Intelect Mobile Combo Model 2778 User Manual Rev G

TABLE OF CONTENTS

Intelect® Mobile Combo

FOREWORD... 1 PRODUCT DESCRIPTION... 1 SAFETY PRECAUTIONS... 2 PRECAUTIONARY DEFINITIONS... 2 CAUTIONS... 3 WARNINGS... 5 DANGERS... 7 INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS FOR ELECTROTHERAPY... 9 Indications for VMS, Russian, TENS, High Voltage Pulsed Current (HVPC), 2 Pole IFC, 4 Pole IFC, and Premodulated Waveforms... 9 Additional Indications for Microcurrent, 2 Pole IFC, 4 Pole IFC, Premodulated, VMS™, and TENS Waveforms... 9 Indications for Galvanic Continuous Mode... 9 Contraindications... 9 Additional Precautions... 9 Adverse Effects... 10 INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS FOR ULTRASOUND THERAPY... 11 Indications for Ultrasound... 11 Contraindications... 11 Additional Precautions... 11 Potential for Burns... 12 Preventing Overheating of the Sound Heads... 12

Preventing Adverse Effects... 12 OVERVIEW... 14 Common Terms... 14 Description of Ultrasonic Field... 19 NOMENCLATURE... 20 SPECIFICATIONS... 24 UNIT SPECIFICATIONS... 24 Description of Device markings... 24 WAVEFORM SPECIFICATIONS... 25 ULTRASOUND TECHNICAL SPECiFiCATiONS... 32 SOUND HEAD SPECIFICATIONS... 33 SETUP... 34 MOUNTING THE UNIT ON THE WALL... 34 INSTALLING THE BATTERY PACK... 38 CHARGING THE BATTERY PACK... 40 USING THE BATTERY PACK... 40 PATIENT PREPARATION... 41 ELECTROTHERAPY PATIENT PREPARATION... 41 Electrode Placement... 41 DURA-STICK® Electrodes... 42 Reusable Carbon Electrodes... 42 DURA-STICK® Electrode Instructions... 43 Connecting Lead Wires... 43 Securing Electrodes... 43 Reusable Carbon Electrodes... 44 i

TABLE OF CONTENTS

Intelect® Mobile Combo

Connecting Lead Wires... 44 Conductive Medium... 44 Securing Electrodes... 44 ULTRASOUND THERAPY PATIENT PREPARATION... 45 OPERATION... 46 STARTING, STOPPING, AND INTERRUPTING ELECTROTHERAPY... 46 STARTING, STOPPING, AND INTERRUPTING ULTRASOUND THERAPY... 51 STARTING, STOPPING, AND INTERRUPTING COMBINATION THERAPY... 56 USING CLINICAL INDICATIONS... 60 CREATING A USER PROTOCOL FOR ELECTROTHERAPY... 61 CREATING A USER PROTOCOL FOR ULTRASOUND THERAPY... 63 CREATING A USER PROTOCOL FOR COMBINATION THERAPY... 65 USING PROTOCOLS... 68 SYSTEM UTILITIES... 70 Audible Tones... 70 Changing Protocol Parameters... 70 Changing Default Protocols for Electrotherapy... 71 Changing Default Protocols for Ultrasound Therapy . . . 73 Changing Default Protocols for Combination Therapy . 74

Brightening or Dimming the LCD... 77 Restoring Factory Protocols... 78 Changing Languages... 79 Restoring Factory Settings... 80 Viewing Unit Version Information... 81 TROUBLESHOOTING... 83 ERROR CODES... 83 TROUBLESHOOTING THE DISPLAY AND ERROR MESSAGES... 85 Troubleshooting the Display... 85 Troubleshooting Error Messages... 85 ACCESSORIES... 86 Standard Accessories... 86 Optional Accessories... 86 Mains Power Cords... 86 MAINTENANCE... 87 MAINTAINING THE UNIT... 87 Cleaning the Unit and the Accessories... 87 FACTORY SERVICE... 88 WARRANTY... 89

ii

FOREWORD

Intelect® Mobile Combo

This manual has been written for the users of the Intelect® Mobile Combo units. It contains general information on the operation, precautionary practices, and maintenance information. In order to maximize use, efficiency, and the life of the unit, read this manual thoroughly and become familiar with the controls, as well as the accessories before operating the system. Specifications put forth in this manual were in effect at the time of publication. However, owing to DJO, LLC's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of DJO, LLC. Before administering any treatment to a patient, the users of this equipment should read, understand, and follow the information contained in this manual for each mode of treatment available, as well as the indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the application of electrotherapy.

