Chattanooga Intelect Advanced 2766 User Manual

Moving Rehabilitation Forward™
User Manual
Model 2766
Intelect® Advanced
DJO is an ISO 13485 Certified Company
TABLE OF CONTENTS
Intelect® Advanced Laser Module
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABOUT LASER THERAPY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Precautionary Instructions. . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Overview of Laser Therapy . . . . . . . . . . . . . . . . . . . . . . . 7
Common Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Additional Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . .11
Preventing Overheating of the Applicators . . . . . . . . . 12
Preventing Adverse Effects . . . . . . . . . . . . . . . . . . . . . . 12
NOMENCLATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Module Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Laser Technical Specifications . . . . . . . . . . . . . . . . . . . . 17
Description of Device Markings . . . . . . . . . . . . . . . . . . 17
Laser Applicator Technical Specifications . . . . . . . . . . . 18
Single Diode Applicators . . . . . . . . . . . . . . . . . . . . . 18
Cluster Diode Applicators. . . . . . . . . . . . . . . . . . . . . 19
Laser Protective Eyewear Technical Specifications . . . 21
SETUP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Attaching the Module to the Unit . . . . . . . . . . . . . . . . . 22
Removing the Module from the Unit . . . . . . . . . . . . . . 28
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Preparing the Patient's Skin for Therapy . . . . . . . . . . . 29
Starting, Stopping, & Interrupting Therapy . . . . . . . . . 30
Using the Acupuncture Point Locator. . . . . . . . . . . . . . 39
Using Clinical Indications . . . . . . . . . . . . . . . . . . . . . . . 43
Saving User Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . 46
System Utilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Changing the Laser PIN . . . . . . . . . . . . . . . . . . . . . . 48
Changing the Display . . . . . . . . . . . . . . . . . . . . . . . . 50
Displaying the Laser Rationale . . . . . . . . . . . . . . . . 50
Treatment Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
ACCESSORIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Standard Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Maintaining the Intelect Advanced Laser Module. . . . 56
Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Warranty Repair/Out of Warranty Repair . . . . . . . . . . . 57
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
i
FOREWORD
This manual has been written for the operators of the Intelect Advanced Laser Module. It contains general instructions for operation, precautionary instructions, and maintenance recommendations. For all other information (i.e., stim, battery pack, remote, ultrasound, etc.) concerning your Intelect Advanced Therapy Systems, consult the user manual shipped with those products. In order to obtain maximum life and efficiency from your Intelect Advanced Laser Module, 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 DJO, LLC’s policy of continuous improvement, changes to these specifications may be made at any time without obligation on the part of DJO, LLC.
Before administering any treatment to a patient, 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. 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.
Intelect® Advanced Laser Module
Product Description
The Intelect Advanced Laser Module, designed and manufactured by DJO offers a new dimension in clinical laser therapy made possible by advanced software design and digital signal processing.
When you add a Laser Module to your existing Intelect Advanced main unit (which may already contain electrotherapy, ultrasound, or both) the result is a unit with extraordinary versatility based on simplicity of operation.
Effectiveness of this treatment is dependent upon correct use. If treatment times are exceeded, the therapy may not result in positive clinical outcomes.
© 2011 DJO, LLC. All rights reserved. Any use of editorial, pictorial, or layout composition of this publication without express written consent from DJO, LLC is strictly prohibited. This publication was written, illustrated, and prepared for distribution by DJO, LLC.
1
FOREWORD
The following features are available on the Intelect Advanced Laser Module:
• Clinical Indications
An efficient approach for setting up a treatment using preset parameters.
• Real Time Feedback
This feature provides a continuously measured and monitored output system that adjusts the dosage
delivered to the patient.
• Electronic Signature™
Automatically calibrate the system to any Intelect Advanced 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 therapy with greater clinician comfort.
• Clear LCD display
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.
• Laser Acupuncture
Combined with the laser applicator (single laser diode), the patient-handheld Acupuncture Point Locator allows
the user to locate optimum treatment sites on the patient’s body.
Intelect® Advanced Laser Module
2
ABOUT LASER THERAPY
DANGER
WARNING
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:
Text with a “CAUTION” indicator will explain possible Safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.
Text with a “WARNING” indicator will explain possible Safety infractions that will potentially cause serious injury and equipment damage.
Text with a “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.
Intelect® Advanced Laser Module
CAUTION
• Read, understand, and practice the precautionary and operating
instructions. Know the limitations and hazards associated with using any laser device. Observe the precautionary and operational decals placed on the unit.
• Do not operate this unit when connected to any unit other than
Chattanooga 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.
