ML20155C524
| ML20155C524 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20155C475 | List: |
| References | |
| SSD, NUDOCS 9811020256 | |
| Download: ML20155C524 (3) | |
Text
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,:NR-1040-D-101-E DATE: October 29, 1998 PAGE 1 OF 3 DEVICE TYPE: Smoke Detector MODEL: EIl00 BUS, EIl00 SUS, EIl00LUS and 1001 DISTRIBUTOR: Hemisphere Forwarding, Inc.
7 Cerro Street Inwood, NY 11696 MANUFACTURER: E.I. Company Ltd.(Model Nos. EIl00 BUS, EIl00 SUS, and EIl00LUS)
Shannon Free Airport, Co. Clare Shannon, Ireland Garvan Enterprises Ltd. (Model No. 1001)
Wing Hing Industrial Building 83-92 Chai Wan Kok St.
Tsuen Wan, N.T. Hong Kong SEALED SOURCE DESIGNATION:
i Nuclear Radiation Development Model A001 (for Smoke Detector Model Nos. EIl00 BUS, EIl00 SUS, and EIl00LUS)
Amersham Model AMM1001H (for Smoke Detector Model No. 1001)
ISOTOPE: MAXIMUM ACTIVITY:
Americium-241 1.0 microcurie (37.0 kBq)
LEAK TEST FREOUENCY: Not required PRINCIPAL USE: (P) Ion Generator, Smoke Detectors CUSTOM DEVICE: YES X NO 981102O256 981028 PDR RC SSD PDR +
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,:NR-1040-D-101-E DATE; October 29, 1998 PAGE 2 OF 3 DEVICE TYPE: Smoke Detector DESCRIPTION:
l The detection chamber design is identical for Model Nos.
l EIl00 BUS, EIl00 SUS, and EIl00LUS. The source is swaged to a stainless steel electrode, which itself is secured by soldering at three different locations to a printed circuit board. The stainless steel electrode is clasped onto a Noryl SE100 insulator which also has a nickel silver electrode clasped to the other side. Interfacing to the smoke detector electronics is accomplished through the nickel silver electrode. The complete insulator / electrode assembly is covered by a carbon filled l polypropolene chamber cover which is secured to the printed l circuit board and the smoke detector base using a tamper-resistant screw and nut. Shielding is provided by this chamber cover and the external cover.
Model EIl00 BUS is the standard smoke detector containing no added features. Model EIl00 SUS is similar to Model EIl00 BUS except that it has a silencer feature which desensitizes the unit when a switch is depressed. Model EIl00LUS is similar to Model EIl00 BUS except that it has an emergency light feature which switches on when the alarm is activated. The expected useful life of these devices is 10 years.
l The Model 1001 smoke detector is an ionization type device containing an Amersham Corporation Model AMM1001H foil type j . source with maximum activity of 1.0 microcurie (37 kBq) . The device is powered by 120 volt AC power supply with a battery back-up. The smoke detector is designed to screw into a standard 120 volt socket, similarly to a light bulb, in a ceiling mounted single light fixture. The owners Manual provides recommendations and illustrations for installation.
The Model 1001 device had been registered between September 26, 1990, and December 17, 1996, under registration issued to Generation 2, Inc. Generation II, Inc. was the distributor during this period marketing the detector under various names with the label containing the NRC registration number. Between December 17, 1996, and the present time the device'was in inactive status. This certificate reactivates registration of
, the Model 1001 device with Hemisphere Forwarding, Inc. as the distributor.
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, e REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO, NR-1040-D-101-E DATE: October 29, 1998 PAGE 3 OF 3 l
DEVICE TYPE: Smoke Detector
REFERENCES:
l The following supporting documents for the Models EIl00 BUS, EIl00 SUS, EIl00LUS and 1001 smoke detectors are hereby incorporated by reference and are made a part of this registry l l document: I
!
- EI Company, Ltd. letters dated August 15, 1994, October 11, 1995, May 27, 1996, August 25, 1997, and October 16, 1997, with enclosures thereto.