Product Description

The Intelect Mobile Combo, designed and manufactured by DJO, LLC, offers a new dimension in clinical electrotherapy and ultrasound made possible by software design and digital signal processing. Effectiveness of this treatment is dependent upon correct use. If treatment times are exceeded, the therapy may not result in positive clinical outcomes. Stay current with the latest clinical developments in the field of electrotherapy. Observe all applicable precautionary measures for treatment. Keep informed of appropriate indications and contraindications for the use of electrotherapy and ultrasound. This equipment is to be used only under the prescription and supervision of a licensed practitioner. NOTE: The unit was calibrated during the manufacturing process and is ready to be placed into service upon delivery.

©2009 DJO, LLC Vista, California, USA. Any use of editorial, pictorial, or layout composition of this publication without express written consent from DJO, LLC is strictly prohibited. This publication was written, illustrated, and prepared for distribution by DJO, LLC.

1

Safety precautions

Intelect® Mobile Combo

Precautionary Definitions 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: Dangerous Voltage Text with a “Dangerous Voltage” indicator serves to inform the user of possible hazards resulting in the electrical charge delivered to the patient in certain treatment configurations of TENS waveforms.

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

Corrosive

Text with a “Corrosive" indicator will explain possible safety infractions if the chemical components of the battery are exposed to air, skin or other materials.

Spontaneous Combustion Text with a “Spontaneous Combustion" indicator will explain possible safety infractions that could create conditions for a spontaneous combustion if the material is mishandled and not disposed of properly.

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

Biohazardous Materials Text with a “Biohazard” indicator serves to inform the user of possible hazards resulting in improper handling of components and accessories that have come in contact with bodily fluids.

Non-Ionizing Electromagnetic Radiation

Text with a “Non-Ionizing Electromagnetic Radiation" indicator informs the user of possible hazards resulting from elevated, potentially dangerous, levels of non-ionizing radiation.

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:

2

Throughout this manual, “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described.

Safety precautions

Intelect® Mobile Combo

cautions

• Inspect cables and connectors before each use. • The Intelect Mobile Combo is not designed to prevent the ingress of

• 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. • DO NOT operate the Intelect Mobile Combo unit when connected to any unit other than DJO, LLC devices. • DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. • 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, transported, and stored in temperatures between 15 °C and 40 °C (59 °F and 104 °F), with relative humidity ranging from 30%-60%, and where the atmospheric pressure is between 950 h Pa and 1050 h Pa. • The Intelect battery pack is designed for use only with Chattanooga Intelect Mobile Stim, Combo, Laser, and Ultrasound systems. • The unit should be routinely checked before each use to determine that all controls function normally; especially that the intensity control properly adjusts the intensity of the electrotherapy and ultrasonic power output in a stable manner. Also, determine that the treatment time control actually terminates electrotherapy and ultrasonic power output when the timer reaches zero.

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 permit any foreign materials or liquids to enter the unit. Take care to prevent any foreign materials including, but not limited to, inflammables, water, and metallic objects from entering the unit. These may cause unit damage, malfunction, electrical shock, fire, or personal injury. • Handle the applicator with care. Inappropriate handling of the applicator may adversely affect its characteristics. • Before each use, inspect the applicator for cracks, which may allow the ingress of conductive fluid. • This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the 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.

