Use the ML830 Smart laser System only as directed.

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1 I. INTRODUCTION This manual provides operators with step-by-step instructions for use, precautions, warnings, care. and maintenance procedures. Please read this manual thoroughly and familiarize yourself with controls before operating the ML830' Smart Laser System. The ML830' Smart Laser System consists of the following components ML830 Triple Laser Diode Probe ML830 Single Laser Diode Probe ML8305 Smart Laser Control Console Smart Wall Charger (UI. listed) Operating Guide and Instructions for Use Carrying Case Protective Eyeglasses (1 pair included) Hands-free holder with Velcro strap Warning Sign 2. 'WARNINGS AND PRECAUTIONS Please read these important warnings and precautions before you begin using your ML830 Smart Laser System. For your safety and that of your staff and equipment, you should always heed the following: When the Laser Probe is not in use, it must be stored in a secured location away from unauthorized users. Keep away from children. Do not use the ML830 Smart Laser System if any of the components become damaged. If the ML830' Smart Laser System is dropped or comes in contact with water or other fluids, do not use until the device is properly examined by a qualified technician. Use the ML830 Smart laser System only as directed. Precautions: Under the FDA classification system, the ML830 Smart Laser is a Class IIIB laser device. The following precautions should be followed: Wear safety eyeglasses appropriate for 830 nanometer (nrn) wavelength to filter out any infrared laser energy. Do not aim the laser beam directly into the eye(s). The lens of the human or animal eye can focus the 830 nm wavelength beam. resulting in retinal burn, partial vision impairment or blindness. Treatment effectiveness depends on correct use.

3. DEVICE DESCRIPTION The ML830. Smart Laser (See Figure 1) is a hand-held. non-invasive, non-heating low level energy infrared laser, therapeutic medical device.

2 3. DEVICE DESCRIPTION The ML830. Smart Laser (See Figure 1) is a hand-held. non-invasive, non-heating low level energy infrared laser, therapeutic medical device. The ML8305 Smart Laser delivers treatment by the Triple Probe through three 30-mW gallium-aluminum-arsenide (GaAlAs) laser diodes operating at 830 nm wavelength or optionally by the Single Probe through one 90-mW gallium-aluminutn-arsenide (GaAIAs) laser diode operating at 830 nm wavelength. Figure 1. ML8305 Smart Laser System

3 Features of the Console 4,0.0 CYCLES : TIME : 188 Sec Beeper OneCiff e Console On,Off MIIME

0 Console On/Off - Hold down this button for 2 seconds to turn on the power and the unit will be in standby mode. Or when the unit N on, hold down this button for 2 seconds to tum the unit off.

4 0 Console On/Off - Hold down this button for 2 seconds to turn on the power and the unit will be in standby mode. Or when the unit N on, hold down this button for 2 seconds to tum the unit off. (Note: the unit will turn itself off after being idle for 2 minutes.) 0 Cycles - While the unit is in standby mode, pressing this button will allow the user to increase the number of treatment cycles to run consecutively. The default number of cycles is set to 1 (equivalent of 33 seconds). Each time this button is pressed the number of cycles will be increased by 1 (33 sec). The number of cycles can be increased up to 18 (equivalent of 594 seconds or about 10 minutes) before resuming to 1. ()Probe On/Off - While unit is in standby mode pressing this button once will activate the laser treatment. Pressing once more will pause the laser treatment. Pressing again will resume the laser treatment. This can be repeated as many times as necessary. ()Beeper On/Off - By default the unit has an audible beeping sound throughout the entire period of treatment cycles (with a brief pause between each cycle) as an auditory alert. However, the user has the option to stop the beeping by pressing this button once. Press again to resume beeping. CI Probe Jack #1 - Connect probe to the console by inserting the probe's DC plug here. Either probe will work. 0 DC Jack for Charger - Connect charger to recharge the battery. 0 Probe Jack #2 - Connect probe to the console by inserting the probe's DC plug here. Either probe will work. (13 Charging Status - When the charger is connected; the word -CHARGING" is displayed next to the blinking battery symbol. Once the battery is hilly charged. the word "FULL" is displayed, the battery symbol will stop blinking. Note: Using the laser while charging is not recommended. Battery Status - When the unit is turned on this symbol is illuminated to provide status of the battery - 3 bars being fully charged and 1 bar being almost completely discharged. When the battery is charging this symbol flashes. (11) Cycles - Indicates the number of cycles selected in standby mode or the number of cycles remaining in operating mode. 0 Time - Indicates the number of seconds selected in standby mode or number of seconds remaining in operating mode. 0 Activation Alert Symbol - Once the laser is activated, this symbol will flash until treatment is paused or completed, Features of Triple Probe:

