ML20206U194
| ML20206U194 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1999 |
| From: | Bhachu U, Jankovich J NRC |
| To: | |
| Shared Package | |
| ML20206U187 | List: |
| References | |
| SSD, NUDOCS 9905250094 | |
| Download: ML20206U194 (16) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 1 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe MODELS: DOPS, HEPS,'LEPS, SAPS, SLPS, SSPS l
(Formerly 820, 840, 880) Probes and Courier 8 Analyzer 1'
l DISTRIBUTOR: Metorex Incorporated (formerly Outokumpu Electronics, Inc.)
860 Town Center Drive Langhorne, PA 19047 MANUFACTURER: Metorex International, Oy (formerly Outokumpu Instruments) l Sh b2 0 l Espoo, Finland SEALED SOURCE MODEL DESIGNATION: Various; See Table in Description Section ISOTOPE: MAXIMUM ACTIVITY:
Americium-241 30 mci (1.11 GBq)
Cadmium-109 20 mci (0.74 GBq) ,
Curium-244 100 mci (3.70 GBq) I Iron-55 80 mci (2.96 GBq) l l
LEAK TEST FREOUENCY: 6 months l
l l
PRINCIPAL USE: (U) X-Ray Fluorescence l
CUSTOM DEVICE: YES X NO 9905250094 990521 PDR RC e MD , , , , , , ,PDR j
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 2 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe l DESCRIPTION:
The Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS X-ray Fluorescence Probes and Courier 8 analyzer are devices designed to perform element analysis of various materials in different environments. The probes are designed for use in laboratory or ,
industrial plant environs or under, field conditions. The Models i HEPS, LEPS, SAPS, and SLPS probes are the same probes which were i previously registered by Princeton Gamma Tech with the 820, 840, j and 880 X-ray Fluorescence Analyzers. The Model DOPS has been previously registered for Columbia Scientific by the State of Texas with the Model 880 X-ray Fluorescence Analyzer. The Model SSPS operates similar to the SAPS probe, but using two sources.
The previously registered Models 820, 840, and 880 X-ray Fluorescence Analyzers included the probes as well as an external j analyzer. The Models 820, 840, and 880 analyzers contain a power supply and controlling electronics and perform an analysis of data received from the probes. These analyzers contain no radioactive material. The probes may be used with the models 820, 840, or 880 analyzers or attached to a personal computer (PC) containing software developed by the manufacturer. The manufacturers PC based software operates the probes in the same manner as the analyzers. The probes will be plugged directly into the PC via an expansion card installed in the PC. No modification to the prob;s is necessary for use with the PC based system.
Each of the Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS probes contain one or two radioactive sources. There are two general categories of probes; the laboratory sample type probe and the surface analysis type probe. A laboratory sample type probe contains a sample chamber into which discrete samples are placed in order to perform elemental analysis. This type of probe may be either a Light Elements Probe System (LEPS) or a Heavy Elements Probe System (HEPS). A surface analysis type probe is physically placed on the surface of an object in order to perform elemental analysis of the object or materials within the object.
This type of probe may be either a Surface Analysis Probe System (SAPS), a Surface Analysis Probe System for Light Elements (SLPS), a Solid State Probe System (SSPS), or a Dual Source Surface Probe (DOPS).
l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 3 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Laboratory sample type probes contain a radioactive source (Am-241, Cd-109, or Cm-244 for the HEPS or Fe-55 for the LEPS), a sample chamber, a chamber cover, a slide or shutter mechanism, shielding and associated electronics. The probes measure approximately 3.25" (8.3 cm) wide by 6.5" (16.5 cm) long by 3.5" (8.9 cm) high. Older laboratory sample type probes employ an automatic shutter mechanism to shield the source when not in use.
Whenever a sample is placed in the sample chamber and the sample lid is closed, the shutter is automatically withdrawn to allow for irradiation of the sample. Characteristic X-rays given off by the sample are detected by the probes and analyzed either by a Model 820, 840, or 880 analyzer or by the PC software. The shutter is automatically moved to the shielded position by a return spring whenever the sample lid is opened.
Newer laboratory sample type probes employ a slide mechanism in order to shield the source during sample change. Operation of the probe consists of opening the sample cover, inserting a sample, closing the sample cover and sliding the sample into the measurement position. Sliding the sample into the measurement position exposes the source which irradiates the sample. Once the analysis is complete, the sample chamber is drawn back to the sample change position and the cover can be lifted and the sample withdrawn. This action automatically shields the source. The design of the probe ensures the cover cannot be lifted unless the sample is in the change position.
Surface analysis type probes are used only with the Models 840 and 880 analyzers or the PC based system. These probes vary in shape, shutter mechanism and number of sources used, but operate using similar principles. The basic operation of these probes is to place the sample window of the probe on the object to be analyzed, expose the source, detect characteristic x-rays given off by the object and analyze these x-rays to determine the elemental makeup of the object.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Phy 21, 1999 PAGE 4 OF 12 i DEVICE TYPE: X-Ray Fluorescence Probe i DESCRIPTION: (Cont'd)
The SAPS probe contains a single source (either Am-241, Cd-109 or Cm-244), a shutter mechanism, and associated electronics. The i
probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6" (15.2 cm) deep and is contained within a Zine (88%)
and Aluminum (12%) shell. A trigger and lever system mechanically operates the shutter mechanism. Source position is indicated by a flag in a window on the side of the probe (green for secured, red for exposed).
The SLPS contains a single source (Fe-55), an automatic mechanical shutter mechanism, and associated electronics.
Operation of the probe consists of placing the probe on the surface of the object to be analyzed. This action depresses a microswitch plunger located on the bottom of the probe which, in turn, rotates the shutter to the irradiate position. The shutter is automatically moved to the shielded position by a return spring whenever the probe is removed from the sample surface.
This shutter assembly is the same as the one used with the older laboratory sample type probes. The probe measures approximately 3.3" (8.3 cm) wide by 6.5" (16.5 cm) long by 3.5" (8.9 cm) high and is contained within a Zinc (88%) and Aluminum (12%) shell.
The SSPS contains two sources (Am-241, Cd-109, or Fe-55), dual shutter mechanisms operated by dual liquid nitrogen pneumatic systems, a liquid nitrogen dewar, and associated electronics.
The probe measures approximately 9.25" (23.5 cm) long by 4" (10.3 cm) wide by 9.75" (24.8 cm) high. Operation of the probe consists of the operator selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, !
and pulling the trigger. An electro-mechanical valve for source 1 number one allows compressed nitrogen gas to enter a pneumatic cylinder which pushes the source into the measurement position.
Once the surface has been irradiated for the appropriate time j interval the pneumatic cylinder is vented and a return spring j pushes the source back into the shielded position. Once source number one is secured, source number two is moved to the measurement position in the same manner using an independent, identical pneumatic system. If desired, tha operator may elect to irradiate the surface using only one source.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Pby 21, 1999 PAGE 5 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd) ,
Motorex has stated that SSPS models with a serial number greater than 206562, will incorporate a reference source assembly to provide a reference spectrum when both shutters are closed. The reference source assembly contains a recessed hole for a reference source covered by a silver cover and an aluminum cover glued and swaged (4 points) into placed. Each shutter mechanism is connected, by an aluminum rod, to the reference source assembly. When either shutter is open, the reference source holder is positioned off the axis of the x-ray detector.
