ML20010J435
| ML20010J435 | |
| Person / Time | |
|---|---|
| Site: | 07002275 |
| Issue date: | 08/31/1981 |
| From: | Janke O CHRIST HOSP., OAK LAWN, IL |
| To: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| 19705, NUDOCS 8110050060 | |
| Download: ML20010J435 (7) | |
Text
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lb 217C' Christ Hospital of the Evangelical Hcsoaal As+ociation
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August 31, 1981 w
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?frs. Patricia Vacca l
Gief, Fhterials Branch Division of Fuel Cycle and Ahterials Safety U.S. Nuclear Regulatory Comission Washington, DC 20555
Dear 1.frs. Vacca:
L Christ Ilospital is desirous of renewing its Special Nuclear hhterials License Stof-1676.
In support of this request, we submit the following for your scnitiny.
1.
Applicant: Christ ilospital 4440 W. 95th Street Oak Ltwn, Illinois 60453 2.
Phterial: Plutonium (principle radionuclide Pu-238) scaled sources (10.0 grams, 40 individual sources not to exceed 250 milligrams each). This special nuclear material will be used in the surgical implantation of Coratomic C-101 isotopic powered pacemakers, each l
containing 250 millicuries (4.3 curies) of Pu-238.
3.
Time requested: We request a five year license, expiring in 1986.
MINYA l
4.
Specification of the devices, manufacturer, rodel no., etc.
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j are enclosed with this application.
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'lhis material will be used by physicians:
Shakeab Alshabkhoun, ?!.U.
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I A. Choudry,?!.D.
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l whose documentation of training and experience were subnitted l
to your office in a letter dated April 27, 1976 and signed by n
l Stephen F. Kasbeer, Executive Vice President.
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Pfrs. Patricia Vacca August 31, 1981 Page two Fe wish also to include:
Dr. Jerry N. King Christ Ibspital Office - Phone 425-6020 Suite 324 South 4440 h'. 95th Street Oak Lawn, Illinois 60453 Licensed in Illinois, Indiana, and Pennsylvania Diplomte: American Poard of Surgery 1973 #19733 American Board of Thoracic Surgery 1976 #2992 Fellow of the American Colleges of Surgery and Cardiology Training: D.S.1961 Indiana University it.D.1965 Indiana l'niversity School of f bdicine Internship 1956 Allentown liospital, Allentown, Pennsylvania Residency in General Surgery 1972 Allentown !!aspital Residency in 'Ihoracic and Cardiovascular Surgery 1974 Temple University Ibspital, Philadelphia, Pennsylvania Experience: 1974-1975 Associate Staff Allentown Sacred IIcart !!ospital, Allentown, Pennsylvania 1975-present Associate Attending Staff Christ Ilospital, Oak Lawn, Illinois 1975-present Attending Staff St. Francis !!ospital, Blue Island, Illinois Assistant Professor of Surgery Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois Pacemaker Experience: 9 years Total number of Implants Done:
298 Total number Done at this Facility:
150 6.
Radiation Safety Prograrn Christ Ibspital operates under NRC Miterials Licenses 12-09239-01-02 for possession of Gmups I threugh VI and Cobalt 60 teletherapy. Documentation of racilities and procedures used to naintain doses as low as is reasonably achievabic to employees and public are contained under those licenses. Specific information t
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Mrs. Patricia Vacca August 31, 1981 Page three regarding the facilities and procedures used in the Pacemher program are contained in a letter dated April 27, 1976 and signed by S'.ephen Kcsbeer, Vice President. No changes have been mde in this program.
I hope this information is sufficient for you to efaluate our application and an availabic if you have any further questions.
- r. y,
/
Otto M. Janlu Vice Presid. / Administrator 4tI:rs Fmcl.
from Cordis...The Programmable Nuclear Pacer
(
Omni-Stanicore D Nu i, Nuclear, Programmable, R-Wave inhibited Cardiac Pacer)
A new generation of Omnicor pacers with a long-life power source and the same demonstrated reliability and programmability that are characteristic of other Omnicor series pacers.
