FTM-029.pdf - Fort Monmouth Economic Revitalization Authority

1. Keywords HEALTH HAZARD RADIATION PROTECTION 1607 X-RAY 2. Start Date: FY 95 Quarter 1 End Date: FY 95 Quarter 1 3. HQ Division: 83 - RADIATION PROTECTION DIVISION 4. Phase: 5. Program NO: 28 6. Survey Type: RS - INDUSTRIAL RADIATION SURVEY 7. INSTALLATION OR SOURCE OF INFORMATION (CITY & STATE OR COUNTY ARE ESSENTIAL) MC - US ARMY MEDICAL COMMAND 8. Authors: 9. ARLOC/Activity: 34054 002 - USA HEALTH CLINIC Location: BAYONNE MIL OC TM State: NJ 9. ARLOC/Activity: 34558 003 - US ARMY MEDDAC Location: MONMOUTH FORT State: NJ 9. ARLOC/Activity: 34558 012 - DENTAL CLINIC Location: FORT MONMOUTH State: NJ 9. ARLOC/Activity: 34693 004 - US ARMY HLTH CLINIC/DENTAL CLINIC Location: PICATINNY ARSENAL State: NJ 9. ARLOC/Activity: 36352 002 - USA DISPNSRY&DENT CL Location: FT HAMILTON State: NY 10. Project Control Number: 83-2490-95 11. Title: RADIATION PROTECTION SURVEY 12. DSA: 61

=

U.S. Army Center for Health Promotionand Preventive Medicine

(Provisional)

FUiDIATION PROTECTION SURVEY NO. 28-83-2490-95U.S. ARMY MEDICAL DEPARTMENT ACTIVITY/DENTAL ACTIVITY

FORT MONMOUTH, NEW JERSEYU.S. ARMY HEALTH/DENTAL CLINICS

FORT HAMILTON, NEW YORKU.S. ARMY HEALTH CLINIC

MILITARY OCEAN TERMINAL BAYONNE, NEWU.S. ARMY DENTAL CLINIC

PICATINNY ARSENAL, NEW JERSEY25 OCTOBER-3 NOVEMBER 1994

JERSEY

Distribution limited to U.S. Government agencies only;protection of privileged information evaluating anothercommand; Mar 95. Requests for this document must bereferred to Commander, U.S. Army Medical Command, ATTN:MCHO–CL-W, Fort Sam Houston, TX 78234-6000.

DESTRUCTION NOTICE - Destroy by any method that willprevent disclosure of contents or reconstruction of the document

/)+

‘y.- G’..”

,)DEPARTMENT OF THE ARMY

U.S. ARMY CENTER FOR HEALTH PROMOTION AND PREVENTIVE MEDICINE [PROVISIONAL)ABERDEEN PROVING GROUND, MARYLAND 21010-5422

RCPLY TOATTENTION O?

MCHB-DS-MH (40) 20 MAR 1995

MEMORANDUM FOR Commander, U.S. Army Medical Command, ATTN:MCHO-CL-W, Fort Sam Houston, TX 78234-6000

SUBJECT : Radiation Protection Survey No. 28–83–2490–95, U.S.Army Medical Department Activity/Dental Activity, Fort Monmouth,New Jersey, 25 October - 3 November 1994

Copies of subject report are enclosed. Findings and specificrecommendations were discussed at the exit briefings conducted26 October 1994 to assist in effecting timely correction ofdeficiencies noted.

FOR THE COMMANDER:

fiJ2.L*y--.,. ( a4a.JEncl L BERT MATTHEWS

MAJ, MSManager, Medical Health

Physics Program

CF (w/encl):CDR, MEDCOM, ATTN: MCDSCDR, USAMMA, ATTN: SGMMA-MPCDR, MEDDAC, FT MONMOUTH, ATTN: PVNTMED SVC (2 CY)CDR, DENTAC, FT MONMOUTH (2 CY)CDR, WRAMC, ATTN: HSHL-H-HP

----

0..”#$$7T!i; DEPARTMENT OF THE ARMY.’7 -

q

U.S. ARMY CENTER FOR HEALTH PROMOTION AND PREVENTIVE MEDICINE (PROVISIONAL). ABERDEEN PROVING GROUND, MARYLAND 21010-5422

REPLY TOAT TCMTIOM OF

MCHB-DS-MH

EXECUTIVE SUMMARYRADIATION PROTECTION SURVEY NO. 28-83-2490-95

U.S. ARMY MEDICAL DEPARTMENT ACTIVITY/DENTAL ACTIVITYFORT MONMOUTH, NEW JERSEY

U.S. ARMY HEALTH/DENTAL CLINICSFORT HAMILTON, NEW YORKU.S. ARMY HEALTH CLINIC

MILITARY OCEAN TERMINAL BAYONNE, NEW JERSEYU.S. ARMY DENTAL CLINIC


1. PURPOSE. This Radiation Protection Survey was performed toassist you in your efforts to use sources of ionizing radiationsafely and in accordance with in accordance with currentregulatory requirements at the U.S. Army Medical DepartmentActivity/U.S. Army Dental Activity (MEDDAC/DENTAC), FortMonmouth; U.S. Army Health Clinic/U.S. Army Dental Clinic, FortHamilton; U.S. Army Health Clinic, Military Ocean TerminalBayonne; and U.S. Army Dental Clinic, Picatinny Arsenal.

2. CONCLUSIONS. There are currently no health hazards resultingfrom the use of the radiation sources at the MEDDAC/DENTAC, FortMonmouth; U.S. Army Health Clinic/U.S. Army Dental Clinic, FortHamilton; U.S. Army Health Clinic, Military Ocean TerminalBayonne; and U.S. Army Dental Clinic, Picatinny Arsenal. Thefollowing recommendations are provided to assist you incorrecting areas of regulatory noncompliance and to assist you inimproving your overall radiation protection program.

3. RECOMMENDATIONS.

a. Personnel Dosimetry Program.

(1) Appointment of an Alternate Radiation ProtectionOfficer (ARPO), Fort Monmouth, in writing [AR 40-14, 5e(3)].

(2) Appointment of a custodian of dosimetry records,Fort Monmouth, in writing [AR 40-14, 5e(8)].

EXSUM, Radn Prot Surv No. 28-83-2490-95, 25 Ott-3 NOV 94

(3) Revise Fort Monmouth SOP #9, Annex C, PreventiveMedicine Service, dated 1 November 1991, to include a procedurefor calculating administrative doses and address workermoonlighting [AR 40–14, paragraph lld(2), 13h, and 13i] .

