ML20195B203
| ML20195B203 | |
| Person / Time | |
|---|---|
| Issue date: | 11/12/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20195B187 | List: |
| References | |
| SSD, NUDOCS 9811160062 | |
| Download: ML20195B203 (13) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0701-D-104-B DATE: ggy12 tG8 E' AGE 1 OF 9 DEVICE TYPE:
X-Ray Fluorescence Analyzer MODEL:
SIPS Probe DISTRIBUTOR:
Metorex Inc.
Princeton Crossroads Corporate Center 250 Phillips Boulevard Center Ewing, NJ 08618
?lANUFACTURER:
Metorex International Oy P.O.
Box 85 SF-02201 Espoo, Finland SEALED SOURCE MODEL DESIGNATION:
Amersham Corporation:
IEC.D1, CUC.D1N, CUC.D1, AMC.D2 Isotope Products Laboratories:
XFB Series, PHI-241 GFS Series ISOTOPE:
MAXIMUM ACTIVITY:
Fe-55 40 mci (1.5 GBq)
Cd-109 20 mci (0.8 GBq)
Am-241 30 mci (1.1 GBq)
LEAK TEST FREOUENCY:
6 Months PRINCIPAL USE:
(U) X-Ray Fluorescence CUSTOM DEVICE:
YES X
NO 9811160062 981112 PDR RC e
l-
@ uuvsvu
___.__-_._.__._m.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) j NO.: NR-0701-D-104-B DATE: NOV 12156 PAGE 2 OF 9 DEVICE TYPE:
X-Ray Fluorescence Analyzer i
DESCRIPTION:
l l
The SIPS probe is a hand-held x-ray fluorescence probe (see attachment 1), designed for measurement of surface types or extended' samples, mainly alloys, composites, and other solids L
such as rocks, minerals, and soils.
The probe may house two radioactive sources that are located symmetrically on the opposite sides of the probe axis, in the tapered snout of the probe, as well as the necessary electronic equipment to run the device.
The probe has the shape of a pistol with a ribbed cylindrical body, approximately 250 mm (9.85 in) long and 76 mm l
(2.99 in) in diameter.
The main body of the probe is aluminum alloy consisting of the. ribbed cylinder, a base and back cover.
The cylinder is screwed in to the base and then secured with two locking allen head screws.
The end cap is attached to the base with four allen head' screws and cannot be easily detached since the screws are neither visible or assessable from the outside.
1 The probe handle is attached to the' cylinder by tongue-and-j groove, and is also secured with allen head screws.
I Sources are pointed at an angle of approximately 45 degrees from the opening above the detector (see attachment 2).
This opening (window) is covered with 50.8 pm (0.002 in) thick Kapton foill, held in place by an aluminum plate.
Each source is installed in a densimeta cup which is threaded to a brass holder.
This assembly is. enclosed in a cup-like shutter made of densimet.
The thinnest part of each shutter is 1 mm (0.04 in) thick. The shutters have an opening, that expose the source when properly oriented.
To expose the source, each shutter rotates 180 degrees on its axis,-parallel to the axis of the probe. The shutters are controlled individually by electric motors.
When the motor drives the shutter open it loads a torsional spring, mounted to the shaft of each motor, that is able to return the shutter back to the closed position in case of power loss. The inner surface of.the end cap is lined with 0.5 mm (0.02 in) of lead sheet, glued in place with loctite.
The middle part of the end cap, which provide support for the measuring window and shielding, is made of tungsten.
The measurement is started by placing the probe snout against the sample and pushing the trigger switch located in the probe handle. The measurement is terminated after the preprogrammed j
'.Kapton: polyimide film manufactured by Dupont.
2 ;Densimet alloy: 95% tungsten, 3% nickel and 2% iron.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0701-D-104-B DATE: NOV 121B8' PAGE 3 OF 9 DEVICE TYPE:
X-Ray Fluorescence Analyzer DESCRIPTION (Cont.):
time of measurement elapses or by pressing the trigger switch before the preset measurement time elapses.
The shutters operate in a sequence with only one source exposed at a time.
There are two red light emitting diodes (LED) in the back on the probe.
The left one is lit whenever a measurement is initiated, that is whenever any of the two sources is exposed.
The other LED turns on only when either of the shutters is in the transition between open and closed. In addition, the probe has two mechanical shutter position indicators, one per shutter.
A red color " flag" is painted on each shutter.
The end cap has on one side two small see-through lexan windows which the flag appears in when source is exposed.
Whenever not in use, the probe snout is covered with a special cover (see attachment 3a), which protects the probe window from damage and also served as additional radiation shielding.
