type B. Its output is not isolated from the secondary voltage of the device. Make sure both the mains connection and the applicator are properly connected to the device.

WARNING

• U.S.A Federal Law restricts these devices to sale by, or on the order of, a physician or licensed practitioner. This device should be used only under the continued supervision of a physician or licensed practitioner.
• Be sure to read all instructions for operation before treating patient
• Make certain the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes
• Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it.
• The safety of TENS waveforms for use during pregnancy or birth has not been established
• TENS is not effective for pain of central origin (This includes headache )
• TENS waveforms have no curative value
• Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is in use.
• TENS is a symptomatic treatment, and as such, suppresses the sensation of pain which would otherwise serve as a protective mechanism
• 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.
• This device should be kept out of the reach of children
• Use of other accessories other than those specified in this User Manual may increase electrical emissions and decrease electrical immunity of the device
• Contaminated sponges, electrodes, lead wires, and gel can lead to infection
• Use of electrode with degraded hydrogel can result in burn to the skin
• DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner.
• Use of electrode on multiple patients can lead to infection
• Clean applicators after each use, otherwise it can lead to cross contamination and infection
• Do not treat through clothing
• Stop treatment immediately if patient experiences discomfort or pain
• Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer
• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy
• Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the application of each mode of treatment
• Disconnect the system from the power source before attempting any maintenance, installation, removal, or replacement procedures to prevent electrical shock and possible damage to system.
• Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns.
• 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 device’s optional modules and associated accessories are designed for use only with this device
• Remove the Ultrasound by pulling the cable connector only DO NOT remove by pulling the cable
• 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.
• 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 to assist in removing the interference.
• Common RF emitting devices (e g , RFID) and electromagnetic security systems (e g , metal detectors) may interfere with the operation of the device. The device 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.
• The ultrasound applicator included in this set can expose you to chemicals including lead/lead components and Bisphenol A (BPA) which are known to the state of California to cause cancer, birth defects or other reproductive harm. For more information  go to www.p65Warnings.ca.gov.
• The electro stimulation lead wires included in this set can expose you to chemicals including lead/lead components which are known to the state of California to cause cancer, birth defects or other reproductive harm. For more information go to www.p65Warnings.ca.gov.

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, anywhere on their body. Energy from diathermy (shortwave, microwave, and ultrasound) 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.
• 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
• 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.
• Charge the Battery Module according to the instructions found in this manual. Never attempt to charge the Battery Module on any other charging mechanism.
• Do not reverse the polarity of the Battery Module. Doing so can increase the individual cell temperature and cause cell rupture or leakage.
• Never dispose of Battery Module in fire. Never short circuit the battery. The battery may explode, ignite, leak or get hot causing serious personal injury.
• Dispose of batteries according to national, state and local codes and regulations.

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® Legend 2 .
SYSTEM SOFTWARE SYMBOLS

	Home
	Back to previous screen
	Settings
	Indicates a USB Flash Drive is Inserted
	Indicates Battery Level
	Indicates more content can be viewed by swiping vertically
	Indicates more content can be viewed by swiping horizontally
	Indicates more content can be viewed by scrolling
	Close window / exit full screen
	Confirm
	Save Data
	Edit
	Guidelines / Assign to
	Pain information
	Setup
	Running
	Paused
	Completed
	Run again
	Exit
	Export
	Import
	Delete
	Delete all
	Stop treatment
	Stim
	Ultrasound
	Combo
	Shortcut
	SPS (Suggested Parameter Setup)
	Custom Protocols
	Treatment Data
	Clinical Resources

DESCRIPTION OF DEVICE MARKINGS
The markings on the unit are assurance of its conformity to the latest applicable standards of medical equipment safety and electromagnetic compatibility and conform to ISO 7010 and ISO 15223-1 One or more of the following markings may appear on the device:

	Consult Instruction for Use
	Follow Instructions for Use
	Warning, Caution, or Danger
	Electrical Type BF Equipment
	Electrical Type B Equipment
	Ultrasound
	Rechargeable
	Stim
	Combo
	Play
	Pause
	ON/OFF
	Manufacturer
	Date of manufacture
	Catalogue number
	Serial number
	Fragile, handle with care
	This end up
	Keep dry
	Storage conditions
	Temperature Range
	Relative Humidity Range
	Atmospheric Pressure Range
	Test agency
	CE Mark of Conformity with notified body number
	Alternating current
	IP20
	Radio frequency equipment
	WEEE Directive conformity
	Shelf life
	Batch number
	US amplitude modulated
	MD
	Unique Device Identification
	Federal Law restricts this unit to sale by, or on the order of, a physician or licensed practitioner. Note: This equipment is to be used only by a licensed medical practitioner.

DEVICE DESCRIPTION

PRODUCT DESCRIPTION
The Intelect® Legend 2 is a two-channel or 4-channel  electrotherapy and ultrasound combo system used withor without an optional Cart, allowing for the inclusion of a Vacuum module. This equipment is to be used only under the prescription and supervision of a licensed healthcare professional.

12-5010	Intelect® Legend 2 Two Channel Combo Device
12-5011	Intelect® Legend 2 Four Channel Combo Device

HEAD2 CHANNEL COMBO SET INCLUDES:

12-5000	Intelect Legend 2 Two Channel Combo
70010	STIM lead wires CH 1 & 2
12-10648	Nylatex strap
14679	Power cord
42198	Dura-Stick+ 5cm square electrodes,
QTY 4
79967	Carbon electrodes
15-0162	5cm2 Ultrasound Applicator
15-1140	USB Drive

4 CHANNEL COMBO SET INCLUDES:

12-5001	Intelect Legend 2 Four Channel Combo
70010	STIM lead wires CH 1 & 2
70011	STIM lead wires CH 3 & 4
12-10648	Nylatex strap
14679	Power cord
42198	Dura-Stick+ 5cm square electrodes, QTY 4
79967	Carbon electrodes
15-0162	5cm2 Ultrasound Applicator
15-1140	USB Drive

CART (OPTIONAL)ULTRASOUND APPLICATORS

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 head.
3. LED
   The component of the applicator that indicates if the Applicator is coupled or uncoupled on the treatment area.