(4) Conduct a quarterly review of dosimetry records (AR40-14, paragraph 13).

(5) Ensure that DD Form 1952 is complete and accuratefor each person occupationally exposed to ionizing radiation (AR40-14, paragraph lld).

(6) Update Fort Monmouth’s Standard Operating Procedure(SOP) #9, Annex C, Preventive Medicine Service, dated1 November 1991, to reflect the current Radiation ProtectionOfficer [TB MED 525 1-4(e)].

(7) Develop a Radiation Protection SOP for theDepartment of Radiology, Patterson Army Community Hospital tocover worker safety, patient safety, and dosimeter use [TB MED525, paragraph 1-4(e)].

b. Diagnostic X-Ray Facilities. Correct the deficienciesfor the x-ray systems listed in Appendix C [AR 40-5, paragraph9-9b(7)].

2

,..,,

. . .

DEPARTMENT OF THE ARMYU.S. ARMY CENTER FOR HEALTH PROMOTION AND PREVENTIVE MEDICINE (PROVISIONAL]

ABERDEEN PROVING GROUND, MARYLAND 21010-5422

REPLY TOAT TI?NTIOM 0?

MCHB-DS-MH 20 MAR 1995

RADIATION PROTECTION SURVEY NO. 28-83-2490-95U.S. ARMY MEDICAL DEPARTMENT ACTIVITY/DENTAL ACTIVITY

FORT MONMOUTH, NEW JERSEYU.S. ARMY HEALTH/DENTAL CLINICS

FORT HAMILTON, NEW YORKU.S. ARMY HEALTH CLINIC

MILITARY OCEAN TERMINAL BAYONNE, NEW JERSEYU.S. ARMY DENTAL CLINIC


,.

1. REFERENCES. See Appendix A for a list of references.

2. AUTHORITY.

a. Memorandum, USACHPPM (PROV), MCHB-M, 28 September 1994,subject: USACHPPM (PROV) Schedule of Field Services, FY 95.

b. Mission service planning meeting between MACOMrepresentatives and program managers, 27–28 July 1994, USAEHA.

3. PURPOSE. This Radiation Protection Survey was performed toaid you in your safe use of ionizing radiation and in conformingto current regulatory requirements. Specifically, we performedthis service to:

a. Alert you to any potential health hazards or areas ofnoncompliance regarding regulatory requirements associated withthe use of ionizing radiation sources.

b. Provide recommendations to correct any health hazards andto ensure regulatory compliance.

c. Provide onsite assistance to improve your radiationprotection program (RPP).

Radn Prot Surv No. 28–83–2490–95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94

4. GENERAL .

a. The survey officers held an entrance interview with COLRoyal C. Hudson, Jr., CDR, PACH, CPT Beth A. Brandford, RadiationProtection Officer (RPO), CW1 Marvin L. Saunders, Chief, MedicalMaintenance, SSG Raymon N. Truitt, NCOIC, Radiology, SGT Otha D.Johnson, Alternate RPO (ARPO), and SPC Daren Davidson,25 October 1994, to discuss the scope of the survey.

b. An exit briefing, to include a discussion of the findingsand recommendations for the U.S. Army Medical Department Activity(MEDDAC), Fort Monmouth, was held with COL Hudson, CDR, PACH, SSGTruitt, NCOIC, Radiology, and SGT Johnson, ARPO, 26 October 1994.

c. An entrance interview was held with SGT Sherry L.McDonald, assistant NCOIC, U.S. Army Dental Activity (DENTAC),27 October 1994, to discuss the scope of the survey.

d. An exit briefing, to include a discussion of the findingsand recommendations for the DENTAC, Fort Monmouth, was held withSGT Leandrew J. Williams, NCOIC, DENTAC, on 27 October 1994.

e. The survey officers held a separate exit briefing withCW1 Marvin L. Saunders, Chief of Medical Maintenance, to discussfindings and recommendations related to his areas of interest.

f. The USACHPPM (PROV), previously USAEHA, conducted asurvey of the overall RPPs at MEDDAC/DENTAC, Fort Monmouth, U.S.Army Health/Dental Clinics, Fort Hamilton, U.S. Army HealthClinic, Military Ocean Terminal Bayonne, and U.S. Army DentalClinic, Picatinny Arsenal, on 16–20 November 1992 (RadiationProtection Survey No. 28-43-FV68-93) .

9. Appendix B contains a list of instrumentation used forthe Radiation Protection Survey and a list of abbreviations usedin this report.

5. FINDINGS AND DISCUSSIONS.

a. General.

(1) CPT Beth A. Brandford was designated in writing asthe RPO for MEDDAC, Fort Monmouth. SGT Otha D. Johnson was theacting ARPO for MEDDAC, Fort Monmouth, but was not designated inwriting.

2

Radn Prot Surv No. 28-83-2490–95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94

(2) LTC Brushan S. Hoshi and SGT Leandrew J. Williamswere designated as the RPO and ARPO for the DENTAC, respectively.

(3) The survey officers reviewed a radiation protectionstanding operating procedure (SOP) for MEDDAC, Fort Monmouth(Fort Monmouth SOP No. 9, Annex C, Preventive Medicine Service,dated 1 November 1991), which appeared adequate for its intendedpurpose. The survey officers made recommendations for theimprovement of the SOP (see paragraph 7).

(4) Documentation was not available for review todemonstrate that all administrative doses were calculated andrecorded in accordance with (IAW) AR 40–14.

(5) Documentation was not available for review todemonstrate that the dosimetry SOP included a procedure forreporting moonlighting doses IAW AR 40–14.

(6) Site–specific radiation protection SOPS werereviewed at each of the outlying clinics (USAHC/DC, FortHamilton, USAHC Military Ocean Terminal Bayonne, and USADCPicatinny Arsenal) and appeared adequate for their intendedpurposes.

(7) Documentation was available for review to indicatethat lead aprons were inspected on a semiannual basis at theMEDDAC/DENTAC, Fort Monmouth, USAHC/DC, Fort Hamilton, USAHC,Military Ocean Terminal Bayonne, and USADC, Picatinny Arsenal.

(8) A radiation protection SOP for the RadiologyDepartment, PACH, was not available for review. The surveyofficers were informed that the SOP was in the process of beingdeveloped.

b. Personnel Dosimetry Program.

