ML20148D467
| ML20148D467 | |
| Person / Time | |
|---|---|
| Issue date: | 08/11/1983 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Nord R NORLAND CORP. |
| Shared Package | |
| ML20148D333 | List: |
| References | |
| FOIA-88-147 NUDOCS 8803240049 | |
| Download: ML20148D467 (123) | |
Text
.
DIS' 30 TION:
FC Central File NHSS rf AUG 111983 FCMC rf SLBaggett Norland Corporation ATTR: Mr. Russell Nord Rt. 4 Norland Drive Fort Atkinson, WI 53538
Dear Mr. Nord:
Based on the information schritted by poor letter dated June 30, 1983, we have concluded that your proposed changer to the Norland Bone Scanner is acceptable l
for licensing purposes in accordance with the conditions of the enclosed cor-tificate of registrai;1on.
If you have asty questions, please contpct me at (381) 427-4240.
sincerely, D' *-1 Signed By l
S. 9 L Baggett Steves L. Baggett Material Certification and Procedures Branch
Enclosure:
Certificate No. NR-482-D-102-5 l
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REGISTRY OF RADI0 ACTIVE SEALE0 SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AMENDED COPY)
(Corrected Page) APR 1 1988 NO: NR-482-0-102-S DATE: August 11, 1983 PAGE:
1 of 5 DEVICE TYPE:
Medical Diagnostic Bone Scanner MODEL:
N2740 (scanner unit), N2780 (computer unit) - Formerly 278 and 278A MANUFACTURER / DISTRIBUTOR:
Norland Corporation Norland Drive Fort Atkinston, WI 53538 MANUFACTURER /0ISTRIBUTOR:
D SEALED SOURCE MODEL DESIGNATION:
AECL Models C-235, C-324, C-236
/
Amersham Models IMC-129, 4U52, 4040, AMC-01 ISOTOPE:
MAXIMUM-ACTIVITY:
Iodine-125 400 millicuries I see description)
Americium-241 45 mil 11 curies LEAX TEST FREQUENCY:
6 months PRINCIPAL USE:
(V) General Medical Use CUSTOM DEVICE:
YES X
N0
i' a*
REGISTRY OF RADI0 ACTIVE SEALE0 SOURCES AND DEVICES SAFETY EVALVATION OF OEVICE (Corrected Page)
NO:
NR-482-0-102-S DATE: August 11, 1983 PAGE:
2 of 5 DEVICE TYPE:
Medical Diagnostic Bone Scanner DESCRIPTION:
The former Model 278 and 278A consisted of a computer module and a scanner module designed for the medical diagnosis of bone maladies.
The manufacturer has assigned a model number to each separate module and made some minor changes in the units. These changes do not alter the radiation safety of the device. The computer module will be the Model N2780.
The module will have a different physical appearance than the Model 278 unit but it will have the same computer program.
The scanner unit will be the Model N2740. But, outside the unit will be a made of some different materials.
The source holders are Models 178A588A for I-125 and 189A020A for Am-241. Shutter and shielding are identical to the Model 278.
This device is designed to emit c well-collimated beam 4 millimeters in diameter at the panel surface, diverging to at'out 4 centimeters in diameter at the point of interception by the detector and its collimator. The source is located in the base I
of the scanner unit, which is about 12 inches by 14 inches by 4 inches and weighs about 40 pounds. The detector and source are at opposite ends (upper and lower) of l
a "C" frame. The "C" frame is moved back and forth by a electric motor to scan a l
patient's arm or leg which is positioned horizontally on top of the scanner panel normal to the scan direction and is controlled by the computer module.
The radiation beam passes through a slot in the scanner panel measuring 1/4 inch by 6 inches filled with 60 mil thick tissue equivalent plastic.
l A lock secures the scanner's upper panel to the base of the scanner, preventing access to the source located in the base of the scanner under the panel.
1 l
The shutter is controlled by the computer to energize (open) a solenoid.
Power failure results in closing the shutter by a spring.
Sealed Source Model Designation Isotope and Activity AECL-CP Models:
l C-235 I-125 400 mci l
C-236*(sourceholder) 1-125 400 mci C-324 I-125 400 mci Amersham Corp. Models:
l IMC-129 I-125 200 mci IMC-4052 1-125 100 mci IMC-4040 I-125 400 mci AMC-01 (formerly AMC-25)
AM-241 45 mci LABELING:
The Model N2740 scanner is labeled in accordance with the provisions of Section 20,203, 10 CFR Part 20 and Section 32.74 of 10 CFR Part 32.
o REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended Copy)-
NO:
NR-482-D-102-S DATE: APR 2 6 $84 PAGE 10F 5 DEVICE TYPE:
Medical Diagnostic Bone Scanner MODEL:
N2740 (scanner unit), N2780 (computer unit) - Formerly 278 and 278A (which replaced the.178 and 189 models)
MANUFACTUR ER/ DISTRIBUTOR:
Norland Corporation Norland Instrument /Ino-Tech, Inc.
Route 4 Noriand Drive Fort Atkinston, WI 53538 MANUFACTURER / DISTRIBUTOR:
l SEALED SOURCE MODEL DESIGNATION:
AECL-CP Models C-235, C-236 and Amersham Models IMC-129, ~4052, 4040, AMC.01 (formerly AMC.25) l ISOTOPE:
MAXIMUM ACTIVITY:
See Description Iodine-125 Up to 400 millicuries Americium-241 45 m1111 curies i
LEAK TEST FRE0VENCY:
6 months PRINCIPAL USE:
(V) General Medical Use i
l CUSTOM DEVICE:
YES X
N0 t
I e
4 REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVAL.UATION OF DEVICE (Amended Copy)
NO: ' N R-482-D- 102-S DATE: APR 2 61984 PAGE 2 0F 5 DEVICE TYPE:
Medical Diagnostic Bone Scanner DESCRIPTION:
The former Model 278 and 278A consisted of a computer module and a scanner module designed for the medical diagnosis of bone maladies.
The manufacturer has assigned a model number to each separate module and made.some minor changes in the units.
These changes do not alter the radiation safety of the device. The computer module will be the Model N2780.
The module will have a different physical appearance than the Model 278 unit but it will have the same computer program. The scanner unit will be the Model N2740.
The unit module will have the same physical appearance as the Model 278 but, outside the unit will be made of some different materials.
The source holders are Models 178A588A for I-125 and 189A020A or N1076 (new modi-fication) for Am-241.
Shutter and shielding are identical to the Model 278.
This device is designed to emit a well-collimated beam 4 millimeters in diameter at the panel surface, diverging to about 4 centimeters in diameter at the point of interception by the detector and its collimator. The source is located in the base of the scanner unit, which is about 12 inches by 14 inches by 4 inches and weighs about 40 pounds.
The detector and source are at opposite ends (upper and lower) of a "C" frame.
The "C" frame is moved back and forth by an electric motor to scan a patient's arm or leg which i's positioned horizontally on top of the scanner panel normal to the scan direction and is controlled by the computer module.
.T he radiation beam passes through a slot in the scanner panel measuring 1/4 inch by 6 incties filled with 60 mil thick tissue equivalent plastic.
A lock secures the scanner's upper panel to the base of the scanner, preventing access to the source located in the base of the scanner under the panel, The shutter is controlled by the computer to energize (open) a solenoid.
Power failure results in closing the shutter by a spring.
l Sealed Source Model Designation Isotope and Activity AECl.-CP Models:
C-235 I.125 400 mci C-236 I-125 400 mci Amershi.m Corp. Models:
IMC-129 I-125 200 mci IMC-4052 1-125 100 mci IMC-4040 1-125 400 mci AMC-D1 (formerly AMC-251 Am-241 45 mci LABELING:
I The Model N2720 scanner is labeled in accordance with the provisions of Section 20.20 10 CFR Part 20 and Section 32.74 of 10 CFR Part 32, i
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEylCE (Amended Copy).
N,0 :
NR-482-D- 102-5 DATE: APR 2 61984 PAGE 1 01 5 DEVICE TYPE:
Medical Diagnostic Bone Scanner OVALITY ASSURANCE AND CONTROL:
The manufacturer performs the following quality assurance and control programs:
o Source holder assembly parts are checked 100% for critical dimensions and tolerances, as well as for good mating surfaces.
Incoming sealed source capsules are accompanied by a leak test. report by the o
source manufacturer.
Leak test results are checked and filed by Norland.
o Source capsules are loaded into source holders and individually checked for Am-241 and I-125 content.
Details of measurement equipment and procedures are provided.
Af ter measurements, source assemblies are labeled.
o The device is tested for proper operation of the shutter mechanism for at least 80 full automatic scans of a phantom.
DIAGRAM:
s Co111 mated 1
Detector R
)
U
^
n
'J Tissue Equivalent Q'~
(Water) g Soft F
Tissue Bone i
\\
43 -
g
~ * * "
t m
CONDITIONS OF NORMAL USE:
The Model N2740 will be used for medical diagnostic bone scanning.
Operating The conditions are typical of those found in inedical diagnostic facilities.
device will be used by trained personnel.
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended Copy)_
N0:
NR-482-0-102-S DATE:
APR 2 61984 PAGE 4 0F 5 DEVICE TYPE:
Medical Diagnostic Bone Scanner EXTERNAL RADIATION LEVELS:
The maximum radiation level associated wit:- t',9 scanner is found at the panel's surface in the primary beam of radiation (passing through 0 mils of tissue-equivalent plastic in the panel).
These levels are:
For 200 millicuries of Iodine-125 32.4 R/Hr for 45 millicuries of Americium-241 0.72 R/Hr The radiation level at the panel with the shutter closed is 0.21 mR/hr for Iodine-125 and 0.12 mr/hr for Americium-241.
The distance between the source and the panel surface at which the above radiation levels exist is about 2.5 centimeters.
The beam distance is 4 millimeters at the panel surface.
The dose rate at the deck surface with a new 200 mci source of I-125 is approximately 9 mR/sec; with a 45 mci Am-241 it is approximately 1D 2 mR/hr.
Dose rates for 400 millicuries of I-125 would be proportional to the I-125 dose rates listed above.
Norland reports that the dose rates on the surface of the N1076 holder is 0.2 mr/hr.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE.:
o The device shall be distributed only to persons specifically licensed by the NRC pursuant to Sections 35.13 or 35.14 and 35.100 of 10 CFR 35, or equivalent l
provisions of an Agreement State regulations, o The source used in this device shall be leak tested at least at 6 month intervals using techniques capable of detecting the presence 'of 0.005 microcurie of removable contamination, o
Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority.
o Reviewers Note: The user is required to remove and replace the source holder.
l You should check to determine if they have adequate controls to perform this task.
o The Norland Corporation provides written instructions covering:
radiation safety, source exchange, patient dose, device operations, maintenance, and repair.
o This registration sheet and the information contained within the references shall not be changed or transferred without the written consent of the NRC.
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REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (AmendedCopy) pl0L:
NR-482-D-102-S DATE: APR 2 61984 PAGE 5 0F 5 DEVICE TYPE: Medical Diagnostic Bone Scanner SAFETY ANALYSI-S
SUMMARY
Based on our review of the information and test data cited below that the Norland Bone Scanner was deemed acceptable for iteensing purposes in July 1980 and that the changes made do not alter the radiation safety of the device, we continue to find the bone scanner design as acceptable for licensing purposes, Furthermore, we conclude that the device would be expected to maintain source containment integrity for normal conditions of use and accidental conditions which might occur during the specified uses in this certificate.
REFERENCES:
The following supporting documents for the bone scanner design are hereby incorporated by reference and are made a part of this registry document <
o Norland Corporation letters dated August 20,1979, April 12,1980, June 16,1980, June 25,1980, June 30,1983, and November 1,1983, with enclosures thereto, o
Supersedes registration sheet dated July 1,1980.
ISSUING AGENCY:
U.S. Nuclear Regulatory Commission 0
APR 2 61984 2
Date:
Reviewer; O Date:
Concurrence:
Mi. b~ u.
G*
4
s REGISTRY OF RADI0 ACTIVE SEALE0 SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended Copy)
M:
NR-482-D-102-5 DATE:
,AUG 1 1 1983 PAGE 1 02 5 (Corrected Page)*
DEVICE-TYPE: Medical Diagnostic Bone Scanner MODEL: N2740 (scanner unit), N2780 (computer unit) - Formerly 278 and 278A M ANUFACTURER/ DISTRIBUTOR:
Norland Corporation Norland Instrument /Ino-Tech, Inc.
Norland Drive Fort Atkinston, WI 53538 MANUFACTURER / DISTRIBUTOR:
SEALED SOURCE MODEL DESIGNATION:
AECL-CP Models C-235, C-236*
Amersham Models IMC-129, 4052, 4040., AMC-01 l
ISOTOPE:
Iodine-125 MAXIMUM ACTIVITY: Up to 400 mill'icuries (see descr 1
Americium-241 45 millicuries tion) l L_EAK TEST FREQUENCY: 6 months l-l PRINCIPAL USE:
(V) General Medical Use 1
CUSTOM DEVICE:
YES X
NO l
l l
l
i REGl..RY OF RADI0 ACTIVE SEALED SOURCEa.ND DEVICES SAFETY EVALUATION OF DEVICE (Amended Copy)
NO: NR-482-D-102-S DATE:
AUG 1 1I333 PAGE 2 0F 5 (Corrected Page)*
DEVICE TYPE: Medical Diagnostic Bone Scanner DESCRIPTION:
The former Model 278 and 278A consisted of a computer module and a scanne.r module designed for the medical diagnosis of bone maladies.
The manufacturer has assigned a model number to each separate module and made some minor changes in the units.
These changes do not alter the radiation safety of the device.
The computer module will be the Model N2780.
The module will have a different physical appearance than the Model 278 unit but it will have the same computer program.
The scanner unit will be the Model N2740.
The unit module will have the same physical appearance as the Model 278. But. outside the unit will be a made of some different materials.
The source holders are Models 178A588A for I-125 and 189A020A for Am-941.- Shutter and shielding are identical to the Model 278.
This device is designed to emit a well-collimated beam 4 millimeters in diameter at the panel surface, diverging to about 4 centimeters in diameter at the point of interception by the detector and its collimator.
The source is located in the base of the scanner unit, which is about 12 inches by 14 inches by 4 inches and weighs about 40 pounds.
The detector and source are at opposite ends (upper and lower) of a "r" frame. The "C" frame is moved back and fortheby an electric motor to scan a patient's arm or leg which is positioned horizontally on top of the scanner panel normal to the scan direction and is controlled by the computer module.
The radiation beam passes through a slot in the scanner panel measuring 1/4 inch by 6 inches filled with 60 mil thick tissue equivalent plastic.
A lock secures the scanner's upper panel to the base of the scanner, preventing access to the source located in the base of the scanner under the panel.
The shutter is controlled by the computer to energize (open) a solenoid. Poiver failure results in closing the shutter by a spring.
Sealed Source Model Designation
_ Isotope and Activity AECL-CP Models:
C-235 I-125 400 mci C-236*
I-125 400 mci Amersham Corp. Models:
IMC-129 I-125 200 mci IMC-4052 I-125 100 mci IMC-4040 I-125 400 mci AMC-01 (formerly AMC-25)
Am-241 45 mci LABELING:
The Mcdel N2740 scanner is labeled in accordance with the provisions of Section 20.203, 10 CFR Part 20 and Section 32.74 of 10 CFR Part 32.