BATTERY MODULE (optional)
Battery (type ABI-L 18650-5S1P) is an 18.15V 3250mA
(58.98 Wh) Li-Ion rechargeable battery.
Operating temperature: 0°C to 45°C
Storage temperature (1month): -20°C to 60°C
Storage temperature (6months): -20°C to 45°C
Storage temperature (12months): -20°C to 25°C
OPERATOR INTERFACE

The Intelect® Legend 2 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. Color Display and touch screen
2. Adjustment dial
3. Play/pause button
4. “On/Off“ button. Press and hold (2 sec) the button to switch OFF the device.
5. ON/OFF switch (only active when connected to the mains)
6. Ultrasound Applicator holder, left and right sides
7. Mains power connector
8. Battery cover
9. USB Flash Drive Port located inside battery trap
10. Magnetic fixation to the cart
11. Vacuum cover
12. Device handle

SETUP INSTRUCTIONS

DEVICE LIGHT INDICATORS
Intelect® Legend 2 has several light indicators:
FRONT PANEL INDICATORS:
1. Colors:

• Light blue around Ultrasound therapy channel Left and Right
• Dark blue indicator around Electrostimulation Channel 1
• Green indicator around Electrostimulation Channel 2
• Orange indicator around Electrostimulation Channel 3
• Red indicator around Electrostimulation Channel 4

2. Behavior:

• Steady when modality is selected and output is not active
• Flashing when output is active
• Quickly flashing when treatment is interrupted and user action is requested

ON/OFF BUTTON BLUE INDICATOR:

• Steady ON from device connection to the mains
• Flashing while powering ON/OFF

PLAY/PAUSE BUTTON BLUE INDICATOR:

• Flashes when user can start/resume a treatment. Otherwise, steady.

HEAD TO CART FIXATION
The optional Therapy System Cart 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.
The fixation of the head to the cart is magnetic.
Remove the Intelect® Legend 2 device and cart from the shipping carton. Visually inspect for damage. Report any damage to the carrier immediately. To assemble the Legend 2 Head to the Cart, follow these steps:

1. Insert device front bottom on the cart lip
2. Release device back gently on the cart. Magnets will help to position the device correctly on the cart top.

IF UNIT SUPPLIED WITH OPTIONAL BATTERY 
After unpacking Intelect® Legend 2 to fit the battery follow the following steps

1. Unscrew the battery cover from the base of the device by removing the 2 screws see below
2. Remove the battery cover
3. Plug the battery into the battery connector on the device
4. Insert the battery into its location
5. Replace the 2 screws to close the battery cover

Note: in case of unused device with the battery installed, it is recommended to connect the device to the mains power and power on the device with the main ON/OFF switch on the back of the device at least once every 4 months to allow the battery to recharge.CONNECTING CABLES AND INSERTING PLUGS 
When inserting the plugs, be sure to align the flat side of the plug with the flat side of the slot and push in gently. This is to avoid bending the pins in the plug.
Insert cable into the appropriate connector prior to starting therapy.
POWERING UP THE DEVICE
When powering up the device for the first time, always use mains power even if a battery is connected. Insert the power cord into the back of the unit, insert the plug into a power outlet, do not position the Intelect® Legend 2 in such a way that makes it difficult to disconnect from the mains power.
Switch device on with ON/OFF switch on the back of the unit.

1. The Initialization screen below will be shown for a few seconds whilst the device starts.
2. The first setup screen will be displayed after this allowing the user to set language, device name, time and choose patient pain scale as either NRS (Numerical Rating Scale) or VAS (Visual Analogue Scale).
3. Click on “Continue” button to go to home screen

DEVICE CONNECTED TO THE MAINS

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 unit in an emergency situation.
2. Turn on the ON/OFF switch located on the back of the device.
3. Press ON/OFF button on LCD Front panel
4. Select desired function on the Home Screen

DEVICE WORKING ON BATTERY

1. Press the ON/OFF button on the LCD Front panel.
2. Select desired function on the Home Screen.

STOP TREATMENT AND TURN OFF THE DEVICE
Press Play/pause button to pause treatment then press stop on touch screen. If device is on mains power press the on/ off button on the front panel then turn off the switch on the back of the unit.
If device is working on battery follow the above procedure but to switch off only press the on/off button on the front panel
DATA SYNCHRONIZATION
Chattannoga Intelect® Connect App is an optional software that can be installed on a computer. It uses Bluetooth® low energy to connect to the device to provide the following features:

1. Import/Export Custom Protocols
2. Import/Export Treatment data
3. Import Sessions of the device on the computer
4. Archive the Treatment Data’s session history in a format that can be used for reporting
5. Backup/Restore device configuration
   Refer to Chattanooga website to download it, Microsoft Windows 10 or higher with Bluetooth® Low Energy communication capabilities computer is required.

Note: device can not be used to deliver treatment while data transfer.
To prepare for communication with the App press the settings button, scroll down the screen and press the Data transfer button. You should now see a screen that says “Waiting for connection…” whilst the device discovers the computer in which it can connect.
Start the Chattanooga Intelect® connect App and follow instructions on computer screen.

SYSTEM

SYSTEM SPECIFICATIONS AND DIMENSIONS

	Width	Depth	Height	Weight (no battery)
Intelect® Legend 2 Head Unit
2 Channel COMBO	34cm	35.5cm	15cm	3.1kg
4 Channel COMBO	34cm	35.5cm	19cm	3.7kg
Cart configurations
Cart (Safe working load 6.5kg)	48cm (MAX)	52cm (MAX)	96cm	10.1kg
Device on cart	–	–	111 cm	–

POWER

Input	100 – 240 V AC, 1.0 to 0.42 A, 50/60 Hz
Electrical Class	CLASS I
Mode of Operation	Continuous

Note: Mains isolation is achieved by use of the double pole switch located on the rear panel.
Electrical Type (Degree of Protection)

Ultrasound	Ultrasound
Electrotherapy	Electrotherapy

ELECTRO STIMULATION SPECIFICATIONS
Output specifications are described for each waveform from pages 18-21.
Unless otherwise specified, electrotherapy controls accuracy is: ± 20 %.
Load impedance: 500-1000 Ohm
CC = constant current, effect of load impedance on voltage
CV = constant voltage, effect of load impedance on current
ULTRASOUND SPECIFICATIONS

Frequency	1 MHz +/- 10%; 3 MHz +/- 10%
Duty Cycles	10%, 20%, 50%, Continuous
Pulse Repetition Rate	100 Hz 1 -5 ms
Pulse duration:	Max (ON): 5 ms Min (OFF): 5ms

OUTPUT POWER

US applicatorFrequency	1cm 2		2cm2		5cm2		10cm 2
	1MHz	3MHz	MHz	3MHz	1MHz	3MHz	1MHz	3MHz
Effective Radiating Area ERA INTL (cm2	1	0.9	1.5	1	2.5	2.7	6	6.8
Max Output power in Continuous mode	2W	1.8W	3W	2W	5W	5.4W	12W	6.8W
Max Output power in Pulsed mode	3W	2.7W (*)	4.5W	3W	7.5W	8.1W	18W	13.6W
Max Amplitude inContinuous mode	2W/ cm2	2W/ cm2	2W/ cm2	2W/ cm2	2W/ cm2	2W/ cm2	2W/ cm2	1W/ cm2
Max Amplitude inPulsed mode	3W/ cm2	3W/ cm2	3W/ cm2	3W/ cm2	3W/ cm2	3W/ cm2	3W/ cm2	2W/ cm2

(*) An error of + 0.25 W can be measured with 1cm2 US applicator, pulse mode 100Hz at 10% or 20% Duty Cycle.

