Intelect ADVANCED User Manual 2005

TABLE OF CONTENTS

Intelect® Advanced Therapy System

FOREWORD... 1 PRODUCT DESCRIPTION... 1 SAFETY PRECAUTIONS... 29 PRECAUTIONARY DEFINITIONS... 2 CAUTIONS... 3 WARNINGS... 4 DANGERS... 6 ELECTROTHERAPY INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS... 7 Indications for VMS, VMS Burst, Russian, TENS, High Voltage Pulsed... Current (HVPC), Interferential, and Premodulated waveforms... 7 Additional Indications for Microcurrent, Interferential, Premodulated, . . VMS™, VMS™ Burst, and TENS waveforms... 7 Indications for Galvanic Continuous Mode... 7 Contraindications... 7 Additional Precautions... 8 Adverse Effects... 8 ULTRASOUND INDICATIONS AND CONTRAINDICATIONS... 9 Indications for Ultrasound... 9 Contraindications... 9 Additional Precautions... 9 NOMENCLATURE...1014 INTELECT ADVANCED ELECTROTHERAPY AND COMBINATION THERAPY SYSTEMS... 10 Two (2) Channel Electrotherapy System... 10 Two (2) Channel Combination System... 10 Front Access Panel... 11 Rear Access Panel... 11 USER INTERFACE... 12 SYMBOL DEFINITIONS... 13 System Hardware Symbols... 13 SystemSoftware Symbols... 13 Operator Remote... 13 Battery Module... 13 Channel 3/4ElectrothrapyModule... 13

GENERAL TERMINOLOGY... 14 SPECIFICATIONS...1526 SYSTEM SPECIFICATIONS... 15 DIMENSIONS... 15 Width... 15 Standard Weight... 15 Power (Combination and Electrotherapy Units)... 15 Electrical Type... 15 WAVEFORM SPECIFICATIONS... 16 IFC (Interferential) Traditional (4 Pole)... 16 TENS- Asymmetrical Biphasic... 16 TENS- Symmetrical Biphasic... 17 TENS- Alternating Rectangular... 17 TENS- Monophasic Rectangular... 18 High Voltage Pulsed Current (HVPC)... 18 VMSTM... 19 Diadynamic Waveforms... 19 IFC Premodulated (2p)... 20 Russian... 20 Microcurrent... 21 VMSTM Burst... 21 MONOPHASIC: Monophasic Rectangular Pulsed... 22 MONOPHASIC: Monophasic Triangular Pulsed... 22 GALVANIC: Continuous... 23 GALVANIC: Interrupted... 23 Träbert (Ultrareiz)... 24 SURGED: Monophasic Rectangular... 24 SURGED: Monophasic Triangular... 25 ULTRASOUND SPECIFICATIONS... 26 Ultrasound... 26 SETUP...2734 INTELECT ADVANCED COLOR SERIES THERAPY SYSTEMS... 27 Color Series Standard Features... 27 Color Series Optional Accessories... 27 Mains Power Cords... 27

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TABLE OF CONTENTS

Intelect® Advanced Therapy System

INTELECT ADVANCED MONOCHROMATIC SERIES THERAPY SYSTEMS... 28 Monochromatic Series Standard Features... 28 Monochromatic Series Optional Accessories... 28 Mains Power Cords... 28 THERAPY SYSTEM SET UP... 29 Clinic Name... 29 Restore Default Protocols... 30 Restore Default Unit Settings... 30 Erase Patient Data Card... 31 Set Date and Time... 31 Setting System Volume... 32 Ultrasound Coupling... 32 Display Unit Version Information... 33 Pad Contact Quality... 33 Select Language... 34 Connecting Accessories to the Therapy System... 34 PATIENT PREPARATION...3539 ELECTROTHERAPY PATIENT PREPARATION... 35 Electrode Placement... 35 Dura-Stick™ Electrodes... 36 Reusable Carbon Electrodes... 36 Dura-Stick™ Electrode Instructions... 37 Connecting Lead Wires... 37 Securing Electrodes... 37 Reusable Carbon Electrodes... 38 Connecting Lead Wires... 38 Conductive Medium... 38 Securing Electrodes... 38 ULTRASOUND PATIENT PREPARATION... 39 Preparing Treatment Area... 39 Size of Applicator... 39 Applicator Preparation... 39 Conductive Medium... 39 Treatment Area... 39

