operation manual

operation manual
Laser Module
OPERATION MANUAL
TABLE OF CONTENTS
Foreword................................................................................................................... 1
Product Description ........................................................................................... 1
Contents....................................................................................................................2
•Richmar Laser and Light Kits
•Optional & Replacement Components
Precautions and Warnings................................................................................2
1. Caution
2. Labels
3. Warning
Indications and Contraindications................................................................3
1. Indications for Use
2. Contraindications
Initial Setup Instructions....................................................................................3
1. Console Device Ports
2. Caution
System Orientation..............................................................................................4
• Richmar LaserPrism Laser Device
• Richmar AutoPrism SLD Cluster Device
Operating Instructions for Laser and Light Devices............................5
1. Dose Selection
2. Device Control
3. Beep Per Joule
4. Configure Mode
5. Volume Control.............................................................................6
6. Delivery of Energy (Joules)
Step by Step Instructions..................................................................................6
User Maintenance.................................................................................................7
1. Ongoing Maintenance
2. Technical Maintenance
Technical Specifications.....................................................................................8
• Richmar LaserPrism Device (500-031)
• Richmar AutoPrism SLD Cluster Device (600-123)
Warranty....................................................................................................................9
Contact Information............................................................................................9
1
FOREWARD
Congratulations on your purchase of a
Richmar Laser Module. Richmar takes
pride in its product lines and the Service
it provides to its customers. This upgrade
may include both the LaserPrism low level
laser and Light Cluster Probe, or only one
of these.
This Guide is written for the owners
and operators of the Richmar Laser
Module Upgrade Kit. It contains general
instructions for operation, warnings,
precautionary practices and maintenance
procedures. In order to maximize the use,
efficiency and life of your product, please
read this Guide thoroughly prior to using
the Richmar Laser Module Upgrade Kit.
In the U.S.A., multiple FDA clearances
covering the laser and light therapy
devices have been obtained.
In Canada, the laser and light devices have
been licensed by the Medical Devices
Bureau of the Therapeutic Products
Directorate, Health Canada.
Laser and Light Therapy (phototherapy)
is a safe and effective therapy which uses
light energy to decrease or eliminate pain.
PRODUCT DESCRIPTION
The Richmar Laser Module has been
developed to offer product flexibility
and choice. The components have been
designed for ease of use by licensed
healthcare professionals and/or their
delegated assistants.
The Richmar LaserPrism device is a
handheld low level laser therapy device for
deeper tissue conditions. This accessory
features three near-infrared laser diodes
for therapeutic applications and a visible
LED guide light for attended therapy.
The convenient, high-quality laser and
light therapy devices are seamlessly
integrated into Richmar EVO devices.
These devices include both a low level
laser therapy device and light therapy
(SLD) accessories.
The Richmar Light Cluster Probe offers
SLD (superluminous diode) light therapy
for broader applications. This device can
be strapped into position for “hands-free”,
unattended treatment.
Richmar LaserPrism
Visible and Invisible laser radiation.
Avoid direct exposure to beam.
Class IIIb laser product.
Richmar Light Cluster Probe
2
CONTENTS
This section of the operating guide
describes the different configurations of
the Richmar Laser Module upgrade kit and
available components.
5.1 Operating Guide
1. 1 LaserPrism (REF 500-031)
• LaserPrism Device (REF 500-031)
2.1 Light Cluster Probe (REF 600-123)
• Light Cluster Probe (REF 600-123)
3.2 Keys
• Standard Protective Goggles
(REF 600-207)
4.2 Pair of Safety Goggles
Optional and Replacement Components
Available for Order:
PRECAUTIONS AND WARNINGS
Before using the Richmar Laser Module,
the operator should become acquainted
with the operating procedures, as well
as the indications, contraindications,
warnings and precautions. Consult other
resources for additional information
regarding the benefits, limitations and
application of low level laser therapy and
SLD therapy.
1. Caution
The Richmar Laser is a Class IIIb laser.