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- Application of Hemisphere Forwarding, Inc. in letters dated l June 5, 1998, and July 6, 1998, and letter dated October 8, 1998, with enclosures thereto.
- Application of Generation 2, Inc. dated May 18, 1990, and j letters dated August 10, 1990, August 15, 1990, and l September 13, 1990, with enclosures thereto, l
i ISSUING AGENCY: 7
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U.S. Nuclear Regulatory Commission /
z/ ,y Reviewer:
l Date: /' [
Jo W Lubinski Date: Concurrence: u It6 ten L. Baggett l
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October 29, 1998 Mr. Steven Rakiec, Operations Manager Hemisphere Forwarding, Inc.
7 Cerro Street inwood, NY 11096
Dear Mr. Rakiec:
I l
Based on the information and test data submitted in your application dated June 5,1998, and l July 6,1998 we conclude the Model 1001 smoke detector is acceptable for licensing purposes !
in accordance with the conditions of the enclosed registration certificate (NR-1040-D-101-E). I Please note that on the registration certificate we listed both the Model 1001 and the Model El100 series smoke detectors which you had registered with us previously.
Please be advised that you must manufacture and distribute the products 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.
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.
- 0 fllD po & [f ~ Opp.
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1 l Some of the enclosures to your letterd dated June 5,1998, were designated as proprietary.
I The contents of these enclosures refer mostly to fabrication details of the source and, to a l lesser extent, to the construction details of the smoke detector housing. The information designated as proprietary was not needed for the review of your application and, therefore, we return it to you as enclosure to this letter, if you have any questions, pleaso contact me at (301) 415-7904 or Mr. Steven Baggett at (301) l 415-7273.
l l
Sincerely, '
/s John P. Jankovich, Sr. Engineer l Materials Safety Branch Division of industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/ encl: SKimberley, LFDCB Distribution:
IMNS r/f SSD-98 77 NE01 h{' AKirkwood/IMNS SSD File # NR-1040-D-102-E -
DOCUMENT NAME: A:\N1040101.CP1 To receive a copy of this docurnent, indicate in the boa: 'C' = Copy without attachmenvenclosure "E" = Copy with attachment / enclosure "N* = No copy OFFICE IMNS '
q t IMNS NAME JJank,ovich/ij f [j SBaggett DATE 10/,20/98 VV 10/ /98 OFFICIAL RECORD COPY
I REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY) ;
I NQt1NR-1040-D-101-E DATE: October 29, 1998 PAGE 1 OF 3 ,
DEVICE TYPE: Smoke Detector l MODEL: EIl00 BUS, EIl00 SUS, EIl00LUS and 1001 I
DISTRIBUTOR: . Hemisphere Forwarding, Inc.
7 Cerro Street Inwood, NY 11696 i
! MANUFACTURER: E.I. Company Ltd.(Model Nos. EIl00 BUS,
- EIl00 SUS, and EIl00LUS)
Shannon Free Airport, Co. Clare Shannon, Ireland I
I Garvan Enterprises Ltd. (Model No. 1001)
Wing Hing Industrial Building 83-92 Chai Wan Kok St.
Tsuen Wan, N.T. Hong Kong l SEALED SOURCE DESIGNATION:
f Nuclear Radiation Development Model A001 (for Smoke Detector Model Nos. EIl00 BUS, EIl00 SUS, and EIl00LUS) l Amersham Model AMM1001H (for Smoke Detector Model No. 1001)
ISOTOPE 1 MAXIMUM ACTIVITY:
Americium-241 1.0 microcurie (37.0 kBq) l
- LEAK TEST FREOUENCY
- Not required l
l l PRINCIPAL USE: (P) Ion Generator, Smoke Detectors CUSTOM DEVICE: YES X NO h/f&dM g
- . . . . - . _ _ ~ - - . . - - ..~.. .-.. . . - ~ .. ~ - . . - -. - -
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO,:NR-1040-D-101-E DATE: October 29, 1998 PAGE 2 OF 3 DEVICE TYPE: Smoke Detector DESCRIPTION:
-The detection chamber design is identical for Model Nos. l EIl00 BUS, EIl00 SUS, and EIl00LUS. The source is swaged to a stainless steel electrode, which itself is secured by soldering l at three different locations to a printed circuit board. The '
stainless steel electrode is clasped onto a Noryl SE100 insulator which also has a nickel silver electrode clasped to the other side. Interfacing to the smoke detector electronics is i accomplished through the nickel silver electrode. The complete I' insulator / electrode assembly is covered by a carbon filled l .polypropolene chamber cover which is cecured to the printed L circuit board and.the smoke detector base using a tamper-
[ resistant screw and nut. Shielding is provided by this chamber l cover and the external cover.