Applicator Coupling... 39 OPERATION...4094 OPERATOR INTERFACE... 40 HOME SCREEN... 41 ELECTROTHERAPY SCREEN... 42 GENERAL ELECTROTHERAPY WAVEFORM SET UP... 43 Prepare Patient... 43 Select Modality... 43 Select Waveform... 43 View Waveform Description... 43 View Electrode Placement... 44 Edit Waveform Parameters... 44 Install Patient Interrupt Switch... 44 Patient Interrupt Switch... 45 Set Waveform Intensity... 45 Intensity Knob Rotation... 45 Start Treatment... 45 Pause Treatment... 46 Stop Treatment... 46 Save to Patient Data Card... 46 ADJUSTING ELECTROTHERAPY CHANNEL PARAMETERS DURING TREATMENT... 47 Select Channel... 47 Edit Channel Paramenters... 47 ULTRASOUND... 48 Prepare Patient... 48 Select Modality... 48 View Parameter Rationale... 48 Sound Head Recommendation... 48 Edit Ultrasound Parameters... 49 Head Warming... 49 Set Ultrasound Intensity... 49 Intensity Knob Rotation... 49 Start Treatment... 50 Pause Treatment... 50

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TABLE OF CONTENTS

Intelect® Advanced Therapy System

Save to Patient Data Card... 50 Stop Treatment... 50 Editing Ultrasound from Home Screen... 51 Editing Ultrasound from Treatment Review Screen... 51 QUICK LINK INDICATIONS... 52 Available Quick Link Indications... 52 Prepare Patient... 52 Select Quick Link Indication... 52 View Waveform Description... 53 View Electrode Placement... 53 Edit Waveform Parameters... 53 Install Patient Interrupt Switch... 54 Patient Interrupt Switch... 54 Setting Waveform Intensity... 55 Intensity Knob Rotation... 55 Start Treatment... 55 Pause Treatment... 55 Stop Treatment... 56 Editing Parameters during Treatment Session... 56 Save to Patient Data Card... 56 COMBINATION... 57 Prepare Patient... 57 Select Modality... 57 View Application Description... 57 View Electrode Placement... 58 Access Combination Parameters... 58 Edit Ultrasound Parameters... 58 Select Waveform... 59 Patient Interrupt Switch... 59 Edit Waveform Parameters... 59 Set Waveform Intensity... 60 Intensity Knob Rotation... 60 Set Ultrasound Intensity... 60 Intensity Knob Rotation... 60 Start Treatment... 60

Pause Treatment... 61 Stop Treatment... 61 Save to Patient Data Card... 61 ADJUSTING COMBINATION PARAMETERS DURING TREATMENT . . . 62 Edit Waveform Parameters... 62 Edit Ultrasound Parameters... 62 PATIENT DATA CARD SET UP OF NEW CARD... 63 General Information... 63 Insert New Patient Data Card... 63 Setup Treatment... 63 Set Up of New Patient Data Card... 63 Enter Patient ID... 64 Access Electrode Placement... 65 Electrode Placement Set Up... 65 Electrode Placement... 65 Access Pain Map... 66 Select Pain Type... 66 Add Pain Locations... 66 Select Location of Pain... 67 Editing Pain Locations... 67 Deleting Pain Locations... 68 Pain Scales... 68 Select Pain Scale... 68 Adjust Pain Scale... 68 Save to Patient Data Card... 69 EXISTING PATIENT DATA CARD USE... 70 Insert Existing Patient Data Card... 70 Access Patient Data Card... 70 View Patient Data Card... 70 Starting a New Treatment from Patient Data Card... 71 Patient Interrupt Switch... 71 Set Intensity... 71 Intensity Knob Rotation... 71 Start Treatment... 72 Pause Treatment... 72