Therefore, the following recommendations
should be adhered to:
• Both the patient and operator must
wear the provided protective goggles
to block any near-infrared energy from
“entering” the eyes during treatment.
(Not required for light cluster probe.)
• DO NOT point the laser beam directly
into human or animal eyes. The eye
does not detect the invisible, coherent
near-infrared 785 nm wavelength beam,
which could potentially result in retinal
damage.
Danger Label
Radiant Surface
Additionally, the following statement is
printed on the product “This product
complies with performance standards for
laser products, under 21 CFR 1040.10 and
1040.11”
Clinician operators should always take
caution to NOT place the Richmar SLD
devices directly over the eyes of a patient
while it is actively in operation. These
are bright sources of visible and infrared
light and comparable to staring into a
household incandescent lamp or heat
source.
• A visible guide LED is active when the
laser is operating to provide a direct
indication at the radiant (treatment)
surface.
3.Warning
2.Labels
• Use of controls or adjustments or
performance or procedures other than
those specified herein may result in
hazardous radiation exposure.
The following label
is located on the
Richmar Laser for
safety precaution
purposes.
• Richmar devices should be operated
by a trained healthcare professional or
delegated trained assistant.
• Patients and operator should wear the
specified safety goggles, when the laser
device is being used.
Label Location
Visible and Invisible laser radiation.
Avoid direct exposure to beam.
Class IIIb laser product.
• Use only as directed
• Avoid excessive use
3
INDICATIONS
The Richmar Laser Module along with
Richmar LaserPrism and/or Light Cluster
Probe are non-invasive, low energy
devices that emit photons, which are
absorbed to produce cellular effects
and biological changes. The photons
temporarily increase microcirculation,
resulting in temporary relief of pain and
stiffness, relaxation of muscles, decrease
of muscle spasms and decreased pain
and stiffness associated with arthritis. The
dosage and frequency of treatment needs
to be adjusted to produce the desired
effects.
2.Contraindications
1. Indications of Use
Research indicates that therapeutic
heat creates a cascade of chemical and
biological effects, which result in the
following benefits:
• Over areas injected with steroids in the
past 72 hours
• Increases microcirculation
• Elevates tissue healing
• Temporarily relieves muscle and soft
tissue injury and pain
• Decreases arthritis pain and stiffness
r Maintenance
• Relieves muscle spasms
urface of laser and light devices with a
tal grade germicide. Follow germicide
ot use highly concentrated germicide
directions of the germicide manufacturer,
OT spray cleaner directly onto radiant
The Richmar LaserPrism SHOULD NOT be
used under the following conditions:
• Where analgesia may mask progressive
pathology, and where the practitioner
would normally avoid the use of any
other analgesia in order to retain the
beneficial aspects of pain.
• Where it might deliver direct irradiation
to the human or animal eye.
AVOID using Richmar Laser and Light
Therapy devices:
• Over suspicious lesions (potential
cancer)
• Over a pregnant uterus
• Over the thyroid region of the neck
• Over areas with open wounds, unless
covered with a clear protective barrier
Visible and Invisible laser radiation.
Avoid
to beam.
Initialdirect
Setupexposure
Instructions
Class IIIb laser product.
After unpacking, make sure all items are present and undamaged.
Remove protective coverings from the radiant surface of each device.
Plug devices into related ports on the Console.
INITIAL SETUP INSTRUCTIONS
i) Console Device Ports
The upgraded Rich-Mar Console has two ports which can be used for
either a combination
of asystem
laser and SLD
devices
only. These
• Use the
only
if it or
islaser
properly
After unpacking, make sure all items
devices can be plugged into either port.
grounded.
are present and undamaged. Remove
protective coverings from the radiant ii) Caution
• Prior to use, the following items should
of each
device. Plug devices into
and Light surface
Kit devices should
be checked
ensure
proper
operation:
1. Placebe
unitchecked
in a location to
where
the power
cord cannot
be tripped
e that all controls
function
normally.
related
ports
on the Console.
over or pulled out during treatment.
ces before each use to ensure cleanliness.
a.Power cord, plug and AC power
2. Use the system only if it is properly grounded.
1. Console Device Ports
supply: Check to ensure the cord is
onnectors before each use.
