This manual is intended for users of Vectra® Neo Clinical
Therapy System. It contains general information on
operation, precautionary practices, and maintenance.
In order to maximize use, e ciency, 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.
In addition to the above information, this manual
contains care and installation instructions for the optional
Cart, Channel 1/2 Electrotherapy module, Channel 1/2
Electrotherapy module + sEMGmodule, Channel 3/4
Electrotherapy module, Laser module, and Ultrasound
module for the users of the Vectra® Neo Clinical Therapy
System.
Speci cations put forth in this manual were in e ect at
the time of publication. However, owing to DJO’s policy of
continual improvement, changes to these speci cations
may be made at any time without noti cation on the part
of DJO.
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, ultrasound, and laser.
PRECAUTIONARY INSTRUCTIONS
The precautionary instructions found in this section and
throughout this manual are indicated by speci c symbols.
Understand these symbols and their de nitions before
operating this equipment. The de nition of these symbols
are as follows:
CAUTION
Text with a “CAUTION” indicator explains possible
safety infractions that have potential to cause minor or
moderate injury or damage to the equipment.
WARNING
Text with a “WARNING” indicator explains possible safety
infractions that will potentially cause serious injury and
equipment damage.
DANGER
Text with a “DANGER” indicator will explain possible safety
infractions that are imminently hazardous situations that
would result in death or serious injury.
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 con gurations
of TENS waveforms.
Warning; Laser beam
Explosion Hazard - Text with an “Explosion
Hazard” indicator will explain possible safety
infractions if this equipment is used in the
presence of ammable anesthetics, mixture
with air, oxygen, or nitrous oxide.
Wear eye protection
NOTE: Throughout this manual, “NOTE”
indicators provide helpful information
regarding the particular area of function being
described.
4
Vectra® Neo Clinical Therapy System
INTRODUCTION
GENERAL TERMINOLOGY
The following are de nitions for the terminology used throughout this manual. Study these terms to become familiar
with them for ease of system operation and control functionality of the Vectra® Neo Clinical Therapy System.
SYSTEM SOFTWARE SYMBOLS
Back Arrow
Home
Electrode Placement
Increase/Decrease Parameter
Stim
Ultrasound
Combo
Scroll Up or Down in a text box
sEMG
Select
Page Up
Laser
CPS
Page Down
Customize
Save Data
When pressed, will print the screen
contents or Patient Treatment Results
Report to the USB ash drive
Indicates a USB ash drive is inserted
Patient Remote/Laser Shut O Icon
Indicates the Remote is plugged in
Custom Protocols
Patient Data
Anatomical Library
5
INTRODUCTION
DESCRIPTION OF DEVICE MARKINGS
The markings on the unit are assurance of its conformity to the highest
applicable standards of medical equipment safety and electromagnetic
compatibility. One or more of the following markings may appear on the
device:
This unit is considered to be a Class 3B laser product and thus emits visible
and invisible laser radiation (IR). Avoid direct eye exposure to the Laser beam.
The symbol to the right is located on the back of the applicator and indicates
the active radiant surface (the area on the applicator that emits infrared laser
energy and the direction of the beam of light) . . . . . . . . . . . . . . . . . . . . . . . . . . .
For VMS (Pulsed Mode, Burst Mode, or FR Mode),
Russian, Monophasic Hi-Volt (NMES) & Interferential, and
Premodulated (IFS):
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to
prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated
(IFS), VMS (Pulsed Mode, Burst Mode, or FR Mode),
Asymmetrical Biphasic (TENS), and HANS:
• Symptomatic relief or management of chronic,
intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain
For DC (Direct Current) Continuous Mode:
• Relaxation of muscle spasm
For FES:
• Stimulation of the muscles of the leg and ankle of
partially paralyzed patients to provide flexion of the
foot and thus improve the patient’s gait.
Contraindications
The Vectra® Neo Clinical Therapy System should NOT be
used under the following conditions:
• Do not use for symptomatic local pain relief unless
etiology is established or unless a pain syndrome has
been diagnosed.
• Do not use when cancerous lesions are present in the
treatment area.
• Do not apply stimulation over swollen, infected,
inflamed areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins, etc.).
• Do not use when patient is suspected or known to
have infectious disease and/or disease where it is
advisable, for general medical purposes, to suppress
heat or fevers.
• Do not place electrode placements to the carotid
sinus region (anterior neck) or transcerebrally (through
the head).
