ML20216B348

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Amended Registry of Radioactive Sealed Sources & Devices & SE of Wrist Watch for Models 100/1,100/2,100/3 (Formerly P375,P550,P600 & P650).Certificate:NR-446-D-103-E
ML20216B348
Person / Time
Issue date: 03/03/1998
From: Steven Baggett, John Lubinski
NRC
To:
Shared Package
ML20216B322 List:
References
SSD, NUDOCS 9803130054
Download: ML20216B348 (14)
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{{#Wiki_filter:.- r REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF PEVICE (AMENDED IN ENTIRETY) l HQ: NR-446-D-103-E DATE: ^* MAR 0 31998 1 DEVICE TYPE: Wrist Watch MODEL: 100/1, 100/2, 100/3 (formerly P375, P550, P600,,P650) DISTRIBUTOR: mb-microtec (USA) P.O. Box 1174 North Tonawands., NY 14120 MAIRTFACTURER : mb-microtec ag Freiburgstrasse CH-3172 Niederwangen { SWITZERLAND l SEALED SOURCE MODEL DESIGNATION: Mb-Microtec Model: 400/1 I 400/2 400/3 ISOTOPE: MAXIMUM ACTIVITY: Hydrogen-3 100 mci (3.7 GBq) in 1 to 20 sources LEAK TEST FREOUENCY: Not required PRINCIPAL USE: (W) Self-Luminous Applications CUSTOM DEVICE: YES X NO { 9003130054 990303 PDR RC SSD PDR j

I l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) HQ: NR-0446-D-103-E DATE: PAGE 2 OF 6 MAR 0 31998 ) DEVICE TY2E: Wrist Watch DESCRIPTION: Models 100/1, 100/2, and 100/3 wrist watches use gaseous tritium light sources to enable the wearer to read the watch dial in low or no light situations. These devices incorporate design and construction features of the former Models P375, P550, P600, P650, and have been redesignated as the Models 100/1, 100/2, and 100/3 to distinguish between the watch type for simplicity purposes. Model 100/1 watches are analog timepieces with mechanical or quartz movement. Model 100/2 watches are digital timepieces with liquid crystal display (LCD). Model 100/3 watches are timepieces with analog reading and LCD display. j Previously, the watches were approved for up to 78 mci (2.9 GBq) tritium in 15 mb-microtec Model 400/1 gas sources (12 sources in the hour positions, one source in each of the hands) or 83 mci (3.1 GBq) tritium in 16 sources (one additional in a rotating bezel). The Models 100/1, 100/2, and 190/3 may contain up to 100 mci (3.7 GBq) tritium in 1 to 20 m' microtec Model 400/1, 400/2, or 400/3 sources. Digital LCD watches may only need one source for illumination where additional sources may be needed to illuminate additional functions of newer watch styles.

However, only Model 400/1 sources will be used for illumination of the watch hands (analog reading).

The design and construction of specific watches within each Model designation may vary, but will be in accordance with the designs of the former Models P375, P550, P600, P650, including:

  • Materials for the case and bottom plate may include one or more of the following: brass, stainless steel, titanium, gold, platinum, injection molded plastic and polymers.

Case bottoms may be snap-on, screw-on, or attached by screws.

  • Acrylic, sapphire, and mineral glass crystals. aecured by a press-fit stainless steel or aluminum ring.

Removal of the crystal requires a special tool normally available only in watch factories or repair shops.

  • Unless the watch is destroyed or the crystal removed, there l

is no access to the sources. Although the case bottom may be removed, the design and construction is such that access to the sources on the hands and dial is not possible without destruction of the watch.

( l' REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) HQ: NR-0446-D-103-E DATE: PAGE 3 OF 6 MAR 0 31993 DEVICE TYP_E: Wrist Watch DESCRIPTION: (Cont'd) j Watch hands are specially designed to permit attaching a e source from below by a non-hardening adhesive. Sources are attached to the dial by either placing them'into milled slots and securing them with a-non-hardening self adhesive, or by a source retaining ring that, when bonded to the watch dial, secures the sources in place.

  • Watches may contain a rotating bezel, with or without a light source.