Sources may be moved to the measurement position only if there is sufficient liquid nitrogen in the dewar and only if external power is applied. Source position is indicated by two windows (one for each source on either side of the probe). Green indicates source secured while red indicates source exposed.
Source position is additionally = indicated by an LED indicator on the probe handle. This LED lights whenever either source is exposed.
The SSPS probe may be used with an optional sample chamber which can be attached to the bottom of the device. This sample chamber is used by inverting the probe, connecting the sample cover, placing the sample on the radiation window, closing the sample cover, and pressing the start button. Operation of the probe is not affected in this configuration.
The DOPS contains two sources (Am-241/Cm-244, Cd-109/Am-241, or Cd-109/Fe-55), an automatic shutter mechanism which sequentially exposes each source for a specific time period, and associated electronics. The probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6.5" (16.5 cm) long. Operation of the probe consists of selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, and pulling the trigger. The probe shutter mechanism consists of a two-piece shutter (one piece fixed and one piece movable) and a movable source holder. Pulling the trigger causes a mechanical linkage to slide the movable shutter and source holder in unison into a configuration which exposes source number one.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: May 21, 1999 PAGE 6 OF 12 l
DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Once the surface has been irradiated for the appropriate time l interval, a microswitch releases the source holder which slides l back to its original position. This action shields source number one and exposes source number two. Once the surface has been i irradiated for the appropriate time interval, a microswitch '
releases the movable shutter which slides back into its original position, shielding source number two.
When used with a Model 820 analyzer, a LEPS and/or HEPS probe is built into the analyzer body. The construction of each probe is not modified for this type of application.
The Courier 8 analyzer is designed for continuos measurement of liquid sasiples. This analyzer contains a HEPS* probe mounted in a sample cell. When the probe is mounted, a lower support arm in the cell releases a safety catch in the probe allowing the shutter to open while locking the probe into the cell. This i action eacposes a radiation hazard label, indicating the probe is properly mounted and the shutter is open. With the shutter open, the probe cannot be removed from the cell. Disconnecting the probe automatically closes the probe. The sample cell is constructed with a 50 pm (1.97E-4 in) Mylar foil window. Should this window leak, it would results in a short circuit between two metal concentric metal rings located around the window, sounding an alarm and stopping the sample flow.
Motoraat refers to the original HEPS probe as the NEPS 2171, and the HEPS that is incorporated as part of the Courier 8 analyzer, as the HEPS 2412.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,: NR-701-D-101-B DATE: thy 21,1999 PAGE 7 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Sources and maximum activities are authorized for use in the probes as listed in the tables below- I MODEL BY MANUFACTURER MAXIMUM ISOTOPE ISOTOPE ACTIVITY AMERSHAM DuPont Mereck PRODUCTS Iron-55 80 mci /3.0 GBq IEC.Al NER-460 A XFB
. IEC.D1 Curium-244 100 mci /3.7 GBq CLCL XFB Cadmium-109 20 mci /0.7 GBq CUC.D1 NER-465 XFB CUC. DIN Americium-241 30 mci /1.1 GBq AMC.D2 NER-478 GFS & XFB
- 50 mci /1.9 GBq for Model XFB.
MAXIMUM ACTIVITY BY PROBE TYPE (mci /GBq)
ISOTOPE SLPS LSP SAPS DOPS SSPS Iron-55(annular) 40/1.5 80/3.0 --- --- ---
Iron-55(disc) ---
40/1.5 40/1.5 40/1.5 40/1.5 Curium-244 ---
100/3.7 100/3.7 100/3.7 ---
Cadmium-109 ---
20/0.7 20/0.7 20/0.7 20/0.7 Americium-241 ---
30/1.1 30/1.1 30/1.1 30/1.1
- Laboratory Sample Probe; includes LEPS, HEPS and Courier 8.
ESPS probes with a serial number greater than 206562, also contains V.G. Khlopin Radium Institute (Russia) Low Energy Photon Source that is registered as part of this registry sheet and is not registered separately. This source contains 1.3 pCi (50 kBq) of cadmium-109, and is 1 nun (0.04") in diameter by 0.2 mm (0.008") thick.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Phy 21, 1999 PAGE 8 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe LABELING:
Each probe will contain an identification label that meets 10 CFR l 20 requirements and which includes the probe type and serial l number, source serial number, isotope, activity and date of assay. Additionally the probes intended for distribution to persons generally licensed will contain a general license label in accordance with the requirements of 10 CFR 32.51.
DIAGRAM:
See Attachments 1 - 4.
CONDITIONS OF NORMAL USE:
The probes are designed for use in various environments including laboratories, industrial plants, and outdoor field uses (e.g.,
agricultural and mineral exploration). The probes may be useo in portable and fixed applications. The probes are not expected to be subjected to corrosive atmospheres, excessive vibration, or extreme temperatures due to the fact that the devices require the operator to be present for operation. The manufacturer states that the expected useful lifetime of each probe is 10 to 15 years.
PROTOTYPE TESTING:
The sealed sources used in the probes have achieved the minimum ANSI classifications as shown below:
MODEL NO. ANSI RATING l IEC.Al 77C33232 i IEC.D1 77C54344 l CLCL 77C54444 CUC.D1 68C44344 CUC.D1N 68C44344 AMC.D2 77C64545 NER-460 A 68C32212 NER-465 68C33232
} NER-478 68C43333 l XFB 68C32232 l
GFS 77C64545 t
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NQui NR-701-D-101-B DATE: Phy 21, 1999 PAGE 9 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe PROTOTYPE TESTING: (Cont'd)
The DOPS and SSPS probes were subjected to shutter reliability tests which continuously operated the shutter mechanism for more than 100,000 cycles for the DOPS probe and 250,000 cycles for the SSPS probe. The manufacturer reported no appreciable wear or problems associated with the operation of the shutter mechanisms following the tests.
These probes (excluding the SSPS, and Courier 8 Models) have been approved by the state of Texas for Columbia Scientific, Inc.,
since 1988 with no reported equipment failures.
EXTERNAL RADIATION LEVELS:
Metorex reports that the highest dose rates exhibited by the DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS probes are 0.2 mR/hr (2 pSv/hr) at 1.97" (5 cm) and less than 0.05 mR/hr (0.5 pSv/hr) at 11.8"(30 cm).
Similarly, Motorex reports that the highest dose rates exhibited by the Courier 8 analyzer are 1.3 mR/hr (13.0 pSv/hr) at 1.97" (5 cm) and 0.09 mR/hr (0.9 pSv/hr) at 11.8" (30 cm).
