G.3_S/W Function: Peripheral Vascular diagnosis een 08S 1. Gosling, R,, King, D. “ Processing Arterial Doppler Signals for Clinical Data” , Handbook of Clinical Ultrasound. New York: John Wiley, 1978:622-3, 632, 2. Johnson, K. W. “ Chapter 8: Peripheral Arterial Doppler Blood Flow Velocity Wave Form; Practical Noninvasive Vascular Diagnosis” , Yearbook Medical Publishers. Chicago 1978:133-142. 3. Nelson, T. R., Pretorius, D. H., “ The Doppler Signal: Where Does It Come From and What Does It Mean” , AJR 151: 439-447, September 1988, 4. Breslau P. Ultrasonic Duplex Scanning in the Evaluation of Carotid Artery Diesase” , Heerlen, Holland, 1981:29. 5. Taylor, K, Burns P, Wells P. “ Clinical applications of Doppler Ultrasound” , Raven Press, New York, 1988:111-118, 130-136. G.4_ S/W Functio: Urology - Baby Hip Joint 1. Jane C. Share, MD ; Rita Littlewood Teele, MD, “ Ultrasonography of the infant hip: A Practical approach” , Applied Radiology, June 1992 2. Boal DKB, Schwentker (sic) EP, “ Assesment of congenital hip dislocation with real-time ultrasound: A pitorial essay” , Clinical Imaging, 15:77-90, 1991 3. Boal DKB, Schwentker (sic) EP, “ Assesment of congenital hip dislocation with real-time ultrasound: A pitorial essay” , Radiology, 15:667-672, 1985 4. Novick G, Ghelman B, Schneider M, “ Sonography of the neonatal and infant hip” , American Journal of Radiology, 141:639-645, 1983 5. Harcke HT, Clarke NMP, Lee MS, etal, “ Examination of the infant hip with real-time ultrasonograhy” , Journal of Ultrasound Medicine 3:131-137, 1984 6. Harcke HT, Grissom LE, “ Performing dynamic sonography of infants hip” , American Journal of Radiology, 155:837-844, 1990 7. Ketler MS, Chawia HS, Welse AA, “ Real-time sonography of infant hip dislocation” , Radiographics, 6:447-456, 1983 Appendix G: References Gs14. 16. a 18. 19. 20. Ga Length/ Abdominal Circumference Ratio” , American Journal of Radiology 141: 979-984, November 1983. Hadlock, F., Deter, R., Harrist, R., Park, S. “ Sonographic Detection of Abdominal Fetal Growth Pattern” , Clinical Obsterics and Gynecology Vol. 27, No. 2: 342-351, June 1984. Hadlock, F., Deter, R,, Harrist, R,, Park, §. “ Estimational Fetal Age: Effect of Head Shape on Biparietal Diameter” , American Journal of Radiology 137: 63-85, July 1981. Campbell, S. “ Ultrasound Measurement of the Fetal Head to Abdomen Circumference Ratio in the Assesment of Growth Retardgration” , Journal of Obsterical and Gynecological, Vol. 84: 165-174, March 1977. Hohler, C., Quetal, T. “ Comparison of Fetal Femur Length and Bipatrietal Diameter in Late Pregnancy” , American Journal of Obsterics and Gynecology Vol. 141, No. 7; 759-762, December 1, 1984. Graf, R. “ Fundamentals of Sonographic Diagnosis of Infant Hip Dysplasia” , Journal of Pediatric Orthopedic Vol. 4, No. 6: 735-740, 1984. Morin, C., Harrist. R, Carpenter, R, Deter, R., Park, S., “ Sonographic Estimation of Fetal Weight” , Radiology 1985; 157; 673-677, December 1985. Brenner, W., Edelman, D., Hendrick, C., “ A Standard of Fetal Growth for the United States of America” , American Journal of Obsterics and Gynecology November 1, 1979. ‘$A-600 Operator's ManualG.2 S/W Function: OB/GYN diagnosis 1. Shepard, M,, Richards, V., Berkowitz, R,, Warsof,.S,, Hobbins, J.“ An Evaluation of Two Equations for Predicting Fetal Weight by Ultrasound” ‘American Journal of Obsterics and Gynecology, Vol. 142 No. 1, 47-54, January 1, 1982 2. Hadlock, F,, Harrist, R., Carpenter, R., Deter, R,, Park $. “ Sonographic Estimation of Fetal Weight” , Radiology 1984; 150: 535-540, 1984, Errata: 2/85, Equation for EFW by BPD and AC. 3, Merz, E.,, Goldhofer, W., Timor-Tritsch, E., “ Ultrasound in Gynecology and Obstetrics” Textbook and Atlas, Georg Thieme Verlag, 308-338, 1991 4. Hadlock, F., Harrist, R, Carpenter, R., Deter, R., Park S. “ Sonographic Estimation of Fetal Weight” , Radiology 1984; 150: 535-540, 1984, Errata: 2/85, Equation for EFW by BPD and AC. 5. Merz, E.,, Goldhofer, W., Timor-Tritsch, E., “ Ultrasound in Gynecology and Obstetrics” ‘Textbook and Atlas, Georg Thieme Verlag, 308-338, 1991 6. Hansmann M.,, Hackeloer BJ, Staudach A Springer-Verlag, Berlin, Heidelberg, New York, Tokyo 1985 7. Park, YongKyun. “ Sonographic standard mean values for each body part of Korean normal fetuses based on number of weeks of gestation” , Journal of Korean Association of Sonography, Vol. 14, No. 2, 1995 8 Hadlock, F., Deter, R, Harrist, R., Park, S. “ Fetal Femur Length as a Predictor of Menstrual Age: Sonographically Measured” , American Journal of Radiology 138, May 1982 9, Nelson, L. “ Comparison of Methods for Determining Crown-Rump Measurement by Real-Time Ultrasound” , Journal of Clinical Ultrasound 9: 67-70, February 1981. 