Microlight ML 830 User manual

OPERATING GUIDE
CAUTION: Federal (or United States) Law restricts this Device to sale by or on
the order of a Licensed Clinician.
MICROLIGHT CORPORATION OF AMERICA
2935 Highland Lakes Drive
Missouri City, Texas 77459
281-433-4648
See U. S. Patent No. 5,464,436
CAUTION: Laser Radiation. Avoid Direct Eye Exposure. Do Not Stare into
Laser Beam.
MICROLIGHT ML830 LASER SYSTEM
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Lit001/Rev.F 2007 MicroLight Corporation ofAmericaAllrightsreserved.
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Noreproduction inany form without express writtenconsent
CAUTION: Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous radiation on exposure.
CUSTOMER SERVICE: [phone]

OPERATING GUIDE TABLE OF CONTENTS
SECTION DESCRIPTION Page Number
1. Introduction........................................................................................1
2. Components........................................................................................1
3. Warnings and Safety Instructions....................................................... 2
4. Setting Up the Recharger .................................................................. 3
5. Testing the Power Output................................................................... 4-5
6. Charging the Batteries.........................................................................6-7
7. Operating the Laser.............................................................................8
8. Use of Remote Interlock.....................................................................8
9. Principles of Operation....................................................................... 9-10
15. Care and Maintenance........................................................................ 12
16. Technical Information.........................................................................13
18. Limited Warranty................................................................................14
10. Indications For Use............................................................................ 10
11. ML830 Study...................................................................................10-11
12. Contraindications................................................................................11
13. Directions For Use of Eyeglasses....................................................... 11-12
14. Treatment Regimen.............................................................................12
17. Calibration..........................................................................................14
APPENDIX
A. CTSTreatmentProtocol...............................................................15
Please read Warning and Safety Instructions in this Operating Guide.Please read Warning and Safety Instructions in this Operating Guide.
MICROLIGHT ML 830 LASER SYSTEM
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CAUTION: Federal (or United States) Law restricts this Device to sale by or on the order
of a Licensed Clinician.
WARNING AND CAUTION
Before connecting the Recharger Console Unit or operating the ML 830 Laser read
the Warning and Safety Instructions in Section 3. Use of controls or adjustments or
1. INTRODUCTION
Welcome to the MicroLight Corporation's ML 830 Laser System. This
Operating Guide will lead you through the steps for operating the ML 830 .
Please proceed through this Guide by following the steps in sequence.
2. COMPONENTS
The ML 830 Laser System comes with the following components. If any
item is missing or damaged, immediately call your dealer, or call MicroLight
Corporation at 281-433-4648.
performance of procedures other than those specified herein may result in hazardous
radiation on exposure.
Recharger Console Unit
Rechargeable Batteries (3)
System Carrying Case
Probe Carrying Case
Model 830 Laser Probe
Safety Glasses (2 pair)
Power Cord
Keys
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MICROLIGHT ML 830 LASER SYSTEM
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3. WARNINGSAND SAFETY INSTRUCTIONS
Before you begin using your ML 830 Laser or the Recharger, read these
important warnings and safety instructions. For your own safety and that of your
equipment, take note of the following:
Warnings:
The Recharger must be grounded. Connection to a non-grounded
outlet is unsafe. The Warranty covering this unit is null and void the
Recharger is connected to a non-grounded electrical outlet.
Wear safety glasses to filter out 830nm infrared energy.
Do not aim the laser beam directly into the eye(s). The lens of the human
eye can focus the 830nm wavelength beam, resulting in retinal burn and / or
vision problems.
When the Laser System is unattended, all three batteries must be
removed and stored in the safety compartment in the base of the Recharger
Unit. This compartment must be locked and the key kept by the authorized
user.
Safety Instructions:
Disconnect the power plug ( by pulling on the plug, not the cord ) under the
following circumstances:
If the power cord or plug becomes frayed or otherwise damaged.