(1) SPC Cuddyer was acting as custodian of dosimetryrecords at Fort Monmouth, but was not designated in writing.

3

. . .

Radn Prot Surv No. 28–83-2490-95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94

(2) Fifty–one MEDDAC/DENTAC personnel and personnel ofoutlying clinics (USAHC/DC Fort Hamilton, USAHC Military OceanTerminal Bayonne, and USADC Picatinny Arsenal) were identified asradiation workers by their inclusion in the Army dosimetryprogram. All individuals had accumulated exposures in thepreceding year of less than 10 percent of the applicable whole-body dose equivalent (AR 40-14). In the opinion of the surveyofficers, the occupational radiation exposures were beingmaintained as low as reasonably achievable (ALARA).

(3) The dosimetry records were maintained IAW AR 40-14with the following exceptions:

(a) A number of the DD Forms 1952, Dosimeter Applicationand Record of Occupational Radiation Exposure, were incomplete.

(b) Dosimetry records were not being reviewed and signedby the RPO on a quarterly basis.

(4) The RPO approved the dosimeter storage locations inwriting.

c. Diagnostic X-Ray Facility. Nine medical and seven dentalx-ray systems were surveyed for compliance with TB MED 521 andTitle 21 Code of Federal Regualtion (CFR), Subchapter J. SeeAppendix C for a description of the deficiencies.

(1)surveyed at

(2)surveyed at

(3)

Seven medical and three dental x–ray systems wereFort Monmouth.

One medical and two dental x–ray systems wereFort Hamilton.

One medical x-ray systemMilitary Ocean Terminal Bayonne.

(4) Two dental x-ray systemsArsenal.

was surveyed at the

were surveyed at Picatinny

Radn Prot Surv No. 28-83-2490-95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94

d. Quality Assurance Program (QAP). The Department ofRadiology, MEDDAC/DENTAC, Fort Monmouth, U.S. Army Health/DentalClinics, Fort Hamilton, U.S. Army Health Clinic, Military OceanTerminal Bayonne, and U.S. Army Dental Clinic, Picatinny Arsenalmaintianed adequate QAPs and met the intent and requirements ofJoint Commission on Accreditation of Healthcare Organizations(JCAHO) standards PI.3.4. 1-PI.3.4.1.3, PI.3.5.3.2, PI.4.2-PI.4.2.2, and DR.2.2.6 and TB MED 521, paragraphs 2–9 and 2-10.All regulatory requirements were being performed and documented.

e. Radiation Protection Training. Documentation wasavailable to demonstrate that personnel in all activities usingradiation producing devices received radiation protectiontraining in the past year.

6. CONCLUSIONS. A review of the findings indicated that thereare no current health hazards associated with the use of theradiation sources at the MEDDAC/DENTAC, Fort Monmouth, USAHC/DC,Fort Hamilton, USAHC, Military Ocean Terminal Bayonne, and USADC,Picatinny Arsenal. The following recommendations are provided toassist you in correcting areas of regulatory noncompliance and inimproving your overall radiation protection program.

7. RECOMMENDAT IONS.

a. General.

(1) Appointment of an ARPO, Fort Monmouth, in writing[AR 40-5, paragraph 9-4b(l)].

(2) Revise Fort Monmouth SOP No. 9, Annex C, PreventiveMedicine Service, dated 1 November 1991, to include a procedurefor calculating administrative doses and address workermoonlighting [AR 40–14, paragraph lld(2), 13h, and 13i]

(3) Update Fort Monmouth’s SOP No. 9, Annex C,Preventive Medicine Service,dated 1 November 1991, to reflect thecurrent RPO [TB MED 525, paragraph 1–4(e)] .

(4) Develop a Radiation Protection SOP for theDepartment of Radiology, PACH, to cover worker safety, patientsafety, and dosimeter use [TB MED 525, paragraph 1-4(e)].


b. Personnel Dosimetry Program.

(1) Appointment of a custodian of dosimetry records,Fort Monmouth, in writing [AR 40–14, paragraph 5e(8)] .

(2) Conduct a quarterly review of dosimetry records (AR40-14, paragraph 13).

(3) Ensure that the DD Form 1952 is complete andaccurate for each person occupationally exposed to ionizingradiation (AR 40-14, paragraph lld) .

c. Diagnostic X-Ray Facilities. Correct the deficienciesfor the x-ray systems listed in Appendix C [AR 40-5, paragraph 9-9b(7)].

,.-) Vj ‘;.3 j

+

.,;/,/,,.~’/’:.,, &/

///

,.” “ 4 . ..--’- ‘

A&.:,’!

PH;LIj?A.‘“~-}‘SHea.J~h Physi{”istORISE, ContractorMedical Health Physics Program

lLT, MSNuclear Medical Science OfficerMedical Health Physics Program

APPROVED:

MAJ, MSManager, Medical Health Physics

Program

6


APPENDIX A

REFERENCES

1. AR 40”5, 15 October 1990, Preventive Medicine.

2. AR 40-14, 11 May 1994, Occupational Ionizing RadiationPersonnel Dosimetry.

3. DA PAM 40-XX, 11 May 1994, Personnel Dosimetry Guidance andDose Recording Procedures for Personnel Occupationally Exposed toIonizing Radiation.

4. TB MED 521, 15 September 1981, Management and Control ofDiagnostic X–Ray, Therapeutic X-Ray, and Gamma-Beam Equipment.

5. Title 21, Code of Federal Regulations, 1991 rev, SubchapterJ, Radiological Health.

6. National Council on Radiation Protection and Measurements(NCRP) Report 35, 9 March 1970, Dental X–Ray Protection.

7. NCRP Report 99, 30 December 1988, Quality Assurance forDiagnostic Imaging.

8. NCRP Report 102, 30 June 1989, Medical X-Ray, Electron Beamand Gamma-Ray Protection for Energies up to 50 MeV (EquipmentDesign, Performance, and Use) .

9. Memorandum, USACHPPM (PROV), 18 October 1994, subject:Radiation Protection Survey.

10. Memorandum, USAEHA, HSHB-MR-HM, 8 February 1993, subject:Radiation Protection Survey No. 28–43–EV68-93, U.S. Army MedicalDepartment Activity/Dental Activity, Fort Momouth, New Jersey,16-20 November 1992.