i Model EIl00 BUS is the standard smoke detector containing no added features. Model EIl00 SUS is similar to Model EIl00 BUS except I that it has a silencer feature which desensitizes the unit when a
. switch is-depresaed. Model-EIl00LUS is similar to Model EIl00 BUS except that it has an emergency light feature which switches on )
when the alarm is activated. The expected useful life of these i devices is 10 years. '
The Model 1001 smoke detector is an ionization type device containing an Amersham Corporation Model AMM1001H foil type source with maximum activity of 1.0 microcurie (37 kBq). The device is powered by 120 volt AC power supply with a battery back-up. The smoke detector is designed to screw into a standard 120 volt socket, similarly to a light bulb, in a ceiling mounted single light fixture. The owners Manual provides recommendations and illustrations for installation.
The Model 1001 device had been registered between September 26, 1990, and December 17, 1996, under registration issued to
-Generation 2, Inc. Generation II, Inc. was the distributor during this period marketing the detector under various names with the label containing the NRC registration number. Between
- December 17, 1996, and the present time the device was in inactive-status. This certificate reactivates registration of 1 the Model 1001 device with Hemisphere Forwarding, Inc. as the distributor.
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES !
SAFETY. EVALUATION OF DEVICE '
-(AMENDED IN ITS ENTIRETY)
NO.:NR-1040-D-101-E DATE: October 29, 1998 PAGE 3 OF 3 DEVICE TYPE: Smoke Detector
REFERENCES:
The following supporting documents for the Models EIl00 BUS, EIl00 SUS, EIl00LUS and 1001 smoke detectors are hereby incorporated by reference and are made a part of this registry document:
- EI Company, Ltd. letters dated August 15, 1994, October 11, 1995, May 27, 1996, August 25, 1997, and October 16, 1997, with enclosures thereto.
- Application of Hemisphere Forvarding, Inc. in letters dated l June 5, 1998, and July 6, 1998, and letter dated Catober 8, i
1998, with enclosures thereto.
]
- Application of Generation 2, Inc. dated May 18, 1990, and l l letters dated August 10, 1990, August 15, 1990, and i l September 13, 1990, with enclosures thereto. I l ISSUING AGENCY: '
l 1.
I U.S. Nuclear Regulatory Commission ,/
I Date: Reviewer:. /'
Jo 'W Lubinski Date:
' Concurrence: % r _
s't6 ten L. Baggett 1
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- pu-. - - a , .-__e -a, s u., -,. ., . - - . .1=.. ,,w__._a October 29, 1998 t
Mr. Steven Rakiec, Operations Manager Hemisphere Forwarding, Inc.
7 Cerro Street inwood, NY 11096
Dear Mr. Rakiec:
Based on the information and test data submitted in your application dated June 5,1998, and 1 July 6,1998 we conclude the Model 1001 smoke detector is acceptable for licensing purposes in accordance with the conditions of the enclosed registration certificate (NR 1040-D-101-E).
! Please note that on the registration certificate we listed both the Model 1001 and the Model
! El100 series smoke detectors which you had registered with us previously.
Please be advised that you must manufacture and distribute the products 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.
Please read over the registration certificate in its entirety and notify us immediately of any errors ,
or omissions. l You are obligated to notify us promptly in writing should you decide to no longer manufacture or
! offer service support for the product.