If anything is spilled into the equipment, & see page 3.
electrical
if
ML 830
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DANGER DANGER
LASER RADIATION
AVOID DIRECT EXPOSURE TOBEAM
LASER RADIATION
AVOID DIRECT EXPOSURE TOBEAM
WAVELENGTH: 830 nm,
MAX OUTPUT: 99mW
CLASS IIIb LASER PRODUCT
LASER
APERTURE
LASER
APERTURE
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If your equipment is exposed to rain or any other excessive moisture.
If your equipment is dropped or the Recharger case is damaged.
If you suspect that your Recharger needs repair or service.
Whenever the Recharger is not in use.
Whenever power surges are expected, such as during thunderstorms or
power outages.
4. SETTING UP THE RECHARGER
Plug in the Recharger.Connect the main power cord to the power inlet socket
on the rear of the Recharger (Figure 1). Connect the main plug to a grounded
electrical outlet. Be sure that the electrical outlet is grounded to the main
breaker box.
Switch the unit on at the power switch. The power display meter (Figure 2)
will illuminate and read "00".
Power Switch Power
Input Socket Fuse Ports
Key Lock Figure 1 Figure 2
Power
Display Meter Triple Diode Probe Sensor
Battery
Mounts
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5. TESTING THE POWER OUTPUT
Connect the rechargeable battery to the ML 830 Laser probe by carefully
threading the battery onto the threaded end of the laser probe. (Be careful not
to strip the threads.) Thread the battery until resistance is felt then tighten
one-half turn. Do not over tighten.
The LED meter on the Recharger measures the laser energy output of the ML
830 Laser. There is a probe sensor (Figure 3) on the Recharger located to
the right of the LED meter for the triple diode laser probe.
Place the head of the ML 830 Laser probe into the probe sensor port and
gently hold the probe steady during testing. When testing the laser probe, note
the 'notch' on the head of the laser probe and line up the 'notch' with the
register pin in the probe sensor port (Figure 4)
Figure 3
LED
Meter Display Triple Diode Probe Sensor
Battery
Mount
Recharger Front
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Activate the laser's annular or tactile (on-off) switch (Figure 5). [The switch is
located beneath the black vinyl area on the laser probe which surrounds the entire
probe.] By gently squeezing, the switch will be activated, turning the power on.
This also activates an audible acoustic "beep" at half-second interval which
continues for 33 seconds. (Note: At the conclusion of the 33-second cycle, there
is a short continuous tone.)
Note the LED meter reading. Output is measured in milliwatts (mW). The meter
should read 90mW(+/-10%).
Figure 4
Switch
Notch & Register Pin
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6. CHARGING THE BATTERIES
Carefully unscrew the battery from the laser probe unit (Figure 6),
Carefully thread the battery onto one of the battery mounts (Figure 7), but only
until finger tight.
Rechargeable
Battery
Figure 7
Figure 6
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Batteries should each be charged at least twelve (12) hours before initial use or after long 
periods of nonuse.
NOTE:

Note the Illuminated Indicator lights on the left of the battery mount
The "CHARGE"Indicator Illuminates when the battery is being charged.
If the battery is left attached to the battery mount, the battery will continue to be
charged at low current. 100% capacity will be reached after 10 hours of
charging.
NOTE:
If a fully charged battery is removed from the battery mount and then replaced, the
"CHARGE" light will illuminate for a short period of time. Likewise, switching OFF the
Recharger briefly, with the battery affixed, then switching the Recharger on again will
cause the "CHARGE" light to illuminate for a short time.
(Figure 8).
period of
Indicator lights
Figure 8
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7. OPERATINGTHE LASER
Warning: Do not aim the laser beam directly into the eye(s). The lens of the
eye can focus the 830nm wavelength beam, resulting in retinal burn and / or
vision problems. Wear the safety glasses provided with the unit during use.
Automatic laser activation cycle is 33 seconds. This safety activation
mechanism is built into the unit to ensure the highest level of safety for the end
user. During the 33-second cycle you will hear an acoustic "beep" at half-
second intervals.