A-1


APPENDIX B

ABBREVIATIONS AND INSTRUMENTS

1. ABBREVIATIONS .

AEc

AlALARAARPOCFRcmDENTACESEHVLIAWinJCAHO

kVpInAMEDDACmmmRmR/mAsmR/minmsNCOICNCRP

PAPBLPROVQAPR/reinRPORPPSCDSIDSOPSSDTFUSACHPPM

automaticaluminumAs LOW AS

alternate

exposure control

Reasonably AchievableRadiation Protection Officer

Code of Federal RegulationscentimeterDental Activityentrance skin exposurehalf value layerin accordance withinchJoint Commission on Accreditation of Health

Organizationskilovolt peakmilliampereMedical Department Activitymillimetermilliroentgenmilliroentgen per milliampere secondmilliroentgen per minutemillisecondNoncommissioned Officer in ChargeNational Council on Radiation Protection and

Measurementsposteroanteriorpositive beam limitationprovisionalQuality Assurance Programroentgen per minuteRadiation Protection OfficerRadiation Protection Programsource to chamber distancesource to image distancestanding operating proceduresource to skin distancetotal filtration (in mm Al)U.S. Army Center for Health Promotion and

Preventive Medicine

B-1

r .$ .,”.

f

Radn Prot Surv No. 28–83–2490–95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NoV 94

USAEHA U.S. Army Environmental Hygiene AgencyUSAIRDC U.S. Army Ionizing Radiation Dosimetry Center

2. INSTRUMENTAT ION.

a. X-Ray Monitors, MDH Industries, Model 1015, SN 1995 andSN 2378, calibration due 25 February 1995.

b. Noninvasive kVp meters, RTI Electronics AB, Model PMX-11,SN 213 and SN 249, calibration due 3 March 1995.

c. Ionization Chamber, Victoreen Survey Meter, Model 440, SN1286, calibration due 28 November 1994.

d. Footcandle Meters, UDT Digaphot, Model 3300, SN 364 andSN 372, calibration due 9 July 1995.

B-2

Radn Prot Surv No. 28–83–2490–95, MEDDAC/DENTAC, Ft Monmouth~ NJ~25 Ott-3 NOV 94

APPENDIX C

ANALYSIS OF DIAGNOSTIC X-RAY SYSTEMS SURVEYEDFORT MONMOUTH, NEW JERSEY

c-1


RADIOLOGY DEPARTMENT - ROOM 1A26PATTERSON ARMY COMMUNITY HOSPITAL

MMCN B9076

1. GENERAL .

a. SURVEYORS: lLT Davis

b. SYSTEM: Triple phaseelectronic timer, phototimer,tube potential is 150 kVp and

2. IDENTIFYING DATA.

MANUFACTURERCONTROL: PICKERTUBE HOUSING: DUNLEEINSERT : DUNLEE

3. BEAM CHARACTERISTICS.

and Mr. Hypes on 25 October 1994.

radiographic unit, with anand automatic PBL. The maximummaximum tube current is 320 mA.

MODEL NUMBER SERIAL NUMBERVECTOR 80 01371366PX 1432CQ 187109-CVDU 404 3201-R

a. OUTPUT : 19.6 mR/mAs at techniques of 90 kVp (94 kVpmeasured) , 61 cm SCD.

b. BEAM QUALITY: HVL = 4.3 mm Al and Total Filtration = 4.8mm Al at the technique of 90 kVp.

c. The entrance skin exposure was 10.6 mR for an AEC PAchest radiograph, using a patient equivalent phantom (1/16–inchcopper) and techniques factors normally used by the x-raytechnician [120 kVp at 72 inches source to image distance (SID)and 62 inches source to chamber distance (SCD)].

4. COMMENT . The general purpose radiographic system wassurveyed for compliance to TB MED 521 and 21 CFR, Subchapter J.Specifically the required documentation (technique chart, coolingcurves, warning label, etc.) was reviewed. The x–ray system wastested in the radiographic mode for source assembly leakage,proper collimator operation, illuminance of the light localizer,kVp accuracy, timer accuracy, radiation output reproducibilityand level, mA linearity, beam quality, x-ray field/light fieldalignment, positive beam limitation operation, sensitivity andexposure level of the phototimers in the chest bucky.

c-2

Radn Prot Surv No. 28–83-2490–95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94

5. DESCRIPTION OF DEFICIENCY.

a. The peak tube potential (kVp) differed from the indicatedkVp by 7% to 10% at the 70, 100, and 120 kVp settings.

b. The average radiation output at the above techniques waslower than the recommended radiation output as specified in TBMED 521 by 58%.

c. The total filtration in the primary beam exceeded therecommended amount given in TB MED 521 by 1.2 mm Al.

6. CORRECTIVE REQUIREMENT.

a. Adjust the actual kVp, so that the accuracy at theindicated kVp meets the manufacturer’s specifications [TB MED521, paragraph 5–3b(2)] or within 5% of the indicated value ifthe manufacturer’s specifications are not available [TB MED 521,paragraph 7-5b(2) (d)].

b. Ensure that the x-ray system is calibrated to themanufacture’s specifications, that the recommended amount offiltration (TB MED 521) is placed in the primary beam, and thatthe x–ray tube is free of defects before rechecking the radiationoutput . If the radiation output continues to differ by more than30% of the recommended radiation output as specified in TB MED521, the x-ray tube should be replaced [TB MED 521, paragraph 7-5b(2) (e)].

c. Remove sufficient filtration in the primary beam todecrease the total filtration to at least 2.5 mm Al but no morethan 3.5 mm Al [TB MED 521, paragraph 5-3b(l)].

c-3

Radn Prot Surv No. 28-83–2490–95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94


MMCN B9076

1. GENERAL .

a. SURVEYORS: lLT Davis and Mr. Hypes on 25 October 1994.

b. SYSTEM: Triple phase fluoroscopic unit, with anelectronic timer, phototimer, and automatic PBL. The maximumtube potential is 125 kVp and maximum fluoroscopic tube currentis 2.5 mA.


MANUFACTURE R MODEL NUMBER SERIAL NUMBERCONTROL: PICKER VECTOR 80 01371366TUBE HOUSING: INACCESSIBLEINSERT : INACCESSIBLE


a. OUTPUT :

(1) Output in spot film mode: 20.8 mR/mAs at techniquesof 90 kVp (84 kVp measured), 61 cm SCD.

(2) Maximum fluoroscopic output in AEC mode, 125 kVp,2.5 mA, at 51 cm SCD: 7.4 R/rein.