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TABLE OF CONTENTS

Intelect® Advanced Therapy System

Erasing Patient Data Card... 72 Stop Treatment... 72 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS™... 73 Clinical Protocols™... 73 Access Clinical Resources... 73 Access Clinical Protocols™... 73 Select Body Area... 73 Select Clinical Indication... 74 Select Pathological Condition... 74 Select Pathological Severity... 74 View Waveform Rationale... 75 View Electrode Placement... 75 Prepare Patient... 75 Edit Modality Parameters... 75 Patient Interrupt Switch... 76 Set Modality Intensity... 76 Intensity Knob Rotation... 76 Start Treatment... 77 Pause Treatment... 77 Save to Patient Data Card... 77 Stop Treatment... 77 CLINICAL RESOURCES LIBRARY CREATING USER PROTOCOLS... 78 General Information... 78 Select Modality... 78 Edit Modality Parameters... 78 Select Clinical Resources Library... 78 Enter User Protocol Name... 79 CLINICAL RESOURCES LIBRARY DELETING USER PROTOCOLS... 80 General Information... 80 Select Clinical Resources Library... 80 Select User Protocol to Delete... 80 Delete User Protocol... 80 CLINICAL RESOURCES LIBRARY USING USER PROTOCOLS... 81 Access User Protocols... 81 Select User Protocol... 81

View Waveform Rationale... 81 View Electrode Placement... 82 Prepare Patient... 82 Edit Modality Parameters... 82 Patient Interrupt Switch... 82 Set Modality Intensity... 83 Intensity Knob Rotation... 83 Start Treatment... 83 Pause Treatment... 84 Stop Treatment... 84 Save to Patient Data Card... 84 CLINICAL RESOURCES LIBRARY CREATING NEW SEQUENCES... 85 General Information... 85 Access Sequencing... 85 Select Sequence... 85 Select First Waveform or Current... 85 Edit First Waveform or Current... 86 Select Second Waveform or Current... 86 Saving New Sequence... 86 Enter Sequence Name... 87 CLINICAL RESOURCES LIBRARY DELETING SEQUENCES... 88 General Information... 88 Access Sequencing... 88 Select Sequence... 88 Delete Sequence... 88 CLINICAL RESOURCES LIBRARY USING SEQUENCES... 89 Access Sequencing... 89 Select Sequence... 89 Select Waveform/Current... 89 View Waveform Rationale... 90 View Electrode Placement... 90 Prepare Patient... 90 Patient Interrupt Switch... 90 Set Sequence Intensity... 91 Intensity Knob Rotation... 91

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TABLE OF CONTENTS

Intelect® Advanced Therapy System

Start Treatment... 92 Pause Treatment... 92 Save to Patient Data Card... 92 Stop Treatment... 92 CLINICAL RESOURCES LIBRARY MMC GRAPHICAL LIBRARY... 93 General Information... 93 Select Clinincal Resources Library... 93 Select MMC Graphical Library... 93 Select Body Area... 93 Select Library Type... 94 INSTALLATION/REMOVAL... 95106 INSTALLATION CHANNEL 3/4 ELECTROTHERAPY MODULE... 95 General Information... 95 Nomenclature... 96 Specifications... 97 Waveform & Current Specifications... 97 Disconnect Mains Power... 98 Remove Lead Wires and Accessories... 98 Remove Therapy System from Cart... 98 Release Ribbon Cable... 99 Position Therapy System and Module... 99 Connect Ribbon Cable... 99 Set Therapy System onto Module...100 Secure Therapy System to Module...100 Front Access Panel...100 Install Lead Wires and Accessories...101 Install Front Access Panel...101 Mount to Therapy System Cart...101 Connect Mains Power...101 Turn Therapy System On...102 REMOVAL CHANNEL 3/4 ELECTROTHERAPY MODULE... 103 Disconnect Mains Power...103 Remove Therapy System from Cart...103 Remove Lead Wires and Accessories...103 Remove Screws Securing Module...104