• Do not use on pregnant women. Safety has not
been established for the use of therapeutic electrical
stimulation during pregnancy.
• Do not use powered muscle stimulators or TENS
waveforms on patients with cardiac demand
pacemakers.
• Do not use Vectra® Neo Clinical Therapy System
on patients who have or have had implantable
neurostimulating cardiac demand pacemakers, ICD, or
other implantable electronic devices.
• Do not use Vectra® Neo Clinical Therapy System on
patients with body worn electro mechanical medical
devices, i.e. insulin pump.
• Do not use this system in an MRI or CT environment.
The Vectra® Neo Clinical Therapy System, its
components, and accessories are not to be present in
an MRI or CT environment.
Additional Precautions
• Use caution for patients with suspected or diagnosed
heart problems.
• Use caution for patients with suspected or diagnosed
epilepsy.
• Use caution in the presence of the following:
- When there is a tendency to hemorrhage
following acute trauma or fracture
- Following recent surgical procedures when
muscle contraction may disrupt the healing
process
- Over a menstruating or pregnant uterus
- Over areas of the skin that lack normal sensation
• Some patients may experience skin irritation or
hypersensitivity due to the electrical stimulation
or electrical conductive medium. The irritation can
usually be reduced by using an alternative conductive
medium or an alternative electrode placement.
• Electrode placement and stimulation settings
should be based on the guidance of the prescribing
practitioner.
• Powered muscle stimulators should be used only with
the lead wires and electrodes recommended for use
by the manufacturer.
• With TENS waveforms, isolated cases of skin irritation
may occur at the site of electrode placement following
long-term application.
• The effective management of pain by TENS waveforms
is highly dependent upon patient selection by a
person qualified in pain management.
Adverse E ects
• 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.
7
INDICATIONS FOR USE
SEMG & STIM INDICATIONS
Vectra® Neo Clinical Therapy System
Indications
For EMG triggered Stim:
• 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
For EMG:
• To determine the activation timing of muscles for:
- Retraining of muscle activation
- Coordinating of muscle activation
• Any indication of the force produced by muscle for
control and maintenance of muscle contractions
- Relaxation muscle training
- Muscle re-education
Contraindications
The Vectra® Neo Clinical Therapy System should not be
used under the following conditions:
• Do not use for symptomatic local pain relief unless
etiology is established or unless a pain syndrome has
been diagnosed.
• Do not use when cancerous lesions are present in the
treatment area.
• Do not apply stimulation over swollen, infected,
inflamed areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins, etc.).
• 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.
• Do not place electrode placements 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.
• Do not use powered muscle stimulators or TENS
waveforms on patients with cardiac demand
pacemakers.
• Do not use Vectra® Neo Clinical Therapy System
on patients who have or have had implantable
neurostimulating cardiac demand pacemakers, ICD, or
other implantable electronic devices.
• Do not use Vectra® Neo Clinical Therapy System on
patients with body worn electro mechanical medical
devices, i.e. insulin pump.
• Do not use this system in an MRI or CT environment.
The Vectra® Neo Clinical Therapy System, its
components, and accessories are not to be present in
an MRI or CT environment.
Additional Precautions
• Use caution for patients with suspected or diagnosed
heart problems.
• Use caution for patients with suspected or diagnosed
epilepsy.
• Use caution in the presence of the following:
- When there is a tendency to hemorrhage
following acute trauma or fracture
- Following recent surgical procedures when
muscle contraction may disrupt the healing
process
- Over a menstruating or pregnant uterus
- Over areas of the skin that lack normal sensation
• Some patients may experience skin irritation or
hypersensitivity due to the electrical stimulation
or electrical conductive medium. The irritation can
usually be reduced by using an alternative conductive
medium or an alternative electrode placement.
• Electrode placement and stimulation settings
should be based on the guidance of the prescribing
practitioner.
• Powered muscle stimulators should be used only with
the lead wires and electrodes recommended for use
by the manufacturer.
• With TENS waveforms, isolated cases of skin irritation
may occur at the site of electrode placement following
long term application.
• The effective management of pain by TENS waveforms
is highly dependent upon patient selection by a
person qualified in the management of pain patients.
