Vectra Genisys User Manual

TABLE OF CONTENTS

Vectra® Genisys Therapy System

FOREWORD... 1 PRODUCT DESCRIPTION... 1 SAFETY PRECAUTIONS... 2-12 PRECAUTIONARY DEFINITIONS... 2 Caution... 2 Warning... 2 Danger... 2 Dangerous Voltage... 2 Corrosive... 2 Spontaneous Combustion... 2 Biohazardous Materials... 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 DC (Direct Current) Mode... 7 Contraindications... 7 Additional Precautions... 8 Adverse Effects... 8 SEMG INDICATIONS... 9 sEMG + STIM INDICATIONS, CONTRAINDICATIONS AND ADVERSE EFFECTS... 10

Indications- sEMG + Stim using VMS™, Symmetrical Biphasic (TENS), Asymmetrical Biphasic (TENS) or Russian waveforms . .10 Contraindications...10 Additional Precautions...11 Adverse Effects...11 ULTRASOUND INDICATIONS AND CONTRAINDICATIONS . . 12 Indications for Ultrasound...12 Contraindications...12 Additional Precautions...12 NOMENCLATURE... 13-17 VECTRA GENISYS ELECTROTHERAPY AND COMBINATION THERAPY SYSTEMS... 13 Two Channel Electrotherapy System...13 Two Channel Combination System...13 Front Access Panel...14 Rear Access Panel...14 USER INTERFACE... 15 SYMBOL DEFINITIONS... 16 System Hardware Symbols...16 SystemSoftware Symbols...16 Optional Module and Accessory Symbols...16 Operator Remote...16 Battery Module...16 Channel 3/4ElectrothrapyModule...16 GENERAL TERMINOLOGY... 17 Back button...17 Previous Page button...17 UP and DOWN Arrows...17 Electrotherapy...17

i

TABLE OF CONTENTS

Vectra® Genisys Therapy System

System...17 Module...17 sEMG...17 sEMG + Stim...17 ULTRASOUND... 17 Sound Head...17 Applicator...17 Coupling LED...17 SPECIFICATIONS... 18-24 SYSTEM SPECIFICATIONS... 18 DIMENSIONS... 18 Width...18 Standard Weight...18 Power (Combination and Electrotherapy Units)...18 Electrical Type...18 WAVEFORM SPECIFICATIONS... 19 IFC (Interferential) Traditional (4 Pole)...19 TENS- Asymmetrical Biphasic...19 TENS- Symmetrical Biphasic...20 Microcurrent...20 IFC Premodulated (2p)...21 High Voltage Pulsed Current (HVPC)...21 VMS™...22 VMS™ Burst...22 Russian...23 DC (Direct Current...23 ULTRASOUND SPECIFICATIONS... 24 Ultrasound...24

SET UP... 25-31 VECTRA GENISYS THERAPY SYSTEMS... 25 THERAPY SYSTEM SET UP... 26 Clinic Name...26 Restore Default Protocols...27 Restore Default Unit Settings...27 Erase Patient Data Card...28 Set Date and Time...28 Setting System Volume...29 Ultrasound Coupling...29 Display Unit Version Information...30 Pad Contact Quality...30 Select Language...31 Connecting Accessories to the Therapy System...31 PATIENT PREPARATION... 32-40 ELECTROTHERAPY PATIENT PREPARATION... 32 Electrode Placement...32 DURA-STICK™ Electrodes...33 Reusable Carbon Electrodes...33 DURA-STICK™ Electrode Instructions...34 Connecting Lead Wires...34 Securing Electrodes...34 Reusable Carbon Electrodes...35 Connecting Lead Wires...35 Conductive Medium...35 Securing Electrodes...35 ULTRASOUND PATIENT PREPARATION... 36 Preparing Treatment Area...36