Disconnect Ribbon Cable at Module...104 Store and Secure Ribbon Cable...104 Front Access Panel...105 Install Lead Wires and Accessories...105 Connect Mains Power...105 Turn Therapy System On...106 TROUBLESHOOTING... 107112 ERROR CODES...107-112 General Information...107 MAINTENANCE...113 CARING FOR THE THERAPY SYSTEM... 113 Cleaning the Therapy System...113 Cleaning the Lens...113 CALIBRATION REQUIREMENTS... 113 Calibrating Ultrasound Applicators...113 FACTORY SERVICE...113 WARRANTY... 114

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FOREWORD

Intelect® Advanced Therapy System

This manual has been written for the users of the Intelect Advanced Therapy Systems. It contains general information on the operation, precautionary practices, and maintenance information. 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. This manual contains general safety, operating, maintenance, and care instructions as well as installation instructions for the optional Channel 3/4 Electrotherapy Module for the users of the Intelect Advanced Therapy two channel electrotherapy and combination systems. Instructions for additional options such as sEMG, sEMG + Stim, Laser, Battery, and Vacuum are found in their respective User Manuals which contain operation and installation instructions. Specifications put forth in this manual were in effect at the time of publication. However, owing to Chattanooga Group's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of Chattanooga Group. 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 and ultrasound. PRODUCT DESCRIPTION The Intelect Advanced Therapy Systems are two channel electrotherapy and combination systems with the option of adding additional channels of electrotherapy by installation of the optional Channel 3/4 Electrotherapy Module. Other optional modality modules are available for separate purchase and may be installed by the end user. Stay current with the latest clinical developments in the field of electrotherapy, ultrasound, laser therapy, sEMG, and sEMG + Stim. Observe all applicable precautionary measures for treatment. Keep informed of appropriate indications and contraindications for the use of electrotherapy, ultrasound, laser therapy, sEMG, and sEMG+Stim. This equipment is to be used only under the prescription and supervision of a licensed practitioner.

©2005 Encore Medical Corporation or its affiliates, Austin, Texas, USA. Any use of editorial, pictorial, or layout composition of this publication without express written consent from Chattanooga Group of Encore Medical, L.P. is strictly prohibited. This publication was written, illustrated, and prepared for distribution by Chattanooga Group of Encore Medical, L.P.

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

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;

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

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

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

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

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

CAUTIONS

• Inspect Applicator cables and associated connectors before

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 Advanced Therapy System when connected to any unit other than Chattanooga Group devices. • DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. • Ultrasound 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, transported and stored in temperatures between 15° C and 40° C (59° F and 104° F), with Relative Humidity ranging from 30%-60%. • Handle Ultrasound Applicator with care. Inappropriate handling of the Ultrasound Applicator may adversely affect its characteristics. • Before each use, inspect Ultrasound Applicator for cracks, which may allow the ingress of conductive fluid.

each use.

• The Intelect Advanced Therapy System is not designed to prevent the ingress of water or liquids. Ingress of water or liquids could cause malfunction of internal components of the system and therefore create a risk of injury to the patient. • 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. The Nylatex® Wraps shipped with this unit contain dry natural rubber and may cause allergic reactions in patients with allergies to latex.

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

WARNINGS

• Powered muscle stimulators should be used only with the leads and

These devices are restricted 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. • For continued protection against fire hazard, replace fuses only with ones of the same type and rating. • 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.

electrodes recommended for use by the manufacturer.

• In the event that an Error message or Warning appears beginning with a 2 or 3, immediately stop all use of the system and contact the dealer or Chattanooga Group for service. Errors and Warnings in these categories indicate an internal problem with the system that must be tested by Chattanooga Group or a Field Service Technician certified by Chattanooga Group before any further operation or use of the system. Use of a system that indicates an Error or Warning in these categories may pose a risk of injury to the patient, user or cause extensive internal damage to the system. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. • Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the application of 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.

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

WARNINGS (continued)

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. 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.

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

DANGERS

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, 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.”

