Vectra Genisys User Manual

Vectra Genisys User Manual
®
User
Manual
Model 2784
Vectra Genisys® Laser
Chattanooga Group is an ISO 13485 Certified Company
TABLE OF CONTENTS
Vectra Genisys® Laser
SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2531
Installing the Laser Interlock
(Door Interrupt Switch) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Mounting the Unit on the Wall. . . . . . . . . . . . . . . . . . . . . . . . . . . 26-28
Installing the Battery Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29-30
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
ABOUT LASER LIGHT THERAPY. . . . . . . . . . . . . . . . . . . . . . .312
Precautionary Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Overview of Laser Light Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Overview-Common Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Adjunctive Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Additional Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Preventing Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Patient Susceptibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Output Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Factors that Affect Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
CHARGING & USING THE BATTERY PACK. . . . . . . . . . . . . . . .31
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3260
Entering & Changing the PIN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32-34
Preparing the Patient’s Skin for Therapy . . . . . . . . . . . . . . . . . . . . . .35
Starting, Stopping, & Interrupting Therapy . . . . . . . . . . . . . . . 36-38
Using Clinical Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39-42
Creating a User Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43-44
Restoring Factory Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45-46
Restoring Factory Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47-48
Selecting a User-Defined Protocol. . . . . . . . . . . . . . . . . . . . . . . . 49-50
System Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51-59
Audible Tones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Changing Power-Up Presets . . . . . . . . . . . . . . . . . . . . . . . . . . 51-53
Brightening or Dimming the LCD . . . . . . . . . . . . . . . . . . . . . . . . .53
Viewing Applicator Information. . . . . . . . . . . . . . . . . . . . . . . 54-55
Changing Languages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56-57
Viewing Unit Version Information . . . . . . . . . . . . . . . . . . . . . 58-59
NOMENCLATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1319
SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Unit Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Laser Light Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . .21
Description of Device Markings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Laser Applicator Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-23
Laser Protective Eyewear Specifications . . . . . . . . . . . . . . . . . . . . . .24
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TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
TREATMENT TIPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Standard Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
Optional Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Troubleshooting the Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Error Codes and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6364
Maintaining the Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Warranty Repair/Out of Warranty Repair. . . . . . . . . . . . . . . . . . . . . .64
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
APPENDIX A  EMC TABLES. . . . . . . . . . . . . . . . . . . . . . . . . 6669
Table 1: Guidance and Manufacturer’s Declaration–
Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . . . . . . . .66
Table 2: Guidance and Manufacturer’s Declaration–
Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . 67-68
Table 3: Recommended Separation Distances between
Portable and Mobile RF Communications
Equipment and the Vectra Genisys Laser . . . . . . . . . . . .69
ii
FOREWORD
TABLE OF CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
This manual has been written for the operators of the Vectra Genisys Laser. It contains general instructions for operation,
precautionary instructions, and maintenance recommendations. In order to obtain maximum life and efficiency from your Vectra
Genisys Laser, and to assist in the proper operation of the unit, read and understand this manual thoroughly.
The specifications put forth in this manual were in effect at the time of publication. However, owing to Chattanooga Group’s policy of
continuous improvement, changes to these specifications may be made at any time without obligation on the part of Chattanooga
Group.
Before administering any treatment to a patient, you should become acquainted with the operating procedures, as well as the
indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the
application of therapeutic laser light. Users of this device should refer to CAN/CSA-Z386-92: Laser Safety in Health Care Facilities or
ANSI Z-136.3, 1996: American National Standard for the Safe Use of Lasers in the Health Care Environment.
Product Description
The Vectra Genisys Laser, designed and manufactured by Chattanooga Group, offers a new dimension in clinical laser light therapy
made possible by advanced software design and digital signal processing.
Effectiveness of this treatment is dependent upon correct use. If treatment times are exceeded, the therapy may not result in positive
clinical outcomes.
©2009 Encore Medical, L.P. and its affiliates, Austin, Texas, USA. Any use of editorial, pictorial or layout composition of this publication without express written consent
from Chattanooga Group of Encore Medical, L.P. is strictly prohibited. This publication was written, illustrated and prepared for print by Chattanooga Group of Encore
Medical, L.P.
NOVUS® is a registered trademark of TCG International Inc.
Virex® II 256 is a registered trademark of Johnson Wax Professional.
PDI Sani-Cloth® Plus/Hb are registered trademarks of Professional Disposables, Inc. (PDI), the Healthcare Division of Nice-Pak Products, Inc.
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FOREWORD
Vectra Genisys® Laser
The following features are available on the Vectra Genisys Laser:
• Clinical Portable Battery Powered Option
The Vectra Genisys Laser is a truly portable laser unit that does not confine you to a wall socket to operate.
• Clinical Indications
An efficient approach for setting up a treatment using preset parameters.
• Real Time Feedback
This feature provides a measured and monitored output system that adjusts the dosage delivered to the patient.
• Electronic Signature™
Automatically calibrate the system to any Vectra Genisys Laser applicator.
• Ergonomic Applicators
A new ergonomic design that offers a 20 degree contour in the applicator hand grip. This ergonomic extra will help deliver
uniform laser light therapy with greater clinician comfort.
• Clear LCD
Guide the operator through the setup process providing continuous feedback about treatment settings. Gives you optimal
visibility during attended procedures.
• User Protocols
User protocols allow you to set, save, and change the parameters of each program (protocol) in order to tailor it to meet your
patients’ specific needs. Ten storage slots are available for user protocols.
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ABOUT
TABLE OF
LASER
CONTENTS
LIGHT THERAPY
®
Intelect
Laser Module
Vectra Genisys®
Laser
CAUTION
Precautionary Instructions
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:
=CAUTION-
• Read, understand, and practice the precautionary and operating instructions.
•
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.
•
=WARNING-
Text with a “WARNING” indicator will explain
possible safety infractions that will potentially cause
serious injury and equipment damage.
•
=DANGER-
Text with a “DANGER” indicator will explain
possible safety infractions that are imminently
hazardous situations that would result in death
or serious injury.
•
NOTE:
Throughout this manual “NOTE” may be found. These Notes
are helpful information to aid in the particular area or
function being described.
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3
Know the limitations and hazards associated with using any laser light device.
Observe the precautionary and operational decals placed on the unit.
Do not operate this unit when connected to any unit other than Chattanooga
Group devices.
Do not operate this unit in an environment where other devices are being used
that intentionally radiate electromagnetic energy in an unshielded manner.
Portable and mobile RF communications equipment can affect Medical Electrical
Equipment.
DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the
buttons on the control panel as damage may result.
Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous exposure to laser light energy.
Handle the applicator with care. Inappropriate handling of the applicator may
adversely affect its characteristics.
Inspect applicator cables and associated connectors before each use.
This unit should be operated in temperatures between 59 to 85°F (15 to 40°C),
and transported and stored in temperatures between - 20 to 110°F (7 to 43°C),
with relative humidity ranging from 30% - 60%.
Where the integrity of the external protective earth conductor arrangement is in
doubt, equipment shall be operated from its internal electrical power source.
DO NOT disassemble, modify, or remodel the unit or accessories. This may cause
unit damage, malfunction, electrical shock, fire, or personal injury.
Failure to use and maintain the Vectra Genisys Laser and its accessories in
accordance with the instructions outlined in this manual will invalidate your
warranty.