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. Powered by the Atomcell", a nuclear-powered thermoelectric generator power source with an expected life of over 25 years.
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. Programmable rate and current settings permit t_
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noninvasive regulation of pacing parameters to match
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[drdni-Stanicor, y -
changing physiological needs of the patient over an f Pu-238 Nuclear, extended period of time
- O b Programmable, O
7,Wy,','g,Qited
. Weighs 90 grams. Lightness and thinness contribute to
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O 184A-patient comfort dnd tolerance, Critical factors in an cuiies
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extended-life pacing system.
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. Hermetically sealed CMOS electronics enclosed within
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l an outer hermetically sealed titanium case, affording the
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circuitry double moisture protection.
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The Cordis Omni-Stanicore 2)(Nu)
(Nuclear, Programmable, R-Wave inhibited Cardiac Pacer)
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A programmable pacer with a long-life
- power source and hermetically sealed CMOS circuitry protected by a hermetically scaled titanium case.
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Programming modu!e
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Pacing module A
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Titanium case Nuclear power sourco w
0H Nominal Specifications (37C)
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Output current, ma (as programmed) 8 (Hi)
Output voltage, v.........
6.0 5 (Med)
Sensitivity (+ or -), mv.
1.5 3.5 (Lo)
Weight.....
...... 90 grams 2.0 (Test)
Diameter.........
56mm Fixed rate, ppm (as programmed)....
.. 60 Thickness...........
19 mm 65 H eigh t..................
. 67 mm 70 Output pulse duration (at 70 ppm)t........ 1.7 msec 80 Refractory period (at 70 ppm)t.
321 msec 90 Expected power source life.
...... over 25 years' 100 Pacer Replacement Credit Policy 10 years
- Calculated longevity based on power source capacity. Earlier replacement may be required because of electronic difficulties or other complications. See the instructions manual for complete information about possible complications and replacement credit, including special
" remanufacturing" option.
tThe output pulse duration and refractory period vary according to the programmed fixed rate of the pacer. Refer to manual for parameters at each fixed ra'.e.
Also see instructions manual for more corr:plete information prior to implantation.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
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Cordis Corporation, Post Office Box 370428. Miami, Florida 33137, U.S.A.
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4A Telephone 305-578 2000 e
149-2156 Rev 0 C Corde Corpor ation.1976 September 1976
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neec ric we rEucmCe ne,wi, ion sevds ime.ec,dy w;oce,e s a.e. sat %wson.ssh,,ss o n n w
e M. iH The heart of the direct conversion concept to tw ATCMCELL genererer ere low heve been legged on a awaber e8 A'9(CELL p,., no.w
- s the thermoelectric module. This module enough to permit continvows espeswre, generators. There he been ne disceen'es e There is no endiction hemord.nvolved in e.gradotton of outpi.e sewer. Life test dote CAP Cmish of May Wsew& telluride thermo-The ATOMCELL genercor delivers continw-their handling or sne.
is avsttable span reewest, electric elements erronged in efectrical eus power at 0.3 vars for anopy years with no series. The module is hoor d orone ord by mo;ntenance or part replacement required.
The red; orion level from we ATOMCELL Nchanicd $bck oC v. oration e
the radioisotope twel. Near is rejected at Opme poww weput is MO-700 microworn.
wait is more then on o< der of magnatwee the opposite end at a lower temperature.
V The temperotwee droo ocross the module is
- 3., een year period the oren circuit voltage Ins than tb 0.17 e emAr. wnshielded o, Tu ATOMCILL waie is designed to wim-T/l MODULE
- 4 ve;jiaod to prWuce the output powe's will decrece by ten percent and the opt'm m 50 cm distance, spaif;ed by the USAEC
3ad 'h*
- 't seen Ms and dbes.n u
power by twenty percent. As shown en the end f NE A for implantobie power sowces.
s.etainchle while in e e implereed candm n.
a outpwr chorecteristic curves, the fotol power it has been tend an w emis. wenstigated Fwel Copwle caput of the device con be varied as e func-ATOMCELL M @thewr seer; neneel effeer','
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.:on of the overoll circuit food. The basic
,,,, Sw*=se 2000 Ha wi ne fuel pellet is contained within a refrac.
design, i.e., the number of thermoelectric to,y ~td, fontd.,,n-iO pe, cent tur.2s,en, de~en cad +e evo,eity a fusi, con be
- -- \\l FUEL CAPSULE welded inner container. This container is speciHcdly ediwared to mec Ae needs of 5ser s4seownfly welded into o nickel bosed the individwol user.
