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Quick Startup Operational Guide—July 2010
AVI HPLL-‐12
www .A v i c e n n a L a s e r . c om | 1 -‐ 8 8 8 -‐ A V I -‐ L A S E R
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Table of Contents
1. CONVENTIONS USED................................................................................................3
2. PRECAUTIONS ..........................................................................................................3
3. WARNINGS ..............................................................................................................4
4. RECOMMENDATION.................................................................................................4
5. INTRODUCTION........................................................................................................4
6. SAFETY.....................................................................................................................6
7. SYSTEM SETUP AND USE ..........................................................................................8
8. CHARTS AND PROTOCOLS ......................................................................................16
8.1. Error Message List ...............................................................................................16
8.2. Head, Neck and Upper Extremities Protocol Chart...............................................16
8.3. Lumbar, Hip, Knee & Lower Extremities Protocol ................................................17
8.4. Foot Pathology Laser Treatment Protocol Chart ..................................................18
8.5. Application Instructions ......................................................................................18
8.6. Treatment Technique ..........................................................................................19
8.7. Overview for Most Injuries..................................................................................19
8.8. Areas Requiring Deeper Penetration ...................................................................19
8.9. Areas Requiring Superficial Penetration ..............................................................20
9. SPECIFICATIONS .....................................................................................................20
10. WARRANTY INFORMATION..................................................................................21
11. CONTRAINDICATIONS ..........................................................................................21
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1. CONVENTIONS USED Various Precautions, warnings, recommendations and notes are presented throughout this document. Explanations and examples of each follow.
A PRECAUTION describes Specific measures that if properly followed beforehand, Will prevent harm.
A WARNING calls the reader’s attention to a specific or potential danger in advance. If ignored or compromised, the situation could result in serious, irreversible personal injury or production damage.
A RECOMMENDATION offers guidance that may be worthy of acceptance or trial within a specific area of AVI HPLL-12 application and may serve to optimize overall AVI HPLL-12 utilization
2. PRECAUTIONS
• Never allow untrained personnel to operate this advice unless directly supervised by a properly trained and experienced individual.
• The protective eyewear supplied with this device has an optical density rating >5 in the 980 nm region. All personnel present during device operation must ware this eyewear. Contact Avicenna Laser Technology at (888) AVI-LASER to purchase additional sets of protective eyewear for this device.
• Select a secure, properly equipped, and well ventilated location in which to install and operate the laser.
• Place “Laser in use” signs at location entrances where people will use the AVI HPLL-12 laser device.
• Remove the key from the device’s key switch when not in use to prevent unauthorized and/or unqualified use of the device as well as inadvertent laser emissions.
• Turn the device off before relocating equipment in the same vicinity. • During any laser procedure, do not allow any nonessential personnel into the treatment
WARNING! Never direct the laser beam at anything other than the area to be treated.
RECOMMENDATION Designate at least one person at each facility that utilizes this device as laser safety supervisor, responsible for providing training on all operating and safety procedures.
CAUTION! Never allow untrained person to operate this device unless directly supervised by a properly trained and experienced individual.
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area. • Never allow the untrained personnel to operate this device unless directly supervised by
a properly trained and experienced individual.
3. WARNINGS! • This laser device is sold solely for VETERINARY, HUMAN, OR SCIENTIFIC purposes
only! • This laser device produces 980nanometer near infrared laser energy that is invisible and
can be an extreme hazard to the eyes of any living being. Irreparable corneal and/or retinal damage may occur if a person exposes one or both eyes to direct or indirect (reflected) laser energy.
• IMPROPER USE OF SYSTEM CONTROLS or performance of procedures other than those specified in this manual may result in hazardous radiation exposure.
• FAILURE TO COMPLY with all safety instructions and warnings may expose all participants to harmful levels of laser radiation and/or dangerous levels of electrical current.
• NEVER direct the laser beam at anything other than the area to be treated. • NEVER allow the eyes of any living being to look directly into the distal end of the optical
hand piece connected to an active laser device WITH or WITHOUT wearing appropriate laser emission protective eyewear.