I 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.
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- Some of the enclosures to your letterd dated June 5,1998, were designated as proprietary.
The contents of these enclosures refer mostly to fabrication details of the source and, to a lesser extent, to the construction details of the smoke detector housing. The information designated as proprietary was not needed for the review of your application and, therefore, we return it to you as enclosure to this letter.
! If you have any questions, please contact me at (301) 415-7904 or Mr. Steven Baggett at (301) 415-7273.
Sincerely, 3
l John P. Jankovich, Sr. Engineer 1
! Materials Safety Branch Division of Industrial and Medical Nuclear Safety ;
Office of Nuclear Material Safety and Safeguards l Enclosure As stated '
cc w/ encl: SKimberley, LFDCB l
l l Distribution:
l IMNS r/f SSD-98-77 NE01,k AKirkwood/lMNS l SSD File # NR-1040-D-102-E DOCUMENT NAME: A:\N1040101.CP1 To receive a copy of this document, indicate in the boa: "C' = Copy without attachment / enclosure "E* = Copy with attachment / enclosure "N' = No copf OFFICE IMNS 'gt c IMNS NAME JJank,ovich/ij g [// SBaggett DATE 10/,26/98 'l / 10/ /98 OFFICIAL RECORD COPY l
I
. _ - . . . . . , - . . _ _ . _ . - . ~ . .... .. . .. . _ __-.- . - -- . . - - . . . - . - - . -
i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDEC IN ITS ENTIRETY) ,
i NO.:NR-1040-D-101-E DATE: October 29,-1998 PAGE 1 OF 3 l
' DEVICE TYPE: Smoke Detector MODEL: EIl00 BUS, EIl00 SUS, EIl00LUS and 1001 DISTRIBUTOR: Hemisphere Forwarding, Inc.
7 Cerro Street Inwood, NY 11696 i
MANUFACTURER: E.I. Company Ltd. (Model Nos. EIl00 BUS, i EIl00 SUS, and EIl00LUS) '
Shannon Free Airport, Co. Clare !
Shannon, Ireland I
Garvan Enterprises Ltd. (Model No. 1001)
. Wing Hing Industrial Building l 83-92 Chai Wan Kok St.
Tsuen Wan, N.T. Hong Kong j SEALED SOURCE DESIGNATION:
Nuclear Radiation Development Model A001 (for Smoke Detector Model Nos. EIl00 BUS, EIl00 SUS, and EIl00LUS)
Amersham Model AMM1001H (for Smoke Detector Model No. 1001)
ISOTOPE: MAXIMUM ACTIVITY:
Americium-241 1.0 microcurie (37.0 kBq)
LEAK TEST FREOUENCY: Not required l PRINCIPAL USE: (P) Ion Generator, Smoke Detectors CUSTOM DEVICE: YES X NO l
^00ILON '5A 3/'f_
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)
NO.:NR-1040-D-101-E DATE: October 29, 1998 PAGE 2 OF 3
. DEVICE TYPE: Smoke Detector DESCRIPTION: )
l The detection chamber design is identical for Model Nos.
EIl00 BUS, EIl00 SUS, and EIl00LUS. The source is swaged to a stainless steel electrode, which itself ic secured by soldering at three different locations to a printed circuit board. The stainless steel electrode is clasped onto a Noryl SE100 insulator
, which also has a nickel silver electrode clasped to the other i side. Interfacing to the smoke detector electronics is I accomplished through the nickel silver electrode. The complete i insulator / electrode assembly is covered by a carbon filled j polypropolene chamber cover which is secured to the printed circuit board and the smoke detector base using a tamper-resistant screw and nut. Shielding is provided by this chamber cover and the external cover.
Model EIl00 BUS is the standard smoke detector containing no added features. Model EIl00 SUS is similar to Model EIl00 BUS except 1 that it has a silencer feature which desensitizes the unit when a switch is depressed. Model EIl00LUS is similar to Model EIl00 BUS except that it has an emergency light feature which switches on '
when the alarm is activated. The expected useful life of these devices is 10 years.