Unless otherwise specified, ultrasound controls accuracy is:	± 20 %.
Peak to Average Ratio:	1:1, at 50% Duty Cycle 4:1, at 20% Duty Cycle 9:1, at 10% Duty Cycle
Beam Nonuniformity Ratio	<5:1
Beam Type	Collimating
Treatment Time	1 to 30 min

GENERAL SYSTEM OPERATING AND STORAGE TEMPERATURE
Operating Conditions
The device will meet its requirement under the following conditions:

Temperature:	10°C to 40°C
Relative Humidity:	30% to 75%
Atmospheric Pressure:	70kPa to 106kPa

Transport and Storage Conditions
The device will remain in proper condition under the following conditions:

Temperature:	-20°C to 60°C
Relative Humidity:	10% to 90%
Atmospheric Pressure:	50kPa to 106kPa

Time required for the Intelect® Legend 2 to warm from the minimum storage temperature between uses until the Intelect® Legend 2 is ready for its INTENDED USE when the ambient temperature is 20 °C: 5h
Time required for the Intelect® Legend 2 to cool from the maximum storage temperature between uses until the Intelect® Legend 2 is ready for its INTENDED USE when the ambient temperature is 20 °C: 5h
IPXX Rating for Unit
Rated to IP20
IP2* Protection against fingers or other object not greater than 80mm in length and 12mm in diameter
*0 No Special Protection Against Liquids
IPXX Rating for US applicator
Rated to IPX7
IPX7 Protection from immersed in water (up to 1m depth)
RED
RF transmitter/receiver characteristics:

– Frequency Band transmission:	2400–2483.5 MHz
– Modulation type:	GFSK
– Data rate:	up to 2Mbps 500kHz deviation at 2Mbps
– Effective radiated power:	+6dBm

WAVEFORMS
Advice on size and type of electrodes to be used is given in device User Interface treatment guidelines.

CC: Constant Current

CV: Constant Voltage

IFC (Interferential) Traditional (4 Pole)
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature Interferential Current is a medium frequency waveform.
Current is distributed through two channels (four electrodes). The currents cross each other in the body at the area requiring treatment. The two currents interfere with each other at this crossing point, resulting in a modulation of the intensity (the current intensity increasesand decreases at a regular frequency).

Output Mode	Electrodes
Available on Channel	1 & 2, 3 & 4
Treatment Time	1-60 Minutes
Mode Selection	CC
Output Intensity	0-100 mA (CC)
Beat Frequency	1-200 Hz
Carrier Frequency	2000-10,000  Hz
Cycle Time	Continuous or User Defined
Sweep Time	14 sec
Sweep Low Beat Frequency	1-199 Hz
Sweep High Beat Frequency	2-200 Hz
Scan Percentage	Static, 40%, 100%, Manual
IRMS	0-78mA
DC component	No

TENS- Asymmetrical Biphasic
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature  The Asymmetrical Biphasic waveform has a short pulse duration. It is capable of strong stimulation of the nervefibers in the skin as well as of muscle tissue. This waveform is often used in TENS devices.Because of its short pulse, the patient typically tolerates the current well, even at relatively high intensities.

Output Mode	Electrodes
Output Intensity	0-140 mA (CC) 0-140 V (CV)
Available on Channel	1, 2, 3, 4
Treatment Time (Stim)	1-60 minutes
Treatment Time (Combo)	1-30 minutes
Mode Selection (Stim)	CC or CV
Mode Selection (Combo)	CV
Amplitude Modulation	0% (off) to 100% on 10% steps
Burst Frequency	0-10 bps
Cycle Time	Continuous or User Defined
Frequency	1-200 pps
FrequencySweep	On/Off
Phase Duration	30-400 μsec
Sweep time	14 sec
Sweep Low Frequency	1-199 pps
Sweep High Frequency	2-200 pps
IRMS	0-50mA
DC component	No

TENS- Symmetrical Biphasic
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature
The Symmetrical Biphasic waveform has a short pulse duration and is capable of strong stimulation of nerve fibers in the skin and in muscle. This waveform is often used in portable muscle stimulation units, and some TENS devices.

Output Mode	Electrodes
Available on Channel	1, 2, 3, 4
Treatment Time (Stim)	1-60 min
Treatment Time (Combo)	1-30 minutes
Mode Selection (Stim)	CC or CV
Mode Selection (Combo)	CV
Output Intensity	0-140 mA (CC) 0-140 V (CV)
Amplitude Modulation	0% (off) to 100% on 10% steps
Burst Frequency	0-10 bps
Cycle Time	Continuous or User Defined
Frequency	1-200 pps
Frequency Sweep	On/Off
Phase Duration	30-400 μsec
Ramp	0-5 sec
Sweep Time	14sec
Sweep Low Frequency	1-199 pps
Sweep High Frequency	2-200 pps
IRMS	0-50mA
DC component	No

TENS – HAN
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature The HAN Waveform provides optimal parameters with a precisely controlled sequence of Dense-and-Disperse (DD) modes of stimulation where a burst of 8 pulses at 80Hz is alternating with continuous stimulation (no burst), each lasting for 3 seconds.

Output Mode	Electrodes
Available on Channels	1, 2, 3, 4
Treatment Time	1-60 min
Mode Selection	CC
Output Intensity	0-100 mA (CC)
Burst Frequency	2 bps
Frequency	80 pps
Phase Duration	180 μsec
IRMS	0-19mA
DC component	No

Microcurrent
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature
Microcurrent is a monophasic waveform of very low intensity.

Output Mode	Electrodes
Available on channels	1, 2, 3, 4
Treatment Time	1-60 Min
Mode Selection	CC
Output Intensity	0-1,000 μA
Duty Cycle	50%
Frequency	0.1-1,000 pps
Polarity	Positive, Negative, or Alternating
IRMS	0- 1mA
DC component	No

VMS™
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature
VMS is a symmetrical biphasic waveform with a 100 µsec interphase interval. Because the pulse is relatively short, the waveform has a low skin load, making it suitable for applications requiring high intensities, such as in muscle re-education protocols.

Output Mode	Electrodes
Available on Channels	1, 2, 3, 4
Treatment Time (Stim)	1-60 min
Treatment time (Combo	1-30 min
Mode Selection	CC or CV
Output Intensity	0- 140 mA (CC) 0-140 V (CV)
Anti-Fatigue	Off or On
Channel Mode	Single, Reciprocal, Co-Contract
Cycle Time	Continuous or User Defined
Frequency	1-200 pps
Phase Duration	30-1,000 μsec
Ramp	0-5 sec
Set Intensity	Individual/both Channel Intensity Setting in Reciprocal and  Co-Contract modes
IRMS	0-50mA
DC component	No

IFC Premodulated (Traditional 2 Pole)
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature Premodulated Current is a medium frequency waveform. Current comes out of one channel (two electrodes). The current intensity is modulated: it increases and decreases at a regular frequency (the Amplitude Modulation Frequency).