(3) Fluoroscopic output in AEC mode using a 10–inchpatient equivalent phantom, 80 kVp, 1.0 mA, at 51 cm SCD:1.7 R/rein.

(4) Maximum fluoroscopic output in manual mode, 125 kVp,2.5 mA, at 51 cm SCD: 7.5 R/rein.

b. BEAM QUALITY: HVL = 3.5 mm Al and Total Filtration = 3.8mm Al mA at the technique of 90 kVp.

4. COMMENT . The fluoroscopic system was surveyed for complianceto TB MED 521 and 21 CFR, Subchapter J. The x–ray system wastested in the fluoroscopic mode for x–ray source image receptorganging, maximum timer setting, primary barrier interlock, source

c-4


assembly under the table stray radiation leakage, propercollimator operation, primary barrier transmission, minimumsource to skin distance, x–ray field/image receptor alignment,maximum entrance exposure rate in automatic and manual modes,high and low contrast resolution of the image intensifier, and inthe spot film mode for kVp accuracy, timer accuracy, beamquality, radiation output reproducibility, mA linearity, and x-ray field/spot film alignment.


a. The x–ray system did not collimate the fluoroscopic x–rayfield to the image receptor properly. The length of the x–rayfield was larger than the image receptor by more than 3% of theSID.

b. The kVp differed from the indicated kVp by 13% at the 100kVp setting.



a. Adjust the collimator to align the x-ray field with theimage receptor. The difference between the edge of the x–rayfield and the edge of the image receptor must be within 3% of theSID, in both the length and width. The sum of the deviation inthe length and width must be within 4% of the SID [TB MED 521,paragraph 5-2b(6)].

b. Adjust the actual kVp, so that the accuracy at theindicated kVp meets the manufacturer’s specifications [TB MED521, paragraph 5-3b(2)] or within 5% of the indicated value ifthe manufacturer’s specifications are not available [TB MED 521,paragraph 7-5b(2) (d)].

c. Remove sufficient filtration in the primary beam todecrease the total filtration to at least 2.5 mm Al but no morethan 3.5 mmAl [TB MED 521, paragraph 5-3b(l)].

c-5



MMCN B6499

1. GENERAL .


b. SYSTEM: Triple phase radiographic/tomographic unit, withan electronic timer, phototimer, and automatic PBL. The maximumtube potential is 150 kVp and maximum tube current is 400 mA.


MANUFACTURER MODEL NUMBER SERIAL NUMBERCONTROL: GE MVP 60 B222E52TUBE HOUSING: GE 46-155400G48 32707EC2INSERT : GE 46-155318G33 228317TU4


a. OUTPUT : 12.6 mR/mAs at techniques of 90 kVp (96 kVpmeasured) , 61 cm SCD.

b. BEAM QUALITY: HVL = 6.0 mm Al and Total Filtration = 9.3mm AL at the technique of 90 kVp.

c. The entrance skin exposure was 27 mR for an AEC PA chestradiograph, using a patient equivalent phantom (1/16–inch copper)and techniques factors normally used by the x-ray technician (120kVp at 72 inches SID and 62 inches SCD).

4. COMMENT . The general purpose radiographic/tomographic systemwas surveyed for compliance to TB MED 521 and 21 CFR, SubchapterJ. Specifically the required documentation (technique chart,cooling curves, warning label, etc.) was reviewed. The x–raysystem was tested in the radiographic mode for source assemblyleakage, proper collimator operation, illuminance of the lightlocalizer, kVp accuracy, timer accuracy, radiation outputreproducibility and level, mA linearity, beam quality, x–rayfield/light field alignment, positive beam limitation operation,sensitivity and exposure level of the phototimers in the chestbucky, and in the tomographic mode for cut level accuracy, beampath uniformity, and resolution.

C-6

Radn Prot Surv No. 28–83–2490-95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94


a. The kVp differed from the indicated kVp by 7% to 9% at the70 kVp to 100 kVp settings.

b. The average radiation output at the above techniques waslower than the recommended radiation output as specified in TBMED 521 by 61%.


d. The positive beam limitation (PBL) did not collimate thex-ray field to the image receptor. The longitudinal collimatorwas inoperable.

e. The entrance skin exposures (ESE’S) for successive AEC PAchest radiographs for each chest bucky phototimer varied by morethan 10%.

f. The imaged tomographic cut level (slice plane) deviatedfrom the set tomographic cut level by +6 mm.


a. Adjust the actual kVp, so that the accuracy at theindicated kVp meets the manufacturer’s specifications [TB MED521, paragraph 5-3b(2)] or within 5% of the indicated value ifthe manufacturer’s specifications are not available [TB MED 521,paragraph 7-5b(2) (d)].

b. Ensure that the x-ray system is calibrated to themanufacture’s specifications, that the recommended amount offiltration (TB MED 521) is placed in the primary beam, and thatthe x-ray tube is free of defects before rechecking the radiationoutput . If the radiation output continues to differ by more than30% of the recommended radiation output as specified in TB MED521, the x-ray tube should be replaced [TB MED 521, paragraph 7-5b(2) (e)].


c-7

Radn Prot Surv No. 28-83–2490–95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94

d. Fix the longitudinal collimator and adjust the PBL sothat the misalignment is less than 3% of the SID per axis and 4%of the SID total [TB MED 521 paragraph 7-5b(6) (b)].

e. Adjust the phototimers in the chest bucky to ensure thatthe ESES are within 10% regardless of the AEC field selected [TBMED 521, paragraph 7-5(9) (b)].

f. Adjust the imaged tomographic cut level to themanufacturer’s specifications or 0.5 mm of the set cut level ifthe manufacturer’s specifications are not available [TB MED 521,paragraph 7-5g(l)l.

C-8



MMCN B6499

1. GENERAL .


b. SYSTEM : Triple phase fluoroscopic unit, with anelectronic timer, phototimer, and automatic PBL. The maximumtube potential is 120 kVp and maximum fluoroscopic tube currentis 2.1 mA.


MANUFACTURER MODEL NUMBERCONTROL: GE MVP 60TUBE HOUSING: INACCESSIBLEINSERT : INACCESSIBLE

SERIAL NUMBERB222E52


a. OUTPUT :

(1) Output in spot film mode: 23.8 mR/mAs at techniquesof 90 kVp (93 kVp measured), 61 cm SCD.

(2) Maximum fluoroscopic output in AEC mode, 120 kVp,2.1 mA, at 50 cm SCD: 6.8 R/rein.

