30W DIODE LASER SURGICAL SYSTEM
Product Manual Model:PD030
Thank you for using our product. Please read the manual carefully before operating, and keep this manual for future reference.
Table of contents Safety Guidelines ................................................................................................................. 1 Preface .................................................................................................................................2 1 Operation Principle ........................................................................................................... 3 1.1 Principle of diode laser surgical system ................................................................. 3 1.2 System description ................................................................................................. 3 1.3 Main cabinet ........................................................................................................... 3 2 Components...................................................................................................................... 4 3. Pre-startup Preparations.................................................................................................. 5 3.1 Unpacking and inspection ...................................................................................... 5 3.2 Checking power voltage ......................................................................................... 5 3.3 Connecting fuse and remote control ...................................................................... 5 3.4 Footswitch connection ............................................................................................ 5 3.5 Connecting power cord .......................................................................................... 5 3.6 Connecting fiber ..................................................................................................... 6 3.7 Connecting fiber pen .............................................................................................. 6 4 Operation Instruction ........................................................................................................ 7 4.1 Power on ................................................................................................................ 7 4.2 Parameter setting ................................................................................................... 8 4.3 Change status and emit ......................................................................................... 9 4.4 Actual power testing ............................................................................................... 9 5 Fiber Cutting ................................................................................................................... 12 6 Troubleshooting .............................................................................................................. 13 6.1 Power failure......................................................................................................... 13 6.2 The power works but no display........................................................................... 13 6.3 All works normally but not emission ..................................................................... 13 6.4 The energy of emission is low .............................................................................. 13 7 Protection ........................................................................................................................ 14 7.1 Overheat protection .............................................................................................. 14 8. Precautions .................................................................................................................... 14 9. Maintenance .................................................................................................................. 15 9.1 Cabinet cleaning ................................................................................................... 15 9.2 Power calibration .................................................................................................. 15 9.3 Fuse replacement ................................................................................................. 15 10 Accessories ................................................................................................................... 16 11 Technical Specification .................................................................................................. 16 12. Warranty & Service ...................................................................................................... 17 13 Structure........................................................................................................................ 18 14 Label Explanations ....................................................................................................... 19
Safety Guidelines The following information is provided for the correct utilization of diode laser surgical system. The information includes not only the accident protection regulations the products comply with, but also the effective precautions regarding proper use of the products. The safety regulations that PD030 series diode laser surgical system comply with can be grouped under 3 categories: 1. Electric safety regulation 2. Laser radiation safety regulation 3. Electromagnetic radiation safety regulation These safety regulations comply with the following standards established by IEC: IEC 60601-1 Medical electric equipment part 1: General requirements for safety IEC 60601-1-2 Medical electric equipment general requirement for safety collateral standard: electromagnetic compatibility requirement and test IEC 60601-1-4 Medical electric equipment general requirement for safety collateral standard: programmable medical electric equipment IEC 60602-2-22 Medical electric equipment part2, specific safety requirement on diagnosing and treatment laser equipment IEC 60825-1 Radiation safety for laser product, equipment classification requirement and user's guidance. Although PD030 series diode laser surgical systems are designed according to accident prevention regulations, only a proper and careful use can guarantee safety. For effective precautions, please refer to next part. The EMC performance of this system has been evaluated and complied with En 60601-1-2. Better use this system in an environment free of strong electromagnetic.
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Preface The PD030 diode laser surgical system is an intelligent laser treatment instrument. This product is featured by compact structure, beautiful appearance, reliable performance, convenient operation and perfect safety. The technical specifications of the product have achieved the advanced international standard. The diode laser has a high electro-optic conversion rate, producing little excess heat, so it does not require a large water cooling system like Nd:YAG or CO2 lasers, which makes it small in size and light in weight. Meanwhile, the diode laser does not contain high-voltage high-temperature components, providing longer service life, more stable power output, lower power consumption and more flexible application. The PD030 surgical diode laser has two operation modes – continuous mode and repeat pulse mode. Optical fibers with diameter of 200,400,600,800,1000um can be used as its delivery system. The diode laser has quick vaporization effect and good hemostatic effect. The laser beam has no electric stimulation to nerve and tissue, there will be little injury, little pain and few complications on the patient, and the hospitalization is short. The laser can match all kinds of endoscopies by using optical fiber of different diameters. The laser also has flexible application in open surgery. The instrument can be applied to general surgery, gynecology, otolaryngology, dermatology and cosmetology etc for different treatment such as cutting, vaporizing, cauterizing and solidifying. It can be used in ward and private clinics for its portability and compactness.