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REGISTRY 0. AADI0 ACTIVE SEALED SOURCES AND udICES SAFETY EVALUATION OF DEVICE (Amended Copy)
@: NR-482-0-102-5 DATE:
PAGE 3 0F 5 DEVICE TYPE: Medical Diagnostic Bone Scanner QUALITY ASSURANCE AND CONTROL:
The manufacturer performs the following quality assurance and control programs:
1.
Source holder assembly parts are checked 100% for critical dimensions and tolerances as well as for good mating surfaces.
2.
Incoming sealed source capsules are accompanied by a leak test report by the source manufacturer. Leak test reports are checked and filed by Norland.
3.
Source capsules are loaded into source holders and individually checked for Am-241 and I-125 content.
Details of measurement equipment and procedures are provided.
Af ter measurements, source assemblies are labeled.
4.
The device is tested for proper operation of the shutter mechanism for at least 80 full automatic scans of a phantom.
DIAGRAM:
Collimated 4
U-g Detector Tissue 7
Equivalent (Water) 4 Soft t u OL,[
Tissu
,a g g
l Bone gg j
\\_
CONDITIONS OF NORMAL USE:
l l
The Model N2/40 will be used for medical diagnostic bone scanning. Operating conditions are:
i Ambient temperatures l
Atmospheric pressures
r '.,
REGISTRY OF RAD'I0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE (Amended Copy)
NO.:
NR-482-D-102-S DATE:
AUG 111963 pAGE 4 0F, 5 (Corrected page)*
DEVICE TYPE:
Medical Diagnostic Bone Scanner EXTERNAL RADIATION LEVELS:
The maximum radiation level associated with the scanner is found at the panel's surface in the primary beam 6f radiation (passing through 0 mils of tissue-equivalent plastic in the panel).
These levels are:
For 200 millicuries of iodine-125:
32.4 R/Hr For 45 millicuries of americium-241:
0.72 R/Hr The radiation level at the panel with the shutter closed is 0.21 mR/hr for iodine-125 and 0.12 'mr/hr for americium-241.
The distance between the source and the panel surface at which the above radiation levels exist is about 2.5 centimeters.
The beam diameter is 4 millimeters at the panel surface.
The dose rate at the deck surface with a new 200 mci source of I-125 is approximately 3 mR/se'c; with a 45 mci Am-241 it is approximately 0.2 mR/hr.
Dose rates for 400 millicur of I-125 would be proportional to the I-125 dote rates listed above.
LIMITATIONS AND/0R OTHER CONSIDERATIONS OF USE.
- This device may be distributed to persons specifically licensed by NRC or o
Agreement States or to persons licensed pursuant to Section 35.14 and Section 35.100(f), Group VI, of 10 CFR part 35, or equivalent.
L'eak Testing: The source used ii1 this device shall be leak tested at least at t
o 6 month intervals using techniques approved by the licensing authority and l
capable of detecting the presence of 0.005 microcuries of removable l
contamination, o
Handlings Storage, Use, Transfer, and Disposal:
To be detemined by the i
licensing autho,rity.
l This device is distributed under terms and conditions of License No.
o l
48-13403-02MD issued to Norland Instruments.
l The Norland Corporation provides written instructions covering:
radiation l
o safety, source exchange, patient dose, device operations, maintenance, and
- repair, i
e l
~~
-REGISTRY-OF RADI0 ACTIVE SEALED SOURCES AND DEVICES
~'
SAFETY EVALUATION OF DEVICE-(Amended Copy)
N_0 : _NR-482-D-102-S DATE:
AUG 111983 PAGE S OF 5 DEVICE TYPE: Medical Diagnostic Bone Scanner SAFETY ANALYSIS SUPNARY_:
Based on our review of the information and test data cited below that th# Norland Bone: Scanner was deemed acceptable for licensing purposes in July 1980 and that the
~
changes.made do not alter the Radiation Safety of the device, we continue to find the bone scanner design as acceptable for licensing purposes'.
Furthermore, we conclude that the device would be expected to maintain source containment integrity for normal conditions of use and accidental conditions which might occur during the specified uses in this certificate.
REFERENCES:
The following supporting documents for the bone scanner design. re hereby incorporated by reference.and are made a part of this registry document:
o Norland Corporation letters dated August 20,1979, April 12,1980, June 16,1980, June 25,1980, and June 30, 1983, with enclosures thereto.
6 Superseder registrition sheet dated Jyly 1,1980.
_ ISSUING AGENCY:
U.S. Nuclear Regulatory Commission I
Dste:
Reviewer:
Y
~'
AUG 1. kd3 Date:
Concurrence: _ J u l # e i.. A U'
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i-o way
/
o UNITED STATES
'. e NUCLEAR REGULATORY COMMISSION
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W ASHING TON, D. C. 20555 l
CERTIFICATE OF REGISTRATION AND SAFETY ANALYSIS SUtHARY DEVICE Manufacturer and Distributor Model Designation _
w Norland Corporation Norland Model 278 Norland Instrument /Ino-Tech, Inc.
(Replaces Models 178 and 189)
Norland Drive Fort Atkinson, WI 53538 Sealed Source Model Designation Isotope and Activity AECL-CP Models:
C-235 I-125, 400 mci C-234 I-125, 400 mci Amersham Corp. Models:
IMC-129 I-125, 200 mci IMC-4052 I-125 100 mci IMC-4040 I-125 400 mci AMC-01 (formerly AMC-25)
Am-241 45 mci Conditions of Normal Use The Model 278 will be used for medical diagnostic bone scanning. Operating conditiors are:
Ambient temperatures Atmospheric pressures Device Description The Model 278 consists of a scanner module and a computer module designed for medical diagnosis of bone maladies. The sealed source is nonna11y contained in a shielded holder such as Norlands 178A588A for I-125 or 189A020A for Am-241.
This device is designed to emit a well-co111 mated beam 4 millimeters in diameter at the' panel surface, diverging to about 4 centimeters in diameter at the point of interception by the detector and its collimator. The source is located in the base of the scanner unit, which is about 12 inches by 14 inches by 4 inches and weighs about 40 pounds. The detector and source are at -'posite ends (upper and lower) of a "C" frame. The "C" frame is mond back e 5rth by an electric motor to scan a patient's arm or leg which is posis....co horizontally on the top of the scanner panel normal to the scan direction and is controlled by the computer module. The radiation beam passes through a slot in the scanner panel measuring 1/4 inch by 6 inches filled with 60 mil thick tissue equivalent plastic.
l
. A lock secures the scanner's upper panel to the base of the scanner, preventing access to the source located in the base of the scanner under the panel.
The shutter is controlled by the computer to energize (open) a solenoid.
Power failure results in closing the shutter by a spring. A sketch of the device is shown below.
1 Collimated y
Detector
(
U D
n Tissue -dA
'J Equivalent T
(Water) g
_O W' T s u /e lw o 1
\\,~n;:23 4 y
External Radiation levels The maximum radiation level associated with the scanner is found at the panel's surface in the primary beam of radiation (passing through 0 mils of tissue-l equivalent plastic in the panel). These levels are:
For 200 millicuries of Iodine-125:
32.4 R/Hr For 45 millicuries of Americium-241:
0.72 R/Hr The radiation level at the panel with the shutter closed in 0.21 mR/hr for iodine-125 and 0.12 mr/hr for Americium-241.
The distance between the source and the panel surface at which the above radiation levels exist is about 2.5 centimeters. The beam diameter is 4 millimeters at the panel surface.
't
.. The dose rate at the deck surface with a new 200 mci source of I-125 is approximately 9 mR/sec; with a 45 mci Am-241 it is approximately 0.2 mR/hr.
Labeling The Model 278 scanner is 1abeled in accordance with provisions of Section 20.203, 10 CFR 20 and Section 32.74 of 10 CFR 32.
1.
Source holder assembly parts are checked 100 percent for critical dimensions and tolerances, as well as for good mating surfaces.
2.
Incoming sealed source capsules are accompanied by a leak test report by the manufacturer.
Leak test reports are checked and filed by Norland.
3.
Source capsules are loaded into source holders and individually checked for I-125 content. Details of measurement equipment and procedures are provided. After measurements, source assemblies are labeled.
4 The device is tested for proper operation of the shutter mechanism at least eighty full automatic scans of a phantom.
Instruction Manual The Norland Corporation provides written instructions covering: radiation safety, source exchange, patient dose, device operation, maintenance, and repair.
Limitations and/or Other Considerations of Use A.
This device may be distributed to persons specifically licensed by NRC or Agreement States or to persons licensed pursuant to Section 32.14 l
and Section 35.100(f), Group VI, of 10 CFR Part 35, or equivalent.
l B.
Leak Testing: The source used in this device shall be leak tested i
at least at 6 month intervals using techniques approved by the l
licensing authority and capable of detecting the presence of 0.005 microcuries of removable contamination.
C.
Handling, Storage, Use, Transfer, and Disposal: To be detennined by the licensing authority.
D.
This device is distributed under terms and conditions of License No. 48-13403-02MD issued to Norland Instruments.
l
[
, References This' Certificate of Registration is based on information and test data provided by the Norland Corporation in their letters of August 20, 1979, April 12,1980, June 16,1980 and June 25, 1980, and enclosures. This certificate supersedes catalog sheet dated May 28, 1976.
Date_ July 1, 1980 Reviewed By 18[
Oate July 1,1980 Concurren
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REGISTRY OF RADI0 ACTIVE. SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE dJ NO.:
NR4820101S DATE:
May 28, 1976 PAGE 1 0F 6 DEVICE TYPE:
Medical Diagnostic Bone Scanner MODEL:
Norland-Cameron 178, 189 MANUFACTURER / DISTRIBUTOR:
Norland Corperation Norland Instrument /Ino-Tech, Inc.
Norland Dr Fort Atkinson WI 53538 MANUFACTURER / DISTRIBUTOR:
SEALED SOURCE MODEL DESIGNATION:
Norland 178A591A and 178A476A, or 189A038A ISOTOPE:
Iodine-125 MAXIMUM ACTIVITY:
400 millicuries Americium-241 45 millicuries LEAK TEST FREQUENCY:
PRINCIPAL USE:
General Medical Use CUSTOM DEVICE:
YES X NO k 1[
~
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
-NO.:
NR4820101S DATE:
May 28, 1976 PAGE 2 0F 6 DEVICE TYPE:
Medical Diagnostic Bone Scanner DESCRIPTION:
Norland Instruments Models 178 and 189 utilize iodine-125 with up to 400 millicuries in Norland Instruments Model 178A591A and 178A476A Sources (Amersham-Searle [A/S] Sources Model IlfC-125).
The Norland-Cameron Bone Mineral Analyzer Model 189 may also utilize up to 45 millicuries of americium-241 in Norland Instruments liodel 189A038A sources (A/S source flodel AMC-25 using an AECL source holder).
The 178 and 189 devices differ only in minor electronic characteristics.
The primary material of construction is stainless steel. Both instruments consist of a scanner module and a computer module designed for medical diagnosis of. bone maladies. The mineral content of the bone (lower arm or leg) is determined by scanning with a low energy ganna source and a solid state detector.
The 178 (I-125) is designed primarily for arm measurements and the 189 for leg measurements (Am-241) and arm measurements (I-125).
The source holder and its mount are designed to emit a well-collimated beam 4 millimeters in diameter at the panel surface, diverging to about 4 centimeters in diameter Lt the point of interception by the detector and its collimator.
The source is located in the base of the scanner unit which is basically a stainless detector and source are at opposite ends (upper and lower)ghs about 40 pounds.
steel box about 12 inches by 14 inches b" 4 inches and wei The of a "C" frame such that they are always opposite each other.
The "C" frame is' moved back and forth by an electric motor to scan a patient's arm or leg which is positioned horizontally on the top of the scanner panel normal to the scan direction. Scans are controlled by the computer module which also computes mineral content and width of the bone.
The radiation beam passes through a slot in the scanner panel measuring 1/4 inch by 6 inches filled with 60 mil thick tissue equivalent plastic.
A key lock secures the scanner's upper panel to the base of the scanner, preventing access to the source located in the base of the scanner under the panel.
The shutter is. controlled by the computer (in a separate module) and is energized (opened)byanelectricalsolenoid.
Power failure or other malfunction interrupting power to the solenoid will result in the sliding shutter being closed i
by a spring. An on-off indicator is not provided; however, if the shutter fails to close, the instrument will malfunction and the shutter failure will be obvious.
Further, the sound of the shutter opening and closing is apparent.
41
.e REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALVATION OF DEVICE NO.: NR482010lS DATE:
May 28, 1976 PAGE 3 0F 6 DEVICE TYPE:
Medical Diagnostic Bone Scanner DESCRIPTION (CONT'0):
The manufacturer normally supplies all sources.
The applicant may refer to utilization of Norland's "program 190" in his application which includes supplying a new I-125 source with exchange instructions every four months.
Source exchange is accomplished by unlocking the scanner panel, removing the screws
'~
securing it to the scanner base, lifting off the panel, lifting a' hinged plate to which the source holder is threaded (shutter is also attached to the bottom of this plate so as to shield the radiation beam) and unscrewing the source holder. The source holder cap (stored under the panel when the source is installed) is then threaded on the source holder to shield the 30 degree conical beam emanating from the end of the holder. The new source is then installed in the reverse order.
LABELING:
One side of the scanner bears a label measuring 6 centimeters by'10 centimeters as described below:
For The Model 178 (RadiationSymbol)
"Caution-Radioactive Material This device may contain a maximum of
- mci of I-125. This machine is to be used only under the direction of qualified personnel.
Primary beam path indicated by plastic inset in scanner deck.
Maximum dose rate in primary beam 9 nr/sec."
c:
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE NO.: _NR48201015
~0 ATE:
May 28, 1976 PAGE 4 0F 6 DEVICE TYPE:
Medical Diagnostic Bone Scanner LABELING (CONT'0):
For The Model 189 (Radiation Symbol)
"Caution-Radioactive Material This device may contain a maximum of
- mci of I-125 or a maximum of 45 mci of Am-241. This machine is to be used only under the direction of qualified personnel.
Primary beam path indicated by plastic insert in scanner deck. Maximum dose rate in primary beam I-125 - 9 mr/sec**
Am-241 - 0.2 mr/sec."
In addition, the hinged panel to which the source holder is attached bears a label on its upper surface with the radiation symbol, and the wording "Radiation Source Below This Arm" with a circled "X" and an arrow pointing to the circled "X" with the warning "Primary Beam." (There, of course, should be no beam since the shutter closesautomatically.)
Also, a horizontal surface adjacent to the hinged panel bears a label with radiation symbol and the wording "Source Description - See Label on Machine Exterior." "For Source Handling, See Instruction Manual or Call Norland Instructions, Fort Atkinscn, Wisconsin 53538."
Each source holder is labeled to show its serial number, activity, date of l
l measurement, model number, radiation symbol and Norland's name and address.