(3) Fluoroscopic output in AEC mode using a 10-inchpatient equivalent phantom, 120 kVp, 0.7 mA, at 50 cm SCD: 0.2R/rein.

(4) Maximum fluoroscopic output in manual mode, 120 kVp,2.1 mA, at 50 cm SCD: 7.3 R/rein.

b. BEAM QUALITY: HVL = 3.3 mm Al and Total Filtration = 2.7mm Al mA at the technique of 90 kVp.

4. COMMENT . The fluoroscopic system was surveyed for complianceto TB MED 521 and 21 CFR, Subchapter J. The x-ray system wastested in the fluoroscopic mode for x–ray source image receptorganging, maximum timer setting, primary barrier interlock, source

c-9


assembly under the table stray radiation leakage, propercollimator operation, primary barrier transmission, minimumachievable SCD, x–ray field/image receptor alignment, maximumentrance exposure rate in automatic and manual modes, high andlow contrast resolution of the image intensifier, and in the spotfilm mode for kVp accuracy, timer accuracy, beam quality,radiation output reproducibility, mA linearity, and x–rayfield/spot film alignment.

5. DESCRIPTION OF DEFICIENCY. None noted.

6. CORRECTIVE REQUIREMENT. None required.

c-lo



MMCN B8350

1. GENERAL .


b. SYSTEM: Single phase, dedicated chest radiographic unit,with an electronic timer, phototimer, and automatic PBL. Themaximum tube potential is 125 kVp and maximum tube current is 600mA.


MANUFACTURER MODEL NUMBER SERIAL NUMBERCONTROL: PICKER BCX 4145TUBE HOUSING: DUNLEE PX-1431C 189495KVINSERT : DUNLEE DU-304 6423R


a. OUTPUT : 3.7 mR/mAs at techniques of 90 kVp (91 kVpmeasured), 102 cm SCD.

b. BEAM QUALITY: HVL = 4.1 mm Al and Total Filtration = 5.2mm AL at the technique of 90 kVp.

c. The entrance skin exposure was 15.5 mR for an AEC PAchest radiograph, using a patient equivalent phantom (1/16–inchcopper) and techniques factors normally used by the x-raytechnician (120 kVp at 72 inches SID and 62 inches SCD).

4. COMMENT . The dedicated chest radiographic system wassurveyed for compliance to TB MED 521 and 21 CFR, Subchapter J.Specifically the required documentation (technique chart, coolingcurves, warning label, etc.) was reviewed. The x–ray system wastested in the radiographic mode for source assembly leakage,proper collimator operation, illuminance of the light localizer,kVp accuracy, timer accuracy, radiation output reproducibilityand level, II-LAlinearity, beam quality, x-ray field/light fieldalignment, sensitivity and exposure level of the phototimers inthe chest bucky.

C-n



a. The average radiation output was lower than therecommended radiation output as specified in TB MED 521 by 47%.

b. The total filtration in the primary beam exceeded therecommended amount given in TB MED 521 by 1.7 mm Al.

c. The ESES for successive AEC PA chest radiograph for eachchest bucky phototimer varied by more than 10%.


a. Ensure that the x-ray system is calibrated to themanufacture’s specifications, that the recommended amount offiltration (TB MED 521) is placed in the primary beam, and thatthe x–ray tube is free of defects before rechecking the radiationoutput . If the radiation output continues to differ by more than30% of the recommended radiation output as specified in TB MED521, the x-ray tube should be replaced [TB MED 521, paragraph 7-5b(2) (e)].

b. Remove sufficient filtration in the primary beam todecrease the total filtration to at least 2.5 mm Al but no morethan 3.5 mm Al [TB MED 521, paragraph 5-3b(l)].

c. Adjust the phototimers in the chest bucky to ensure thatthe ESES are within 10% regardless of the AEC field selected [TBMED 521, paragraph 7-5(9) (b)].

C-12

,. ...j.

Radn Prot Surv No. 28-83-2490–95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NOV 94

RADIOLOGY DEPARTMENTPATTERSON ARMY COMMUNITY HOSPITAL

MMCN C3874

1. GENERAL .


b. SYSTEM: Mobile x–ray unit with an electronic timer. Themaximum tube potential is 125 kVp and maximum tube current–timeis 200 mAs.


MANUFACTURER MODEL NUMBER SERIAL NUMBERCONTROL: GE AMX-4 433361WK3TUBE HOUSING: GE 46-155750G8 59064EC6INSERT : GE 46-125686G8 034308


a. OUTPUT : 20.5 mR/mAs at techniques of 90 (93 kVpmeasured), 61 cm SCD.


4. COMMENT . The mobile radiographic system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label, etc.) was reviewed. The x–ray system was testedfor source assembly leakage, proper collimator operation,illuminance of the light localizer, kVp accuracy, timer accuracy,radiation output reproducibility and level, mA linearity, beamquality, and x-ray field/light field alignment.

5. DESCRIPTION OF DEFICIENCY. None Noted.

6. CORRECTIVE REQUIREMENT. None Required.

C-13


RADIOLOGY DEPARTMENTPATTERSON ARMY COMMUNITY HOSPITAL

MMCN B7143 I

1. GENERAL .


b. SYSTEM: Mobile x-ray unit with an electronic timer. Themaximum tube potential is 125 kVp and maximum tube current–timeis 200 mAs.


MANUFACTURE R MODEL NUMBER SERIAL NUMBERCONTROL: GE AMX-4 246861WC9TUBE HOUSING: GE 46-125686G8 234409TU1INSERT : GE 46-155750G8 35652EC7


a. OUTPUT : 19.6 mR/mAs at measured techniques of 90 kVp,61 cm SCD.


4. COMMENT . The mobile radiographic system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label, etc.) was reviewed. The x-ray system was testedfor source assembly leakage, proper collimator operation,illuminance of the light localizer, kVp accuracy, timer accuracy,radiation output reproducibility and level, mA linearity, beamquality, and x-ray field/light field alignment.


a. The average illumination of the light localizer used todefine the perimeter of the x-ray field was only 9 footcandlesabove the ambient light level at 40 inches SID.

b. The average radiation output was lower than therecommended radiation output as specified in TB MED 521 by 31%.

C-14

., .