3

Safety precautions

Intelect® Mobile Combo

cautions (continued)

• Failure to use and maintain the Intelect Mobile Combo and its

• Where the integrity of the external protective earth conductor

accessories in accordance with the instructions outlined in this manual will invalidate your warranty. • Nylatex® Wraps contain dry natural rubber and may cause allergic reactions in patients with allergies to latex. • Use of parts or materials other than DJO, LLC's can degrade minimum safety. • Unit contains an internal battery charger. Never attempt to charge the battery using an external power source.

arrangement is in doubt, equipment shall be operated from its internal electrical power source. • Using a high intensity electrotherapy setting in conjunction with high intensity ultrasound setting may cause the unit to reset. • The battery pack should be removed when storing the unit for extended periods of time. • DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury. • DO NOT remove the cover. This 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 the dealer for repair service.

4

Safety precautions

Intelect® Mobile Combo

Warnings

• These devices are restricted to sale by, or on the order of, a physician

• Before administering any treatment to a patient you should become

or licensed practitioner. This device should be used only under the continued supervision of a physician or licensed practitioner. • 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 should be used only under the continued supervision of a physician or licensed practitioner. • TENS waveforms have no curative value. • TENS is a symptomatic treatment, and as such, suppresses the sensation of pain which would otherwise serve as a protective mechanism. • The user must keep the device out of the reach of children. • Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when TENS stimulation is in use. • Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer.

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 electrotherapy and ultrasound. • To prevent electrical shock, disconnect the unit from the power source before attempting any maintenance procedures. • 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 because 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.

5

Safety precautions

Intelect® Mobile Combo

Warnings (continued)

• Output current density is inversely related to electrode size. Improper application may result in patient injury. • Always keep the sound head in constant motion. • Always keep the sound head in full contact with the patient’s skin or submerged under water when setting intensity. • Use ample conductive gel to ensure good coupling throughout the treatment. If needed, apply when setting intensity. • Be sure to read all instructions for operation before treating a patient. • Dispose of all products in accordance with local and national regulations and codes. • Use of controls, adjustments, or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous conditions causing damage to the battery pack or cells. • To prevent electrical shock, disconnect the battery pack from the system before attempting any maintenance procedures. • Do not drop the applicator on hard surfaces. Do not cool an overheated sound head with ice water or ice packs. Do not allow the sound head to reach maximum temperatures repeatedly. All of these conditions are likely to damage the sound head crystal. Damage resulting from these conditions is not covered under the warranty.

• In the event that an Error message or Warning appears beginning

with a 2 or 3, immediately stop all use of the unit and contact the dealer or DJO, LLC for service. Errors and Warnings in these categories indicate an internal problem with the unit that must be tested by DJO, LLC or a Field Service Technician certified by DJO, LLC before any further operation or use of the system. • Use of a unit 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. • Do not turn the unit on or off while it is connected to the patient. • 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. • Use only accessories that are specially designed for this (table, unit, device, etc). Do not use accessories manufactured by other companies on this (table, unit, device, etc). DJO, LLC is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories or cables may result in increased emissions or decreased immunity of this (table, unit, device, etc). • Remove the Ultrasound or Laser Applicator by pulling the cable connector only. DO NOT remove by pulling the cable.

6

Safety precautions

Intelect® Mobile Combo

Dangers

• DO NOT connect the unit to an electrical supply without

• Stimulus delivered by the TENS waveforms of this

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, LLC dealer if the unit is not properly rated. • NiMH Batteries contain Class E corrosive materials. In the event of battery cell rupture or leakage, handle battery pack wearing neoprene or natural rubber gloves. Contents of a ruptured or leaking battery can cause respiratory irritation. Hypersensitivity to nickel can cause allergic pulmonary asthma. Contents of cell coming in contact with skin can cause skin irritation and/or chemical burns. • Never, under any circumstances, open the battery pack housing or cells. Should an individual battery from a battery pack become disassembled, spontaneous combustion of the negative electrode is possible. There can be a delay between exposure to air and spontaneous combustion.

