Text

Forwards Advance Copy of Graesby-STI Technical Assistance Request from Arkansas
	ML20216C411
Person / Time
Issue date:	08/18/1994
From:	Bolling L; NRC
To:	; NRC
Shared Package
ML20216C378	List: ML20216C371; ML20216C386; ML20216C400; ML20216C411; ML20216C420;
References
	SSD, NUDOCS 9805190256
	Download: ML20216C411 (47)
	v • d • e

n /

From: Lloyd A. Bolling (LAB To:

SLB Date: Thursday, August 1B, 1994 1:06 pm

Subject:

TAR - GREASBY-STI STEVE:

I AM SENDING YOU, BY MAIL, AN ADVANCE COPY OF THE GRAESBY-STI TECHNICAL ASSISTANCE REQUEST FROM ARKANSAS.

I FORMAL REQUEST IN WRITING WILL BE SENT TO CARL PAPERIELLO S00N.

LLOYD CC:

PHL i

[851g256940127 g

SSD pop l-L

GRASEBYA V STI 06/16/94 b.

4 Greta Dieus

((n/ s h. 5 Director, Arkansas Department of Health

% p;. +f7(,,A Division of Radiation Control and Emergency Management

.,s.

f 4815 West Markham Street Mail Slot #30

.>3..,,-

Little Rock, AR 72205-3867

Dear Greta,

The following are responses to the Arkansas Department of Health's questions, dated June 9, 1994, relating to Graseby STI's application for license.

I.

Response to remaining first round questions 1.

The dimensions of the circular " Caution Do Not Handle" label is 2.5" in diameter.

Please find enclosed an updated drawing of this label.

2.

The exposure limits listed in the Radiation Safety Manual have been updated to reflect current standards (Jan 1994). Please find enclosed an amended copy of the Radiation Safety Manual.

3.

1)

Reference to Chapter 34 in line one removed and reference to 10CFR31 or comparable agreement state regulations made. Please find amended Operators Manual Radiological and Legal Requirement Suppleme~nt.

2)

Suggested changes made.

4.

Since the last application submittal, it has been determined that the Model 4000 IMS is excepted from the specification packaging, shipping paper and certification, marking and labeling requirements per 49CFR173.422. Graseby STI is however required to provide a notice within or on the package, included with the packing list or otherwise forwarded with the instmment stating "This Package conforms to the conditions and limitations specified in 49CFR 173.422 for radioactive material, excepted packages-instmments or articles, UN 2910".

GRASEBY ST1 41 HR sf RF F1.N WT OFHCl lu)\\ 24'n 4 ALDRON. AR "2958.U5A l

I TF L. Enl a t* 4152 fu 501 *)" 2An*

GRASEBY 8.

Typos corrected.

r STI 9.

You are correct in that a wipe test is performed on all units prior to shipment.

Quality assurance manuals do not typically address each individual process which a component or assembly must undergo during testing and/or evaluation.

Requirements for Contamination wipes added to QA manual.

10.

Draft copy of Operator's Manual submitted for your review.

11.

Appendices to Radiological and Legal Requirements Supplement corrected.

Appendix 1 is General License Requirements and Appendix 2 is Radiation Control Authorities.

III. Responses to U.S. Nuclear Regulatory Questions 1.

Graseby STI has added 8 screws which require a special spanner wrench for removal. Updated drawing reflecting these changes are enclosed along with one of the screws which we plan to use. It is intended that the external housing be tamper t

proof, eliminating the possibility of access to the internal cell of the " device". The screws used in the Torlon components are socket cap screws.

2.

Torlon is a Polyamide-imide which exhibits much of the same characteristics of Teflon (extremely inert). Unlike Teflon, Torlon exhibits a very high teasile strength, very low coeflicient of thermal expansion and a high service temperature.

i Do to its chemical characteristics, Torlon is very well suited for this application.

As for the effects on Torlon of ammonia, due to the extreme sensitivity of the Model 4000 IMS, the maximum concentration which is delivered to the analyzer is of the order of 10 5 % ammonia by volume (0.lppm or 100 ppb) with the remainder of the volume consisting ofinstrument air. Due to the extreme sensitivity of the Model 4000 IMS the only cleaning fluid which is allowed is deionized water. This is due to analytical interferences not the Torlon. Also, all internal repairs on the

" device" must be performed at the Graseby STI facilities.

- 3.

The initial design of the cell holder used a 316 stainless steel screw to hold the i

source in place and to make electrical contact with the source. The Torlon holder was machined to be 0.008" larger than the source and the screw was used to hold the source against the Torlon. Since the last application submittal, the source holder has been redesigned to incorporate two stainless steal springs to hold the source in place. We have found that the springs do not cause a breaching of the electroplate on the source. The springs used are 0.057" in diameter and provide a maximum force each of 0.6 pounds which is suflicient to secure the source in place and also provide the electrical connection which is required. Updated drawings of the source holder is provided.