- will usually read "200", but in some cases will read "400" (400 mCisource).
- will read 18 mr/sec for 400 mci source EXTERNAL RADIATION LEVELS:
The maximum radiation level associated with the scanner is found at the panel's surface in the primary beam of radiation (passing through 60 mils of tissue-equivalent plastic in the panel). These levels are:
For 200 millicuries-of iodine-125:
32.4 R/Hr For 45 millicuries of americium-241:
0.72 R/Hr l
l l
l
0 REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALVATION OF DEVICE
&: NR48201015 DATE:
May 28, 1976 PAGE 5 0F 6 DEVICE TYPE:
Medical Diagnostic Bone Scanner EXTERNAL RADIATION LEVELS (CONT'0):
The radiation level at the panel with the shutter closed is 0.21 mr/hr for iodine-125 and 0.12 mr/hr for americium-241.
The distance between the source and the panel surface at which the atove radiation levels exist is about 2.5 centimeters.
The beam diameter is 4 millimeters at the panel surface.
Radiation levels with a 5 centimeter cube of water in place (to represent a patient's arm or. leg):
For 200 millicuries iodine-125 Radiation levels range from 3 mr/24 hours (12 centimeters from the primary beam and 7 centimeters above the panel surface) to 35 mr/24 hours at a point 6 centimeters from the beam and flush with the panel surface.
The radiation level at the upper surface of a 5 cm water phantom (representing a patient's arm) is about 160 mr/hr in the primary beam. The radiation level in the primary beam at the detector collimator after passing through the phantom is about 40 mr/hr.-
For 45 millicuries americium-241 Radiation levels range from less than 1 mr/24 hours (at points 8,11,12 and 13 centimeters from the primary beam and from positions flush with the panel surface to 5 centimeters above the panel surface) to 7 mr/24 hours at a point 6 centimeters from tN primary beam and flush with the panel surface. The radiation level at the upper surface of a 10 cm water phantom (representing a patient's leg) is about 1 mr/hr in the primary beam.
Surface radiation levels of the two source holders are:
2.5 x 10-2 mr/hr for 45 mci americium-241 0.1 mr/hr for 200 mci iodine-125 Two scanning speeds are available, 2 mm/sec and 1 rm1/sec. Two m/sec is normally used. Usable scan length is 13.5 cm, but a single arm bone scan is about 3 cm.
Dose to the segment of tissue exposed to the beam varies over the scan length (and with depth in the tissue).
Exposure varies from about 2 mr to a maximum of about 84 mr for the 1-125(200 mci) equipped unit and from about 0.1 mr to a maximum of
REGISTRY OF RADI0 ACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE
'NO.:
NR4820101S DATE:
May 28, 1976 PAGE 6 0F 6 DEVICE TYPE:
Medical Diagnostic Bone Nanner EXTERNAL RA0!ATION LEVELS (CONT'0),.
about 2 mr for the Am-241 (45 mCiI equipped unit.
The higher exposures result from-the scanner pausing about 9 seconus at scaa initiation to obtain a baseline counting rate.
QUALITY ASSURANCE AND CONTROL:
Norland Instruments has furnished Pfor ation concerning quality control which assure that production devi:es will mee; thi 9tandards of design and prototype tests.
LIMITATIONS AND/OR 0 THEL CONSIDEaATJCN OF UK:
Separate instruction) ma.cals ce provided for each device covering:
1.
Radiation safety.
(Ir11udirj f a61ad.vn levels, bam location, scanning characteristics, shott.r charccturisths, and rogr:e holder characteristics).
2.
Source excbenge.
3.
Patient dose (to ann or 'e9 segment).
4.
Operation.
5.
Maintenance (cleaning, lubricating and belt i%pe -tion).
6.
Repair. The user is advised to call Nwland Inst: men'.", for repairs and to remove the source holder prior to disassemb'iy of Me device for repair purposes.
Norland Instruments Models 178 and 189 may be licesed for ssecific / Henses using the information above.
For licensing pursuant to 10 CFR 32, the obt le infonnation together with modified labels meeting Specifications set forth in 10 CFR 3?
Section 32.74(a)(2)(vii) and (a)(3) may 'c used.
ISSUING AGENCY:
U.S. Nuclear Regulatory Comission i
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- NORLAND INSTRUMENTS Post Office Box 4 7 A St,DS-C Ff of Cofd S COf poraton Fori AtOnson Wsconsin 53538 Te; (414) 563 8456 iWX 910 :60 3732
March 28,1973 Mr. J. C. Malaro, Chief Materia'is Branch Directorate of Licensing Atomic Energy Commission Washington, D. C. 20545
Dear Mr. Malaro:
We currently have instruments in Japan and they a.re_ experiencing problems in obtaining licenses. Would you please make available to tho Japanese Atomic Energy Commission data which is pertinent to the N6rland-Cameron photon absorption technique and the Norland-Cameron bone mineral analyzer which would be of value to their assignment of the technique for device approval and clinical use licenses. We appreciate your assistance. Sincerely, NORLAND INSTRUMENTS LCdA h Russell H. Nord, Ph.D. N Radiation Safety Officer / I l ( RHN:rb N COT ~ QM TO Sff>U I e v v-e 8 9 e _, _ +
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b f CD .k. C0 m y9 ) r-4 - 4..-?g .id -Q*. u firy=l ):- .os 4. m \\w {i$ 'fA *- l p- @~ ~k, _ a.- w: 7 -- 5 YOTN) U T ,g ~ ) ,..O { R ADIOACTIVE MATERIAL ] 'gg.,/C / ( i This device } may contoin 125]I.' o ,, eg I oximum of 200 mci of ,~ or o maximum of 45 mci of 2U / !"',e s ~/'- Am A ' 83 'h This machine is to be used only under 2,f9- ', f' N i the d ire c tio n of qualified &l s-i personnel. Prima ry beam I pat h indicated by plastic +; Inset in scanner decic. Ma x imurce dose rote } j in primary boom 125 1 9 mR/ sec. 1 241 Am -0.2 mR/ sec. ' g/ l w,:TlflS.LAEIEL MUSTNGTBEREMOVED ORRENDERED ILLEElBLEi, {'$/ [4 // ( t i? ^* ~ I "' / '~ ' 4 22]E.* l.- MRTLr Hi-GLO.SS CR/7CK-N-PEEL PERN7RNENT~ \\ MDH._E. _S/,VE ORRER S_ Y.OCK. 2.- COLOR.RLL LE7 TERS d F/GURE5 7D 8?MR6ENTP ' N R L i-- 8HCKGRO:JMD TD BE"YELLOW.' \\ A ~~ "'L~5" NORLAND 1NSTRUMENTS B ~ ~ vm.: @ 2.ooo OUTS /DE LRBEL. .c ~~ N 1.oso ~ MACMENE 80NE MINEMIL. PNRt YZEW ~ k. ANG.1 %. StAM. g gg nogeN ~ ,.g[ y nn, on. ecALs onAtRNe ""*"' .S* F4 7/ . r.
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h a V hi a C A U T I O N RADIOACTIVE MATERIAL This device may contain a maximum of 200 mci of 125, This machine is to be used only under the dir e c tio n of qualified personnel. Pri m a ry beam path indicated by plastic inset in scanner deck. Maximum dose rate in primary beam 9 mR / sec 6 (76 v), # b R T
i l i i i F ,7 C A U T I O N A R ADIOACTIVE MATERIAL U A This device may contain o 'j, I maximum of 200 mci of I I# {.30 241 or a maximum of 45 mci of Am s ,y This machine is to be. used only under l I 'gjc' ,tk, the direction of qualifie'd p e.r s o n n e l. I g Prima ry beam pa t h indicated by pla s tic l V' l' I f i l' l inset in scanner deck. Maximum dose rate 125 I, i s #e 1 - 9 mR / sec in primary beam 24I Am -0.2 mR/ sec y e ~ dt87 6/ & vj?t -
s. w.. .N -w i NORLAND CAMERON BONE M[NERAL ANALYZER
- v. 'w For the first time accurate, routine measurements of bone mineral are possible
- In vivo
- Non violatory
- Fast-less than one minute total Accurate and precise-I to 2%
Very simple operation Completely automatic analysis of bone mineral (equivalent to ash residuum) using the tech-nique developed at the University of Wisconsin Medical School under the direction of Dr. John R. Cameron, Professor of Radiology and Physics. Each Instrument is certified by Dr. Cameron or a scientific member of his bone mineral laboratory. Allows measurement of mineral and diagnosis for the first time in
- Osteoporosis
- Ostellis fibrosa
- Osteomalacia
- Uremic osteodystrophy
- Hyperparathyroidism Bone disease accompanying chronic acidosis These measurements are also of interest in many other bone ar.d joint diseases, such as arthritis.
For complete technical information complete end mail the enclosed card or caII 414 563 2862 /27 NORLAND /NSTRUMEN7'S l 1009 Janesville Avenue, Fort Atkinson, Wisconsin, 414-563-2862 A Division of Norland Corporation ':J/ ' Dedicated to excellence in premier medical instrumentation
.,_g. ,4 _.m, 3 A s 7<_s.4 2 4 e=- e. ^*- a---.aa' 4 1 1. 4 m1... e 1983 ' M I. %w - ' N -n. s a PRELIMINARY COPY - INSTRUCTION MANUAL MODEL 189 - r BONE MINER AL - ANALYZER Li
- 1 LI o/ p 7/9/7/
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, j? '//A/;9 ' /4'liO ' l s Inside Front Cover This lastrument has been thorougbly calibrated and tested by the factory for compliance to the specifications published for it by Norland Instruments. This testing and calibration has been carried out by highly quallfled personnel directly supervised by engineers and using periodically calibrated test equipment. Many of the; tests are performed using specially designed semi-automatic test equipment in an effort to provide instrumentation of the highest reliabl?Ry and performance which present technology can insure. Occasionally, damage is inflicted to an instrument during shipment. To properly obtain credit against such dame.;e please read and follow the instructions in section I as soon as possible after delivery of this instrument. e e
.... _ _.. - _.. ~ t '\\ CONTENTS Section Page Contents. T......................... 1 List of Figures....................... 11 Fo rw ard........................... 1 I Unpacking and Damage Report Information........ Y II Specifications.................... 5 III I.ist of Ancillary Parts................ [ IV Cporating Instructions A. Radiation Safety ...............f B. Operation ............ // C. Auxillary Inputs and Outputs...........f 7 V Mainten ance..................... '. g VI Repair A. Ge n e r al............. '...... 11. B. Instrument Description and Diock Diagram... 2 3 C. Technical I:xhibits 1. Tests.................. U 2. Disassembly.............. 3 0 3. Minor Adjustments........... 30 I
Ilst of Figures Figure Number _ _ Description g IV-1... sour ce holde r.................. IV-2 .. safe area when loading scanner.......... l IV-3... lift sourco holder arm.............. IV-4.., hold source in position. I IV-5... screw source into arm.............. l IV-0... securo source er.p for luter use......... IV-7... dose to patient.. IV-8... packing instructions for carrying case...... IV-9... measure patient's arm and mark......... IV-10... se tting T-square................. IV-11 locating tissue equivalent on limb holder..... IV-12.. placing patient's arm IV-13.. securing arm in limb holder........... VI-1... block diagram, power supplies.......... VI-2... block diagram, main electronics......... VI-3... exploded view, scanner module.......... VI-4... exploded view, computer module.........
i FORWAIID The Cameron technique of bone mineral analysis passes a col-limated beam of monoenergette photons.through the combination of tissue and bone in a limb and the resulting attenuation is monitored with a suitable gamma ray detector. The tissue cover is made to be uniform by applying tissue equivalent material around the subject to provide flat parallel surfaces above and below the limb. The source and detector are moved across the limb and the resulting absorption curve can be related directly to the total bone mineral por unit length of the bone being scanned. The Norland-Cameron Eone Mineral Analyzer is a completely automated instrument for the in vivo determination of bone mineral content using the Cameron technique. The Norland-Cameron Analyzer minimizes operator variability and provides direct digital rendouts of both bone mineral and bone width without external calcu-lation or manipulation of datn. For most general surveys and as a general indicator of nyerage bone mineral content, it has been found that scanning the rndius gives good results which are well correlated with axial skeleton parameters. Although in specific cases it may be found that some otber bone is a more sensitive indicator of the particular malady being studied, the bone mineral of the radius is correlated to general bone mineral and when the ease of measure-ment is conaldered, it generally is found to be the best choice, t f. The instrument to be described on the following pages was designed 'V'I 9 ' T *1 with forearm measurements primarily in mind but is casily adapted to measuring 4r s the humerus or the tibia and fibula. Obviously any bone can be scanned if the user devises a suitable method of providing the necessary constant tissue equivalent and puts the resulting assembly in a reproducible position in the scanner. The functions of the instrument can be most easily appreciated by considering the following description of the measurement process. The fore-arm to be measured is placed in the limb holder and surrounded by tissue equivalent material. If an extremity is to be scanned which contains two bones (e.g. radius and ulna) the operator presses a button to indicate to the instrument which bono is to be measured. The"SCAN" button is then pressed. The machine thereafter scans the limb, automatically locates the bone to be measured, sets its own baseline and completes the measurernent. The scanner returns to its original position and the results are displayed on two digital panel l readouts indicating bone mineral in grams / centimeter of length and bone width in centimeters. The calibration procedure is equally convenient. The primary call-l bration controls and indicators are located behind the hinged lower section of the front panel. After allowing the detector system to come to eqdilibrium the discriminator window position control is adjusted to maximize the indication of ~ the analog count rate meter. The count rate meter range switches are selected to give the largest possible on-scale deflection. The phantom calibration standard If the is then scanned by the same procedure used for a bone measurement. results displayed on the digital meters are significantly different from those t I (
stamped on the standard the calibration controls are turned and the PESET ~ button is pushed.' This procedure is continued untti the correct reading is obtained The instrument is then completely calibrated. h J f e e u d "# N N 1 6 4 4 1. UNPACKING AND DAMAGE REPORTS Inspect the shipping container for damage. If obvious damage is present request inspection by an agent of the carrier, Unpack the instrument and save the packing materials for possible later use and for inspection by the carrier's agent if internal damage should become apparent. Check the instrument for physical damage to the cabinet, knobs, connectors, etc. If the physical inspection indicates that the instrument is undamaged, check electronic operation of the machine by the procedure outlined in section VI-C-1 of this manual. If the instrument passes this set of performance criteria it has probably arrived safely. If it does not pass the tests in VI-C-1 notify the carrier immediately and then notify either our local repre-sentative or Norland Instruments directly. If we are to assist you in properly, receiving reimbursement for shipping damage you must notify the' carrier immediately. O e 0 ~ t
- 11. SPECIFICAT ONS A.