E.N.T Orthopaedics Urinary surgery
Staphyloplasty, Cavernous hemangiomas, rhinitis(chronic,hypertrophic, allergic, amygdalectomy(partial), subglottic stenosis PLDDďźŒmeniscectomyďźŒsynovectomy cauliflower excrescencebladder tumor resection, scrotum cysts, ankyl urethria, circumcision, sphincterotomy
Gynecology
cervical erosion, leukoplakia vulvae, condyloma acuminatum, Fallopi an Tube Recanalization, oophorocystectomy, salpingoplasty
General surgery
Adenomammectomy, hepatectomy, splenectomy, hemorrhoidectomy, a ppendectomy, lumpectomy, herniorrhaphy
Warning This instrument generates high voltages and laser radiation within the cabinet. Operators must pay much attention to safety during operation. Operation safety instructions are specified in this manual. Any improper use, adjustment or maintenance may cause laser radiation hazards or high-voltage electric shock. 2
1 Operation Principle 1.1 Principle of diode laser surgical system 980nm diode laser is absorbed by hemoglobin and water, which cause cutting, vaporization coagulation and hemostatic effect on organization. It is not a hot-burning but a optical burning, this priorities point makes the surrounding tissues have minimal damage and can maintain a longer period of hemostatic effect, making patients safer during surgical procedures.
1.2 System description The diode laser surgical system is the latest microprocessor-controlled instrument based on a diode laser module, providing up to 30W output power on body tissue. It is easy and safe to operate.
1.3 Main cabinet 1．Diode laser and aiming beam 2．Power supply 3．Main control panel (LCD touch screen) 4．Power meter 5．Foot switch 6．Fiber 1.3.1 Diode laser and aiming beam Diode laser emission from the diode module, when power on, the forward voltage excited electronic transition, laser emits from the module, and guided by fiber. The aiming beam is visible laser, which can display the location of laser output. 1.3.2 Power supply Power supply is made up of switching power supply, which can stimulate the diode module. 1.3.3 Main control panel The microprocessor-based main panel is used to control all functions. Time and power are displayed digitally, which is clear and accurate. 1.3.4 Power meter Power meter supplies power calibration and real-time power monitor, which ensures excellent accuracy and safety. 3
1.3.5 Foot switch A footswitch is used to control laser output. When the footswitch is pressed, the power is on and laser emits from the diode module. 1.3.6 Fiber The fiber is connected to the system by sma905, the system can identify fiber with diameter of 200um、400um、600um、800um. The fiber can be used in a fiber pen or with an endoscope.
2 Components
1 Fiber pen shelf 2 Emergency stop switch 3 LCD touch screen 4 Power meter socket 5 Key switch 6 SMA905 socket 7 Fiber socket cap
8 Remote Control socket 9 Footswitch socket 10 Power socket 11 Fuse holder
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3. Pre-startup Preparations 3.1 Unpacking and inspection After unpacking, please check to ensure that the instrument is not seriously damaged, circuit lines are well connected and accessories are available (see accessories list)
3.2 Checking power voltage Ensure that the power voltage complies with the requirement of the instrument. Socket is in working order.
3.3 Connecting fuse and remote control Screw the fuse and remote control on the proper socket of the unit.
3.4 Footswitch connection Plug the footswitch cable into the socket on the rear part of the instrument. Push in alignment of the notch until a tone is heard which means a successful lockup.
3.5 Connecting power cord Plug the two terminals of the power cable into the power input socket and the power socket. (Make sure the ground socket is in working order.)
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3.6 Connecting fiber 1) 2) 3) 4)
Choose a proper plastic shell and insert the fiber into the shell. Turn the two fixing screws alternatively to fix the fiber in the center of the shell. Take off the protective cap, clear the tip of SMA905 with absolute alcohol. Screw SMA905 into the socket carefully.
fixing screws
protective cap
Notice: You should use a genuine plastic shell of our company. SMA905 should be connected before power on. It is recommended to use a fiber with diameter of 400um or above, because thin fiber is likely to get burnt.