GRASEBY STI 4 5 i nn slMt iT.11 hl ott WI ikW 24N. 4 M i>RON. AR *2Hil. USA 11 t Oil al* 4i(2 l A% 411 n 4" 2Mi'

GRASEBY, All references to the DOT 7A shipping requirements have been s emoveu hviiim4 sections of the Graseby STI application.

JD l

5.

Reference to the Department ofHuman Resources removed from document.

6.

A current list of agreement states was obtained from the NRC and added into document in the place of the previous listing. Listing of NRC regional offices also corrected. Please find enclosed an updated copy of the Operator's Manual l

Radiological and Legal Requirements Supplement.

J 7.

Draft copy of the Operator's Manual Submitted. Please inform Graseby STI on how to address changes to this document.

II. Response to new Questions 1.

The Q.A. Manual has been approved by Mr. Simms. When all modifications to this L

document due to these proceedings has been finalized and approved by your i

department, a signed copy of the QA manual shall be submitted for your files.

2.

All noncompliance issues will be reported to the Division as soon as possible after confirmation of the problem.

3.

A physical layout of the plant is mapped and posted.

l 4.

Graseby STI acknowledges that design, drawing and procedural changes that changes the conditions of our license must be authorized by an amendment to our l

license before it is implemented. Graseby STI is working to isolate radiological issues in the customer supplied manuals to the Radiological and Legal Requirements Supplement to allow flexibility in making operational changes to the analyzer, which do not concern radiological issues, without the need for license amendments. Your assistance in addressing this issue is much appreciated.

l l

S.

Shipping documents include Operator's Manual, Operator's Manual Radiological and Legal Requirements Supplement, Notice to Employees, Copies of 10CFR31.5 and 10CFR32.51, Certificate of Assay for the source and the " device" and all DOT required documents (see question 1-4 above) 6.

As outlined in Section 10.5 (c) of the Quality Assurance Manual, the Material Review Board records identify recurring discrepancies on all incoming and returned parts and components.

7.

As outlined in the Graseby STI Quality Assurance Manual, Section 1.0, last line,

" Quality records will be identifbble and retrievable, and retained permanently".

GRAMBY $TI 4 5 llR si R t I1, Pt hi Of t h 't 1t0% 24*0. 4 41DRON. AR '29511. U$A M 1. Mi ni' 4112 F A\\. 401 a l' 2u*

4 GRASEBY 4.

The labels are permanently attached with a permanent adhesive. ine iaoeis can be removed without leaving evidence that the label has been removed. A warni I

label is present on the external chassis of the Model 4000 stating that removal of the labels is prohibited. As stated in question III-2 above, the levels of ammonia are of a extremely low concentration and the IMS sample path is a closed system.

]

l Standard cleaning fluids will not degrade tl'a labels.

5.

A drop test of the " device" was not conducted. The IMS " device" is constructed l

from a large block of aluminum for the purpose of making the " device" rugged. An excess of fasteners is used to ensure that the device will not become disassembled due to incidental abuse. A total of 44 screws must be removed for total disassembly of the " device". Each fastener is also held in place with loc-tight to ensure that the screws can not back out due to vibration.

6.

The screws which hold the " device" to the main enclosure are also tamper proof screws. (These are not included in the 44 screws mentioned above)

If we can be of further assistance please feel free to call.

Sincerely, g nn

% MW WMD_

Micha Halter, RSO Director, Research and Development GRASEBY ST1 i

44 FIR s1RI FT.1%T OI F3G BON 24*0, ULDRON. AR ~29tR. USA Til; 401 al' 4142 I AN: 401 Al" 2 An'

)

GRASEBYA r STI l

FROM FAX NO. (501) 637-2687 l

l l

FACSIMILE COVER SHEET TO: Greta Dicus COMPANY: Arkansas Department of Health FAX NO: 661-2468 FROM: MIKE HALTER DATE: 07/06/94 NUMBER OF PAGES (EXCLUDING THIS COVER PAGE) :4

Greta, Please find attached a copy of the letter which I submitted as part of Graseby STI's application for license.

In our phone conversation this morning you made reference to our response to question I-4.

Question I4 refers to the prototype testing of the DOT 7A shipping container. Elince our last application submittal, we have had conversations with the DOT and it has been determined that a DOT 7A container is not required for shipment of the IMS 4000 for the reasons outlined in the application.

1 i

If you need further explanations please feel free to call.