The end cover is made of aluminum alloy and is lined with 2 mm (0.08 in) covered with a 0.5 mm (0.02 in), 25 mm (0.98 in) copper disk.
When small parts have to be measured that do not cover the end cap during measurements, a small sample cover is used (see attachment 3b), similar in shape to the end cover except taller to allow more room for the sample.
The SIPS probe is used principally with the Metorex Model 960 Portable XRF Analyzer for measurements on location (in-situ).
LABELING:
Small radioisotope labels, are placed on the measuring head of the probe, one for each isotope used in the device containing:
the radiation trefoil, the words " CAUTION RADIOACTIVE MATERIAL" and "REVOMAL OF THIS LABEL IS PROHIBITED", the device model and serial numbers, isotope, isotope serial number, activity, date of assay, and manufacturer's name.
When the SIPS probe is distributed to a generally licensed user an additional label, meeting the requirements of 10 CFR 32.51, is placed on the body of the probe.
m_.
i I
1
' REGISTRY.0F RADIOACTIVE SEALED SOURCES AND DEVICES
. SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: -NR-0701-D-104-B DATE:.'NOV 12 tes PAGE 4 OF 9 DEVICE TYPE:
X-Ray l Fluorescence Analyzer
' LABELING (Cont.):
~An additional" label _ intended to inhibit disassembly of the probe will be' affixed-to the base:of'the probe covering access screws.
This. label states that only authorized personnel should open or service the device.
' DIAGRAM:
See attachments 1-3.
CONDITIONS OF NORMAL USE:
The probe is intended for measurements of extended surfaces such as. metal' plates,. bars,-rods, shaped,.etc. The measured object must cover.the window of the probe end cap. For small parts measurements the probe is mounted vertically on a stand, which is attached'to the probe back cover with a thumb screw.
Listed below arelthe normal operating conditions, as stated by Metorex, for.the SIPS probe:
Ambient temperature:
' Operation 0 to 50 C (32 to 122 F)
Storage
-20 to 85 C (-4 to 185 F)
Humidity:
Continuous operation at 20 to 95% RH, no condensation
' Air pressure during transport:
i 30 to 200 kPa (1/3 to 2 atm)
Shock resistance:
Vibration:
2 g, 10 to 150 Hz
]
L Bump:
25 g lMetorex estimates'the expected life cycle of the SIPS probes to
-I be at.leastJ5 years.
i I-l i
1 i
i' i
.~. -..- -
_~.- -. -.~_
i i
L REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE i
(AMENDED IN ITS ENTIRETY)
NO.: NR-0701-D-104-B DATE:
PAGE 5 OF 9 NOV12138 i
l DEVICE TYPE:
X-Ray Fluorescence Analyzer PROTOTYPE TESTING:
A prototype SIPS probe was subjected to a drop test.
It comprised of dropping the probe from various heights (300, 400, 550, 750, and 1000 mm) onto a concrete floor with industrial J
carpet (no foam under), glued to the concrete.
It was noticed that each time the probe was dropped the probe measuring head (snout) exhibited the tendency to hit the floor first because the probe snout is the heaviest part of the probe. The integrity of the source mechanism, shutters and shielding were not compromised l
by dropping the probe up to 1 m (39.4 in) in height.
No increase in dose rate was observed around the probe after the test.
Another SIPS probe was subjected to a 2 m (68.8 in) drop test onto a concrete floor.
The probe was dropped four times.
After the first drop, a functional test was performed.
It was discovered that the shutter did not open on impact, but after the functional test it remained open and did not close automatically.
l'
_The shutter was manually closed and the same probe was tested for drops 2-4.
The radiation measurements after the drop test indicated no increase in radiation levels.
A vibration test was performed on a SIPS probe.
The vibration was performed in the direction of the three principal axis for 30 minutes over a frequency range of 10 to 500 Hz with acceleration of 2 g. The probe did not sustain any damage and functioned normally after testing.
In addition, a SIPS probe was subjected to a reliability test.
-The probe executed 300,000 test cycles exercising shutter l'
mechanisms.
No noticeable signs of wear were observed in the probe mechanics after the test.