ABOUT LASER LIGHT THERAPY
Vectra Genisys® Laser
CAUTION
• DO NOT remove the cover. This may cause unit damage, malfunction, electrical shock, fire, or personal injury. There are no user-serviceable parts inside the unit. If a
malfunction occurs, discontinue use immediately and consult the dealer for repair service.
• DO NOT permit any foreign materials or liquids to enter the unit. Take care to prevent any foreign materials including, but not limited to, inflammables, water, and
metallic objects from entering the unit. These may cause unit damage, malfunction, electrical shock, fire, or personal injury.
• If you have difficulty operating the unit after carefully reviewing this user manual, contact your Chattanooga Group dealer for assistance.
• U.S. federal law restricts this device to sale by, or on the order of, a physician or licensed practitioner.
• This unit 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 unit 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 which the other device(s) are connected and consult the
Chattanooga Group Service Department for help.
Use of parts or materials other than Chattanooga Group's can degrade minimum safety.
WARNING
• Before each use, clean the plastic lens with NOVUS® Polish System (www.novuspolish.com). Apply with a clean cloth. Failure to clean the lens between patient therapy
sessions could cause beam fragmentation.
• Be sure to read all instructions for operation before treating a patient.
• Do not drop the applicator or unit on hard surfaces. Do not submerge the applicator or unit in water. All of these conditions 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 light energy.
• Make certain that the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local
electrical codes.
• This device should be kept out of the reach of children.
• This device should be used only under the continued supervision of a licensed practitioner.
4
ABOUT
TABLE OF
LASER
CONTENTS
LIGHT THERAPY
®
Intelect
Laser Module
Vectra Genisys®
Laser
WARNING
• Dispose of all products in accordance with local and national regulations and codes.
• This equipment 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.
• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous conditions causing damage to the unit and
applicator.
• Care must be taken when operating this unit adjacent to or stacked with other equipment. Potential electromagnetic or other interference could occur to this or other
equipment. Try to minimize this interference by not using other equipment (i.e. cell phones, etc.) in conjunction with it.
• Use only accessories that are specially designed for this unit. Do not use accessories manufactured by other companies on this (table, unit, device, etc). Chattanooga
•
•
•
•
•
•
•
•
•
•
•
•
Group is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories or cables may result in
increased emissions or decreased immunity of this unit.
Use of other accessories other than those specified may result in increased emissions and decreased immunity.
If laser is not in use, power off unit or remove applicator.
Laser equipment not in use should be protected against unqualified use.
Remove battery pack if unit is not to be used for an extended 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.
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 on or over a tattoo.
Inspect the plastic lens of the laser head for blemishes, deformation, pitting, scratches, discoloration and cleanliness before each use.
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 that
no liquids enter into the laser head while cleaning. Do not use any chlorine-based cleaners on the laser head.
The following factors may affect laser treatment: color of skin, age of lesion, depth of lesion, sensitivity of the patient, tissue type and medications that increase sensitivity
to light.
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ABOUT LASER LIGHT THERAPY
Vectra Genisys® Laser
DANGER
• Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
• 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 Chattanooga Group dealer if the unit is not properly rated.
Laser protective eyewear should be worn by the operator and patient to block infrared light energy from the eyes during treatment.
DO NOT point the laser light beam directly into human or animal eyes. The lens of the eye does not detect the invisible, coherent laser light
beams, potentially resulting in permanent retinal damage.
This unit is considered to be a Class 3B laser light product and thus emits visible and invisible laser light radiation (IR). Avoid direct eye
exposure to the laser light 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 light 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 Group laser protective eyewear.
6
ABOUT
LASER
LIGHT THERAPY
TABLE OF
CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
OVERVIEW OF LASER LIGHT THERAPY
In short, the light energy absorbed into the patient’s tissue triggers biological changes at a cellular level to provide topical heating
for the temporary increase in local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation
of muscles and relief of muscle spasms; and temporary relief of minor pain and stiffness associated with arthritis. The dose and
frequency of treatment can be adjusted to produce the desired effect.
Low Level Laser Light differs from ordinary light in four ways. Briefly, it is much more intense, directional, monochromatic and
coherent. Most lasers consist of a column of active material with a partly reflecting mirror at one end and a fully reflecting mirror at
the other. The active material can be solid (ruby crystal), liquid or gas (HeNe, CO2 etc.).
Low Level Laser Light has unique physical properties that no ordinary light has. This is the key to why laser light is so effective
compared to other kinds of light in healing. There are more than 100 double-blind positive studies confirming the clinical effect
of LLLT (Low Level Laser Therapy). More than 2500 research reports are published. The book Laser Therapy - clinical practice and
scientific background by Jan Tunér and Lars Hode is a good reference guide for literary documentation.
There is no exact limit with respect to the penetration of the light. The light gets weaker the further from the surface it penetrates.
There is, however, a limit at which the light intensity is so low that no biological effect of the light can be registered. This limit, where
the effect ceases, is called the greatest active depth. In addition to the factors mentioned above, this depth is also contingent on
tissue type, pigmentation, and dirt on the skin. Fat tissue is more transparent than muscle tissue.
Some laser applicators may cause a noticeable heat sensation, particularly in hairy areas and on sensitive tissues such as lips.
Common Terms
Applicator - The hand held assembly used to deliver laser light energy. The applicator includes the laser head, diode, and related
electronics.
Collimating - The shape of the laser light beam. While neither focused nor dispersed, this laser light beam resembles a column when
applied from the unit through the applicator.
7
ABOUT LASER LIGHT THERAPY
Vectra Genisys® Laser
OVERVIEW OF LASER LIGHT THERAPY (CONTINUED)
Continuous Mode – The output of the laser light is not interrupted during the treatment time.
Dosage – A measure of the intensity of the laser light energy over the treatment area. The unit of measure is Joules or Joules/cm2.
Energy – Measured in Joules, energy equals the treatment time multiplied by the power. More importantly, Energy Density equals
the power output multiplied by the treatment time, and divided by the spot size (cm2). This gives a more specific measurement of
energy delivered.
Frequency – Pulsed frequencies are selectable from 8 to 10,000 Hz.
Laser Head – The clear lens face of the applicator that contacts the patient’s skin. It consists of laser diodes with or without LED’s or
SLD’s (depending on the applicator).
Power – Measured in Watts (W), power wattage is directly proportional to the treatment time and penetration of the laser light
energy. High-powered diodes will reduce patients’ treatment time and give a higher amount of energy at a deeper depth. Power
output can be either continuous or pulsed.
Power Density - Ratio of power divided by treatment time.
Pulsed Mode – This is the ratio of the “On” time to “Total” time of the cycle, expressed as a percentage. The lower the percentage, the
lower temporal average intensity. 100% is continuous laser light. Pulsed Mode is 90% on and 10% off.
NOTE: Pulsed Mode is also equivalent to Duty Cycle.
Spot Size - Area of the LED, SLD, or laser beam when it leaves the face of the lens.
Treatment Area - Area of tissue affected by LED, SLD, or laser when wavelength, divergence angles, and depth of penetration are
factored. This is the area used to calculate dosage.
Treatment Time – Measured in seconds, it is the suggested time per laser point that therapy is given.