• DO NOT allow any reflective object to fall into or obstruct the path of the laser energy produced by this device. Scattered or reflected laser energy can cause serious damage to eyes and skin. The operator, all assistants, and the patient must remove all reflective objects (such as rings, metal watchbands, and jewelry) prior to treatment with this device.
• THERE ARE NO USERSERVICEABLE COMPONENTS inside this laser device. Therefore, do not attempt to gain access to any internal device component. Doing so may cause serious and/or irreversible injury.
• AVOID THE USE of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen. The high temperatures produced in normal use of the laser equipment may ignite some material, for example cotton or wool, when saturated with oxygen. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used. Attention should also be drawn to the danger of ignition of endogenous gases.
• If the laser fails to operate properly, immediately contact Avicenna Laser Technology at
(888) AVILASER.
4. RECOMMENDATION Designate at least one person at each facility that utilizes this device as laser safety supervisor, responsible for providing training on all operating and safety procedures. 5. INTRODUCTION The AVI HPLL-12 laser system is classified as a class IV laser device. It is part of the Avicenna HP Class IV Therapeutic Laser System Family. The model number for any product in the AVI HP Series is designated by the following convention located on the DANGER deal on the outside of the unit: AVI HPXX (where XX = the maximum power output. For example; The AVI HPLL-12 is Model AVI HPLL-12.)
5.1. Device Description AVI HPLL-12
Class IV therapeutic laser system is designed for multispecialty application in bio-
stimulation. Operating at a wavelength of 980nm in the near infrared portion of the spectrum, it has unsurpassed penetration to target tissues. It allows controlled tissue biostimulation for the management of pain. Unlike Class III therapeutic lasers, AVI HPLL-12 Class IV therapeutic laser system achieves a greater penetration of depth with a greater therapeutic dose of photonic energy. Treatment procedures using AVI HPLL-12 Class IV therapeutic laser system are pain free. The laser source of this device is a solid-state diode semiconductor system. It produces
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invisible laser energy at the 980nanometer (nm) wavelength. A convenient and easy to use membrane display panel allows the operator to adjust or set laser output level with minimal effort. The laser operates in a continuous wave mode. The device features nine user programmable presets for storing frequently used treatment parameters.
5.2. Usage Prerequisites Every facility or institution utilizing this device is encouraged to adopt an ongoing training and safety program.
5.3. Protective Eyewear All Individuals present during the operation of this device must wear protective eyewear with an optical density of 5.0 or greater at 980nm wavelength. Two pairs are included with this device. For additional pairs of protective eyewear, contact Avicenna Laser Technology at (888) AVI-LASER.
5.4. Environmental and Electrical The laser device is air-cooled and designed for use in a well ventilated veterinary office environment that maintains relative humidity and temperature conditions conducive to conventional human productivity.
RECOMMENDATION Individuals planning to use the AVI HPLL-12 system are actively encouraged to attend laser orientation and education sessions.
CAUTION! ALWAYS WEAR protective eyewear until the operator terminates the laser procedure.
CAUTION! Place Laser Warning Sign at location entrance where people will use the AVI HPLL-12 laser device.
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6. SAFETY This section provides a collection of safety guidelines and safety related statements relevant to the safe and effective operation of the AVI HPLL-12 therapeutic laser. Additional statement and protocols regarding safety appear elsewhere in this document. Use this laser device according to all printed guidelines cautionary statement, and protocols.
6.1. Guidelines Avicenna Laser Technology’s user information is in compliance with section 1040.10 of Title 21 of the code of Federal Regulations, Chapter1, Subchapter J of Health and Human Services, Food and drug Administration, and center for the devices and Radiological Health.
6.2. Laser Safety Supervision Designate at least one person at each facility that utilizes this device as laser safety supervisor, responsible for providing training on all operating safety procedures.
6.3. Laser Safety Precautions • ALWAYS WEAR protective eyewear when the laser is in operation.
• NEVER let untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual.
