ML020910037
| ML020910037 | |
| Person / Time | |
|---|---|
| Issue date: | 04/01/2002 |
| From: | Samson Lee NRC/NMSS/IMNS/MSIB |
| To: | |
| References | |
| SSD 02-13 | |
| Download: ML020910037 (10) | |
Text
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-1145-D-101-E DATE:
PAGE 1 OF 5 DEVICE TYPE:
Self-Luminous Flashlight MODELS:
Teknolite 2 Teknolite 4 DISTRIBUTOR:
Litepro, LLC 3731 North Country Club Drive, Suite 525 Aventura, FL 33180 MANUFACTURER:
Keens Tools, Inc.
49-1 Feng Hwa, Feng Hwa Tsuen Shin Shyh Hsiang, Tainan Hsien Taiwan, Republic of China Ningbo TLC Plastic Products Co., Ltd.
South of No. 329 National Highway Zhangqi Town, Cixi City Zhejiang Province, 315313 Peoples Republic of China SEALED SOURCE MODEL DESIGNATION:
mb-microtec 400/1 ISOTOPE:
MAXIMUM ACTIVITY:
Hydrogen-3 156 mCi (5.77 GBq) for Teknolite 4
78 mCi (2.88 GBq) for Teknolite 2 (39 mCi [1.44 GBq] for each source)
LEAK TEST FREQUENCY:
Not Required
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-1145-D-101-E DATE:
PAGE 2 OF 5 DEVICE TYPE:
Self-Luminous Flashlight PRINCIPAL USE:
(W) Self-Luminous Applications CUSTOM DEVICE:
YES X NO
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-1145-D-101-E DATE:
PAGE 3 OF 5 DEVICE TYPE:
Self-Luminous Flashlight DESCRIPTION:
The self-luminous flashlight Models Teknolite 2 and Teknolite 4 consist of lens cap, light-emitting diodes (LED), two o-rings, body casing, and three AA size batteries.
The lens cap is made of high-strength (shatterproof) clear polycarbonate, molded such that it includes four outer 90° opposing (or two outer 180° opposing), parallel cylindrical cavities (1.8 mm [0.07"] diameter, 11 mm [0.43"] deep). Each gaseous tritium light sources (GTLS) are installed in the lens cap of the Model Teknolite 2 and Teknolite 4 flashlights, respectively (1.4 mm [0.06"] outer diameter, 8 mm [0.31"] long),
manufactured by mb-microtec in Niederwangen, Switzerland, is inserted first in the cavity of the lens cap by Keens Tool, Inc.
A cylindrical silicone plug (1.8 mm [0.07"] diameter, 1 mm
[0.04"] thick) is subsequently inserted, which serves to absorb mechanical shock. The GTLS and silicone plug are then secured in-place with a translucent hard epoxy adhesive. The maximum activity for each GLTS is 39 mCi (1.44 GBq).
The conventional flashlight body casing is made of high-impact acrylonitrilebutadine styrene (high-impact ABS).
These Models are manufactured, tested, and packaged by Keens Tools, Inc. in Tainan Hsien, Taiwan, or Ningbo TLC Plastic Products Co., Ltd. in China, then shipped to Litepro, LLC (Litepro) warehouse facility (8439 NW 72nd Street, Miami, FL 33166), and distributed from that facility as an exempt product.
DIAGRAMS:
See Attachments 1 and 2.
LABELING:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-1145-D-101-E DATE:
PAGE 4 OF 5 DEVICE TYPE:
Self-Luminous Flashlight Each self-luminous lens cap is labeled with the isotope name (3H) and the website address (www.teknolite.com) established by the distributor to provide information exclusively on the Model Teknolite 2 and Teknolite 4 flashlights.
LABELING (Contd):
The above information is legibly and durably labeled on the lens cap. All labeling is expected to remain intact and legible throughout the life of the flashlight, even under extreme cases of normal use.
CONDITIONS OF NORMAL USE:
The use of self-luminous flashlight may include in-home use, automobile use, and outdoor sporting such as camping and boating. The environments would, therefore, be suitable for humans.
The useful life is estimated at eight years from the date of purchase, with a pre-purchase shelf life of no more than a few weeks or months.
PROTOTYPE TESTING:
Based on the total activity of 156 mCi (5.77 GBq) in gaseous form, ANSI/HPS N43.4-2000 requires the classification designation be T2GC1222222 as a minimum.
The Keens Tools, Inc. sent two fully-assembled prototypes to the mb-microtec. The mb-microtec performed prototype testing according to the T4GC1333333 classification. The test results indicated that the flashlights met the latter, more demanding, test conditions.
The results of the prototype testing demonstrated that the GTLS installed in the self-luminous flashlight will withstand
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-1145-D-101-E DATE:
PAGE 5 OF 5 DEVICE TYPE:
Self-Luminous Flashlight environmental and handling conditions at a level of higher than required in the testing standards accepted by the industry.
Furthermore, it can be concluded that under extreme conditions of normal use, the flashlight will likely cease to function prior to any compromise in the integrity of the GTLS holder.
QUALITY ASSURANCE AND CONTROL:
Litepro has submitted a quality assurance and control (QA/QC) program that has been found to be acceptable by NRC for the production and distribution of these self-luminous flashlights.
In addition, Litepro has submitted information concerning the QA/QC program of Keen Tools, Inc. and Ningbo TLC Plastic Products Co., Ltd. which, combined with periodic audits by Litepro, has been found to be acceptable. Copies of these programs are on file with the NRC.
LIMITATIONS AND OTHER CONSIDERATIONS OF USE:
- This registration sheet and the information contained with the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test data cited below, we continue to conclude that Litepro, LLC has submitted sufficient information to assure that the Models Teknolite 2 and Teknolite 4 self-luminous flashlights are designed and manufactured such that they will meet the safety criteria set forth in 10 CFR 32.23. In addition, we conclude that the Models Teknolite 2 and Teknolite 4 are acceptable for exempt licensing purposes.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-1145-D-101-E DATE:
PAGE 6 OF 5 DEVICE TYPE:
Self-Luminous Flashlight Furthermore, we continue to conclude that the Models Teknolite 2 and Teknolite 4 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 self-luminous flashlights are hereby incorporated by reference and are made a part of this registry document.
- Litepro, LLCs application dated May 23, 2001, with enclosures thereto.
REFERENCES (Contd):
- Professional Radiation Consulting, Inc.s letters dated July 24, 2001, August 10, 2001, and August 13, 2001, with enclosures thereto.
- Litepro, LLCs letters dated October 9, 2001, and October 15, 2001, with enclosures thereto.
- Litepro, LLCs letter dated March 20, 2002.
- Professional Radiation Consulting, Inc.s e-mail dated April 1, 2002, with enclosures thereto.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission Date:
Reviewer:
Seung J. Lee
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.: NR-1145-D-101-E DATE:
PAGE 7 OF 5 DEVICE TYPE:
Self-Luminous Flashlight Date:
Concurrence:
John P. Jankovich
REGISTRATION OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO:
NR-1145-D-101-E DATE:
ATTACHMENT 1 Lens Cap for Teknolite 2
REGISTRATION OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO:
NR-1145-D-101-E DATE:
ATTACHMENT 2
REGISTRATION OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO:
NR-1145-D-101-E DATE:
ATTACHMENT 3 Body Casing