ii

TABLE OF CONTENTS

Vectra® Genisys Therapy System Intensity Knob Rotation...46 Start Treatment...46 Pause Treatment...47 Stop Treatment...47 Save to Patient Data Card...47 ADJUSTING ELECTROTHERAPY CHANNEL PARAMETERS DURING TREATMENT... 48 Select Channel...48 Edit Channel Paramenters...48 ULTRASOUND... 49 Prepare Patient...49 Select Modality...49 View Parameter Rationale...49 Sound Head Recommendation...49 Edit Ultrasound Parameters...50 Head Warming...50 Set Ultrasound Intensity...50 Intensity Knob Rotation...50 Start Treatment...51 Pause Treatment...51 Stop Treatment...51 Save to Patient Data Card...51 Editing Ultrasound from Home Screen...52 Editing Ultrasound from Treatment Review Screen...52 SEMG THERAPY SET UP... 53 General Information...53 Optional Patient Data Management System (PDMS)...53 sEMG Screen...54

Size of Applicator...36 Applicator Preparation...36 Conductive Medium...36 Treatment Area...36 Applicator Coupling...36 Install sEMG Lead Wires to System...37 Install DURA-STICK™ II Electrodes...37 Select Modality...37 Select Body Area...38 View Electrode Placement Graphic...38 View Electrode Placement Text...39 Prepare Treatment Area...39 Electrode Placement...40 Intra-Vaginal Probe...40 OPERATION... 41-114 OPERATOR INTERFACE... 41 HOME SCREEN... 42 ELECTROTHERAPY SCREEN... 43 GENERAL ELECTROTHERAPY WAVEFORM SET UP... 44 Prepare Patient...44 Select Modality...44 Select Waveform...44 View Waveform Description...44 View Electrode Placement...45 Edit Waveform Parameters...45 Install Patient Interrupt Switch...45 Patient Interrupt Switch...46 Set Waveform Intensity...46

iii

TABLE OF CONTENTS

Vectra® Genisys Therapy System Editing Parameters during Treatment Session...65 Save to Patient Data Card...65 COMBINATION... 66 Prepare Patient...66 Select Modality...66 View Application Description...66 View Electrode Placement...67 Access Combination Parameters...67 Edit Ultrasound Parameters...67 Select Waveform...68 Patient Interrupt Switch...68 Edit Waveform Parameters...68 Set Waveform Intensity...69 Intensity Knob Rotation...69 Set Ultrasound Intensity...69 Intensity Knob Rotation...69 Start Treatment...69 Pause Treatment...70 Stop Treatment...70 Save to Patient Data Card...70 ADJUSTING COMBINATION PARAMETERS DURING TREATMENT... 71 Edit Waveform Parameters...71 Edit Ultrasound Parameters...71 SEMG+STIM THERAPY SET UP... 72 General Information...72 Prepare System and Patient...73 Select sEMG + Stim Modality...73

Prepare System and Patient...55 Select sEMG Modality...55 View sEMG Description Text...55 Select Edit...56 Select Channel...56 Set Alarm...56 Set Audio Type...57 Select Target Option...57 Setting Max Target...57 Setting Avg Target...58 Setting Manual Target...59 Set Volume...59 Start sEMG Therapy Session...60 Stopping sEMG Therapy Session...60 INDICATIONS... 61 Available Indications...61 Prepare Patient...61 Select Indication...61 View Waveform Description...61 View Electrode Placement...62 Edit Waveform Parameters...62 Install Patient Interrupt Switch...62 Patient Interrupt Switch...63 Setting Waveform Intensity...63 Intensity Knob Rotation...63 Start Treatment...64 Pause Treatment...64 Stop Treatment...64

iv

TABLE OF CONTENTS

Vectra® Genisys Therapy System Editing Pain Locations...84 Deleting Pain Locations...85 Pain Scales...85 Select Pain Scale...85 Adjust Pain Scale...85 Save to Patient Data Card...86 EXISTING PATIENT DATA CARD USE... 87 Insert Existing Patient Data Card...87 Access Patient Data Card...87 View Patient Data Card...87 Starting a New Treatment from Patient Data Card...88 Patient Interrupt Switch...88 Set Intensity...88 Intensity Knob Rotation...88 Start Treatment...89 Pause Treatment...89 Stop Treatment...89 Erasing Patient Data Card...89 SET UP OF NEW sEMG DATA CARD... 90 General Information...90 Insert New sEMG Data Card...91 Prepare System and Patient...91 Set Up sEMG Therapy Session...91 Enter Patient ID...91 Begin Save...92 End Save...92 CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS™ . 93 Clinical Protocols™...93