One 33-second cycle administers approximately one joule of energy per diode
according to the following formula:
Energy(joule)=Mean Power(W) x Time (sec.)
Energy = 30mW x 33 sec. = 0.99 joule
Activate the black annular or tactile switch on the laser probe. (Figure 5). Once
the switch is pressed, the laser is activated one (1) 33-second cycle or until the
switch is lightly depressed again.
8. USE OF THE REMOTE INTERLOCK
MicroLight provides a remote interlock for use in those rare situations where the
operator wishes to terminate the emission of low-level laser energy when a door or
portal into the area of usage is opened. Call your Microlight dealer for assistance
on this module.
The remote interlock module, if used, requires unscrewing the battery from the laser
probe, screwing on the remote interlock onto the laser probe, and then replacing
the battery to the open end of the interlock.
Select a switch, or microswitch, that can be operated by the opening of the door
or other portal for which the interlock function is desired. The switch should be
electrically open when the portal is open and electrically closed when the portal
is closed.
Connect the switch across the two (2) conductors at the other end of the
interlock cable and mount the switch so as to be operated by the opening of the
portal as described above. The laser can then be operated when the portal is
closed and will be inoperable when the portal is open.
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9. PRINCIPLES OF OPERATION
The activating switch is located beneath the black vinyl area surrounding the entire
circumference of the laser probe. By gently squeezing, the switch will be activated,
turning the power on. This also activates an audible "beep" at half-second intervals
which continues for 33 seconds. At the conclusion of the 33-second cycle, there is a
short continuous tone and the cycle is deactivated.
It is important to check the power output of the laser on a periodic basis to ensure
that the laser is functioning properly and has not been damaged by handling.
Plugging in the Recharger does this. Connect the main power cord to the power inlet
socket on the rear of the Recharger (Figure 1). Connect the main plug to a grounded
electrical outlet. Be sure that the electrical outlet is grounded to the main breaker box.
(The plug should be removed from the outlet when the recharger is not in uses.)
Switch ON the unit at the power switch. The power display meter (Figure 2) will
illuminate and read "00".
Activate the laser switch. By gently squeezing, the switch will be activated, turning
the power on. This also activates an audible acoustic "beep" at half-second intervals
which continues for 33 seconds. Note the LED meter reading. Output is measured
in milliwatts(mW). The meter should read 90 mW (+ /- 10%). If the value is within
the limits the unit is ready for use.
The ML 830 Laser is programmed with an "automatic" laser activation
cycle of 33 seconds. Once the switch is depressed the laser automatically stays
on for 33 seconds or until the switch is lightly depressed again. No further
pressure is required to continue the cycle. Each cycle administers approximately
one joule of energy per diode according to the following formula:
Energy(joule) = Mean Power (W) x Time (sec.)
Energy = 30mW x 33 sec. = 0.99 joule
To begin a new cycle the switch must be depressed again. During treatment
and administration of each 33-second cycle, the laser should be held still to
allow full absorption of photons available to the target site. The triple diode
laser, due to its configuration should be kept on the same spot for a
completed cycle and rotated 40 degrees between each cycle. By rotating the laser,
the target area will be more thoroughly treated.
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The ML 830 laser probe generally will require a recharge of batteries after
about 50 - 100 cycles. The unit will continue to output the proper milliwatts of
power to the point of depletion; however, the 33-second cycle will be interrupted
should the battery power become too low. Depleted batteries should be recharged.
To recharge the batteries unscrew the battery from the laser probe and thread the
battery onto one of the battery mounts on the Recharger Unit. A "CHARGE"
indicator light will illuminate when the battery is being charged. Afull charge to
100% capacity requires about 10 hours of charging.
10. INDICATIONS FOR USE:
The ML 830 Laser is indicated for adjunctive use in the temporary
relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
11. ML 830 STUDY
In 1998, the a double blind study to determine the
efficacy of low level lasers in the treatment of Carpal Tunnel Syndrome. The
study protocol targeted approximately 135 patients diagnosed with carpal tunnel
syndrome with moderate to severe symptoms, with a mean Symptom Severity
Scale score of at least 2.0, with a score of at least 30 on a 100 point VAS pain
scale, who have failed conservative therapy for at least one month and who have
not had previous carpal tunnel release surgery. One-half of the study subjects
received treatment with an active the and one-half received treatment
with a placebo .