8
ABOUT
TABLE OF
LASER
CONTENTS
LIGHT THERAPY
®
Intelect
Laser Module
Vectra Genisys®
Laser
OVERVIEW OF LASER LIGHT THERAPY - COMMON TERMS (CONTINUED)
Wavelength – Measured in nanometers (nm), wavelength is the key component in obtaining effective therapy as different
wavelengths bring about different physiological effects. Superficial skin disorders have been found to be most effectively
treated at wavelengths 600-700 nm, while deeper muscular or ligament lesions and joint conditions are better treated at higher
wavelengths of 700-1000 nm.
9
ABOUT LASER LIGHT THERAPY
Vectra Genisys® Laser
Indications for Laser Light
Contraindications
The Vectra Genisys Laser is indicated to provide topical
heating for the following:
The Vectra Genisys Laser should NOT be used:
• temporary increase of local blood circulation.
• temporary relief of minor muscle and joint aches, pains,
and stiffness.
• 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 or animals.
• temporary relaxation of muscles.
• over areas injected with steroids in the past 2-3 weeks.
• temporary relief of muscle spasms.
• over areas that are suspicious or contain potentially cancerous tissue.
• temporary relief of minor pain and stiffness associated
with arthritis.
• over areas of active hemorrhage.
Adjunctive Use
• over the neck (thyroid or carotid sinus region) or chest (vagus nerve
or cardiac region of the thorax).
The Vectra Genisys Laser may be used adjunctively for the
following:
• over a pregnant uterus.
• symptomatic relief of minor pain
• directly over areas with open wounds, unless covered with a clear
protective barrier.
• minor muscle and joint pain
• treatment over sympathetic ganglia.
• minor muscle spasms
• for symptomatic local pain relief unless etiology is established or
unless a pain syndrome has been diagnosed.
• relief of associated minor stiffness and pain associated
with arthritis
• promoting relaxation of muscles
• 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.
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ABOUT
LASER
LIGHT THERAPY
TABLE OF
CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
• over the thoracic area if the patient is using a cardiac
pacemaker.
DANGER
Patients with an implanted neurostimulation device must not be treated
with or be in close proximity to any shortwave diathermy, microwave
diathermy, therapeutic laser 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."
• 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.
Additional Precautions
Additional precaution should be used when the laser light is
used on patients with the following conditions:
Preventing Adverse Effects
• Over an area of the spinal cord following a laminectomy, i.e.,
when major covering tissues have been removed.
• Over anesthetic areas.
Perform the following procedures to avoid the negative effects
of laser light therapy:
• On patients with hemorrhagic diatheses.
Patient Susceptibility
WARNING
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.
Be sure to inspect the treatment area during and following
treatment, and discontinue if an adverse reaction does occur.
Output Power
Higher output levels have a greater potential for patient
11
ABOUT LASER LIGHT THERAPY
Vectra Genisys® Laser
discomfort. Choose a lower dosage to reduce output or select a
pulsed duty cycle to decrease patient discomfort.
Factors that Affect Treatment
The following factors may affect laser light 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
12
NOMENCLATURE
TABLE OF CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
UNIT
LCD Intensity/
Contrast Dial
Power
On/Off
Pause/Resume
LCD
Laser Head
TIME
Up Arrow
Clinical
Resources
LED Indicator
(Output Power)
STOP
Frequency/Back
Applicator
(see page 14)
Down
Arrow
DOSAGE
PAUSE
START Intensity
Display/Enter
Accessory
Panel
Laser Stop Switch
Connection (Required)
Laser Interlock
(Door Interrupt Switch Connection)
13
Applicator
Connection
Not Applicable in
US Market
NOMENCLATURE
Vectra Genisys® Laser
APPLICATOR
LED Indicator
(Output Power)
Lens
Laser
Diode
Laser Head
Pause/Resume
Button
Laser Head
LED’s/SLD’s
14
NOMENCLATURE
TABLE OF CONTENTS
®
Vectra Genisys®
Intelect
Laser Module
Laser
Power On/Off
The Power On/Off button controls the flow of electricity to the unit.
LCD
The LCD (Liquid Crystal Display) allows the user to view and monitor the information displayed during laser light therapy.
The following information is displayed on the LCD:
• Frequency
• Duty Cycle
• Dosage
• Treatment Time
• Clinical Indications
Time
Press the Up or Down arrow buttons to set total treatment time of therapy.
Clinical Resources
Select this button to access the following functions:
• Clinical Indications
• Utilities
• Retrieve User Protocols
• Save User Protocols
Use the Up and Down arrow buttons to navigate through the available options.
STOP
Select this button to stop a treatment session.
15
NOMENCLATURE
Vectra Genisys® Laser
Frequency/Back
Use this button to return to the previous window and toggle between 12 preset frequencies.
Down Arrow
When the window displays a list of options, press the Down Arrow button to scroll down the list.
PAUSE
Use this button to pause the treatment session. When pressed, the
button.
icon displays. To restart therapy, press the PAUSE
Accessory Panel
The Accessory Panel serves as a port of connection for the various accessories.
Laser Interlock (Door Interrupt Switch Connection)
This option allows you to set up a switch (similar to the laser stop switch) that interrupts treatment when the door of
the treatment room is opened during a therapy session.
Laser Stop Switch Connection
As a safety measure and to minimize any apprehension, it is recommended that you always allow the patient to hold the
Laser Stop Switch during laser light therapy. When the red button on the end of the switch is pressed, a beeper
sounds and the treatment is paused. Parameters can then be verified and changed (if necessary) and therapy can be
resumed.
The Laser Stop Switch is very sensitive. Explain this to the patient when using it in order to prevent unnecessary
interruptions in treatment.
16
NOMENCLATURE
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
Applicator Connection
This port serves as the connection point between the unit and the applicator.
START
Select Start to begin a treatment session.
J
J/cm2
Intensity Display/Enter
Select this button to change display from J/cm2 to Joules. Also, this button is used to accept the highlighted selection.
Dosage
Use the Up or Down arrow to increase or decrease output power dosage.
Applicator
The hand held assembly used to deliver laser light energy. The applicator includes the laser head, diode, and related
electronics.
Up Arrow
When the window displays a list of options, press the Up Arrow button to scroll up the list.
Battery Indicator
When displayed on the LCD, this symbol indicates the battery pack option is present on the Vectra Genisys® Laser. This
symbol also displays the charge status of the battery.

LCD Intensity/Contrast Dial
If the intensity of the LCD display diminishes, turn the dial until the display contrast is optimal.
17
NOMENCLATURE
Indicator
 Charge
This symbol displays when the unit is connected to mains power and the battery pack is charging.
Vectra Genisys® Laser
NOTE: During battery operation, if the unit is left on, but not active, for more than five minutes, it will power off to
conserve battery power. To restore power, press the Power On/Off button.
Applicator Symbols
These symbols denote the status of the Laser Applicator.
This symbol indicates that therapy is in progress, output is being distributed to the patient, and the applicator is functioning
normally.
This symbol indicates that although the applicator is plugged in, no laser light energy is being emitted from the applicator.
This symbol indicates that the Pause button has been pressed, and no output is being emitted from the applicator.
This symbol indicates that the applicator has been unplugged from the unit.
Lens
This clear lens acts as a shield to protect the patient’s skin.
Laser Head
This aluminum housing located on the end of the applicator accommodates the lens, laser diodes, LED’s, SLD’s, and their
associated electronics.
Pause/Resume
Use this button to begin or pause the treatment session. To restart therapy, press the PAUSE button.
18
NOMENCLATURE
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
LED’s/SLD’s
These Light Emitting Diodes generate different wavelengths of light that allow the user to treat topical or surface symptoms.
