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Page 1: Quality Assurance in Nuclear Medicine

Quality Assurance in Nuclear Medicine

Reference Sources and Solutions • Radiation Measurement Instruments

Surgical Guidance System • Education and Training

Fourth Edition

Page 2: Quality Assurance in Nuclear Medicine

Gd-153 sources for SPECT Cameras (page 11)

Calibrated I-131 Capsules (page 22)

C-Thru™Co-57 Flood Source (page 3ff.)

C-Trak® Surgical Guidance System for Sentinel Lymph Node Diagnostic (page 25f.)

Ge-68 sources for PET Scanners (page 7ff.)

Page 3: Quality Assurance in Nuclear Medicine

Quality Assurance in Nuclear Medicine

Reference Sources and Solutions • Radiation Measurement Instruments

Surgical Guidance System • Education and Training

Fourth Edition

Page 4: Quality Assurance in Nuclear Medicine

Quality Assurance in Nuclear Medicine

Fourth Edition / 2004

Published by AEA Technology QSA

Printed in Germany

Designed and produced by

impulse Werbeagentur + Verlag GmbH,

D-38114 Braunschweig,Germany

Page 5: Quality Assurance in Nuclear Medicine

3

Contents

In the sections listed below you can find Check Sources, Reference Sources andReference Solutions for:

C-Thru Flood Sources Page 4Positron Emission Tomography (PET) Page 7Single Photon Emission Computed Tomography (SPECT) Page 11Gamma cameras Page 12Scintigraphy Page 15Dose calibrators (Ionisation Chambers) Page 19Gamma counters Page 23

For Sentinal Lymph Node diagnostics you will find detailed information aboutthe new

C-Trak® Surgical Guidance System Page 25

A range of high-quality radiation measurement instruments and radiationsources is shown in

Health Physics Page 28

If you are looking for easy to use equipment for training in the basicproperties of radioactivity please see

Training Page 35

General information Page 36

Ordering information Page 40

Quality Assurance in Nuclear Medicine

Page 6: Quality Assurance in Nuclear Medicine

4

Quality Assurance in Nuclear Medicine

Application

High uniformity Co-57 floodsources are used for gamma

camera image quality assurace. The objective of these routinequality assurance checks is to

ensure that the gamma camerafield-of-view image isfree from

non-uniformitiesand artifacts.

Construction

Isotrak’s unique C-Thru™ designand technology (patent peding)

Co-57 Flood Sources providesusers with exeptional perfor-mance in a user-friendly and

functional format. This repre-sents a considerable advance

and improvement over conven-tional flood source design.

The laser joined source holdermaterial is made of transparent,durable plastic. The radioactivearea is clearly visible, enabling

C-Thru™ sources to be easilypositioned on the gamma

camera head, assuring the fulland accurate coverage of the

field-of-view.

Dual head cameras can bechecked simultaneously as the

radiation field produced by theflood source is the same on

both sides. C-Thru™ flood sour-ces have two handles for safe

manipulation allowing hands tobe clear of the active area.

All C-Thru™ flood sources aresupplied in a stable, easy to

handle, lead-lined roller casefor safe transport and storage.The roller case is also a Type A

approved shipping containerthat meets all the requirements

of IAEA TS-R-1 and 49CFR.

Features

• Transparent, durable capsule material• Active area visible through its transparent holder• Lead-lined durable transport and storage roller case

(Type A approved)• Coefficient of variation < 1 % – typically the CoV is 0.5 %

or less (Unit cell size 1 cm2)• Integral uniformity < 2.0 % – typically it is 1.0 % - 1.7 %• Radionuclide impurity < 0.1 % (Co-58, Co-56, Co-60) • Sources are available for all common gamma cameras• Patented technology allows custom designs for most

dimensions and activities• Source return service

Image courtesy of SiemensMedical Solutions USA, Inc.

C-Thru™ Co-57 Flood Sources

Page 7: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Tolerances

The maximum deviation of the delivered activity from the nominalvalue is -10 % +20 %.

Control Scanner

Uniformity Measurement

The homogeneity of each C-Thru™ flood source is measured with aspecial dedicated gamma camera measuring system. 100 % of theactive area is measured with a unit cell size of 1 cm2. The results are stated in a certificate supplied with each source.

