ML20197C008
| ML20197C008 | |
| Person / Time | |
|---|---|
| Issue date: | 11/03/1997 |
| From: | Steven Baggett, Doug Broaddus NRC |
| To: | |
| Shared Package | |
| ML20197B831 | List:
|
| References | |
| SSD, NUDOCS 9712240087 | |
| Download: ML20197C008 (10) | |
Text
l REGISTRY OF RADIOACTIVE SEALED SOURCES-AND DEVICES SAFETY EVALUATION OF DEVICE NO. :- NR-104 0-D-101-E DATE:
November 3, 1997 PAGE 1 OF 3 DEVICE TYPE:
Smoke Detector MODEL:
EIl00 BUS, EIl00 SUS, and EIl00LUS DISTRIBUTOR:
Hemisphere Forwarding, Inc.
7 Cerro street Inwood, NY 11696
-MANUFACTURER:
E.I.= Company Ltd.
Shannon Free Airport, Co. Clare Shannon, Ireland r
SEALED SOURCE MCDEL DESIGNATION:
Nuclear Radiation Development Model A001 1.
ISOTOPE 1 MAXIMUM ACTIVITY:
Americium-241 1.0 microcurie (37.0 kBq)
LEAK TEST FREQUENCY:
Not required PRINCIPAL USE,
-(P) Ion Generator, Smoke Detectors CUSTOM DEVICE:
YES X
NO i.
9712240087'971104 "If POR RC 4
SSD PDR
r REGISTRY-OFfRADIOACTIVE SEALED-.SOURCESIAND: DEVICES
- SAFETY-- EVALUATION: OF1 DEVICE l
NO,1. NR-1040-D-101-E:
DATE: -November:3; 1997; ~PAGE 2 OF'3
- DEVICE TYPE '
Smoke: Detector-
-DESCRIPTION:
=The' detection chamber design is identical for Model Nos..
EIl00 BUS,yEIl00 SUS,'and EIl00LUS.-- The source is swaged to c
. stainless steel electroder.which itself is secured-by soldering atathree different locations to a printed circuit ~ board. : The stainlessisteel' electrode is clasped onto a Noryl SE100 insulator
-which also has a~ nickel silver electrode clasped-to the other=
side.-
Interfacing to1the smoke detector electronics is-Laccomplished-through'the nickel silver electrode.
The-complete insulator / electrode. assembly:is covered by a: carbon filled-
.polypropolene1 chamber. cover-_which is secured to.the printed i
circuit board and the smoke detector base using a tamper-._
E resistant screw and nut..
Shielding is-provided by this chamber
-cover and the external cover.
ModEl;EIl00BUSnissthecstandard smoke detector containing no added features. "Model EIl00SUSfisisimilar to Model EIl00 BUS except
~
lthatJ it-.hac - a silencer: feature 'which. desensitizes the' unit-when a
./switchlisEdepressed.- ModeltEIl00LUS isisimilarito Model EIl00 BUS lexcept!that-it_-has an emergency' light feature which switches on c
y
"';when'the alarm is activated.
The expected useful life of these Ldevices is 10 years -
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~
-REGISTRY.OF RADIOACTIVE: SEALED SOURCES AND: DEVICES:-
SAFETY EVALUATION:OF DEVICE-
-NO i NR-1040-D _101-E.
- DATE: ~ November 3,i199_7i PAGE ' 3 'OF 3 '
i:
'y DEVICE TYPE:. Smoke Detector-I
-1REFERENCESt -
The f'ollowing supporting documents forithe Models'EIl00 BUS, EIl00 SUS,::and EIl00LUS: smoke detectors are hereby incorporated _by.
. reference-;anddare made-a partLof_this registry-document:
EI Company, Ltd. letters dated August 15, 1994 October 11, 1995, May 27,-1996i August 25, _1997, and Oct.ober 16,.1997, with enclosures-thereto.
. ISSUING AGENCY:
U~S; Nuclear _ Regulatory-Commission
-Date:
November 3, 1997
_ Reviewer:
Nee m
IE f65%
=Broaddus Date:5 November 3.
1997 Concurrence:
J Steven 1. Baggett I
4 1
I
Phon 3. Int + 353 61471277 El C6idpany Ltd.
~
y Fat int + 353 61471053 e-m:st: John.sinnott@:iltd ie Fax To Susan Greene From: John Sinnott Fax:
30i 4155369 Pages:1 Phone:
Date: 11/19/97 Re:
Application for bempt Distribution License CC:
O Urgent O For Rev$ew D Moose Comment D Please Reply D Messe Recycle With reference to our telephono conversation on 11/17/97, please disregard any reference to proprietary or confidential information in our application. All information contained in the application can be made available for public record.
if you nood any further information please ao not hesitate to get in touch.
e
- Regards, John Sinnott Ls t
( O
- cl C 4 01/. b 19 C9C 010 01
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Source / Device Review Checklist MANUFACTURER / DISTRIBUTOR: E1[1%
w's d.a REGISTRATION #; d u)
' //
MODEL#: tSt I m 4 0f 5. L"T l to 9 4 5 4 FI/(D Llif
REFERENCES:
<c A M b N/' $- E4 I ~ 8 DESCRIPTION OK/DEF COMMENTS FIRST PAGE Registrant's name and address s'
' A U+ N # N^O't?