Scanner Module 1. Scan size: a. 15 centimeters vertical clearance b. 13.5 centimeters usable scan length 2. Scan speeds: rapid search at 1 centimeter /second ~ a. b. scan at 1 millimeter /second scan at 2 millimeter /second c. I3 3. Scan drive: synchronous motor, accuracy determined by ac line i a. frequency l 4. Power: 1 n. supplied by computer module i 5. Weight: a. 40 pounds 6. Source: 125 designed for tisc r ith sealed 200 mci I source or a. l 241Am source and source holder. User sealed 45 mci must acquire source license in accordance with AEC regulations. Assistance in this procedure is available from Norland Instruments.
i B. Computer Module 1. Power; a. 110 VAC, 60 cycle,1.2 amps total (including power furnished to scanne'r mMule) 2. Weight: a. 21 pounds 3. Ace'tracy: a. determined by calibration standard i 4. Precision: 1 l a. standard deviation of ten successive scans guaranteed to l l be less than two percent - will typically be about one l l percent. Higher precision can be obtained through special techniques 5. Front Panel Controls and Indicators: a. accessible: 1. power switch and pilot light 2. count rate meter (CRM) range push buttons S. scan speed push buttons 4. "scan" push buttons 5. bone selector push buttons 6. digital bone mineral and width indicators b. under hinged lower section of front panel 1. analog CRM 2. energy window control 3. "shutter" push button 4. "calibrate" push button 5. two calibrate potentiometers 6. use-carry push button 7. fuse.
t ~ ( 6. Rear Panel Inputs discriminator (for use with external 3 amplifier 'and dif-a. ferential discriminator) i,- b. external-internal discriminator switch 125g _ 241Am switch c. 7. Rear Panel Outputs a. PMT signal b, discriminator c. CRM d. log of CRM c. bone mineral (analog) f. bone width (analog) g. measurement complete h. cable between computer module and scanner module 9 'M )'1 '% g-p AM't.be '..
III LIST OF ANCILLARY MATERIAIE. AND HOW TO ORDER REPLACEMENT PARTS III-A.. STANDARD ITEMS The Model 189 is supplied with: Part No. Description 178A172B limb holder 178A293B 189A01GD standard tissue equivalent bag large tissue equivalent bag 178A173B limb locator T-square 178A322A calibration standard, small 189A005B 178D107A calibration standard, large power cord 178A10G B computer to scanner cable 178A391B scanner signal cable 178D358C 178D357D accessory carrying case main instrument carrying case 178D433A key for scanner deck 178D134A key for instrument carrying case 178A435A operating instructions and service manual III-B. HOW TO ORDER REPLACEMENT MATERIALS Orders can be sent to either our local representative or directly to Norland Instruments. When possible, the part number of the item should be included to avoid confusion. If the part number is not knowr. please include the model number and serial number of the instrument a ~ well as a complete description of the part ordered and the quantity desi ') g v# I I -
IV. OPER ATING INSTRUCTIONS IV-A. RADIATION SAFETY IV-A-1. GENERAL INFORM' TION A Although the radiation produced by the source used in this instrument is highly localized and of low energy, it is quite intense in the primary beam path and should be treated with due respect. The dose rate at the deck surface with a new 200mC source of 125g is approximately 9 mR/sec. The beam is highly collimated and is scanned across the deck in the path indicated by the black plastic insert. At the deck the beam is 4.5 mm in diameter and at the detector head it is 4 cm in diameter. The beam is completely absorbed by the detector assembly. Additionally, a shutter mechanism absorbs the beam almost completely i l (residual dose rate in the beam path approximately.21 mR/hr.) except i when the instrument is in the process of a measurement or when the shutter button is pushed to peak the count rate meter (see section IV-B-2). Check opertion of the shutter mechanism at least once each day by noting that the count rate meter deflects when the SIIUTTER push button is actuated and that the meter drops to zero when the button is released. ' Exposure to an operator 50 cm from the machine is about.014 mR/hr. IV-A-2. SOURCE INSTALLATION The source holde" (figure IV-1) absorbs almost all of the radiation from the source when the cap is in place. When the cap is removed (by unscrewing) the beam exits from the exposed end with a 0 ~ total angular spread of approximately 30. The beam delivers a maxi-mum dose rate of approximately 9 mR/sec at a distance of 2.5 cm.
241 A m ) 3...y' O.E m A /SEC. i APPROX. DOSE RATE \\ ,\\p j6m ea u .) 125I s mn /SEC. E APPROX. DOSE RATE , o,, ,- o i,,, c.
spread of approximately 30. The beam delivers a maximum dose ra 0 of approximately 9 mR/sec, at a distance of 2. 5 cm, with 1251and approximately.2 mR/sec. at a distance of 2. 5 cm. with 241Am. The protective cap should be left on the source holder until immediately before installation of the source. To install the source in the machine proceed as follows: Turn off the power. Remove the thumb screws holding the limb holder and deck to the scanner base (two in front and one in back). Using the deck key l unlock the deck from the base. This lock is a screw type. Turn it counter-clockwise several turns until the deck is free. Disconnect the cable from the back of the scanner and then lift the stainless steel deck. l Be sure no persons are in the area indicated by the diagram in figure IV-2. Lift the source holder arm as shown in figure IV-3. Iloiding the l source in the position illustrated in figure IV-4 roceed with installation Y M Ned $le w of the sou ce as demonstrated i igure IV-5.h -t__-. MMNw M 6M i holder cap onto the stud provide on the carriage assembly (figure IV-6). l l to store it for later use. KEEP FINGERS AWAY FROM TIIE EXPOSED l END OF THE SOURCE HOLDER AT ALL TIMES AND DO NOT POINT TifE EXPOSED SOURCE TOWARD ANYONE. i When removing the source from the machine reverse the above sequence. Be sure to replace the cap on the source holder before trans-porting the source anywhere. IV-A-3. PATIENT DOSE The dose delivered to a patient is illustrated in figure IV-7A 'A for a new 200 mCl 1251 source for a typical scan. Figure IV-7B gives i DANGER THERE SHALL BE NO PERSONS IN THIS AREA WHILE A SOURCE IS BEING LOADED INTO THE INSTRUMEt 1 ,* -+. l l / g e O O L ,k n
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4 the same information for a 45 mci 241 Am source. The dose delivered will be reduced proportionally as the activity.of the source decreases with age. This dose can be compared with about 200-to 300 mr for a typical diagnostic radiograph of the forearm. - IV B-1. INSTALLATION AND POWER CONNECTIONS Remove the accessory case, corr.puter module and scanner module from the carrying case. Figure IV-8 shows the order and orientation of each of the components in the carrying case. Place the scanner module on a table of convenient height for positioning.the patient's arm on the scanner deck. If the scanner module is to be mounted on an adjustable or tiltable stand or cart be sure to bolt it to the surface using the four threaded mounting holes (see figure VI-3 using 1/4 x 20 machine screws (not furnished) of appropriate length. Connect the power cord to the back of the computer module and to a grounded (three prong) outlet. __DO NOT SUBSTITUTE A TWO WIRE CORD OR USE A "CHEATER" ADAPTOR ON A TWO W OUTLET. Connect the two cables provided - the short one from the scanner arm to the scanner base and the long one between the scanner and computer modules. Turn the unit on by pressing the POWER ON button (some random numbers may appear on the numeric display). Open the hinged lower panel and release the PUSH TO CARRY button by pushing it. The scanner arm will traverse to its fully extended "home" position and stop. Install the limb holder on the deck by securing it with the two front thumb screws (see figure VI-3 for details). ' IV-B-2.' CALIBRATION Prepare the machine as outlined in the previous section. Install a source as directed in section IV-A-2. Set the 125 _ 241Am 1 ] switch on the back of the computer module to the position representing When using 241 m remove the collimator insert -the source installed. A by unscrewing (see figure VI-3). The 1/4" hole which remains is the appropriate collimator size for 241Am scans. Be sure the DISC (discriminator) switch on the back panel is set to INT (internal). Allow five minutes for the machine to stabilize before proceeding. r Open the hinged lower section of the front panel and push the SHUTTER button. Using the PEAK control and the three RANGE switches (1000, 3000 and 10,000 counts /second full scale) obtain the highest possible on-scale deflection of the COUNT R ATE meter. Re-lease the SIIUTTER button. Check that the shutier is working by noting that the count rate meter returns to zero. Place the standard (small for 125I and large for 241 Am) on the deck with the indexing key located in the slot on the vertical member of the limb holder and swing the locking bar out of the beam path. Calibration may be done with the hinged section of the'stanc'trd either in or out of the beam and using either of the phantoms provided within the standard.,, -. -
IS For routine clinical measurements the usual procedure is to turn the machine on in the morning, let it stabilize for five minutes and calibrate it. The machine is then simply left running with the ' calibration being checked in the early afternoon. The use of the two phantoms and the two tissue equivalent levels to check instrument function is explained in section' VI-C-1. Select a scanning speed (imm/second or 2mm/second). Normally 2mm/second would be selected. The primary use of the imm/ second speed is for special circumstances such as the measurement of '"very small bones (usually non-human). Press'one of the two DONE buttons to select the first or second phantom encountered by the scanner and then press the SCAN button. The scanner arm will start forward at a speed of one centi-meter per second until it encounters the phantoms selected. It will reverse for three to four millimeters and then sit still for about-nine seconds. During this time the computer module is averaging the base line counting rate. At the end of the nine seconds the computer module-stores the information gathered during that period and sends the scanner arm forward at the selected scanning speed. The phantom is scanned , and the equivalent mineral and width 'are calculated. When the other ~ side of the bone is reached the shtiter closes and the scanner arm is sent to the home position and the results are displayed on the numeric readout. If the results differ significantly from the values engraved i on the standard they can be corrected by use of the BONE MINERAL a and BONE WIDTil controls located behind the hinged lower section of. the panel. To change either presentation turn the corresponding knob a trial distance and push the RESET button. A new value will appear on the^ display. Repeat this operation until the desired numbers appear. Since the processes involved in this measurement are statistical in nature, some variation in readings will occur from one scan to another. The standard deviation of a ser es of ten. measurements should not exceed two percent. However, as those schooled in statistics can appreciate an individual measurement can vary by somewhat more than this value, llence it is wise to tase the calibration on the average of three or four scans of the phantom. After calibrating the instrument as outlined above most operators perform several "check" scans of the phantom. IV-B- 3. PREPARING PATIENT FOR MEASUREMENT If the measurement is being performed on the patient's 241Am source must be used. The procedure leg (tibia or fibula) the for scanning a leg is essentially the same as that used for an arm except that the larger tissue equivalent bag is used and positioning i is usually accomplished'with the help of external means fastened to' l whatever table or other support is provided for the scanner module. 1 If the arm is measured (radius or ulna) the 1251 source is used. The following details of the scanning process refer to measurements of the radius. l l o IV-B-3-a. PATIENT liAS BEEN PREVIOUSLY SCANNED If the patient to be measured has been previously scanned consult the patient's record to determine the reference number to be used_ to poaPion the arm ati-the deck. After securing this positioning data proceed to Step C. IV-D-3-b. PATIENT HAS NOT BEEN PREVIOl: SLY-SCANNED-If the patient has not been previously scanned measure the distance from the styloid process of the ulna to the olecranon on the patient's off-handedness arm (left arm for a right-handed person). Make a mark on the patient's arm at a point one third of this distance from the styloid process of the ulna. Place the patient's arm on the limb holder (palm down) without the bag of tissue equivalent material in position and align the mark on the ' arm with the black plastic inset. These steps are shown in figures IV-0 and IV-10. Slide the positioning T-square into the location which gives the best fit of the stop against the web between the patient's ring and middle finger?. Re cord the number visible on the scale of the T-square in the patient's record and also record which arm is being measured. Remove the patient's arm from the limb holder.
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measurement is an average of n trials..Ilence, more than three or ( four scans does not improve the results enough to warrant the additional time. IV-C. AUXILIAllY INPUTS AND OUTPUTS On the back panel of the instrument are located eight BNC connectors and a slide switch. The function of each of these components is explained ' below: IV-C- 1. PMT SIGNAL This output is the signal supplied by the source follower mounted on the base of the photomultiplier tube in the detector head. It is negative, about one microsecond wide and has an amplitude of eighteen millivolts per kev deposited in the detector. IV-C-2. DISC OUT This signal is a TTL compatible positive. pulse about 0.G microseconds wide which represents the output of the internal differential discriminator. The window of this discriminator is set internally to be 40?o of the iower level. The lower level is varied by the PEAK control on the front panel. IV-C-3. DISC IN This is an input. It requires a TTL compatible pulse with a minimum width of 0.5 microseconds and a maximum width of 0.8 microseconds.
IV-C-4. DISC - INT - EXT SWITCII The DISC IN input may be used in conjunctica with the DISC - INT - EXT switch on' the back panel. In normal operation the switch is set to the INT position. In this position the internal. discriminator is used to drive the count rate meter circuitry and any input to the DISC IN connector is ignored. if desired, the PMT signal may be amplified externally, fed to an external differential discriminator and the output of that discriminator applied to the DISC IN connector. The DISC - INT - EXT switch should then be set to the EXT position. The output of the external discriminator will then be used to drive the internal count rate meter circuits. IV-C-5. CRM (count rate meter) This signal is an analog signal ranging from zero to six volts positive as the front panel meter indicates zero to full scale. IV-C-G. LOG (CRM) (log of count rate meter) This analog signal represents the logarithm of the count rate signal. The output changes two volts per decade of counting rate. Full scale on the count rate meter is represented by minue four volte, l I .one tenth of full scale is represented by minus two volts, etc. IV-C-7. BM (bone mineral) i BM is a positive analog voltage representing bone mineral ( in grams per centimeter and is approximately equal in magnitude (volts) to the reading on the display panel. l I
' IV-C-8. BW (bone width) BW is a positive analog voltage representing bone width -in-centimeters and is approximately equal in magnitude (volts) to the. reading on the display panel. IV-C-9. VALID RESULT A TTL compatible output signal about fifty microseconds wide which can be used to notify external equipment that the voltages present at the BM and BW outputs are true representatives of the measurement just completed. 241Am 125! SWITCII IV-C-10. This switch changes a number of parameters within the computer module to allow the use of either 241 125 Am or 1 as the radioactive source. The position of this switch must correspond to the source being used if the results displayed are to be meaningful. 1 l - -.,.. -. -. -..... _ _ -..
V. MAINTENANCF V-A. GENERAL Normal care appropriate to a precision instrument should be given to your NORLAND equipment. This care should include periodic inspection for loose screws or any ir.dication of wetr. General cleanliness should be observed and the machine should be kept free of dirt and chemical spillages or res! dues. V-D. C LEANING Both exposed metal surfaces and the painted suede finish surfaces may be cleaned by the following procedure: Remove dust and light dirt marks with a damp, lint-free cloth or, preferably, a sponge. Remove more difficult stains with a liquid cleaner such as "Mr. Clean", "liandy Andy", "Lesto11" or "Liquid l Ajax". Rub the de'ergent onto the stain, then rinse thoroughly. If the stain can-not be removed with liquid cleaner, a naphtha dampened sponge or cloth may be used. Change cloths frequently to remove grease without spreading. USE ONLY VM&P NAPHTHA - _DO NOT__USE: lacquer thinner Xylot i Tolulol ethyl alcohol V-C. COMPUTER MODULE ~ The only periodic maintenance which need 13 performed on the computer I module is to remove the front panel after each 200 to 300 hours of use and clean the accumulated dirt from behind the air intake holes at the bottom of the hinged section. l
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- V-D.