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senaurie.
INLA As d acussed prevs.ounf, there.6s ne tedo-t r
tT,j.'*ReOlM'l1*"o'"o',7 ne r-p-vdto e p
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t.en hemord assocenteo with henolia0 or v
use s~**Citt - - ~-ir coer63 notion of materiots provides the wit;.
ATOMCELL generc+or is easily converted to g
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oAer penW hesord a rdeose s Ae more in protection ogoinst fire, impact, a more useful 5 to 7 volts by ~ans of a de-pisen.wm;238 #wel. To cembe Ass poss.-
crush, and corrosion.
oc convener. This voltage step up con be 3
bility, en enkeresely stable. non pyroJoe_;
Fill INSUL ATION occomplished or 50 pee.ene efficiency or o
fuel for*, PwO2 ** 6'd 8* 'ddi'i*a. 'h*
ro;i so, to,;-
greater, leavin o
,t-of usef%.,n ec,re han 300 microworts pisoniwe-238 is hid wiAin eree stvedy.
. wo,mo,;o., concerni,.
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d di mod. w~t. con y seda -oi-m.
1 rhe fon ins.,uon is e gna,ioi,oaoge, yeg,-* a~~ is ~we 5,,
t',w**f,y 7;S*e*l,*gdd; Arce cion.d o~ eu, whic sw, unds the.d
%,,,,,s capsule and module. The thermal conduc-
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,,,he, c,n.eined wi,,;n e so,e,,oy-C27d tivity oceoss the foils is opprom.motdy Radia' ion levels
=ddd osw cA,. TW tieeivm ever 1/100 of that of conventional insulations.
Dis!ANCf f acu x
,,,,,,,,g gg g g,,;,,
The fo.ts 1.ruelly channel the heat throwgh ne radiorjonemonorino from 'h* ATOMCEL L ATOMCELL CEMERLN, em s
i j the themoelectric module.
generaror sa composed of neutrons and ganwne The A70MCELL safety one is in The entens.ty o the radiar.on es de-8eliobif a,
8 accord with USAEC.er d ( A ensinrg rays.
CASING f Co*In9 E*"d# ' "P*". boe the quantity and quality The ATOMCELL genevator conreins no mov-sho.ing rh enutra of kse ents ;s eveil-g,;,
g g
of the pluton um-238 used for fuel. The gng p,,,,,h,,,,,,;,
f*31**Ia0 Cu'***, F o"'d 3a mN* (thereby ry,;
,,p,,,,g,, gon,,e rdiobility.
oble upon reqwnt.
The casing of the generator is fabricated of 6
l gi,,p,7,4 g
titanium alloy for monimum s'rength, relie*
Ming Into occount As biological f0Crort i
bility, and compatibility wita body tissue.
for the various pes of radiation) indicates in the power producing thermoelectric Q
The cosing and cop are closed by sool weld-
- do** l***l. '*O*a*d I'o* * 'yP'Cel module is 200cf. Temperoe res.a this 6 v
ing or essembly. The entire inner volume is ATOMCELL waer.
ver e een year l'fe span songe are not ddewious to f4 motwids g
! evoc oved to enhance the effectiveness of
- 'odiWien leve' well :ncreene by e.shty invdvd. De ourw cae is bordy e to the foil insulation.
PC*a' =
the towch la eswiene air,
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The ATOMCELL aenerotor is the higheir power level, with corresponding !awest rodfotion level, Implantable nuclear power supply avoilable. It is safe, reliable and most efficient, having the i
._lownt plutonium-238 inventory of any such comparable device.