Adverse E ects
• 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
Vectra® Neo Clinical Therapy System
ULTRASOUND INDICATIONS
INDICATIONS FOR USE
Indications
Application of therapeutic deep heat for the treatment of
selected sub-chronic and chronic medical conditions such
as:
• Relief of pain, muscle spasms, and joint contractures
• Relief of pain, muscle spasms, and joint contractures
that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar
tissues
• Relief of sub-chronic and chronic pain and joint
contractures resulting from:
- Capsular tightness
- Capsular scarring
Contraindications
• 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.
• 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.
• Tissue necrosis might result if the device is used on
ischemic tissues in individuals with vascular disease,
where the blood supply would not keep up with the
metabolic demand.
• Do not use Vectra® Neo Clinical Therapy System
on patients who have or have had implantable
neurostimulating cardiac demand pacemakers, ICD, or
other implantable electronic devices.
• Do not use Vectra® Neo Clinical Therapy System on
patients with body worn electro mechanical medical
devices, i.e. insulin pump.
• Do not use this system in an MRI or CT environment.
The Vectra® Neo Clinical Therapy System, its
components, and accessories are not to be present in
an MRI or CT environment.
Additional Precautions
Additional precautions should be used when ultrasound
is used on patients with the following conditions:
• Over an area of the spinal cord following a
laminectomy, i.e., when major covering tissues have
been removed
• Over anesthetic areas
• On patients with hemorrhagic diatheses
9
INDICATIONS FOR USE
LASER INDICATIONS
Vectra® Neo Clinical Therapy System
Indications
To provide topical heating for the following:
• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches,
pains, and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporarty relief of minor pain and stiffness
associated with arthritis
Contraindications
The Vectra® Neo Clinical Therapy System Laser should NOT
be used:
• Where analgesia may mask progressive pathology,
and where the practitioner would normally avoid
the use of any other analgesia in order to retain the
beneficial aspects of pain
• For direct aim into the eyes of humans over areas
injected with steroids in the past 2-3 weeks
• Over areas that are suspicious or contain potentially
cancerous tissue
• Over areas of active hemorrhage
• Over a pregnant uterus
• Over the neck (thyroid or carotid sinus region) or chest
(vagus nerve or cardiac region of the thorax)
• Directly over areas with open wounds, unless covered
with a clear protective barrier
• Treatment over sympathetic ganglia
• For symptomatic local pain relief unless etiology
is established or unless a pain syndrome has been
diagnosed
• On patients suspected of carrying serious infectious
disease and/or disease where it is advisable, for
general medical purposes, to suppress heat or fevers
• Over or near bone growth centers until bone growth is
complete
• Over the thoracic area if the patient is using a cardiac
pacemaker
• Over or applied to the eye
• 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
• Do not use Vectra® Neo Clinical Therapy System
on patients who have or have had implantable
neurostimulating cardiac demand pacemakers, ICD, or
other implantable electronic devices.
• Do not use Vectra® Neo Clinical Therapy System on
patients with body worn electro mechanical medical
devices, i.e. insulin pump.
• Do not use this system in an MRI or CT environment.
The Vectra® Neo Clinical Therapy System, its
components and accessories, are not to be present in
an MRI or CT environment.
Additional Precautions
Additional precaution should be used when the Laser is
used on patients with the following conditions:
• Over an area of the spinal cord following a
laminectomy, i.e., when major covering tissues have
been removed
• Over anesthetic areas
• On patients with hemorrhagic diatheses
Preventing Adverse E ects
Perform the following procedures to avoid the negative
e ects of Laser therapy:
• Inspect the treatment area during and following
treatment, and discontinue if an adverse reaction does
occur.
• Higher output levels have a greater potential for
patient discomfort. Choose a lower dosage to reduce
output or select a pulsed duty cycle to decrease
patient discomfort.
Factors that A ect Treatment
The following factors may a ect Laser treatment:
• Color of skin (light or dark)
• Age of lesion
• Depth of lesion
• Sensitivity of patient
• Type of tissue
• Medications that increase sensitivity to light
10
Vectra® Neo Clinical Therapy System
PRODUCT DESCRIPTION
The Vectra® Neo Clinical Therapy System is a modular
system used with or without an optional Cart, allowing for
the inclusion of Channel 1/2 Electrotherapy module with
or without sEMG, Channel 3/4 Electrotherapy module,
Laser module, and Ultrasound module.
To maximize functionality and life of Vectra® Neo, be sure
to:
• Stay current with the latest clinical developments in
the field of electrotherapy, ultrasound, laser therapy,
sEMG, and sEMG + electrotherapy.