3. Prior to use, the following items should be checked to ensure
free of kinks, and not frayed, torn
Richmar
Laser
Module has two
and Light The
Kit should
be operated
in
proper operation:
n 32°F and
104°F which
(0°C to 40°C),
or cut, exposing insulation.
ports
canwith
be used for either a
ing from 20% to 95% non-condensing.
cord, plug and AC power supply
combination of a laser and SLD devices or (a) Power
m -4°F to 149°F (-20°C to 65°C).
Check
to ensure theaccessories:
cord is free of kinks,
and not frayed,
b.Therapy
Check
to
laser only. These devices can be plugged
torn or ensure
cut, exposing
insulation.
the
cables are flexible,
into either port.
free
of kinks, not frayed and that
(b) Therapy
accessories
Check the
to ensure
the cables are
flexible, free
of kinks,
not
insulation
is intact.
Check
the
2.Caution
frayed and
that thesurfaces
insulation is to
intact.
Check the
radiant
disassemble the unit. Only authorized
radiant
ensure
they
are
surfaces to ensure they are free of foreign materials, grease
•and
Place
a location where the power
aintenance
repairs.unit
The in
manufacturer
free of foreign materials, grease or
or cream.
the results ofcord
maintenance
or repairs
by
cannot
be tripped
over or pulled
cream.
out during treatment.
Device plug in and out instructions;
Kit should be tested annually to verify
mmended that all Rich-Mar Laser and
DEVICE
PLUG
IN AND OUT INSTRUCTIONS
viced by the
factory or
an authorized
recalibration. Recalibration is also
plug
line
up top with arrows and
ement or To
repair
of anyin:
major
component.
push in until it clicks
To remove: slide back outer sleeve to
unlock
4
System Orientation
Richmar LaserPrism
1. ON / OFF
Click this switch to Start/Stop the
treatment.
2.Service LED
Solid red indicates the unit needs to be
serviced. Try to retrigger, if Service LED is
still on, contact your distributor.
3.Dosage LED / Active
• Slow flashing Green with 1 short beep
indicates 8 joules
• Slow flashing Blue with 2 short beeps
indicates 14 joules
• Fast flashing Turquoise with 1 long beep
indicates 18
4.Infrared Laser Diode
Three near-infrared laser diodes.
5.Dosage Selection Button
Push this button to cycle the dosage
among 8, 14 and 18 joules, as indicated in
Item 3 Dosage LED.
6.Beam Attenuator
Laser cap to be utilized to cover the
radiant surface when the device is not in
use.
Light Cluster Probe
1. Visible Diodes
There are 9 visible, red diodes. These
form the visible red “X”.
2.Infrared Laser Diodes
There are 52 infrared diodes. These
infrared diodes are not visible to the
human eye. If the red “X” is ON, then the
infrared diodes are also active. Using a
digital camera, it is possible to take a
picture and see the active diodes.
Visible and Invisible laser radiation.
Avoid direct exposure to beam.
Class IIIb laser product.
5
OPERATING INSTRUCTIONS
Both the Richmar LaserPrism and Light
Cluster Probe are controlled by the
laser module; therefore the following
combinations can be used:
• Simultaneously plug both the Laser and
Light devices into the Laser Module
- OR
• Only the Laser device plugged into the
Laser Module
Note: The SLD light
device will not function
without the laser
device.
Note: The safety key
must be on to operate
the devices. The safety
key location may vary.
Key
1. Plug device(s) into Richmar console,
Laser device only or combination Laser
and SLD cluster devices (see page 3).