SCANNER MODULE-As indicated in section IV-A. the operation of the shutter should be - checked at least once each day by notitig that the count rate meter deflects when the SHUTTER button is actuated and that the meter drops to zero when the button is released. At lease once each year the drive belts should be inspected for wear. Normally, nene will be found. DO NOT LUBRICATE ANY OF THE COMPONENTS IN Tile SCANNER. All parts have been permanently lubricated at the factory and no lubrication should ever be applied in the field, Certain parts cannot tolerate other than special lubricants. DO NOT ALLOW THE R ADIATION WARNING LABELS ON TIIE SCANNER MODULE TO BECOME REMOVED -OR ILLEGIBLE. If replacement is necessary write or call Norland Instruments to obtain new labels. l l l l i i l
VI. REPA!R VI-A. GENERAL The Norland plug-in concept of repair goes beyond the usual meaning of plug-in. Everything electronic can be replaced without the use of a soldering iron. Field repair consists only of replacing modules, with the repair of the modules themselves done at the factory where it can be accomplished most ef-ficiently. Field module replacement and fault isolation are made very simple by functional definition of the plug-in entitles. Functional definition requires each module to contain those components, and only those components, necessary to perform a particular block diagram functic,n. S!nce these block diagram functions are easily understood and not very technical in nature, the location of a fault is easily done by almost anyone. 1 Once the fault is isolated he instrument is easily returned to service by replacing the offending mo.:ule. Another mnus of f motional definition is that, if carried through without compromise, it also assures that cach module can be l Independently calibrated at the factory. Hence no field adjustments are necessary 1 when replacing modules. 1 Reppir is usually done by a field representative. If the user is unable to contact a representativ, in his area the factory nhould be consulted. Im-mediate steps will be takea to restore the instrume::t. h!!nor replacements and, ",.wk adjustments can be accomplished by referring to section VI-C-4. '
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~ A general description of the instrument by iunctional block diagram (and bence by plug-in module) appears in the next section. Following the block diagram is the technical exhibits section ZG ; which includen information on field testing C
to determine whether the instrument is functioning properly, disassembly instructions for replacement of modules and the information on replacements and adjustments referred to above. VI-D. INSTRUMENT DESCRIPTION AND BLOCK DIAGRAM VI-B-1. POWER SUPPLIES The block diagram for tse power supplies, figure VI-1 is largely soif explanatory. The only point which requires mention is that the +9 volt supply is an unregulated supply and provides raw voltage to each board which contains digital integrated circuits. Each board then provides its own logic supp sy using the raw 4 volts and a aener diode. Superior isolation between boards is thus Pchieved. All of the other power supplies are regulated. VI-B-2. DETECTOR AND PREAMPLIFIER The main instrument electronics are diagramed in figure VI-2. The gamma rays from the radioactive source react with the detector and produce a pulse of light (scintillation) proportional to the gamma ray energy. This minute light pulse is amplified in the photo-multiplier tube (PMT) and produces an electrical pulse. The pulse from the PMT is amplified by the preamplifier and passed through the scanner i signal cable and the computer to scanner cable to the amplifier board in the connuter module. VI-B-3. AUPLIFIER BOARD The computer module amplifier board further amplifies the detector signal and presents it to the discriminator board. ~2 ?:
IS L 0 Cl4 DI AG R AM - POWE.C SU PPLIES ~ GCANNEG. 17& A4 20C j78 A7.65 0 MODULE-ISOLATloN HV HV l TR A WsFORM&(Z titan 6F0GNER POW 8G SUPPLY a c A rt o 17 8 A 4 1~1 D n MOTOC POWER -~-TH ROUGH 12ELAY 60AGO l 1 l 178ASotC 178A'2.8 } f l
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t VI-3-4. DISCRIMINATOR BOARD The discriminator board sets a 40% window on the locoming pulsea, the baseline of which is varted by the operator through the WINDOW control on the front panel. The output of the differential discriminator then represents only the gamma rays with the energy of interest and is applied to the input of the logarithmic count rato meter board. VI-B-5. I.OGARITIIMIC COUNT RATE METER BOARD The count rate indication is produced by the "Icaky integrator" technique and is then filtered by two stages of active Icw pass filter. Ectween the active filter stages la a passive filter which has its characteristic switched by an FET to match the CRM time constant to the scanner speed (Icm/second or 2mm/second). The output of the filter stages is applicd to a logsrithmic converter. The output of the log module is presented to the automatic zeroing board. VI-B-6. AUTOMATIC ZEROING DOARD During the search phase of the measurement cycle, the auto zero board simply passes the CRM signal to the bone edge board. When the bone to be rneasured has been located and the scanner has been positioned adjacent to the bone of interest, the auto zero board averages the baseline counting rate and stores this information for use in the next phase of the mensurement cycle. When the scanner is sent forward by-the logic sequence board in its measure mode (Imm/second or 2mm/seconi). _ _
i the averaged baseline value which has been stored ')y the auto zero board is subtracted from the CRM signal. Thus the output from this board is the absorption signal referenced to zero volts. The signal from the auto zero board la passed to both i-integrator board and tho bono edge board. The integrator board is controlled by the bone edge board. VI-B-7. BONE EDGE DOARD The bone edge board contains both a crude edge detector and a fine edge detector. The crudo edge detector locates the edges of the bones as the scanner proceed:, in the search phase of the measurement cycle. The output of the crude edge detector is fed to logic circuits which are controlicJ by the bone selection push buttons on the front panel. Thece logic circuits combine the informattoa from the crude edge detector with l l the requect from the front panel buttonn and provide an output to the logic sequence board which Indicates when the trane of interest has been found. 1 ) The fine edge detector to enabled when the measurement mode is entered l and informs the int :grntor board w'n:n to star
- Ind stop the integrations l
used in the calculations of bone mb:aral and !~ne width. l VI-B-8. INTEGRATOR BOARD l l The Integrator board performa all of the calculation and scaling operations nece. scary to generate the final answer. Tids board is controlle ! l by both the logic sequence board and bor.e edge board. l \\ l t -2 5-
r VI-B-9. READOUT 1 BOARD The analog signals representing bone mineral (DM) and bone width (BW) are sent to the Readout 1 board. This board is controlled by the logic circuits on the Readout 2 board and contains an analog to frequency converter IAFC) and a clock. The BM and BW signals are multiplexed into the AFC by the logic on Readout 2 and the resultant train of pulses is sent l to Readout 2. VI-D-10. READOUT 2 DOARD Ileadout 2 takes the trains of pulses and the clock signal from Readout I and through gr. ting generates two more trains of pulses. The sum of the pulses in each of these trains is the digital representation of each of the analog signels. These trains of pulses are steered by the logic on Readout 2 to the counters on the display board. A signal also is generated from this board to control the 180V power supply and turn the display tubes on and off. VI-B-11. DISPLAY BOARD The display board contains integrated circuit counters to receive the pulses from Readout 2 as well as decoders and drivers for the i gas discharge tube display. The alsplay tube ignition is controlled by the g' ted 180V supply which in turn is controlled by the Readout 2 board. a l VI-D-12. I.O';IC SEQUENCE 3OARD i ( The logic sequence board contains the circuits which generate the master sequence of operations. It recei es inputs from the r. tart push i button, from the bone edge board and from the motor logic board. It also i ^#
cor.taine circuits which decode the state of the limit switches in the scanner module and decide whether or not the instrument is existing in t, "legal" condition. VI-D-13. MOTOR LOGIC BOARD The motor logic board contains n series of flip-flops which determine the state of the machine. Inputs are received from the logic sc-quence board and used to set and reset the "state" flip-flops. The board also contains certain bookkeeping functions which nre used to monitor the machine for"lllegal" states. VI-B-14. REI.AY BOARD l This bonrd is in the scanner module and receives its signals from the motor logic board. These signals are decoded and used to drive the various motor and clutch relays. j VI-C. TECilNICAL EXIIIBITS VI-C-1. TESTS FOD FUNCTION Testing for the logical operation of the machine to very simple. If, when the SCAN button is pushed, the instrumt-nt performs the sequence described in section IV-B-2 for selection of clther the first or second phantoms the l logic portion of the instrument is performing correctly. The computation sections of the instrument can be checked using the phantom standard and a few simple procedures. The baseline l counting rate should be at-least 2000 ets/second in the home posit!on when performing those tests. l l l m V I-C a. First Test With no phantom in the limb holder and with the locking bar in a normally closed position push the SCAN button. The scanner will go forward all the way to the limit owitch, reverse, and return to the home position. About a half sacond after the scanner reverses the display will light and shootd rend 0.02 or 0.03 for the bone mineral and 0.00 for bone width. If the display does not read as indicated above see section VI-C-3-a. VI-r-1-b, Second Test Put the phantom in place on the limb holder and swing the locking bar out of the scan path. Usi ng the lower tissuo equivalent (i.e. with the hinned section of the standard open) take ten scans of the inrger phantom (without disturbing calibration) using the procedure outlined in section IV-p-2. Close the hinged section of the phantom and without changing any settings of control take ten v 'e scan of the same phantom. Compare the nycrages of the two sets'of scans. If the baseline counting rate for the first set of scans was :t lenet 2000 cts /second the two values should not differ by more thn, 2%. If tney do differ by more than 2'I. perform the operation of section VI-C-3-b and then re-do this test. If the difference still exists perform the adjustment in section VI-C-3-c nor!.
re-do this test. If the machine still falls this test notify Norland Instruments. VI-C- 1-c. Third Test After performing tbe above tests take ten scans of cach of the phantoms and compare the averages of these scans to the calibrations stamped on the side of the standard. If the unit is calibrated on the large "bone" the other average should be within 2% of the second value indicated. If it is not within the specified tolerance perform the test in the next paragraph and notify Norland Instrumente. V I-C-1-d. Fourth Test Calculate the standard doviation of each of the two measurements made in the Second Test. These standard 1 1 deviat! ns should be less than 2% The standard deviation of l a series of numbers is inost easil;/ computed fro.n tbc following i formula: ' T *: N+ bC V* u u I A l = pt g. 4.c. the standard deviation where. e- = the at: ebraic deviation of each d = eleme it of the series from any chose number the nuinber of elements in the series n a 1 l l l l 9n.
c. VI-C-2. DISASSEMB LY INSTRUCTIONS The only disassembly which need to be done in the routine maintenance or adjustment of the unit is shown in the exploded drawings of figures VI-3 and VI-4. No tools other than a screwdriver are needed. DO NOT ATTEMPT TO LUBRICATE ANY PARTS OF THE SCANNER MODULE. ONLY THE ADJUSTMENTS INDICATED IN TIIE NEXT SECTION SHOULD BE ATTEMPTED. Leave all other servicing to Norland Instruments personngl. REMOVE THE SOURCE BEFORE ATTEMFrlNG ANY WORK ON TIIE SCANNER MODULE. See source installation and removal instructions in section IV-A-2. IV-C-3. MINOR ADJUSTMENTS AND REPAIRS VI-C-3-a, Adjustment of Display Zero If the test in section VI-C-1-a is not satisfactory the zero of the display can be corrected by using the adjustment on Readout 1 board labeled (A) on figure VI-4. After making a trial adjustment push the RESET button in the calibration group on the lower front panel and note the results. When the result appears to be satisfactory repeat the First Test of section VI-C-1-a, VI-C-3-b, Adjustment of CRM Zero Connect an oscilloscope or zero center voltmeter capable of resolving 10 millivolts to the CRM output on the back of the computer module. With the shutter closed (or with the
souren removed from the instrument) the reading at this connector should be between 0 and +10 millivolts. If it is not within this limit it can be set by means of the adjustment on the logarithmic count rate meter board labeled (B) on the drawing of figure VI-4. V !-C 't-c. Adjustment of Auto Zero Board This adjustment should be undertaken only by persons qualified in electronics. Attach an oscilloscope to the post on the auto zero bocrd marked (C) on figure VI-4. Set the oscilloscope for 1 second/cm and.05 v/cm. Push the SCAN button. The beam will be off the screen of the oscilloscope until the scarmer has completed its baseline averaging operation, it should then give zero volte (t statir.tical fluctuation in the counting rate) unt!! the edge of the bone is again encountered in the mensuring sequence. If it is not zero during this time the control marked (D) on figure VI-4 can be adjusted to correct the situation. Only the voltage level which is present during the tir e between the n:oment when the scanner s(arts moving forward after having paused for the nine second averaging operation and the moment when the beam again encounters the bone enn be used to observo the voltage which is to be set to zero. Due to statistical variations in the radioactive source some vnelation in the average voltage observed at point (C) will be observed. This varintion norraally does nat exccod i 30 milliv71ts.
'f _- ~e m e: _ s '_ Inside Back Cover WARRANTY Norland instruments warrants to the original retail purchaser that its equipment will be free from defects in workmanship and materials for a period of one year after date of purchase. Norland's liability under this guarantec is limited to repair or replacement of equipment returned prepaid to Morland and detern'ined by Norland to have a defect in workmanship or materint during the warranty period and specifically excludes any liability for defects caused by abuse er misuse of the equipment. No other warranty la expressed or implied and no liability will be assumed for consequential damages. l l l l l l l L
t o. I4 s /27 woeursoinsinumwrs 1 C2 1009 J ANESVILLE AVENUE
- P.O. BOX 47 o FOR T A T KIN S ON, WIS C ONSIN $ 35 38 * (414) 5 63-2862 NORLAND - CAMERON BONE MINERAL ANALYZER MODEL 178-A CONTENTS GENERAL INSTALLATION INSTRUCTIONS Pages 1-2 i
l RADIATION SAFETY Page 3 CALIBRATION INSTRUCTIONS Pages 4-6 PATIENT SCANNING Pages 7-9 ACCURACY PROCEDURES Page 10 1
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Y! A5C2 fj,rp'f >s THE CAMERON TECHNIQUE.., ", FOR BONE MINERAL ANALYSIS' ' In the Cameron technique
- for bone mineral analysis a collim'ated b'eam of mono-energetic photons is passed through the combination of tissue ind bone in a limb and the resulting attenuation is monitored with a suitable Y-ray detector. The tissue cover is made to be uniform by applying tissue equivalent material around the subject to provide flat parallel surfaces above and below the limb. The source and detector are moved across the limb and the resulting absorption curve can be related directly to the total bone mineral per unit length of the bone being scanned.
For most general surveys and as a general indicator of average bone mineral con-tent, it has been found_ that scanning the radius gives good results., Although in specific cases it may be found that some other bone is a more sensitive indicator of the particular malady being studied, the bone mineral of the radius is correlated to general bone mineral and when the ease of measurement is cdns,ldered, it gen-erally is found to be the best choice. The instrument to be described on the following pages was designed with forearm measurements primarily in mind but is easily aCapted to measuring the humerus or the tibia and fibula. Obviously any bone can be scanned if tiie experimenter can devise a suitable method of providing the necessary constant tissue equivalent and can put the resulting assembly in a reproducible position in the scanner. GENERAL DESCRIPTION OF THE NORLAND-CAMERON ANALYZER - l The Norland-Cameron Bone Mineral Analyzer is a completely automated instrument for the in vivo determination of bone mineral content using the Cameron technique, i I
- Cameron, J.* R. et al., Radiology 3, Ill, (January,1962.)
i Cameron, J. R., and Sorenson, J., Science 142, 230, (1963.) l Sorenson, J. R., and Cameron, J. R., J. Bone and Joint Surgery 49-A, No. 3, l ( April 1967.) IJ
- l,l.