Akquisition date : 2.26.2003Product code : CTF10000Serial Number : 10029CModel Number : 1000R-COH-42-62Remarks : Date 26-FEB-2003Isotope : Co-57Activity (approx.) : 419 MBq

Unit Cell size : 1.07 cm 2

Mean in UFOV : 16450 (2128 Unit Cells)Standard Deviation : 60Coefficient of Variation : 0.36 %Integral uniformity : 1.17 %Differential uniformity : 0.91 %

Typical Gamma Camera Scanner Protocol

Certification

Each source is supplied with a test report, which states:- Activity of the nuclide- Reference time and date- Result and date of leakage test- Serial number - US NRC / Agreement State Model Number- ISO / ANSI Classification- Overall dimensions

Availability

Delivery within 2 to 4 weeks after receipt of order.

Page 8: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Model 1000R Series Rectangular Sources

Product Code Activity Active Dimensions Overall Dimensions

CTRF10000 370 MBq (10 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"CTRF10001 185 MBq (5 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"CTRF10002 555 MBq (15 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"CTRF10003 740 MBq (20 mCi) 24.4" x 16.5" 620 x 420 mm 700 x 538 x 8 mm 27.5" x 21.2" x 0.32"

CTRF10005 370 MBq (10 mCi) 18.1" X 14.2" 460 x 360 mm 540 x 478 x 8 mm 21.3" x 18.8" x 0.32"CTRF10006 185 MBq (5 mCi) 18.1" X 14.2" 460 x 360 mm 540 x 478 x 8 mm 21.3" x 18.8" x 0.32"CTRF10008 740 MBq (20 mCi) 18.1" X 14.2" 460 x 360 mm 540 x 478 x 8 mm 21.3" x 18.8" x 0.32"

CTRF10009 370 MBq (10 mCi) 29.1" x 18.1" 740 x 460 mm 820 x 578 x 8 mm 32.3" x 22.8" x 0.32"CTRF10011 740 MBq (20 mCi) 29.1" x 18.1" 740 x 460 mm 820 x 578 x 8 mm 32.3" x 22.8" x 0.32"

CTRF10012 370 MBq (10 mCi) 8.9" x 8.9" 225 x 225 mm 318 x 280 x 8 mm 12.5" x 11.0" x 0.32"

Model 1000C Series Circular Sources

Product Code Activity Active Dimensions Overall Dimensions

CTRF10050 370 MBq (10 mCi) 18.5" diameter 470 mm diameter 534 dia x 8 mm 21" dia x 0.32"CTRF10051 185 MBq (5 mCi) 18.5" diameter 470 mm diameter 534 dia x 8 mm 21" dia x 0.32"CTRF10053 740 MBq (20 mCi) 18.5" diameter 470 mm diameter 534 dia x 8 mm 21" dia x 0.32"

CTRF10054 370 MBq (10 mCi) 14.2" diameter 360 mm diameter 424 dia x 8 mm 16.7" dia x 0.32"CTRF10055 185 MBq (5 mCi) 14.2" diameter 360 mm diameter 424 dia x 8 mm 16.7" dia x 0.32"

CTRF10058 370 MBq (10 mCi) 24" diameter 610 mm diameter 674 dia x 8 mm 26.5" x 0.32"CTRF10059 185 MBq (5 mCi) 24" diameter 610 mm diameter 674 dia x 8 mm 26.5" x 0.32"CTRF10061 740 MBq (20 mCi) 24" diameter 610 mm diameter 674 dia x 8 mm 26.5" x 0.32"

Ordering information

C-Thru™ Model 1000R / 1000C Series flood sources are approved for licensing purposes by the

“Massachusetts Department of Public Health Radiation Control Program”. The Sealed Sources and Devices

Registration Number is MA-1059-S-359-S.

The individual sub-model numbers are stated in the certificate supplied with each source.

Source return

To return decayed sources for recycling or disposition please contact AEA Technology QSAor your local distributor for the provision of a source return authorization.

C-Thru™ Co-57 Flood Sources

Page 9: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Features

• High uniformity of Ge-68 activity• Meet requirements of the European Medical Device Directive,

CE marked• Return of spent sources is included in the service on request• On-site ring source installation service is available on request• Precision laser-welded ends• Clean laser engraving for enhanced legibility

Uniformity

• Rod- and ring sources better than ±5% for any 5mm length vs mean value

• Cylindrical phantom better than ±5% for any 1cm3 vs mean value• Plane source better than ±5% for any 1cm2 vs mean value

The linear attenuation coefficient for the cylindrical phantom has beenmeasured and checked with an active and a cold (inactive) cylindricalphantom µ=0.1029cm-1 ± 0.5% (511keV). The active volume is 5969ml ± 2%.The cylindrical phantom includes the supply of a low activity tube typereference source using the same polymer composition as used in thephantom.

