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Related Manuals for Mectronic Opton 8000
Summary of Contents for Mectronic Opton 8000
- Page 1 User Manual Opton BiPower Y2 Model...
- Page 2 Pictures Laser unit Control panel Main switch (key) Lateral movement locking lever Laser emission point Stand Trolley base Screen Laser power regulation X axis area adjustment Y axis area adjustment Verical keys: scan control Horizontal keys: start & stop commands, display interraction Emergency stop button...
- Page 3 Accessories 2 x 3 pole interlocks Power cable Start keys (1 x 3 pole interlock on CO COD. 80035 COD. 455 models) COD. 80038 Protective glasses Laser warning sign Patient button (only CO COD. 651 COD. LAMP models) COD. 80054 Protective glasses only with 650nm COD.
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Page 4: Table Of Contents
Index 1. Introduction ................ 6 1.1 What is the Opton BiPower Y2? ......... 6 1.2 What is the Opton BiPower Y2 for? ......6 1.3 Advantages ..............6 1.4 Who can use the Opton BiPower Y2? ......6 1.5 Indications .............. - Page 5 5.3 Patient safety ............20 5.4 Classification ............21 5.5 DNRO ............... 22 6. Maintenance ..............23 6.1 Ordinary maintenance..........23 6.2 Troubleshooting and periodical maintenance ... 23 7. Labels ................24 7.1 Generic Labeling ............24 7.2 Specific Labeling ............
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Page 6: Introduction
1. Introduction 1.1 What is the Opton The Opton BiPower Y2 is a scanning laser system designed for the treatment of muscular-skeletral pathologies. Mectronic Medicale’s scanning system BiPower Y2? allows the area to be treated to be defined, allowing a balanced distribution of laser energy in the zone in question, reducing the margin of error. -
Page 7: Indications
1.5 Indications Subacromial conflict Rotator cuff injury Arthrosis Calcification Epicondylitis Epitrocleitis Bunions Aftereffects of Fractures Tendinitis Carpal Tunnel Syndrome Rizarthritis Snap finger Dupuytren’s disease Popliteal cyst Spe syndrome Distortion of the Patella Patellar tendonitis Pubalgia Gonarthrosis Treatment following anterior cruciate ligament reconstruction surgery Goose leg bursitis Sprains Plantar fasciitis... -
Page 8: Contraindications
1.6 Contraindications As the laser source is in the near infra-red, there are two types of contraindication: - Eye damage - Heat damage to tissue exposed to treatment, with particular attention to continuous emission and the phototype of the patient. The first is avoided by the use of protective glasses, while the second can be negated by the skill of the operator, who must evaluate the correct thermal sensitivity of the patient and the phototype. -
Page 9: Quick Use Guide
2. Quick use guide Before using the Opton BiPower Y2, ensure it is securely positioned. Make sure the main key switch is in the OFF position (turned to the left). Make sure that the power cable is connected to the machine, and is plugged in. - Page 10 Make sure that all persons present wear certified protective glasses. Position the Opton BiPower Y2 so that it covers the area to be treated. Use the locking lever to adjust the position if oblique emission is required. Turn the main key switch, under the laser, from left to right.
- Page 11 After setting the required values, start the treatment by pressing the START button. This command starts the powered laser. *For models 8000 C, Bi-Power 980, Bi-Power 810 and Bi-Power 1064. The stop button must be available for use by the patient throughout the treatment.