Select Edit...73 Select Channel...73 Set Alarm...74 Set Audio Type...74 Select Stim Waveform...74 Edit Stim...75 Select Target Option...75 Setting Max Target...75 Setting Avg Target...76 Setting Manual Target...77 Set Volume...77 Set Auto Feature...78 Start sEMG Therapy Session...78 Stopping Stim...79 Stopping Therapy Session...79 PATIENT DATA CARD SET UP OF NEW CARD... 80 General Information...80 Insert New Patient Data Card...80 Setup Treatment...80 Set Up of New Patient Data Card...80 Enter Patient ID...81 Access Electrode Placement...82 Electrode Placement Set Up...82 Electrode Placement...82 Access Pain Map...83 Select Pain Type...83 Add Pain Locations...83 Select Location of Pain...84

v

TABLE OF CONTENTS

Vectra® Genisys Therapy System Delete User Protocol... 100 CLINICAL RESOURCES LIBRARY USING USER PROTOCOLS...101 Access User Protocols... 101 Select User Protocol... 101 View Waveform Rationale... 101 View Electrode Placement... 102 Prepare Patient... 102 Edit Modality Parameters... 102 Patient Interrupt Switch... 102 Set Modality Intensity... 103 Intensity Knob Rotation... 103 Start Treatment... 103 Pause Treatment... 104 Stop Treatment... 104 Save to Patient Data Card... 104 CLINICAL RESOURCES LIBRARY CREATING NEW SEQUENCES...105 General Information... 105 Access Sequencing... 105 Select Sequence... 105 Select First Waveform or Current... 105 Edit First Waveform or Current... 106 Select Second Waveform or Current... 106 Saving New Sequence... 106 Enter Sequence Name... 107 CLINICAL RESOURCES LIBRARY DELETING SEQUENCES...108 General Information... 108

Access Clinical Resources...93 Access Clinical Protocols™...93 Select Body Area...93 Select Clinical Indication...94 Select Pathological Condition...94 Select Pathological Severity...94 View Waveform Rationale...95 View Electrode Placement...95 Prepare Patient...95 Edit Modality Parameters...95 Patient Interrupt Switch...96 Set Modality Intensity...96 Intensity Knob Rotation...96 Start Treatment...97 Pause Treatment...97 Stop Treatment...97 Save to Patient Data Card...97 CLINICAL RESOURCES LIBRARY CREATING USER PROTOCOLS... 98 General Information...98 Select Modality...98 Edit Modality Parameters...98 Select Clinical Resources Library...98 Enter User Protocol Name...99 CLINICAL RESOURCES LIBRARY DELETING USER PROTOCOLS...100 General Information... 100 Select Clinical Resources Library... 100 Select User Protocol to Delete... 100

vi

TABLE OF CONTENTS

Vectra® Genisys Therapy System

Access Sequencing... 108 Select Sequence... 108 Delete Sequence... 108 CLINICAL RESOURCES LIBRARY USING SEQUENCES...109 Access Sequencing... 109 Select Sequence... 109 Select Waveform/Current... 109 View Waveform Rationale... 110 View Electrode Placement... 110 Prepare Patient... 110 Patient Interrupt Switch... 110 Set Sequence Intensity... 111 Intensity Knob Rotation... 111 Start Treatment... 112 Pause Treatment... 112 Stop Treatment... 112 Save to Patient Data Card... 112 CLINICAL RESOURCES LIBRARY MMC GRAPHICAL LIBRARY...113 General Information... 113 Select Clinincal Resources Library... 113 Select MMC Graphical Library... 113 Select Body Area... 113 Select Library Type... 114 INSTALLATION/REMOVAL...115-133 INSTALLATION CHANNEL 3/4 ELECTROTHERAPY, NIMH BATTERY AND LASER MODULE...115 Nomenclature- Channel 3/4 Electrotherapy Module... 116