Radn Prot Surv No. 28-83-2490-95, MEDDAC/DENTAC, Ft Monmouth, NJ,25 Ott-3 NoV 94



a. Take the necessary action to increase the illumination ofthe light localizer to at least 15 footcandles at 40 inches SID(corrected for ambient light). The corrective action may includeinstalling a bulb of the proper wattage, verifying the voltageand current, adjusting or replacing the reflector, or removingany buildup of material that may be diffusing the light [TB MED521, paragraph 5-3b(14)].

b. Ensure that the x-ray system is calibrated to themanufacture’s specifications, that the recommended amount offiltration (TB MED 521) is placed in the primary beam, and thatthe x–ray tube is free of defects before rechecking the radiationoutput . If the radiation output continues to differ by more than30% of the recommended radiation output as specified in TB MED521, the x-ray tube should be replaced [TB MED 521, paragraph 7-5b(2) (e)].


C-15


DENTAL CLINIC - ROOM D2DENTAC

MMCN B6237

1. GENERAL .


b. SYSTEM: Single phase dental intraoral x–ray unit with anelectronic timer. The fixed tube potential is 70 kVp and fixedtube current is 7 mA.


MANUFACTURER MODEL NUMBER SERIAL NUMBERCONTROL: SIEMENS D3104 01261TUBE HOUSING: SIEMENS HELIODENT 70 08774S02INSERT : SIEMENS 5337241X341 08774S02


a. OUTPUT : 70.0 mR/mAs at techniques of 70 kVp (71 kVpmeasured) at 30 cm SCD.


4. COMMENT . The intraoral x-ray system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label and radiation warning signs, etc.) was reviewed.The x–ray system was tested for source assembly leakage, conecutting, kVp accuracy, timer accuracy, radiation outputreproducibility and level, and beam quality.


a. The timer accuracy varied by more than 23% at the 200millisecond (ins)exposure setting.



C-16


a. Adjust the timer to the standards specified by themanufacturer or within 5% of the indicated value if themanufacturer’s specifications are not available [TB MED 521,paragraph 7-5b(2) (d)].

b. Remove sufficient filtration in the primary beam todecrease the total filtration to at least 1.5 mm Al but no morethan 2.1 mm Al [TB MED 521, paragraph 5-6b(l) (b)].

C-17


DENTAL CLINIC - ROOM F1DENTAC

MMCN C3850

1. GENERAL .




MANUFACTURER MODEL NUMBER SERIAL NUMBERCONTROL: PHILIPS DENS-O-MAT 9220224TUBE HOUSING: ORALIX 9801 100 50004 9200294INSERT : INACCESSIBLE


a. OUTPUT : 44.8 mR/mAs at techniques of 70 kVp (68 kVpmeasured) at 30 cm SCD.


4. COMMENT . The intraoral x–ray system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label and radiation warning signs, etc.) was reviewed.The x–ray system was tested for source assembly leakage, conecutting, kVp accuracy, timer accuracy, radiation outputreproducibility and level, and beam quality.


a. The timer accuracy varied by more than 15% at the 200 ms,250 ms and 320 ms exposure settings.


C-18


6. CORRECTIVE

a. Adjust

REQUIREMENT.

the timer to the standards specified by themanufacturer or within 5% of the indicated value if themanufacturer’s specifications are not available [TB MED 521,paragraph 7-5b(2) (d)].

b. Remove sufficient filtration in the primary beam todecrease the total filtration to at least 1.5 mm Al but no morethan 2.1 mm Al [TB MED 521, paragraph 5-6b(l) (b)].

C-19

.,


DENTAL CLINIC - ROOM D2DENTAC

MMCN C3567

1. GENERAL .


b. SYSTEM: Single phase Panographic x-ray unit, with anelectronic timer. The maximum tube potential is 81 kVp and themaximum tube current is 10 mA.


MANUFACTURER MODEL NUMBER SERIAL NUMBERCONTROL: PHILIPS PTIOP 885002TUBE HOUSING: INACCESSIBLEINSERT : INACCESSIBLE


a. OUTPUT : 0.008 R/mAs at techniques of 75 kVp, 48 cm SCD.


4. COMMENT . The dental panoramic x-ray system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label and radiation warning signs, etc.) was reviewed.The x–ray system was tested for source assembly leakage, fixedcollimator accuracy, radiation output reproducibility and level,timer accuracy, and beam quality.

5. DESCRIPTION OF DEFICIENCY. The total filtration in theprimary beam fell short of the recommended amount given in TB MED521 by 1 mmA1.

6. CORRECTIVE REQUIREMENT. Add sufficient filtration in theprimary beam to increase the total filtration to at least 2.5 mmAl but no more than 3.5 mm Al [TB MED 521, paragraph 5-6b(l) (b)].

C-20


MILITARY OCEAN TERMINAL, BAYONNEUSAHC

ROOM 19B

1. GENERAL .

a. SURVEYOR: Mr. Hypes on 2 November 1994.

b. SYSTEM : Single phase radiographic unit’,with anelectronic timer. The maximum tube potential is 125 kVp and themaximum tube current is 600 mA.


CONTROL:TUBE HOUSING:INSERT :

MANUFACTURE R MODEL NUMBERPICKER 760-367DUNLEE DURATRON PX-1431CDUNLEE DURATRON DU 304

SERIAL NUMBER4197192390HW8686R


a. OUTPUT : 8.1 mR/mAs at techniques of 90 kVp, 61 cm SCD.

b. BEAMmm Al at the

4. COMMENT .surveyed forSpecifically

QUALITY: HVL = 3.5 mm Al and Total Filtration = 4.1technique of 90 kVp.

The general purpose radiographic system wascompliance to TB MED 521 and 21 CFR, Subchapter J.the required documentation (technique chart, cooling

curves, warning label, etc.) was reviewed. The x-ray system wastested for source assembly leakage, proper collimator operation,illuminance of the light localizer, kVp accuracy, timer accuracy,radiation output reproducibility and level, mA linearity, beamquality, x–ray field/light field alignment, and sensitivity andexposure level of the phototimers in the chest bucky.

5. DESCRIPTION OF DEFICIENCY. The timer was not restricting theexposure times to within 5 percent of the setting on the control[TB MED 521 5-6b(2)].

6. CORRECTIVE REQUIREMENTS. Adjust the timer so that theexposure times are within 5 percent of the setting on thecontrol.

C-21

,.. .


FORT HAMILTON, NYUSAHC

MMCN A0408

1. GENERAL .


b. SYSTEM: Single phase radiographic unit, with anelectronic timer. The maximum tube potential is 125 kVp and themaximum tube current is 600 mA.