Metorex stated that the number of-cycles executed by the probe during the test was equivalent to more than 6 years of continuous operations, 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> / day.
i i
a
l
)
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0701-D-104-B DATE:
'NOV 121998 PAGE 6 OF 9 DEVICE TYPE:
X-Ray Fluorescence Analyzer EXTERNAL RADIATION LEVELS:
The following dose rates were reported by the manufacturer for the SIPS probe containing the following isotope combinations:
20 mci Cd2" and 40 mci Fe55, 30 mci Am'1 and 20 mci Cd2", and 2
~
30 mci Am241 and 40 mci Fe55 :
l Measured Dose Rates for SIPS Probe
[ mrem /hr(pSv/hr)]
Isotopes Cd-109/Fe-55 Am-241/Cd-109 Am-241/Fe-55 Fe-55 Shutter Cd closed Cd open Am closed Am open Am closed Am closed Am open open Position Fe closed Fe closed Cd closed Cd closed Cd open -
Fe closed Fe closed or closed 5cm
<0.05 3.0 0.1 0.65 3.0
<0.1 0.6
<0.05 i
(1.97 in)
(<0.5).
(30.0)
(1,0)
(6.5)
(30.0)
(<l.0)
(6.0)
(<0.5) 30 cm
<0.05 0.2 0.05 0.1 0.2 0.05 0.1
<0.05 (11.81 in)
(<0.5)
(2.0)
(0.5)
(l.0)
(2.0) -
(0.5)
(l.0)
(<0.5) 100 cm
<0.05
<0.05
<0.05 0.05
<0.05
<0.05 0.05
<0.05 (39.37 in)
(<0.5)
(<0.5)
(<0.5)
(0.5)
(<0.5)
(<0.5)
(0.5)
(<0.5)
The maximum dose rates at the back of the probe and at the 4
trigger never exceeded 0.05 mrem /hr (0.5 pSv/hr). When either the probe' cover or small sample. cover were placed over the probe snout, no dose rate measurement reading was reported higher than 0,05 mrem /hr, regardless of whether the shutter was open or closed.
!~
All measurements with shutter open were made with a 2 mm thick stainless steel standard placed over the probe measuring window (typical of normal use conditions).
.During measurement, the operator presses the probe against the l'
measured ~ object, pointing the probe snout away from himself, holding the probe by the handle.
It is reasonable to assume that l
l during normal operation of the probe, no part of the worker's body'would be closer than 30 cm to the radiation area in front of the probe snout.
Based on these realistic assumptions, Metorex's concluded that the maximum radiation dose to an operator per L
calendar year quarter is not likely to exceed 24 mrem (240 SV)
(8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> / day, 50%. duty cycle at 0.1 mrem /hr).
-~
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN,NOV 12168 ITS ENTIRETY)
NO.: NR-0701-D-104-B DATE:
PAGE 7 OF 9 DEVICE TYPE:
X-Ray Fluorescence Analyzer i
i l
u OUALITY ASSURANCE AND CONTROL-i l
l l
Metorex is an ISO 9001 certified company. Production of Metorex devices is performed under Q/A, Q/C procedures as required by the i
ISO 9001.
The analyzers and probes delivered to Metorex, Inc.
l from Finland for distribution are tested for operation, integrity l
of construction and assembly, accuracy of paper documentation, j
and analytical performance.
All SIPS probes will be wiped tested and surveyed for radiation levels prior to distribution.
. LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
l The device may be distributed to specific or general licensees of NRC or an Agreement State.
i
- Handling, storage, use, transfer, and disposal:
To be
]
L determined by the. licensing authority or, for general licensees, in.accordance with 10 CFR 31.5 or Agreement State l '
equivalent.
j L
- The device shall be leak tested at intervals not to' exceed i
6 months using techniques capable of detecting
'0.005' microcurie (185 Bq) of removable contamination.
o This registration sheet and the information contained within e
l the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Metorex has provided sufficient information to provide reasonable assurance that:
l
- The device can be safely operated by persons not having i
training in radiological protection.
- Under ordinary conditions of handling, storage, and use of the device, the byproduct material contained in the device will not be' released or inadvertently removed from the l.
_ _. ~ _ _ _ _
l.
i REGISTRY: OF RADIOACTIVE SEALED SOURCES AND DEVICES o
l SAFETY EVALUATION OF DEVICE j
j (AMENDED IN ITS ENTIRETY)
NO.: NR-0701-D-104-B pATE: NOV 12156 PAGE 8 OF 9
(~
DEVICE TYPE:
X-Ray Fluorescence Analyzer SAFETY ANALYSIS
SUMMARY
(Cont.)-
source housing, and it is unlikely that any person will receive in any period of one year a dose in excess of 10 percent of the limits specified in Section 20.1201 (a ),
l l
- Under accident conditions associated with handling, storage, l
and use of the source housing, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ as specified in the following chart:
PART OF ~20Y DOSE Whole body; head and trunk; active blood-forming organs; j
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) l Other organs 50 rem (0.50 Sv) 1 Based on review of the SIPS probe, and the information and test data cited below,, we' conclude that this device is acceptable for licensing' purposes.