• This laser device produces 980 nanometer near infrared laser energy that can be an extreme hazard to the eyes of any living being. Irreparable corneal and/or retinal damage may occur if a person exposes one or both eyes to direct or indirect (reflected) laser energy.
• The Protective eyewear supplied with this device has an optical density rating > 5.0 for 980 nm laser emission. All personnel present during device operation must wear this eyewear. Contact Avicenna Laser Technology, Inc. at (888) AVI-LASER to purchase additional sets of protective eyewear for this device.
• Select a secure, properly equipped, and well ventilated location in which to install and operate the laser.
• Place “Laser in Use” signs at location entrances where people will use the AVI HPLL-12 laser device. Please contact Avicenna Laser Technology at (888) AVI-LASER for more information regarding these signs.
• Remove the key from device’s key switch when not in use to prevent unauthorized and/or unqualified use of the device as well as inadvertent laser emissions.
• Turn the device off before relocating equipment in the same vicinity.
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• During any laser procedure, do not allow any nonessential personnel into the treatment area.
• Never allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual.
• If the laser fails to operate properly, immediately contact Avicenna Laser Technology at (888)-AVI-LASER.
6.4 Labels and Symbols The following labels appear on the AVI HPLL-12 laser device.
Manufacturer's General Safety Declaration and Identification Label Located on the side of the device. This label indicates the laser classification and warns of the radiation exposure hazard potential to eyes and skin. The label also displays the manufacturer information, model number, serial number and date of manufacturing of the AVI HP-7.5TM. This label also presents various regulatory compliance declarations.
Protective Housing Label Located on the back of the device. This label warns of radiation exposure hazard. Do not attempt to gain access to any internal device component.
Laser Emission (Aperture) Label Located on the front of the device. This label warns of radiation exposure hazard. Do not attempt to gain access to any internal device component.
Voltage, Frequency, and more Laser Radiation Information Label This label is positioned on the back of the laser.
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6.7. Sources for Additional Information and Assistance on Laser Safety Center for Devices and Radiological Health Office of Compliance 2098 Gaither Rd. Rockville, MD 20850 Tel: 3015944654 Fax: 3015944672 http://www.fda.gov/cdrh/index.html
Laser Institute of America 12424 Research Parkway, Suite 125 Orlando, FL 32826 Tel: 407 380 1553 Fax: 407 380 5588 http://www.laserinstitute.org/
7. SYSTEM SETUP
7.1. Receipt and Unpacking Unpack your laser as follows:
1. Open the box.
2. Remove the protective packaging cover.
3. Remove the accessories.
Item Description Quantity 1 Foot Switch 1 2 Keys 2 3 Interlock Plug Fixed 1 4 Laser-‐protective
Eyewear 2
5 Liquid Light Guide 1 6 Power Supply Cord 1 7 User Manual 1
Item Description Qty
4. Locate and keep this manual in a secure location.
5. Remove any intermediate protective packaging material.
6. Remove the power supply and power cord.
7. Remove the AVI HPLL-12 laser system.
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7.2. Setup
AVI HPPL-12 Quick Startup Operational Guide
1. Place laser on flat surface or into the heavy duty mobile cart. Ensure proper ventilation is available.
2. Do not place any obstruction at the back of the laser, which may block appropriate airflow into the laser and interfere with ventilation of the internal components.
3. Insert power cord into back of unit. Turn switch to on.
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4. Clean liquid light guide with lens paper or a clean optical grade cloth before inserting into the laser console.
5. Attach cable and wand to unit. Align red dots on the wand with red dots on the unit. Insert firmly.
6. After inserting cable into laser wrap the cable counter clockwise around the pole as shown below. This minimizes the strain on the cable at the insertion site.)
Upon completion of treatment at the end of the day, detach the cable form the laser console. (This minimizes the strain on the cable at the insertion site.) Store the wand by wrapping it around the cable holder. Do not store the wand attached to the laser unit after treatment is completed.
Overnight Storage of Cable-‐Option 1
Overnight Storage of Cable-‐Option 2
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7. Attach footswitch cable into front of unit. Align red dots on the footswitch cable with red dots on the unit. Insert firmly.