2.Dose Selection
Push the Dosage button to select the
dosage for both the laser and SLD
devices. The dose selection will cycle
through 8, 14 and 18 joules. When you
push the Dosage button the Dosage
LED will change color and sound
indicating dose selection.
Note: Dose selection is made for both the
laser and SLD light cluster (if plugged in
simultaneously).
• Slow flashing Green LED with short
beep indicates 8 joules, treatment time
is 40 seconds.
• Slow flashing Blue LED with two short
beeps indicates 14 joules, treatment
time is 70 seconds.
• Fast flashing Turquoise LED with a long
beep indicates 18 joules, treatment time
is 90 seconds.
3.Device Control
• Clicking “ON/OFF” Switch of the laser
will control the laser alone, both the
laser and SLD light cluster or the SLD
light cluster alone.
• LaserPrism - Single click to start or stop
• SLD Cluster - Double-click to start
or stop (similar to double clicking a
mouse)
• Stops both - Single longer (2 second)
click to stop both devices
4.Once the ON/OFF switch has been
triggered to activate the device, the
Dosage LED will remain the color
selected in Step 2. There will be a
1-second delay before treatment is
initiated. Initiation is indicated by a
single beep, the device beeps every 5
seconds. (Beep per Joule feature).
Once the treatment is complete, the
device will immediately emit three beeps.
The DOSAGE LED will blink the color
selected. To initiate the same dosage, click
the ON/OFF switch.
Dose selection will return to original
setting of 8 joules (green) if the laser is
unplugged or the console is turned off or
unplugged.
Treatment can be interrupted at any point
by clicking ON/OFF switch.
5.Beep per Joule:
This option can be turned OFF or ON
by holding down the Dosage Selection
button for 5 seconds. After releasing
the Dosage button a single beep will
acknowledge the ‘beep per joule’ is OFF.
To turn this feature ON again, hold the
Dosage button for longer than 5 seconds.
Two beeps will acknowledge the ‘beep per
joule’ feature is active again.
6.Configure Mode
This Mode is used to adjust volume of
beeps or to stop beeps. To initiate the
Configure Mode, complete the following
steps.
a.First unplug the laser and SLD
devices from the console.
b.Simultaneously hold down the ON/
OFF switch and the Dosage button
on the Laser device with one hand
and with the other hand, plug laser
device into the console.
c. The primary function of the
configure mode is to change
the volume of the beeps or stop
the beeps. As well, the version
numbers for the equipment
can be determined. For further
information contact the Richmar
Service Department.
d.To Exit Configure Mode unplug the
laser device from the console.
Visible and Invisible laser radiation.
Avoid direct exposure to beam.
Class IIIb laser product.
6
OPERATING INSTRUCTIONS
7.Volume Control:
8.Delivery of Energy (Joules)
While in Configure Mode, hold the Dosage
button down for 5 seconds or longer.
There are four volume settings. Repeat to
move to the next volume setting:
• Laser delivers 1 joule every 5 seconds
• SLD Cluster delivers 1 joule/cm² every
45 seconds
• Low: One (1) beep (factory setting)
• Medium: Two (2) beeps
• High volume: Three (3) beeps
Visible and Invisible laser radiation.
Avoid direct exposure to beam.
Class IIIb laser product.
• Off: Silence (no beeps at all)
STEP-BY-STEP INSTRUCTIONS
1. Cleanse and degrease skin with alcohol
or soap and water to reduce reflection
and refraction. Cover treatment head
with a clear barrier for asepsis if skin
over the treatment area is open.
2.Plug in the Laser and SLD devices into
the ports on the Richmar console.
3.Insert the safety key into keyhole and
turn on. (Page 10)
4.Remove the clear protective barrier
from the radiant surface of the SLD
device. Place radiant surface of the SLD
device directly on appropriate area
of the skin for treatment. Use strap to
secure into position.
5.Remove the red protective cap (beam
attenuator) from the Laser device.
Position the Laser device directly onto
skin applying gentle pressure, at a 90
degree angle perpendicular to the
target tissue.