OUALITY ASSURANCE AND CONTROL:
Metorex has agreed to abide by the quality assurance and control standards previously submitted by Princeton Gamma-Tech, and found to be adequate by the NRC. These Quality Assurance standards cover the following areas:
- 1) Quality Assurance Organization;
- 2) General Quality Assurance Policy;
- 3) Incoming Inspections and Vendor Qualifications;
- 4) Test Procedures;
- 5) Personnel Training;
- 6) Non-Conforming Items Policy (Rejects);
- 7) Document Control;
- 8) Final Testing;
- 9) Quality Audits and Reports.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l l (AMENDED IN ITS ENTIRETY) l 1
NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 10 OF 12 l
1 1
DEVICE TYPE: X-Ray Fluorescence Probe i l
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE :
l Probes intended for distribution to persons generally licensed pursuant to Section 31.5, 10 CFR Part 31, must be initially transferred in accordance with the requirements of Section 32.51, 10 CFR Part 32 or equivalent provisions of an Agreement State.
- Probes shall be tested for leakage at intervals not to exceed 6 months using techniques and instrunnentation capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- Probes intended for use by persons generally licensed shall be initidlly tested for proper operation of the l source exposure mechanism, safety warning components, labels, external radiation levels and leak tested by i Motorax, Inc., or other persons specifically licensed by the NRC.or an Agreement State.
i
- This registration sheet and the information contained I within the references shall not be changed without the l written consent of the NRC.
l l l
SAFETY ANALYSIS
SUMMARY
1 Based on our review of the information submitted and test data cited below, we continue to conclude that Metorex, Inc., has provided reasonable assurance that:
- Probes limited herein can be safely operated by persons i not having training in radiological protection.
- Under ordinary conditions of handling, storage, and use i of the devices, the byproduct material contained in the l I devices will not be released or inadvertently removed l
from the devices, and it is unlikely that any person will receive in one year a dose in excess of 10 percent of the limits specified in Section 20.1201(a), 10 CFR {
Part 20.
l i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
.(AMENDED IN ITS ENTIRETY)
NO. NR-701-D-101-B DATE: Fby 21, 1999 PAGE 11 OF 12 REVICE TYPE: X-Ray Fluorescence Probe SAFETY ANALYSIS
SUMMARY
- (Cont'd)
- Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any persons would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified below.
PART QF BODY DQS3 Whole body; head and trunk active blood-forming organs; gonads; or lens of eye 15 rem (0.15 Sv)
Hands and ftrearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 rem (2.0 Sv)
Furthermore, continue to conclude that these devices. would be expected to maintain their containment integrity fo'; normal conditions of use and accidental conditions which inight occur during uses specified in this certificate.
REFERENCES:
The following supporting documents ror the Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS, X-Ray Fluorescence Probes and the Courier 8. analyzer, are hereby incorporated by reference and are made a part of this registry document.
- Princeton Gamma-Tech, Inc. lett2rs dated December 30,1985, January 15, 1987, May 18, 1987, June 12, 1987, and May 5, 1988.
4 I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: May 21, 1999 PAGE 12 OF 12 DEVICE TY,P_E.
El X-Ray Fluorescence Probe REFERENCES 1 (Cont'd)
- Outokumpu Electronics, Inc. letters dated February 8, 1991, September 12, 1991, February 3, 1992, October 9, 1992, December 18, 1992, December 30, 1992, February 22, 1993, March 29, 1993, and April 29, 1993, with enclosures thereto.
- Metorex Incorporated's letters dated March 5, 1999, July 24, 1995, and July 5, 1994, with enclosures thereto. l
- Motorex Incorporated's email dated May 7, 1999.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date: May 21, 1999 Reviewer:
Uja g hachu, P. Eng I I 1 ~
l Date: May 21, !.999 Concurrence:
su f cCctV J % P. d)Ankovich, Ph.D.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
I NO.: NR-701-101-B DATE: May 21, 1999 ATTACHMENT 1 i
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
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f REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-101-B DATE : May 21, 1999 ATTACHMENT 3
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Note: Other parts listed in background file
- John I. H. Patt:rson, Ph.D.
Metorax, Inc. May 21, 1999 Princ ton Crossroads Corporata C:nter 250 Phillips Boulevard Ewing, NJ 08618
Dear Dr. Patterson:
Based on the information and test data submitted in your amendment request dated December 4,1998, and follow-up correspondence dated March 5,1999, we conclude the modified SSPS probe and Courier 8 analyzer are acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate j (NR-701-D-101-D). l l
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and l
j obtain an amendment to the certificate before you make changes or modifications to the j information submitted to obtain the certificate. I Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096. ;
If you have any questions, please contact me at (301) 415-5799 or Mr. John Jankovich at (301) 415-7904.
Sincerely,
)
Eric B. Compton, Engineering Aide Materials Safety and Inspection Branch Division of industrial and Medical Nuclear Safety Ofiice of Nuclear Material Safety And Safeguards j
Enclosure:
As stated l cc w/ encl: SKimberley, LFDCB A. Randolph Blough, Director, DNMS, RG-1 l
Distribution.
IMNS r/f SSD-99-01 NE0d SSD File # NR-701-D-101-B DOCUMENT NAME: H:\EFilC\COMPLTR\NR701101. CMP l T a receive a copy of th6s document. 3rdicate in the box: "C" = Copy without attachment! enclosure 'E' - Copy with attachment / enclosure "N" = No copy OFFICE MSIB 1C MSIB ,m lD l NAME ECompton Jf JJankovichDg '
d DATE 08 /1/99 ,_ OM /99 9 OFnCIAL RECOF.O COPY
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1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.- NR-701-D-101-B DATE: May 21, 1999 PAGE 1 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe MODELS: DOPS, HEPS, LEPS, SAPS, SLPS, SSPS (Formerly 820, 840, 880) Probes and Courier 8 Analyzer DISTRIBUTOR: Metorex Incorporated (formerly Outokumpu Electronics, Inc.)
860 Town Center Drive Langhorne, PA 19047 MANUFACTURER: Metorex International, Oy (formerly Outokumpu Instruments)
P.O. Box 85 SF-02201 Espoo, Finland SEALED SOURCE MODEL DESIGNATION: Various; See Table in Description Section ISOTOPE: MAXIMUM ACTIVITY:
Americium-241 30 mci (1.11 GBq)
Cadmium-109 20 mci (0.74 GBq)
Curium-244 100 mci (3.70 GBq)
Iron-55 80 mci (2.96 GBq)
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (U) X-Ray Fluorescence CUSTOM DEVICE: YES X NO
%o9E%Y1 I GRP-
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) -
NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 2 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION:
The Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS X-ray Fluorescence Probes and Courier 8 analyzer are devices designed to perform element analysis of various materials in different environments. The probes are designed for use in laboratory or industrial plant environs or under field conditions. The Models HEPS, LEPS, SAPS, and SLPS probes are the same probes which were previously registered by Princeton Gamma Tech with the 820, 840, and 880 X-ray Fluorescence Analyzers. The Model DOPS has been previously registered for Columbia Scientific by the State of Texas with the Model 880 X-ray Fluorescence Analyzer. The Model SSPS operates similar to the SAPS probe, but using two sources.