• Observe all applicable precautionary measures for
treatment.
• Keep informed of appropriate indications and
contraindications for the use of the Vectra® Neo
Clinical Therapy System.
NOTE: This equipment is to be used only under the
prescription and supervision of a licensed medical
practitioner.
DEVICE DESCRIPTION
11
DEVICE DESCRIPTION
OPERATOR INTERFACE
Vectra® Neo Clinical Therapy System
The Vectra® Neo Clinical Therapy System Operator
Interface contains all the functions and controls necessary
for operator access to all operator utilities, modalities, and
parameters for modi cation and system set up.
1. Color Display
2. Intensity Dial (Gray outer ring)
3. Start/Pause button
4. Stop button
5. ON/OFF switch
6. Ultrasound Applicator holder, left and right sides
7. Laser Applicator holder, left and right sides
8. Patient Remote/Laser Interrupt Switch port
9. Mains Power Cord
10. Rear Access Panel
11. Serial Label
12. USB Flash Drive Port (USB flash drive not included)
13. Tilt Screen
14. Swivel function
15. Laser Interlock Port and Icon
Front Controls
1
2
4
3
Rear Access Panel
12
5
16. Lead wire holders
Side Holders
16
45
11
6,7
10
8
6,7
º
90
º
13
14
15
9
12
Vectra® Neo Clinical Therapy System
GENERAL WARNINGS AND PRECAUTIONS
CAUTION
• Read, understand, and practice the precautionary and operating
instructions. Know the limitations and hazards associated with using
any electrical stimulation, Laser device, or ultrasound device. Observe
the precautionary and operational decals placed on the unit.
• All modalities should be routinely checked before each use to
determine that all controls function normally, especially that the
intensity control does properly adjust the intensity of the ultrasonic
power output in a stable manner. Also, determine that the treatment
time control does actually terminate ultrasonic power output when
the timer reaches zero.
• DO NOT use sharp objects such as a pencil point or ballpoint pen to
operate the buttons on the control panel.
• This unit should be operated at 10°C to 45°C and 0% to 90% relative
humidity. The unit should be transported and stored at 0°C to 60°C and
0% to 95% relative humidity.
• Handle Ultrasound Applicator and Laser Applicator with care.
Inappropriate handling may adversely affect its characteristics.
• Before each use, inspect Ultrasound Applicator for cracks, which may
allow the ingress of conductive fluid.
CAUTION
• Failure to use and maintain the Vectra® Neo Clinical Therapy System,
its modules, and its accessories in accordance with the instructions
outlined in this manual will invalidate the warranty.
• DO NOT permit foreign materials, liquids, or cleaning agents (including,
but not limited to, inflammables, water, and metallic objects) to enter
the unit to prevent unit damage, malfunction, electrical shock, fire, or
personal injury.
• If you have difficulty operating the unit after carefully reviewing this
user manual, contact your DJO dealer for assistance.
• DO NOT remove the cover. Doing so may cause unit damage,
malfunction, electrical shock, fire, or personal injury. There are no
user-serviceable parts inside the unit. If a malfunction occurs,
discontinue use immediately and consult dealer for repair service.
• Use of parts or materials other than DJO’s can degrade minimum
safety.
• The Vectra® Neo Clinical 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.
• Inspect Applicator cables and associated connectors before each use.
• Device is designed to comply with electromagnetic safety standards.
This equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with instructions,
may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a
particular installation. Harmful interference to other devices can be
determined by turning this equipment on and off. Try to correct the
interference using one or more of the following:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment to an outlet on a different circuit from that
to which the other device(s) are connected and consult the factory
field service technician for help.
- Consult your authorized DJO dealer for help.
• Do not operate this unit when connected to any unit other than DJO
devices or accessories specifically described in user or service manuals.
• Use of controls, adjustments or performance of procedures other than
those specified herein may result in hazardous exposure to Laser
energy.
• DO NOT operate the Vectra® Neo Clinical Therapy System within the
vicinity or environment as any microware and RF shortwave diathermy
system.
• DO NOT operate the Vectra® Neo Clinical Therapy System within the
vicinity or environment as an ultrasonic diathermy system. The
Ultrasound (diathermy) Module of the Vectra® Neo Clinical Therapy
System does not require separation distance.