The Model 1001 smoke detector is an ionization type device containing an. Amersham Corporation Model AMM1001H foil type source with maximum activity of 1.0 microcurie (37 kBq) . The device is powered by 120 volt AC power supply with a battery back-up. The smoke detector is designed to screw into a standard 120 volt socket, similarly to a light bulb, in a ceiling mounted single light fixture. The Owners Manual provides recommendations and illustrations for installation.
l i The Model 1001 device had been registered between September 26, 1990, and December 17, 1996, under registration issued to I- Generation 2, Inc. Generation II, Inc. was the distributor during this period marketing the detector under various names with the label containing the NRC registration number. Between December 17, 1996, and the present time the device was in inactive status. This certificate reactivates registration of the Model 1001 device with Hemisphere Forwarding, Inc. as the
! distributor.
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l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l SAFETY EVALUATION OF DEVICE l (AMENDED IN ITS ENTIRETY) l NO :NR-1040-D-101-E DATE: October 29, 1998 PAGE 3 OF 3 DEVICE TYPE: Smoke Detector
REFERENCES:
'The following supporting documents for the Models EIl00 BUS, EIl00 SUS, EIl00LUS and 1001 smoke detectors are hereby incorporated by reference and are made a part of this registry document:
- EI Company, Ltd. letters dated August 15, 1994, October 11, 1995, May 27, 1996, August 25, 1997, and October 16, 1997, with enclosures thereto.
!
- Application of Hemisphere Forwarding, Inc. in letters dated June 5, 1998, and July 6, 1998, and letter dated October 8, 1998, with enclosures thereto.
- Application of Generation 2, Inc. dated May 18, 1990, and letters dated August 10, 1990, August 15, 1990, and
! September 13, 1990, with enclosures thereto.
ISSUING AGENCY: -
//
U.S. Nuclear Regulatory Commission z' Date: Reviewer: /'
Jo 'W Lubinski Date: Concurrence: 4 C st6+en L. Baggett l
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! July 14,1998 L
i ASSIGNMENT NUMBER: 98-77 ;
1 Mr. Steven Rakiec j Hemisphere Forwarding, Inc. I 7 Cerro Street inwood, NY 11096
Dear Mr. Rakiec:
l
SUBJECT:
ACKNOWLEDGMENT OF REQUEST FOR SAFETY EVALUATION i
Dear Mr. Rakiec:
This letter acknowledges the receipt of your July 6,1998, application to reactivate Registration Certificate Number NR-323-D-101-E in Hemisphere Forwarding's names. We have performed a cursory review of your application and determined that enough information has been provided to allow a technical reviewer to initiate the evaluation process. Applications are assigned to tecnnical reviewers on a first-in basis. Therefore, your application will be aasigned in turn.
Please note that the technical reviewer may contact you to request information that was omitted from your application or to obtain clarification of technical issues concerning your application. If you have any questions concerning the status of your application, please contact me at (301) 415-8140. Please reference the assignment number listed above in your questions or correspondence.
Please be aware that your request may be subject to the NRC's application fees in accordance with 10 CFR Part 170. Therefore, a copy of your application has been forwarded to the License Fee and Debt Collection Branch for approval of the fee category and amount. If you have any questions concerning the fees associated with your application, please contact the License Fee and Debt Collection Branch at (301) 415-7554.
Sincerely /.5 /,
Traci Kime, Acting Registration Assistant Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:
IMNS r/f SSD-98-77 SBaggett NE018.-
DOCUMENT NAME:h:\traci\98-77.tsk Ta receive a copy of thie document. Indicate in the bom: "C" = Copy w,thout attachment / enclosure "E" = Copy with attachment / enclosure *N* = No copy OFFICE MSB- l NAME TKimed DATE 7/y/98 OFFICIAL RECORD COPY
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September 26, 1990 MEMORANDUM FOR:
Michael A. Lamastra, Section Leader Commercial Section '
Medical, Academic, and Commercial Use Safety Branch FROM: Steven Baggett, Section Chief Scaled Source Safety Section ,
I Medical, Academi,,c, and Commercial Use Safety Branch
SUBJECT:
EXEMPT LICENSING ACTION - GENERATION 2, INC.