The previously registered Models 820, 840, and 880 X-ray Fluorescence Analyzers included the probes as well as an external analyzer. The Models 820, 840, and 880 analyzers contain a power supply and controlling electronics and perform an analysis of data received from the probes. These analyzers contain no radioactive material. The probes may be used with the models 820, 840, or 880 analyzers or attached to a personal computer (PC) containing software developed by the manufacturer. The manufacturers PC based software operates the probes in the same manner as the analyzers. The probes will be plugged directly into the PC via an expansion card installed in the PC.. No modification to the probes is necessary for use with the PC: based system.
Each of the Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS probes
-contain one or two radioactive sources. There are two general l categories of probes; the laboratory sample type probe and the l surface analysis type probe. A laboratory sample type probe contains_a sample chamber into which discrete samples are placed in order to perform elemental analysis. This type of probe may be either a Light Elements Probe System (LEPS) or a Heavy )
Elements Probe-System (HEPS). A surface analysis type probe is physically placed on the surface of an object in order to perform i elemental analysis of the object or materials within the object.
This type of probe may be either a Surface Analysis Probe System (SAPS), a Surface Analysis Probe System for Light Elements (SLPS), a Solid State Probe _ System (SSPS), or a Dual Source Surface Probe (DOPS).
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) I l
NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 3 OF 12 l l
DEVICE TYPE: X-Ray Fluorescence Probe '
DESCRIPTION: (Cont'd)
Laboratory sample type probes contain a radioactive source (Am-241, Cd-109, or Cm-244 for the HEPS or Fe-55 for the LEPS), a j sample chamber, a chamber cover, a slide or shutter mechanism, i shielding and associated electronics. The probes measure approximately 3.25" (8.3 cm) wide by 6.5" (16.5 cm) long by 3.5" l (8.9 cm) high. Older laboratory sample type probes employ an automatic shutter mechanism to shield the source when not in use. ;
Whenever a sample is placed in the sample chamber and the sample {
lid is closed, the shutter is automatically withdrawn to allow !
for irradiation of the sample. Characteristic X-rays given off by the sample are detected by the probes and analyzed either by a !
Model 820, 840, or 880 analyzer or by the PC software. The j shutter is automatically moved to the shielded position by a J return spring whenever the sample lid is opened.
Newer laboratory sample type probes employ a slide mechanism in order to shield the source during sample change. Operation of the probe consists of opening the sample cover, inserting a sample, closing the sample cover and sliding the sample into the measurement position. Sliding the sample into the measurement position exposes the source which irradiates the sample. Once the analysis is complete, the sample chamber is drawn back to the sample change position and the cover can be lifted and the sample withdrawn. This action automatically shields the source. The design of the probe ensures the cover cannot be lifted unless the sample is in the change position.
Surface analysis type probes are used only with the Models 840 l and 880 analyzers or the PC based system. These probes vary in shape, shutter mechanism and number of sources used, but operate using similar principles. The basic operation of-these probes is to place the sample window of the probe on the object to be analyzed, expose the source, detect characteristic x-rays given off by the object and analyze these x-rays to determine the ,
elemental makeup of the object. i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Phy 21, 1999 PAGE 4 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
The SAPS probe contains a single source (either Am-241, Cd-109 or i Cm-244), a shutter mechanism, and associated electronics. The probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6" (15.2 cm) deep and is contained within a Zine (88%)
and Aluminum (12%) shell. A trigger and lever system mechanically operates the shutter mechanism. Source position is indicated by a flag in a window on the side of the probe (green for secured, red for exposed).
The SLPS contains a single source (Fe-55), an automatic mechanical shutter mechanism, and associated electronics.
Operation of the probe consists of placing the probe on the surface of the object to be analyzed. This action depresses a microswitch plunger located on the bottom of the probe which, in turn, rotates the shutter to the irradiate position. The shutter is automatically moved to the shielded position by a' return spring whenever the probe is removed from the sample surface.
This shutter assembly is the same as the one used with the older laboratory sample type probes. The probe measures approximately 3.3" (8.3 cm) wide by 6.5" (16.5 cm) long by 3.5" (8.9 cm) high and is contained within a Zinc (88%) and Aluminum (12%) shell.
The SSPS contains two sources (Am-241, Cd-109, or.Fe-55), dual shutter mechanisms operated by dual liquid nitrogen pneumatic systems, a liquid nitrogen dewar, and associated electronics.
The probe measures approximately 9.25" (23 5 cm) long by 4" (10.3 cm) wide by 9.75" (24.8 cm) high. Operation of the probe consists of the operator selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, and pulling the trigger. An electro-mechanical valve for source number one allows compressed nitrogen gas.to enter a pneumatic cylinder which pushes the source into the measurement position.
Once the surface has been' irradiated for the appropriate time interval the pneumatic cylinder is vented and a return spring pushes the source back into the shielded position. Once source
-number one is secured, source number two is moved to the measurement position in the same manner using an independent, identical pneumatic system. If desired, the operator may elect to irradiate the surface using only one source.
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) l NO : NR-701-D-101-B DATE: May 21, 1999 PAGE 5 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe l l
DESCRIPTION: (Cont'd) .
Motorex has stated that SSPS models with a serial number greater than 206562, will incorporate a reference source assembly to provide a reference spectrum when both shutters are closed. The reference source assembly contains a recessed hole for a reference source covered by a silver cover and an aluminum cover glued and craged (4 points) into placed. Each shutter mechanism is connected, by an aluminum rod, to the reference source assembly. When either shutter is open, the reference source holder is positior.ed off the axis of the x-ray detector.
Sources may be moved to the measurement position only if there is sufficient liquid nitrogen in the dewar and only if external power is applied. Source position is indicated by two windows (one for each source on either side of the probe). Green indicates source secured while red indicates source exposed.
Source position is additionally indicated by an LED indicator on the probe handle. This LED lights whenever either source is exposed.
The SSPS probe may be used with an optional sample chamber which can be attached to the bottom of the device. This sample chamber is used by inverting the probe, connecting the sample cover, placing the sample on the radiation window, closing the sample cover, and pressing the start button. Operation of the probe is not affected in this configuration.
The DOPS contains two sources (Am-241/Cm-244, Cd-109/Am-241, or Cd-109/Fe-55), an automatic shutter mechanism which sequentially exposes each source for a specific time period, and associated electronics. The probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6.5" (16.5 cm) long. Operation of the probe consists of selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, and pulling the trigger. The probe shutter mechanism consists of a two-piece shutter (one piece fixed and one piece movable) and a movable source holder. Pulling the trigger causes a mechanical linkage to slide the movable shutter and source holder in unison into a configuration which exposes source number one.
I
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO. NR-701-D-101-B DATE: thy 21,1999 PAGE 6 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Once the surface has been irradiated for the appropriate time interval, a microswitch releases the source holder which slides back to its original position. This action shields source number one and exposes source number two. Once the surface has been irradiated for the appropriate time interval, a microswitch releases the movable shutter which slides back into its original position, shielding source number two.
When used with a Model 820 analyzer, a LEPS and/or HEPS probe is built into the analyzer body. The construction of each probe is not modified for this type of application.