10. Robinson, H. P., Fleming, J. E. “ A Critical Evaluation of Sonar “ Crown-Rump Length’ Measurements” , Journal of Obsterics and Gynecology 82: 702-710, September 1975. 11. Hadlock, F., Deter, R., Harrist, R.,, Park, S. “ Fetal Head Circumference: Relation to. Menstrual Age” , American Journal of Radiology 138: 649-653, April 1982 12. Hadlock, F., Deter, R., Harrist, R., Park, S.“ Fetal Abdominal Circumference asa Predictor of Menstrual Age” , American Journal of Radiology 139: 367-370, August 1982 Hadlock, F, Deter, R, Harrist, R, Park, S, Roecker, E. “A Date-Independent Predictor of Intrauterine Growth Retardation: Femur 1 @ Appendix G: References Gs13. 14, x & 16. 17. 18. 19. 20. 21. Cardiac Output in Man” , Circulation 67, No. 3, 593-597, 1983. Kosturakiso, Allen HD “ Noninvasive Quantification of Stenotic Semilunar Valve Areas by Doppler Echocardiography” , JACC 3: 1256-60, 1984, 1256-60. Labovitz, A. J,, Buckingham, T. A. “ The Effects of Sampling Site on the Two-Dimensional Echo Doppler Determination of Cardiac Output.” Am. Heart Journal 109:327, 1985 . Miller, M. J., Mckay, R. G. “ Right Arterial Pressure-Volume Relationships in Tricuspid Regurgitation.” Circulation 73, No. 4, 799-808, 1986 Otto, C. M,, Pearlman, A. S. “ Determination of the Stenotic Aortic Valve Area in Adults Using Doppler Echocardiography” , JACC, Vol. 7, No. 3, 509-517, 1986 Popp, R. L., Yock, P. G. “ Noninvasive Intracardiac Pressure Measurement Using Doppler Ultrasound.” JACC, Vol. 6, NO.4, 757-758, 1985 Stamm, R. B., Martin, R. P. “ Quantification of Pressure Grdadients Across Stenotic Valves by Doppler Ultrasound” , JACC, Vol. 2, No. 4, 707-718, 1983 Yeager, M., Yock, P. G. “ Comparison of Doppler-Derived Pressure Gradient to That Determined at Catheterization in Adults with Aortic Valve Stenosis: Implications for Management” , Am. J. Cardiology 57:644-648, 1986 Yock, P. G., Popp, R. L. “ Noninvasive Estimation of Ven‘ricular Pressures by Doppler Ultrasound in Patients with Triscuspid or Aortic Regurgitation” , Circulation at Il, Vo! 68, No. 4, 111-230, 1983 Zoghbiwa, Farmer, K. L. Accurate Noninvasive Quantification of Stenotic Aortic Valve Area by Doppler Echocardiography” , Circulation, Vol. 73, No. 3, 454, 1986 . Hatle, Liv, Angelsen, Bjorn “ Doppler Ultrasound in Cardiology” , 24 Ed. Philadelphia: Lea & Febieger, 1985 ‘SA-600 Operator's ManualAppendix G References S/W Function: Cardiac diagnos’ 1. Clark, R. D. “ Case Studies in Echocardiogrphy” , Philadelphia: W. B. Saunders Company, 1977. 2, Feigenbaum, H.“ Echocardiogrphy” , Philadelphia: Lea and Febiger 1976. 3. Goldberg, S. J., Allen, H. D,, Sahn, D. J., “ Pediatric and Adolescent Echocardiogrphy “ , Chicago, Yearbook Medical Publishers, Inc., 1975. 4. Grossman, W. (ed) Cardiac Catheterization and Angiography” , Philadelphia: Lea and Febiger 1980 5, Hagen-Ansert, §. L. Textbook of Diagnostic Ultrasonography” , St. Louis: The C. V. Mosby Company, 1978. 6. Pai, A.L, Cahill, N.S., DuBroft, R.J,, Fozzard, H. A., Brooks, H. L.,“ Digital Computer Anaysis of M-scan Echocardiograms” , J. Clinical Ultrasound 4:3, 1976. 7. Salcedo, E. E.," Atlas of Echocardiogrphy” , Philadelphia: W. B. Saunders Company, 1978. 8. Weyman, A. E., “ Cross-Sectional Echocardiogrphy” , Philadelphia: Lea and Febiger 1982:293, 296. 9. Currie, P. J, Hagler, D. J., “Instantaneous Pressure Grdient: A Simultaneous Doppler and Dual Catheter Correltive Study” , JACC 7:8006, 1986 10. Handshoe, R, Handshoe, S, “ Value and Limitations of Doppler Measurement in the Estimation of Left-Ventricular-End-Diastolic-Pressure in Patients with Aortic Regurgitation” , (abstr.) Circulation Part Il, Vol. 7, No. 41-117, 1984 Hirschfeld, $, Meyer, R. “ Measurement of Right and Left Ventricular systolic Time Intervals by Echocardiography” , Circulation, Vol. 51, February 1975. 