Ge-68 Sources for dedicated PET, PET/CT and Coincidence Cameras

Application

These sources are used in qualityassurance for positron emissiontomography (PET). Rod and line

sources are used for attenuationcorrection and detector set-up.The calibration of the detectorsin the PET scanner, the 2D- and

3D- normalization, is performedusing a cylindrical phantom or a

plane source.

Construction

Ceramic or polymer compoundsare used to permanently bind

the Germanium-68 into a highly-uniform solid matrix. The purity

of the Ge-68 used is measuredusing high resolution gamma rayspectrometry, and is better than99%. The activated compound is

sealed either in a stainless steeltube or in a cylindrical or plane

outer shell.The sources are supplied with a

measurement report stating theuniformity of the activity

distribution.

Page 10: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

*) The cylindrical phantom always contains a tube type reference source taking an aliquot from the active resin ofthe phantom (Product code: GRRB9285)

ISO classification

Rod SourcesISO C.32312 (ANSI 77C32312)Cylinder PhantomISO C.22212 (ANSI 77C22212)

Availability

Within 6 weeks from receipt of order.The sources are shipped in a Type A approved packaging which can alsobe used for the spent sources.

Tolerances

The maximum deviation of the delivered activity from the nominalactivity is ±15%.

SIEMENS Ge-68 source set Drawing Outer Active Nominal Product codescanner type consisting of: Dimensions [mm] Dimensions [mm] Ge-68 activity

ECAT®EXACT 3 rod sources VZ-2464 Ø 3.2 x 190 168 3 x 122 MBq GRRB57761 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB91161 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115

ECAT EXACT™HR 3 rod sources VZ-2464 Ø 3.2 x 190 168 3 x 185 MBq GRRB5767and 1 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB9116ECAT ACCEL 1 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115

ECAT EXACT HR+ 3 rod sources VZ-2464 Ø 3.2 x 190 168 3 x 140 MBq GRRB99491 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB91161 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115

Biograph®PET/CT 2 rod sources VZ-2753 Ø 3.2 x 200 180 44MBq GRRB89791 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 44 MBq GRRB9115

ECAT ART™ 2 rod sources VZ-2467 Ø 3.2 x 183 168 2 x 37 MBq GRRB62861 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 37 MBq GRRB6287

Please enquire Ge-68 sources for other PET-Scanners

951R 3 rod sources VZ-2466 Ø 3.17 x 142.2 131 3 x 92.5 MBq GRRB62881 cylindrical phantom*) VZ-2465 Ø 213 x 275 Ø200 x 190 120 MBq GRRB9116

Ordering information

Sources for SIEMENS Medical Solutions PET Scanners

Ge-68 Sources for dedicated PET, PET/CT and Coincidence Cameras

Page 11: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

GE Ge-68 source Drawing Outer Active Nominal Product codescanner type Dimensions [mm] Dimensions [mm] Activity

ADVANCE™ rod source VZ-2487 Ø 4 x 225.6 155 60 MBq GRRB8465ADVANCE™ NXI rod source VZ-2487 Ø 4 x 225.6 155 400 MBq GRRB8466Discovery™ LS

Discovery ST rod source VZ-3189 Ø 4 x 293 161 55 MBq GRRB11844

Please enquire Ge-68 sources for other PET-Scanners

Sources for GENERAL ELECTRIC (GE) PET Scanners

Type Ge-68 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity

ADAC MCD rod source VZ-2631 Ø 3.17 x 140 130 18.5 MBq GRRB8003

Source for Philips Medical Systems Scanners

Sources for HAMAMATSU PET Scanners

Set type Ge-68 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity

SHR-2000 rod source VZ-2624 Ø 1.65 x 59.5 54.0 18.5 MBq GRRB7833

SHR-2400 rod source VZ-2625 Ø 1.65 x 115.5 110.0 37 MBq GRRB7834

SHR-7700 rod source VZ-2506 Ø 1.7 x 124.0 118.0 74 MBq GRRB7036

SHR-22000 rod source VZ-2505 Ø 1.7 x 241.1 235.0 74 MBq GRRB7037(PCT-4300W)