. $h'n s 1 ,, !.. s '1 ' - 1.' The Norland-Cameron analyzer minimizes operator variability and provides direct digital readouts of both bone mineral and bone width without external calculation or manipulation of data. Although the instrument is designed principally for use on the forearm it incorpor-ates features allowing the upper arm or lower leg to be easily scanned. The functions of the instrument can be most easily appreciated by considering the follow-ing description of the measurement process. The limb to be measured is placed in the limb holder and surrounded by tissue equivalent material. If an extremity is to be scanned which contains two bones (e. g radius and ulna) the operator presses a button to indicate to the instrument which bone is to be measured. The "scan" button is then pressed. The machine thereafter scans the limb, automatically locates the bone to be measured, sets its own baseline and completes the measure-ment. The scanner returns to its original position and the results are displayed on two digital panel readouts indicating bone minoral in grams /c'entimeter and bone width in centimeters The calibration procedure is equally convenient. The primary calibration controls and indicators are located behind the hinged lower section of the front panel. After allowing the detector system to come to equilibrium the discriminator winde position control is adjusted to maximize the indication of the analog count rr,te meter. The count rate meter range switches are selected to give the largest possible on-scale deflection. The phantom calibration standard is then scanned by the same procedure used for a bone measurement. If the results displayed on the digital meters are significantly different from those stamped on the standard the "calibrate" push button is depitssed and the two ten turn potentionmeters provided are adjusted to give the correct reading. The instrument is then completely calibrated. FEATURES OF THE INSTRUMENT I. Physical Features The electronic components are housed in a cabinet made of steel and aluminum with a baked finish. The electronic components are located on numerous plug-in circuit boards which are functionally independent for easy servicing. l Only operating controls are normally visable on the front panel. Calibration controls and the analog count rate meter are conveniently located behind the hinged lower section of this area. The "hidden" controls allow easy access for calibration while minimizing the possibility of the operator either confusing i I l _
.}(.... .i 1 one control for another or accidently brushing a calibration control. The scanning unit is ruggedly built of rigid aluminum castings and stainless steel. The finish is a combination of brushed or polished metal and baked finishes. The internal mechanism was designed with the same ruggedness and wide safety margins characteristic of precision machine tools. The constant speed and accuracy of the scan is maintained in any operating position. When scanning the forearm, position of the limb is determined by a vertical stop which is placed between the subjects middle and ring fingers. This stop can be located at one centimeter intervals. The source is easily accessed from the top of the instrument and is held securely in a mechanism which allows convenient removal. The sizes of the two units are shown on the outline drawings presented on page,s G and 7. Total weight for the two modules is about 60 pounds. 11. Electronic Features The detector is a 3 mm thick Nal (T1) crystal mounted on a 1-1/2 inch photo-multiplier tube. The photomultiplier is driven by a highly regulated high voltage supply. All other supplies 1,n the unit are also regulated for the best possible stability. Integrated circuits are used extensively for increased reliability and reduced costs. The highest quality materials are used through-out with plug-in glass epoxy circuit boards. Push button controls operate through dtgital integrated circuits to control the completely automated analysis. Numerous outputs are provided on the back panel to, allow the greatest possible flexibility in interfacing with external equipment. Outputs allow access to the signal at various points in the processing and to both of the final results. l A logic output indicates to external equipment the completion of an analysis. I f i l l l l l l l
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4%'Q','Y!'Yli. 1 = y SPECIFICATIONS _ Scanner Module 1. Scan size: 15 centimeter ve? tical clearance 13.5 centimeter usable scan length 2. Scan speeds: 1. rapid search at 1 centimeter /second 2. scan at 1 millimeter /second 3. ' scan at 2 millimeter /second 3. Scan drive: synchronous motor, accuracy determined by ac'line frequency 4. Power: supplied by computer module 5. Weight: 40 pounds 6. Source: Designed for use with sealed 200 mC 1251 source and source holder as supplied by Atomic Energy of Canada, Ltd. or equivalent (source is not supplied with the instrument). User must acquire source in accordance with AEC regulations. _C.:nputer Module i 1. Power: 110 VAC, 60 cycle,1.0 amps total (includes motor power furnished to scanner module) 2. Weight: 21 pounds 3. Precision and Accuracy: 1% precision and 2% accuracy See: Cameron, J. R., et al., Investigative Radiology 3,,141, (May-June 1968), also private communication. i 4. Front Pa'nel Controls and Indicators A. Accessible a. power switch and pilot light l l t . i l [ l l
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.s b, count rate meter (CRM) range push buttons ~~, c. scan speed push buttons d. "scan" p.ish button e. bone selector push buttons . f. digital bone mineral and bone width indicators B. Under hinged lower section of front panel a.- analog CRM b. energy window control c. "calibrate" push button d. two calibrate potentiometers e. use-carry switch f. fuse 5. Rear Panel Inputs A. Discriminator (for use with external amplifier and differential discriminator) B. External-internal discriminator switch G. Rear Panel Outputs A. PMT signal B. Discriminator C. CRM D. Log of CRM E. Bonewineral (analog) F. Bone width (analog) G. Measurement complete H. Cable between computer module and scanner moddle Price and Delivery 1. Delivery: 90 days after receipt of order 2.. Price: $9675. 00, F. O. B. : Fort Athinson, Wisco'n'in s Price includes scanner and electronics as described above, limb holder to accommodate forearm, upper arm, and lower leg, phantom standard and instruction manual. Rugged carrying cases especially designed to protect each of the modules and to make them readily portable. O L r < -.w... -~..,- - -.. -... -... * -*be e ~..
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so em. saceE.ucurs /f.Z ear. I 1 M: I! l.-.. ..,.. -, y i l "8 1 1 l t i. l l l l l I. l l i. s i. ' I, et e 11111l l 1 ll l l ll l l11 l l io,e - e i i e 1 1 1 1 I I.i i i i i .r.s. o --. .s u a,,, ' J 7. 0 m. A/Ok'L.RNC ASSOC /R7ES /NC. MODEL Nf. / 76-R 80NC M/NdMWL ANAL YZEt By K3. MAR 2/r 19M '55 A7M/NSON, in)/SCONS/N ScMNMCC MOOu/ d S C R t. L.' VJ s / SH7~ / Of 2 L
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NOk CAMERON BONE M '!"Ij! j{ d Model 178-A General Installation Instructionsd' :,. 5' f. Q' E,f 3 4. 3. .., N
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Remove the Accessory Case, Computer M Module from
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Place the Scanner Module o ' 1.] ?!' %. 't.N, of convenient height for positioning patient's limb in thd; holddr.. If the ...t,.. p.- *: se.. ;,+Iihmd "or cart, be "t Scanner Module is to be mounted on an adjustable o( W" J,tri sure to bolt it down using the four threaded mounting bo
- ppy'ided with.
1/4 x 20 machine screws (not furnished) of appropriate leng;}th*.' p(,: N'* 'n m. 1 '4 /7 1
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2) From the accessory box, remove the two connec and the Take the shorter of the two connec'tdh.e 'yq '.Kk.
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.ab! if f(which power supply cord. 'yf.JPi".y;...c has 90 five pin fittings on each end) and insbrt the' femahM ed end into 0
- iLjjf;j y the socket located on the back of the scanner arm; th;e male'llth',,on the other end is then incerted into the' five pin socket on Scanner
..n.v.a... ,, - Q: 'lU['N' Module baso. - $. ?!. '.. 3) Take the longer connecting cable, with 19 pin-ind ' .ftttings on each end Ju-W. and insert the female fitting into the socket on the back ibf.the Scanner Module base. Insert the male fitted end into the socket providhlb!k,back plate of 9 %t l the Computer Module. (Be sure that both connector cabh securely inserted . 'W. $ lill
- and not in a location where they might become accideftallyjdslodged during
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'.,.p. s'. 4,;. 2 operation of the Bone Mineral Analyzer.) S. 9, '. [.I:E- 'I ' % '. 4) Take the power supply cord and insert the female end,, info the socket on ,,.; G the back plate of the Computer Module. Insert the three@ronged male plug . f y,.!, W. t-into a 110 VAC 60 cycle power outlet. If you must and:an adapter be sure the 4:P;p(N..' cfyk@ii \\ &).,e$'{. a.,$?:l
,,. ~ .t c. 2 lg ground wire is. attach'edh the wall plate. Unde [, 4' - -- .a.. h this unit a. r.. to be operated without kn electrical ground connectid' .N L[F Press the "ON" switch under the Power label $p'~W',p.. i.. Computer Module 5) .m ,%'.. ;?i k . s. a.. control panel. The red pilot light should come on,',','(69 in numbers s.iU)4 . Width; may appear on the numeric displays for Mineral ContcitM@ ':b. these can be ignored at this time.) Iower the hinged portion of the front panel onlthe(' w ' ter Module 6) , T, Q. 1. '- / The motorN11th. b.Q L: %ndthe and depress the "Push to Carry" button. dh. scanner arm will move out of its retracted positionkn,,.'k u ~ When the scanner arm stops moving (and the' motor-st6ps)[S cIdee.the hinged ,;.3.- portion of the control panel and turn the power off.,', '.:n.W.g.'.i - ei Unscrew the three black anchoring screws oUth...f$gf ' v. .n - 6it.ind back edges 7) .i.s. ' f && l4 ': of. the stainless steel scanner deck..With the key prom, refense the lock on . A '.';T1'- the right center side of the scanner deck. The lock is a'.scEew ' type '-- just ...c keep turning until the deck is free. Remove the deck,from'ths: scanner. -' ' h.\\'. 8) Raise the hinged plate located below the detector,o6hh[ scanner arm 3 k' assembly. This is the source holder, j '.{p.,' . 7: m 7 9) Following your standard laboratory isotope handlin'g procedures, remove 125I source (type C-236),aNTscidw the capsule the. cap from the brass AECL ,W.N..- 4 into the threads provided on the bottom of the source holdef@ Depress the source holder firmly to a horizontal position. ,,'s- .p 10) Replace the stainless steel scanner deck. Place'the,11mb holder on the deck so that the two holes in the edge of the holder line up' with the two noles .y in the front edge of the scanner deck. Replace the thrr#. black anchoring p,..(. screws and relock the deck. '~[ t . s.1. W;- ' ' i;.4 . ;. '/, 34Qi[u!;,. ;.- 4.ex
LC 3. NORM' CAMERON BONE Mk.f.7 k ~ 3.., .>,..f s r. .s ~ Model 178-A % T.....Yr' ' Radiation Safety. i'Q ny., ge,, Always remember that although the radiation produce'd.$ ' ("' s Pr! vt r# "% i l .g ce used e' pg, s, .,: g..,, . 2.' ...,i .p y in this instrument is highly localized and of very low ener"' ! .,gitte intense in the direct beam path and should be treated with due. V: ' urce 7 4 .. a,... handling procedures outlined on your AEC license should al Ilhwed. When a spirce is installed in the machine, be sure,pe.9.i.$ Appippriate s- , t6 ft radiation warning labels to the scanner module as called x t
- 20. b F
r c'* ,.. ;.',' t ,s sc.h/. (f) (1) and (2), 10 CFR 20 (AEC publication) or as called for on ]'str. license. y )(0 ..,Q [5)h,(.} In the event that mechanical damage is done to the scginer,medu e' and ..v.w,., o. l .,s...,. l the integrity of the sealed source is suspected, personnel qualMI % handle i .t. f.~.' s 9.; 1 ,+;,,.- unsealed byproduct material should be summoned. If you areipp/'t!' :h. I tisure of the l M procedure to be followed in the event of a problem, call th.e.fE.IgS..h... nergy l l 's' .".i.'.',' Commission office nearest you or call Norland Instruments p'g{,' ;" l y..... l If electronic repair is performed by the user on any$oitidn$'.df f.b6 scanner '..g;). e;; l module, be sure t rirst remove the source from the module.dzd)ilbp$ sit in a ...:r '.; ,! t i storage container. .. [i, . i' . A.. w, m Radiation six inches from any surface of the scanner.d.oed incl.iriormall s it..;i I source in position.' Ther'e' tan'na[ measur- ! 3 l 125 exceed.5 mr/hr. with a 200 mC .i.',. ^ h .~ ;Q. f', l able radiction,which penetrates the detector assembly. < i The dose delivered to the patient during one scan of the:fdharns is .%.,I,9, ', typically less tnan 5 mrem and is confined entirely to a path, at tho' scanning ic ), t site approximately 1/4" wide. , s (. 'f [,,', iY.. hgc 3 h ~~ ..g... gf / 't,a - .;s. ' u '? r;'. ',..'t g. ., 3.f.ll4,f.. J'. A.l h. }y'; vb. %.. d'.'
.... _ ? i.s s. .. ? i,'kh NORISNb-CAMERON BONE MI (s . !q j, MODEL 178-A 1.5.-[ h . m[# a -. g h, ~,>.!.l' N.' Calibration Instructions .s.
- a. w 125 )'is;$) ythe-Assuming that the source (usually 200 milicurie 1
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j,?;.. scanner and that all connecting cables are in place with gly cord plugged into a 110 V AC 60 cycle outlet, proceed abkkdhalibrate k (<. z. 3- .i-.%,pisc. the Bone Mineral Analyzer prior to (patient) scanning Bd W::' _ mi: (discriminator) switch on the back panel of the compute'r kh,',tsiin the '!DA b.?l\\,7
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INT. (Internal) position. ?Ch.'. '. 1) Push the power "on" button. The red pilot light wiYL.coM.'d Random figures may appear on the numeric displays and c f'.Q.),' t', lgnote Iower the . n 4*r."..J hinged portion of the control panel so that all controls ar$=a#-cce'agible. e ,, t *. J$'? ?.$$!.W.'l. 2). The limb holder should be on the Scanner Module dec,g:'.{.Thegehnner - r v;., If it is fif tk@N ",'Chr;y... arm should be in the "Use" (extended) position. 4*/A. j position, push the carry button and it will move to the "Ush'Mtionb. n.5# _; % 3) Allow 10 to 15 minutes initial warm up time before pro'cc with );,.,.,, l calibration. .y -lptMi% Using the N,!]h,;
- r:,
'dd, next to 4) Depress the Range switch marked 10,000. _....>c the count rate meter, adjust until meter needle registers d5E ' btimum on '
- 0).f? ?f$T, scale deflection. If the count rate is less than 3,000; depress' e Range
- 'd;;.(.' -l'/ ;
suitch marked 3,000 and again maximize the on scale riecdle (ctf1pstion on , fi. t... ;.f.b,3.y the count rate meter using the Peak knob. If the count rate l'a fess tilan Y.. 1,00^; depress the Range switch marked 1,000 and maximizHb(needle deflection on the count rate meter with the Peak knob. ">g/..;:..<[.. 3 J.'.:.d.. i I When you have maximized the on scale needle deflection odtid6onnt rata \\\\al.'. *.;:. < a 1, meter on any one of the three ranges, within the limits degerfbdd, u,. se that . e. ;.,: 125 source ages, you will be scanning'bn the;1okIf,ange setting.) i range. (As the 1 l m,' : M '>.:'.s,
.-. t. c.. 9,.,U[ }.. 55 ,.s Pull the black locking ba' on the limb holder up a;n' 4-l ' 5) i r ' '., gg. way. Remove the black, water filled bladder. ... g i. < - 6) Place the two step phantom standard (furnished withihe. s.. the 'h. scan path with the lower step toward the front of the se ~~ t .n Sg g - f,st ' = decision on which of the two levels (on the standard) to'af, h of the two bones (phantoms) to scan will be determined by.thefes and(size - *tfsa. , p;.; of the patient. Examples below: Scanning.(' 13,. 4.p(., Bon level on ,Vif,V.'.i. Phantom) Forearm i Patient Characteristics Star.dard d 6
- to be scanned WRR.....