MANUFACTURER MODEL NUMBER SERIAL NUMBERCONTROL: PICKER BGX-625 1119-FTUBE HOUSING: PICKER PX-1402C 126565K1INSERT : EUREKA RAD 16 A072168


a. OUTPUT : 6.4 mR/mAs at calculated techniques of 90 kVp,61 cm SCD.

b. BEAM QUALITY: HVL = 4.6 mm Al and Total Filtration = 5.8mm Al at the calculated technique of 90 kVp.

4. COMMENT . The general purpose radiographic system wassurveyed for compliance to TB MED 521 and 21 CFR, Subchapter J.Specifically the required documentation (technique chart, coolingcurves, warning label, etc.) was reviewed. The x–ray system wastested for source assembly leakage, proper collimator operation,illuminance of the light localizer, kVp accuracy, timer accuracy,radiation output reproducibility and level, mA linearity, beamquality, x-ray field/light field alignment, and sensitivity andexposure level of the phototimers in the chest bucky.

5. DEFICIENCIES .

a. The light field does not provide an illumination of morethan 15 footcandles more than the ambient illumination.

b. The measured kVp differed from the indicated kVp by morethan 5% at the 70 and 90 kVp settings.

c-22

Radn Prot Surv No. 28-83-2490–95,25 Ott-3 NOV 94

6. CORRECTIVE REQUIREMENTS

a. Adjust the light field sogreater than 15 footcandles aboveMED 521, paragraph 5-3b(14)].

b. Adjust the actual kVp, so

MEDDAC/DENTAC, Ft Monmouth, NJ,

that the illumination isthe ambient illumination [TB

that the accuracy at theindicated kVp meets the manufacturer’s specifications [TB MED521, paragraph 5-3b(2)] or within 5% of the indicated value ifthe manufacturer’s specifications are not available [TB MED 521,paragraph 7-5b(2) (d)].

C-23

:. .1


FORT HAMILTON, NYUSADC

MMCN G2457

1. GENERAL .




MANUFACTURE R MODEL NUMBER SERIAL NUMBERCONTROL: GE INACC 301311DN7TUBE HOUSING: S.S. WHITE ICNG BEAM HG9008INSERT : EUREKA OIR 9540H


a. OUTPUT : 8.6 mR/mAs at calculated techniques of 90 kVpat 61 cm SCD.


4. COMMENT . The intraoral x-ray system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label and radiation warning signs, etc.) was reviewed.The x-ray system was tested for source assembly leakage, conecutting, kVp accuracy, timer accuracy, radiation outputreproducibility and level, and beam quality.

5. DESCRIPTION OF DEFICIENCY. None.

6. CORRECTIVE REQUIREMENTS. None.

C-24

,..,,

I


FORT HAMILTON, NYUSADC

ROOM 2-23

1. GENERAL .




CONTROL:MANUFACTURER MODEL NUMBER SERIAL NUMBERG.E. 46-197490G1 301311DN7

TUBE HOUSING: INACCESSIBLEINSERT : INACCESSIBLE


a. OUTPUT : 7.9 mR/mAs at techniques of 75 kVp.


4. COMMENT . The dental panoramic x–ray system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label and radiation warning signs, etc.) was reviewed.The x-ray system was tested for source assembly leakage, fixedcollimator accuracy, radiation output reproducibility and level,and beam quality.

5. DESCRIPTION OF DEFICIENCY. The total filtration in theprimary beam fell short of the recommended amount given in TB MED521 by .5 mmA1.

6. CORRECTIVE REQUIREMENT. Add sufficient filtration in theprimary beam to increase the total filtration to at least 2.7 mmAl but no more than 3.8 mm Al [TB MED 521, paragraph 5-6b(l) (b)].

C-25


PICATINNY ARSENAL, NJUSADC

MMCN B8114

1. GENERAL .




CONTROL:TUBE HOUSING:INSERT :

MANUFACTURE RGEGEINACCESSIBLE


a. OUTPUT : 14.9 mR/mAsat 61 cm SCD.

MODEL NUMBERGE 700INACC

SERIAL NUMBER2121617DN544141TU0

at calculated techniques of 90 kVp

b. BEAMmm Al at the

4. COMMENT .

QUALITY: HVL = 1.7 mm Al and Total Filtration = 1.6calculated technique of 90 kVp.

The intraoral x-ray system was surveyed forcompliance to TB MED 521 and 21 CFR~ Subchapter J.- Specificallythe required documentation (technique chart, cooling curves,warning label and radiation warning signs, etc.) was reviewed.The x-ray system was tested for source assembly leakage, conecutting, kVp accuracy, timer accuracy, radiation outputreproducibility and level, and beam quality.

5. DESCRIPTION OF DEFICIENCY. The kVp differed from theindicated kVp by 12% at the 70 kVp setting.

6. CORRECTIVE REQUIREMENTS. Adjust the actual kVp, so that theaccuracy at the indicated kVp meets the manufacturer’sspecifications or within 5% of the indicated value if themanufacturer’s specifications are not available [TB MED 521,paragraph 5-6b (5)].

C-26


PICATINNY ARSENAL, NJUSADC

1. GENERAL .




MANUFACTURE R MODEL NUMBER SERIAL NUMBERCONTROL: PHILLIPS INACCESSIBLETUBE HOUSING: PHILLIPS PT-1OP PO0698INSERT : INACCESSIBLE


a. OUTPUT : 7.9 mR/mAs at techniques of 75 kVp.


4. COMMENT . The dental panoramic x-ray system was surveyed forcompliance to TB MED 521 and 21 CFR, Subchapter J. Specificallythe required documentation (technique chart, cooling curves,warning label and radiation warning signs, etc.) was reviewed.The x-ray system was tested for source assembly leakage, fixedcollimator accuracy, radiation output reproducibility and level,and beam quality.

5. DESCRIPTION OF DEFICIENCY. The total filtration in theprimary beam exceeded the recommended amount given in TB MED 521by .75 mmA1.

6. CORRECTIVE REQUIREMENT. Remove sufficient filtration fromthe primary beam to decrease the total filtration to at least 2.3mm Al but no more than 3.2 mm Al [TB MED 521, paragraph 5-6b(l) (b)].

C-27

FTM-029.pdf - Fort Monmouth Economic Revitalization Authority

Documents

Transcript of FTM-029.pdf - Fort Monmouth Economic Revitalization Authority