Sincerely,,

3 '\\ C. w. h \\ h 'd D Mike' Halter RSO Director, Research and Development

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No.101 l No.102 l No.105 l No. 200 No. 240 l No. 747 l No. 750 l No.130 Base Compound Ethyl Cyanoacrylate Methyl Cyanoacrylate Viscosity 23 75 100 30 40 1300 1700 2000-2400 15 25 80-100 500-550 (eps @ 20*C)

Soluble In MEK acetone MEK acetone MEK MEK

Acetone, MEK acetone MEK acetone MEK sectone nitromethane nitromethane nitromethane

acetone, acetone,

toluene, nitromethane toluene toluene nittomethane

toluene, nitromethane nitromethane nitromethane CURED ADHESIVE STATE (POLYMER)

Softening Range 284-293*F 280-293*F 284-293*F 284 293*F 284 293*F 320-328'F 320-328'F 320-328'F Melting Range 347 374*F 340-365'F 340 365*F 340-345'F 347 365*F 392-401*F 392 401*F 392-401*F Weatherabdity No change otserved after 200 hours0.00231 days 0.0556 hours 3.306878e-4 weeks 7.61e-5 months in weatherometer Solubihty Soluble in acetone, MEK nitromethane, DMF l

Soluble in DMF and nitromethane TORLON* PROPE_RTIE.S.;C_HA_R.*CM.L M W A.jil. ibg.)f d.,l1^&.; ;L.

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(

GRASEBY STI GRASEBY STI MODEL 4000 ION MOBILITY SPECTROMETER AMMONIA ANALYZER OPERATOR'S MANUAL (preliminerf)

Graseby STI 45 Fir Street, P.O. Box 2470 Wsidron, AR 72958 32/E

WARNINGS l

READ AND UNDERSTAND ALL WARNINGS BEFORE USE j

l l

Read and understand all warnings before use of this product. Failure to read, understand, -

or comply with all warnings could result in property damage, severe personal injury, or death.

l Read and understand all applicable Federal, State, and Local environmental Health and L

Safety Laws and Regulations including OSHA. Ensure complete conipliance with all applicable laws and regulations before use of this product.

Read and understand the operation and service manual before operation of this product and its accessories. Do not apply power before ensuring that all equipment is properly installed. To obtain additional manuals, call Graseby STI at (501) 637-4152.

GRASEBY STI ASSUMES NO RESPONSIBILITY WHATSOEVER, TO ANY PARTY WHOSOEVER, FOR ANY PROPERTY DAMAGE, PERSONAL INJURY, OR DEATH RECEIVED BY OR RESULTING FROM,IN WHOLE, OR IN PART, THE IMPROPER USE, INSTALLATION, OR STORAGE OF THIS PRODUCT BY THE USER, PERSON, FIRM, ENTITY, CORPORATION OR PARTY NOT ADHERING TO THE INSTRUCTIONS AND WARNINGS OR NOT ADHERING TO ALL FEDERAL, STATE, AND LOCAL ENVIRONMENTAL AND OCCUPATIONAL HEALTH AND SAFETY LAWS AND REGULATIONS.

THE SELLER SHALL NOT BE LIABLE FOR DIRECT, INDIRECT, CONSEQUENTIAL, INCIDENTAL OR OTHER DAMAGES RESULTING FROM THE SALE AND USE OF ANY GOODS AND SELLERS' LIABILITY HEREUNDER SHOULD BE LIMITED TO REPAIR OR REPLACEMENT OF ANY GOOD FOUND DEFECTIVE. THE WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, l

EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND DTNESS FOR USE OR FOR A l

l PARTICULAR PURPOSE WHICH ARE EXPRES$LY DISCLAIMED.

l Do not remove, cover, or alter any label _on this product, its accessories, or related products.

Use of this product requires the handling of compressed, hazardous, gaseous substances.

Under no circumstances should this product be used except by qualified, trained, i

technically competent personnel and not until the warnings, operation and service manual, labels, and other literature accompanying this product have been read and understood.

1 l

B.2/y

1 Unknown substances are dangerous. Always treat unknown chemicals as dangerous, toxic, acidic, flammable, explosive, and poisonous. Learn the properties, characteristics, and precautions associated with the hazardous gas used with this product. Read the MSDS and follow all recommended health and safety precautions for maximum safety.

Close all containers of substances used with this product after use. All containers of substances should be kept closed when not in use.

Keep all substances used with this product out of the reach of children.

Wear protective clothing for eyes, hands and body when handling any s.

ce used with this product. Always wash your hands thoroughly after servicing this and especially before eating, drinking, smoking or applying cosmetics. Chemicals, e a liquids, gases, fumes and vapors may cause severe burns to eyes and skin. If acw;. 41 contact occurs, wash the affected area with copious amounts of water and call a physician.

Calibrate in a well ventilated area. Prevent the buildup of any calibration source or vapor.

Open all doors and windows and only calibrate in well cross-ventilated areas. Avoid breathing all calibration fumes or vapors as they are hazardous to your health. Do not mix chemicals in combinations that are not specified in the manual. Failure to strictly follow the instructions in the selected preparations, dilution and mixing of calibration sources may result in personal injury or death. Failure to calibrate in accordance with instructions in the manual or at specified intervals may result in the product not operating correctly or malfunctioning.

Do not operate this product should it malfunction or require repair. This product was sold wita a warranty for free repair of a product with a manufacturing defect. Contact Graseby STI for service and repair immediately.

Use clean, inert and dry materials to contain hazardous gas and to transfer substances used for calibration.