3.7 Connecting fiber pen Insert a well-cut fiber into the fiber pen and extend the fiber tip out of the pen for 4~6mm. Screw the bottom of fiber pen to fix the fiber.
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4 Operation Instruction 4.1 Power on a. Turn on the power switch at the backside. b. Insert the key into the key switch, turn clockwise to power on. The logo (as shown in figure 1) will be displayed for 3 seconds, then switches to user interface. If SMA905 is connected correctly, system will recognize the fiber diameter and display it in “Diam� area.
Figure 1
User Interface
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4.2 Parameter setting a. Power setting Press "Power", the "Key Parameter" area will be highlighted, press "△" "▽" to adjust power, then press "Enter" to confirm the setting.
Key Parameter Area
b. Emitting mode and detail parameters setting There are two alternative emitting modes: continuous pulse and repeat pulse. The default mode is continuous. The waveform schematic diagram is shown in “Time parameter” area. If you want to choose repeat pulse, press "Repeat Pulse" in “Mode” area, the waveform, idle time, duty time will be shown in “Time parameter” area. Press the parameter you want to adjust, adjust by press number buttons or "+" "-". Press "Enter" to confirm.
Mode area
Time parameter area
c. Output time setting There three ways of output: 1. Free output: The laser emits when footswitch is pressed, it is also called real-time output. 2. Pre-set pulse amount: Input the amount of pulses need to output. When the footswitch is pressed, the laser emits pulse of the amount you set. 3. Pre-set time: Estimate and then input the treatment time. When the footswitch is pressed, the laser emits for the time you set. Notice: Pre-set pulse and Pre-set time are designed for experienced users. We strongly recommend that new users use free output. Press the output mode you want and set the value (same as detail parameter setting), then press "Enter" to confirm.
Output area 8
4.3 Change status and emit After all parameters are set and confirmed, press "Ready" to switch to ready status, the parameters will be locked. Then press the footswitch, laser will emit as you set. If you want to change parameters, press "Stand by" to switch to stand-by status.
4.4 Actual power testing When power is set up, user can test the actual output power: 1. Set power to that you want to test (e.g. 5 watt), then insert the fiber pen into the power meter socket, the system would change to power testing interface.
2. Press OK to start testing.
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3. Please wait for several seconds, the reading of actual power output would be displayed. If the actual power is lower than the power you set, it means the fiber is not well-cut or bended too much or there’s a problem with the diode module.
4. If the indication shows “Testing failed”, please make sure fiber is well-placed in the fiber pen and the fiber is not broken.
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5. Please operate according to the indication until test is finished, then take out the fiber pen.
Caution: Do not take out the fiber pen while testing. The parameter areas are locked during the test.
4.5 Additional function Aiming Beam You can turn on/off the aiming beam by pressing “Aiming Beam�.
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5 Fiber Cutting Dirty, over-bend, or cut improperly can cause fiber get burned, then the fiber need to be re-cut. Steps of cutting fiber: 1. Insert SMA905 into the socket, then take out the fiber from the fiber pen. 2. Rotate the knob of stripper, make the arrow point to the fiber diameter, slide the slider to a proper length. 3. Insert the fiber into the hole, hold strippers tightly on both sides, pull it, remove two layers of skin, strip again if the skin is not totally stripped. 4. Open the fiber scissors and put fiber in, make the blade gently cut around the optical fiber, then cut it.
5. If the aiming beam displays a complete circle on the paper, it means the fiber is well- cut, otherwise repeat step 4. 6. Insert the fiber into fiber pen.
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6 Troubleshooting 6.1 Power failure A. Make sure the power socket is working and the power cord is well-connected. B. Check if the fuse is loose, screw it tightly. C. Check if the power switch on the backside is on.
6.2 The power works but no display A. Check if the key switch is on. B. Make sure the emergency stop button is up, if not, turn it clockwise. C. If the power switch is not open.
6.3 Not emission A. Make sure you have pressed “READY�. B. The interlock key is not connected. C. The footswitch is bad.
6.4 The energy of emission is low A. The fiber tip is not well-cut, re-cut it. B. SMA905 is polluted, clean it with absolute alcohol. C. The diode module is aging, need to be replaced.