6.Click the “ON/OFF” switch once for
the Laser device and double click for
the SLD device. There is a 1-second
delay prior to the device activating.
While the laser is ON, the Dosage LED
is illuminated with the color related
to the dose selected. To deliver the
desired dosage of energy and optimize
penetration, the laser should be held
firmly in one position for the entire
treatment.
WARNING
Patient and operator should wear safety
goggles when laser device is to be used.
7.The Laser and SLD devices are
programmed to shut off after the
selected number of Joules has been
delivered.
(Laser = 5 sec/joule, SLD = 45 sec/
joule/cm²).
Unless volume control has been turned
off, there are three short beeps after
treatment has been delivered. The Dosage
LED will continue to blink the selected
dosage color while the unit is ON. If same
treatment dose is required, re-click the
ON/OFF switch for the corresponding
Laser and SLD devices.
8.While treatment is being provided,
maintain the device in one position
without moving it. NO MEDIUM OR GEL
IS REQUIRED
7
USER MAINTENANCE
Between uses, wipe radiant surface of
laser and light devices with a clean, damp
cloth with a hospital grade germicide.
Follow germicide manufacturer directions.
Do not use highly concentrated germicide
mixtures. Dilute according to directions of
the germicide manufacturer, or damage
may result. DO NOT spray cleaner directly
onto radiant surface.
1. Ongoing Maintenance
• The Richmar Laser and Light Kit
devices should be checked regularly
to determine that all controls function
normally.
• Inspect radiant surfaces before each
use to ensure cleanliness.
• Inspect associated connectors before
each use.
• The Richmar Laser Module should be
operated in temperatures between 32°F
and 104°F (0°C to 40°C), with relative
humidity ranging from 20% to 95% noncondensing. Store or transport from
-4°F to 149°F (-20°C to 65°C).
2.Technical Maintenance
NO attempt should be made to
disassemble the unit. Only authorized
personnel should complete maintenance
and repairs. The manufacturer will not
be held responsible for the results of
maintenance or repairs by unauthorized
persons.
To maintain full compliance with The
United States Code of Federal Regulations
Title 21 (21 CFR, part 1040.10 and 1040.11),
the device should be tested annually. It is
recommended all Richmar products be
serviced by the manufacturer or sent to
an authorized servicing dealer for repairs
and recalibration. Calibration procedures
are NIST traceable and available at
selected authorized service dealers or the
manufacturer’s service and repair center.
Recalibration is also recommended after
the replacement or repair of any major
component.
Visible and Invisible laser radiation.
Avoid direct exposure to beam.
Class IIIb laser product.
8
TECHNICAL SPECIFICATIONS
Richmar LaserPrism
Light Source
3 near infrared laser diodes (GaAlAs)
Laser Equipment Safety Classification
Class 3B 111b
FDA Regulatory Classification
Class II
Nominal Laser Wavelength
785 nm (near infrared)
Guide Light Wavelength
470 nm (visible blue)
Duty Cycle
100% (continuous mode)
Total Optical Output
Power (Continuous Mode)
200 mW ± 10%
Max Optical Output Power
(per Diode at Continuous Mode)
80 mW
Energy Delivered
1 Joule per 5 seconds
Treatment Area at Skin
0.026 cm² from 3 laser spots
Spot Size
0.00881 cm² single laser spot
Power Monitoring
Continuous with automatic shutdown if
optical power is ± 30%
Beam Divergence
17°x8° typical (15°x6° minimum)
Nominal Ocular Hazard
Distance (NOHD)
188 mm (NOHD is calculated for the worst
case 80 mW condition. Normal operating
conditions are typically 67 mW per diode,
which reduces the NOHD).