• DO NOT use electrodes with an active area less than 7.92 cm
2
, as there
will be a risk of suffering a burn injury. Always exercise caution with
current densities more than 2mA/cm
2
. Refer to the CURRENT DENSIT
CALCULATIONS FOR DJO ELECTRODES table in Appendix 3.
• DO NOT disassemble, modify, or remodel the unit or accessories. This
may cause unit damage, malfunction, electrical shock, fire, or personal
injury.
13
GENERAL WARNINGS AND PRECAUTIONS
Vectra® Neo Clinical Therapy System
WARNING
• U.S.A. Federal Law restricts these devices to sale by, or on the order of,
a physician or licensed practitioner. This device should be used only
under the continued supervision of a physician or licensed
practitioner.
• Be sure to read all instructions for operation before treating patient.
• Make certain the unit is electrically grounded by connecting only to a
grounded electrical service receptacle conforming to the applicable
national and local electrical codes.
• Care must be taken when operating this equipment around other
equipment. Potential electromagnetic or other interference could
occur to this or to the other equipment. Try to minimize this
interference by not using other equipment in conjunction with it.
• The safety of TENS waveforms for use during pregnancy or birth has
not been established.
• TENS is not effective for pain of central origin. (This includes
headache.)
• TENS waveforms have no curative value.
• Electronic monitoring equipment (such as ECG monitors and ECG
alarms) may not operate properly when electrical stimulation is in use.
• TENS is a symptomatic treatment, and as such, suppresses the
sensation of pain which would otherwise serve as a protective
mechanism.
• Inspect the plastic lens of the laser head for blemishes, deformation,
pitting, scratches, discoloration, and cleanliness before each use.
• Do not drop the applicator or unit on hard surfaces or submerge in
water. These actions will damage the applicator and unit. Damage
resulting from these conditions is not covered under the warranty.
• Use of controls or adjustments or performance of procedures other
than those specified herein may result in hazardous exposure to Laser
energy.
• This device should be kept out of the reach of children.
WARNING
• Do not treat through clothing.
• Stop treatment immediately if patient experiences discomfort or pain.
• Do not apply laser on an area of skin that has lotion or ointments
applied as burns may occur.
• Do not use laser on or over a tattoo.
• The laser head must be cleaned with a disinfectant cleaner
(i.e. Virex® II 256) or germicidal cloth (i.e. PDI Sani-Cloth® Plus/Hb)
between each therapy session. Ensure no liquids enter into the laser
head while cleaning. Do not use any chlorine-based cleaners on the
laser head.
• The color of skin, age of lesion, depth of lesion, sensitivity of the
patient, tissue type, and medications that increase sensitivity to light
may affect therapy.
• Powered muscle stimulators should be used only with the leads and
electrodes recommended for use by the manufacturer.
• In the event of all 300-Level or a 200-Level error message that cannot
be resolved, immediately stop all use of the system, and contact the
dealer or DJO for service. Errors and Warnings in these categories
indicate an internal problem with the system that must be tested by
DJO or a Trained Technician 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
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 each mode of treatment.
• Use of other accessories other than those specified in this User Manual
may increase electrical emissions and decrease electrical immunity of
the device.
• Contaminated sponges, electrodes, lead wires, and gel can lead to
infection.
• Use of electrode with degraded hydrogel can result in burn to the skin.
• DO NOT operate this unit in an environment where other devices are
being used that intentionally radiate electromagnetic energy in an
unshielded manner.
• Use of electrode on multiple patients can lead to infection.
• Clean applicators after each use, otherwise it can lead to cross
contamination and infection.
• When the Laser Module is not in use, it should be protected against
unqualified use.
• Disconnect the system from the power source before attempting any
maintenance, installation, removal, or replacement procedures to
prevent electrical shock and possible damage to system.
• Keep electrodes separated during treatment. Electrodes in contact
with each other could result in improper stimulation or skin burns.
14
Vectra® Neo Clinical Therapy System
GENERAL WARNINGS AND PRECAUTIONS
WARNING
• The Vectra® Neo Clinical Therapy System may be susceptible to ElectroStatic Discharge (ESD) at greater than ±4 kV when first grasping either
the Ultrasound or Laser Applicator. In the event of such a discharge,
the Vectra® Neo Clinical Therapy System may experience
communication loss with the installed modules. The Vectra® Neo
Clinical Therapy System will terminate all active outputs (stim,
ultrasound, laser), automatically place the unit in a safe state, and
issue an error message 301 or 307.
