ML20138G047

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Registry of Radioactive Sealed Sources & Devices,Safety Evaluation of Wrist Watch Models 100/1,100/2 & 100/3. Certificate:NR-446-D-103-E
ML20138G047
Person / Time
Issue date: 10/01/1996
From: Steven Baggett, Doug Broaddus
NRC
To:
Shared Package
ML20138G040 List:
References
SSD, NUDOCS 9610180177
Download: ML20138G047 (13)
v • d • e


Text

. _ _ _ . . . . _ _ _ . _ . . . . _ _ _ . ..._._.___m . _ . . _ . . . . _ _ _ _ _ _ _ .. _ _._ _ _ _ _ . _ _ ~ . _

i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE )

(AMENDED IN ITS ENTIRETY) 1 HQ: NR-0446-D-103-E DATE: October 1, 1996 PAGE 1 OF 6 DEVICE TYPE: Wrist Watch MODEL: 100/1, 100/2, 100/3 (formerly P375, P550, P600, P650)

DISTRIBUTOR: mb-microtec (USA)

P.O. Box 1174 I North Tonowanda, NY 14120 l I

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MANUFACTURER: mb-microtec ag Freiburgstrasse CH-3172 Niederwangen SWITZERLAND SEALED SOURCE MODEL DESIGNATION: Mb-Microtec Model: 400/1 400/2 400/3 ISOTOPE: MAXIMUM' ACTIVITY:

Hydrogen-3 e 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 9610100177 961017 PDR RC

~ -_ . , . . . - .-

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY 1 EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ: NR-0446-D-103-E DATE: October.1, 1996 PAGE 2 OF 6 DEVICE' TYPE: Nrist 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.

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 100/3 may contain up to 100 mci (3.7 GBq) . tritium in 1 to 20 mb-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, secured by a press-fit stainless steel 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 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. For quartz analog modules, a I hatch is used in the case bottom to change batteries.

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ: NR-0446-D-103-E DATE: October 1, 1996 PAGE 3 OF 6 I

l DEVICE TYPE: Wrist Watch i DESCRIPTION: (Cont'd) l e

Watch hands are specially designed to permit attaching a 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 silicone adhesive, or by a source retaining ring that, when bonded to the watch dial, secures the sources in place.

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  • 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.

l DIAGRAM:

See attachments 1-4.

l 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 l

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.

PROTOTYPE TESTING:

The manufacturer has subjected prototype timepieces to the requirements of ANSI N540. The prototype timepieces passed the requirement for classification T2GC1222222.

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...:. .. - .- - - . . . .. . - - - - . ~ . - - _ _

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDEDLIN ITS ENTIRETY)

HQ: NR-0446-D-103-E DATE: October 1, 1996 PAGE 4 OF 6 l

l DEVICE TYPE: Wrist Watch 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 l display have been estimated and are reported in NUREG/CR-0215,

! ORNL/NUREG/TM-255 " Estimates of Potential Radiation Doses from Wristwatches Containing Tritium Gas" by McDowell-Bayer and O'Donnell.

OUALITY ASSURANCE AND CONTROL l

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mb-nicrotec has specified the following quality control test on p: oduction 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 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. J LOT TESTING OF FINISHED WATCHES 4

! All finished watches are subjected to a 100% visual l inspection for missing, dislodged, dim, or black light sources. In addition, a random sample of each finished lot is subjected to the following: a visual inspection for the "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 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 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Any failure will trigger a 100% '

inspection of the lot for the defect. I LIMITATIONS'AND/OR OTHER CONSIDERATIONS OF USE:

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

i REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE- *

(AMENDED IN ITS ENTIRETY) ,

HQ: NR-0446-D-103-E DATE: October 1, 1996 EbGE 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.

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.

L 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 registry document.

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  • 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 and September 17, 1996, with.anclosures thereto.

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.. -- . . . . . . . .. -.- ..- - . .~ . - -. - - ._ . ~ -- .. - ., . . _. ..- . . . . _ ~ . .