Laser Diode
This mechanism generates different wavelengths of light that allow the user to treat various, deeper penetrating symptoms.
LED Indicator (Output Power)
This orange light illuminates when laser light energy is being distributed by the applicator.
19
SPECIFICATIONS
Vectra Genisys® Laser
UNIT SPECIFICATIONS
DIMENSIONS
Height (with base)......................................................... 6.4 in (16.3 cm)
Complies with 21CFR 1040.10 & 1040.11
IEC/UL/EN 60601-1, 60601-1-2, and 60601-2-22
IEC 60825-1:2001, CAN/CSA C22.2 No. 601.1-M90 w/A2
Width (with applicator) ............................................ 11.3 in (28.8 cm)
Each unit is shipped with repositional base, laser protective
eyewear, laser stop switch, and this manual.
Width (without applicator) ........................................ 9.4 in (23.9 cm)
Depth (front to rear) .................................................. 12.9 in (32.8 cm)
For a complete list of standard and optional accessories, see
page 61.
WEIGHT
Standard Weight (with applicator and base) ....................... 5.07 lb
............................................................................................................. (2.3 kg)
Battery Pack ................................................................... 1.87 lb (0.85 kg)
0413
POWER
Input........................................................120 - 240 V ~, 50/60 Hz 75 VA
Electrical Class ...............................................................................CLASS 1
Electrical Type ......................................................................TYPE B
Output Type ......................................................... Infrared Lamp (laser)
Laser Class ................................................................................................. 3B
Battery Type ..........................................Nickel Metal Hydride (NiMH)
........................................................................................(1.2 V x 20 size AA)
20
SPECIFICATIONS
TABLE OF CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
LASER TECHNICAL SPECIFICATIONS
DESCRIPTION OF DEVICE MARKINGS
Duty Cycles
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:
Pulsed ........................................................................................................ 90%
Continuous ............................................................................................ 100%
Pulse Frequencies ......................................................... 8 Hz - 10000 Hz
............................................................................................... and continuous.
Output ............................. 100-1440 mW (dependent on applicator)
Standards:
Classified by Intertek Testing Services NA Inc.
9700675
Complies with 21CFR 1040.10 & 1040.11
IEC/UL/EN 60601-1, 60601-1-2, and 60601-2-22
CAN/CSA C22.2 No. 601.1-M90 w/A2. ....................................................................
0413
Output accuracy ..................................................... +/- 20% of nominal
Refer to ACCOMPANYING DOCUMENTS...............................................................
Wavelengths..................... 670-950 nm (dependent on applicator)
Equipment capable of delivering output values in excess
of 10 mA r.m.s. or 10V r.m.s. averaged over any period of 5 s
Type B Equipment ..............................................................................................................
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 light 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). ........................................................................
21
SPECIFICATIONS
Vectra Genisys® Laser
LASER APPLICATOR SPECIFICATIONS
For all single diode and cluster laser and LED applicators, the expected increase in the measured quantities after manufacture added to the values
measured at the time of manufacture is ±20%.
The new software incorporates a cooling function that forces the user to cool the laser clusters prior to the next treatment. The software will
calculate the cooling time needed when treatment times exceed 3 minutes per application. For a 3 minute treatment, it will force a 15 second cool
down period before the next treatment can begin. For a 4 minute treatment, it will force a 2 minute cool down period before the next treatment
can begin. The software extrapolates for times between 3 and 4 minutes.
A message will display on the screen informing the user that the probe is cooling down and the time period required. After 5 seconds, this message
will disappear. If the user attempts to use the probe before the cool down period is completed, the message will re-display to signify that the
applicator is still in cool down mode. After the cool down period is complete, a message displays that informs the user that the unit is ready for use.
Single Diode Applicators
Applicator
Wavelength
(nm)
Output
Power
(mW)
Power
Density
(W/cm2)
Treatment
Area
(cm2)
Diode
Type
Nominal Ocular Hazard
Distance
(NOHD-in meters for
AEL<.0175 W/cm2)
Divergance
a1
(rad)
Divergance
a2
(rad)
Spot Size
(cm2)
850 nm 100 mW Laser
850
100
1.43
0.07
GaAlA
6.2218
0.097
0.54334
0.012
850 nm 150 mW Laser
850
150
2.14
0.07
GaAlA
8.8
0.097
0.54334
0.012
850 nm 200 mW Laser
850
200
2.85
0.07
GaAlA
12.44
0.097
0.54334
0.0376
820 nm 300 mW Laser
820
300
0.606
0.495
GaAlA
15.24
0.097
0.54334
0.242
22
SPECIFICATIONS
TABLE OF CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
LASER APPLICATOR SPECIFICATIONS CONTINUED
Cluster Diode Applicators
Applicator
Output
Power
(mW)
Power
Density
(W/cm2)
Contact
Area
(cm2)
9 Diode Cluster Laser 540 mW
540
0.072
7.55
9 Diode Cluster Laser 1040 mW
13 Diode Cluster Laser 415 mW
13 Diode Cluster Laser 715 mW
33 Diode Cluster Laser 1440 mW
1040
415
715
1440
0.138
0.055
0.095
0.046
7.55
7.55
7.55
31.2
Diode
Type
Diode Specifications
Nominal Ocular Hazard
Distance
(NOHD-in meters for
AEL<.0175 W/cm2)
Divergance
a1
(rad)
Divergance
a2
(rad)
GaAlAs SLD Four 670 nm (10 mW) LED
LED
Five 850 nm (100 mW) Laser
6.2218
0.097
0.54334
0.64
0.06
GaAlAs SLD Four 670 nm (10 mW) LED
LED
Five 850 nm (200 mW) Laser
12.4438
0.097
0.54334
0.64
0.188
0.54334
1.12
0.136
0.48
0.54334
1.12
0.1128
0.48
0.54334
1.92
1.28
1.28
0.06
GaAlAs SLD Seven 670 nm (10 mW) LED
LED
Three 850 nm (100 mW) Laser
Three 950 nm (15 mW) SLD
GaAlAs SLD Seven 670 nm (10 mW) LED
LED
Three 850 nm (200 mW) Laser
Three 950 nm (15 mW) SLD
GaAlAs SLD Twelve 670 nm (10 mW) LED
LED
Eight 880 nm (25 mW) SLD
Eight 950 nm (15 mW) SLD
Five 850 nm (200 mW) Laser
23
6.2218
12.4438
12.4438
0.097
0.097
0.097
Spot Size
(cm2)
SPECIFICATIONS
Vectra Genisys® Laser
LASER PROTECTIVE EYEWEAR SPECIFICATIONS
OPTICAL DENSITY vs. WAVELENGTH
8
Optical Density
7
6
5
4
3
2
1
0
200
300
400
500
600
700
800
900
1000
1100
Wavelength
Useful Range
Optical Density 5+ .................................................................. 190-400 nm
Optical Density 3+ .................................................................. 625-830 nm
Optical Density 3+ ................................................................815-1050 nm
Each unit is shipped with Laser Protective Eyewear. The eyewear is L3 rated and approved and EN207 compliant.
24
0413
TABLE OF CONTENTS
SETUP
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
INSTALLING THE LASER INTERLOCK DOOR INTERRUPT SWITCH
The Laser Interlock is an optional safety device designed to interrupt Laser Light Therapy anytime the door to the the therapy room is
opened. Contact only qualified electricians to install the Laser Interlock kit and have them refer to the wiring diagram below.