L Furthermore, we conclude that this device would be expected to l
maintain it's containment integrity for normal conditions of use and likely accidental conditions which might occur during uses specified in this certificate.
1 I
l
~~..
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN' ITS ENTIRETY)
NO.: NR-0701-D-104-B DATE:
NOV 12 g PAGE 9 OF 9 DEVICE TYPE:
X-Ray Fluorescence Analyzer
REFERENCES:
The following supporting documents for the SIPS probe are hereby incorporated by reference and are made a part of this registry document.
Metorex's application dated October 16, 1997.
Metorex's letters dated April 19, 1998, June 17, 1998, July 6, 1998, October 12, 1998, and November 10, 1998, with i
enclosures thereto.
Metorex's facsimile-dated October 20, 1998.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission
/
.Date:
Reviewer:
/
~
ohn W.
Lubinski 12 3 Concurrence:
th
"*F5h Date:
' Tteven L. Baggett I
l
(
s i
l
REGISTRY OF RADICACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
EL MR-0701-D-104-B DATE:
ATTACHMENT 1 j
NOV 121998 f'
j LOCATION OF LEDs END CUP (SNOUT) j
]
l t(b\\k=
?"- '.&
4 a
I.
a
=
z =
n
-I
-s l s
{-%
7, m
3 1 s
t
=
g y
sul-l+:
-:1 i
ni "
fe' - -
e o
t Jll L J P
{f-llp 1lp r-7 1
l E
g TRIGGER SWITCH HANDLE i
W ii' P!
l 1:J 5!PS DP0]E i
I
~<r
.,.c
..n..,
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.
NR-0701-D-104-B RA_TE_;- 'NOV 12 Ig ATTACHMENT 2 END CAP (ALUMINUM)
I 3
4 MOTOR O
-SOURCE 2 Oh d-l I
~
rw
-LIMITER
~
[
(DENSIMET)
I
=
l
--DETECTOR
=
lk SOURCE HOLDER (ALUMINUM)
-~
IM f-_
p SHUTTER MOTOR 1
l l
(DENSIMET) t QL I
- =welE;B c--
<~ SOURCE 1 r--
l U
l6 I
l
!t
\\
f FLUORESCENCE SHIEL i
i l
l (ALUMINUM)
SOURCE BACKING (BRASS) ame
\\
\\
RETRACTING SPRING
\\
OPTICAL POSITION SENSOR
(
a
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-0701-D-104-B
_D_ ATE 1
'NOV 12 m ATTACHMENT 3 C)
^
3 m. -.r y
I
[
w a
s i
t j
/
n rr At 1
O 5
- % s..
q e
V i
s s
4 :- -
}
c-
,,, e
_______-c lGo.o _
'g
(
si 4
2mm P6 l
Nr l
4 i
o r
s
.es--
j g
m_
.C.. _ _ _ _ _
Q g
l Ii I
3.
I J'
k J
u t
1 w
(a)
(b)
PROBE END COVER AND SMALL SAMPLE COVER AND RADIATION SHIELD
11/11/1998 16: 48 16695309055 MXI:PRINCETCH PAGE 01 l
FAX TRANSMISSION METOREX INC.
250 PHitups BLVD.
Ewmo. NJ 0803S (0001400-9000 ext I 2 i fax: (6091530-9055 To:
MR JOHN LUBINSKI Date:
November 11,1998 Fax #:
301-415-5369 Pages:
15, including this cover sheet.
From:
Beth Schultz
Subject:
REGISTRY NO. NR-7071-D-104-B DEAR MR LUBINSKI, ATTACHED, PLEASE FIND A LETTER OF REQUEST AND FURTHER INFORMATION REGARDING THE ABOVE MENTIONED REGISTRY NUMBER. PLEASE BE AWARE THAT AS JOHN PATTERSON IS CURRENTLY OUT OF TOWN I AM SIGNING THIS LETTER ON HIS ' BEHALF. THE ORIGINAL OF THIS LETTER AS WELL AS SUPPORTING DOCUMENTATION IS BEING FORWARDED TO YOU TODAY VIA FEDERAL EXPRESS. IF YOU HAVE ANY QUESTIONS FOR JOHN, HE CAN BE REACHED AT (609)841-6632. IF YOU HAVE ANY QUESTIONS FOR ME,I CAN BE REACHED AT (609)406-9000 EXT 121.
SINCERELY,__
BETH SCHULTZ FINANCIAL ASSOCIATE METOREX INC.
--