- To recover from an error message 301 or 307, turn the unit off and
on using the ON/OFF switch located at the top of the display. Once
the system restarts, re-initiate all treatments that were
interrupted.
• To prevent Electro-Static Discharge (ESD) at greater than ±4 kV:
- Grasp and hold the Ultrasound or Laser Applicator prior to starting
treatment. If the applicator must be put down prior to completion
of treatment, stop the current treatment first and then place the
applicator in the holder.
- Maintain humidity in the use environment to at least 50% relative
humidity.
- Floors should be wood, concrete, or ceramic tile. If floors are
covered with synthetic material, DJO recommends implementing
additional controls to maintain relative humidity to at least 50%.
- Communicate these ESD-precautionary procedures to healthcare
staff, contractors, visitors, and patients.
• Long term effects of chronic electrical stimulation are unknown.
WARNING
• 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.
• Do not apply the Ultrasound Applicator to the patient during the Head
Warming period. Applicator must remain in Applicator Hook during the
Head Warming period.
• Some patients are more sensitive to Laser output (i.e., patients taking
medications that increase sensitivity to light) and may experience a
reaction similar to a heat rash.
• Before each Laser use, clean the plastic lens with a clean cloth. Make
certain to apply with a clean cloth. Failure to clean the lens between
patient therapy sessions could cause beam fragmentation, which may
reduce the effectiveness of the treatment.
• Medical electrical equipment needs special precautions regarding EMC.
Portable and mobile RF communication equipment can be affected by
other medical electrical devices. If you believe interference is
occurring, please consult the ELECTROMAGNETIC COMPATIBILITY (EMC)
section on page 73, to assist in removing the interference.
• Common RF emitting devices (e.g., RFID) and electromagnetic security
systems (e.g., metal detectors) may interfere with the operation of the
Vectra® Neo Clinical Therapy System. The Vectra® Neo Clinical Therapy
System has been tested in the presence of these types of devices and
while no adverse event occurred, the device should not be operated
within the vicinity or environment as another RF emitting device.
• Stimulation should not be applied over the anterior neck or mouth.
Severe spasm of the laryngeal and pharyngeal muscles may occur and
the contractions may be strong enough to close the airway or cause
difficulty in breathing.
• Stimulation should not be applied transthoracically in that the
introduction of electrical current into the heart may cause cardiac
arrhythmia.
• Stimulation should not be applied over swollen, infected, and
inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis,
varicose veins, etc.
• Stimulation should not be applied over, or in proximity
to, cancerous lesions.
• Electrotherapy output current density is related to electrode size.
Improper application may result in patient injury. If any question
arises as to the proper electrode size, consult a licensed practitioner
prior to therapy session.
• The Vectra® Neo Clinical Therapy System optional modules and
associated accessories are designed for use only with the Vectra® Neo
Clinical Therapy System.
• Remove the Ultrasound or Laser Applicator by pulling the cable
connector only. DO NOT remove by pulling the cable.
15
GENERAL WARNINGS AND PRECAUTIONS
DANGER
• Stimulus delivered by the TENS waveforms of this device,
in certain configurations, will deliver a charge of
25 microcoulombs (μC) or greater per pulse and may be
sufficient to cause electrocution. Electrical current of this
magnitude must not flow through the thorax because it
may cause a cardiac arrhythmia.
• Patients with an implanted neurostimulation device must
not be treated with or be in close proximity to any
shortwave diathermy, therapeutic ultrasound diathermy,
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.
Vectra® Neo Clinical Therapy System
• This unit is considered to be a Class 3B Laser product and
thus emits visible and invisible Laser radiation (IR). Avoid
direct eye exposure to the Laser beam. The symbol to the
left is located on the back of the applicator and indicates
the active radiant surface (the area on the applicator that
emits infrared Laser energy and the direction of the beam
of light). When the unit is on, not all wavelengths are
visible to the naked eye. Therefore, when performing any
operational or functional check, always wear Chattanooga
laser protective eyewear.
• The solvents of adhesives and flammable solutions used
for cleaning and disinfecting should be allowed to
evaporate before the unit is used.
• DO NOT connect the unit to an electrical supply without
first verifying that the power supply is the correct voltage.
