Vectra Fitness Genisys 2761 User manual

User Manual
Operation & Installation
Instructions for:
Therapy Systems
2761- Two Channel Combination System
2789- Four Channel Combination System
2764- Two Channel Electrotherapy System
2787- Four Channel Electrotherapy System
2871- Two Channel Electrotherapy System- no sEMG
2872- Two Channel Combination System- no sEMG
2873- Four Channel Electrotherapy System- no sEMG
2874- Four Channel Combination System- no sEMG
2875K- Two Channel Electrotherapy System with Cart- no sEMG
2876K- Two Channel Combination System with Cart- no sEMG
2877K- Four Channel Electrotherapy System with Cart- no sEMG
2878K- Four Channel Combination System with Cart- no sEMG
Optional Equipment
2775- Therapy System Cart (Unassembled)
2775ASY- Therapy System Cart (Assembled)
2767- NiMH Battery Module
2799- Dual Channel sEMG Module
27508 and 27079- User Remote Controls
2781- Channel 3/4 Electrotherapy Module
ISO 13485 CERTIFIED

TABLE OF CONTENTS
i
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
Non-Ionizing Electromagnetic Radiation........................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 Eects ...................................................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 Eects ..................................................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
System Software Symbols.......................................16
Optional Module and Accessory Symbols ......................16
Operator Remote ................................................16
Battery Module ..................................................16
Channel 3/4 Electrothrapy Module .............................16
GENERAL TERMINOLOGY ...................................17
Back Button......................................................17
Previous Page Button ...........................................17
UP and DOWN Arrows...........................................17
Electrotherapy...................................................17

TABLE OF CONTENTS
ii
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 AND DIMENSIONS ..............18
DESCRIPTION OF DEVICE MARKINGS ......................18
WAVEFORM SPECIFICATIONS ..............................19
IFC - Interferential (Traditional 4 Pole) ..........................19
TENS- Asymmetrical Biphasic ...................................19
TENS- Symmetrical Biphasic.....................................20
Microcurrent.....................................................20
IFC Premodulated (Traditional 2 Pole IFC) ......................21
High Voltage Pulsed Current (HVPC) ............................21
VMS™............................................................22
VMS™Burst ......................................................22
Russian ..........................................................23
DC (Direct Current) ..............................................23
ULTRASOUND SPECIFICATIONS ............................24
Ultrasound.......................................................24
Ouput Power ....................................................24
Head Warming Feature..........................................24
SET UP ................................................25-31
VECTRA GENISYS THERAPY SYSTEMS......................25
THERAPY SYSTEM SET UP ..................................26
Accessing Operator Utilities .................................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 (Optional).........................33
DURA-STICK™ Electrode Instructions ...........................34
Connecting Lead Wires ..........................................34
Securing Electrodes .............................................34
Reusable Carbon Electrodes (Optional).........................35
Connecting Lead Wires ..........................................35
Conductive Medium.............................................35
Securing Electrodes .............................................35
ULTRASOUND PATIENT PREPARATION .....................36
Preparing Treatment Area.......................................36
Size of Applicator................................................36

TABLE OF CONTENTS
iii
Vectra Genisys® Therapy System
Applicator Preparation ..........................................36
Conductive Medium.............................................36
Treatment Area ..................................................36
Applicator Coupling .............................................36
sEMG AND sEMG+STIM PATIENT PREPARATION..........37
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 Optional Patient Interrupt Switch .......................45
Optional Patient Interrupt Switch ..............................46
Set Waveform Intensity..........................................46
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
ADJUSTING ULTRASOUND PARAMETERS
DURING TREATMENT .......................................52
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

TABLE OF CONTENTS
iv
Vectra Genisys® Therapy System
sEMG Screen.....................................................54
Prepare System and Patient .....................................55
Select sEMG Modality ...........................................55
View sEMG Description Text.....................................55
Electrode Placement ............................................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 Optional Patient Interrupt Switch .......................62
Optional Patient Interrupt Switch ..............................63
Setting Waveform Intensity .....................................63
Intensity Knob Rotation .........................................63
Start Treatment..................................................64
Pause Treatment.................................................64
Stop Treatment ..................................................64
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
Optional 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

TABLE OF CONTENTS
v
Vectra Genisys® Therapy System
Prepare System and Patient .....................................73
Select sEMG + Stim Modality....................................73
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
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
Optional 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

TABLE OF CONTENTS
vi
Vectra Genisys® Therapy System
CLINICAL RESOURCES LIBRARY CLINICAL PROTOCOLS™ ....93
Clinical Protocols™...............................................93
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
Optional 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
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
Optional 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

TABLE OF CONTENTS
vii
Vectra Genisys® Therapy System
CLINICAL RESOURCES LIBRARY
DELETING SEQUENCES ....................................108
General Information........................................... 108
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
Optional 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 Clinical 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
Possible System Congurations............................... 115
Nomenclature- Channel 3/4 Electrotherapy Module ......... 116
Specications.................................................. 117
Waveform & Current Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

TABLE OF CONTENTS
viii
Vectra Genisys® Therapy System
Install Lead Wires and Accessories ............................ 125
Connect Mains Power ......................................... 125
Turn Therapy System On ...................................... 126
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
Specications.................................................. 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
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

Vectra Genisys® Therapy System
FOREWORD
1
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 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 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.
©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.