Verify the concentration of the calibration substance before making calibration adjustments.

l Dispose of all chemicals, calibration sources, and scrubber / permeation tubes carefully in L

compliance with all applicable safety laws, regulations, and guidelines for proper disposal.

Failure to do so may result in environmental and property damage, personal injury or death.

l Ensurc.nat all compressed calibration substance sources are empty prior to disposal.

Do not attempt to repair or modify the instrument. Contact the Graseby STI Service Department to arrange for Returned Material Authorization (RMA).

/322C

Do not, at any time, cover the cell exhaust port as serious damage to the instrument may result.

f This instrument is not explosion-proof. The unit can be made explosion-proof only by implementation of customer purge procedures.

Do not use inert gas in place of instrument air. Inert gas will cause erroneous readings and will damage the instrument.

This instrument contains high voltage components. Keep the enclosure door closed during normal operation. Disconnect all power to the IMS before performing any maintenance procedures. A GROUNDING WRIST STRAP MUST BE WORN AT ALLTIMES WHEN SERVICING THE IMS CELL.

822.i

i i

1.0 INTRODUCTION

SPECIFICATIONS Measuring Range i

Analyzer 0 to 100 ppb FS Analyzer with Dilution Probe I to 25 ppm FS to 0 to 500 ppm FS Minimum Detectable Concentration Analyzer lppb Analyzer with Dilution Probe 0.25 ppm Accuracy

+/- 2.5% FS Zero/ Span Drift (24 hr)

+/- 2%FS Detector Life

>10 years Operating Temperature Range 5 C to 40 C Operating Humitiy Range 0 to 100% noncondensing Outputs 0 to 5VDC standard; 4-20ma and Digital Outputs Available Configuration 19" Rack Mount or Bench Top,7.25"H x 22"D; Less than 50lbs; LCD display Power 115 VAC,60 Hz 150 Watts Instrun:ent Air

< -400C dew point, oil free; 5 liters / min 1

(

E221

2.0 INSTALLATION AND OPERATION INSTALLATION GENERAL i

The following sections describe certain procedures that must be implemented before attempting calibration and/or operation of the Model 4000 IMS. In order to ensure proper operation of the instrument, these procedures should be strictley followed.

Refer to the Operator's Manual Radiological and Legal Requirements Supplement prior to installation of the Model 4000 IMS.

UNPACKING THE MODEL 4000 IMS The Model 4000 IMS is shipped in a container specifically designed to protect the instrument from damage. To avoid damaging the IMS, remove the instrument from the s

shipping container as follows:

1)

Open the outer carton and remove the 4 corner pieces supporting the inner carton.

Remove the inner carton. The outer carton should also contain a Operator's Manual, Operator's Manual Radiological and Legal Requirement Supplement, an M.S.D.S. for Dimethyl-methyl-phosphanate, Notice to Employees, a copy of 10CFR31.5 and 10CFR32.51, and a radioactive material leak test certificate. The radioactive material leak test certificate provides the sealed source " device" serial number, the unit number, the date when the last leak test was performed, and the date by which the next leak test should be performed. If the radioactive material leak test certificate is not enclosed, contact Graseby STI immediatly.

2)

Open the inner container and remove the four coner pieces surrounding the Model 4000 IMS and lift the instrument from the carton.

3)

Place the instrument on a solid surface.

IF INSTALLATION OF THE MODEL 4000 WILL NOT BE PERFORMED IMMEDIATELY, DO NOT REMOVE THE CAPS COVERING THE EXHAUST PORT, SAMPLE INLET PORT, AND THE INSTRUMENT AIR PORT. THESE CAPS SHOULD REMAIN IN PLACE UNTIL INSTALLATION B21

i INSTALLATION PROCEDURES The Model 4000 IMS is shipped from the factory with the nuclear device installed. The customer can implement installation only if all procedures in this manual are followed and all applicable rules of the U.S. Nuclear Regulatory Commission or an Agreement i

State are met. It is highly suggested that trained representatives of Graseby STI be contracted to complete installation. Under no circumstances are customer personnel permitted to install, service or remove the " device" itself or the radiation source. This must be performed only by qualified personnel representing Graseby STI.

RECOMMENDATIONS FOR BEST PERFORMANCE 4

The non-nuclear portions of the system should always be installed as per the explicit instructions in the installation instructions provided. Failure to do so could impair the proper operation and performance of the system. The nuclear portions of the system require no adjustments except for periodic calibration due to changes in material being measured and source decay. The use of weak radiation sources is detrimental to the l

performance of the system. Only representatives of Graseby STI are licensed to replace weak radiation sources with fresh ones.

WARNING: DO NOT ATTEMPT TO OVERRIDE THE SAFETY FEATURES I

OF THE SYSTEM. BESIDES BEING ILLEGAL, THE POSSIBLE RADIATION DOSE RECEIVED IN THE DIRECT BEAM OF RADIATION COULD EXCEED SAFE LIMITS PRESCRIBED BY THE U.S. NUCLEAR REGULATORY COMMISSION AND COULD CAUSE PERMANENTINJURY.

l INSTALLATION LOCATIONS Select a location for the analyzer where temperature variations, dust, and moisture are minimal. Place the analyzer in a ventilated location. The analyzer is capable of operating i

in the range of 5 C to 40 C without risk of damage. After installation the analyzer should allow convient access to the operator controls and front panel display.