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

ELECTROTHERAPY INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS INDICATIONS FOR VMS, VMS BURST, RUSSIAN, TENS, HIGH Contraindications VOLTAGE PULSED CURRENT HVPC, INTERFERENTIAL AND • This device should not be used for symptomatic local pain relief PREMODULATED WAVEFORMS unless etiology is established or unless a pain syndrome has • Relaxation of muscle spasms been diagnosed. • Prevention or retardation of disuse atrophy • This device should not be used when cancerous lesions are present in the treatment area. • Increase local blood circulation • Stimulation should not be applied over swollen, • Muscle re-education infected, inflamed areas, or skin erruptions, e.g. phlebitis, • Maintaining or increasing range of motion thrombophlebitis, varicose veins, etc. Additional Indications for Microcurrent, Interferential, • Other contraindications are patients suspected of carrying Premodulated, VMS™, VMS™ Burst and TENS waveforms serious infectious disease and or disease, where it is advisable, • Symptomatic relief and management of chronic, for general medical purposes, to suppress heat or fevers. intractable pain • Electrode placements must be avoided that apply current • Post-traumatic acute pain to the carotid sinus region (anterior neck) or transcerebrally • Post-surgical acute pain (through the head). Indications for Galvanic Continuous Mode • Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. • Relaxation of muscle spasm • Powered muscle stimulators should not be used on patients with cardiac demand pacemakers. There should not be any use of TENS waveforms on patients with cardiac demand pacemakers.

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

ELECTROTHERAPY INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS (continued)

• With TENS waveforms, isolated cases of skin irritation may

ADDITIONAL PRECAUTIONS • Caution should be used for patients with suspected or diagnosed heart problems. • Caution should be used for patients with suspected or diagnosed epilepsy. • Caution should be used 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 which 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.

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

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SAFETY PRECAUTIONS

Intelect® Advanced Therapy System

ULTRASOUND INDICATIONS AND CONTRAINDICATIONS INDICATIONS FOR ULTRASOUND • Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: • Relief of pain, muscle spasms, and joint contractures • Relief of pain, muscle spasms, and joint contractures that may be associated with: • Adhesive capsulitis • Bursitis with slight calcification • Myositis • Soft tissue injuries • Shortened tendons due to past injuries and scar tissues • Relief of sub-chronic, chronic pain, and joint contractures resulting from: • Capsular tightness • Capsular scarring Contraindications • This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • This device should not be used when cancerous lesions are present in the treatment area. • Stimulation should not be applied over swollen, infected, inflamed areas, or skin erruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc.

• Other contraindications are patients suspected of carrying serious infectious disease and disease where it is advisable for general medical purposes to suppress heat or fevers. • This device should not be used over or near bone growth centers until bone growth is complete. • This device should not be used over the thoracic area if the patient is using a cardiac pacemaker. • This device should not be used over a healing fracture. • This device should not be used over or applied to the eye. • This device should not be used over a pregnant uterus. • This device should not be used on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result. 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; • Laminectomy, i.e., when major covering tissues have been removed. • Over anesthetic areas. On patients with hemorrhagic diatheses.

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NOMENCLATURE

Intelect® Advanced Therapy System

INTELECT ADVANCED ELECTROTHERAPY AND COMBINATION THERAPY SYSTEMS Two (2) Channel Electrotherapy System

Two (2) Channel Combination System 4

4

1

1 6

6 2

7 2 3

3 5

5

1. Two Channel Combination System 2. User Interface (See Page 12) 3. Front Access Panel 4. Rear Access Panel 5. Patient Data Card and sEMG Data Card access port. 6. Multimedia Card (MMC) access port. Ultrasound Applicator (5cm2 shown) Combination Systems Only

1. Two (2) Channel Electrotherapy System 2. User Interface (See Page 12) 3. Front Access Panel 4. Rear Access Panel 5. Patient Data Card and sEMG Data Card access port. 6. Multimedia Card (MMC) access port. 10

NOMENCLATURE

Intelect® Advanced Therapy System

INTELECT ADVANCED ELECTROTHERAPY AND COMBINATION THERAPY SYSTEMS (continued) Front Access Panel Rear Access Panel 1 7 2 5 3 4 1

3 2

5 4

7 6 6

1. Front Access Panel Lanyard When reinstalling the Front Access Panel, make certain the Lanyard does not become kinked. 2. Operator Remote Control Connector 3. Patient Interrupt Switch Connector 4. Channel 1 Lead Wire Connector 5. Channel 2 Lead Wire Connector 6. Microcurrent Probe Connector 7. Ultrasound Applicator Connector