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, microwave diathermy, therapeutic ultrasound diathermy, or laser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave, ultrasound, and laser) can be transferred through the implanted neurostimulation system, can cause tissue damage, and can result in severe injury or death. Injury, damage, or death can occur during diathermy therapy even if the implanted neurostimulation system is turned “off.” • Before each use, check the condition of the housing and the insulation of the electrodes, electrode connection cable, and the power supply cable. Also make sure that the cables have been routed correctly.

7

Safety precautions

Intelect® Mobile Combo

Dangers (continued)

• Charge the battery pack according to the instructions found in this

manual. Never attempt to charge the battery pack on any other charging mechanism. • Use the battery pack only with the Intelect Mobile Series units. • Do not reverse the polarity of the battery pack. Doing so can increase the individual cell temperature and cause cell rupture or leakage. • Never dispose of the battery pack in fire. Never short circuit the battery pack. The battery pack may explode, ignite, leak, or get hot causing serious personal injury. • Dispose of NiMH batteries according to national, state, and local codes and regulations.

8

Safety precautions

Intelect® Mobile Combo

Indications, Contraindications, and Adverse Effects for electrotherapy • Other contraindications are patients suspected of carrying serious Indications for VMS, Russian, TENS, High Voltage Pulsed infectious disease and or disease where it is advisable, for general Current (HVPC), 2 Pole IFC, 4 Pole IFC, and Premodulated medical purposes, to suppress heat or fevers. Waveforms • Relaxation of muscle spasms • Electrode placements must be avoided that apply current to the carotid sinus region (anterior neck) or transcereberally (through • Prevention or retardation of disuse atrophy the head). • Increase local blood circulation • Safety has not been established for the use of therapeutic • Muscle re-education electrical stimulation during pregnancy. • Maintaining or increasing range of motion • Powered muscle stimulators should not be used on patients with Additional Indications for Microcurrent, 2 Pole IFC, 4 Pole IFC, cardiac demand pacemakers. Premodulated, VMS™, and TENS Waveforms • There should not be any use of TENS waveforms on patients with • Symptomatic relief of chronic, intractable pain cardiac demand pacemakers. • Post-traumatic acute pain Additional Precautions • Post-surgical acute pain • Caution should be used for patients with suspected or diagnosed heart problems. Indications for Galvanic Continuous Mode • Relaxation of muscle spasms • Caution should be used for patients with suspected or diagnosed epilepsy. Contraindications • Caution should be used in the presence of the following: • This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome xxWhen there is a tendency to hemorrhage following acute has been diagnosed. trauma or fracture; xxFollowing recent surgical procedures when muscle contraction • This device should not be used when cancerous lesions are may disrupt the healing process present in the treatment area. xxOver a menstruating or pregnant uterus • This device should not be used when open wounds are xxOver areas of the skin which lack normal sensation present in the treatment area.

9

Safety precautions

Intelect® Mobile Combo

Indications, Contraindications, and Adverse Effects for electrotherapy (continued)

• 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 effectiveness of TENS waveforms is highly dependent upon patient selection by a person qualified in the management of pain patients. Adverse Effects • Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators. • Potential adverse effects with TENS are skin irritation and electrode burns.

10

Safety precautions

Intelect® Mobile Combo

Indications, Contraindications, and Adverse Effects for ultrasound Therapy • Over the thoracic area if the patient is using a cardiac pacemaker. Indications for Ultrasound • Over a healing fracture. Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: • Over or applied to the eye. • Over a pregnant uterus. • Relief of pain, muscle spasms and joint contractures • On ischemic tissues in individuals with vascular disease where • Relief of pain, muscle spasms and joint contractures that may be the blood supply would be unable to follow the increase in associated with: metabolic demand and tissue necrosis might result. • Adhesive capsulitis Additional Precautions • Bursitis with slight calcification Additional precaution should be used when the ultrasound is used • Myositis on patients with the following conditions: • Soft tissue injuries • Over an area of the spinal cord following a laminectomy (i.e., • Shortened tendons due to past injuries and scar tissues when major covering tissues have been removed). • Relief of sub-chronic and chronic pain and joint contractures • Over anesthetic areas. resulting from: • On patients with hemorrhagic diatheses. • Capsular tightness • Capsular scarring