42, Huntsman L. L,, Stewart, D. K,, “ Noninvasive Doppler Determination of i.G. References medison i ———E.2_ How to Obtain Service for the SA-600 &@ If there is a problem with your system or if it is defective, do the following: 1. Contact Medison Customer Service Department as described below. Have the model, serial number, and date of purchase ready, plus a description of any problem. 2. Medison Customer Service Department personnel will troubleshoot problems over the telephone, and if unable to resolve the problem, they will advise you how to ship your system for repair, and arrange for a loaner system. 3. Medison Customer Service Department will make available on request circuit diagrams, component part list, descriptions, calibration instructions or _ other information which will assist your appropriately qualified technical personnel to repair those parts of equipment which are designated by Medison Customer spartment <3 repai @ How to Contact Medison Customer Service Department Medison Venture tower, 997-10, Daechi-dong, Kangnam-ku, Seoul, 135-280, Korea Telephone = 82-2-2194-1234 Fax EC Representative SonoAce Deutschland GmbH Elbestrasse 10, 45768, Marl, Germany Telephone —_: 49-2365-915410 Fax :49-2365-915411 E44 ‘SA-600 Operator's Manualorientation marker. Apply acoustic coupling gel to the patient Begin scanning the patient and maneuver the probe so that the puncture target falls in the biopsy guide line. Use a straight, new needle for each procedure. The biopsy guide line is only intended to provide an indication of the expected path of the needle. The |actual position must be verified by identifying the echoes from needle. If| the needle is not following the expected path, discontinue the procedure land contact Medison Customer Service Department. Perform the puncture by sliding the needle through the needle guide in the biopsy guide. To keep the needle securely in the needle guide, press down on the top of the Diopsy adapter with your index finger. To move the probe away, After the needle is removed from the patient, Joosen the thumbnut and remove the biopsy guide from the probe. User Maintenance: ‘Maintenance of the biopsy guide consists of cleaning and sterilization. Prior to each use, examine the biopsy guide for damage. Cleaning and disinfecting biopsy guide: L After use, remove the biopsy guide from the probe. ‘Use a small brush and water to remove any trapped tissue or other foreign ‘matter from the biopsy guide. All needle guides and/or holder require high-level disinfecting methods after each use by using Cidex Plus™, following the manufacturer’s instructions. The target sterility assurance level that should be reached following the recommended disinfecting and sterilization procedures is 10 and 10* for a high level of disinfecting. Appendix E: Specifications and Service E43Attaching the Biopsy Guide: 1. Install the sterile sheath. 2. Prepare the specific biopsy guide according to the probe, as follows ; (1) Linear Biopsy Guides are 4 types for 3.5MHz/85mm and 5.0MHz/65mm and 7.5MHz/40mm and 7.5MHz/60mm. Nese Gude =e 7 2) Convex Biopsy Guides are 2 types for Convex 3.5MHz and 5.0MHz. (3) 6.5/13 Endocavity probe Biopsy Guide ae 3. To seat “Linear or Convex probe Biopsy Guide” on probe ; (1) Putit into the projected part at one side of probe case and delving hole at Biopsy Adapter by matching (2) Place it on the probe and tighten up with thumbnut until firm. Do not pinch or cut the sterile sheath. (3) Put the Needle Guide into the slot of Biopsy Adapter. 4. To seat “6.5/13 Endocavity probe Biopsy Guide” on probe; (1) Attach the Locking to Needle Guide. (2) Put Needle Guide into the slot of Biopsy Adapter (8) Tighten Locking until firm to make complete Biopsy Adapter Kit (4) Place this kit on the probe and tighten up with thumbnut until firm. Do not pinch or cut the sterile sheath. Biopsy PROCEDURE: 1. Set SA-600 system controls for the biopsy procedure. 2. Orient the probe to match image presentation. Use the 2D scan plane E42 ‘SA-600 Operator's ManualThe needle used for this alignment procedure must not be used for the biopsy procedure. Always use a new, sterile needle for each biopsy procedure. To perform the alignment procedure: ‘Attach the biopsy guide. Set the system depth for the procedure to be performed Select the menu, BIOPSY Immerse the probe into the water bath, and insert the needle in the biopsy guide. Confirm that the needle is visible between the biopsy needle-path guidelines. Ifo, then the biopsy guide is properly aligned. 