The Laser Interlock kit consists of a switch resistor and a jack. You must supply the necessary cable that complies with local and
international codes.
DANGER
The Laser Interlock must be installed by a professional or qualified electrician. Serious eye injury can result if the device is not properly installed. Also, when
installing the device for multiple doors, the resistance total may not exceed 4800 ohm.
Diagram for Therapy Room with Multiple Doors
Diagram for Therapy Room with One Door
25
SETUP
Vectra Genisys® Laser
MOUNTING THE UNIT ON THE WALL
The Vectra Genisys Laser can be operated while the unit is resting on a flat surface, or mounted on a wall. To mount the unit on a
wall, do the following:
1.
Remove the repositional base from the bottom of the unit.
2.
Using the repositional base as a guide, mark the 4 wall holes with a pencil or pen.
26
SETUP
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
MOUNTING THE UNIT ON THE WALL CONTINUED
3.
Using a 9/64 (3.6 mm or 0.357 cm) drill bit, drill four holes you marked in the previous
step.
4.
Press 4 appropriately sized sheetrock anchors into the wall so that the sheetrock anchor is
flush with the wall.
5.
Screw four #8 flathead wood screws (1 inch or 2.54 cm) into the wall anchors. Make sure
you leave 1/4 of an inch (0.635 cm) between the wall and the head of the screw.
27
SETUP
Vectra Genisys® Laser
MOUNTING THE UNIT ON THE WALL CONTINUED
6.
Replace the repositional base on the bottom of the unit.
7.
Line up the screw heads with the holes on the repositional base, and slide the unit down
slightly until the screw heads are securely fastened to the repositional base.
28
TABLE OF CONTENTS
SETUP
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
INSTALLING THE BATTERY PACK
The Vectra Genisys Laser accommodates both AC mains power and an optional battery pack. The pack contains 20 Nickel Metal
Hydride (NiMH) drycell batteries. The unit can operate with the rechargeable power supply for approximately five hours of
continuous use.
To install the battery pack in the Vectra Genisys Laser, do the following:
1.
Locate the battery access door at the bottom of the unit and loosen the screw with a
regular screwdriver.
2.
Remove the battery access door and retain this cover.
29
SETUP
Vectra Genisys® Laser
INSTALLING THE BATTERY PACK (CONTINUED)
3.
Connect the battery pack cable to the unit’s battery connector in the bottom of the
battery recess.
4.
Put the battery pack into the unit, making sure to orient it as shown.
5.
Replace the battery access door and re-tighten the screw using the screwdriver.
6.
Reverse the steps in this section in order to remove the battery pack.
30
TABLE OF CONTENTS
SETUP
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
CHARGING & USING THE BATTERY PACK
CHARGING THE BATTERY PACK
The battery pack is automatically charged by the unit whenever there is mains power connected. Charging may be interrupted
during operation of the unit by the control circuitry to limit total power consumption. A fully charged battery will provide 2-5 hours
of treatment depending on the power, pulsed mode, and frequency used.
NOTE: Even when the battery pack is connected, the unit will default to mains power.
USING THE BATTERY PACK
To save battery power, the Vectra Genisys Laser is equipped with a “power off” function. This function is activated when the unit is
powered on and has been left idle for approximately 5 minutes, at which time the unit powers off. To restore power, press the Power
On/Off button.
31
OPERATION
Vectra Genisys® Laser
ENTERING AND CHANGING THE PIN
To gain access to any part of the Vectra Genisys Laser unit, you must enter a Personal Identification Number (PIN). The unit is shipped
with a default PIN that allows you initial access, but you may change the number anytime. To enter and change the PIN, do the
following:
1.
Turn the system power “ON” by pressing the Power On/Off button.
The unit displays the message “Initializing System.” Then, the Enter PIN window displays.
2.
1 1 1 1 is the default PIN. Press the button representing the number 1 four times
so that * * * * displays briefly.
The main window displays.
If you enter the wrong PIN, the message “Incorrect PIN was entered. Please try again. Press
any key to continue” displays. Press any key on the Operator Interface.
NOTE: If you lose or forget your PIN, contact Chattanooga Group Service Department at
(866) 864-0598 or (423) 870-2281.
32
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
ENTERING AND CHANGING THE PIN (CONTINUED)
3.
Press the Clinical Resources button.
The Clinical Library window displays.
4.
Using the Up Arrow and Down Arrow buttons, highlight Change PIN.
5.
Press the Display (Enter) button to select the highlighted selection.
The Change PIN window displays.
33
OPERATION
Vectra Genisys® Laser
ENTERING AND CHANGING THE PIN (CONTINUED)
6.
Press the buttons that represent the numbers to which you want to change the PIN.
Once you enter four numbers, a message displays to inform you of the new PIN.
7.
Press any key on the Operator Interface.
You are returned to the Clinical Library window.
34
TABLE OF CONTENTS
OPERATION
®
Intelect
Laser Module
Vectra Genisys®
Laser
PREPARING THE PATIENT’S SKIN FOR LASER LIGHT THERAPY
Before applying laser light therapy to the patient, you must first prepare the patient’s skin. By properly preparing the patient’s skin
for laser light therapy, you will allow more laser light energy to reach the targeted areas and reduce the risk of skin irritation.
To prepare the patient’s skin for laser light therapy, do the following:
1.
Thoroughly wash the skin on which you intend to place the laser head with mild soap and water or alcohol wipe.
2.
Dry the skin thoroughly.
WARNING
Before each use, clean the plastic lens with NOVUS® Polish System (www.novuspolish.com). 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.
35
OPERATION
Vectra Genisys® Laser
STARTING, STOPPING, AND INTERRUPTING THERAPY
The LCD will provide continuous information during the treatments concerning dosage and elapsed time. Parameters are adjusted
using Operator Interface buttons on the front of the unit. The laser light output can be stopped by pressing the PAUSE or STOP
buttons located on the Operator Interface.
To apply laser light therapy, do the following:
1.
Plug the Laser Stop Switch into the connection of the unit. If the switch is depressed,
the treatment will be paused and a message will appear on the screen. Press any button
to clear the message.
2.
Press the Frequency button to select one of the 12 preset frequencies. Press the Up Arrow
button to increase the frequency in 1 Hz increments. Hold the button down to quickly
display higher frequencies. Press the Down Arrow button to decrease the frequency in 1
Hz increments. Hold the button down to quickly display lower frequencies.
An audible tone will be heard when changes are made.
3.
Press the TIME button and raise or lower treatment time using the up and down arrows.
NOTE: The Treatment Time and the Dosage are directly correlated. Whenever Treatment
Time is changed, the Dosage is automatically changed and reflected on the
window.
36
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
STARTING, STOPPING, AND INTERRUPTING THERAPY CONTINUED
4.
Press the DOSAGE button and raise or lower the unit’s output using the up and down
arrows.
NOTE: The Dosage and the Treatment Time are directly correlated. Whenever Dosage is
changed, the Treatment Time is automatically changed and reflected on the
window.
5.
Press the START button. A message displays to alert you to the fact that the laser is
armed. The unit will beep two times to count down the number of seconds left until the
applicator is ready, and an orange light will blink two times on the back of the applicator.
Press the Pause/Resume button to begin the treatment.
After you press the Pause/Resume button, the orange light will illuminate on the back of
the applicator to indicate that laser light output is being distributed.