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE l (AMENDED IN ITS ENTIRETY) i HQ: NR-0446-D-103-E DATE: October 1, 1996 PAGE 6 OF 6 DEVICE TYPE: Wrist Watch ISSUING AGENCY:

U.S. Nuclear Regulatory Commission Date: October 1, 1996 Reviewer: / I. bM--

  1. Douglas A. Broaddus Date: October 1, 1996 Reviewer:

Stieven L. Baggett 1

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE

, (AMENDED IN ITS ENTIRETY)

HQ: NR-0446-D-103-E DAT_R: October 1, 1996 ATTACHMENT 1 h c g3--

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m 1 0 mier tec 2 ,4

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HAND SOURCES DI A L ( PL A STIC )

I ~ ~ ~ ~'~ ~ l DIAL SOURCES h2 u I l RING ( STAINLESS STEEL)

C ASE ( POLYAMID )

l CROWN (STAINLESS STEEL) r,, - - , ', , yr .. / '{

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N QU A RTZ ANALOG g c,, . k ,Mr / 2

, ' MODUL c5 '

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( RONDA CAL 375 )

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i , 0-RING ( SILICON )

i 1.56  ; NBOTTON (STAINLESS STEEL) 39,7 SCREWED TO CASE Former Model 375 Wrist Watch

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ: NR-0446-D-103-E DATE: October 1, 1996 ATTACHMENT 2 I

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1 3 m)2 2/

10 eC

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-lff ll k HANDS with sources (P339)

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9 DIAL-RING ASSEMBLY

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C Rr$TAL , tempered l glass C ASE , polyomid BEZEL ,stointess steel

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n y ::w r + yX: s

/ '*' ' ." ' or aluminium anodized

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l . - -N MOVEMENT T _ RONDA 713 or 715 ETA 2801,2804, 156 , 2821or 282c 39.5 B ATT ERY HATCH

( only f or RON DA -

movements )

Former Model 550 Wrist Watch

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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE I

(AMENDED IN ITS ENTIRETY) l HQ: NR-0446-D-103-E DATE: October 1~ , 1996 ATTACHMENT 3 f

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66 60 A S

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C. N Q% HANDS with sources l

C (P339)

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! Se b c.;t, witn sources (P551) i OE j CR6TAL, tempered glass

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CASE, stainless steet/brc0 i i

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_ g e[b l . 0,4 k'4 9 ' '. 9 % ;'4W4 '/.W/X,9,'l'/)('y  ? ,,,,,, MOVEMENT // /7 4id, Q- 6 1 (~~J -

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RONDA 713 or 715 y m_ _

m E TA 2 B01, 2804 ,

l l 2821 or 2B24 1 1,53

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39,0 N N C ASE BOTTOM, snop-on, i

l stainless ste?l l

Former Model 600 Wrist Watch

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED IN ITS ENTIRETY)

HQ: NR-0446-D-103-E DATE: October 1, 1996 ATTACHMENT 4 O ~

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N 7 I CD O C Gi t i > =E ts u'f - ==

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HANDS with sources O IP339) 05 O ';Q ,....  % ;b# &

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(.) DIAL-RING ASSEMBLY e incl mounting ( P 651)

CR$TAL', tempered glc0 BEZEL,potymer with mounted housing

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?4' ?4',%%% 744','C,pg,; eontoining source (P651) ts O dwv- ,$

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clllltF-J m u u u- j g

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- - - - - - N C ASE, polymer y

N MOVEMENT I 1,77 RONDA 713 or 715

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45,0 ETA 2 B 01,2804, )

2 821 2824 STArNLESS STEE'_

BOT TOM . screwed -on i

Former Model 650 Wrist Watch

<o PAGEi NRG FORM 567 U. S. NUCLEAR REGULATORY COMM3SION h.

REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION

/g/76 INSTRUCTIONS: Send this request AND a copy of all rehsted letters /appik:ations and drawings to: The Sealed Source Safety Section, ATTN: Chief, OWFN Mail Stop 6 H3. Change the License Tracking Systern milestone to 19 and assign to reviewer code I-5.

NOTE: Retain a copy of this request with the appik:ation and background files.