Incorrect voltage may cause unit damage, malfunction,
electrical shock, fire, or personal injury. Your unit was
constructed to operate only on the electrical voltage
specified on the Voltage Rating and Serial Number Plate.
Contact your DJO dealer if the unit is not properly rated.
• Laser protective eyewear should be worn during laser
treatment by the operator and patient to block infrared
light energy from the eyes during treatment.
• DO NOT point the Laser beam directly into human or
animal eyes. The lens of the eye does not detect the
invisible, coherent Laser beams, potentially resulting in
permanent retinal damage.
• Device is not designed to be used in oxygen rich
environment. Explosion hazard if the device is used in the
presence of flammable anesthetic mixture with air,
oxygen, or nitrous oxide.
16
Vectra® Neo Clinical Therapy System
COMPONENTS
DETAIL DEVICE DESCRIPTION
Throughout these instructions the terms “left” and “right”
referring to the machine sides are from the perspective of
a user standing in front of the unit.
The Vectra® Neo Clinical Therapy System allows
installation of optional modality modules by the user.
Speci cally designed for use with the Vectra® Neo Clinical
Therapy System, these modules con gure the system to
meet virtually every therapeutic need that a clinician may
have. The components of the Vectra® Neo Clinical Therapy
System are shown below.
NOTE: The Vectra® Neo Clinical Therapy System, when
ordered as a Tabletop System, without cart, is assembled
with Base (shown below). The only assembly required is
the installation of the desired Modules described in the
MODULE INSTALLATION section on page 23.
Head
Modules
• Stimulation Channel 1/2
• Stimulation Channel 1/2 + sEMG
• Stimulation Channel 3/4
• Laser
• Ultrasound
Lead Wires
The available lead wires are shown below. If the user
orders Stimulation Channel 1/2 module, the box will
include the blue and green lead wires. Stimulation
Channel 3/4 is the cranberry and orange lead wires.
If both modules are ordered, the box contains all four
colored lead wires. Stimulation modules channel 1/2 with
sEMG includes blue and green sEMG lead wires.
• Stimulation module (2 channel Stimulation with
sEMG)
• sEMG Lead Wires
• DURA-STICK® 2 in (5 cm) Round Disposable Electrodes
(2 packs of 4)
• Faceplates (to cover module after inserted into main
unit)
Laser Module – PN 70005
• Laser module
• Protective Eyewear, 2 Pair
• Interlock
• Patient Remote/Laser Interrupt Switch
• Faceplates (to cover module after inserted into main
unit)
18
Vectra® Neo Clinical Therapy System
ULTRASOUND APPLICATOR
1. Applicator Head
The component of the applicator that makes
contact with the patient during Ultrasound or
1
Combination therapy.
2. Applicator
The assembly that connects to the system and
incorporates the Applicator.
3. LED
The component of the applicator that indicates if the
Applicator is coupled or uncoupled on the treatment area.
2
Coupling is not available on the 1 cm
applicator.
LASER APPLICATOR
DETAIL DEVICE DESCRIPTION
3
2
Aperture
Laser Head
Pause/Resume Button
Laser Diode
LED’s/SLD’s
Laser Head
LED Indicator (Output Power)
LED Indicator (Output Power) This orange light illuminates
when Laser energy is being distributed by the applicator.
19
DETAIL DEVICE DESCRIPTION
PATIENT REMOTE/LASER INTERRUPT SWITCH
The Vectra® Neo Patient Remote/Laser Interrupt Switch
buttons are described in the table below. By default, the
remote is not assigned to any treatment. When assigned,
the buttons function as follows:
Only) - Increases the intensity of the assigned stim
treatment; button is not active if stim treatment is
unassigned. Button is not active and has no function for
Ultrasound or Laser treatments.
Vectra® Neo Clinical Therapy System
Decrease Intensity (2) (Electrical Stimulation Treatments
Only) - Decreases the intensity of the assigned stim
treatment; button is not active if stim treatment is
unassigned. Button is not active and has no function for
Ultrasound or Laser treatments.
M (Manual Stimulation) (4) (Electrical Stimulation
Treatments Only) - Provides one cycle of stimulation.
Can only be operated when the clinician enables
manual mode on the base unit (head). This mode is
clinician monitored and is not for use when the patient is
unattended. Button is not active and has no function for
Ultrasound or Laser treatments.