Output Mode	Electrodes
Available on Channel	1, 2, 3, 4
Treatment Time (STIM)	1-60 Min
Treatment Time (COMBO)	1-30 Min
Mode Selection	CC or CV
Output Intensity	0-100 mA (CC) 0-100 V (CV)) Carrier
Beat Fixed (Sweep Off)	1-200  Hz
Cycle Time	Continuous or User Defined
Frequency	2,000-10,000 Hz
Sweep Low Beat Frequency	1- 199 Hz
Sweep High Beat Frequency	2-200 Hz
IRMS	0-55mA
DC component	No

 Russian
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature
Russian Current is a sinusoidal waveform, delivered in bursts or series of pulses.

Output Mode	Electrodes
Available on Channels	1, 2, 3, 4
Treatment Time	1-60 min
Mode Selection	CC or CV
Output Intensity	0-100 mA (CC) 0-100 V (CV)
Burst Frequency	1-100 bps
Carrier Frequency	2,500 Hz
Cycle Time	Continuous or User Defined
Duty Cycle	10%, 20%, 30%, 40%, 50%
Ramp	0-5 sec
IRMS	0-39mA DC component

VMS™ Burst
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature VMS Burst is a symmetrical biphasic waveform delivered in a burst format. Because the pulse is relatively short, the waveform has a low skin load, making it suitable for applications requiring high intensities, such as muscle reeducation protocols.

Output Mode	Electrodes
Available on Channels	1, 2, 3, 4
Treatment Time	1-60 min
Mode Selection	CC or CV
Output Intensity	0-140 mA (CC) 0-140 V (CV)
Anti-	Off or On
Burst Frequency	1-200 bps
Channel Mode	Single, Reciprocal, Co-Contract Phase
Cycle Time	Continuous or User Defined
Duration	30-400 μsec
Ramp	0-5 sec
Set Intensity	Individual/both Channel Intensity Setting in Reciprocal and Co-Contract modes
IRMS	0-50mA
DC component	No

DC (Direct Current)
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature Galvanic Current is a direct current flowing in one direction only.
The current can be continuous or interrupted.

Output Mode	Electrodes
Available on Channels	1, 2, 3, 4
Treatment Time	1-60 min
Mode Selection	CC
Output Intensity	0-40 mA (CC)
Cycle Time	Continuous, or User Defined
Polarity Reversal	On or Off With Polarity Reversal On, Polarity will change in the middle of the treatment time.
IRMS	0-44mA
DC component	Yes

VMS™ FR
The VMS-FR version of the VMS waveform is a physiologically based channel interaction in which one channel stimulates the agonist and the other the antagonist of the muscle group that is being exercised.
The agonistic channel initiates the movement with a brief burst of power, followed by a period of sustained activity to complete the movement. The antagonistic channel has a brief burst of power to slow down the initial acceleration of the agonist, followed by a low output to regulate the movement of the agonist. The movement is completed by a final burst of activity in both channels. VMS is a symmetrical biphasic waveform with a 100 µsec interphase interval. Because the pulse is relatively short, the waveform has a low skin load, making it suitable for applications requiring high intensities, such as in muscle re-education protocols.

Output Mode	Electrodes
Available on	Channels 1, 2, 3, 4
Treatment Time	1-60 min
Mode Selection	CC
Output Intensity	0-140 mA (CC)
Burst Duration	200 – 5,000 ms
Cycle Time	TBD
Frequency	20-80 pps
Phase Duration	30-400 μsec
IRMS	0-39mA
DC component	No

High Voltage Pulsed Current (HVPC)
Advice on size and type of electrodes to be used is given in device GUI “treatment guidelines” feature The High Voltage Pulsed Current (HVPC) has a very brief pulse duration characterized by two distinct peaks delivered at high voltage. The waveform is monophasic (current flows in one direction only). The high voltage causes a decreased skin resistance making the current comfortable and easy to tolerate.

Output Mode	Electrodes
Available on Channels	1, 2, 3, 4
Treatment Time (Stim)	1-60 Min
Treatment Time (Combo)	1-30 Min
Mode Selection	CV
Output Intensity	0-500 V (CV)
Cycle Time	Continuous or User Defined
Display	Volts
Frequency	1-200 pps
Polarity	Positive or Negative
Ramp	0.5-5 sec
Sweep time	14sec
Sweep High Frequency	2-200 pps
Sweep Low Frequency	1-199 pps
IRMS	0-45mA
DC component	0 – 1.5mA

ELECTROTHERAPY PATIENT PREPARATION AND ELECTRODE PLACEMENT

• Examine the skin for any wounds and clean the skin.
•  Apply the electrodes to the treatment area.
• Ensure the electrodes are applied securely to the skin.
• Ensure good contact between each electrode and the skin.
• Check the electrode contact regularly during the treatment.
• Examine the skin again after the treatment.
• Choose electrodes that fit the anatomy.
• Prior to administering treatment, view the Electrode Placement recommendations in the Treatment Review screen for the selected modality.
• Follow electrode manufacturer instructions.
• Please note the smaller the electrode size the higher the current density.

DURA-STICK® Electrodes
DURA-STICK® Electrodes are a self adhesive, disposable product designed specifically for use with Intelect® Legend 2.
It is recommended that DURA-STICK® Electrodes be used whenever possible to ensure the highest level of contact with the treatment area and most uniform delivery of the prescribed electrotherapy treatment.
For Electrotherapy operation refer to page 30
DURA-STICK® Electrode Instructions
Connecting Lead Wires

1. Insert the lead with the Red (+) electrode connector into one DURA-STICK ®Electrode.
2. Insert the lead with the Black (-) electrode connector into the other electrode.
3. Make certain the lead wires are seated completely into the electrodes.

NOTE: Use of conductive medium or sponges is not required or recommended. DURA-STICK® electrodes are manufactured to ensure the optimum conductivity during therapy when properly applied.
Securing Electrodes

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

ULTRASOUND PATIENT PREPARATION

1. Examine the skin for any wounds and clean the skin
2. View the Applicator recommendation in the treatment guidelines.
3. Review guidelines for Ultrasound (as a reference point only) on the treatment review screen prior to administering treatment.

NOTE: Applicators are available in the sizes shown below:Applicator Preparation and Use

1. Clean applicator before each therapy session with warm soapy water, check the applicator has no cracks prior to use.
2. Liberally apply transmission gel to the treatment area on the patient.
3. Move the applicator during therapy session in a circular motion. The area treated should be:
   Twice the diameter of the applicator
   For 5cm2 and 10 cm2 US applicator: three times the diameter of the applicator if output power > 4 W, Continuous mode.
   The applicator should always be held by the grip and not by the Ultrasound Applicator head.
4. If US Coupling is “On”, the Applicator is properly  coupled to the patient and administering ultrasound when the LED is constantly illuminated. If the applicator head becomes uncoupled the LED on the head will flash. If “US coupling” setting is ON, several beeps will be also heard until the head is coupled again. Treatment time stops during uncoupling.