8. Make sure red emergency Stop button (front unit) is not depressed or unit will not turn on.
9. Place key in keyhole in front of unit.
10. Turn key to on position.
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11. To set power output and time presets scroll thru the Menu screen by pressing the Menu button until you come to the screen below. You are now ready to create power output and time presets.
12. Scroll to #1.
13. Press and hold left arrow till the P: starts to flash.
14. Once the P (Power) begins to flash, adjust to the desired level of output using Up/Down buttons.
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15. Once desired output is achieved, press the left arrow once and flashing will stop.
16. Press and hold right arrow till it flashes, to adjust treatment time (T).
17. Once the T (time) begins to blink, adjust to the desired time using Up/Down arrows.
18. Once desired time is achieved, press the right arrow once and flashing will stop.
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19. When desired wattage and time has been set, press Enter to save.
20. Repeat steps 11 -‐19 for presets 2-‐9 (bottom left corner). User has option to set power output and treatment time for the presets based on treatment of the most common pathologies related to the user’s medical discipline.
To Begin Laser Emission—Operation
21. When the presets have been entered. Scroll thru the menu screen until you come back to select desired Preset or to the start up screen below, where you can manually set the power output and treatment time as you desire.
22. To begin laser emission depress and hold the foot pedal while simultaneously pressing in sequence the far right arrow.
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23. Then pressing enter to begin emission
24. Laser beeps 3 times and red aiming beam flashes 3 times. Always keep foot on pedal or laser will stop emitting. If you stop in the middle of a treatment you only need to press and hold the foot pedal to continue the treatment.
25. At the end of treatment, laser will again beep 3 times and flash 3 times to signal completion of a treatment.
To initiate a new treatment, repeat step 21.
Important Note:
Upon completion of treatment at the end of the day, detach the cable from the laser console. This minimizes the strain on the cable at the insertion site. Store the wand by wrapping it around the cable holder or in the drawer. Do not store the wand attached to the laser unit after treatment is completed.
Laser Wand Lens Maintenance:
Clean the lens after every treatment using 91% alcohol. You can purchase the alcohol at Wal-‐Mart, and lens paper can be purchased at any pharmacy.
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8. Charts and Protocols
8.1. Error Message List
«Err2» Laser 2 temperature >30 C degree.
«Err3» Laser 1 IR PD is broken .
«Err4» Laser 1 thermistor is broken.
«Err5» Laser 2 thermistor is broken.
«Err6» Laser 2 IR PD is broken
«Err7» Door is open.
«Err8» Wand is open.
«Err9» Red Laser 1 is broken.
«ErrA» Red Laser 2 is broken.
«ErrF» External DACs not respond to MCU.
8.2. Head, Neck and Upper Extremities Protocol Chart
Treatment Condition Power Level
(Acute) Power Level
(Chronic) Time
(Minutes) Therapeutic
Dosage (Joules)
Headache 1.0-3.5W 3.5-12W 15-20 900 – 14,400
Sinusitis 1.5-4.0W 4.0-12W 15-20 1,350 – 14,400
TMJ Syndrome 1.5-3.0W 3.0-12W 15-20 1,350 – 14,400