Contraindications

Patients with an implanted neurostimulation or defibrillator device must not be treated with or be in close proximity to any shortwave diathermy, microwave diathermy, therapeutic ultrasound diathermy or laser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave, ultrasound, and laser) can be transferred through the implanted neurostimulation system, can cause tissue damage and can result in severe injury or death. Injury, damage or death can occur during diathermy therapy even if the implanted neurostimulation system is turned “off.”

This device should not be used: • For symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • When cancerous lesions are present in the treatment area. • When open wounds are present in the treatment area. • 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. 11

Safety precautions

Intelect® Mobile Combo

Indications, Contraindications, and Adverse Effects for ultrasound (continued) • You can also reduce the power or duty cycle during the Potential for Burns treatment if you are treating an area where it is difficult to obtain It is possible for ultrasound therapy to cause burns if the therapy is good coupling. not properly performed. Skin burns can result from one or more of Preventing Adverse Effects the following: Perform the following procedures to avoid the negative effects of • If the intensity (power) is too high. ultrasound therapy. • If you are using too low a frequency. Sound Head Movement • Using a stationary technique (holding the sound head in one place). If movement of the sound head is too slow, the patient may feel • Moving the sound head too slowly. periosteal pain characterized by a deep ache or pain. If motion is too • Treating an area with sensory nerve damage (or the loss of fast, or if the sound head does not maintain good contact with the normal skin sensations). skin, the therapeutic effect of the sound waves will be reduced and • Desensitized areas can be overheated or burned without the the sound head may overheat. patient’s knowledge. Use extreme caution with these patients Patient Susceptibility (e.g., diabetes, neural damage, etc.). Some patients are more sensitive to ultrasound output and may • Bony prominences are especially vulnerable: they reflect sound experience a reaction similar to a heat rash. Be sure to inspect the waves and increase intensity to the periosteum. treatment area during and following treatment. Discontinue if an Preventing Overheating of the Sound Heads adverse reaction occurs. To prevent the sound head from becoming overheated, do the Output Power following: Choose a lower watt setting to reduce output or select a pulsed • Check to be sure proper contact is being made throughout the duty cycle. Higher output levels have a greater potential for patient treatment. discomfort. • When treating in water, make sure that the sound head is completely under water. • For direct coupling, you may need to apply more conductive gel or lotion during the treatment to achieve better coupling.

12

Safety precautions

Intelect® Mobile Combo

Indications, Contraindications, and Adverse Effects for ultrasound (continued) Coupling Coupling is described as contact between the sound head and the treatment site and may be accomplished through the use of a coupling agent, such as gel, lotion, or water (underwater treatments only). Anything used as a coupling agent must be highly conductive. Air is a very poor conductor of ultrasonic waves. Head Max. Temp. Disclaimer Head Max. Temp. is for the protection of the equipment, not for the protection of the patient. For more information, see page 85.

13

OVERVIEW

Intelect® Mobile Combo

The Intelect Mobile Combo, designed and manufactured by DJO, LLC, offers a new dimension in portable electrotherapy and ultrasound made possible by advanced software design and digital signal processing. The result is a unit with extraordinary versatility based on simplicity of operation. The Intelect Mobile Combo offers "On the Go" clinical electrotherapy and ultrasound. The unit provides an innovative case design, with a logical control system and a large, easy to read graphical LCD. User defined protocols allow you to customize any treatment to the specific needs of your patient. The repositional base allows the unit to be configured for desktop or wall-mount use. The following features are available on the Intelect Mobile Combo: • Two channels of electrotherapy stimulation output • Eleven currents - 2 & 4 Pole IFC, Galvanic, High Voltage Pulsed Current (HVPC), Microcurrent, VMS, TENS, Russian, Träbert, Monophasic, and Diadynamic • 1 or 3 MHz frequencies for each applicator (excluding the 1 cm2 sound head) • Four available sound heads: 1 cm2, 2 cm2, 5 cm2, and 10 cm2 • Fifteen user-defined memory positions • Lightweight design • Battery powered option