Type Ge-68 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity

HZL™ and mPower™ rod source VZ-2632 Ø 6 x 190mm 172mm 185 MBq GRRB8004

Auricle™ and HZ™ rod source VZ-2633 Ø 6 x 146mm 127mm 185 MBq GRRB8005

Sources for Positron PET Scanners

Page 12: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Sources for SHIMADZU PET Scanners

Set type Ge-68 source Drawing Outer Active Nominal Product code Dimensions [mm] Dimensions [mm] Activity

SET-1300W rod source VZ-2537 Ø 6 x 116.0 78.0 74 MBq GRRB7024rod source VZ-2537 Ø 6 x 116.0 78.0 92.5 MBq GRRB8106

SET-1400W rod source VZ-2507 Ø 6 x 116.0 104.0 74 MBq GRRB6682rod source VZ-2507 Ø 6 x 116.0 104.0 111 MBq GRRB7853

SET-2200W rod source VZ-2591 Ø 3.17 x 230.1 117.4 111 MBq GRRB7498

SET-2300W rod source VZ-2538 Ø 3.17 x 230.1 167.4 37 MBq GRRB6687rod source VZ-2538 Ø 3.17 x 230.1 167.4 111 MBq GRRB6687rod source VZ-2538 Ø 3.17 x 230.1 167.4 140 MBq GRRB8104rod source VZ-2538 Ø 3.17 x 230.1 167.4 185 MBq GRRB6687cylindrical phantom VZ-2767 Ø 213 x 232 Ø 200 x 190 37 MBq GRRB9081

SET-2400W rod source VZ-2504 Ø 3.17 x 230.1 217.4 37 MBq GRRB6684rod source VZ-2504 Ø 3.17 x 230.1 217.4 185 MBq GRRB6683rod source VZ-2504 Ø 3.17 x 230.1 217.4 370 MBq GRRB7035cylindrical phantom VZ-2768 Ø 213 x 280 Ø 200 x 240 37 MBq GRRB9082

Sources for Concorde Microsystems® Scanners

Other Ge-68 reference sources, check sources and solutions are available on request

Ge-68 Sources for dedicated PET, PET/CT and Coincidence Cameras

Set type Ge-68 source Drawing Outer Active Nominal Product code Dimensions [mm] Dimensions [mm] Activity

micro PET® point source VZ-2758 Ø 3.4 x 59.3 18.5 MBq GRRB9004cylindrical phantom VZ-2757 Ø 110 x 125 Ø 100 x 100 18.5 MBq GRRB9002

Page 13: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Gd-153 sources for Single Photon Emission Computed Tomography (SPECT)

Features

• High uniformity of Gd-153 activity• Meet requirements of the European Medical Device Directive,

CE marked• Return of spent sources is included in the service

MDPH model number

GD.LIN 1 Drawing: VZ-2171GD.LIN 2 Drawing: VZ-2352

ISO classification

C.33333 Drawing: VZ-2171 (for Philips Cameras)C.44343 Drawing: VZ-2352 (for SIEMENS Cameras)

Tolerances

The maximum deviation of the delivered activity from the nominal value is: + 25% - 5% for sources for Philips cameras,+ 25% - 10% for sources for SIEMENS cameras.

Application

Gd-153 line sources are used forattenuation correction to

improve SPECT camera images.

Construction

The activity is incorporated into aceramic matrix. These ceramic

rods are inserted into analuminium tube. The assembly isthen welded into a stainless steel

tube. The line sources for theSIEMENS E.CAM™ camera are

mounted into aspecial source holder.

Availability

Sources are delivered within 6 to8 weeks of receipt of order.

Type Gd-153 source Drawing Outer Active Nominal Product codeDimensions [mm] Dimensions [mm] Activity

Prism 2000XP line source VZ-2171 Ø 6.35 x 267 Ø 5.35 x 235 2.2 GBq GDRB5451Prism 3000XP

Sources for Philips Medical Systems Cameras

Type Gd-153 source Drawing Outer Active Nominal Product codeset consisting of Dimensions [mm] Dimensions [mm] Activity

E.CAM 4 line sources VZ-2352 Ø 3.05 x 207 Ø1.6 x 199.9 4 x 740 MBq GDRB8066

Sources for SIEMENS Medical Solutions E.CAM

Page 14: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Check sources for gamma camerasPoint sources

Application

For checking: • Homogeneity• Resolution• Field of view• Centre of rotation

Construction

The Co-57 is electrodeposited onto a metal disc or incorporated into anion exchange bead, which is sealed in a welded stainless steel capsuleof drawing VZ-2761.

