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AVI	
  HPLL-­‐12	
  
          	
  
          	
  
          	
  
          	
  
          	
  


	
  
          	
  
          	
  
                                                                                                      	
  
 Quick	
  Startup	
  Operational	
  Guide—July	
  2010	
                                              	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
                                                                                                      	
  
          	
  
          	
  
          	
  


       w w w . A v i c e n n a L a s e r . c o m 	
   	
   | 	
   	
   1 -­‐ 8 8 8 -­‐ A V I -­‐ L A S E R 	
  
          	
  
          	
  
          	
  
          	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
     	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  


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	
  




	
  
	
  
                                                                                                                                           2	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
     	
     	
            	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

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.                                         WARNING!
                                                                                         Never direct the laser beam at
                                                                                         anything other than the area to
                                                                                         be treated.	
  
                                                                                         	
  


A WARNING calls the reader’s attention to a specific or
potential danger in advance. If ignored or compromised,
                                                                                         CAUTION!
the situation could result in serious, irreversible personal
                                                                                         Never allow untrained person to
injury or production damage.
                                                                                         operate this device unless
                                                                                         directly supervised by a properly
                                                                                         trained and experienced
                                                                                         individual.	
  
                                                                                         	
  


A RECOMMENDATION offers guidance that may be
worthy of acceptance or trial within a specific area of AVI
                                                                                         RECOMMENDATION
HPLL-12 application and may serve to optimize overall
                                                                                         Designate at least one person
AVI HPLL-12 utilization
                                                                                         at each facility that utilizes this
                                                                                         device as laser safety
                                                                                         supervisor, responsible for
                                                                                         providing training on all
                                                                                         operating and safety
                                                                                         procedures.	
  
                                                                                         	
  



	
  
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
                                                                                                                                                  3	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
     	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

                  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
                                                                                                                                           4	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
      	
      	
      	
      	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

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.




             RECOMMENDATION
             Individuals planning to use the AVI HPLL-12 system are actively encouraged to
             attend laser orientation and education sessions.	
  


	
  
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.




	
                                                 CAUTION!
                                                   ALWAYS WEAR protective eyewear until the
	
                                                 operator terminates the laser procedure.	
  
	
  
	
  
	
  
	
  
	
  
	
  

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.

	
  
                                                   CAUTION!
	
                                                 Place Laser Warning Sign at location entrance
	
                                                 where people will use the AVI HPLL-12 laser
	
                                                 device.	
  
	
  
	
  
	
  
	
  
	
  
	
  




                                                                                                                                               5	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
     	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

	
  
	
  
	
  
	
  




	
  
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.
                                                                                                                                           6	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
     	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

•             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-7.5 . This label also presents
                                   TM

 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.	
  



                                                                                                                                           	
  


                                                                                                                                           7	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
       	
          	
          	
      	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

	
  

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	
                         2	
  
                                                                          Eyewear	
  
                                                5	
                  Liquid	
  Light	
  Guide	
                       1	
  
                                                6	
                 Power	
  Supply	
  Cord	
                         1	
  
                                                7	
                     User	
  Manual	
                              1	
  


         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.




                                                                                                                                                        8	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
             	
        	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

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.	
  




                                                                                                                                                    	
  
                                                                                                                  	
  
                                                                                                                  	
  




                                                                                                                                                            9	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
           	
             	
            	
           	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  


         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	
  
	
                                                                                              	
  




                                                                                                                                                                          10	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
          	
              	
            	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  


         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.	
  

                                                                                         	
  
	
  




                                                                                                                                                              	
  
                                                                                                                            	
  
                                                                                                                            	
  




                                                                                                                                                             11	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
            	
                  	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  


         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.	
  

                                                                                        	
  
	
  




                                                                                                                                                             	
  
                                                                                                                           	
  
                                                                                                                           	
  




                                                                                                                                                            12	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
           	
                     	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  


         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.	
  

                                                                                          	
  
	
  




                                                                                                                                                               	
  
                                                                                                                             	
  




                                                                                                                                                              13	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
                  	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  


         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.	
  

                                                                                 	
  
	
  




                                                                                                                                                        	
  
                                                                                                                    	
  
                                                                                                                    	
  

                                                                                                                                                       14	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
      	
         	
                	
     	
          	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  


         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.	
  	
  

	
  
	
  



                                                                                                                                                                15	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
               	
              	
              	
           	
      	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

	
  
	
  
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                     Power Level      Time                   Therapeutic
                                                                                (Acute)                        (Chronic)     (Minutes)                  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                                                          1.5-4.0W                        4.0-12W           15-20              1,350 – 14,400
Strain/Sprain)

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)                                                  2.5-5.0W                        5.0-12W           15-20              2,250 – 14,400

Rotator cuff, Lat. Epicondylitis

Upper Extremity (Articular)                                                    3.0-5.0W                        5.0-12W           15-20              2,700 – 14,400
DJD, Labral Tear


                                                                                                                                                                           16	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
         	
        	
         	
      	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

Upper Extremity (bone) Radial                                       3.0-5.0W             5.0-12W          15-20              2,700 – 14,400
Head Fracture,Phalynx Fracture

Upper Extremity (Nerve) Cubital                                     2.0-4.0W             4.0-12W          10-15              1,800 – 10,800
tunnel, Carpal Tunnel