NOTE: When treatment time has expired, a tone will sound.
The therapy can be interrupted at any time by pressing the Pause/Resume button on the
back of the applicator, the STOP button (on the Operator Interface), or the PAUSE button
(on the Operator Interface).
When the STOP button is pressed, the applicator stops emitting laser light energy, and
the unit returns to the default settings. To resume therapy, press the Start button.
During treatment, the following occurs whenever the PAUSE button on the Operator
Interface or the Pause/Resume button on the back of the applicator are pressed:
37
OPERATION
Vectra Genisys® Laser
STARTING, STOPPING, AND INTERRUPTING THERAPY CONTINUED
• the timer pauses
• the unit beeps once
• the
icon displays
• the laser applicator stops emitting laser light energy
• the orange light goes out
To resume therapy, press the PAUSE button on the Operator Interface, the Pause/Resume
button on the back of the laser applicator, or the START button.
6.
To finish the laser light therapy, press the STOP button.
38
TABLE OF CONTENTS
OPERATION
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
USING CLINICAL INDICATIONS
The indications contained in this section are to be used only as guidelines.
Each patient should be individually assessed to determine the appropriateness of the parameter setting prior to use.
To select an indication for a patient, do the following:
1.
Press the Clinical Resources button.
The Clinical Library window displays.
2.
Using the Up Arrow and Down Arrow buttons, highlight Clinical Indications and press the
DISPLAY (Enter) button.
The Clinical Indications menu displays.
39
OPERATION
Vectra Genisys® Laser
USING CLINICAL INDICATIONS (CONTINUED)
3.
Using the Up Arrow and Down Arrow buttons, highlight the appropriate indication. The
indications displayed depend upon the applicator used.
4.
Press the DISPLAY (Enter) button to accept the highlighted selection.
5.
If available, highlight the appropriate laser light tissue depth with the indication you
selected using the Up Arrow and Down Arrow buttons.
40
TABLE OF CONTENTS
OPERATION
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
USING CLINICAL INDICATIONS (CONTINUED)
6.
Press the DISPLAY (Enter) button to accept the highlighted selection.
You are returned to the main window with the settings from the indication you selected
displayed.
7.
Review the final indication parameters for the laser light treatment. Make any necessary
modifications or corrections.
8.
Press the DOSAGE button (either the up or down arrow) to adjust the output to the
prescribed dosage.
NOTE: The Dosage and the Treatment Time are directly correlated. Whenever Dosage is
changed, the Treatment Time is automatically changed and reflected on the
window.
41
OPERATION
Vectra Genisys® Laser
USING CLINICAL INDICATIONS (CONTINUED)
9.
To begin therapy, continue with the instructions outlined in the section entitled “Preparing the
Patient’s Skin for Laser light Therapy” on page 35. Then, proceed to step 4 on page 37.
42
TABLE OF CONTENTS
OPERATION
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
CREATING A USER PROTOCOL
This is a library you create. You may store up to 10 protocols in the User Protocol Library. To create User Protocols, do the following:
1.
Make the desired parameter changes.
2.
Press the Clinical Resources button.
The Clinical Library window displays.
3.
Press the Down Arrow or Up Arrow buttons to highlight the Save Protocol option.
4.
Press the DISPLAY (Enter) button to accept the Save Protocol selection.
The Save Protocol menu displays.
43
OPERATION
Vectra Genisys® Laser
CREATING A USER PROTOCOL (CONTINUED)
5.
Use the Up Arrow and Down Arrow buttons to highlight any unused user protocol.
If you select Unit Default Protocol, this will become the protocol displayed when the unit
powers up.
6.
Press the DISPLAY (Enter) button to accept the highlighted selection and save your
custom protocol.
The User Protocol Confirmation window displays to indicate that the protocol is now
saved as the number you specified.
7.
Press any button on the Operator Interface.
The Clinical Library window displays and your new user-defined protocol is now saved.
44
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
RESTORING FACTORY SETTINGS
Certain default utility settings on the unit may be changed to suit your requirements. These settings consist of the unit’s language
and power up settings. However, you may want to return the unit to its original settings.
To restore the original power up default settings on the unit, do the following:
1.
On the main window, press the Clinical Resources button.
The Clinical Library window displays.
2.
Press the Up Arrow or Down Arrow buttons to highlight the Restore Factory Settings
option.
45
OPERATION
Vectra Genisys® Laser
RESTORING FACTORY SETTINGS CONTINUED
3.
Press the DISPLAY (Enter) button to accept the highlighted selection.
The Restore Factory Settings Confirmation window displays.
4.
Press any button on the Operator Interface.
The default power up settings are restored and you are returned to the Clinical Library
window.
46
TABLE OF CONTENTS
OPERATION
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
RESTORING FACTORY PROTOCOLS
If necessary, you can choose to restore the user-defined protocols to the unit’s original parameters when it was shipped to you. To do
this, do the following:
1.
Press the Clinical Resources button.
The Clinical Library window displays.
2.
Press the Up Arrow or Down Arrow buttons to highlight the Restore Factory Protocols
option.
47
OPERATION
Vectra Genisys® Laser
RESTORING FACTORY PROTOCOLS CONTINUED)
3.
Press the DISPLAY (Enter) button to accept the highlighted selection.
The Restore Factory Protocols Confirmation window displays.
4.
Press any button on the Operator Interface.
The user-defined protocols are erased and restored to the original parameters. You are
returned to the Clinical Library window.
48
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
SELECTING A USER-DEFINED PROTOCOL
To select a predefined laser light therapy program, do the following:
1.
Press the Clinical Resources button.
The Clinical Library window displays.
2.
Use the Up Arrow and Down Arrow buttons to highlight the Retrieve User Protocol
option.
3.
Press the Display (Enter) button to accept the highlighted selection.
A list of user-defined protocols displays.
49
OPERATION
Vectra Genisys® Laser
SELECTING A USER-DEFINED PROTOCOL (CONTINUED)
4.
Use the Down Arrow button to highlight the appropriate protocol.
As you highlight each protocol, a description of the protocol’s parameters displays to the
right.
5.
Press the Display (Enter) button to select the highlighted protocol.
The main window displays with the parameters of the protocol you selected.
6.
Verify the parameters of this program, and use the appropriate buttons on the Operator
Interface to adjust any setting, if necessary. For example, to adjust the time, press the up
and down arrows on the TIME button.
7.
To begin therapy, perform all the procedures outlined in the section entitled “Preparing
the Patient’s Skin for Laser light Therapy” on page 35. Then continue with step 4 of the
section entitled “Starting, Stopping, and Interrupting Therapy” on page 37.
50
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Genisys®
Ultrasound
Laser
SYSTEM UTILITIES
Audible Tones
Audible tones will be heard in the following conditions:
• The laser is arming
• Any button is pressed.
• The rechargeable battery’s power is low (in which case the Low Battery icon will display).
• Any error message is displayed.
• The therapy time reaches 0:00.
• The treatment session is paused or resumed.
Changing Power-Up Presets
The following power up presets can be changed and stored as new presets:
• Frequency
• Treatment Time
• Dosage
To change the power up presets, do the following:
51
OPERATION
Vectra Genisys® Laser
SYSTEM UTILITIES CONTINUED
1.
Make the desired changes.
2.
Press the Clinical Resources button.
The Clinical Library window displays.
3.