Light sources mounted external to the case and crystal (such as in a bezel) will be secured and protected from damage by a metal housing and crystal, as described above. DIAGRAM: See attachments 1-4. LABELING: The dial face is marked with a "T" (for tritium) as recommended in " Radiation Protection Standards for Gaseous Tritium Light Devices" Section 7 - Marking and Labeling (Nuclear Energy Agency, OECD, 1973). The bottom is marked by etching with "3H" for the contained tritium and with "mbm" for the manufacturer's logo. CONDITIONS OF NORMAL USE: The expected useful life of the watch is 10 years. The watch will be subjected to environs allowing human occupancy. i PROTOTYPE TESTING: The manufacturer has subjected prototype timepieces to the requirements of ANSI N540. The prototype timepieces passed the requirement for classification T2GC1222222. l i

l-I. REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) EQ: NR-0446-D-103-E DATE:

  1. ^U 4 0F 6 N R 0 31998

-DEVICE TYPE: Wrist W;tch EXTERNAL RADIATION LEVELS: External radiation dose rates are minimal and need not be considered. Primary tritium beta rays do not-penetrate the GTLS glass enclosure. Traces of very-soft (a few kev) secondary Bremsstrahlung are absorbed by the watch case. Potential doses for LCD watches with GTLS backlighting of the display have been estimated and are reported in NUREG/CR-0215, ORNL/NUREG/TM-255 " Estimates of Potential Radiation Doses from 1 Wristwatches Containing Tritium Gas" by McDowell-Bayer and l O'Donnell. l' OUALITY ASSURANCE AND CONTROL L mb-microtec has specified the following quality control test on production lots of wrist watches. SOURCE, TESTING All (100%) of the sources used are tested'for tritium leakage and must pass the soaking test per. ANSI N540, section 8.3.2. Lots of 1 to 20 sources are accepted when total leakage is less than 50 nCi (1.85 kBq) in 24 hours. LOT TESTING OF FINISHED WATCHES All finished watches are subjected to a 100% visual ~ inspection for missing,. dislodged, dim, or black light i sources. In addition, a random' sample of each finished lot is subjected to the following: a visual inspection for the l "H-3" and "mbm" on the watch; a drop test from 3.28 feet (1 m) to a steel plate, then a visual inspection for l missing, dislodged, dim, or black light sources; and a soak test per section 8.3.2. of ANSI N540 to a maximum of 50 nCi (1.85 kBq) in 24 hours. Any failure will trigger a 100% j inspection of the lot'for the defect. LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

  • The import'of the device is subject to the provisions of Section 110.27, 10 CFR Part 110.

[

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) HQ: NR-0446-D-103-E DATE: MAR 0 3 M88 PAGE 5 OF 6 DEVICE TYPE: Wrist Watch LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE: (Cont'd)

  • These devices may be distributed to persons exempt from the requirements for a license as defined in Section 30.19 if manufactured and initially transferred in accordance with a specific license issued pursuant to 10 CFR, section 32.22.

This license shall only be issued by the NRC.

  • This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.

i SAFETY ANALYSIS

SUMMARY

Based on our review of the information submitted, we conclude that Model 100/1, 100/2, and 100/3 (formerly P375, P550, P600, P650) wrist watch designs are acceptable for licensing purposes. Furthermore, we conclude that these watch models would be expected to maintain their integrity under the conditions associated with their intended use.

REFERENCES:

The following supporting documents for the Models 100/1, 100/2, and 100/3 (formerly P375, P550, P600, P650) wrist watch designs are hereby incorporated by reference and are made a part of this i registry document.

  • mb-microtec's letters dated June 19, 1987, July 23, 1987, June 27, 1991, August 30, 1991, October 20, 1993, January 13, 1994, November 10, 1994, December 21, 1994, July 18, 1995, January 11, 1996, and September 5, 1996, with enclosures thereto.
  • mb-microtec's faxes dated February 14, 1995, September 17, 1996, and October 22, 1996, with enclosures thereto.

l I J

REGISTRY'OF RADIOACTIVE SE,iLED SOURCES AND DEVICES SAFETY EVALUATILN OF DEVICE (AMENDED IN ENTIRETY) i 1 HQ: NR-0446-D-103-E DATE: PAGE 6 OF 6 MAR 0 31998 DEVICE TYPE: Wrist Watch ISSUING AGENCY': ~ U.S. Nuclear Regulatory Commission f' Date: . Reviewer: ohn W. Lubinski Date: MAR 0 31998 ppw" Concurrence: St6 Yen L. faggett l i l l l j l l I l l l l l

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) EQ: NR-0446-D-103-E DATE: MAR 0 31998 ATTACHMENT 1 ) -h=-- a A i 12 '1 1b mici tec 2 l 15 8 RT2 / k HAND SOURCES o I DI A L ( PLA STIC ) 1 DIAL SOURCES ( - - - - - * - ~ - - -EE-- l ~ 3l RING ( STAINLESS STEEL 1 l l C AS E ( POLYA MID ) [ CROWN (STAINLESS STEELL .....,, v.. s e ,., w. /,.: r,....,.... 'S M / D QUARTZ ANALO G h, N ./ , ' MODUL ~- s m, ( ROND A: CAL. 375 ) l ci d i . - ~ ~ L: s'. s? i c, o O-RING ( SILICON ) i 1.55 NEOTTOM [ STAIN LESS STEEL) ' 9.7 SCREWED TO CASE J Former Model 375 Wrist Watch l l