Stop (3)
Increase (1)
Decrease (2)
Manual (4)
20
Vectra® Neo Clinical Therapy System
HEAD TO CART ASSEMBLY
SETUP INSTRUCTIONS
The optional Therapy System Cart, PN 70001, is designed
for use with the Vectra® Neo Clinical Therapy System only
and allows the user to easily transport the System from
patient to patient within the clinic as well as store all
necessary accessories, supplies, and applicators used for
the various modalities of the System.
Tools required (not included): #2 Phillips screwdriver and
standard slotted screwdriver.
Remove the Vectra® Neo Clinical Therapy System from the
shipping carton. Visually inspect for damage. Report any
damage to the carrier immediately.
To assemble the Neo Head to the Cart, follow these steps:
1. Remove the top drawer from the Cart. Pull the drawer
open. Press the plastic tabs on both drawer slides
simultaneously in opposite directions, as shown. Pull
the drawer completely out.
3. Place the Neo Head on the cart facing toward the
drawers.
4. Fasten the Neo Head to the cart using four screws to
connect the base to the Neo Head.
2. Remove the base from the head unit prior to placing
it on the cart. Do this by removing the four screws
from the underside of the base where they secure to
the Neo Head. Retain for use when attaching the Neo
Head to the Cart.
5. If desired, replace the closed Handles with the open
Handles. Each Handle is attached with four screws as
shown.
6. Reinstall the drawer.
21
SETUP INSTRUCTIONS
NEO LEG TO CART ASSEMBLY/ADJUSTMENT
Vectra® Neo Clinical Therapy System
The Neo Cart is shipped without the legs attached.
• Socket Head Cap Screw ¼-20 x 1-1/4”, quantity 6
(provided)
To install or adjust the leg assemblies onto the Neo Cart,
follow these steps:
1. Remove the bottom drawer from the Cart. Pull the
drawer open. Press the plastic tabs on both drawer
slides simultaneously in opposite directions, as shown.
Completely pull the drawer out.
2. There are two Cart height adjustments. Standard
shown on the left and lowered, shown on the right.
For initial installation, determine the desired height.
Locate three Allen-style bolts for each leg, left and
right and insert, by hand, in their respective slots. Use
the Allen wrench to secure the legs.
NOTE: To adjust height at a later time, simply remove
the Allen-style bolts, re-position the legs, and re-insert
the bolts.
3. Reinstall the Bottom Drawer.
22
Vectra® Neo Clinical Therapy System
MODULE INSTALLATION
SETUP INSTRUCTIONS
All modules are installed from the left side (when facing
the screen) of the Neo Head unit and are each installed
in the same manner. Each has color-coded lead wires
that correspond to the appropriate colored labeling on
the modules. Module-speci c installation instructions
are shown after the generic instructions. To install the
modules in the Vectra® Neo Clinical Therapy System,
follow the steps shown.
Tools required (not included): #2 Phillips screwdriver and
standard slotted screwdriver.
The System is programmed to automatically recognize
the new Module(s), therefore, no software installation is
required.
UltrasoundLaser
3. Insert a standard slotted screwdriver (not provided)
into the top slot, pressing down with slight pressure.
Pull the faceplate off (in this example showing
Electrotherapy Channel 3/4).
4. The module is inserted on the left side of the Neo
Head in the slot as shown in this example (with the
Ultrasound module).
Stimulation3/4Stimulation 1/2
1. Ensure that the power cord is removed from the
device.
2. Remove the blank faceplate over the slot from the
left and right sides of the Neo head. (The example
displays the Ultrasound module.)
5. Carefully insert the module into the slot, with 32 pins
(2x16) in first. Secure the module in place with gentle
pressure until you feel the module is seated.
6. Secure the module with a screw provided at the
bottom as shown (using channel 3/4 as example).
7. In this example showing the Laser faceplate, insert
the faceplate at the bottom and snap into place at the
top, as shown on the left and right sides (Vectra® Neo
Clinical Therapy System allows Laser access on the left
and right sides.)
Ultrasound Cable Insertion
Shown below is the Ultrasound Cable Insertion location.
INSERTING PLUGS
When inserting the plugs for the Ultrasound and Laser
modules, be sure to align the at side of the plug with
the at side of the slot and push in gently. This is to avoid
bending the pins in the plug
8. Plug in the unit and press the power button. Allow
the unit to initialize, and then verify that the newly
installed module is shown as available on the Home
screen.
Flat side of plug
Flat side of slot
24
Loading...
+ 60 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.