NOTE: Ultrasound output will continue to be emitted in all US coupling modes even if the applicator is uncoupled. The output power is reduced to a very low level to prevent ultrasound head warming.
For ULTRASOUND OPERATION, refer to page 32

DEVICE USER INTERFACE

SCREEN DESCRIPTIONEach screen contains the following areas:
Menu Bar
Located at the top of each screen and lists the current screen name.Channel Bar
Located at the bottom of each screen, this area displays the status information about each channel.
When starting a treatment, channels are automatically assigned to the next available channel. Manual selection is done by touching the desired channel.Channel status possibilities:

	Indicates the channel is available for use
	Indicates a treatment for the channel is currently being setup but treatment has not yet begun
	Indicates a treatment for the channel is currently running
	Indicates a treatment for the channel is currently paused
	Indicates a treatment for the channel has completed
	Indicates an ultrasound treatment is running with the left (L) applicator

SETTINGS
The settings icon on the top right hand corner of the home screen menu bar offers users the opportunity to set preferences and can be accessed by pressing the button.Swipe vertically to see more settings

1. On the home screen, the “current screen name” displayed in the middle portion of the menu bar is by default ‘Intelect® Legend 2’.
2. Language: touch this box if you want to choose another language
3. The device name can be changed to a name of your choice, e.g clinic name to do this press the Device name button and enter the new name with the displayed keyboard press Enter and the new device name will be displayed on the home screen.
4.  The date and time can be set by pressing the date and time button, date format and time format can also be set in this screen.
5. Press the screen and sounds button to enter this menu:
   » To adjust the display brightness, select Brightness button. The brightness range is 0% (dimmest) to 100% (brightest) in increments of 10%. Default setting is 80%.
   » To adjust the volume of sound, select the volume button. The volume range is 0% (off) to 100% (loudest) in increments of 10%. Default setting is 40%.
   » Pressing the keyboard sounds button selects either on or off for keyboard sounds. Default setting is ON.
   » Pressing the Keypad layout button allows the keypad format to be changed to QWERTY, AZERTY or QWERTZ
   » Pressing the US coupling sound button allows the user to switch between US coupling sound on or off.
   Default setting is ON.
6. Press the Ultrasound button to enter this menu:
   » Pressing the US coupling sound button allows the user to switch between US coupling sound on or off.
   Default setting is ON
   » Pressing the coupling time button allows the user to switch between Pause (treatment time stops counting down while applicator is uncoupled) and No pause (treatment time will count down even if ultrasound head is uncoupled). Default setting is Pause.
7. Pressing the Display unit version information will show current software version serial number and several device parameters as shown below.
8. Choose pain scale display as NRS or VAS by pressing pain scale button to set required option.
9. Pressing the Data Transfer button will enable the device to connect via Bluetooth® to a Bluetooth® enabled Computer.
10. Press Reset to factory defaults to restore the device to the factory settings, pressing this button will result in a restart and the user will be taken to the initial setup screen on restart.
11. When a USB drive is inserted a new button appears to allow safe ejection of the USB drive, simply press the button and follow the on screen prompts.

HOME SCREEN
The Intelect® Legend 2 Home screen provides access to all of the system modalities and functions. The Home screen has the following information:TREATMENT REVIEW SCREEN
The Intelect® Legend 2 Treatment Review screens for Electrotherapy, Ultrasound and Combo include the following information:
Treatment Review Screen let the user to confirm and modify treatment parameters.Parameter Submenu ScreenIntensity management in dual channel

• Intensity of each channel can be managed individually by simply touching the box to activate it
• If treatment offers the possibility to manage both channel intensities together, a “+” symbol appears in the channel intensity box
• By touching this symbol, both channel intensities boxes are activated together. Turn the rotary knob to increase/ decrease both together
• When intensities are working together, a “-” symbol on each box appears. By touching this symbol the related channel is desactivated so knob will only be aging on the remaining active channel.

GUIDELINES SCREEN
The Guidelines for electrotherapy, ultrasound and combo therapy provide the following information:
Instructions for optimal electrode placement and/or US applicator use at the left side of the screen.
Images illustrating electrode placement and/or US treatment area and recommended applicator choice at the right side of the screen.ELECTROTHERAPY OPERATION
Complete the following steps to begin Electrotherapy treatment:

1. Prepare patient and therapy system for Electrotherapy. Refer to the PATIENT PREPARATION section on for electrode selection, preparing the patient, and securing electrodes.
2. Select ELECTROTHERAPY icon from the home screen
3. Select desired waveformNote: Refer to the System Specifications section of this manual for all waveform specifications for the Intelect Legend 2.
4. SET UP TREATMENT
   On the treatment review screen – you can adjust treatment parameters to desired level.
   Never start with intensity adjustment – first adjust all other parameters and set Intensity just before starting treatment
   Pressing the save button will save the treatment as a custom protocol which can be named by the user Pressing the Assign to button will give two buttons
   -Assign to: this button assigns the treatment data to a specific treatment data file which can be named by the user
   -Open pain scale: this button opens up the pain scale so the pre treatment pain can be recorded
5. START TREATMENT
   Press the start/pause button
6. PAUSE TREATMENT
7. Press the Start/Pause button
   Pausing treatment will automatically display stop treatment button on the Treatment Review screenTo resume treatment, press the Start /Pause button again
   Note: Pause applies to the selected channel only
8. STOP TREATMENT
   First pause treatment by pressing the Start/Pause button

Then press the ‘Stop treatment‘ button on the Treatment Review screen.
When treatment has completed, the Treatment Summary screen will appear with the following options:

• Repeat the treatment by pressing Run again.
• Save button
  » the treatment protocol as a Custom Protocols
• Assign to button
  » Assign therapy information to treatment data
  » Open Pain scale to record post-treatment pain
• Exit Modality and return to home screen

ULTRASOUND OPERATION
Complete the following steps to begin Ultrasound treatment:

1. To prepare the patient’s skin for Ultrasound Therapy, prepare patient as described in the ULTRASOUND PATIENT PREPARATION section.
   NOTE: Use only Intelect® Legend 2 Ultrasound Applicators . Previous models of Chattanooga Ultrasound Applicators will not work with the Intelect® Legend 2.
2. From the home screen, select the Ultrasound icon
3. SET UP TREATMENT
   On the treatment review screen you can adjust treatment parameters to desired level.
   Never start with intensity adjustment – first adjust all other parameters and set Intensity just before starting treatment Save and Assign to buttons behave the same as in Electrotherapy treatment.
4. START TREATMENT
   Press the START button to begin the therapy
5. PAUSE TREATMENT
   Press the Start/Pause button. To resume treatment, press the Start /Pause button again.
   Note: Pause applies to the selected channel only
6. STOP TREATMENT
   – First pause treatment by pressing the Start/Pause button
   – Then press the ‘Stop treatment ‘ box on the treatment review screen.