1. Screen Contrast Control (Not functional on Color Systems) 2. Power On/Off Switch 3. Technical Maintenance Port 4. Fuses 5. Mains Power Cord 6. Rear Access Panel 7. Serial Decal 11

NOMENCLATURE

Intelect® Advanced Therapy System

USER INTERFACE 1 15

2 3

16

14 4 13 12 5

11 10 9

6

8 7 6 12

1. Rear Access Panel (See Page 11) 2. User Interface (Color Shown) 3. Ultrasound LED Coupling Indicator (Combination only) 4. Ultrasound Applicator- 5 cm2 Standard. (Optional 1 cm2, 2 cm2 and 10 cm2 ) applicators available (Combination only) 5. Intensity Knob 6. Cable and Lead Wire Hook 7. Front Access Panel (See Page 11) 8. Start Button 9. Pause Button 10. Stop Button 11. Clinical Resources Library Button 12. Home Screen button 13. Back Button 14. Patient Data Card and sEMG Data Card Port 15. User Set Up and Parameter Control buttons 16. Multimedia Card (MMC) Port

NOMENCLATURE

Intelect® Advanced Therapy System

SYMBOL DEFINITIONS Below are the definitions for all of the symbols used in the Intelect Advanced hardware and software. Study and learn these symbols before any operation of the system. System Software Symbols

System Hardware Symbols CONTRAST CONTROL NOT FUNCTIONAL ON COLOR SYSTEMS ON/OFF SWITCH

PATIENT INTERRUPT SWITCH THERAPY INTENSITY CONTROL

MOVE UP

MULTIMEDIA CARD, PATIENT DATA CARD, AND SEMG DATA CARD

PAUSE TREATMENT

MOVE RIGHT CHANNEL 2 LEAD WIRES MOVE LEFT CLINICAL RESOURCES LIBRARY

START TREATMENT

DECREASE INTENSITY PAUSE TREATMENT

PATIENT INTERRUPT SWITCH

CHANNEL 3 LEAD WIRES

MANUAL

ACCEPT AND RETURN

BACK

CHANNEL 1/2 OPERATOR REMOTE CONTROL OPTIONAL

Channel 3/4 Electrothrapy Module

MOVE DOWN

CHANNEL 1 LEAD WIRES

MICROCURRENT PROBE STOP TREATMENT

Operator Remote INCREASE INTENSITY

DATA PORT HOME

Optional Module and Accessory Symbols

DO NOT ACCEPT AND RETURN

ULTRASOUND APPLICATOR

PAD CONTACT QUALITY SINGLE CHANNEL GRAPH

M STIMULATION Battery Module

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MICROCURRENT PROBE

CHARGE LEVEL BATTERY CHARGING

PAD CONTACT QUALITY DUAL CHANNEL GRAPH

CHANNEL 4 LEAD WIRES

CHANNEL 3/4 OPERATOR REMOTE CONTROL OPTIONAL

NOMENCLATURE

Intelect® Advanced Therapy System

Below are the definitions for all of the unique terminology used throughout this manual. Study these and become familiar with these terms for ease of system operation and familiarization with the components and control functionality of the Intelect Adavnced Therapy System. Some of these terms and definitions refer to a specific button or control on the system. Refer to page 13 for Symbol Definitions. GENERAL TERMINOLOGY Back button The dedicated button on the Main unit, below the display, that each time pressed takes the user back one screen at a time.

ULTRASOUND 3

1

Previous Page button The button used in some modalities and functions that will take the user back one page when reading multiple pages of text. UP and DOWN Arrows Controls used in various modality parameter screens to navigate or change a value up or down within the parameter.

2

Electrotherapy Refers to the Electrical muscle or nerve Stimulation modalities of the system.

1. Sound Head That 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 Sound Head.

System The primary system with all controls and functions. Module Any optional modular modality component designed for installation onto the System.

3. Coupling LED The component of the Applicator which indicates if the Sound Head is Coupled or Uncoupled on the the treatment area. 14