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Avicenna AVI HPLL 12 User Manual

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Quick Startup Operational Guide—July 2010 AVI HPLL12 www.AvicennaLaser.com | 1888AVILASER
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Page 1: Avicenna AVI HPLL 12 User Manual

                                                               

                                   

     

       

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.  


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