ISO Classification

C.64444

Activity tolerance

The maximum deviation of the delivered activity from the nominalactivity is + 20%, - 10%.

Availability

Within 6 weeks of receipt of order.

Radionuclide Nominal activity Product code[MBq]

Co-57 37 CTCB 10122Co-57 111 CTCB 10123

Activity

Ordering information

Features

• Robust, sealed, source• Small active area (point source geometry)

3

10

Page 15: Quality Assurance in Nuclear Medicine

13

Quality Assurance in Nuclear Medicine

Ø 2

200225

Ø 6,5

Activity

Application

Line sources are used fordetermining

the centre of rotation ofgamma cameras.

Availability

Within 4 - 6 weeks of receipt of order.

Tolerances

The maximum deviation of the delivered activity from the nominalactivity is ± 30%.

Construction

Co-57 is mixed homogeneouslywith a plastic resin in a flexible

tube (2 mm in diameter, 200 mmlong) which is sealed in an

aluminium tube. The tube ismounted in an acrylic glass

holder. The line source (totaldimensions: 6.5 mm diameter x225 mm length) is supplied in a

lead-shielded woodenpresentation box. Drawing: VZ-503

Radionuclide Nominal activity [MBq] Product code

Co-57 55 CTRK1716

Ordering information

Check sources for gamma camerasLine sources

Page 16: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Application

These sources are designed forchecking gamma cameras and

scanners and for demonstrationpurposes.

Construction

The radioactive material is homogeneously distributed in a plasticresin, covered with a protective coating. The phantom has the shape ofa normal thyroid with ‘hot’ and ‘cold’ nodules.

The phantom is available containing:Ba-133 (92%)/ Cs-137 (8%) to simulate I-131 or Co-57 to simulate Tc-99m.

Drawing: VZ-361

Tolerances

The maximum deviation of thedelivered activity from thenominal activity is ± 30%.

Availability

Within 6 - 8 weeks of receipt oforder.

9

18

Radionuclide Nominal activity [MBq] Product code

Ba-133/Cs-137 1.85 IZR36105Co-57 3.7 CTR36110

Ordering information

Check sources for gamma camerasThyroid phantom

18

9

Page 17: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Ordering information

Application

Spot marker sources are intended to be held in place on the subjectwith adhesive tape to mark anatomically significant points or toorientate the scintigram.

Construction

The activity is adsorbed onto an organic ion exchange resin bead with adiameter of 1 mm and mounted at the centre of a transparent epoxyresin disc. The sources are available either as single sources inunshielded storage boxes or as sets of three sources of the same nuclidein a wooden storage box with lead shielding.

ISO Classification

C.34313 Drawing: VZ-584

Tolerances

The maximum deviation of thedelivered activity from the

nominal value stated is -25% to +0%.

Availability

Within 3 - 4 weeks of receipt of order.

Type Radionuclide Nominal activity Product code[MBq]

Single source Ba-133 0.37 BDR81003.7 BDR8200

Source set Ba-133 3 x 0.37 BDR381003 x 3.7 BDR38200

Single sources Co-57 0.37 CTR81003.7 CTR8200

Source sets Co-57 3 x 0.37 CTR381003 x 3.7 CTR38200

Activity

Anatomical markersSpot marker sources

25

3

Page 18: Quality Assurance in Nuclear Medicine

16

Quality Assurance in Nuclear Medicine

Ordering information

Tolerance

The maximum deviation of thedelivered activity from the

nominal value stated is-25% to +0%.

Availability

Within 2 - 3 weeks of receipt oforder.

Application

This source is used for tracing theoutlines of anatomical features

on the patient.

Construction

The Co-57 activity is incorporated in a 1mm diameter bead, sealed inthe tip of an aluminium holder shaped like a pen. Each source isprovided with a brass cap to shield the active end when the source isnot in use.

ISO Classification

C.34344Drawing: VZ-1186

Radionuclide Nominal activity Product code[MBq]

Co-57 3.7 CTR710

Activity

Anatomical markersPenpoint marker source

150

Ø7

Page 19: Quality Assurance in Nuclear Medicine

17

Quality Assurance in Nuclear Medicine

Ordering information

Application

Rigid marker sources can be used to outline or scale anatomical featuresduring scintigraphy using gamma cameras and scanners. They are also

useful for demonstration purposes.