APPLICATION / LETTER DATED MAY 18, 1990 MAIL CONTROL # 021001 DOCKET # 03031781 - NEW LICENSEE In response to your memorandum dated September 18, 1990, we have completed the SSD review and issued the enclosed registration sheet. All background material submitted to us is being returned to you so that you may complete the licensing action.
No further reviews or actions for this applicant need to be taken by the Sealed Source Safety Section at this time. Please forward a copy of the registration certificate with the license once it has been completed.
Sincerely, I n
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S even Baggett, Section Chief Sealed Source Safety Section l Medical, Academic, and Commercial l Use Safety Branch l l
l Enclosure (s): (1) Registration Certificate NR-323-D-101-E _
(2) Background Information cc: Principle SSSS Staff l Glenda Jackson w/ Enclosure (1) i l 5
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l r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l HQ2: NR-323-D-101-E DATE: , P 2 8 rg%)
PAGE 1 OF 2
- DEVICE TYPE:
Screw-In Smoke Detector MODEL: 1001 \
DISTRIBUTOR: Generation 2 Inc.
10777 Barkley Suite 101 Overland Park, KS 66211 i
MANUFACTURER:
Houten International Technology LTD.
Rm 16-17, 21F Wing Hing Industrial Building i
83-93 Chai Wan Kok St.
Tsuen Wan, N.T. Hong Kong SEALED SOURCE MODEL DESIGNATION: 1 Amersham Model AMM-1001H '
i i
' s ISOTOPE:
MAXIMUM ACTIVITY:
Am2ricium-241 ,
1 Microcurie }
l l LEAK TEST FREOUENCY:
\
Not Required
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! PRINCIPAL USE: 'l (P) Ion Generators, Smoke Detectors le 5
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REGISTRY.OF RADIOACTIVE SEALED SOURCES AND DEVICES-l SAFETY EVALUATION OF DEVICE
- l
(. LL: NR-323-D-101-E DATE: SEP 2 61910 'PAGE 2 OF 2 l
l' DEVICE TYPE: Screw-In Smoke Detector l
REFERENCES:
The following supporting documents for the Model 1001 screw-in type smoke-detector are hereby incorporated by reference and are made a part of this registration document:
o
! Application dated May 18, 1990, and letters dated August 10, 1990, August 15, 1990, and September 13, 1990 with enclosures thereto.
l I
l ISSUING AGENCY:
l . U.S. Nuclear Regulatory Commission Date. I490 Reviewer: -
' Date: 00'2 .
Concurrence ' h" r-L j ' k'. 4>(
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August 24, 19.90 MEMORANDUM FOR: Michael A. Lamastra, Section Leader
. Commercial Section Medical, Academic, and Commercial Use Safety Branch FROM: Steven Baggett, Section Chief Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch j
SUBJECT:
APPLICANT - GENERATION 2, INC.
APPLICATION / LETTER DATED - MAY 18, 1990 I MAIL CONTROL # 021001 DOCKET # 03031781 - NEW LICENSE In response to Generation 2, Inc.,'s application for a license that authorizes distribution of smoke detectors to person exempt from the requirements for a license, we have found certain areas that are deficient. On August 10, 1990 we presented oui
- concerns to Generation 2, Inc. by phone. They agreed to send in the necessary information. We received additional information on August 20, 1990. We sill find certain areas that are deficient. To complete the sealed source and device review part of this application, we need the applicant to provide the following additional information or clarification:
-o We have no record that the sealed source has been a previously approved and registered. The model AMMK1235 is not acceptable. Please have them submit'to us the registration number, or the information as outlined in Regulatory Guide 10.11.
o We need to know the maximum external radiation levels at 5 and 25 centimeters from any external surface of the products.