Common Terms

Applicator - This apparatus is the hand held assembly used to deliver ultrasonic energy. The applicator includes the sound head, transducer, and related electronics. Accommodation - This condition is where nerves lose their ability (sensitivity) to respond to electrotherapy. Amplitude Modulation (Ampl. Mod.) - Amplitude Modulation is an increase and decrease in intensity during treatment. For example, at an 80% amplitude modulation, with the intensity set to 10 mA, the intensity decreases to 2 mA, and then increases to 10 mA throughout the treatment. The available amplitude modulations are 40%, 60%, 80%, 100%, and Static (none).

14

OVERVIEW

Intelect® Mobile Combo

Beam Non-Uniformity Ratio (BNR) – By nature, an ultrasound beam is not homogeneous. The BNR is a ratio of the highest intensity found in the beam field to the average intensity as indicated on the output display of the unit. This measure may not exceed 5.0:1. Because of the areas of increased intensity, the sound head is moved continuously during the treatment. Beat Fixed - Associated with the Interferential waveform, Beat Fixed is the parameter at which the beat frequency remains constant. When the Sweep setting is turned off, you must select a fixed beat for the therapy session. The available settings for Beat Fixed are 1 to 100 Hz. Beat Frequency - Associated with the Interferential waveform, Beat Frequency is the frequency at which the amplitude of the current increases and decreases. The beat frequency is considered to be the therapeutic frequency and is measured in hertz (Hz). Beat High - During a sweep, the Beat High setting is the highest number to which the beat frequency increases. The available range for the Beat High parameter is 2 to 200 Hz. This parameter is unique to the 2 Pole and 4 Pole IFC waveforms. Beat Low - During a sweep, the Beat Low setting is the lowest number to which the beat frequency decreases. The available range for the Beat Low parameter is 1 to 199 Hz. This parameter is unique to the 2 Pole and 4 Pole IFC waveforms. Burst - A burst is a series of pulses at a predetermined pulse frequency. Burst Frequency (Freq.) - This is the number of bursts per second (bps). The available burst frequencies on the Intelect Mobile Combo are 1 to 10 bps. Carrier Frequency (Freq.) - Associated with the Interferential and Russian waveforms, Carrier Frequency is the frequency of the un-modulated medium frequency current. The available carrier frequencies are 2000, 2500, 4000, 5000, and 10000 Hz. CC/CV - This is the abbreviation for Constant Current/Constant Voltage. Constant current is a stimulator capable of delivering an electric current that flows at the same amplitude regardless of changes in tissue impedance over time. Constant voltage is a stimulator capable of delivering a source of voltage at the same amplitude regardless of changes in tissue impedance over time. Keep in mind that the amount of stimulation is directly proportional to the current. Channel Mode - The available channel modes are Single Channel (in which electrotherapy is distributed from one channel), Reciprocal (where electrotherapy alternates between channels), and Co-Contract (where electrotherapy is distributed from both channels at the same time). 15