Construction

The activity is sealed within a plastic matrix with 20 mm long active andinactive zones, which are mounted into a transparent plastic ruler.

The active zones are coloured.The source is supplied in a wooden storage box.

Tolerances

The maximum deviation of thedelivered activity from thenominal value stated is ±30%.

Availability

Within 6 weeks of receipt oforder.

Radionuclide Nominal activity [MBq] Product code

Co-57 3.7 CTR415

Activity

Anatomical markersRigid marker source

300

20

20

6

6

Page 20: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Ordering information

Application

These sources can be used to outline or scale anatomical featuresduring scintigraphy. They can be held in place with adhesive tape, ifnecessary.

Construction

Flexible marker sources can be supplied with the activity eitheruniformly dispersed in an inner core of active plastic and sealed in PVCtubing, or loaded in 20mm long active and inactive zones (scalingtype). The inner diameter is approximately 0.9mm and the activelength is 500mm. The inner tubing is mounted into a outer PVC-tubing (length approximately 550mm, 3mm diameter) and sealedwith inactive plastic at the ends.

VZ-432 (uniformly dispersed)VZ-413 (scaling type)

Tolerances

The maximum deviation of the delivered activity from the nominalvalues stated is ± 30%.

Availability

Within 4 - 6 weeks of receipt of order.

Type Radionuclide Nominal activity [MBq] Product code

uniformly Co-57 3.7 CTR432dispersed

scaling Co-57 3.7 CTR413

ActivityActivity

Anatomical markersFlexible marker source

33

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Quality Assurance in Nuclear Medicine

Application

These sources are designed to perform periodic calibration checks onradionuclide calibrators to demonstrate the measurement stability of the

equipment. The QC-tests may be required by national or stateregulations. This source type meet the requirements of the American

USNRC Regulatory Guide 10.8 (Revision 2, Aug. 1987), Appendix C, part 3.

Construction

The active material is homogeneously incorporated in approximately10ml resin in a 25ml plastic vial. The active layer is colour coded by

nuclide and is covered by inactive resin. The source is supplied in a leadcontainer.

Tolerances

The maximum deviation of thedelivered activity from thenominal values stated is ± 15%.

The activities are calibrated with a measurement uncertaintyof ±5%.

Availability

Within 3 - 4 weeks of receipt oforder.

ISO Classification

C.22222 Drawing: VZ-505

Inactiveresin

Resincontainingradionuclide

Dose calibrator check sourcesReference sources for radionuclide calibrators

Ordering Information

Radionuclide*) Nominal activity MDPH Colour code Product code [MBq] model number

Co-57 37 CTC.V1 blue CTR564111 blue CTR566185 blue CTR568

Cs-137 9.3 CDC.V1 yellow CDR562Co-60 1.9 CKC.V1 light green CKR560Ba-133 9.3 BDC.V1 brown BDR562

*) For Ge-68 sources please enquire.

Ø27

61

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Quality Assurance in Nuclear Medicine

Ordering information

Application

Dose calibrators must be checked regularly to demonstrate that theyare operating correctly. Such checks may be required by national orstate authorities.

This Cs-137 source has been designed to check the stability of dosecalibrators. Note: For this type of instrument, it is important that standards used toverify the calibration factors should match the form of the samples tobe assayed. This source is therefore not suitable for checkingcalibration factors, and reference solutions should be used.In some countries AEA Technology QSA offers a range of standardizedsolutions containing short lived nuclides often used in nuclearmedicine. Please see next page.

Tolerance

The maximum deviation of thedelivered activity from thenominal value stated is -20% to +0%.

License1

Nds 180/78

Construction

The Cs-137 is incorporated in aceramic pellet and welded in a

stainless steel capsule. Thiscapsule is then encased in an

aluminium holder and securedwith epoxy resin. For safe

handling, the source is suppliedin a wooden storage container

with integral lead shielding. Theshape of the source allows easy

handling with forceps.

ISO Classification

C.23323 Drawing: VZ-322

Availability

Within 3-4 weeks of receipt oforder.

1 The design of this source has been tested by the Physikalisch-Technische Bundesanstalt (PTB) and is approved by the German legal authorities.