Press the Up Arrow and Down Arrow buttons to highlight Save Protocol, and press the
DISPLAY (Enter) button to accept the highlighted selection.
The Save Protocol menu displays.
4.
Press the Up Arrow or Down Arrow buttons to highlight Default Protocol.
52
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
SYSTEM UTILITIES (CONTINUED)
5.
Press the DISPLAY (Enter) button to accept the highlighted selection.
The User Default Protocol confirmation window displays.
6.
Press any key to confirm the settings.
You are returned to the Clinical Library window.
Brightening or Dimming the LCD
To brighten or dim the LCD, turn the contrast control dial until the display contrast is optimal.
53
OPERATION
Vectra Genisys® Laser
SYSTEM UTILITIES (CONTINUED)
Viewing Applicator Information
Use this utility to verify applicator specifications. To do this, do the following:
1.
Press the Clinical Resources button.
The Clinical Library window displays.
2.
Press Up Arrow and Down Arrow buttons to highlight the View Applicator Info option.
54
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
SYSTEM UTILITIES (CONTINUED)
3.
Press the DISPLAY (Enter) button to accept the highlighted selection.
The Laser Applicator Information window displays.
4.
Verify the information on the window and press the Back button to return to the Clinical
Library window.
55
OPERATION
Vectra Genisys® Laser
SYSTEM UTILITIES (CONTINUED)
Changing Languages
You may change the language displayed by the Vectra Genisys Laser to either English or Spanish. To change the language displayed
on the LCD, do the following:
1.
Press the Clinical Resources button.
The Clinical Library window displays.
2.
Use the Up Arrow and Down Arrow buttons to highlight the Language option.
56
TABLE OF CONTENTS
OPERATION
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
SYSTEM UTILITIES CONTINUED)
3.
Press the DISPLAY (Enter) button to accept the highlighted selection.
4.
Press the Up Arrow and Down Arrow buttons to highlight the appropriate language.
5.
Press the DISPLAY (Enter) button to accept the highlighted selection.
Your unit now displays the language you selected.
57
OPERATION
Vectra Genisys® Laser
SYSTEM UTILITIES CONTINUED)
Viewing Unit Version Information
Use this utility to verify that the unit is using the latest software available. To do this, do the following:
1.
Press the Clinical Resources button.
The Clinical Library window displays.
2.
Use the Up Arrow and Down Arrow buttons to highlight the View Unit Version Info option.
58
OPERATION
TABLE OF CONTENTS
VectraVectra
Genisys®
Ultrasound
Genisys®
Laser
SYSTEM UTILITIES (CONTINUED)
3.
Press the Display button to accept the highlighted selection.
The Unit Version Information window displays.
4.
Press any key to return to the Clinical Library window.
59
OPERATION
Vectra Genisys® Laser
TREATMENT TIPS
Contact
To obtain the most effective results, the applicator should be in contact with the patient’s skin.
Applicator Position
Due to the characteristics of laser light, the angle at which the light enters the patient’s skin is very important. Therefore, the
applicator lens should always be parallel to the treatment area.
Treating Joints
If you are applying laser light therapy to a patient’s joint, it is more effective to apply the laser light energy into the joint by
positioning the joint in an open position (e.g., knee in flexion). However, do not attempt this method if it is uncomfortable to the
patient.
Applicator Selection
If the injury you intend to treat is very small (pinpoint), you should only need to treat the area with a single diode applicator. If the
area surrounding the treatment area is sensitive, it is recommended that you apply therapy with a single diode applicator first, then
use the cluster applicator for the surrounding area.
Cold and Heat
If you intend to apply cold or heat in conjunction with laser light therapy, use the following guidelines:
• Use cold before laser light therapy. This slows the flow of red blood cells and reduces the amount of energy removed from the
area.
• Use heat after the treatment. This speeds the flow of red blood cells so that more energy can be removed from the area.
60
TABLE OF CONTENTS
ACCESSORIES
Standard Accessories
Ref.
Description
®
Intelect
Laser Module
Vectra Genisys®
Laser
Optional Accessories
Ref.
Description
28066
User Manual (CD-ROM)
27805
Single Diode 820 nm Laser 300 mW Applicator [26 AWG, 68.89 in (174.143 cm), Shielded]
27525
Laser Protective Eyewear
27840
Single Diode 850 nm Laser 100 mW Applicator [26 AWG, 68.89 in (174.143 cm), Shielded]
27325
Power Supply Cord (US) [18 AWG, 80 in (203.2 cm), Shielded]
27804
Single Diode 850 nm Laser 150 mW Applicator [26 AWG, 68.89 in (174.143 cm), Shielded]
27470
Laser Stop Switch [26 AWG, 68.89 in (174.143 cm), Shielded]
27841
Single Diode 850 nm Laser 200 mW Applicator [26 AWG, 68.89 in (174.143 cm), Shielded]
27811
9 Diode Applicator 540 mW [26 AWG, 68.89 in (174.143 cm), Shielded]
27812
9 Diode Applicator 1040 mW [26 AWG, 68.89 in (174.143 cm), Shielded]
27814
13 Diode Applicator 415 mW [26 AWG, 68.89 in (174.143 cm), Shielded]
27816
13 Diode Applicator 715 mW [26 AWG, 68.89 in (174.143 cm), Shielded]
27808
33 Diode cluster Applicator 1440 mW [26 AWG, 68.89 in (174.143 cm), Shielded]
27478
Battery Pack
27904K
Laser Interlock Kit
27468
Carrying Bag
61
TROUBLESHOOTING
Vectra Genisys® Laser
ERRORS
Troubleshooting the Display
If you press the Power On/Off button, and the LCD remains blank longer than a few seconds, the
contrast may require adjusting. To adjust it, turn the contrast control dial clockwise until the display
contrast is optimal.
ERROR CODES AND DESCRIPTIONS
Error
Code
Description
Error
Code
Description
100
entered an invalid PIN number
201
laser output is too high
101
tried to calibrate an applicator but none is plugged in
202
laser output is too low
102
applicator became unplugged during treatment
203
LED output is too high
103
attempted to save a protocol with no applicator plugged in
204
LED output is too low
104
pressed START but treatment time is zero
205
laser internal treatment time error occurred; laser treatment has been terminated
105
retrieved a user protocol but no applicator plugged in
300
some type of critical laser board error has occurred
106
retrieved a user protocol not previously saved and no applicator plugged in
301
no laser board is detected in unit
107
retrieved a user protocol for an applicator different from the applicator plugged in
302
error reading from laser board
108
user selected clinical indication but no applicator is plugged in
303
error reading from laser board
109
user selected clinical indication but there are not clinical indications for the
probe plugged in
304
error writing to laser board
111
laser stop switch is unplugged. Plug in the laser stop switch before starting a
laser treatment. Press any key to continue.
305
error calibrating applicator
200
error accessing the internal EPROM used to store system configuration settings
and protocols
62
MAINTENANCE
TABLE OF CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
Maintaining the Vectra Genisys Laser
The following items should be checked at least monthly to ensure proper operation of this unit:
• Power cord and plug: Check to make sure the cord is not frayed, kinked, and does not have torn or cut insulation.
• Applicator cable: Check to make sure the cable is flexible, free of kinks, not frayed, and the insulation is intact.
• Applicator lens: Check to see that there is no build-up of oil or foreign material on or behind the applicator lens.