The analyzer is supplied with chassis slides for rack-mounting. The instrument is 22 l

inches deep and fits into a 19" (48.3 cm) RETMA instrument rack. Refer to the instructions provided with the rack-mount kit for assembly into a rack.

t This device is classified as a portable device. Portable means that it can be legally moved from one location to another by the customer without having to be specifically licensed by the U.S. Nuclear Regulatory Commission or an Agreement State to do so. This

" portability" leads to some potential hazards, however.

822.

The Model 4000 IMS should only be located in an area that is protected from general access by the public. This equipment contains radioactive material that can be hazardous to the health ofpersons that do not follow the proper procedures pertaining to the equipment. All installations should be protected by anti-theft systems including keyed lock. Wherever possible, the Model 4000 IMS should be located inside a locked room or enclosure. When not in immediate use, the Model 4000 IMS should be stored inside a locked room.

The location of the Model 4000 IMS should be checked periodically to ascertain proper function and system integrity. If the system is missing or shows signs of tampering, l

report the information immediately to the radiological authorities in your state listed in the appendices. If your state is not listed, contact the U.S. Nuclear Regulatory Commission for your area.

REMEMBER:

Criminal and civil liabilities can result from negligence in securing the Model 4000 IMS from theft and pilferage.

ELECTRICAL INSTALLATION The electrical wiring during installation is performed by customer personnel and/or Graseby STI personnel per the installation instructions provided. The Model 4000 IMS

" device" is installed by representatives of Graseby STI and is electrically connected by means of a detachable electrical connector or hard-wired. If service of either the electrical or non-electrical portions of the Model 4000 IMS device is indicated, Graseby STI must be contacted.

l l

The analyzer provides either a current output or voltage output signal to drive a strip-chart recorder or a data acquisition system. These outputs are available on the rear panel terminal strip as illustrated in Figure X.X.

l PNEUMATIC CONNECTIONS l

All pneumatic connections must be secure to ensure accurate operation of the analyzer.

l

1) Cut all connecting tubing squarely and remove any internal or external burrs.

i f

2) Insert the tubing through the back of the nut until it reaches the tube stop in the fitting.

3) Turn the nut finger tight.

4) Wrench tighten the nut 1 1/2 -2 turns.

l B225 i

t

i

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5) All connections should be re-checked after the analyzer has reached operating temperature.

NOTE:

Tubing used for sample gas and exhaust connections must be 3/16" ID max - 1/8"ID min and 1/4"OD. The tubing must not exceed 6 feet for minimum pressure drop.

i l

l l

l

J OPERATION The operation section describes the actions necessary to operate the instrument, first in general then in specific terms. In the Menu Screens section, the menus are shown as they appear on the

- display screen. The illustration is followed by a brief explanation regarding the menu entries and choices. The entire menu structure is included at the end of this chapter.

GENERAL OPERATIONINFORMATION All operator responses needed to operate the Model 4000 are performed by pressing the 5 keys available on the front panel of the instrument, to the right of the display screen. The key functions are as follows:

Up Arrow - Moves the cursor to the previous menu item. Also moves the cursor to the next choice or increments the digit in a numerical field.

Down Arrow - Moves the cursor to the next menu item. Also moves the cursor to the next choice or decrements the digit in a numerical field.

Select - Selects the menu choice or selects the field for input.

Exit - Leaves a field without making a change or returns the cursor to the initial screen.

PGUP - Moves the cursor to the previous page or screen.

USING THE MENU AND MAKING ENTRIES The Model 4000 Ammonia Analyzer is programmed with a series of menus that allow the operator to view parameters, to enter digital parameters, or to select from among the choices displayed.

The position of the cursor is evident as a letter or character appearing in reverse video (the letter is light and the background is dark).

Screen fields-The screen fields that allow input can be divided into two categories; l) a series of choices in a wrap around scrolling format 822..'

l 2) a field of setable digits (these fields may be either wrap-around scrolling L

or non-wrap-around scrolling).

CHOICE FIELDS-To select among the choice fields, simply press the ENTER key when the desired selection is displayed.

DIGIT FIELDS-To set digits in a field, first press the select key to designate the field.

When the cursor indicates the digit you wish to change press the up or down arrow until l

the desired digit appears. Go to the next digit by pressing SELECT. When all digits of an i

i entry are correct, press the ENTER key to confirm the entry.

Microprocessor Generated Information-1 Some fields, such as those on the Instnunent Status screen contain information generated by the microprocessor. The operator cannot affect the reading in these fields. (ifyou find that the cursor will not enter the field, the field contains microprocessor generated information).

u MENU SCREENS This section of the manual first identifies the screen, then shows a replica of the screen, followed by a brief discussion of the fields of that screen. The values shown are for illustration purposes only. The entire menu structure is located at the end of this chapter.