• The laser unit should be routinely checked before each use to
determine that all controls function normally; especially that the dosage control properly adjusts the intensity of the laser output in a stable manner. Also, determine that the treatment time control actually terminates the laser 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 Operator Interface 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 energy.
• Handle the applicator with care. Inappropriate handling of the
applicator may adversely affect its characteristics.
• Inspect treatment head cables and associated connectors
before each use.
• This unit should be operated in temperatures between 15 to
40°C (59 to 85°F), and transported and stored in temperatures between -7 to 43°C (20 to 110°F), with relative humidity ranging from 30% - 60%.
3
WARNING
ABOUT LASER THERAPY
• Use of parts or materials other than Chattanooga's can
degrade minimum safety.
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 Intelect Advanced Laser and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty.
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 users manual, contact your DJO dealer for assistance.
• This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off, try to correct the interference using one or more of the following: Reorient or relocate
Intelect® Advanced Laser Module
CAUTIONCAUTION
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/or consult the factory field service technician for help.
• Before each use, clean the plastic lens with NOVUS® Polish
System. Contact Novus at: www.novuspolish.com. Apply with a clean cloth. Failure to clean the lens between patient therapy sessions could cause beam fragmentation, which may result in serious injury and equipment damage.
• Be sure to read all instructions for operation before treating a
patient.
DO NOT drop the applicator or module on hard surfaces. Do not cool an overheated applicator with ice water or ice packs. Do not allow the applicator to reach maximum temperatures repeatedly. Do not submerge the applicator or module in water. All of these conditions will damage the applicator and module. 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.
• 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.
4
WARNING
ABOUT LASER THERAPY
• 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.
• 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 (e.g., cell phones) in conjunction with it.
• 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 module and applicator.
• 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.
Intelect® Advanced Laser Module
5
DANGER
DANGER
ABOUT LASER THERAPY
Intelect® Advanced Laser Module
• 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 DJO dealer if the unit is not properly rated.
• Protective safety glasses should be worn by the
operator and patient to block infrared 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.
• This unit is considered to be a Class IIIB laser product and
thus emits visible and invisible laser radiation (IR). Avoid direct 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 DJO laser protective eyewear.
6
ABOUT LASER THERAPY
Intelect® Advanced Laser Module
OVERVIEW OF LASER THERAPY
In short, the light energy absorbed into the patient’s tissue triggers biological changes at a cellular level to provide 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, CO
, etc.).
2
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.
7
ABOUT LASER THERAPY
Intelect® Advanced Laser Module
OVERVIEW OF LASER THERAPY– COMMON TERMS
Common Terms
Applicator - The hand held assembly used to deliver laser energy. The applicator includes the laser head, transducer, and related
electronics.
Collimating - The shape of the laser beam. While neither focused nor dispersed, this laser beam resembles a column when
applied from the unit through the applicator.
Continuous Mode – The output of the laser is not interrupted during the treatment time. This mode imparts the most energy to
the tissues and is used when a maximal effect is desired. (See Duty Cycle).
Dosage – A measure of the intensity of the laser over the treatment area. The unit of measure is Joules or joules/cm
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 (cm measurement of energy delivered.
Frequency – Pulsed frequencies are selectable from 2.5 to 20,000 Hz. The lower the frequency, the longer the wavelength, the
deeper the penetration of laser.
Galvanic Skin Response (GSR) – Located by the Acupuncture Point Locator and Laser Applicator (single diode), GSR are the areas
on the human body that indicate the most sensitivity and serve to be good points of treatment for laser therapy to simulate acupuncture.
Laser Acupuncture – A function available on the Laser Module that allows the user to locate GSR’s (Galvanized Skin Responses)
on the patient’s body and treat those areas accordingly.
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
(depending on the applicator).
Power – Measured in Watts (W), power wattage is directly proportional to the treatment time and penetration of the laser 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.
8
2
). This gives a more specific
2
.
ABOUT LASER THERAPY
Intelect® Advanced Laser Module
OVERVIEW OF LASER THERAPY– COMMON TERMS
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.
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 THERAPY
Intelect® Advanced Laser Module
Indications
The Intelect Advanced Laser Module is indicated for the following:
• increasing local blood circulation.
• relieving minor muscle and joint aches, pains,
and stiffness.
• relaxing muscles.
• relieving muscle spasms.
• relieving minor pain and stiffness associated
with arthritis.
• promoting nerve regeneration, bone growth,
and ligament repair.
• healing wounds.
Contraindications
The Intelect Advanced Laser Module 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 or animals.
• 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.
10
ABOUT LASER THERAPY
• 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.
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.
Intelect® Advanced Laser Module
11
DANGER
ABOUT LASER THERAPY
WARNING
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."
Preventing Overheating of the Applicators
To prevent the applicator from becoming overheated, check to be sure proper contact is being made throughout the treatment.