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7 Protection 7.1 Overheat protection To prevent overheat, when the temperature is above 50℃, the system will stop emitting automatically. Please wait until the machine is cooled down.
8. Precautions 1. Never let the laser beam be directed to human eyes or healthy skin. 2. To prevent human eyes or skin from being hurt by the reflection of laser light, never allow the laser beam, be directed to any smooth reflective surface, such as stainless steel device surface, mirror surface, etc. 3. If 75% alcohol is used to clean or sterilize relevant part of the instrument, don't use the instrument till the alcohol vaporizes. Never operate the instrument in the presence of flammable anesthetics. 4. The laser beam generated by this instrument is hazardous to eyes in the area within 35m from the instrument (when someone is staring directly at the laser) operators must use safety eyewear when operating. 5. This instrument generates high voltages inside. No attempt should be made by non-professional to open the cabinet of the instrument to avoid electric shock risk. 6. If the instrument gives out abnormal smell or sound, stop operation at once. Cut off the power first before any inspection. 7. Keep the instrument in an environment with the temperature between 1C~50C and the relative humidity between 10%~80%. 8. To avoid improper use of the instrument, remove the key from the key switch and keep it properly when the instrument is not in use. The instrument generates high voltages within the power supply. Please refer to professional personnel for maintenance to avoid electric shock. 9. Operation room should be equipped with a dust or fume exhauster, because the dust arising during operations may be mixed with biological tissue particles. 14
9. Maintenance The instrument generates high voltages within power supply. Refer to professional personnel for maintenance to avoid electric shock.
9.1 Cabinet cleaning If there is dirt on the cabinet, wipe gently with moistened cotton cloth and some detergent or toothpaste. Don't use over-wet cloth in case the water leaks into the inner part of the instrument, causing short circuit and damage.
9.2 Power calibration The practical laser output power and the preset panel power must be calibrated each year with standard laser power meter within validity period by trained of professional personnel.
9.3 Fuse replacement Open the fuse holder with a screwdriver and remove the original fuse. Before replacement, check and ensure the new fuse is identical in type and specification to the original one to avoid damage arising from unfit fuses.
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10 Accessories
Fiber (400um) Fiber pen Power cord Footswitch Remote control Switch key Fiber stripper Fiber scissors Fuse (5A)
1 1 1 1 1 2 1 1 2
Notice: Accessories may change according to the actual situation.
11 Technical Specification
Working Modes
Continuous, Repeat pulse
Output Power
0～30W adjustable
Laser Type
Diode laser
Wavelength
980nm
Duty Time
0.001~9.999s
Idle Time
0.001~9.999s
Aiming Beam
635nm diode laser
Delivery System
200um，400um，600um，800um diameter fiber
Control System
Foot switch，LCD touch screen
Temperature
5～40℃
Relative Humidity
＜80%
Power Input
AC110V~240V，50~60Hz
Weight
10kg
Dimension
43×30×20cm
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12. Warranty & Service The instrument is a well designed, user friendly laser surgical system with high quality. It performs perfectly under normal use and maintenance. Within a year from the date of purchasing, any damage caused by manufacturing or components defects can enjoy free repairing service.
Such service is valid only if the instrument is properly used. Any damage cause by improper use of the instrument, such as using unfitted power supply and wrong accessories, operating in a manner other than specified in this operator’s manual, damages caused by transportation, accidents unauthorized installation or maintenance, etc, such free service will be invalid immediately. The free service does not include accessories transportation free and door-to-door service charge of professional personnel.
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13 Structure
1. 2. 3. 4. A. B. C.
MCU Power supply Power meter Diode laser module Power measurement Real-time power monitor Automatic fiber identification
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14 Label Explanations No.
Symbol
Definition
Warning and explanation label
1
Warning label – Hazard symbol
2
3
Emergency stop switch
4
Position “1” is power “ON” (power: connection to the mains) Position “0” is power “OFF”(power: disconnection from the mains)
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Attention, consult ACCOMPANYING DOCUMENTS
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Aperture label
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HIGH VOLTAGE Dangerous voltage
8
Protect earth
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