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"t.firLING AND 0f't3T174G wie;on l
MIsuC TiONS dIAO N M,.
N radiation levels odiacene eo the i
l N ATOMCELL genererer is e arvedity ATOMCELL genwaeor ere low enough so 12 i
built, twgged device wl.icle occepts normel permit coreinwove emponure. Fueled with l
b l
harmiling elched risk e. domoge. Its com.
the bi,jh purity plveaMe, ent;ched in "o
' T ie c%
- n i
-t as. end c-eMe..t shape m.6e is-ope avg--i6, the.-it con be wid 4
emos. one wndiing e ample procem.
ia *e head cweinveydy without esce.d-4, y
l Its USAIC fimits for whole bruty or entre-t i
< t n Circvie "i'T '"P**W"
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If placed on open cirev t, the fareenol Sain,;ng remperotures will incrase slightly end 3
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4 w4n wesequerely switched onto e load, N ATOMCELL careein 2.3 C1 or 7
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w;tt resvit in a power ourpw volve higher pivronium-238 in *5peclot Farm."
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conditions. If placed on short cirewit, simvironeously in e Type A conreiner
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As many as eig t devices con be shipped than that schievable under stoody stor, er f
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the opposite effect will occur. The which is sie,ly e 6%y duty, neoled, f.
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ATOMCtLL generseer.311 then reqvtre and labeled cardboard bom. Shipping several minutes to stabillae, details and lastructions con be otroined i
ime Port 20 of the Code of Fesarol R,.
VOLT!
The generator con be stored under open gulariers or will be supplied by Nuclear cirsv.t or aboet circuit conditioni althout Gottwy Corp. WPon request.
pg,'armom e end 5.se i
deleterious effects.
Ov put poww Lw) 600 e
L; censing
, c, g,,i Lead voitage (volti) 0.3 i
o 1
N ATOMCELL has been evolvered by Open circ ie tweies) 0.44 The outer cosing of eb ATOMCELL e4 Sree of Maryland and is listed in the Efficiency (percent) 1.0 r
i generator acts on the roulating surface
" Sealed Saveces and Devices
- catolog.
Length On.)
1.00 1
for e4 radioisotope dec sy hear. If this Organizatiore elready processieg e nuclear Diameter On.)
0.67 i
sur%ce is insulated, the laternal hearing lkerne con easily have it amended by a Weight (oms) 35 mill raise the generator s temperature, simple request to their cogMaore licensing Pw-238 careece (mges) 140 e
cad, os Ifudicated, the power will de.
ourhority nferencing the Marylond evalue-Lifelmo (years) 40 i
crecie while In this conditten. The tion. Nuclear Battwy Corp. wil; supply Heat rejectien 37 ATOMCELL con be stored in well insu.
Ikwetag ossisonce end nuclear technology hapanevre (*C) 4 lared condirloes withewt detrimentog signport a those orgcMrotions destrieg to effect.
possess ATOMCELL vaits and who do not F uet i
ofready possess e nuclear license.
N ouen casing operares et ambie,v tempe,o-Tw radi. iso pe ea, lot.4 es u is f ure. No discern ble hear flow occurs so p y,,;y,,,.g33 ;n aan pide farm M ochieve g
t that the unit will ret feel diffwently to the touch than any Inert, attollic object.
ma,,imum stabil;ty ed idey of use.
pqy ogy. 238 hos e half-life J 89.7 yees.
I This long half-life assures that the ov pwe
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e po w of the device will remein very stable oww the design liferime.
l High purity (i.e., > 90 percare) pivtonium-(
238 is weitised and the wygen employed to kan PuC2 is wwkhed in the i=orace *=ygea-16 ro provide miMewm radiation levels.
N PuC2 is Fressed ord sia2ered lato e dea *e i
pellet to achieve the red'elog;celly seted end loweit radierian level form of plweeniv=-
238 presently known.
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