The Courier 8 analyzer is designed for continuos measurement of liquid samples. This analyzer contains a HEPS* probe mounted in a sample cell. When the probe is mounted, a lower support arm in the cell releases a safety catch in the probe allowing the shutter to open while locking the probe into the cell. This action exposes a radiation hazard label, indicating the probe is properly mounted and the shutter is open. With the shutter open, the probe cannot be removed from the cell. Disconnecting the probe automatically closes the probe. The sample cell is constructed with a 50 pm (1.97E-4 in) Mylar foil window. Should this window leak,.it would results in a short circuit between two metal concentric metal rings located around the window, sounding an alarm and stopping the sample flow.
Motores refers to the original HEPS probe as the HEPS 2171, and the HEPS that 'is incorporated as part of the Courier 8 analyser, as the HEPS 2412.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: May 21, 1999 PAGE 7 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Sources and maximum activities are authorized for use in the probes as listed in the tables below:
MODEL BY MANUFACTURER MAXIMUM ISOTOPE ISOTOPE ACTIVITY AMERSHAM DuPont Mereck PRODUCTE Iron-55 80 mci /3.0 GBq IEO.Al NER-460 A XFB
, IEC.D1 Curium-244 100 mci /3.7 GBq CLCL XFB Cadmium-109 20 mci /0.7 GBq CUC.D1 NER-465 XFB CUC.D1N Americium-241 30 mci /1.1 GBq AMC.D2 NER-478 GFS & XFB
- 50 mci /1.9 GBq for Model XFB.
MAXIMUM ACTIVITY BY PROBE TYPE (mci /GBq)
ISOTOPE SLPS LSP SAPS _DOPS SSPS Iron-55(annular) 40/1.5 80/3.0 --- --- ---
Iron-55(disc) ---
40/1.5 40/1.5 40/1.5 40/1.5 Curium-244 ---
100/3.7 100/3.7 100/3.7 ---
Cadmium-109 ---
20/0.7 20/0.7 20/0.7 20/0.7 Americium-241 ---
30/1.1 30/1.1 30/1.1 30/1.1
- Laboratory Sample Probe; includes LEPS, HEPS and Courier 8.
SSPS probes with a serial number greater than 206562, also contains V.G. Khlopin Radium Institute (Russia) Low Energy Photon Source that is registered as part of this registry sheet and is not registered separately. This source contains 1.3 pCi (50 kBq) of cadmium-109, and is 1 mm (0.04") in diameter by 0.2 mm'(0.008") thick.
j
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.- NR-701-D-101-B DATE: Eby 21,1999 PAGE 8 OF 12 {
DEVICE TYPE: X-Ray Fluorescence Probe LABELING:
1 Each probe will contain an identification label that meets 10 CFR 20 requirements and which includes the probe t' and serial number, source serial number, isotope, acti- ad date of assay. Additionally the probes intended fo ,tribution to persons generally licensed will contain a < .al license label in accordance with the requirements of 10 s 32.51.
DIAGRAM:
See Attachments 1 - 4.
CONDITIONS OF NORMAL USE:
The probes are designed for use in various environments including i laboratories, industrial plants, and outdoor field uses (e.g., j agricultural and mineral exploration). The probes may be used in portable and fixed applications. The probes are not expected to )
be subjected to corrosive atmospheres, excessive vibration, or extreme temperatures due to the fact that the devices require the operator to be present for operation. The manufacturer states that the expected useful lifetime of each probe is 10 to 15 years.
PROTOTYPE TESTING:
The sealed sources used in the probes have achieved the minimum ANSI classifications as shown below:
MODEL NO. ANSI RATING IEC.Al 77C33232 IEC.D1 77C54344 CLCL 77C54444 CUC.D1 68C44344 CUC.D1N 68C44344 AMC.D2 77C64545 NER-460 A 68C32212 NER-465 68C33232 NER-478 68C43333 XFB 68C32232 !
GFS 77C64545
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 9 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe s
l PROTOTYPE TESTING: (Cont'd)
The DOPS and SSPS probes were subjected to shutter reliability tests which continuously operated the shutter mechanism for more than 100,000 cycles for the DOPS probe and 250,000 cycles for the SSPS probe. The manufacturer reported no appreciable wear or problems associated with the operation of the shutter mechanisms following the tests.
These probes (excluding the SSPS, and Courier 8 Models) have been approved by the state of Texas for Columbia Scientific, Inc.,
since 1988 with no reported equipment failures.
EXTERNAL RADIATION LEVELS:
Metorex reports that the highest dose rates exhibited by the DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS probes are 0.2 mR/hr (2 pSv/hr) at 1.97" (5 cm) and less than 0.05 mR/hr (0.5 pSv/hr) at 11.8"(50 cm).
Similarly, Motorex reports that the highest dose rates exhibited by the Courier 8 analyzer are 1.3 mR/hr (13.0 pSv/hr) at 1.97" j (5 cm) and 0.09 mR/hr (0.9 pSv/hr) at 11.8" (30 cm).
i OUALITY ASSURANCE AND CONTROL:
Metorex has agreed to abide by the quality assurance and control standards previously submitted by Princeton Gamma-Tech, and found to be adequate by the NRC. These Quality Assurance standards cover the following areas:
- 1) Quality Assurance Organization;
- 2) General Quality Assurance Policy;
- 3) Incoming Inspections and Vendor Qualifications;
- 4) Test Procedures;
- 5) Personnel Training:
- 6) Non-Conforming Items Policy (Rejects);
- 7) Document Control;
- 8) Final Testing;
- 9) Quality Audits and Reports.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Phy 21,1999 PAGE 10 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE :
Probes intended for distribution to persons generally licensed pursuant to Section 31.5, 10 CFR Part 31, must be initially transferred in accordance with the requirements of Section 32.51, 10 CFR Part 32 or equivalent provisions of an Agreement State.
- Probes shall be tested for leakage at intervals not to exceed 6 months using techniques and instrumentation capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- Probes intended for use by persons generally licensed shall be initially tested for proper operation of the source exposure mechanism, safety warning components, labels, external radiation levels and leak tested by Motorax, Inc., or other persons specifically licensed by the NRC or an Agreement State.
- This registration sheet and the information contained within the references shall not be changed without the written. consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information submitted and test data cited below, we continue to conclude that Metorex, Inc., has provided reasonable assurance that:
- Probes limited herein can be safely operated by persons not having training in radiological protection.
- Under ordinary conditions of handling, storage, and use {
of the devices, the byproduct material contained in the l devices will not be released or inadvertently removed from the devices, and it is unlikely that any person will receive in one year a dose in excess of 10 percent ,
of the limits specified in Section 20.1201(a), 10.CFR Part 20.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
'NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 11 OF 12 f
DEVICE TYPE: X-Ray Fluorescence Probe SAFETY ANALYSIS
SUMMARY
- (Cont'd)
Under accident conditions (such as fire and explosion) associated with handling, storage and use of the device, it is unlikely that any persons would receive t an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified below.