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Page 12: Instructions
3. Instructions figure 1 3.1 Interface The control panel features the following: A) Display: operative parameters and meaasges are displayed B) Horizontal keyboard: start-stop commands and display interaction C) Emergency stop button D) Vertical keyboard: scan control E) Size knob: amplitude adjustment on x and y axes F) Power knob: laser power adjustment 3.1.1 Display The display gives information on power, time, and set parameters. -
Page 13: Keyboard
Display messages: - PUT LASER: press Laser button - AIMING ON, PUT START: Laser on, press Start button - POWER LASER ON: Power laser on - LASER CALIBRATION: calibration control - CALIBRATION OK - CALIBRATION FAULT - INTERLOCK OPEN - SCANNING FAILURE - SMALL AREA! DANGER!: Scanning area too small 3.1.2 Keyboard The horizontal keyboard allows the laser functions to be set:... -
Page 14: Power Knob
3.1.3 Power Knob The knob is used to adjust the laser power according to the label data figure 5 3.1.4 Size Knob The two knobs separately adjust the area of the scan area on two axes, X and Y. The display shows the percentage of the pre- selected area. -
Page 15: Method Of Use
3.2 Method of use By pressing the Laser button the guide light is activated. The display shows the message “AIMING ON, PUT LASER”. (fig.8) At this time the laser is not working, just allowing positioning of the laser in the area in question to be treated, and the area to be changed. figure 8 To change the area of the laser use the Size Knob. -
Page 16: Pathologies
The pathologic library is provided only with powers higher than 4W. 3.2.4 Calibration The Opton BiPower Y2 features a laser power check feature. The calibration system measures whether the power emitted is within the required limits (CEI EN 60601-2-22:1997-06). -
Page 17: Warning
4. Warning 4.1 Attention during use Electrostatic discharges outside of the machine (operator with electrosta- tically charged synthetic clothing or similar) can cause the Opton Bi- Power Y2 to reset. In this case repeat the start-up procedure. In the case of overload or current surge (during thunder storm, for example) the laser emission may stop. -
Page 18: Norms And Safety
ISO 10993-1:2009/AC:2010 5.2 Safety Opton BiPower Y2 is a class IV laser and as such features a safety inter- lock. Mectronic Medicale has introduced a further safety measure for the patient (ScanX model). Through a special button (patient button) con- nected to the machine it is possible to interrupt the treatment at any time. - Page 19 Protection With regard to heat damage caused to tissues exposed to radiation, given the power involved and the focusing systems used in Mectronic Medicale devices, there is a real danger of heat damage which cannot be removed without making the exposure values provided for by the protocols impossible.
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Page 20: Patient Safety
The button is connected to the connector on the bottom of the machine body, labelled ‘Patient Safety’. The button is used during operation of the Opton BiPower Y2. The patient can interrupt the treatment at any time. The button must be connected to... -
Page 21: Classification
- Device for continuous function. General description The Opton BiPower Y2 is constructed from a stainless steel frame cove- red by a painted PVC case. The structure features four wheels for ease of movement and can easily be dismantled into three parts by removing the screws (which fix the ‘tube’... -
Page 22: Dnro
The transport and storage of the device must be carried out at tempera- tures between –40 e +70 °C, with relative humidity between 10 and 100% (including condensation) and atmospheric pressure of between 500 and 1060 hPa. 5.5 DNRO Nominal Distance of Ocular Risk It is the parameter, expressed in meters, that indicates the security di- stance to haven’t ocular damage by the direct vision of laser. -
Page 23: Maintenance
6. Maintenance 6.1 Ordinary The Opton BiPower Y2 laser system does not require particular mainte- nance procedures; however it is recommended for use in areas which are maintenance free of dust and well ventilated. The power cable should be checked regularly for wear or damage. -
Page 24: Labels
7. Labels 7.1 Generic Labeling Sicurezza Interblocco Paziente Porta Laser opening label Opton Bipower OB00019 Laser classification label Opton Bipower Opton Bipower Y2 OBY200019 Opton Bipower Y2 Distance lock connector Sicurezza Interblocco Paziente Porta Opton Bipower N2 OBN200019 Opton Bipower... -
Page 25: Specific Labeling
7.2 Specific Labeling Opton Bipower OB00019 Opton Bipower Opton Bipower Y2 OBY200019 Opton Bipower Y2 Opton Bipower N2 OBN200019 Opton Bipower N2 Opton Bipower O2 OBO200019 Opton Bipower O2 Opton Bipower R1 OBR100019 Opton Bipower R1 Opton CO2 OC00019 Opton CO2... -
Page 26: Technical Data
8. Technical data Modelli Opton BiPower Y2 Caratteristiche Power Requirement (230V, 50Hz) 310 VA Operative Temperature Range (°C) 10÷35 Stocking Temperature (°C) -20÷60 Interlock Calibration Control Optical Timer Safety Stop Laser Power Regulation 4÷22 W Laser Class Pointing Light (650 nm) -
Page 27: Emc Tables
9. EMC Tables Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower... - Page 28 Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower...
- Page 29 Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower...
- Page 30 Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower Opton 8000 Bipower...
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