Upon applying power to the unit, the screen displays the Graseby STI logo for a few seconds and then identifies the analyzer. After a warm-up period, the words MAIN l

MENU are highlighted and the current measurement of ammonia indicated in the center of the display.

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' MEASURE MENU i

BnS:: NH3i.

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. Instrument setup, status and calibration are controlled by use of the instrument menu system.
When the initial screen is displayed and words MAIN MENU are highlighted, press the SELECT key to enter the MAIN MENU.
MAIN MENU '
INSTRUMENTMENU
. CALIBRATION MENU TEST MENU.
INTERFACE MENU.
TREND SELECT MENUi EVENTIMG INSTRUMENT STATUS.
Each of these menus has one or more levels of menu items within it, except the final three items.
The INSTRUMENT STATUS, AND INSTRUMENT PARAMETERS are constantly updated 822,#
readings that apply to the operation of the instrument. The EVENT LOG is a log created by the microprocessor to indicate certain deviations in the operating parameters of the instrument that
. may be used in diagnosing and troubleshooting instrument problems.
INSTRUMENT MENU The items in the INSTRUMENT MENU addre.s instrument settings needed to initiate operation.
. INSTRUMENT MENU.
MEASUREMENTMENU
, :Date: 06/12/93 DATE-The date format is month / day / year TIME -
Set in 24-hour format. Setting the time resets the seconds (internally) to zero for synchronization with an external clock. See setting the Date and Time in the Warm Up section of this chapter.
The MEASUREMENT MENU consists of three items needed for basic operation and data integrity.
MEASUREMENTMENU Unit Selection: PPM Average Period: MINUTE Filter Type:
Noise; Unit Selection: ppm or mg/m3 Average Period - Set time in 1,3,5,10,15,30,45 or 60 minutes. This field is a wrap-around field.
Filter Type -
Noise - is the standard deviation of the concentration taken over one hour.
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1 CALIBRATION MENU The CALIBRATION MENU contains entries used to set up the instrument. The choice of TIMED or MANUAL calibration creates a slightly differer.t screen. TIMED calibration generates a zero/ span check that will occur at the interval chosen, without operator intervention.
MANUAL calibration allows for operator controlled calibration. Only one choice (TIMED or MANUAL) applies at any time.
When CALIBRATION: TIMED is chosen, the following screen is displayed.
CALIBRATION MENU Calibration Timed Time Interval 24 hour2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months Starting Hour 0 NH3 Timed Span 50 ppm Calibration Internal Span Comp Enable NH3 Span Ratio I.000 i
Calibration: Timed (to run microprocessor controlled zero/ span check at specific time).
Time Interval - Is the number of hours between microprocessor generated zero/ span checks.
Starting Hour - The operator selected hour when the microprocessor controlled zero/ span check will occur.
NH3 Timed Span - Digital setting of the span concentration the operator expects the instrument to read.
Calibration - The choice ofInternal or External valves that will operate during a zero/ span check.
Span Compensation - A choice of Enable or Disabled.
NH3 Span Ratio - A microprocessor generated field that is the value by which the span reading is multiplied to correct it to the calibration value.
When CALIBRATION: MANUAL is chosen, the following screen is displayed.
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CALIBRATION MENU Calibration-Manual -
Cal. Mode :
} Measure NH3: Timed Span i? /50.00 ppm -
Calibration :
Internal *
' Span Compensation Enable:
. NH3 Span Ratio
' l.000 -
Calibration Manuai - To initiate operator controlled calibration Calibration Mode - A choice of MEASURE (normal mode), CYCLE (zero/ span), SPAN (span valve), or ZERO (zero valve). This choice is based o the valve the operator wcnts to open.
NH3 Timed Span - Digital setting of the span concentration the operator expects the instrument to read during an automatic zero/ span cycle.
Calibration - The choice ofINTERNAL or EXTERNAL valves that will operate during a zero/ span check.
Span Compensation - A choice of ENABLED or DISABLED.
NH3 Span Ratio - a microprocessor generated field. The NH3 span ratio is the factor that is used to compensate fo-the last automatic zero/ span cycle of the instrument. If the SPAN COMPENSATION is ENABLED, the ratio is multiplied to obtain the current NH3 reading. If the SPAN COMPENSATION is DISABLED, the ratio is reported only.
I S255
TEST MENU i
The TEST MENU includes a series of submenus containing information and en itrol settings for test and instrument functions. The operator may make changes to settings, ho' ever, when the instrument is returned to normal operations the instrument's automatic contr 21 fun:tions resumes.
Changes made from this menu are for diagnostics and test purposes only.
TEST MENU OUTPUT TEST MENU DIAGNOSTIC MENU MEASURMENT GAIN
4 J
PRES / TEMP COMPENSATION
ON l
MEASUREMENT GAIN - Entries are software controlled settings of 1,2,4, 8,16.
PRESSURE / TEMPERATURE COMPENSATION - Is either set to ON or OFF. OFF is used when running diagnostics to see fluctuations in readings. ON is used to compensate for enviromental fluctuations that might affect readings.
The DIAGNOSTIC MENU is information used to diagnose problems or suspected problems.
The settings return to the previously set conditions when the operator leaves this menu.
DIAGNOSITIC MENU FUNCIONAL TEST
LPT1 DISPLAY TEST For FUNTIONAL TEST choose from:
DAC TEST - Puts approxiamately 1 HZ sawtooth waveform on all DAC outputs. Test runs approximatly 2 minutes and the rest of the system is locked out during this test.
COMM TEST - Sends test of all printable characters to both serial ports.
B2.3l
4 LPT 1 - Sends text to the printer port. If the printer is capable of printing the extended charatcer set, it will print a gray bar below the text.
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INTERFACE MENU The INTERFACE MENb is used for adjustments related to the interfacing instnunents.
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INTERFACEMENU a:
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' ANALOG OUTPUT MENU J
2 RS232/RS48,5 BAUfi
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.s ANALOG OUTPUT MENU RANGE
50 PPM OFFSET
0.00 FULL SCALE ADJUST
0.00 ZERO ADJUST
0.00 RANGE - Set the upper range limit to the desired concentration.
OFFSET - Choices are 0,5%, and 10%. Recorder output will reflect this on the strip-chart.
FULL SCALE ADJUST - X.XX%, a correction factor for Full Scale Setting.
ZERO ADJUST - X.XX%, a correction factor for Zero Setting.
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B234
TREND SELECTION TREND SELECTION MENU is a graphic display of the parameters listed.
- TREND SELECTION MENU CONCENTRATION AVERAGE CONCENTRATION
REFERENCE:
ZERO OFFSET SPAN COMPENSATION Each graph is displayed as an x-y axis with the x-axis 0 being the current time and the most distant number being the most historic data.
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INSTRUMENT STATUS INSTRUMENT STATUS is information continuouly generated by the microprocessor for various parameters.
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INSTRUMENT STA' US T
1 CELL OUTPUTI CELL TEMPERATURE PERMTUBE OVENTEMP HIGH-VOLTAGE SUPPLY CELL OUTPUT displays the current voltage output of the cell (electrometer) and allows the operator to adjust the gain of the electronic circuit.
CELL TEMPERATURE displays the current cell temperature.
PERMTUBE OVEN TEMP. displays the current temperature of the permtube oven.
HIGH VOLTAGE SUPPLY displays the current setting of the high voltage power supply.
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MAINTENANCE 4
l The Model 4000 IMS is designed for continuous operation under industrial conditions,
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with minimum maintenance.
Any major system fault should be referred to Graseby STI as well as any faults with the device. The customer is legally required to contract with Graseby STI or someone specifically licensed by either the U.S. Nuclear Regulatory Commission or an Agreement State for a six-month service call to perform a radiation survey and a safety evaluation in lieu of a shutter mechanism test.
MODEL 4000 IMS DEVICE No periodic maintenance is possible on the Model 4000 IMS " device" by the customer, and all faults must be referred to representatives of Graseby STI.
The measurement cell of the Model 4000 IMS " device" should never need cleaning.
I However, if the measurement cell gets some foreign matter wedged inside that cannot be removed easily by tweezers, it is probable that the device may have to be dismantled for cleaning. This task can only be performed by authorized representatives of Graseby STI i
or personnel specifically licensed by the U.S. Nuclear Regulatory Commission or an I
Agreement State, l
i NUCLEAR AND NON-NUCLEAR PORTIONS j
i Maintenance on the nuclear and non-nuclear portion is discussed in great detail in the j
following sections. The customer is not legally permitted to remove or work on the nuclear sensor, source holder (device) or anything located in the cabinet housing the I
source holder or the ion-chamber assembly. All such work must be referred to Graseby i
STI. The customer is also not pennitted to relocate the Model 4000 IMS, no matter how 7mcha small the distance unless all safety precautions in this manual are met as well as all rules of the U.S. Nuclear Regulatory Commission or an Agreement State, j
LEAK TEST The IMS unit must be tested for leaks of radioactive materials at intervals not to exceed six (6) months. Refer to the Operator's Manual Radiological and Legal Requirements Supplement for details on performance of the radioactive material leak test.
B231 i
NOTE:
A COPY OF THE CURRENT RADIOACTIVE MATERI/,L LEAK TEST CERTIFICATE MUST ACCOMPANY THE UNIT AT ALL TIMES.
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PERMEATION TUBE REPLACEMENT (ADD TEXT) l l
D%
1 JManeas DEPARTMENT OF HEALTH 4815 WEST MARKHAM STREET
LITTLE ROCK, ARKANSAS 72205-3867 g
TELEPHONE AC 5016612000 JIM GUY TUCKER SANDRA B. NICHOLS, M.D.
GOVERNOR DIRECTOR Mr. Mike Halter, R.S.O.
August 3, 1994 Director, Research & Development Graseby STI P.O. Box 2470 Haldron, AR 72958
Dear Mr. Halter,
A review of yJur response to seCond round questions has been completed.
There remain a few questions before the device safety analysis and evaluation
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documents can be completed.
Also, as a result of our recent conversation, some additional information is required which I will address in the last part of this letter.
Please note, in responding to these remaining items, DO NOT resubmit the entire application as you have done in the past two submits.
This has only delayed the process.
Simply respor.d to the questions and only submit pages or other information requiring modification as necessary to complete the response.
The questions are:
1.