Specifications... 117 Waveform & Current Specifications... 117 Disconnect Mains Power... 118 Remove Lead Wires and Accessories... 118 Remove Therapy System from Cart... 118 Release Ribbon Cable... 119 Position Therapy System and Module... 119 Connect Ribbon Cable... 119 Set Therapy System onto Module... 120 Secure Therapy System to Module... 120 Front Access Panel... 120 Install Lead Wires and Accessories... 121 Install Front Access Panel... 121 Mount to Therapy System Cart... 121 Connect Mains Power... 121 Turn Therapy System On... 122 REMOVAL CHANNEL 3/4 ELECTROTHERAPY, NiMH BATTERY AND LASER MODULE...123 Disconnect Mains Power... 123 Remove Lead Wires and Accessories... 123 Remove Therapy System from Cart... 123 Remove Screws Securing Module... 124 Disconnect Ribbon Cable at Module... 124 Store and Secure Ribbon Cable... 124 Front Access Panel... 125 Install Lead Wires and Accessories... 125 Connect Mains Power... 125 Turn Therapy System On... 126

vii

TABLE OF CONTENTS

Vectra® Genisys Therapy System Operator Remote Storage... 135 THERAPY SYSTEM CART OPERATION...136 Nomenclature... 136 Operation... 136 NIMH BATTERY MODULE OPERATION...137 Nomenclature... 137 CHARGING BATTERY MODULE...138 When to Recharge... 138 Charging Temperature... 138 BATTERY MODULE SERVICE LIFE...139 STORAGE OF BATTERY MODULE...139 Short Term Storage... 139 Long Term Storage... 139 TROUBLESHOOTING...140-145 ERROR CODES... 140-145 General Information... 140 REPLACEMENT ACCESSORIES... 146 GENERAL INFORMATION...146 MAINTENANCE... 147 CARING FOR THE THERAPY SYSTEM...147 Cleaning the Therapy System... 147 Cleaning the Lens... 147 CALIBRATION REQUIREMENTS...147 Calibrating Ultrasound Applicators... 147 FACTORY SERVICE...147 WARRANTY... 148

INSTALLING SEMG MODULE...127 Position sEMG Module... 127 Secure sEMG Module... 127 Install and Reinstall Additional Module... 127 Install Rear Access Panel... 127 Install Cables and Accessories... 128 Apply Mains Power... 128 REMOVING SEMG MODULE...129 Prepare System... 129 Remove sEMG Module... 129 sEMG Plug Kit... 129 GENERAL INFORMATION OPERATOR REMOTE...130 Operator Remote Installation... 130 GENERAL INFORMATION THERAPY SYSTEM CART...131 Nomenclature... 131 Specifications... 131 MOUNTING THERAPY SYSTEM TO THERAPY SYSTEM CART...132 Therapy System Cart Assembly... 132 Prepare Therapy System Cart... 132 Mount Therapy System to Cart... 132 Connect Mains Power... 133 Install Storage Bins... 133 Removing System from Therapy System Cart... 133 OPTION OPERATION...134-139 OPERATOR REMOTE OPERATION...134 Nomenclature... 134 Operation... 134

viii

FOREWORD

Vectra® Genisys Therapy System

This manual has been written for the users of the Vectra Genisys 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 Therapy System Cart, Channel 3/4 Electrotherapy, NiMH Battery, Laser and Dual Channel sEMG Modules for the users of the Vectra Genisys Therapy two channel electrotherapy and combination systems. 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 Vectra Genisys 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, 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.

1

SAFETY PRECAUTIONS

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

Warning Text with a “WARNING” indicator will explain 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.

