Surgitron ® F.F.P.F. EMCTM
Quality Record and Maintenance
Manual
Cat. No. EMCMM10
Surgitron ® F.F.P.F. EMCTM
CONTENTS
I. |
DECLARATION OF CONFORMITY |
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1.1 |
Declaration of Conformity |
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II. |
QUALITY RECORD |
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2.1 |
General |
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2.2 |
First Degree Inspection |
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2.3 |
Second Degree Inspection |
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2.4 |
Output Power Characteristic |
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2.5 |
Output Power Characteristic |
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III. |
MAINTENANCE & TROUBLE SHOOTING |
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3.1 |
Surgitron System Block Diagram |
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3.2 |
Basic Circuit Diagrams |
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3.3 |
Repair Kit |
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I. DECLARATION OF CONFORMITY
Application of Council Directive: Medical Device Directive (93/42/EEC)
Standards to Which Conformity is Declared:
1.Conforms to the immunity requirements of EN 60601-1-2
2.Conforms to the emissions requirements of EN 60601-1-2 and EN 60601-2-2
For technical support, telephone 516-594-3333 or 800-835-5355, Fax 516-569-0054, or email ellman@ellman.com
Congratulations on your purchase of Ellman International’s radiosurgical device, the Surgitron® F.F.P.F. EMC™.
ellman® International is the leader in the field of Radiosurgery®. Our innovations, 25+ U.S. Patents, and commitment to our proven record of safety and superior performance is documented in numerous clinical articles and textbooks in the specialties of otolaryngology, ophthalmology, gynecology, dermatology, family practice, plastic surgery, general surgery, podiatry, and neurosurgery.
Be assured that you are testing the safest, most reliable high-frequency radiosurgical instrument available.
The following technical and safety information is provided to assist you, the bio-medical engineer, in a thorough, trouble-free performance verification and safety inspection of the Surgitron® F.F.P.F. EMC™.
If you require additional information or have any questions or comments regarding this device, feel free to contact ellman® International.
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II. QUALITY RECORD
ellman International, Inc.
3333 Royal Avenue, Oceanside, NY 11572 U.S.A tel: (800) 835-5355, (516) 594-3333, fax: (516) 569-0054
2.1 |
GENERAL |
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a. Model:______________________________________ |
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b. Serial Number:______________________________ |
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c. Power Supply Voltage:_______________________ |
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d. Thermo Transformer Type: MAGNET WOUND |
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2.2 |
FIRST DEGREE INSPECTION Inspector:___________________________ |
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Date:________________ |
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(Refer to the 500 ohm load output power curve with 20% tolerance.) |
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Test equipment: Tektronics DPO 4032, Tektronics Probe P5100, 500 ohm Non-Inductive Load, DMM. |
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1. Operating Modes Inspection (Waveform inspection) and Primary Output Inspection |
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a. CUT:__________(Check waveform with oscilloscope: Pure Filtered Wave) |
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Dial # |
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Power |
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b. CUT COAG:________(Check waveform with oscilloscope: Fully Rectified) |
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Dial # |
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Hi |
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Power |
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c. COAG:________(Check waveform with oscilloscope: Partially Rectified) |
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Dial # |
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Hi |
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Power |
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d. FULGURATE:_____(Only an oscilloscope is to be used for this measurement: Spark-Gap) |
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Dial # |
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Power |
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ROOM TEMP.: ____°F |
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ROOM HUMIDITY: ____% |
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