Preventing Adverse Effects
Perform the following procedures to avoid the negative
effects of laser therapy.
Patient Susceptibility
Intelect® Advanced Laser Module
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 discomfort. Choose a lower setting to reduce output or select a pulsed duty cycle to decrease patient discomfort.
Head Max. Temp. Disclaimer
Head Max. Temp. is for the protection of the equipment, not for the protection of the patient.
Factors that Affect Treatment
The following factors may affect laser treatment:
• Color of skin (light or dark)
• Age of lesion
• Depth of lesion
• Sensitivity of patient
• Medications that increase sensitivity to light.
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.
12
NOMENCLATURE
Intelect® Advanced Laser Module
MODULE APPLICATOR
Feet Indentions
Ribbon Cable
Connection
Patient Interrupt
Switch Connection
Door Interrupt
Switch Connection
Power Cord
Routing Area
Applicator
Connection
Acupuncture Point
Locator Connection
13
Lens
LED’s
Pause/Resume
Button
Laser
Diode
Laser Head
LED Indicator
(Output Power)
NOMENCLATURE
Feet Indentions
These indentions retain the rubber feet of the unit. This allows the module to align and rest directly underneath the unit.
Ribbon Cable Connection
A ribbon cable connects the unit to the module at this location on the module in order to transfer data from the laser module to the unit.
Patient Interrupt Switch Connection
As a safety measure and to minimize any apprehension, it is recommended that you always allow the patient to hold the Patient Interrupt Switch during laser 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. Use of the Patient Interrupt Switch should always be explained to the patient before starting treatment.
Patients will feel safer knowing they can stop the treatment if necessary. The Patient Interrupt Switch is very sensitive. Explain this to the patient when using it in order to prevent
unnecessary interruptions in treatment.
Laser Interlock (Door Interrupt Switch Connection)
This option allows you to set up a switch (similar to the patient interrupt switch) that interrupts treatment when the door of the treatment room is opened during a therapy session.
Acupuncture Point Locator Connection
This port serves as the connection between the Acupuncture Point Locator and the module.
Intelect® Advanced Laser Module
14
NOMENCLATURE
Applicator Connection
This port serves as the connection point between the module and the applicator.
Power Cord Routing Area
This hollow area on the back of the module allows you to feed the power cord from the unit through the module and out to the electrical outlet.
Lens
This clear lens acts as a shield to protect the patient’s skin.
LED’s
The LED’s (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.
Laser Head
This aluminum housing located on the end of the applicator accommodates the lens, laser diodes, LED’s, and their associated electronics.
Pause/Resume Button
Use this button to pause the treatment session. To restart therapy, press the PAUSE button.
LED Indicator (Output Power)
This orange light illuminates when laser energy is being distributed by the applicator.
Intelect® Advanced Laser Module
15
SPECIFICATIONS
MODULE SPECIFICATIONS
DIMENSIONS
Length .................................................... 27.8 cm (10.95 in)
Height ..................................................... 21.2 cm (8.35 in)
Width ........................................................ 4.2 cm (1.65 in)
WEIGHT
Standard Weight ........................................1.3 kg (2.9 lbs)
Intelect® Advanced Laser Module
POWER
Input ................... 120 - 240 V - 1.0 A, 50/60 Hz 75 W Max
Fuses ..................... 1.0A Time Lag (not user serviceable)
Electrical Class .................................................... CLASS 1
Electrical Type ................................................... TYPE B
Output Type ................................... infrared Lamp (laser)
Laser Class .................................................................... 3B
Complies with EN/IEC 60601-1, 60601-1-2, 60601-2-22, and 60825-1. CAN/CSA C22.2 No. 601.1-M90 w/A2.
Each module is shipped with four screws, laser protective eyewear, this manual, and an extended front access panel.
For a complete list of standard and optional accessories, see page 52.
16
SPECIFICATIONS
Intelect® Advanced Laser Module
LASER TECHNICAL SPECIFICATIONS DESCRIPTION OF DEVICE MARKINGS
Duty Cycles
Pulsed ........................................................................... 90%
Continuous ................................................................. 10 0%
Pulse Frequencies ...................................... 2.5 Hz - 20000 Hz
................................................................... and continuous.
Wavelengths ......... 670-950 nm (dependent on applicator)
Output ................. 10-1440 mW (dependent on applicator)
Output accuracy ...................................... +/- 20% of nominal
Maximum Treatment Time ...................... 4 min for any laser,
...................................................................... 10 min for LED
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:
Standards:
Classified by Intertek Testing Services NA Inc.
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. ..........................
Refer to ACCOMPANYING DOCUMENTS ....................
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). .............................................
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