Trigeminal Neuralgia 1.0-3.0W 3.0-12W 15-20 900 – 14,400
Cervical (Soft tissue Strain/Sprain)
1.5-4.0W 4.0-12W 15-20 1,350 – 14,400
Cervical (Disc Herniation) 2.5-5.0 5.0-12W 15-20 2,250 – 14,400
Cervical (Radiculopathy) 2.0-4.0W 8.0-12W 5-10 1,800 – 7,200
Cervical (Spondylosis/Stenosis) 3.0-5.0W 5.0-12W 15-20 2,700 – 14,400
Upper Extremity (Soft tissue)
Rotator cuff, Lat. Epicondylitis
2.5-5.0W 5.0-12W 15-20 2,250 – 14,400
Upper Extremity (Articular) DJD, Labral Tear
3.0-5.0W 5.0-12W 15-20 2,700 – 14,400
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Upper Extremity (bone) Radial Head Fracture,Phalynx Fracture
3.0-5.0W 5.0-12W 15-20 2,700 – 14,400
Upper Extremity (Nerve) Cubital tunnel, Carpal Tunnel
2.0-4.0W 4.0-12W 10-15 1,800 – 10,800
8.3. Lumbar, Hip, Knee & Lower Extremities Protocol
Treatment Condition Power Level
(Acute) Power Level
(Chronic) Time
(Minutes) Therapeutic
Dosage (Joules)
Lumbar Soft tissues 2.0-6.0W 6.0-12W 15-20 1800 – 14,400
Lumbar Facet joints 2.0-6.0W 8.0-12W 15-20 1800 – 14,400
Lumbar Disc Pathology 3.0-8.0W 8.0-12W 15-20 2,700 – 14,400
Lumbar Spondylosis 4.0-8.0W 8.0-12W 15-20 1,350 – 14,400
Lumbar Stenosis 4.0-8.0W 8.0-12W 15-20 1,350 – 14,400
Lumbosacral Radiculopathy 2.0-6.0W 6.0-12W 15-20 2,700 – 14,400
Hip (periarticular) 2.0-6.0W 6.0-12W 15-20 1800 – 14,400
Hip joint (DJD,RA) 3.0-8.0W 8.0-12W 15-20 2,700 – 14,400
ITB/TFL, Bursitis 2.0-6.0W 6.0-12W 15-20 1800 – 14,400
Knee Bursitis 2.0-6.0W 6.0-12W 10-15 1800 – 14,400
Knee Strain/Sprain (Superficial) 2.0-6.0W 6.0-12W 10-15 1800 – 14,400
Knee Sprain (Deep) 3.0-8.0W 8.0-12W 15-20 2,700 – 14,400
Knee (DJD/ RA) 3.0-8.0W 8.0-12W 15-20 2,700 – 14,400
Patellofemoral (AP & PA) 2.0-6.0W 6.0-12W 15-20 1800 – 14,400
Fracture 2.0-6.0W 6.0-12W 10-15 1800 – 14,400
Meniscus 2.0-6.0W 6.0-12W 10-15 1800 – 14,400
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8.4. Foot Pathology Laser Treatment Protocol Chart
Treatment Condition Power Level (Acute)
Power Level (Chronic)
Time (Minutes)
Therapeutic Dosage (Joules)
Achilles Tendonitis/Tear 1.5-‐3.5W 6.0-‐12.0W 15-‐20 1,350 – 1,800
Plantar Fasciitis 1.5-‐3.5W 8.0-‐12.0W 15-‐20 1,350 – 14,400
Morton’s Neuroma 1.5-‐3.5W 6.0-‐12.0W 10-‐15 1,350 – 10,800
Ankle Sprain (I-‐III) 1.0-‐3.0W 6.0-‐12.0W 10-‐15 600 – 10,800
Peripheral Neuropathy 1.0-‐3.0W 1.0-‐12W 15 each leg 1800 -‐ 21,600
Metatarsalgia 1.5-‐3.5W 6.0-‐12.0W 10-‐15 1,350 – 10,800
Ant. & Post Tibialis Tendonitis 1.5-‐3.5W 6.0-‐12.0W 15-‐20 1,350 – 14,400
Plantaris strain 1.5-‐3.5W 6.0-‐12.0W 15-‐20 1,350 – 14,400
Heal Pain 2.5-‐4.5W 8.0-‐12.0 15-‐20 2,250 – 14,400
Stress Fracture 1.0-‐3.0W 5.0-‐12W 10-‐15 600 – 10,800
Turf Toe 1.5-‐3.5W 5.0-‐12W 10-‐15 1,350 – 10,800
Hallux Valgus 1.5-‐3.5W 5.0-‐12W 10-‐15 1,350 – 10,800
Tarsal Tunnel Syn 2.5-‐4.5W 6.0-‐12.0W 15-‐20 2,250 – 14,400
High Ankle Sprain 2.5-‐4.5W 6.0-‐12.0W 10-‐15 2,250 – 10,800
Ant/Post Shin Splints 2.5-‐4.5W 6.0-‐12.0W 15 per leg 2,250–10,800
Popleuteus/Tendonitis, MCL,LCL Sprain
1.5-‐3.5W 6.0-‐12.0W 15-‐20 1,350 – 14,400
Meniscus Injury 1.5-‐3.5W 8.0-‐12.0W 15-‐20 1,350 – 14,400
Anterior/Posterior Cruciate 2.5-‐4.5W 8.0-‐12.0W 10-‐15 2,250 – 10,800
8.5. Application Instructions
We recommend treating a wide area that includes at least 1-‐2 inches of healthy tissue outside of the targeted area. This helps to establish proper circulation to the affected tissues. The majority of energy should be delivered over the area of pathology.