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
2
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:
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.
Text with a “WARNING”indicator will explain possible safety infractions that
will potentially cause serious injury and equipment damage.
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.
NOTE: Throughout this manual, “NOTE” may be found. These Notes are
helpful information to aid in the particular area or function
being described.
PRECAUTIONARY DEFINITIONS
Caution
Warning
Dangerous Voltage
Text with a “DANGER” indicator will explain possible safety infractions that
are imminently hazardous situations that would result in death or serious
injury.
Danger
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.
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.
Biohazardous Materials
Text with a “Non-Ionizing Electromagnetic Radiation" indicator
informs the user of possible hazards resulting from elevated,
potentially dangerous, levels of non-ionizing radiation.
Non-Ionizing Electromagnetic Radiation

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
3
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 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.
Inspect Applicator cables and associated connectors before•
each use.
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.
Nylatex® Wraps contain dry natural rubber and may cause allergic
•
reactions in patients with allergies to latex.
Use of parts or materials other than Chattanooga's can degrade
•
minimum safety.

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
4
U.S.A. Federal Law restricts these devices to sale by, or on the order•
of, a physician or licensed practitioner. This device should be used
only under the continued supervision of a physician or licensed
practitioner.
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.
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 DJO, LLC for service. Errors and Warnings in these categories
indicate an internal problem with the system 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 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.
•

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
5
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 Vectra
Genisys Electrotherapy and Combination Therapy Systems.
Remove the Ultrasound or Laser Applicator by pulling the cable
•
connector only. DO NOT remove by pulling the cable.

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
6
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.”
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.
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.

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
7
ELECTROTHERAPY INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS
Indications for VMS, VMS Burst, Russian, TENS, High Voltage
Pulsed Current (HVPC), Interferential, and Premodulated
Waveforms
Relaxation of muscle spasms
•
Prevention or retardation of disuse atrophy•
Increase local blood circulation•
Muscle re-education•
Maintaining or increasing range of motion•
Additional Indications for Microcurrent, Interferential,
Premodulated, VMS™, VMS™ Burst, and TENS Waveforms
Symptomatic relief and management of chronic, intractable•
pain
Post-traumatic acute pain•
Post-surgical acute pain•
Indications for DC (Direct Current) Mode
Relaxation of muscle spasm•
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 eruptions (e.g. phlebitis,
thrombophlebitis, varicose veins, etc.).
Other contraindications are patients suspected of carrying•
serious infectious disease and or disease where it is advisable,
for general medical purposes, to suppress heat or fevers.
Electrode placements must be avoided that apply current•
to the carotid sinus region (anterior neck) or transcerebrally
(through the head).
Safety has not been established for the use of therapeutic•
electrical stimulation during pregnancy.
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.

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
8
ELECTROTHERAPY INDICATIONS, CONTRAINDICATIONS, AND ADVERSE EFFECTS (CONTINUED)
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.
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 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.

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
9
sEMG INDICATIONS
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•
Indications- Surface EMG

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
10
sEMG + STIM INDICATIONS, CONTRAINDICATIONS AND ADVERSE EFFECTS
Stroke rehab by muscle re-education
•
Relaxation of muscle spasms•
Prevention or retardation of disuse atrophy•
Increase local blood circulation•
Muscle re-education•
Maintaining or increasing range of motion•
Indications- sEMG + Stim using VMS™, Symmetrical Biphasic
(TENS), Asymmetrical Biphasic (TENS), or Russian waveforms
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 eruptions (e.g. phlebitis,
thrombophlebitis, varicose veins, etc.).
Other contraindications are patients suspected of carrying•
serious infectious disease and/or disease where it is advisable,
for general medical purposes, to suppress heat or fevers.
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.

Vectra Genisys® Therapy System
SAFETY PRECAUTIONS
11
sEMG + STIM INDICATIONS, CONTRAINDICATIONS AND ADVERSE EFFECTS (CONTINUED)
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.
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.
Additional Precautions
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.
Adverse Effects