PART OF BODY DOSE Whole body; head and trunk active blood-forming organs; gonads; or lens of eye 15 rem (0.15 Sv)
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter 200 rem (2.0 Sv)
Other organs 50 rem (0.5 Sv)
Furthermore, continue to conclude that these devices would be expected to maintain their containment integrity for normal conditions of use and accidental conditions which might occur during uses specified in this certificate.
REFERENCES:
The following supporting documents for the Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS, X-Ray Fluorescence Probes and the Courier 8 analyzer, are hereby incorporated by reference and are made a part of thic registry document.
- Princeton Gamma-Tech, Inc. letters dated December 30,1985, January 15, 1987, May 18, 1987, June 12, 1987, and May 5, 1988.
4
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.i NR-701-D-101-B DATE: Fby 21, 1999 PAGE 12 OF 12
' DEVICE TYPE: X-Ray Fluorescence Probe
REFERENCES:
(Cont'd)
Outokumpu Electronics, Inc, letters dated February 8, 1991, September 12, 1991, February 3, 1992, October 9, 1992, December 18, 1992, December 30, 1992, February 22, 1993, March 29, 1993, and April 29, 1993, with enclosures thereto.
- Metorex Incorporated's letters dated March 5, 1999, July 24, 1995, and July 5, 1994, with enclosures thereto.
- Motorex Incorporated's email dated May 7, 1999.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
-Date: bby 21, 1999 Reviewer:
Uja g hachu, P. Eng Date: May 21, 1999 Concurrence:
J%nP. dfnkovich, Ph.D.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-101-B DATE: May 21, 1999 ATTACHMENT 4 l
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Courier 8 Analyzer (P/N 1: HEPS Probe)
Note: Other parts listed in background file 1
, John I. H. Patt:rson, Ph.D. !
Metor:x, Inc. May 21, 1999 Princ: ton Crossroads Corporate Center 250 Phillips Boulevard Ewing, NJ 08618
)
Dear Dr. Patterson:
^ - ~
l Based on the information and test data submitted in your amendment request dated l December 4,1998, and follow-up correspondence dated March 5,1999, we conclude the i modified SSPS probe and Courier 8 analyzer are acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR-701-D-101-B).
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
1 Please read over the registration certificate in its entirety and notify us immediately of any errors or ornissions.
You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fces in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
If you have any questions, please contact me at (301) 415-5799 or Mr. John Jankovich at (301) 415-7904.
Sincerely, l5 Eric B. Compton, Engineering Aide Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards
Enclosure:
As stated cc w/ encl: SKimberley; LFDCB ,
A. Randolph Blough, Director, DNMS, RG-1 '
Distribution:
IMNS r/f SSD-99-01 NE0d SSD File # NR-701-D-101-B j 1
DOCUMENT NAME: H:\ERIC\COMPLTR\NR701101. CMP Ta receive e copy of this document, Indicate in the box: 'C' = Copy without attachment' enclosure 'E' = Copy with attachment / enclosure *N* = No copy I OFFICE MSIB lC MSIB m lO l NAME ECompton E JJankovich M DATE Og/J /99 OM /99 d d ICIAL RECORD COPY
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVTCE (AMENDED IN ITS ENTIRETY)
NO,: NR-701-D-101-B DATE: bby 21, 1999 PAGE 1 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe MODELS: DOPS, HEPS, LEPS, SAPS, SLPS, SSPS f (Formerly 820, 840, 880) Probes I and Courier 8 Analyzer DISTRIBUTOR: Metorex Incorporated *
(formerly Outokumpu Electronics, Inc.)
860 Town Center Drive Langhorne, PA 19047 MANUFACTURER: Metorex International, Oy (formerly Outokumpu Instruments)
P.O. Box 85 SF-02201 Espoo, Finland SEALED SOURCE MODEL DESIGNATION: Various; See Table in Description Section ISOTOPE: MAXIMUM ACTIVITY:
Americium-241 30 mci (1.11 GBq)
Cadmium-109 20 mci (0.74 GBq)
Curium-244 100 mci (3.70 GBq)
Iron-55 80 mci (2.96 GBq)
LEAK TEST FREOUENCY: 6 months PRINCIPAL USE: (U) X-Ray Fluorescence CUSTOM DEVICE: YES X NO
%C-j CL ' & lb{f'
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: thy 21,1999 PAGE 2 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION:
The Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS X-ray Fluorescence Probes and Courier 8 analyzer are devices designed to perform element analysis of various materials in different environments. The probes are designed for use in laboratory or industrial plant environs or under field conditions. The Models HEPS, LEPS, SAPS, and SLPS probes are the same probes which were previously registered by Princeton Gamma Tech with the 820, 840, and 880 X-ray Fluorescence Analyzers. The Model DOPS has been previously registered for Columbia Scientific by the State of Texas with the Model 880 X-ray Fluorescence Analyzer. The Model SSPS operates similar to the SAPS probe, but using two sources.
The previously registered Models 820, 840, and 880 X-ray Fluorescence Analyzers included the probes as well as an external analyzer. The Models 820, 840, and 880 analyzers contain a power supply and controlling electronics and perform an analysis of data received from the probes. These analyzers contain no radioactive material. The probes may be used with the models 820, 840, or 880 analyzers or attached to a personal computer (PC) containing software developed by the manufacturer. The manufacturers PC based software operates the probes in the same manner as the analyzers. The probes will be plugged directly into the PC via an expansion card installed in the PC. No modification to the probes is necessary for use with the PC based system.
Each of the Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS probes contain one or two radioactive sources. There are two general categories of probes; the laboratory sample type probe and the surface analysis type probe. A laboratory sample type probe contains a sample chamber into which discrete samples are placed in order to perform elemental analysis. This type of probe may be either a Light Elements Probe System (LEPS) or a Heavy Elements Probe System (HEPS). A surface analysis type probe is physically placed on the surface of an object in order to perform elemental analysis of the object or materials within the object.
This type of probe may be either a Surface Analysis Probe System (SAPS), a Surface Anrlysis Probe System for Light Elements (SLPS), a Solid Fit..e Probe System (SSPS), or a Dual Source Surface Probe ( DC PS) .
I 1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO : NR-701-D-101-B DATE: Fby 21,1999 PAGE 3 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Laboratory sample type probes contain a radioactive source (Am-241, Cd-109, or Cm-244 for the HEPS or Fe-55 for the LEPS), a sample chamber, a chamber cover, a slide or shutter mechanism, shielding and associated electronics. The probes measure approximately 3.25" (8.3 cm) wide by 6.5' (16.5 cm) long by 3.5" (8.9 cm) high. Older laboratory sample type probes employ an automatic shutter mechanism to shield the source when not in use.
Whenever a sample is placed in the sample chamber and the sample lid is closed, the shutter is automatically withdrawn to allow for irradiation of the sample. Characteristic X-rays given off by the sample are detected by the probes and analyzed either by a Model 820, 840, or 880 analyzer or by the PC software. The shutter is automatically moved to the shielded position by a return spring whenever the sample lid is opened.