When treatment has completed, the Treatment Summary screen will appear with the following options:

• Repeat the treatment by pressing Run again.
• Save
  » the treatment protocol to the Custom Protocols
• Assign to:
  » Assign therapy information to treatment data
  » Open Pain scale to record post-treatment pain
• Exit Modality and return to home screen

COMBINATION OPERATION
The Combo modality allows the user to select and use ultrasound therapy in combination with electrical muscle stimulation.
Combination therapy utilizes the Ultrasound modality in conjunction with High Voltage Pulsed Current (HVPC), IFC Premodulated (2p), Asymmetrical Biphasic, Symmetrical Biphasic, or VMS™ to generate a therapeutic effect .
In this mode of therapy, the Ultrasound Applicator becomes one half of the electrical circuit. An electrode attached to the Red (+) Lead Wire completes the circuit .
Complete the following steps to begin Combo treatment:

1. Prepare Patient and therapy system – Refer to the PATIENT PREPARATION section for electrode selection, preparing the patient, and securing electrodes. Ultrasound Patient preparation is found on page 32.
2. Connect the Red (+) Lead Wire from Channel 1 to the electrode. Make certain the Lead Wire is completely seated in the electrode . The Black (-) Lead Wire is not used. The Ultrasound Applicator completes the circuit for Combination Therapy.
3. From the HOME SCREEN, select the COMBO icon.
4. Select the ultrasound combination therapy desired by touching the corresponding icon. Note: for safety reasons not all wave forms are available for combo therapy.
5. SET UP TREATMENT
   On the treatment review screen you can adjust treatment parameters to desired level.
   Never start with intensity adjustment – first adjust all other parameters and set Intensity just before starting treatment
   Pressing the save button will save the treatment as a custom protocol which can be named by the user
   Pressing the Assign to button will give two buttons as seen below
   – Assign to: this button assigns the treatment data to a specific treatment data file which can be named by the user
   – Open pain scale: this button opens up the pain scale so the pre-treatment pain can be recorded
6. START TREATMENT
   Press the START button to begin the therapy
7. PAUSE TREATMENT
   Press the Start/Pause button. To resume treatment, press the Start /Pause button again
   Note: Pause applies to the selected channel only
8. STOP TREATMENT
   – First pause treatment by pressing the Start/Pause button
   – Then press the ‘Stop treatment ‘ box on the treatment review screen.

When treatment has completed, the Treatment Summary screen will appear with the following options:

• Repeat the treatment by pressing Run again.
• Save
  » the treatment protocol to the Custom Protocols
• Assign to:
  » Assign therapy information to treatment data
  » Open Pain scale to record post-treatment pain
• Exit Modality and return to home screen

SPS (SUGGESTED PARAMETER SETUP)
The Intelect® Legend 2 has a Suggested Parameter Setup (SPS) icon that is a series of protocol presets where the clinical benefit and target condition are selected by the user, and the suggested algorithm will select the parameter settings. All settings can be edited to suit appropriate patient treatment prescription and patient comfort.
Please note, the referenced SPS parameters are suggestions/guidelines only, and are based on historical experience obtained for the device within the clinical setting. 
COMPLETE THE FOLLOWING STEPS TO START AN SPS PROTOCOL:

1. Select SPS from the Home Screen
2. Select Clinical Benefit
3. Select target
4. Select MODALITY/WAVEFORM
5. SET UP TREATMENT
   On the treatment review screen the suggested treatment settings are displayed and you can adjust parameters to desired level.
   Never start with intensity adjustment – first adjust all other parameters and set Intensity just before starting treatment Pressing the save button will save the treatment as a custom protocol which can be named by the user Pressing the Assign to button will give two buttons as seen below
   – Assign to: this button assigns the treatment data to a specific treatment data file which can be named by the user
   – Open pain scale: this button opens up the pain scale so the pre-treatment pain can be recorded
6. START TREATMENT
   Press the START button

TREATMENT DATA
After a treatment has been completed, Treatment data can be saved on the Intelect® Legend 2 for later use on the unit.
Click on Assign To button. Treatment data can be assigned to a folder at any time of the treatment (set up, running or completed) but data will only be saved once the treatment is finished and channel is free for next treatment (after pressing EXIT button on Treatment Summary screen)
Open Pain scale to record post-treatment pain
The TREATMENT DATA screen appears
Save treatment data to an existing ID folder or create and save to a new ID folderSAVE TREATMENT DATA TO A NEW ID: Enter ID and Save
VIEW AND MANAGE TREATMENT DATA: Press the TREATMENT DATA ICON on the home screen

1. VIEW Treatment Data
   Select desired ID folder
   The TREATMENT HISTORY is displayed including all previously saved treatment sessions ranked chronologically
2. DELETE Treatment Data

CUSTOM PROTOCOLS
The Intelect® Legend 2 allows for a maximum of 25 custom protocols to be defined.
SAVE A CUSTOMIZED PROTOCOL
A new custom protocol may be saved at any time using SAVE button

1. Touch SAVE on the TREATMENT REVIEW or TREATMENT SUMMARY screen2. NAME CUSTOM PROTOCOL WITH KEYBOARD
   CREATE NEW CUSTOM PROTOCOL: Enter Custom Protocol Name and Save
   VIEW AND MANAGE CUSTOM PROTOCOLS: Touch the CUSTOM PROTOCOLS icon on the Home Screen

1. VIEW Custom Protocol
Select desired Custom Protocol. The TREATMENT REVIEW SCREEN is displayed showing the protocol settings.
Start treatment or perform other actions as described in the Electrotherapy/Ultrasound/Combo Operations section
2. DELETE custom protocolSHORT CUTS
Intelect® Legend 2 allows for 12 custom protocol shortcut assignments on the home screen.
ASSIGN SHORTCUT
Complete the following steps to assign a home screen shortcut. Unassigned Shortcut icons appear grey in colour: Press one of the unassigned “Shortcut” icons on the Home screen .
Select the desired protocol in the Custom Protocol library
Shortcut assigned on Home screen: Once assigned the shortcut icon becomes the colour and icon associated with the modality it containsUNASSIGN SHORT CUT
Complete the following steps to unassign a Home screen shortcut for a customized protocol:
From the Home screen, press and hold the shortcut icon you wish to unassign.
The unit will display a text box asking, “Remove “My Custom Protocol 1” shortcut?”
Select Cancel to quit the unassignment process and return to the Home screen or “Confirm” to continue with the unassignment process. After selecting “Confirm” the previously assigned shortcut will no longer appear on the Home screen.