The information regarding dose limits is still not accurate.
The opening statement on dose limits mentions quarterly limits. Quarterly limits no longer exist.
This language should be removed.
It should also be noted that the dose limits stated are total effective dose equivalents.
2.
In your response to question I.4, the UN number should be UN2911 not UN2910.
3.
Regarding your response in question I.6., 11 states and the District of Columbia were not included in the Appendix.
Do we assume that you do not plan to market in those states? Additionally, telephone numbers were not checked so we assume they were correct however, it should be noted that numbers change from time to time.
You should have a mechanism to keep your list up to date.
Also, as it will be necessary to send quarterly reports to radiation control jurisdiction into which devices are sold, please confirm that you have current addresses to these jurisdictions.
Finally, you may wish to list the NRC Region IV Field Office in California.
% Cpd 0;;:-g &,yhy"
4.
The Department agrees that the first section of the operator's manual can be changed without a license amendment subject to the following restrictions:
the change cannot be in conflict with other material submitted and the change cannot relate to radiation issues.
The Radiation Safety and Legal Requirements Supplement to the Operator's Manual cannot be changed.
Please confirm the above.
5.
In responding to II.8., we note that 'therefore" is still spelled as
' therefor'.
6.
Referring to your response to III.4., what adhesive is used?
7.
During my re-review of the resubmitted application, I noted that the Radiation Safety Manual has some language that :nakes it appear that the manual will be given to customers.
If this manual is to go to customers some modifications may be necessary because some parts of it may not apply.
Customers will need to understand this.
Please comment.
8.
In the first submittal of your QA Program, some staffing diagrams were submitted.
These were not included in the most recent submittal.
Was that intentional?
9.
On page 18 of the QA Manual, N.B.S. should be changed to the National Institute for Standards and Testing.
10. Step 6 of the leak test procedure references another section of the submittal if the leak test wipe is positive.
In at least two of the procedures a section is referenced that either does not exist or does not provide very clear instructions on what to do if the test is positive.
Please clarify.
11. Also, regarding leak tests, please change 0.005 uCl to 0.05 uC1.
12.
Item 3.j of Appendix I of the Radiological Safety and Legal Requirements Supplement should have the following added as 3.j.(5):
The licensee shall notify the Department as-soon as possible but not later than four (4) hours after the discovery of an event that may allow unnecessary exposure to or release of radiation or licensed radioactive material in excess of regulatory limits.
Events may include fires, natural disasters, explosions or toxic gas releases, etc.."
13.
Section 8 of the Radiological Safety & Legal Requirements Supplement, in the second paragraph, references the use of Eberitne survey meters.
Very few if Any of your custoe rs may have survey meters much less Eberline meters.
This paragraph may need to be restructured or at least more thoroughly explained to customers.
14. Reference your Radiation Safety Manual,Section VIII. A., second paragraph.
Please explain the statement that if N1-63 is the only radioisotope present, no leak tests will be required.
There is also a typo in this part.
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o 15.
If a leak test of a device belonging to a customer comes back positive, what action will you take regarding this device? For example, will the device be returned to you and if so, what will you do with the source?
As I stated in the opening of this letter, we recently discussed two points both of which require either additional information and/or modifications to submitted material, a.
You have stated that you will use a different source in the device than the Hi-63 source listed in previous submits.
Please submit the Sealed Source Evaluation documentation for the new source, b.
You also stated that your company has made the decision to have the device manufactured by your sister company in England.
This does change the Quality Assurance program that Graseby STI has but does not completely eliminate the need for a QA Program. Attached is a copy of a newly released draft of HRC guidelines for sealed source / device QA Programs.
Please refer to the areas of the document that I have marked and provide the stated information for your QA Program if the device is manufactured in England.
Also enclosed are those pages from your last submittal which were identical to pages previously submitted and therefore were not necessary.
Pages where changes had been made or pages representing " spacing" were retained and have become part of the device evaluation and/or license amendment documentation.
If you have any questions, please call me at 661-2301.
Sincerely, t%
Gr ta J. Dicus, Director Division of Radiation Control and Emergency Management P.ADDOC:
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ML20216C411

Contents

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Subject:

Dear Greta,

..

1.0 INTRODUCTION

REFERENCE:

Dear Mr. Halter,

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ML20216C411

Text

Subject:

Dear Greta,

..

1.0 INTRODUCTION

REFERENCE:

Dear Mr. Halter,

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