MicroLight
ML 830 was utilized in
ML 830 ,
ML 830
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The MicroLight ML 830 system utilizes three semiconductor laser diodes, each
diode emitting approximately 30 milliwatts continuous wave at an 30 nanometer
wavelength. It is an infrared gallium - aluminum - arsenide laser. The device
automatically turns off 33 seconds after activation and each operation of the laser
delivers approximately 1 joule of energy per diode. There are no user adjustments
or user serviceable features. Only recharging of batteries and periodic verification
of power output are to be performed the user.
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Patients were treated three times a week for five weeks. Follow up times were 1,
6, and 12 weeks after the last treatment, at which time information was recorded
on each patient. Once the study was completed, a statistical analysis was
performed on the active and placebo groups.
Treatment was considered successful if a patient showed a 30% or more reduction
in VAS pain score at the 12-week follow-up point. By this definition, the
laser successfully treated 55.8% of the patients in the active group,
compared to 40.0% success for patients in the placebo group. No adverse effects
from the ML 830 treatment were noted.
ML 830
IMPROVEMENT MicroLight Placebo
Percent of Patients
Any
30% or more
50% or more
75.6%
55.8%
45.3%
69.3%
40.0%
29.3%
12. CONTRAINDICATIONS:
Use of the ML 830 is contraindicated where analgesia may mask progressive
pathology, and should not be used where the practitioner would normally avoid
the use of any other analgesia in order to retain beneficial aspects of pain.
13.
The ML 830 is a Class IIIb laser that poses a significant potential for eye
damage if the laser is directed toward the unprotected eye. Protective glasses are
provided with the ML 830 Laser System and must be worn by patients and
operators.
Prior to each use, the ML 830 Laser probe should be checked for energy level
on the Recharger unit in accordance with the Operating Instructions. Remove the
protective glasses provided from the ML 830 carrying case. Place one pair on
the patient and one pair on the operator. Do not
DIRECTIONS FOR USE OF EYEGLASSES:
remove glasses until treatment
is completed.
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14. The laser probe should be placed directlyover the area to be treated with the
"notch" onthe laser head at the 12 o'clock position. Activatethe black switch
on the laser probe. All lasersare activated first by depressing the switch by
gentlysqueezing. Oncethe switch ispressed, the laser is activated for one (1)
33-cycle oruntil the switchis lightlydepressedagain. RefertotheTreatment
15. CAREAND MAINTENANCE:
Cleaning Laser Port: To clean the laser port, lightly moisten a lint-free cloth
with 70%solution ofrubbing alcohol. Gently dab laser port with themoistened
cloth untilclean.
Cleaning Laser Probe: Toclean thelaser probe,lightly moisten a lint-free cloth
with 70% solution of rubbing alcohol and gentlywipe the laser diode lenses to
remove any potential residueor film. Wipe the outersurface of the laser probe
with alint-free softcloth to remove any dust or film that may build up on the
outside ofthe laserprobe.
NOTE: DONOT APPLY LIQUID DIRECTLY ON THE LASER PORT,
LASER PROBEOR BATTERIES.
TREATMENT REGIMEN:
Regimen Protocol provided in the Appendix A of this manual.