CLINICAL RESOURCES
The Intelect® Legend 2 contains a unique Clinical Resources Library. The anatomical and pathological image library are designed to aid the operator in visually understanding and locating specific muscle groups and commonly identified issues associated with pathological conditions, as well as providing an educational tool for the clinician to use with the patient. The modality and waveform descriptions provide information about the physical background and physiological effects of the different electrotherapy waveforms and ultrasound therapy, aiming to assist the user in selecting the appropriate modality/waveform.
Complete the following steps to view the Clinical Resources Library:
Press the Clinical Resources Library icon on the Home screen .
ANATOMICAL /PATHOLOGICAL IMAGE LIBRARY
Complete the following steps to view the Anatomical or Pathological Image Library:

1. Press the Anatomical or Pathological Image Library icon on the Clinical Resources screen
2. Touch the body part for which you wish to view information.
   Choose either anterior (on left of screen) or posterior (on right of screen).
3. The available images for the selected body part are displayed.
   Touch the image you want to see in full screen mode.
4. Full screen image

MODALITY/WAVEFORM DESCRIPTIONS
Complete the following steps to view the ultrasound or waveform descriptions:

1. Press the Electrotherapy Waveform/Ultrasound/Combo Description icon on the Clinical Resources screen
2. Select the desired waveform (in case of Electrotherapy Waveform description)
3. The modality or waveform description is displayed

TROUBLESHOOTING

1. All system messages, warning messages and fault messages that are generated by the device are self-explanatory excepting system error.
2. If System error occurs, note error code and contact Enovis selling dealer or Enovis Service Department at ChattProduct.Support@djoglobal.com or +1 800-494-3395

REPLACEMENT ACCESSORIES
The following provides users of the Intelect® Legend 2 the necessary information to order replacement accessories used with the system. This list of replacement accessories is designed for use with the Intelect® Legend 2. When ordering, provide the respective part number, description, and quantity desired.
ELECTRODES

Model Number	Description
42209	Durastick Premium 5 cm (2”) Square (40/Case = 10 packs of 4)
42210	Durastick Premium 5 x 9 cm (2 x 3.5”) Rectangle (40/Case = 10 packs of 4)
42205	Durastick Premium 3.2 cm (1.25”) Round (40/Case = 10 packs of 4) (not recommended for sEMG use)
42206	Durastick Premium 5 cm (2”) Round (40/Case = 10 packs of 4)
42207	Durastick Premium 4 x 6 cm (1.5 x 2.5”) Oval (40/Case = 10 packs of 4)
42208	Durastick Premium 8 x 13 cm (3 x 5”) (2 pack)
42211	Durastick Premium 5 cm (2”) blue gel Oval (40/Case = 10 packs of 4)
42212	Durastick Premium 4 x 9 cm (1.5 x 3.5”) blue gel Rectangle (40/Case = 10 packs of 4)
42198	Durastick Plus 5 cm (2”) cloth Square (40/Case = 10 packs of 4)
42193	Durastick Plus 5 cm (2”) foam Square (40/Case = 10 packs of 4)
42199	Durastick Plus 5 x 9 cm (2 x 3.5”) cloth Rectangle (40/Case = 10 packs of 4)
42194	Durastick Plus 5 x 9 cm (2 x 3.5”) foam Rectangle (40/Case = 10 packs of 4)
42200	Durastick Plus 5 x 10 cm (2 x 4”) cloth – double wire (2 pack) Rectangle
42218	Durastick Plus 1.5 x 15 cm (0.5 x 6”) cloth (6 pack) Rectangle
42219	Durastick Plus 3.2 cm (1.25”) cloth Round (40/Case = 10 packs of 4) (not recommended for sEMG use)
42197	Durastick Plus 5 cm (2”) cloth Round (40/Case = 10 packs of 4)
42192	Durastick Plus 5 cm (2”) foam Round (40/Case = 10 packs of 4)
42195	Durastick Plus 4 x 6 cm (1.5 x 2.5”) foam Oval (40/Case = 10 packs of 4)
42196	Durastick Plus 5 x 10 cm (2 x 4”) foam Oval (40/Case = 10 packs of 4)
42201	Durastick Plus 5 cm (2”) cloth – clip Square (40/Case = 10 packs of 4)
42202	Durastick Plus 5 x 10 cm (2 x 4”) cloth – clip Rectangle (40/Case = 10 packs of 4)
42204	Durastick Plus 5 cm (2”) cloth Square (40/Case = 10 packs of 4)
42203	Durastick Plus 5 x 10 cm (2 x 4”) cloth – double snap (2 pack) Rectangle
42188	Durastick Plus 5 cm (2”) (2 pack) Square
42189	Durastick Plus 5 x 9 cm (2 x 3.5”) (2 pack) Rectangle
42190	Durastick Plus 5 cm (2”) Square (40/Case = 10 packs of 4)
42191	Durastick Plus 5 x 9 cm (2 x 3.5”) Rectangle (40/Case = 10 packs of 4)

ELECTROTHERAPY ACCESSORIES

Model Number	Description
12-10648	Nylatex strap
79967	6 x 8 cm (2.5 x 3”) carbon electrodes (4x)

GENERAL ACCESSORIES

Model Number	Description
14679	Wall power cable 3m USA
14819	Wall power cable 3m Australia plug
15-1136	Mobile 2 Cart
79977	HIGHVOLT PROBE KIT- Includes Probe and Sponge Applicator Tips (15 and 8 mm)
114.121	Finger guard
70010	STIM CH 1/2 LEADWIRE KIT STD
70011	STIM CH 3/4 LEADWIRE KIT STD
70012	STIM CH 1/2 LEADWIRE KIT XL
70013	STIM CH 3/4 LEADWIRE KIT XL

BATTERY

Model Number	Description
14-1086	Battery type ABI-L 18650-5S1P

ULTRASOUND APPLICATORS AND GEL

Model Number	Description
15-0160	G16 Ultrasound Applicator 1 cm2
15-0161	G16 Ultrasound Applicator 2 cm2
15-0162	G16 Ultrasound Applicator 5 cm2
15-0163	G16 Ultrasound Applicator 10 cm2
4248	Conductor™ Transmission Gel – 9 oz Bottle

CLEANING THE INTELECT® LEGEND 2
With the system disconnected from the power source, clean the system with a clean, lint-free cloth moistened with water and mild antibacterial soap. If a more sterile cleaning is needed, use a cloth moistened with an antimicrobial cleaner.
Cleaning should be performed daily.
Do not submerge the system in liquids. Should the unit accidentally become submerged, contact the dealer or DJO Service Department immediately.
Cleaning the LCD Screen
Clean the LCD with a clean, dry cloth, in the same way as cleaning the computer monitor screen. Do not use abrasive materials or chemicals or liquids.
Cleaning instruction for the Ultrasound applicator
The sound head may be cleaned with alcohol between each therapy session. The Aluminium surface may be disinfected with alcohol, but avoid the plastic area.
CALIBRATION REQUIREMENTS
The unit was calibrated during the manufacturing process and doesn’t need calibration during the product life.
INSTRUCTION FOR SOFTWARE
UPGRADE