The wand should be placed directly on the skin for most musculoskeletal conditions. If you are treating a deep injury (i.e: to the back or hip joint), the wand should be placed on the skin to achieve maximum power density and penetration. The wand/lens must be cleaned meticulously with either 91% isopropyl or methyl alcohol after each treatment for aseptic purposes and to assure proper laser transmission. A dirty lens will cause the laser light to be scattered into the hand piece and overheating will occur.
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For treatment over skin lesions, small peripheral joints, or boney prominences, the wand can be held as far as 1-‐2 inches off the body. This will effectively increase the treatment surface area and decrease the power density.
The wand should move at a rate of 1 inch per second. If the patient experiences thermal sensitivity, make the following adjustments:
First try increasing the rate of wand movement (greater than 1 inch per second) without changing the treatment probe to skin distance or decreasing the output power of the laser. (This method will not effect energy density of the treatment beam). Increase the distance between the treatment probe and the skin. (This method will effect energy density of the treatment beam). Decrease the power (wattage). (This method will effect energy density and dosage of the treatment beam)
Treating toward the higher duration of the suggested treatment times will accelerate recovery. The frequency of treatments can vary depending on the phase of injury (acute, sub-‐acute, chronic) and the patient’s response to therapy. Generally speaking, treatments range from once every 24 hours to once every 48 hours.
8.6. Treatment Technique
When performing treatment with the Avicenna Class IV therapeutic laser, different techniques can be used. Most healthcare providers use variations of a scanning technique, requiring the wand to be moved at a consistent speed over a specified pattern. The pattern that the operator follows is not as important as maintaining a consistent speed while delivering the therapeutic laser treatment.
Note: overlapping patterns do result in increased thermal perception by the patient. Variances in probe to skin distance alter power density and consequently dosage delivered to the injured tissue.
8.7. Overview for Most Injuries
Wand Position: Perpendicular to treatment area, usually directly on the skin.
Treatment Area: Area that includes at least 1-‐2 inches of healthy tissue outside the targeted area.
Treatment Rate: Move wand at a rate of 1” per second. You may increase rate if patient experiences thermal sensitivity.
Treatment Frequency: Acute: daily. Chronic: every other day: 3 times/week.
Treatment Duration: Refer to treatment protocol chart.
Dosage: Refer to treatment protocol chart.
8.8. Areas Requiring Deeper Penetration
Wand Position: Perpendicular to treatment area, place wand on the skin.
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8.9. Areas Requiring Superficial Penetration
Wand Position: Perpendicular to treatment area, 1 -‐2 inches from the skin.
Regions: Fingers, Toes and over open wounds.
9. SPECIFICATIONS
AVI HPLL-‐12 Technical Specifications
Input Voltage 90 — 264 VAC Input Frequency 47 — 63 Hz Laser Type GaAs Diode Classification Class IV Laser Product Treatment Spot Size Variable 2 — 8 cm Wavelength (Treatment Beam) 980 nm Continuous Wave Output Power .25 — 12 Watts (250 —12,000 mW) Wavelength (Aiming Beam) 650 nm Visible Red Diode (Aiming Beam) Fixed Programmable Presets 9 Warrantee 1 year Approved Testing EN 60825-‐1 Compliance 21 CFR 1040.10 and 1040.11 Accessories Included Two Safety Glasses Patent Pending
10. WARRANTY INFORMATION
10.1. Terms and Conditions Avicenna’s lasers and power supplies are warranted to be free from defects in materials and workmanship for a period of 12 months, starting from the date of initial shipment. This warranty does not extend to incidental or consequential damages and to damage caused by negligent or improper handling in use, storage, nor to products from which the original identification markings or labels have been defaced, altered or removed.