Light Cluster Probe
Light Source
52 near infrared diodes
9 visible red diodes
FDA Regulatory Classification
Class II
Treatment Wavelength
870 nm (near infrared)
Guide Light Wavelength
633 nm (visible red)
Duty Cycle
100% (continuous mode)
Total Optical Output
Power (Continuous Mode)
500 mW ± 20%
Irradiance
22.2 mW/cm² ± 20%
Treatment Area at Skin
22.48 cm²
Spot Size
0.00881 cm² single laser spot
Treatment Time
1.0 Joules/cm² in 45 seconds
Beam Divergence
17°x8° typical (15°x6° minimum)
Nominal Ocular Hazard
Distance (NOHD)
Not applicable for these diodes. (Avoid
direct exposure to eyes. 188 mm or greater
is recommended.)
Visible and Invisible laser radiation.
Avoid direct exposure to beam.
Class IIIb laser product.
9
WARRANTY
Richmar (“Company”) warrants that
the Richmar Laser and Light Kit
(“Product”) is free of defects in material
and workmanship. This warranty shall
remain in effect for one (1) year on the
accessories (Laser and SLD) from the
date of original consumer purchase of this
Product. It is extended to any owner of
the Product during the warranty period.
Extended warranties may be available. If
this Product fails to function during the
warranty period because of a defect in
material or workmanship, the Company
at its discretion will repair or replace this
Product without charge. The Company
or dealer will ship the Product to the
customer as quickly as possible.
All repairs must be performed by Richmar
or an authorized service center. Any
modifications or repairs performed by
unauthorized centers or groups will void
this warranty. To participate in warranty
coverage, this Product’s warranty
registration card (included with Product)
must be filled out and returned to Richmar
by the original owner within 15 business
days of purchase.
This Warranty Does Not Cover:
1. Replacement parts or labor furnished
by anyone other than the Company,
the dealer or an authorized Company
service agent.
2.Defects or damage caused by labor
furnished by someone other than
Company, the dealer or an authorized
Company service agent.
3.Any malfunction or failure in the
Product while it is in the possession of
the owner during the warranty period if
the malfunction or failure is not caused
by defect in material or workmanship, or
if the malfunction or failure is caused by
unreasonable use, including the failure
to provide reasonable and necessary
maintenance.
Richmar Shall Not Be Liable for Incidental
or Consequential Damages to Property or
Business
Some states do not allow the exclusion or
limitation of incidental or
consequential damages, so the above
limitation or exclusion may not
apply.
TO OBTAIN SERVICE from Richmar or
the authorized service agent under this
warranty, the owner must do or abide by
the following:
1. A written claim must be made within
the warranty period to Richmar or
the selling dealer. If claim is made to
Richmar, a written claim should be sent
to:
Richmar
4120 South Creek Road
Chattanooga, Tennessee
37406 USA
Phone: (423) 648-7730
Toll Free: (888) 549-4945
Fax: (423) 648-7735
Email: technicalsupport@richmarweb.com
Web: www.richmarweb.com
2.Contact Richmar Technical Service to
obtain a Return Materials Authorization
(RMA) number.
3.The product must be returned (freight
prepaid) to Richmar or the authorized
service agent by the owner and clearly
marked with the RMA number.
This warranty grants the owner specific
legal rights. The owner may have other
rights, which vary from state to state or
other jurisdictions. Richmar does not
authorize any person or representative to
create for it any other obligation or liability
in connection with the sale of the Product.
Any representation or agreement not
contained in the warranty shall be void
and of no effect.
Information in this document is subject to
change without notice. The manufacturer
of the equipment may have patents, patent
applications, trademarks, or copyrights
covering material in this document. This
document does not grant license to any
of these intellectual property rights. The
manufacturer shall not be liable for any
errors and/or omissions for incidental or
consequential damages in connection with
the performance, or use of this material.
All rights reserved. Without limiting the
rights under copyright law, no part of this
document may be reproduced, stored in
or introduced into a retrieval system, or
transmitted in any way without the express
written permission of the manufacturer.
Richmar is an ISO 13485 Certified Company.
3017.15.11.A ©2015 Richmar
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