Newer laboratory sample type probes employ a slide mechanism in order to shield the source during sample change. Operation of the probe consists of opening the sample cover, inserting a sample, closing the sample cover and sliding the sample into the measurement position. Sliding the sample into the measurement position exposes the source which irradiates the sample. Once the analysis is complete, the sample chamber is drawn back to the sample change position and the cover can be lifted and the sample withdrawn. This action automatically shields the source. The design of the probe ensures the cover cannot be lifted unless the sample is in the change position.
Surface analysis type probes are used only with the Models 840 and 880 analyzers or the PC based system. These probes vary in shape, shutter mechanism and r. umber of sources used, but operate using similar principles. The basic operation of these probes is to place the sample window of the probe on the object to be ;
analyzed, expose the source, detect characteristic x-rays given off by the object and analyze these x-rays to determine the elemental makeup of the object.
l 1
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Eby 21, 1999 PAGE 4 OF 12 l DEVICE TYPE: X-Ray Fluorescence Probe l DESCRIPTION: (Cont'd)
The SAPS probe ccntains a single source (either Am-241, Cd-109 or Cm-244), a shutter mechanism, and associated electronics. The probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6" (15.2 cm) deep and is contained within a Zine (88%)
and Aluminum (12%) shell. A trigger and lever system mechanically operates the shutter mechanism. Source position is indicated by a flag in a window on the side of the probe (green for secured, red for exposed).
The SLPS contains a single source (Fe-55), an automatic mechanical shutter mechanism, and associated electronics.
Operation of the probe consists of placing the probe on the surface of the object to be analyzed. This action depresses a microswitch plunger located on the bottom of the probe which, in turn, rotates the shutter to the irradiate position. The shutter is automatically moved to the shielded position by a return spring whenever the probe is removed from the sample surface.
This shutter assembly is the same as the one used with the older laboratory sample type probes. The probe measures approximately 3.3" (8.3 cm) wide by 6.5" (16.5 cm) long by 3.5" (8.9 cm) high and is contained within a Zinc (88%) and Aluminum (12%) shell.
The SSPS contains two sources (Am-241, Cd-109, or Fe-55), dual shutter mechanisms operated by dual liquid nitrogen pneumatic systems, a liquid nitrogen dewar, and associated electronics.
The probe measures approximately 9.25" (23.5 cm) long by 4" (10.3 cm) wide by 9.75" (24. 8 cm) high. Operation of the probe consists of the operator selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, and pulling the trigger. An electro-mechanical valve for source number one allows compressed nitrogen gas to enter a pneumatic cylinder which pushes the source into the measurement position.
Once the surface has been irradiated for the appropriate time interval the pneumatic cylinder is vented and a return spring pushes the source back into the shielded position. Once source number one is secured, source number two is moved to the measurement position in the same manner using an independent, identical pneumatic system. If desired, the operator may elect to irradiate the surface using only one source.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVWE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: May 21, 1999 PAGE 5 0F 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd) ,
Motorex has stated that SSPS models with a serial number greater than 206562, will incorporate a reference source assembly to provide a reference spectrum when both shutters are closed. The reference source assembly contains a recessed hole for a reference source covered by a silver cover and an aluminum cover glued and swaged (4 points) into placed. Each shutter mechanism is connected, by an aluminum rod, to the reference source assembly. When either shutter is open, the reference source holder is positioned off the axis of the x-ray detector.
Sources may be moved to the measurement position only if there is sufficient liquid nitrogen in the dewar and only if external power is applied. Source position is indicated by two windows (one for each source on either side of the probe). Green indicates source secured while red indicates source exposed. j Source position is additionally indicated by an LED indicator on i the probe handle. This LED lights whenever either source is exposed.
The SSPS probe may be used with an optional sample chamber which can be attached to the bottom of the device. This sample chamber is used by inverting the probe, connecting the sample cover, placing the sample on the radiation window, closing the sample cover, and pressing the start button. Operation of the probe is not affected in this configuration.
The DOPS contains two sources (Am-241/Cm-244, Cd-109/Am-241, or Cd-109/Fe-55), an automatic shutter mechanism which sequentially exposes e 5 source for a specific time period, and associated electrons ;. The probe measures approximately 2" (5.1 cm) wide by 8" (20.3 cm) high by 6.5" (16.5 cm) long. Operation of the probe consists of selecting the source or sources to be used, placing the radiation window on the surface to be analyzed, and pulling the trigger. The probe shutter mechanism consists of a two-piece shutter (one piece fixed and one piece movable) and a movable source holder. Pulling the trigger causes a mechanical linkage to slide the movable shutter and source holder in unison into a configuration which exposes source number one.
1
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i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-0-101-B DATE: May 21, 1999 PAGE 6 OF 12
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DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Once the surface has been irradiated for the appropriate time interval, a microswitch releases the source holder which slides back to its original position. This action shields source number one and exposes source number two. Once the surface has been irradiated for the appropriate time interval, a microswitch releases the movable shutter which slides back into its original position, shielding source number two.
When used with a Model 820 analyzer, a LEPS and/or HEPS probe is built into the analyzer body. The construction of each probe is not modified for this type of application.
The Courier 8 analyzer is designed for continuos measurement of liquid samples. This analyzer contains a HEPS* probe mounted in a sample cell. When the probe is mounted, a lower support arm in the cell releases a safety catch in the probe allowing the shutter to'open while locking the probe into the cell. This action escposes a radiation hazard label, indicating the probe is properly mounted and the shutter is open. With the shutter open, the probe cannot be removed from the cell. Disconnecting the probe automatically closes the probe. The sample cell is constructed with a 50 11m (1.97E-4 in) Mylar foil window. Should this window leak, it would results in a short circuit between two metal concentric metal rings located around the window, sounding an alarm and stopping the sample flow.
l Motorex refers to the original HEPS probe as the HEPS 2171, and the HEPS that is incorporated as part of the Courier 8 analyser, as the REPS 2112.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.- NR-701-D-101-B DATE: May 21, 1999 PAGE 7 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe DESCRIPTION: (Cont'd)
Sources and maximum activities are authorized for use in the probes as listed in the tables below:
MODEL BY MANUFACTURER MAXIMUM ISOTOPE ISOTOPE ACTIVITY AMERSHAM DuPont Mereck PRODUCTS Iron-55 80 mci /3.0 GBq IEC.Al NER-460 A XFB
. IEC.D1 Curium-244 100 mci /3.7 GBq CLCL XFB Cadmium-109 20 mci /0.7 GBq CUC.D1 NER-465 XFB CUC.D1N Americium-241 30 mci /1.1 GBq AMC.D2 NER-478 GPS & XFB 50 mci /1.9 GBq for Model XFB.
MAXIMUM ACTIVITY BY PROBE TYPE (mci /GBq)
ISOTOPE SLPS LSP SAPS DOPS SSPS Iron-55(annular) 40/1.5 80/3.0 --- --- ---
Iron-55(disc) ---
40/1.5 40/1.5 40/1.5 40/1.5 Curium-244 ---
100/3.7 100/3.7 100/3.7 ---
Cadmium-109 ---
20/0.7 20/0.7 20/0.7 20/0.7 Americium-241 ---
30/1.1 30/1.1 30/1.1 30/1.1 Laboratory Sample Probe; includes LEPS, HEPS and Courier 8.