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16. TECHNICAL INFORMATION:
DESCRIPTION
MODEL 830 LASER
Laser Diodes
GaAlAs
Regulatory Class
IIIb
Wavelength 830 nm
Norminal Power
3 x 30 mW continuous wave(cw)
Energy per Treatment Cycle 3 x 0.99 Joule
Treatment Cycle Duration 33 seconds
Beam Configuration
1 x 3 m m
2.1 cm diameter x 21.0cm long
Laser Weight
300 gm
Laser Energy Fully Charged Battery Maximum output: 99mW
DESCRIPTION
RECHARGER
110/220/240 volts AC
Power Consumption 9 W
Charging Current for Batteries
Stable Charge Current 60 mA
Fuses
10 mA
Voltage
Laser Dimensions
2 pcs.200 mA located in rear panel
Dimension(L x W x H)
Weight 308 x 220 x 80 mm 2.33 kg
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17. CALIBRATION:
YourML 830 laser probe was calibrated at the factory to a fixed output of
each laser
diode's level of radiation output. At least once a year, an authorized person should
examine and measure each of the three ML830 diode-testing sensors, using
a calibration standard laser probe (or some other certified and reliable measuring
device) to measure each censor and make any necessary calibration at that time.
Contact MicroLight for the name, address, and telephone number of such an
90 mW +/- 10%, a maximum of 99mW (33mW each diode). The probe testing
port in the Recharger was also calibrated at the factory to measure
authorized person.
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18. LIMITED WARRANTY- First Year
MicroLight Corporation warrants that your new ML 830 Laser System is free
from defects in materials and workmanship for a period of one (1) year from the
date of original purchase by your dealer.
If you discover a defect, MicroLight Corporation, at its option, will repair,
replace or refund your purchase price, provided you return the ML830 during the
first year warranty period. You are responsible for shipping, handling and
applicable taxes.
General
In the unlikely event your ML 830 Laser is returned for manufacturing defects,
please attach your name, address, telephone number and a copy of your Bill of
Sale. Return the product with transportation charges prepaid to our Customer
Service Office.
This warranty does not apply if the product has been damaged by accident, abuse,
misuse or misapplication, or if the product has been modified without written
permission from the Company,or if any serial number has been removed or
defaced.
MicroLight Corporation is not responsible for special, incidental or consequential
damages resulting from any breach of warranty, or under legal theory, including
but not limited to lost profits, downtime, goodwill, damage to or replacement of
equipment or property.
EXCEPT AS SPECIFICALLY SET FORTH ABOVE, THE COMPANY DISCLAIMS
ANY AND ALL SPECIFIC OR IMPLIED WARRANTIES, INCLUDING
WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE AND
WARRANTIES OF MERCHANTABILITY. THERE ARE NO WARRANTIES WHICH
EXTEND BEYOND THE DESCRIPTION SHOWN ABOVE.
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Do not open the laser diode housing of the
laser probe or the warranty is void.
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Appendix A
ML 830 Laser Treatment Protocol for CTS
Dose per treatment point: 9 joules (0.99 joule/laser diode x 3 diodes x 3 cycles)
Number of treatment points 4 points (wrist and palm area)
Treatment Intervals: 3 times / week
Treatment Session 5 weeks
Treatment Point Palmar. Position
# 1 across the thenar muscle
between the Radial
longitudinal crease and
the proximal thumb joint
# 2 Radial side of wrist at
the proximal wrist crease
across the carpal ligament
# 3 Middle of wrist at the
proximal wrist crease
across the carpal ligament
# 4 Ulnar side of wrist at the proximal
wrist crease across the carpal ligament
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The ML 830 Laser Probe should be applied as follows:
1. Place the Laser Probe to the area to be treated.
2. Activate the Laser beam by depressing the switch (beneath the black vinyl
area on the laser which surrounds the entire circumference of the laser
probe). The laser diodes are now activated and the switch may be released.
3. Laser energy is emitted for 33 seconds (one cycle), which is equivalent to
0.99 joules of energy per laser diode or 3 joules of accumulative energy.
4. The probe has an audible radiation signal in the form of an acoustic beep
during the activation cycle.
5. At the end of the 33-second cycle, the laser automatically switches off and
the beep is replaced by one continuous tone for 2 seconds.
6. During the 33-second cycle the laser should be held completely still and in
direct contact with the tissue. The same treatment point should be
maintained for three cycles, rotating the laser head 40 degrees after each
cycle to ensure full coverage of the target point.
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Laser Rotation - 40 Degrees
Front View of Laser Head
4040
4040