5 03 x 30 MW 830 nm diodes - Warning: Do not look directly into the diodes while activated. 0 Red LED - Use the red light as guide to the treatment spot. DC Plug - Plug this into either Probe Jack #1 or Probe Jack #2 to use the Triple Probe. ()Handle - Hold the probe by the handle to perform treatment. ostraln Relief- DO NOT pull the power cord to pick up the probe. Always pick up the probe by the handle. ()Visual Alert -This area has a flashing red light indicator when the laser is activated. 7Q Vent - Do not block the vent. Features of Battery Charger 0 Unpolarized Prong The NEMA 1-15 Type A prongs are compatible with wall outlets in North America. Using the ML830 Smart Laser in other parts of the world might require a travel adapter (not provided) to connect the charger to a suitable outlet. 0 Smart Charger The battery charger can be used with electrical outlets of 120VAC-240VAC and 50 Hz-60 Hz. The charger will automatically switch to trickle charge mode when the battery is fully charged. IMPORTANT: Only use the charger provided. Using any other charger might damage the unit and void your warranty. 0 Strain Relief DO NOT pull the power cord to remove the charger from the wall outlet. Always hold the charger body to remove it from the wall outlet. 0 DC plug Connect the DC plug to the DC jack on the top of the console to recharge the battery. ML830 SMART Laser System Technical Information: Triple Probe Single Probe Laser Diodes GaAlAs (3). Visible Red LED!) GaAlAs 11) Wavelength 830 em NIR nm visible red light-emitting LED Laser Output 30 mwx 3 = 90 mw 90 mw Laser Energy Delivered I Joule per laser diode x 3 laser diodes = 3 Joules per treatment cycle 3 Joules per treatment

6 cycle Beam Configuration Elliptical (1mm x 3 mm) x 3 Elliptical (1mm x 3 mm) Input Voltage / Frequency for Battery Charger 100 / 240 volts AC 47/63 Hz-0.5 A I Output Voltage of Battery Charger 5 Volts DC, maximum I Output Watts/Amps of Battery Charger 15 Watts Amps. Weight grams grams Dimensions 8.75 inches long and 2.8 inches wide and 1 inch high (22 cm long s 7 cm wide x 2.5 cm high) 7 inches long and 0.8 inches wide and 1 inches high (18cm long x 2cm wide x 2.5 cm high) Functional Components The ML830 Smart User triple probe contains three GaAlAs continuous wave diodes operating in the near infrared at a wavelength of 830 nm with a power output measured at 30 mw for each diode with a non-collimating beam with dimensions of approximately 1 by 3 millimeters at the lens. The ML830. Smart Laser single probe contains one GaAlAs continuous wave diode operating in the near infrared at a wavelength of 830 em with a power output measured at 90 mw with a noncollimating beam with dimensions of approximately 1 by 3 millimeters at the lens. The visible frequency red LED in the triple probe is a 5 millimeter super luminous milliwatt LED used as an -on" and "off" indicator and guide beam. This LED is located on the diode PCB. The laser PCB also contains the laser diodes and power connection to the diode PCB. The diode PCB contain, the circuitry that regulates the power to the laser diodes. The activation button on the console provides a means to interrupt an operational cycle at any time, as will removing the probe cord from the top of the console. Principles of Operation: The ML830 Smart Laser is activated by pressing the button on the console labeled "Probe On/Off'. At the conclusion of all of the 33-second treatment cycles selected. the device automatically deactivates. The ML8300 Smart Laser is automatically programmed for one 33 seconds cycle unless it is interrupted by either another press on the Probe On/Off button, or if the probe cord is removed from the probe jack on top of the console. Each 33-second treatment cycle is considered one treatment dose and administers approximately three Joules of energy to the designated treatment area. To resume an interrupted series of cycles or begin a new series of cycles, the Probe On/Off button must be pressed once again. The laser should be held steady to allow the light to be fully absorbed in the target area during the administration of treatment cycles. The triple diode laser, due to its configuration, should be maintained on the same area for a complete dose of a 33-second cycle and rotated 40 degrees clockwise between each cycle. By rotating the device in this manner. the target area receives the selected number of 33-second treatment cycles evenly. 4. OPERATING INSTRUCTIONS The NIL8300 Smart Laser is designed for simple operation. With proper care the ML83010 Smart Laser unit will provide many hours of safe use. Prior to using the ML8300 Smart Laser, place a pair of laser protective eyeglasses on the operator and any other person involved in the treatment process. Protective eyeglasses should not be removed until the treatment is completed and laser off.

7 Follow these steps to prepare and operate the ML83010 Smart Laser: Remove the laser probes and console from the carrying case and inspect the laser for any damage to the main body or housing. Ensure all diode lenses arc clean and clear. Connect the probe of your choice to the console and press the Console On/Off button on the console to turn on the unit. Press the cycle button on the console to select the number of cycles desired to run consecutively. Grasp the triple probe handle as if it were a paddle or the single probe as if it were a pencil, while placing your free hand on the activation button on the console when you are ready to commence treatment. When using the triple probe. place the laser probe above the skin surface so that the red LED illuminates the middle of the treatment area and then lower the probe with the face of the probe against the skin. When using the single probe. place the laser probe against the skin surface no that the tip of the probe is directly on the treatment spot and hold the tip of the probe against the skin. Start treatment by pressing the Probe On/Off button on the console. The selected number of treatment cycles will begin. A visible red glow at the hack of the laser device (away from the treating end) flashes continuously at intervals for the duration of the selected 33-second treatment cycles. In the meantime an audible "beep** will be heard throughout the treatment cycles unless the operator choses to mute the beeping. If the selected series of cycles is paused or completed, the activation button must be pressed again in order to resume the interrupted series of cycles or to begin a new series of cycles. 5. CARE AND MAINTENANCE OF THE ML830. SMART LASER Cleaning the ML830. Smart Laser Probe: To clean the laser probe, lightly moisten a lint-bee cloth with 70% solution of rubbing alcohol and gently wipe the laser diode lenses to remove any potential residue or film. Wipe the outer surface of the laser probe with a lint-free soft cloth to remove any dust or film that may build up on the outside of the probe. Protect the ML830. Smart Laser from mechanical abuse or shock. heat or water. The ML830e Smart Laser is a precision medical device. With proper care your ML830. SMART Laser should work for many years without problems.

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