3' o We need a description or facsimile of the proposed labels or marking on the device AND its point-of-sale package to satisfy the requirements of 10 CFR Section
, 32.29(b).
o The applicant needs to submit their estimates of the external radiation doses and dose commitments to e demonstrate that the device is designed and will be manufactured so that it meets the safety criteria in 10 CFR Section 32.27. These estimates must also
- include a discussion of the basis for such estimates.
r Based on our review of the application, we st~rongly recommend that the applicant be advised to seek the assistance of a consultant to prepare the response to our questions.
The application and all background material is enclosed for your use. When the response is received from the applicant please submit the original application and the response to us so that we may continue the device evaluation.
Please note that the applicant calls frequently to get status reports and is concerned about the length of time to acquire a license from NRC.
If you have any questions please contact me. My extension is 20542.
Sincerely, l W~
1 (5te d'ett g
g- Sealed source Safety Section Medical, Academic, and Commercial i Use Safety Branch ;
e
Enclosure:
Background Material 3
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/* %, UNITED STATES f g NUCLEAR REGULATORY COMMISSION l t 'j WASHING TON, D. C.,20555
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. j MEMORANDUM FOR: Michael A. Iamastra, Section Leader l
, Commercial Section Medical, Academic, and Commercial i
Use Safety Branch FROM: Steven Baggett, Section Chief i Scaled Source Safety Section Medical, Academic, and Commercial Use Safety Branch
SUBJECT:
APPLICANT - GENERATION 2, INC. i APPLICATION / LETTER DATED - MAY 18, 1990 MAIL CONTROL # 021001 DOCKET # 03031781 - NEW LICENSE l
In response to Generation 2, Inc.,'s application for a l license that authorizes distribution of smoke detectors to l person exempt from the requirements for a license, we have i found certain areas that are deficient. To complete the l sealed source and device review part of this application, we '
need the applicant to provide the following additional information or clarification:
o We have no record that the sealed source has been
'O d Previously approved and' registered. Please have them ,
submit to us the registration number, or the information I as outlined in Regulatory Guide 10.11. I o We need to have a set of mechanical drawings that show all v' related safety features, overall dimensions, where the source is held in the device, how the source is secured in the device, and the materials of construction.
o We need to know the maximum external radiation levels at 5
// and 25 centimeters from any external surface of the products.
o We need to know the expected quantity of byproduct - -
v' material to be distributed annually, and the expected useful life of the product.
o We need a description or facsimile of the proposed labels or marking on the device AND its point-of-sale
/VD package to satisfy the requirements of 10 CFR Section 32.29(b).
,, o We cannot find any mention of prototype tests performed on the device to demonstrate the effectiveness of the l
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containment and other safety features. Please have them l submit the prototype tests (including the procedures and the results) that were performed on the device. If no prototype tests were performed have them submit an .
engineering analysis that will'show that the device will
- withstand the proposed conditions of use. ,
o The applicant needs to submit their estimates of the external radiation doses and dose commitments to demonstrate that the device is designed and will be manufactured so that it meets the safety criteria in j
10 CFR Section 32.27. These estimates must also include a discussion of the basis for such estimates.
a There was no mention of the manufacturer's Quality l Assurance and Quality Control program that they have in i place. please have the applicant submit a copy of the manufacture's QA/QC manual or a list of the QA/QC procedures they perform on the device and/or source.
i Also, we need to know what QA/QC checks or receipt. ,
3 i inspection procedures that will be performed by the !
applicant prior to distribution to ensure that the product being transferred conforms to the device registration and the license requirements.
Based on our review of the application, we strongly recommend that the applicant be advised to seek the assistance of a l consultant to prepare the response to our questions. ,
The use. application and all background material is enclosed for your 3
When the response is received from the applicant please submit the original application and the response to us so that we may continue the device evaluation.
1 4
' If you have any questions please contact me. My extension is '
20542.
Sincerp, _
3 even ag t i
Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch 4
Enclosure:
Background Material cc: Principle SSSS Staff 4