WARNING
Before each use, clean the plastic lens with NOVUS® Polish System (www.novuspolish.com). 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.
Cleaning
To clean the accessories, use only soap and water.
The Vectra Genisys Laser’s case may be cleaned by wiping with a damp cloth or mild cleaning solution. Avoid abrasive cleansers.
The Laser Head must be cleaned with a disinfectant cleaner (i.e. Virex® II 256) or a germicidal disposable cloth
(i.e. PDI Sani-Cloth® Plus/Hb) between each therapy session. Do not use any chlorine-based cleaners on the laser head.
63
MAINTENANCE
Vectra Genisys® Laser
Service
The Vectra Genisys Laser applicators must be recalibrated annually. It is recommended that all Chattanooga Group laser products be returned to the
factory or an authorized servicing dealer for repairs or recalibration. Recalibration is also recommended after the replacement or repair of any major
component. Should the Vectra Genisys Laser unit require service, contact the selling dealer or Chattanooga Group Service Department.
NOTE:
The Vectra Genisys Laser unit was calibrated during the manufacturing process. The unit is ready to be placed into service upon delivery.
All units returned to the factory for service must include the following:
WARRANTY REPAIR/OUT OF WARRANTY REPAIR
1. Written statement containing the following information:
• Return Authorization (RA) Number - Obtain from Factory
• Unit Model Number
• Unit Serial Number
• Contact person with Phone and Fax Numbers
• Billing Address (for Out of Warranty Repair)
• Shipping Address (Where to Ship Unit after Repair)
• Detailed Description of Problem or Symptoms
2. Copy of original invoice issued at purchase of the unit.
3. Ship the unit to address specified by an authorized service technician.
Service to these units should be performed only by Service Technicians certified by Chattanooga Group. Laser requires annual calibration, from the date
placed in service, by a Service Technician certified by Chattanooga Group.
The Vectra Genisys Laser Service Manual is available for purchase and can be requested from the selling dealer or Chattanooga Group Service Department.
The Service Manual contains safety precautions, nomenclature, specifications, troubleshooting, removal and replacement instructions, general
maintenance, calibration instructions, parts lists, schematics, warranty and other information which would assist a certified service technician to repair the
unit.
Council Directive 2002/96/EC concerning Waste Electrical and Electronic Equipment (WEEE). Indicates a requirement not to dispose of WEEE as
municipal waste. Contact your local distributor for information regarding disposal of the unit and accessories.
64
WARRANTY
TABLE OF CONTENTS
®
Intelect
Laser Module
Vectra Genisys®
Laser
Chattanooga Group, a division of Encore Medical L.P., ("Company") warrants that the Vectra Genisys® Laser ("Product") is free of defects in material and workmanship.
This warranty shall remain in effect for two years (24 months) from the date of original consumer purchase. If this Product fails to function during the two year
warranty period due to a defect in material or workmanship, at the Company's option, Company or the selling dealer will repair or replace this Product without charge
within a period of thirty (30) days from the date on which the Product is returned to the Company or the dealer. All repairs to the Product must be performed by a
service center certified by the Company. Any modifications or repairs performed by unauthorized centers or groups will void this warranty.
The warranty period for applicators is one year (12 months).
This Warranty Does Not Cover:
• ANY MALFUNCTION OR FAILURE IN THE PRODUCT CAUSED BY PRODUCT MISUSE, INCLUDING, BUT NOT LIMITED TO, DROPPING THE UNIT OR APPLICATOR AND
FAILURE TO PROVIDE REASONABLE AND NECESSARY MAINTENANCE OR ANY USE THAT IS INCONSISTENT WITH THE PRODUCT USER MANUAL.
• Replacement parts or labor furnished by anyone other than the Company, the selling dealer or a certified Company service technician.
• Defects or damage caused by labor furnished by someone other than Company, the selling dealer or a certified Company service technician.
COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES.
Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. To Obtain
Service From Company or the selling dealer under this warranty:
1. A written claim must be made within the warranty period to the Company or the selling dealer. Written claims made to the Company should be
sent to:
Telephone: (800) 592-7329 USA
(423) 870-2281
(866) 864-0598 - Service
FAX: (423) 875-5497
and
2. The Product must be returned to the Company or the selling dealer by the owner.
This warranty gives you specific legal rights and you may also have other rights which vary from state to state or location to location.
The Company does not authorize any person or representative to create for it any other obligation or liability in connection with the sale of the Product. Any
representation or agreement not contained in the warranty shall be void and of no effect.
THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING ANY WARRANTY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
65
APPENDIX A - EMC TABLES
Vectra Genisys® Laser
TABLE 1: GUIDANCE AND MANUFACTURER’S DECLARATIONELECTROMAGNETIC EMISSIONS
The Vectra Genisys Laser unit is intended for use in the electromagnetic environment specified in the table below. The user of the Vectra
Genisys Laser unit should assure that it is used in such an environment.
Emission Tests
Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/Flicker
Emissions
IEC 61000-3-3
Complies
Electromagnetic Environment - Guidance
The Vectra Genisys Laser uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
The Vectra Genisys Laser is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
66
APPENDIX A - EMC TABLES
Vectra Genisys® Laser
TABLE 2: GUIDANCE AND MANUFACTURER’S DECLARATIONELECTROMAGNETIC IMMUNITY
The Vectra Genisys Laser is intended for use in the electromagnetic environment specified in the table below. The user of the Vectra
Genisys Laser should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality should be that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user
of the Vectra Genisys Laser requires continued operation during power mains interruptions, it is
recommended that the Vectra Genisys Laser be powered from an uninterrupted power supply or a
battery.
Power frequency (50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
commercial or hospital environment.
NOTE:
Electromagnetic Environment - Guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the
relative humidity should be at least 30%.
UT is the a.c. mains voltage prior to application of the test level.
67
APPENDIX A - EMC TABLES
Vectra Genisys® Laser
TABLE 2: GUIDANCE AND MANUFACTURER’S DECLARATIONELECTROMAGNETIC IMMUNITY CONTINUED
The Vectra Genisys Laser is intended for use in the electromagnetic environment specified in the table below. The user of the Vectra
Genisys Laser unit should assure that it is used in such an environment.
Immunity
Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment - Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the Vectra Genisys Laser , including cables,
than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
±1 kV differential mode
±2 kV common mode
d = [3.5]√P
V1
d = [3.5]√P 80 MHz to 800 MHz
E1
d = [7]√P 800 MHz to 2.5 GHz
E1
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in
each frequency rangeb.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Vectra Genisys Laser is used exceeds the applicable RF compliance level above, the Vectra
Genisys Laser should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the Vectra Genisys Laser .
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
68
APPENDIX A - EMC TABLES
TABLE 3:
Vectra Genisys® Laser
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE VECTRA GENISYS LASER
The Vectra Genisys Laser unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Vectra Genisys Laser can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Vectra Genisys Laser as recommended below,
according to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum Output Power of
Transmitter
W
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 800 MHz
d = [3.5]√P
V1
d = [3.5]√P
E1
d = [7]√P
E1
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people.
69
Chattanooga Group
4717 Adams Road
P.O. Box 489
Hixson, TN 37343 U.S.A.
(800) 592-7329 - U.S.A.
(423) 870-2281
(423) 875-5497 FAX
chattgroup.com
Chattanooga Group is an ISO 13485 Certified Company
© 2009 Encore Medical, L.P.
28050D
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