Adult Female Very Fleshy Upper ' !. e.' %!!econd Adult Female Little Flesh lower' %.%E,Second Adult Male Very Fleshy Upper ,.. ypt:g. First Adult Male Little Flesh lower ',4/d.First 1..,g"i,Second Child Iower ,..,,.r,., To get maximum accuracy you should calibrrte the instrument.tp'ths'. bone ,,....9,. standard, which is most like that of the patient to be scanned.I'Recalibrate between patients. (Special standards can be supplied to represent smaller i.,'s
- 1.... a t
or larger bones and tissue equivalents, if requi-cd.) .F c < *. c 7) Depress the button marked 1st or 2nd under the Bone labef $ndhpress (- the button marked 2mm/sec under the Speed label. " F I.M." ' ' 8) Push the Scan Start switch. When scan is completed, comkare'the J'- Mineral Content and Bone Width numbers on the numeric display't6 the g: numbers representing thet,e values on your standard. De sur6Nu dre comparing to the first (or second) bone phantom in the standar,d and that it is positioned as instructed in 6 above. 4' 9) On the Calibration Panel, adjust the knobs marked Bone Mitieral and q. Bone Width, pressing the reset button between adjustmenta until the numbers v
- f.
on the display agree with the numbers on the standard for the appropriate measurements (ie. Bono Mineral Content and Bone Width.}.... T'. 'lp.,e'; 9.S. Q *i M,.'.: ' ' . ~,.Kf.& l,
,;;r v - s, x. a),t' ..n. % k, ; .r For best :a: curacy several calibration scans eSould be. ' the +. p). .r e. :., ~ '@t y/SP instrument set to the average value of the scans. . j#y ay <'vs t.w ' M .., f..,:e4.c%..i f.{:4$,p.*;b. /,. 4,*,,Ld[W.l'E.* gym - 6'r.N:
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1 t, .o F. " . 2. o - 1 .T 3 ' q./. .. 't..RATIENT SCANNING WIT y'* l' :.... ,.M*. ,1 NORLAND.- CAMERON BONE MINERAI/ E55 ' . ; ;.: m...., > d 'y... 0.,. t d... ' M ~ Since it has been established that for most general surveyd.had so.a general ,...:.* jp. Indicatoi of average bone mineral content, scanningihefr' ' i pM
- 1.'
".n -:. -.c '. y s .\\ results, the following description of the scanning procedd e.f., khe,}j . %. s.),Nf' '.;,:.. ai ., y. ,,. ;.r,:/. *I :.,:,., '.3;s directed to radius scans. ....,.t...- r ,,(- /,, j Preliminary Set Up ^ %.. u k Calibrate the instrument according to the instructlons,l e ;"the phantom 1) f l., y,p..- ji standard configuration which most nearly conforms to the sio6/{ '.' size - . )$.'N$!?,!.).. l " l V-Ik c' and fleshiness of the patient to be scanned. i.k.
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/ S..,'. 2) Place water filled bladder on the limb holder.
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.:Q e. 3) Using a ruler marked in centimeters, measure the l'on h.. the patient's N[,"t.?'h.k., radius. Record this measurement on the patient's record bek huke 'to note ..i. 6'c. ' c'![.[3 $h )./ which arm was measured. uf.v.c .,.. I s f ', 3
- 4)
Determine the point on the patient's arm which represenfs4ne-third of Mark the poi $l on t(,'$ arm with ., : q. '.. ~ this length from the distal end of the radius. ' I 5 a fine point marking pen and record this measurement on the;pa% 's r tient < J' :L. Positioning Limb 14 Limb Holder ' 3,',' lO'.'r, - Tf;.. 1) Seat the patient in front of the scanner in a position where'hi.can place ..,'Q'g.p#'p.;- ' ' h< M" his forearm in the limb holder comfortably.
- A$'..
2) Lift the positioning stop up and move out of the way; " 5l ' .o D.p s 3) Place patient's arm, palta down, in the limb holder,.on.thg bottoin half ~r,. 3. ' p of the bladder so that the mark you made on the arm is lined'uis with the .r. v' scan path. N.' ' '.J. ' k ,.c 4) Move the position stop toward the patient between the,mi.ddle and ring .T : . ',..; 3. <...:, \\.;.,,.. fingers until it is snug and depress it into the nearest hole.:r No.W:p> ave the h - y,.. s patient reposition his arm comfortably and snugly against th@e' atop.and
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.ge.??.~9.. m.yw.i,;q. l:. c .r.y., p: .r a t y,. 4s.. i determine that the bladder.is. smo. h and unwrinkT. ,...O ot .? s.. q u.' Record the number:whloh appears in the scale on; '. .g ptop 5) on the patient's record, being sure that theistpIf is s nu'
- O tl m. % %
middle and ring fingers. b-6) Place the top half of the bladder across the armi.s ,. f ~ ",'{*'!, locking bar over the arm and firmly depress the locking .....,,v, 6.. f,j b%. limb and secure the bar with the set screw. (Bladder up. J;):; t&. ,. <.,: 1:. :k.,$.,b. u about the locking bar and otherwise tend to envelope the l.istii,-)g.y.. ' s.
- .. E %%' '.fid.. s.
,.,/, ;;s.' j?., s Bone Selection h' C;.&,,R. I l Bone selection (1st Bone or 2nd Bone) is determined, accork{i6g A which ' ~u.. b .. '..h:t lly b* 'V bone you wish to measure (ie, radius or ulna) and which forea.. v6..e. s, .v c I rm you'have '"/,Tiy}-$4.5 .. : U . + ;. q$'9 k')i '.. in the limb holder. 'dkVe '. If the left arm is in the limb holder and yo........:.. enduring Example: u'arg..,6.i t the radius, you would depress the 1st Bone Switch. If the f6, ha,rm.. is in. a.. :", ;G, the limb holder and you want to measure the radius,' you wdu$dMled,t.the
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1 2nd bone for measurement. , -yl@;.s 'y', Scan Speed Selection .-;p ,.cs.< 125 sotired[has aged, Normally scans will be done at 2mm/sec. When the I . a., ;,, ' - better results aro obtained at the Imm/sec. scan speediioh.g .com'e v aware of the time to use imm/sec. scans when you find it necessary to F., a. 4,' use the lowest range setting on the Count Rate Meter in brder '(d. call'b' rate - s t; :, f. o j.. ;. ~ >). j.. the instrument. ... :6' ... 7. ;c ).f5 ?,.y. ,e. 2
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,p tion, With the unit propery "warmed up",' calibrated and the. pa ppal .1 f,. f e you are ready to scan. ' Be sure the patient is as comfprtable' a$d relaxed ,...;.y. - Even though the forearm is locked in position Eftp;.e4 .s.....ns... ogstble as possible. ,;.:'.:.L..s n..,. v'.. s: y t;. for the patient to move during the scan and this will..cause.arrotaF/As in ,t.iy,',$h'h:I other radiologic procedures, the patient should remMn immobileidgring .Uj;'dE v'i the scan. If you are ready, push the scan button. The sc$nEef ahAdmbly ..v a.y,};>,; <;..<,. ~ will move fairly rapidly (1 centimeter /sec.) toward tiie'limbfacArc99g for the bone you have indicated (1st Bone or 2nd Bone). Oe.. h.?' (N. '. n ft ffMa the ' :r
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...c~.... appropriate bone it will back up and then stop moving for abo 6QSe,bobds.
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While it is in this stopped position, it is averaging counts thr[ongtr;{be tissue 4.yfl40 The scanner theh{tl'[/,.Iukoves-equivale.nt to establish the automatic baseline. ' l.:Q.' ji.s.l, for' ward to scan at the speed you have selected, usually 2mm/ sea,.When u. 3. *o,
- i..-
. w scan (from right to left) has been. completed, the scanner'assedibly
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moves back to the "Use" (extended) position, raady for,the nexthan.and ' y : 1 f,.. the measurements obtained appear in the displays on the co$pdt[tr mbdule. I b ?.. These values will remain displayed until a new scan is. initiated./ [. 4+ ,,ll, f',_':{ Qjj. .;,. i f _. .,, y %,0,: .,,., 'ih. 3,.&. o:'? ,2.' Note: When scanner is to be shut down for extended periods (overnig$t for example) press the "Push to Carry" button before turning.off the' power. The ..s. scanner assembly will retract into the base carrying the pou'rge under the .R..: k ri,.y' c '. n stainless steel dock which effectively absorbs the beamo . i, p4 s , y.;.p g ..,.,v- '. 1 * / 'f.' * [. e . ',., ~;.h'. j'.[$. y Y/ 'g
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f '- ih ' N .*,.,,,f.l. l_ 'i'Nfuh 'N' p'- ',.', b - p.;( Procedures To Insure Best Accuracy 9:. y Although the warm-up drift of the instrument is smal! Pit se ' 'es be ' ' ilQq,: ? significant. It is therefore recommended that at least 10k MIND pre- .m. o,;, ferably 15 or 20 minutes be allowed for the instrument thh.a s librium. Y:q
- -)
If the analyzer is left on for long periods, it is a good prod 6dhe iM Beave it in
- -:.k';;e39y the home (extended) position so that the photomultiplier tykYill.ts exposed to a flux of gamma rays of approximately the intensity'to 16 hen
./, L, :- o This procedure will minimize gain shifts in the p%.(v; o qltiplier scanning.
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_,,~#. When in the home position, the beam is attenuated byp;abastber tube.
- h,,, p y;p located beneath the deck of the scanner module to simulatettliekn t of y,i,,'! bh ;','3 I *
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'., e ;V..'n *. ?. - l When standardizing the instrument, several measuremeiits 'ofibislborib standard u. l 5U. I should be made and the computer module adjusted to agree with'the 'nican value
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n...- of the numbers obtained. Some variation should be expectedlihtiththe statistical , _,- Q,5 D..: nature of the radioactive source but in this instrument,L, e'atahdid, deviation of th 5.i'. it'k; y'The bone width t't'e the bone mineral measurements should be typically 17p or measurements can be expected to vary about half that.amou$...f'~ '.c; ! l ..g ~k $c h When scanning live subjects, larger variations in botl$ the[bdainSimral and bone
- . - $fkh,f.5 ' 2. '
widths wilfbe observed. These variations are due to subject';novement and can W l5' best be remedied by taking precautions against such movements and by'taking a ,'I* ~, 4 a number of measurements and averaging the results. It will be;noted that if the i, J mean bone width is calculated and is then used to correct,tl55M' da served bone mineral values will agree with each other as,welbp:agwhen phantom . ',f .s standards are scanned. 4.a,' ef ch.' l:,' ..f./3 ..l,ys. .3. 's '. '. Ml[?<*E.'l
- 'i
the web between the patient'n rtng and middle fingers. Itecord the number visible on the scale of the T-square in the patient's record and also record which arm is being measured. Remove the patient's arm from the limb holder. IV-B-3-c. Final Patient Positioning Place the. bag of tissue equivalent material on the limb holder as shown in figure IV-11. Position the T-square at the location Indicated in the patient's record or determined in step b above. Be sure the patient is seated comfortably. Precise measurements depend critically on the patient not moving during a scan. Place the top half of the bladder across the arm (figure IV-12) and check to b.s sure there are no wrinkles around the arm. Swing the limb locking bar over the arm and press firmly down over the tissue equivalent bag. Secure the i arm in place with the thumb wrew at the' back of the locking bar (figure IV-13). ? l IV-B-4. MEASURING PATIENT Check that the scanning speed (Imm/second or 2n:m/secondi 1 l 1s the same as that selected for calibration. Press one of the two PONE l l buttons to select the first or second bor.e encountered as the one to be analyzed. For example: to measure the ra.lius on a patient whose left arm is in the limb holder select the first tone. Press the FCAN button. The scanner will go through the same sequence ao that described in the l _m
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7-calibration seetion. Most operators scan the measuring site three or four times and average the results. Fuch a procedure will reduce the standard deviation of a series of means by the factor Vii, if each measurement is an average of n trials. Hence, more than three or four scans does not improve the results enough to warrant the additional time. IV-C. AUXILIADY INPUTS AND OUTPUTS On the back panol of the instrument are located eight BNC connectors and a slide switch. The function of each of these components is explained below: IV-C-1. PMT SIGNAL This output is the signal supplied by the source follower mounted on the base of the photomultiplier tube in the detector head. It is negative, about one microsecond wide and has an amplitude of eighteen millivolts per kev deposited tu the detector. IV-C-2. DISC OUT This signal is a TTI, compatible positive pulse about 0 G microseconds wide which represents the output of the internal differential discriminator. T!'e window of this discriminator is set internally to be 40% of the lower level. The lower level is varied by the PEAK control on the front panel. -
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== IV-C-3. DISC IN This is an input. It requires a TTI. compatible pulse with a minimum width of 0.5 microseconds and a maximum width of 0.8 microseconds. This input may bo used in conjunction with the DISC - INT - EXT switch on the back panel. In normal operation the switch is set to the INT position. In this position the internal discriminator is used ~ to drive the count rate meter circuitry and any input to the DISC IN con-nector is ignored. If desired, the PMT signnt may be amplifed externally, fed to an external differential discriminntor and the output of that discriminator applied to the DISC IN connector.. The DISC - INT - EXT switch chould then be set to the EXT position. The output of the external d!scriminator will then be used to drive the internal 1 count rate meter circuits. IV-C-4. CRM (count rate meter) ~ Thlo signal le ananalog signal ranging from zero to six volts positive as the front panel meter indicates zero to full scate. ~ IV-C-5. LOG (CRM) (log of count rate meter) This analog signal reprocents the logarithm of the count 1 rate signal. The output changes two volto per decade of counting rate. j Full scale on the count rate mete: is repreaented by minus four volto, one tenth of full ccato is represented by minus two volta, etc. M $O
l IV.C-6. .BM (bone mineral) BM is a positive analog voltage representing bone mineral in grams per centimeter and is approximately equn! In magnitude (volts) to the reading on the display panel. IV-C-7. BW (bone width) BW 18 a positive analog voltage representing bone width in centimeters and is approximately equal in magnitude (volts) to the reading on the dieplay panel. IV-C-8. VAi,ID RESUT,T A TTL compatible output signal about fifty microseconds wide which can be used to notify external equipment that the voltages present at the BM nod BW outputs are true representatives of the measurement just completed. 9 0 0 8
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V. MAINTENANCE V-A. GENERAL Normal care appropriate to a precision instrument should be given to your NORLAND equipment. This care should include periodic inspection for loose screws or any indication of wear. General cleanliness should be observed and the machine should be kept free of dirt and chemical spillages or residues. V-D. CLEANING Both exposed metal surfaces and the painted suede finish surfaces may be cleaned by the following procedure: Remove duel and light dirt marks with a ' damp, lint-free cloth or, preferably, a sponge. Remove more difficult stains with a liquid cleaner such as "Mr. Clean", "Itandy Andy", "Lestoll" or "Liquid Ajax". Rub the detergent onto the stain, then rinse thoroughly. If the stain can-1 not be removed with liquid cleaner, a naphtha dampened sponge or cloth may be i used. Change cloths frequently to remove grease without spreading. l USE ONLY VM&P NAPHTHA - _DO NOT USE: lacquer thinner Xylot Tolclot i, ethyl alcohol V-C. COMPUTER MODULE ~ The only periodic maintenance which need be performed on the computer module is to remove the front panel after each 200 to 300 hours of use and clean the accumuisted dirt from behind the air intake holes at the bottom of the hinged section. V-D. SCANNER MODULE As indicated in section IV-A the operation of the shutter should be checked at least once each day by noting that the count rate meter deflects when the SHUTTER button is actuated and that the meter drops to zero when the button is released. At lecse once each year the drive belts should be inspected for wear. Normally, none will be found. DO NOT LUBRICATE ANY OF THE COMPONENTS IN THE SCANNER. All parts have been permanently lubricated at the factory and no lubrication should ever be applied in the field. Certain parts cannot tolerate other than special lubricants. DO NOT ALLOW THE RADIATION WARNING LABELS ON THE SCANNER MODULE TO BECOME REMOVED OR ILLEGIBLE. If replacement is necessary write or call Norland Instruments to c,btain new labels.