6. If the needle enters the image from the wrong side of the image display, check the orientation of the probe. Reno Ca Installing the sterile sheath: The probe can only be cleaned or disinfected, it cannot be sterilized. The| sheath provides the only sterile barrier required for the surgical of| puncture procedures. Maintain the sterility of the sheath. The sheath is| [disposable and must not be used more than once. If the sheath is cut or contaminated, the probe must be wiped clean and a new sterile sheath installed. The sheath may contain natural rubber and talc, which may cause allergic| reactions. For more information, see the FDA’s March 29,1991, Medical [Alert on latex products. Follow sterile techniques when installing the sheath. Two people may be required to perform the procedure: one-person, wearing sterile gloves, holds the sheath; without sterile gloves, holds the probe. Cover the probe with sterile sheath as follows: 4. Using aseptic techniques, hold the nose end of the sheath and turn the sheath inside out. Place a quantity of acoustic coupling gel inside the nose section of the sheath. 2. Insert the probe into the sheath nose section. 3. Hold the probe firmly while covering the rest of the probe and a portion of the cable. ‘Wrap the secure the probe to the cable. Check for air bubbles between the acoustic window of the probe and the sheath. All bubbles must be moves inside. The probe is now ready for use. oe Appendix E: Specifications and Service EatE14 Biopsy Guides Biopsy guides with SA-600 snap over the condom, presenting a smooth, stable surface for scanning and biopsy. A biopsy guide directs the biopsy needle into the path of the ultrasound scan. Taking a Biopsy: Ultrasound-guided biopsy may be indicated for a patient. Loading, cocking and firing the biopsy-needle gun varies with each manufacturer. “the operating instructions from the manufacturer usually include the following information, Suggestions for successful biopsies distance of needle motion size of the specimen collected During a biopsy a guide appears on the monitor. The angle of the biopsy guideline varies ‘with each transducer. The indicated guideline may be different from the actual position. The accuracy is guaranteed as + 2mm. ‘The biopsy guide should only be used after proper training and after aligning the guide according to the instructions in this manual. A Siainless-steel Fixed-Angle Biopsy Guide attaches to Medison's probes, enabling real-time ultrasound visualization and guidance during procedures such as amniocentesis, cyst aspiration, and tissue biopsy. When attached to the Medison’s probes, the biopsy guide directs their path in the scanning sector at Predetermined fixed angle, Ore the instrument can be removed from the guide and the probe with thumbnut. Do not attempt to use the biopsy guide until you have read the instructions, iehen the biopsy display is active, needle-path guide lines are displayed on the left side of the screen during normal left/right image presentation and on the right side when the image presentation is reversed right/left. Alignment: The following items are needed for the alignment procedure: (1) Biopsy guide (2) New, straight, 17-gauge biopsy-needle (3) Beaker of water (or water bath) E10 ‘SA-600 Operator's ManualE.1.3 Monitor Specifications GENERAL This is a 7 inch monochrome monitor for medical equipment installations. RESOLUTION @ Number of scan lines: 525 Lines / 625 Lines @ Field frequency: 60 Hz / 50.4 Hz INPUT SIGNAL @ Inputsignal _- Analog Composite Video Signal - Video Signal: 1.0 Vp-p (Positive) - Sync Signal: 0.3 Vp-p (Negative) © Input Impedance: 75 OHM @ Connector: BNC Connector POWER REQUIREMENT © AC operated: 25V @ Power Consumption: 23 W LINEARITY: 5 % or Less GEOMETRIC DISTORTION: Less than 1 mm AMBIENT CONDITION @ Storage - Temperature: -400C to 70°C - Humidity: 10% to. 90% @ Operation - Temperature: 10 °C to. 40°C - Humidity: 30% to 75% ‘Appendix E: Specifications and Service Es