Special contracts or contracts for nonstandard products may have modified terms of warranty and, in such cases, the terms as stated in the individual contract must be signed by the duty officer of Avicenna and will supersede the standard terms.
Avicenna reserves the right of determining cause or existence of defect and the options to repair the products, which prove to be defective during the warranty period. Products replaced under warranty will be warranted only for the balance of the warranty period starting from the date of the first shipment.
This warranty extends only to the original purchaser of the equipment from Avicenna. The purchaser must notify Avicenna within 15 days of first detecting the defect and promptly return the defective product before expiration of the warranty period.
Products claimed by purchaser to be defective shall be returned to Avicenna with transportation and insurance (if necessary) prepaid by purchaser. Avicenna will return repaired or replaced products to purchaser with FOB city destination within the Continental United States. Transportation fees insurance (if necessary) beyond this limit will be charged to purchaser.
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10.2. Return Procedure Please review terms of purchase and date of shipment to determine validity of warranty claim. Warranty claim should only be made for products within terms of warranty policy.
Call Avicenna at (561) 722-1153 and obtain a Return Material Authorization number (RMA) and detailed return instructions. A form will be faxed and must be completed, signed and returned to Avicenna. For customers in the USA and countries where distributorship and/or a representative is not available, all claims should be addressed to:
Avicenna Laser Technology, Inc. 1209 North Flagler Drive West Palm Beach, FL 33401
Be prepared to furnish:
• Product Model number and Serial number
• Purchase and Shipment Date
• Reason for return
• Name of person and phone number at your organization for further communication. Adhere to Avicenna’s complete return instructions for transportation and packaging and ship the product (freight and insurance prepaid) with proper documentation containing the RMA number and the information specified above. Avicenna will advise the purchaser of its determination of warranty at the earliest possible time. Providing complete information as requested will expedite the procedure.
11. CONTRAINDICATIONS • Do not apply infrared light to abdominal or lumbosacral points in pregnant females.
(Laser is contraindicated for use over the pregnant uterus. It may be used on the pregnant woman as an adjunct to the other modalities being used for the treatment of back pain or other complaints
• Do not apply infrared light over the pacemaker itself in patients with pacemakers.
• Do not apply infrared light over the thyroid gland, ovaries and testicles.
• Do not apply infrared light to patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
• Do not apply infrared light over areas recently injected with corticosteroids.
• Do not apply infrared light when individual intolerance of the treatment is noted.
• Do not shine laser light into eyes, with or without eyewear protection (Class 3b and Class
NOTE A laser output power calibration is recommended at least one a year!
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4 lasers are potentially harmful to the retina. Safety goggles must, be worn by the patient, practitioner, any individuals in the treatment area.)
• Carcinoma. Do not use laser over any known primary or secondary lesions. (Laser treatment may be given for pain relief during the terminal stages of the illness we recommend this be done only with the full consent of both patient and primary medical physician (oncologist) involved.)
• Immunosuppressant Drugs. Laser Therapy may increase the function of the immune system.
• Avoid applying laser over tattoos.
NOTE: Many products, including prescribed medications, over the counter patent medicines, and a wide range of personal care products can increase the skin's sensitivity to light. This can result in photosensitivity, an intense reaction of the skin, which can cause burning (or erythema) in a much shorter time period than would normally be expected. Photosensitivity can be caused by products applied directly to the skin or from medications or other substances that have been ingested.
Because there are literally hundreds of known photosensitizing agents under these general categories, individuals taking any medications or using any of the other products listed below should be advised to consult a physician or pharmacist before receiving laser therapy.