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) 1 EQ: NR-0446-D-103-E DATE: MAR 0 31998 ATTACHMENT 2 I h I . c. j 9 .0 1 21 'N ~ g. 2}p " g O mi# eC g m a a*g H e lll i g'f g HANDS with sources m I (P339) 8 9 7 6 5 OlAL-RING ASSEMBLY l5l\\ with sources (P551 ) , _ _ _.,_.- _ _ ) . -Ed-.. ~ U j. C RPSTAL, tempered j gloss C ASE, poly omid / BEZEL.stointess steet [ m.v.3 ry wr:rpr.# *::r..y : V W Gw 4,h.,. N h + /7 e'

  1. /

w ~ =../ 4 O ,,,,/ .l M'WI MOVEMENT d '~ 2-

i. ~

c- _,, u,,,,, u.,,. ui i n aw3,m.a. 9999g 733,7ygg ETA 2801.280I., 1,56 2821er 2e2c = 39.5 BATTERY HATCH (only f or RONDA-movements ) Former Model 550 Wrist Watch i

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) EQ: NR-0446-D-103-E p_AT_R: Mta 0 31998 ATTACHMENT 3 A 0 BO N (b ^ S 1 O 6 N s l 2 m ~ m q H ANDS with sources C. N C (P339) N ousar: / \\ b DI AL-RING ASSEMBLY Se c,t with sources (P 551) OC CRISTAL, tempered glass y CASE, stainless steel /brc0 f%,'M%%%%%W %%%W,%lff h kW f 17 ' rh _ HOVEMENT y EA 2 B01,280 2621 or 2624 1,53 e 39,0 N N CASE soTTos, snon-on, steinless steel Former Model 600 Wrist Watch l

l t REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ENTIRETY) HQ: NR-0446-D-103-E DATE: ATTACHMENT 4 MAP. 0 31998 i h .-h------ ni s + a o / o ,s o,h s l 0 ,h O 0 E ~ ( 5 CD (D C 0 l t i 6 tri gig

  • e

~ [ HANDS with sourtes o$ Q$ 0 O (P339) 0 s 0,.7.. }, 5 Y + DIAL-RING ASSEMBLY ~ ~~~~~ inct. mounting ( P 651) l CR)$TAL, tempered 9100 BEZEL. polymer with mounted hcusing i h

  1. 4?%MM: VAs% sf',M; y containing source (P651) ts o

muum o.: .. u -- g

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{--- - - - 3 N C ASE, polymer 4 l 3 x auu 1 - 1 y . t. N MOVEMENT 1,77 RONDA 713 er 715

l. 5.0 ETA 2601,2B04 2 B21 2B24 STATNLESS STEE' BOT TOM. screwed -on Former Model 650 Wrist Watch 4

9

ne w 33361%$$1 p.@i g 4 13 To: Christopher Brown USNRC i \\ j 1 Faz #: 301 415 5370 \\ Frosa: LARRY KEATING, mb rnicrotec Inc.. \\ ..s Date: October 22,1996 Pages: 4, including this cover sheet l t f re: NR - 0446.D-103.E f a X tuggestions. I have pencilled in the suggestions on the attached f 1 have reviewed the above registration and have a few l pages 2,3,and 5 of 6. I would be happy to discuss the proposal at anytime. l ) / / / '6~ v i' s ('v f f VICE PPctDENT ...v tet (716) 773-7634 tut (/16) 775 7744

nc W 13014255401 P.02 'd'u ~* n..um aa ...u, Ygf ((b R GIsTRY OF RADICACTIVE SEALSD 80VRCRs AND DEVICBs SAFSTY EVALUATION OF DEVICS-(AMENDED 2N ETS ENTIRETY) MQ hTR 044G-D-103-E DAZE: october 1, 19s6 W1E_2 QF G navicht TYPES Wrist Watch Y y T DEACR.1PTION: M I Modelin 100 assous tritium or no.soukc/1,1.'0/2, and 100/3 wrist watches use k light es to enable the wearer to read the wa ch dial in low light situations. These devices incorporate design and construction features o) the former Models P37s, P5so, P6co, 100/2, and 100/b.and have been redesignated as the Models 100/1to distinguish between the P650 f -{ l timepieces with C purposes. Model 100/1 watchen are analog /3 watches are digital neonatical or quarts novement. Model 100 y; ti ioce4 with liquid crystal display (LCD). Nodal 100/3 wat es are timepieces with analog reading and LCD display. Previously, the watches were approved for up to 1s mei (2.9 GBg) tritium in is ab-microtec Model 400/1 gas sources (12 sources an the hour positions, one source in each of the hende) or 83 pCi tritium in 16 sources (one additianal in a rotating besel).q) - (3.1 GB The Models 100/1, 100/2, and 100/3 may contain up to 100 mqi (3.7 Gaq) tritium in 1 to 20 mb-micsotee Model 400/1, 400/2, or 400/2 sources. Digital Lc0 watchem may only need one sourca for illumination where additional sources may be needed to illuminate additional functions of newer watch st los.