OVERVIEW

Intelect® Mobile Combo

Clinical Indications™- An efficient approach for setting up a treatment using preset parameters. Clinical Library- Select this button to access the following functions: Clinical Indications, Retrieve User Protocols, Restore Factory Settings, Restore Factory Protocols, Language and View Unit Information. Collimating (Coll)- The shape of the ultrasound beam. While neither focused nor dispersed, this ultrasound beam resembles a column when applied from the unit through the sound head. Continuous Mode – The output of the ultrasound is not interrupted during the treatment time. This mode imparts the most energy to the tissues and is used when a maximal effect is desired. (See Duty Cycle). Coupling Media – An agent used to insure that the ultrasound is transmitted from the sound head to the tissue to be treated. Gels or lotions labeled for therapeutic ultrasound use are recommended. Cycle Time - Cycle Time is the alternating time which the current is "on" and "off." Using the 10/30 setting as an example, the current is on for 10 seconds and off for 30. The available cycle times are Continuous, 5/5, 4/12, 10/10, 10/20, 10/30, and 10/50. Display - Available only on the High Volt waveform, the Display feature allows you to change the displayed Intensity parameter from Volts to Peak Current (Amps). Duty Cycle - This is the ratio of the “On” time to “Total” time of the cycle, expressed as a percentage. The duty cycle describes the pulsed modes of electric stimulation and ultrasound. The lower the percentage, the lower temporal average intensity. 100% is continuous electrotherapy. The available Duty Cycles are 10, 20, 30, 40, 50%. Effective Radiating Area (ERA) – A measure of the ultrasound beam made underwater, 5 mm from the radiating surface of the sound head. The ERA is always smaller than the geometric area of the sound head, but should be as close as possible. This measurement is used to calculate the ultrasound intensity in W/cm2. Frequency (Electrotherapy) - Frequency is the number of times per second a pulse, cycle, burst, or beat will repeat itself. The unit is selectable from 0-200 Hz (beat), 20-100 Hz (burst), and 2000-10000 Hz (carrier). Frequency (Ultrasound) – Selectable to 1 or 3 MHz with the 2 cm2, 5 cm2, or 10 cm2 sound head (excluding the 1 cm2 sound head). The lower the frequency, the longer the wavelength, the deeper the penetration of ultrasound. Frequency Modulation (Freq. Mod.) - This is the rhythm at which a frequency changes. The available frequency modulations are 0 to 250 Hz in increments of 5 Hz. 16

OVERVIEW

Intelect® Mobile Combo

Intensity (Electrotherapy) - Intensity is the output of electrotherapy distributed by the unit to the patient. Depending on the waveform, intensity is measured in milliamps (mA), volts (V), and micro amps (µa). Intensity (Ultrasound) – Ultrasound power delivered to the patient expressed in total power as watts (W) or in terms of the sound head’s effective radiating area, watts per centimeter squared (W/cm2). LCD- The LCD (Liquid Crystal Display) allows the user to view and monitor the information displayed during ultrasound therapy. The following information is displayed on the LCD: Frequency, Duty Cycle, Power, Treatment Time and Clinical Indications. Lead Zirconate Titanate – A synthetic crystal used to create the ultrasound beam by vibrating 1,000,000 (1 MHz) or 3,300,000 (3 MHz) times per second. This type of crystal is both durable and efficient in its functions. Leadwires - The leadwires consist of the main plugs that are connected to the unit, and 4 leads (2 black and 2 red) that connect to electrodes. Medium Frequency Current - These are the currents used by the Traditional Interferential (IFC 4-Pole), Interferential Premodulated, and Russian waveforms that is higher than 1000 Hz, but lower than 10000 Hz. Operating Channels - Operating Channels are the paths by which the electrotherapy is distributed from the unit to the patient. The unit provides two channels of electrical stimulation. Phase Duration - This is the time in which the current flows in one direction only. Phase duration is the determined period of time elapsing from the beginning to the end of one phase, usually expressed in microseconds (µsec) or milliseconds (ms). Phase Interval - Available only with the Monophasic waveforms, it is the brief interruption of current flow between the individual phases of a pulse. The available phase intervals are 5 to 5000 ms in increments of 5 ms. Polarity - Polarity refers to the charge of an individual lead: positive or negative. Polarity Reversal - This is a feature available on the unit in which the polarity changes at a determined time. Power – A measure of the intensity of the ultrasound delivered to the patient. The unit of measure is watts (W). Protocol – A group of parameters (e.g., Frequency, Duty Cycle, etc.) unique to a form of therapy (i.e., electrotherapy or ultrasound). Pulse Duration – Refers to the amount of time the ultrasound is being delivered in the pulsed mode. For example, in the 20% duty cycle mode, the ultrasound is delivered for 2 msec and off for 8 msec (at 100 Hz) throughout the treatment period. 17