I Cy VI. REPAIR VI-A. GENERAL The Norland plug-in concept of repair goes beyond the usual meaning of plug-in. Everything electronic can be replaced without the use of a soldering iron. Field repair consists only of replacing modules, with the repair of the modules themselves done at the factory where it can be accomplished most ef-ficiently. Field trodule replacement and fault isolation are made very simple by functional definition of the plug-in entities. Functional definition requires each module to contain those components, and only those components, necessary to perform a particular block diagram function. Since these block diagram functions are easily understood and not very technical in nature, the location of a fault la easily done by almost anyone. Once the fault is isolated the instrument ts easily returned to service by replacing the offending module. Another bonus of finctional defluttion is that, if carried through without compromise, it also assures that each module can be independently calibrated at the factory. Hence no field adjustments are necessary when replactog modules. Repair is usually done by a field representative. If the user is unable to conta' t a representative in his area the factory nhould be consulted. Im-e mediate steps will be taken to restore the instrument. Minor replacements and ss~l 'e adjustments can be accomplished by referring to section VI-C-4. - jUf A general description of the instrument by functional block dingram tand hence by plug-in module) appears in the next section. Following the block diagram is the technical exhibits section M which includou information on field testing
O e to determine whether the instrument is functioning property, disassembly instructions for replacement of modules and the information on replacements and adjustments referred to above. VI-B. INSTRUMENT DESCRIPTION AND BLOCK DIAGRAM VI-B-1. POWER SUPPLIES The block diagram for the power supplies, figure VI-1 is largely self explanatory. The only point which requires mention is that the +9 volt supply is an unregulated supply and provides raw voltage to each board which contains digital integrated circuits. Each board then provides its own logic supply using the raw 4 volts and a zener diode. Superior isolation between boards is thus achieved. All of the other power supplies are regulated. l VI-B-2. DETECTOR AND PREAMPLIFIER l The main instrument electronics are diagramed in figure l VI-2. The gamma rays from the radioactive source react with the detector and produce a pulse of light (scintillation) proportional to the gamma ray energy. This minute light pulse is amplified in the photo-multiplier tube (PMT) and produces an electrical pulse. The pulse from l the PMT is amplified by the preamplifier and passed through the scanner signal cable and the computer to scanner cal.te to the amplifier board in the computer module. VI-B-3. AMPLIFIER BOARD l The computer module amplifier board further amplifies the detector signal and presents it to the discriminator board, l
22 L O Cl4 DI AGG AM-POWEE SLIPPLIES ~ GCANNER. 178 A 4 2 6C 176 A7.65 O MODULE Ito LATioN HV HV l ~ TRAusFORMER TP.AN S S:oCMEG WS4 pp y GCARD 17 8 A 417 D ~ MOTOR POWER l ~~ THROOGH CELAY SCAQD l ~ I 178 A S o ?., C 178A181 E l'i l l POWGG tisv swercs' l 'O A"O ] y,qpjspoqMe,c "I Po w e r2. PILCT LIGHT g gyppLy. Eb o A R O i L i j t_ - - - t (, l 17B A 12 O O l i +9V [ LI N E Cof4 D i RAW LO6ic i 176 0lo T A gyppty I !GOACO i i l I j \\ ~ T7 & A tb6 0 l +isov i _ _ _ GATED DIS P L AY i ~ supply C O NA PU T E f2. BO AR D M O O LIL.E. 1 __ __. -l p4re, E""/_ Block Diagram, Power Supplies
B> LOC K DI AGI2 AM - M AI N ELECTGO N I C S 1 S C. A N N E.r2 MOD U L e. l l'1 8 A 41 I O IT 8 D ?.91 A ~ l asLAY carEcroc Awo EC A r% D PHOTOM U LTI P L.l E a T U Pa @. 3 'Lt MIT SWlYCHP. G P RE A M P L i c l E (2. ~- ~ [- (MCUNTED ON PHOTO MULTIPLIE R T O P.G) 1 _ = ~ 'I l*f 8 A ?.*l 9 E l 76 A ?. 07 O M OTO C LO G I.. I AMPLI WI S R SOACO 1 l (Sc4qo 1 L._._....._.__- _ _. _. l. _.. _ _. [.. . I-1 I P. A 4 L 9 E l 1 1 B A 1.7 3 E + LC 4 i C Di C C P.RE NTI AL S E Q U r:. N C S [ DISC GI M IN ATo R I Eb C A r. o I l Bo A r2 D c -._
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VI-B-4. DISCRIMINATOR DOARD The discriminator board sets a 40% window on the incoming pulses, the baseline of which is varied by the operator through the WINDOW control on the front panel. The output of the differential discriminator then represents only the gamma rays with the energy of Interest and is applied to tk. Input of the logarithmic count rate meter board. VI-B-5. LOGARITIDIIC COUNT RATE METER BOARD The count rate ludication is produced by the "leaky l Integ; ator" technique and is then filtered by two stages of active low pass filter. Between the active filter stages la a passive filter which has its characteristic switched by an FET to match the CRM time l constant to the scanner speed (Icm/second or 2mm/second). The output of the filter stages is applied to a logarithmic converter. The output of the log modale is presented to the automatic zeroing board. VI-B- G. AUTOMATIC ZEROING DOARD l During the scarch phase of the measurement cycle, the auto zero board simply passes the CRM signal to the bone edge board. % ten the bone to be measured has been located and the scanner has been positioned adjacent to the bone of interest, the auto zero board averages i the baseline counting rate and stores this information for use in the next phase of the measurement cycle. When the scanner is sent forward by 1 the logic cequence board in its measure mode (Imm/second or 2mm/second) l n
the averaged b tsellne value which has been stored by the auto zero board is subtracted from the CRM signal. Thus the output from this board is the absorption signal referenced to zero volts. The signal from the auto zero board is passed to both the integrator board and the bono edge board. The integrator board is controlled by t'ta bone edge board. V I-G-7. DONE EDGE BOARD The bone edge board contains both a crude edge detector and n fine edge detectc,r. The crudo edge detector locates the edges of the bones as the scanner proceeds in the search phase of the measurement cycle. The output of the crude edge detector is fed to logic circuits which are controlled by the bone selection push but'ons on the front panel. Thece logic circuits combino the information from the crude edge detector' with the requect from the front panet buttons and provide en output to the logic sequence board which indicates when the bone of interest has been found. The fine edge detector is enabled when the mensurement mode is entered and informs the integrator board when to star., and stop the integrations used in the calculations of bone mineral and bone width. VI-B-8. INTEGRATOR BOARD The integrator board performs all cf the calculation and sec.ing operations necessary to generate the final answer. This board is controlicJ by both the logic sequence board and bor.e edge board.
C VI-B-9. READOUT 1 BOARD The analog signals representing bone mineral (BM) and bone width (BW) are sent to the Readout 1 board. This board is controlled by the logic circuits on the Readout 2 board and contains an analog to frequency converter (AFC) and a clock. The DM and BW signals are multiplexed into the AFC by the logic on 11eadout 2 and the resultant train of pulses in sent to Readout 2. VI-B-10. READOUT 2 DOARD Readout 2 takes the trains of pulses and the clock signal from Readout 1 and through gating generates two more trains of pulses. The sum of the pulses in each of these trains is the digital representation of each of the analog signals. These trains of pulses are steered by the logic on Readout 2 to the counters on the display board. A signal also is generated from this board to control the 180V power cupply and turn the dispiny tubes l~ on and off. VI-B-11. DISPLAY BOARD The display board contains integrated circuit counters to receive the pulses from Readout 2 as well as decoders and drivers for the gas discharge tube display. The display tube ignition is controlled by the gated 180V supply which in turn is controlle 1 by the Roadout 2 board. 3 VI-B-12. I.OGIC SEQUENCE BOARD The logic sequence board contains the circuits which generate I the master sequence of operations. It receives inputs from the start push button, from the none edge board and from t';e motor logic board. It also l
g 1 containe circuits which decode the state of the limit switches in the scanner module and decide whether or not the instrument is existing in a "legal" condition. VI-B-13. MOTOR LOGIC BOARD The motor logic board contains a series of flip-flops which determine the state of the machine. Inputs are received from the logic se-quence board and used to set and reset the "state" flip-flops. The board siso contains certain bookkeeping functions which are used to monitor the machine for"illegal" states. VI-B-14. RELAY DOARD This board is in the scanner module and receives its signals from the motor logic board. These signals are decoded and used to drive the various motor and clutch relays. l VI-C. TECilNICAL EXIUDITS VI-C-1. TESTS FOR FUNCTION l Testing for the logical operation of the machine is very simple. If, when the SCAN button is pusher, the Jnstrument performs the sequence described in section IV-B-? for selection of either the first or second phantoms the logic portion of the instrument is performing correctly. The computation sections of the instrument can be checked using the phantom standard and a few simple procedures. The baseline l l l counting rate should be at least 2000 ets/socond in the home posit!on when l performing those tests. l l l l
VI-C-1-a. First Test With no phantom in the limb holder and with the locking bar in a normally closed position push the SCAN ~ button. The scanner will go forward all the way to the limit switch, reverse, and return to the home position. About a half second after the scanner reverses the display willlight and should rend 0.02 or 0.03 for 'the bone mineral and 0.00 for bone width. If the display does not read as indicated above ace section VI-C-3-a. VI-C-1-b. Second Test Put the phantom in place on the limb holder and swing the locking bar out of the scan path. Usi ng the lower tissue equivalent (i.e. with the hinged section of the standard i open) take ten scans of the larger phantom (without disturbing calibrvtlon) using the procedure-outlined in section IV-P-2. l Close ?he hinged sectirn of the phantom and without changing any settings of control.s take ten uore scan; of the same phantom. Compare the averager, of the two sets'of scans. If the baseline counting rate for the first set of scans was rt leant j 2000 ets/second the two values should not differ by more tlan l l 2% If they do differ by more than 2% perform the operation of section VI-C-3-b and then re-lo this to: t. If the difference still exicts perform the adjustment in section VI-C-3-c and l l m.
l re-do this test. If the machine still fails this test notify Norland Instruments. VI-C- 1-c. Third Test After performing the above tests take ten scans of each of the phantoms and compare the averages of these scans to the calibrations stamped on the utdo of the standard. If the unit is calibrated on the large "bone" the other average should be within 2% of the second value indicated. If it is not within the specified tolerance perform the test in the next paragraph and notify Norland Instrumente. V I-C-1-d. Fourth Test Calculate the standard deviation of each of the two measurements made in the Second Test. These standard deviations should be less than 27.. The standard deviation of a series of numbers is most easily computed from the fol'.owing formula: h l f7 ~ e*A C. A ftjA-3 se. c. the standard deviation where. P = d the algebrale deviation of each = element of the series from any chocen number the number of elements in the series n = _-___--- _ _~
p VI-C-2. DISASSEMB LY INSTRUCTIONS The only disassembly which need to be done in the routine maintenance or adjustment of the unit is shown in the exploded drawings of figures VI-3 and VI-4. No tools other then a screwdriver are needed. DO NOT ATTEMPT TO LUBRICATE ANY PARTS OF THE SCANNER MODULE. ONLY THE ADJUSTMENTS INDICATED IN THE NEXT SECTION SHOULD BE ATTEMPI'ED. Leave all other servicing to Norland Instruments personnel. REMOVE Tile SOURCE BEFORE t TEMFI'ING ANY WORK ON Tile SCANNER MODULE. See source installation and removal instructions in section IV-A-2. IV-C-3. MINOR ADJUSTMENTS.\\ND REPAIRt VI-C-3-a. Adjustment of Display 7 sero If the test in section VI-C-1-a is not satisfactory the zero of the display can be corrected by using the adjustment on Readout 1 board labeled (A) on figure VI-4. After making a trial adjustment push the RESET button in the calibration group on the lower front panel and note the results. When the result appears to be satisfactory repeat the First Test of section VI-C-1-a. VI-C-3-b. Adjustment of CRM Zero Cowiect an oscilloscope (,r zero center voltmeter capable of resolving 10 millivolts to the CRM output on the back of the computer module. With the shutter closed (or with the f' ....._.i...._. source removed from the instrument) the reading at this connector should be between 0 and +10 millivbits. If it is not within this limit it can be set by menns of the adjustment on the logarithmic count rate meter board labeled (B) on the drawing of figure VI-4. V I-C-3-c. Adjustment of Auto Zero Board This adjustment should be undertaken only by persons qualified in electronics. Attach an oscilloscope to the nost on the auto zero board marked (C) on figure VI-4. Set the oscilloscope for 1 second/cm and.05 v/cm. Push the SCAN button. The beam will bo off the screen of the oscilloscope until the scanner has completed its baselino averaging operation. It should then give zero volts (i statistical fluctuation in the counting rate) until the edge of the bone is again encountered in the measuring sequence. If it is not zero during this time the control mar!:ed (D) on figure VT-t can be adjurted to correct the situation. Only the voltage 1 nel which is present during the time between the moment when the scanner starts moving forward at~ter having paused for the nine second averaging operatinn and the moment when the beam again encounters the bone can be used to observe the voltage which is to be set to zero. Dtte to statistical variations in he radioactive source some variation in tho average voltnge observed at point <C) will be observed. This varintion ncrmally does not execed i 30 t millivolts. 1 _____________________________________________A}}