However, 4

only Mode 2, 400/1 sources will be used for illumi tion of the watch hands (analog reading). The design and construction of specific watches within each Model designation may vary, but will ~ be in accordance with the designs of the former Models P375, P550, P400, P650, including:

  • Materials for the case and bottom plate may include one or brass, stainless steel, titanium, i

more of the following: ion molded plastic and olymers, case ) gold, platinum, inject bottoms may be snap-on, screw-on, or attache by screws. k

y A'crylic, sapphire, and nineral glass crystals, secured by a e

press-fit stainless steel ring. Removal of the crystal requires a special tool normally available only in watch o4 factories or repair shops. e Unless the watch is destroyed or the crystal removed, there is no access to the sources. Although the case bottom may be removed, the design and construction ie much that access to the sourcesi on the hand and dial is not possible without or quarts analog modules,)a doctruction of the watch. ttom to change batteries. hatch is used in the cas bnk 4 &N #b &y d. $s& 'k 4t.sacn AA i

ggy;r&'ss lh%F~T@l NRD Inc TO 13014155401 P.03

c. 4 i

M ISTRY OF RADIDACTIVR SRALED SOURCBs AND DEVICas SAF8Tif NVAWATION OF DEVICE i A 1 (AManDmo Im ITs unrzRario Ets NR-044 6-D-103 -3 3423: october 1, its6 Dant 1 OP s DEVICE TYPE: Wrist Watch nonem b rnN (Cont'd) e Watch hande are specially designed to permit attaching a source from below by a non-hardening adhesiva.

  • Sources are attached to the dial by either placing them into w

milled slota and securing them with a mili m a ad sesive, or t by a source retaining ring that, when b6 aces to t u watch { dial, secures the sources in place. d

  • Ctches may contain a rotating bezel, with or without a iteht source.

Light sources mounted external to the came an$ crystal (such as in a basel) will be secured and protected from damage by a metal housing and crystal, as described above. 21MBhHe seesheechmente24. e.hmarNm6: The diai face is marked with a 'T" (for tritium) es rocoseended in *Ra'diation Protection Standards for Caseous Tritium Light Devices" Section 7 - MarXing and Labeling (Nucisar Energy Agoney, DECD, 1973). The bottom is marked by etching with '3Ha for the contained tritium and with *mbm" for the manufacturer's toge. reunr'irrita or unaw.AL usa The exbeet'ed useful life of the watch is 10 years. The watch will be subjected to environs allowing human occupancy. PROTOTYPE trESTING The inanufacturer has subjected prototype timepieces to the requirpmento of ANs! N540. The prototype tit;.epieces passed the i requirement for classtfication T20c1322222.

ne Mc0 13014155402 P.04 4(.. a'a n =p=a= of m eu, e REGISTRY OF RAD 20 ACTIVE SEAL 5p SOURCES AND DBVICas SAFETY EVALUATIQW OF DEVICE (AMENDED Elf 178 BNTIRSTY) MQt NR-0446-D-101-3 Q&ZRs October 1, 1996 PAGE s QF E \\ pEVICE TXPEt 9: l l Wrist Watch ,i.! j '} LIM 4TATIQMB AMD/OR OTHER cQMaIDEsATTOKs OF USEi (Cont'd) e These devices may be distributed to persons exempt from the requirements fer a license as defined in section 30.191f (' M manufactured and initially transferred in accordance with a specific license issued Jursuant to 10 CFR, section 32 23. 1 This license shall only 3e issued by the NRC. J

  • This' registration sheet and the information oontained within

{[' g the references shall not be changed without the written ) cohsent of the'NRC. nArnN kujtvers _stmaak=Y: d Based!onourreviewoftheinformationsubmitted,weconclude that Hodel 200/1, 100/3, and 100/3 (formerly P375, P550, P600, 4 P650)' wrist watch designs are acceptable for licensing purposes. Furthermore, we conclude that these watch models would be expected to maintain their integrity under the conditions associated with their intended use. REFtsSNf*EA : The following supporting documents for the Models 100/1, 200/2, and 100/3 '(formerly P378, P550, P600, P650) wrist watch designe l are hereby incorporated by reference and are made a part of this registry document. a mb-microtee's letters dated June is, its7, July as,1987, June 27, 1991, August 30, 1991, October 20, 1993, January 13, 1994,. November 10, 1994, December 21, 1994, culy s it, 1995, January 11, 1996, and September 5, 1996, with / N i enclosures thereto. i

  • mb-microsso's f axes dated February 14, 1995 and September 17, 1996, with enclosures thereto.

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