SSPS probes with a serial number greater than 206562, also contains V.G. Khlopin Radium Institute (Russia) Low Energy Photon Source that is registered as part of this registry sheet and is not registered separately. This source contains 1.3 pCi (50 kBq) of cadmium-109, and is 1 tem (0.04") in diameter by 0.2 mm (0.008") thick.
1 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: Fby 21, 1999 PAGE 8 OF 12 {
l I
DEVICE TYPE: X-Ray Fluorescence Probe LABELING:
Each probe will contain an identification label that meets 10 CFR 20 requirements and which includes the probe type and serial number, source serial number, isotope, activity and date of assay. Additionally the probes intended for distribution to persons generally licensed will contain a general license label in accordance with the requirements of 10 CFR 32.51.
DIAGRAM:
See Attachments 1 - 4.
CONDITIONS OF NORMAL USE:
The probes are designed for use in various environments including laboratories, industrial plants, and outdoor field uses (e.g.,
agricultural and mineral exploration). The probes may be used in portable and fixed applications. The probes are not expected to be subjected to corrosive atmospheres, excessive vibration, or extreme temperatures due to the fact that the devices require the operator to be present for operation. The manufacturer states that the expected useful lifetime of each probe is 10 to 15 years.
PROTOTYPE TESTING:
The sealed sources used in the probes have achieved the minimwm ANSI classifications as shown below:
MODEL NO. ANSI RATING IEC.Al 77C33232 IEC.D1 77C54344 CLCL 77C54444 CUC.D1 68C44344 CUC.DlN 68C44344 AMC.D2 77C64545 NER-460 A 68C32212 NER-465 68C33232 NER-478 68C43333 XFB 68C32232 GFS 77C64545 3
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: May 21, 1999 PAGE 9 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe PROTOTYPE TESTING: (Cont'd)
The DOPS and SSPS probes were subjected to shutter reliability tests which continuously operated the shutter mechanism for more than 100,000 cycles for the DOPS probe and 250,000 cycles for the SSPS probe. The manufacturer reported no appreciable wear or problems associated with the operation of the shutter mechanisms following the tests.
These probes (excluding the SSPS, and Ccurier 8 Models) have been approved by the state of Texas for Columbia Scientific, Inc.,
since 1988 with no reported equipment failures.
EXTERNAL RADIATION LEVELS:
Metorex reports that the highest dose rates exhibited by the DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS probes are 0.2 mR/hr (2 pSv/hr) at 1.97" (5 cm) and less than 0.05 mR/hr (0.5 pSv/hr) at 11.8"(30 cm).
Similarly, Motorex reports that the highest dose rates exhibited by the courier 8 analyzer are 1.3 mR/hr (13.0 pSv/hr) at 1.97" (5 cm) and 0.09 mR/hr (0.9 pSv/hr) at 11.8" (30 cm).
1 OUALITY ASSURANCE AND CONTROL:
Metorex has agreed to abide by the quality assurance and control i standards previously submitted by Princeton Gamma-Tech, and found l to be adequate by the NRC. These Quality Assurance standards I cover the following areas:
- 1) Quality Assurance Organization;
- 2) General Quality Assurance Policy;
- 3) Incoming Inspections and Vendor Qualifications;
- 4) Test Procedures;
- 5) Personnel Training;
- 6) Non-Conforming Items Policy (Rejects);
- 7) Document Control;
- 8) Final Testing;
- 9) Quality Audits and Reports.
1
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,: NR-701-D-101-B DATE: May 21, 1999 PAGE 10 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE :
- Probes intended for distribution to persons generally licensed pursuant to Section 31.5, 10 CFR Part 31, must be initially transferred in accordance with the requirements of Section 32.51, 10 CFR Part 32 or equivalent provisions of an Agreement State.
- Probes shall be tested for leakage at intervals not to exceed 6 months using techniques and instrumentation capable of detecting 0.005 microcurie (185 Bq) of removable contamination.
- Probes intended for use by persons generally licensed shall be initially tested for proper operation of the source exposure mechanism, safety warning components, labels, external radiation levels and leak tested by Motorex, Inc., or other persons specifically licensed by the NRC or an Agreement State.
- This registration sheet and the information contained within the references shal? not be changed without the written consent of the NPC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information submitted and test data cited below, we continue to conclude that Metorex, Inc., has provided reasonable assurance that:
- Probes limited herein can be safely operated by persons not having training in radiological protection.
- Under ordinary conditions of handling, storage, and use of the devices, the byproduct material contained in the devices will not be released or inadvertently removed from the devices, and it is unlikely that any person will receive in one year a dose in excess of 10 percent of the limits specified in Section 20.1201(a), 10 CFR Part.20.
r 1 4
REGICTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B RATE: Fby 21, 1999 PAGE 11 OF 12 i
i
. DEVICE TYPE: X-Ray Fluorescence Probe SAFETY ANALYSIS
SUMMARY
- (Cont'd) l
- Under accident conditions (such as fire and explosion) l associated with handling, storage and use of the device, it is unlikely that any persons would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified below.
i l PART OF BODY DOSE l
r Whole body; head and trunk ,
l active blood-forming organs; gonads; or lens of eye 15 rem (0.15 Sv)
Hands and forearms; feet and ankles; locali' zed areas of skin averaged over areas no larger j than 1 square centimeter 200 rem (2.0 Sv) l Other organs 50 rem (0.5 Sv)
Furthermore, continue to conclude that these devices would be expected to maintain their containment integrity for normal
' conditions of use and accidental conditions which might occur during uses specified in this certificate.
i
REFERENCES:
i The following supporting documents for the Models DOPS, HEPS, LEPS, SAPS, SLPS, and SSPS, X-Ray Fluorescence Probes and the Courier ~8 analyzer, are hereby incorporated by reference and are made a part of this registry document.
- Princeton Gamma-Tech, Inc. letters dated December 30,1985, January 15, 1987, May 18, 1987, June 12, 1987, and May 5, 1988.
L
i REGISTAY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-D-101-B DATE: bby 21, 1999 PAGE 12 OF 12 DEVICE TYPE: X-Ray Fluorescence Probe
REFERENCES:
(Cont'd)
Outokumpu Electronics, Inc. letters dated February 8, 1991, September 12, 1991, February 3, 1992, October 9, 1992, December 18, 1992, December 30, 1992, February 22, 1993, March 29, 1993, and April 29, 1993, with enclosures thereto.
- Metorex Incorporated's letters dated March 5, 1999, July 24, 1995, and July 5, 1994, with enclosures thereto.
- Motorex Incorporated's email dated May 7, 1999.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date: May 21, 1999 Reviewer:
Ujagg hachu, P. Eng L
Date: Fby 21,1999 a4 P ' cJSv41v Concurrence: A Jphn P. h6nkovich, Ph.D.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEV7FE (AMENDED IN ITS ENTIRETY)
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-701-101-B DATE: May 21, 1999 ATTACHMENT 2 ,
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9 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
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