1. Go to the Chattanooga website www.chattanoogarehab.com
2. Go to Intelect® Legend 2 product page
3. Complete the registration form to be informed about new product software version availability and IFU updates (if not already done before)
4. Go to the downloads tab
5. Download firmware upgrade zip file and extract the file
6. Erase the USB drive supplied with the Intelect® Legend 2
7. Copy the extracted files on to the USB drive
8. Switch OFF the device
9. Remove optional Battery and insert USB key drive into the USB port inside of the battery compartment on the bottom of the device
10. Switch ON the device
11. Device will automatically detect firmware update availability and commence upgrade, the upgrade will take some minutes and the power must not be switched off during the upgrade
12. Once firmware update is finished, Home screen will be displayed and the USB drive can be removed. Device is ready for use.
13. Check software version in settings

DEVICE DISPOSAL
Council Directive 2012/19/EU concerning Waste Electrical and Electronic Equipment (WEEE) requires not to dispose of WEEE as municipal waste. Contact your local distributor for information regarding disposal of the unit and accessories.

WARRANTY REPAIR/OUT OF WARRANTY REPAIR

Service
When the Intelect® Legend 2 or any accessories require service, contact your selling dealer or your DJO Service Department contact.
Service to these units will be performed only by a service technician certified by the Company.
Expected Life

• Device expected life is five years
• Accessories expected life is one year
• Gel electrodes and ultrasound gel are shelf life accessories and their shelf life is less than device expected service life. Shelf life is indicated in electrodes packaging and gel bottle.

WARRANTY
DJO LLC (“Company”) warrants that the Intelect® Legend 2 and Vacuum Module (“Products”) are free of defects in material and workmanship. This warranty shall remain in effect for two years (24 months) from the date of original consumer purchase.
During the two-year warranty period from the date of delivery of the product to the end customer, defects will be remedied at no charge to the customer upon the customer furnishing adequate proof that the defect is due to defects in material or workmanship.
Attention
Modifications to the device are not permitted. Any unauthorized opening, repair or modification of the device by unauthorized personnel will relieve the manufacturer of its liability and responsibility for safe system operation. This will automatically void the warranty even before the end of the warranty period.
The warranty period for accessories is 90 days. Accessories consist of Lead Wires and Electrodes.
The warranty period for the Therapy System Cart and Ultrasound Applicators is one year (12 months).
This Warranty Does Not Cover:

• Replacement parts or labor furnished by anyone other than the Company, the selling dealer or a Company service technician
• Defects or damage caused by labor furnished by someone other than Company, the selling dealer or a Company service technician
• Any malfunction or failure in the Product caused by product misuse, including, but not limited to, the failure to provide reasonable and required maintenance or any use that is inconsistent with the Product User’s Manual

COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES.
This warranty gives you specific legal rights and you may also have other rights which vary from location to location. The Company does not authorize any person or representative to create for it any other obligation or liability in connection with the sale of the Product.
Any representative or agreement not contained in the warranty shall be void and of no effect.
THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

APPENDIX

ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES
Guidance and manufacturer’s declaration – electromagnetic emissions
The Intelect® Legend 2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Intelect® Legend 2 should assure that it is used in such an environment.

Emissions test	Compliance	Electromagnetic environment – guidance
RF emissions CISPR 11	Group 1	The Intelect® Legend 2 uses RF energy only for its internal function. Additionally the Intelect® Legend 2 contains a Bluetooth® radio module. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11	Class B
Harmonic emissions IEC 61000-3-2	Class A	The Intelect® Legend 2 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/ flicker emissions IEC 61000-3-3	Complies

Guidance and manufacturer’s declaration – electromagnetic immunity
The Intelect® Legend 2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Intelect® Legend 2 should assure that it is used in such an environment.

Immunity Test	IEC 60601 Test Level	Compliance Level	Electromagnetic Environment – Guidance
Electrostatic discharge (ESD) IEC 61000-4-2	± 8 kV contact ± 15 kV air	± 8 kV contact ± 15 kV air	• Maintain humidity in the use environment to at least 50% relative humidity. • Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, DJO recommends implementing additional controls to maintain relative humidity to at least 50%. • Communicate these ESD-precautionary procedures to healthcare staff, contractors, visitors and patients.
Electrical fast transient/burst IEC 61000-4-4	± 2 kV for power supply lines	± 2 kV for power supply lines	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	± 1 kV line(s) to line(s) ± 2 kV line(s) to ground	± 1 kV differential mode ± 2 kV line(s) to ground	Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on  power supply input linesIEC 61000-4-11	0% UT; 0.5 cycle at 0°,45°, 90°, 135°, 180°, 225°, 270°, 315° 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase at 0°	0% UT; 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315° 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase at 0°	Mains power quality should be that of a typical commercial or hospital environment. If the user of the Intelect® Legend 2 requires continued operation during power mains interruptions, it is recommended that the Intelect® Legend 2 be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	30 A/m	30 A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Proximity magnetic fields IEC 61000-4-39	CW; 8 A/M 2.1 KHZ; 65 A/M 50 KHZ; 7.5 A/M	CW; 8 A/M 2.1 KHZ; 65 A/M 50 KHZ; 7.5 A/M	Test frequency 30 kHz Test frequency 134.2 kHz Test frequency 13.56 MHz
NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity
The Intelect® Legend 2 is intended for use in the electromagnetic environment specified below.
The customer or the user of the Intelect® Legend 2 should assure that it is used in such an electromagnetic environment.

IMMUNITY test	IEC 60601 TEST LEVEL	Compliance level	Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6	3 Vrms 150 kHz to 80 MHz outside ISM bandsa 6 Vrms 150 kHz to 80 MHz in ISM bandsa	3 Vrms 6 Vrms	The device is intended for use in a typical professional healthcare facility environment.
Radiated RF IEC 61000-4-3	3 V/m 80 MHz to 2.7 GHz 9-28V/min w ireless bands	3 V/m 9-28V/m	Portable RF communications equipment should be used no closer than 30 cm (12 inches) to any part of the Intelect® Legend 2, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Individual results may vary. Neither DJO Global, Inc. nor any of its subsidiaries dispense medical advice.
The contents of this brochure do not constitute medical, legal, or any other type of professional advice.
Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.

DJO Global
5919 Sea Otter Place, Suite 200
Carlsbad, CA 92010 U.S.A.DJO LLC
5919 Sea Otter Pl
Ste 200, Carlsbad,
California, 92010-6750
djoglobal.com
© 2023 DJO – 14-1602
EN – Rev B 5/23/2023

Documents / Resources

Intelect Legend 2 Combo Units [pdf] User Manual 12-5010, 12-5011, Legend 2 Combo Units, Legend 2, Combo Units, Units

References

• User Manual