2

SAFETY PRECAUTIONS

Vectra® Genisys Therapy System

CAUTIONS

• Inspect Applicator cables and associated connectors before

• Read, understand, and practice the precautionary and operating

each use.

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 Vectra Genisys 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 59° F and 104° F (15° C and 40° C), 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.

• The Vectra Genisys 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.

3

SAFETY PRECAUTIONS

Vectra® Genisys Therapy System

WARNINGS

• U.S.A. Federal Law restricts these devices to sale by, or on the order

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

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.

4

SAFETY PRECAUTIONS

Vectra® Genisys 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. • The Vectra Genisys Therapy System optional modules and associated accessories are designed for use only with the Chattanooga Group Vectra Genisys Electrotherapy and Combination Therapy Systems.

5

SAFETY PRECAUTIONS

Vectra® Genisys Therapy System

DANGERS

• Stimulus delivered by the TENS waveforms of this

• NiMH Batteries contain Class E Corrosive materials. In the event of battery cell rupture or leakage, handle Battery Module 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 Module housing or cells. Should an individual cell from a battery become disassembled, spontaneous combustion of the negative electrode is possible. There can be a delay between exposure to air and spontaneous combustion. • Charge the Battery Module according to the instructions found in this manual. Never attempt to charge the Battery Module on any other charging mechanism. • Use the Battery Module only with the Vectra Genisys Therapy Systems. • 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 NiMH batteries according to national, state and local codes and regulations.

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.” • 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.

6

SAFETY PRECAUTIONS

Vectra® Genisys Therapy System

ELECTROTHERAPY INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS Indications for VMS, VMS Burst, Russian, TENS, High Voltage Contraindications Pulsed Current (HVPC), Interferential and Premodulated • This device should not be used for symptomatic local pain relief 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 eruptions (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 (through the head). • Post-surgical acute pain • Safety has not been established for the use of therapeutic Indications for DC (Direct Current) Mode 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.

7

SAFETY PRECAUTIONS

Vectra® Genisys 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.

8

SAFETY PRECAUTIONS

Vectra® Genisys Therapy System

SEMG INDICATIONS

Indications- Surface EMG To determine the activation timing of muscles for: • Retraining of muscle activation • Coordination of muscle activation • An indication of the force produced by muscle for control and maintenance of muscle contractions • Relaxation muscle training • Muscle re-education

9

SAFETY PRECAUTIONS

Vectra® Genisys Therapy System

sEMG + STIM INDICATIONS, CONTRAINDICATIONS AND ADVERSE EFFECTS Indications- sEMG + Stim using VMS™, Symmetrical Biphasic Contraindications (TENS), Asymmetrical Biphasic (TENS) or Russian waveforms • This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome • Stroke rehab by muscle re-education has been diagnosed. • Relaxation of muscle spasms • This device should not be used when cancerous lesions are • Prevention or retardation of disuse atrophy present in the treatment area. • Increase local blood circulation • Stimulation should not be applied over swollen, • Muscle re-education infected, inflamed areas, or skin eruptions (e.g. phlebitis, • Maintaining or increasing range of motion thrombophlebitis, varicose veins, etc.). • Other contraindications are patients suspected of carrying serious infectious disease and/or disease where it is advisable, for general medical purposes, to suppress heat or fevers. • Electrode placements must be avoided that apply current to the carotid sinus region (anterior neck) or transcereberally (through the head). • Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. • 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.

10

SAFETY PRECAUTIONS

Vectra® Genisys Therapy System

sEMG + STIM INDICATIONS, CONTRAINDICATIONS AND ADVERSE EFFECTS (continued) Adverse Effects Additional Precautions • Skin irritation and burns beneath the electrodes have been • Caution should be used for patients with suspected or diagnosed reported with the use of powered muscle stimulators. heart problems. • Potential adverse effects with TENS are skin irritation and • Caution should be used for patients with suspected or diagnosed electrode burns. 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. • 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. 11