Manufacturers and distributors name and address
/
Custom usert name and address M/A Model number
/
Type (from Reg. Guide 10.10 or 10.11)
/
Users authority to possess
/
Fd44 V
(specific, general. both, exempt)
Radionuclides? activity (Max w/% error), form,
-manufacturer, model, NRC registered
/
(note on registration certificate if source is registered
, as part of the device)
Leak test frequency no periodic leak test for: krypton-85, tritium, radioactive gas, isotopes with half-lives of 30 days or
/
less, beta or gamma-emitting material of no more Nl/
than 3.7 MBq (100 microcuries), or alpha-emitting material of no more than 370 kBq (10 microcuries).
Greater than 6 month frequency:
use criteria in 10 CFR 32.51(b) or 32.74(b)(1)
DESCRIPTION / CONSTRUCTION 7
If registrant is requesting to register more than one go g g.y-yg source / device on a certificate, are designs similar t/
enough to do so?
Device / source design with complete engineering drawings (dimensions, tolerances, list of materials)
Assembly methods (screw, welds, etc.);
verify integrity J
~
i u
j
- DESCRIPTION -
OK/DEF COMMENTS Source mounting (size and integrity) and security is source ANSI classification sufficient:
Radiography - Unprotected - 43515 Radiography -In Device
-43313 Medical-. Radiography.
- 32312-Medical-y Teletherapy 53524 y Gauges - Unprotected
- 43333
- y Gauges - in Device
-43232 p Gauges, Low Energy y Gauges, or X-ray fluorescenco
- 33222 OilWell Logging
- 56522 Portable Moist / Density
- 43333 Neutron Applications
-43323
~ y irradiators (11,111, IV)
-43424
- y irradiators (1)
- 43323 Static Eliminators 22 Smoke Detectors
- 32222
'(from ANSI N542-1'977)
Definition of shutter operation (locked in Off position, not locked in'On position), Fall safe, spacing and
//
tolerances -
+
On-Off in'didators (description, qty., location)
A////
Safety interlocks, guards, etc, to prevent access to f
besm or high radiation levels Corrosion between unlike materials (aluminum &
steel, depleted uranium & steel, etc.) see " Corrosion"
/
Information Shielding efficiency and integrity
/
For medical devices - was a FDA 510k provide?
(provide written notification to FDA)
Weillogging sources must be nondispersible and
-nonsoluble, (see Appendix H for a list of approved Alp welllogging sources)
See " ANSI and Other Standards" list for references for particular source / device designs (e.g. radiography, Brachytherapy, etc.)
a 4
1-w-
DESCRIPTION OK/DEF COMMENTS 1.ABELING Copy of label Materials, dimensions, colors (note on registration
-, 'TpU [/r & ^M -
certificate if labeling is exempt from the color requirements of 10 CFR Part 20)
Permanent attachment and location (s) - visible to -
- M k.///fw -oA?
users?
Contents: Modet#, Serial #, Isotope, Activity, Manufacturer, Date of Assay, Trefoil," CAUTION -
RADIOACTIVE MATERIAL"(Depleted Uranium information must be included)
CONDITIONS OF USE Expected working life of the source / device (years, operations)
. Actions to be taken when product reaches end of its
/t////- -.3,%.4 4 /u / -
I l
working life, Maximum allowable temperature, vibration, shock,
/
. corrosion, etc. (during use, handling, storage, and p/ -
transport)
Flow the device will be used
/
Meets dose limits of Part 32 for G and E distribution PROTOTYPE TESTING / HISTORICAL USE
(/I
@ /di-4~?
4 Tests methods and conditions (for source and device)
Tests results Years of use (incic'ents, failures, etc.)
Similarities to other sources / devices if they are used as basis.
5
s.
EdSCRIPTION OK/DEF COMMENTS RADIATION PROFILES
-- /SyddrTp Abw -)
Survey instrument used (type, window, sensitivity, f
"' d 7' etc.)
Conditions
/-
Distance from source / surface -
/
(per ANSI 538-1979) c Shutter On and Off/ source shielded i
Scatter (product in beam)
Guards t
. shields in place Verify radiation : rveys for y radiation meet inv law.
Verify radiation surveys for non-y radiation have not i
2 been calculated using inv law.
i, QUALITY ASSURANCE
- M'aterials, subassemblies, services 17 - - t2 m*
Ass $mbik methods (screws,. welding, etc.)
2 fanhMr Dirbensloris'and tolerances
/Per-<-s444/ /
/
g
' Activity, radiation levels, leak tests h( e ecd 4
^
-[
.QX Manual
.b *M""
b,'l [,,/.(L p y, INSTALLATION
$# Wd Fixed, portable, movable, fixed lastallation but portable source housing inherent shielding, inaccessibility Interlocks, locks, barriers Beam access: size of air gap / opening to beam (verify size with new GL rule)'
Mounting integrity m
\\
DESCRIPTION OK/DEF '
COMMENTS' i SAFETY INSTRUCTIONS f
. Operation, maintenance, calibration, damage / failure, M
specific warnings, leak test l and radiation surveys ACCOMPANYING DOCUMENTATION q
Leak tests results and radiation surveys Transportation documents Operation, maintenance, calibration, damage / failure, specific warnings, leak test, and radiation survey instructionsif applicable For GL dist.. Verify NRC Regions and Agreement State listing is up-to-date and copies of all pertinent regulations SERVICING g
Manufact'urer provides or user performs:
instaliation -
Calibration TL Relocation Leak Test Maintenance Radiation Survey
[
Repair
' Training Source Change / Installation
' FOREIGN MANUFACTURERS
- Drop ship 7
/
Who and where is source installed t
Leak test and radiation surveys.
/
Y-QA in the U.S.
1
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