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