REQUESTER j REGION / LOCATION:

/td b - / 54/C v*M ]I U 11 U 111 IV V HQ LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)

APPUCANTS NAME SollRCE REVIEW hMENDMENT OF REGISTRATION SHEET u.ML CONrROL NUMBER (S) DEVICE REVIEW BER(S) l LETIER/APPUCATION DATE LICENSE NUMBER (S) CUSTOM REVIEW <

COMMENTS' p- e.rv 7v l p a 6, ww A t NY / Y/ te ~ W 7'f '

FOR SSSS USE ONLY REYlEWER MODEL NUMBERS NUMBER AS$1GNED C. % ini sma> Fipox t/n/7&

DATE RECEfVED DATE ASSIGNED DATE TO FEES t/ml19 3/4 / 94 TYPE OF ACTION'(Ind6 cafe the number of each type) / ' /

MOMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (98)

NEW NEW NEW NEW AMENDMENT g AMENDMENT _

AMENDMENT ] AMENDMENT SAFETY EVALUATION REQUIRED NO FEES REQUIRED

[ LICENSING /,CTION REQUIRED IF KNOWN b NO

] OTHER (Spec #y)

TOTAL NUMBER OF NOTES j Ay q g%

REVIEW HOURS

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g #v q d < MA

  • NUMBER OF g 09 -

DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALL 3 FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE NEW REGISNION - ] PRODUCT INACM -

ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY ~

h TVN, b ] 9A U 9B 9C 90

^ CHECK NUMBER DD k' 'd Q MATANN UPDATED

- AS REQUIRED f

DATE OF CHECK p N APPROVED DATRMN M COMMENTS f NRC FORM 567 (&93)

.m ORIGINAL TO SSSS

- .. .- - ~_. . . . .-.

\

  • i PAGE1  ;

, NRC FORM 567 s 4 U. S. NUCLEAR REGULATORY COMMISSION i

  1. ~~

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, h, gg/74

' REQUEST FOR A SEALED SOURCE OR ,~

DEVICE EVALUATION i

,( , .

5tiTRUCTIONS: Send this request AND a, copy of all related letters / applications and drawings to: The Sealed Source Safety Section, AT OWFN Mail Stop 6 H3. Change the Ucense Tracidng System milestone to 19 and assign to revwwer code I-5. ';

NOTE: Retain a copy of this request with the application and background files.

REQUESTER REGION / LOCATION: .i t

/A / $'7ti^ b s

]I R 11 R lli R IV V HQ LFDCB ,

TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)

CPPUCANTS NAME SOURCE REVIEW [ AMENDMENT OF {

REGISTRATION SHEET -

MCJL CONTROL NUMBER (S) DEVICE REVIEW

" (b)

LETTER /APPUCATION DATE UCENSE NUMBER (# CUSTOM REVIEW rOY COMMENTS:

fa ' 6w ii 71

, ,, p pi.r w c4, ,A/f i yne * // 7V '

FOR SSSS USE ONLY REVIEWER MODEL NUMBERS NUMBER ASSIGNED ,

0. & I o'o Sweu > 'ffo -OL t/n/7h DATE RECElvED DATE ASSIGNED DATE TO FEES $

f ilief7& 3 /4 / 94 TYPE OF ACTIOW(indicat'e the number of each type) / /

i MOMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (98)

NEW NEW NEW NEW k AMENDMENT g AMENDMENT _

AMENDMENT _

AMENDMENT -

F SAFETY EVALUATION REQUIRED NO FEES REQUIRED

. [ LICENSING ACTION REQUIRED IF KNOWN b NO 2 '

] OTHER (Spec #y) gf TOTAL NUMBER OF NOTES REVIEW HOURS g y d<IM ' .. ,

NUMBER OF g cu - /

DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE j NEW REGISTRATION - ] PRODUCT INACTIVE -

ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY ,

f TW OF FEE FEE CATEGORY . ~

$ [Nn O l9A 9B OC 90 C#0UNT RECElVED CHECK NUMBER MATANN UPDATED D g y ~ AS REQUIRED DCTE OF CHECM U LOG M.. / { { pjd MATSYS UPDATED g .

([ AS REQUIRED CPPROVED I' OATRRETURN e DATE yy  % <

>~ ~ ~ m a n- .- gyg 'T 1 M' M COPY

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