	
  
8.3.	
  Lumbar,	
  Hip,	
  Knee	
  &	
  Lower	
  Extremities	
  Protocol	
  
	
  
            Treatment Condition                                     Power Level          Power Level         Time                 Therapeutic
                                                                      (Acute)             (Chronic)        (Minutes)                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

	
  




                                                                                                                                                     17	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
             	
               	
              	
              	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

8.4.	
  Foot	
  Pathology	
  Laser	
  Treatment	
  Protocol	
  Chart	
  
	
  

                 Treatment	
  Condition	
                           Power	
  Level	
  	
            Power	
  Level	
  	
  	
         Time	
                 Therapeutic	
  
                                                                      (Acute)	
                      (Chronic)	
                   (Minutes)	
                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	
                            1.5-­‐3.5W	
                   6.0-­‐12.0W	
                    15-­‐20	
           1,350	
  –	
  14,400	
  
       Sprain	
  

       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.	
  


                                                                                                                                                                                                   18	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
      	
            	
            	
            	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

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.	
  



                                                                                                                                                                 19	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
            	
           	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

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.



                                                                                                                                                     20	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
           	
     	
      	
      	
      	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

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.




                                                             NOTE
	
                                                           A laser output power calibration is recommended
                                                             at least one a year!	
  

	
  

	
  

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

                                                                                                                                                 21	
  
	
  
1-­‐888-­‐AVI-­‐LASER	
  	
  	
  	
  	
  	
  	
  	
   	
     	
     	
     	
     	
     	
  	
  	
  	
  	
  	
  	
  www.AvicennaLaser.com	
  

                  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.
	
  




                                                                                                                                        22	
  
	
  

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Avicenna AVI HPLL 12 User Manual

  • 1.                                                   AVI  HPLL-­‐12                     Quick  Startup  Operational  Guide—July  2010                                           w w w . A v i c e n n a L a s e r . c o m     |     1 -­‐ 8 8 8 -­‐ A V I -­‐ L A S E R          
  • 2. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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       2    
  • 3. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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. WARNING! Never direct the laser beam at anything other than the area to be treated.     A WARNING calls the reader’s attention to a specific or potential danger in advance. If ignored or compromised, CAUTION! the situation could result in serious, irreversible personal Never allow untrained person to injury or production damage. operate this device unless directly supervised by a properly trained and experienced individual.     A RECOMMENDATION offers guidance that may be worthy of acceptance or trial within a specific area of AVI RECOMMENDATION HPLL-12 application and may serve to optimize overall Designate at least one person AVI HPLL-12 utilization at each facility that utilizes this device as laser safety supervisor, responsible for providing training on all operating and safety procedures.       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 3    
  • 4. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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 4    
  • 5. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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. RECOMMENDATION Individuals planning to use the AVI HPLL-12 system are actively encouraged to attend laser orientation and education sessions.     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.   CAUTION! ALWAYS WEAR protective eyewear until the   operator terminates the laser procedure.               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.   CAUTION!   Place Laser Warning Sign at location entrance   where people will use the AVI HPLL-12 laser   device.               5    
  • 6. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com             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. 6    
  • 7. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   • 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-7.5 . This label also presents TM 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.     7    
  • 8. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com     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   2   Eyewear   5   Liquid  Light  Guide   1   6   Power  Supply  Cord   1   7   User  Manual   1   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. 8    
  • 9. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.         9    
  • 10. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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       10    
  • 11. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.             11    
  • 12. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.             12    
  • 13. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.           13    
  • 14. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.             14    
  • 15. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.         15    
  • 16. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com       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 Power Level Time Therapeutic (Acute) (Chronic) (Minutes) 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 1.5-4.0W 4.0-12W 15-20 1,350 – 14,400 Strain/Sprain) 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) 2.5-5.0W 5.0-12W 15-20 2,250 – 14,400 Rotator cuff, Lat. Epicondylitis Upper Extremity (Articular) 3.0-5.0W 5.0-12W 15-20 2,700 – 14,400 DJD, Labral Tear 16    
  • 17. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   Upper Extremity (bone) Radial 3.0-5.0W 5.0-12W 15-20 2,700 – 14,400 Head Fracture,Phalynx Fracture Upper Extremity (Nerve) Cubital 2.0-4.0W 4.0-12W 10-15 1,800 – 10,800 tunnel, Carpal Tunnel   8.3.  Lumbar,  Hip,  Knee  &  Lower  Extremities  Protocol     Treatment Condition Power Level Power Level Time Therapeutic (Acute) (Chronic) (Minutes) 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   17    
  • 18. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   8.4.  Foot  Pathology  Laser  Treatment  Protocol  Chart     Treatment  Condition   Power  Level     Power  Level       Time   Therapeutic   (Acute)   (Chronic)   (Minutes)   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   1.5-­‐3.5W   6.0-­‐12.0W   15-­‐20   1,350  –  14,400   Sprain   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.   18    
  • 19. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.   19    
  • 20. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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. 20    
  • 21. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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. NOTE   A laser output power calibration is recommended at least one a year!       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 21    
  • 22. 1-­‐888-­‐AVI-­‐LASER                                        www.AvicennaLaser.com   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.   22