Ellman Surgitron FFPF EMC User manual

Surgitron

®

F. F. P. F. E M C

TM

Quality Record and Maintenance

Manual

Cat. No. EMCMM10

3

Surgitron

®

F. F.P. F. E M C

TM

CONTENTS

I. DECLARATION OF CONFORMITY 4

1.1 Declaration of Conformity

II. QUALITY RECORD 5

2.1 General

2.2 First Degree Inspection

2.3 Second Degree Inspection

2.4 Output Power Characteristic

2.5 Output Power Characteristic

III. MAINTENANCE & TROUBLE SHOOTING 9

3.1 Surgitron System Block Diagram

3.2 Basic Circuit Diagrams

3.3 Repair Kit

4

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 [phone] or 800-835-5355,
Fax [phone], or email [e-mail]

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.

5

II. QUALITY RECORD

ellman International, Inc.

3333 Royal Avenue, Oceanside, NY 11572 U.S.A

tel: [phone], fax: [phone]

2.1 GENERAL

a. Model:______________________________________

b. Serial Number:______________________________

c. Power Supply Voltage:_______________________

d. Thermo Transformer Type: MAGNET WOUND

2.2 FIRST DEGREE INSPECTION Inspector:___________________________ Date:________________

(Refer to the 500 ohm load output power curve with 20% tolerance.)
Test equipment: Tektronics DPO 4032, Tektronics Probe P5100, 500 ohm Non-Inductive Load, DMM.

1. Operating Modes Inspection (Waveform inspection) and Primary Output Inspection

a. CUT:__________(Check waveform with oscilloscope: Pure Filtered Wave)

Dial # 1 23456789Hi
Power

b. CUT COAG:________(Check waveform with oscilloscope: Fully Rectified)

Dial # 1 23456789Hi
Power

c. COAG:________(Check waveform with oscilloscope: Partially Rectified)

Dial # 1 23456789Hi
Power

d. FULGURATE:_____(Only an oscilloscope is to be used for this measurement: Spark-Gap)

Dial # 1 23456
Power

ROOM TEMP.: ____°F ROOM HUMIDITY: ____%