Radionuclide Nominal activity Product code[MBq]

Cs-137 (including 3.7 CDRB1548shielded container)

Activity

Ø 20 mm

57 m

m

Dose calibrator check sourcesCs-137 dose calibrator check source

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Quality Assurance in Nuclear Medicine

Reference Solutions

Application

These solution standards ofradiopharmaceutical nuclides

are supplied in standard P6 vialsfor accurate, traceable,

calibration of the RadionuclideCalibrators.

These solutions are traceable tonational standards (including

NIST, PTB, NPL, BNM-LNHB etc).Each source is supplied with a

UKAS or DKD Certificate ofMeasurement stating:

• Activity • Reference date

• Measurement uncertainty• Gamma-ray emitting

impurities• Traceability Availability

Within 4 weeks of receipt of order. An annual delivery scheme isavailable for customers in Germany, Austria and Switzerland. Pleasecontact your local office for details.

Ordering information

Radionuclide Nominal activity Volume Availability Product code

In-111 40MBq 10ml please enquire INY95*)I-131 20MBq 10ml four times a year IBY95I-131 4MBq 10ml four times a year IBY75Ga-67 40MBq 10ml please enquire GJY95*)Tc-99m 40MBq 10ml on request TKY95**)I-123 40MBq 10ml please enquire IRYK7576**)

*) Europe only**) United Kingdom only

for customers in Germany, Austria and Switzerland

Radionuclide Nominal activity Volume Availability Product code(no carrier added)I-131 10MBq 2ml twice a year IBYB2495Tl-201 10MBq 2ml twice a year TDYB2495Tc-99m 40MBq 10ml twice a year TKYB2495

ø ≈ 20≈

58

Active Solution

Label

Al-cap

Plug

≈58

Ø ≈ 20

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Quality Assurance in Nuclear Medicine

Calibrated Sodium Iodide Capsules(Use only for measurement purposes)

Application

Calibration figures onradionuclide calibrators often

assume that the sample has theform of liquid in a glass vial. If the

sample has a different form, thereported activity can be in error

as a result. This capsule can beused for an accurate, traceablecalibration of dose calibrators

which are used to check theactual activity of a I-131 therapy

capsule.

Features

• Matches the geometry of I-131 therapy capsules for accurate calibration

• Traceable to national standards and international standards• Activity of 74MBq chosen to keep operator dose as low as reasonably

practicable but yield accurate measurement results

Availability

The capsules are delivered 3 times a year. An annual delivery

scheme is available. Pleasecontact your local office for

details.

Ordering information

Construction

The I-131 capsules are manufactured at the Amersham Health facilityin Braunschweig. They are exactly of the same design as the I-131 TheraCap™ radiopharmaceutical. The capsule is supplied in thespecifically designed lead pot with the applicator to put it into thedose calibrator. A detailed operating instruction will be supplied withthe product.They will be calibrated in our accredited measurement laboratory andare traceable to national standards (including NIST, PTB, NPL, BNM-LNHB etc). Each source is supplied with a DKD Certificate ofMeasurement.

Tolerance

The maximum deviation of the delivered activity from the nominalvalues stated is +/-10%.

Radionuclide Nominal Drawing Availability Product codeactivity

I-131 74MBq VZ-2578 twice a year IBRB4571

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Ordering information - Reference sources, calibrated, DKD- certificate

Radionuclide2) Nominal activity Overall Product code[kBq] uncertainty [%]

Am-241 3.7 3 AMRB4541Ba-133 3.7 3 BDRB4543Cs-137 3.7 3 CDRB4545Co-57 3.7 3 CTRB4547Co-60 3.7 3 CKRB4549Eu-152 3.7 3 EFRB4551Na-22 3.7 3 SKRB4555I-129 3.7 3 ISRB4557I-125 3.7 3 IMRB58291)

Ordering information - Check sources, uncalibrated

Radionuclide Nominal activity Product code[kBq]

Ba-133/Cs-137 3.7 IZR5410Ba-133 3.7 BDR5410Cs-137 3.7 CDR5410Co-57 3.7 CTR5410Co-60 3.7 CKR5410Mn-54 3.7 MFR5410Na-22 3.7 SKR5410I-129 3.7 ISR5410I-125 3.7 IMRB56041)

1) Please allow 12 weeks for delivery of this source from receipt of order.2) For Ge-68 source please see page 10.

Inactiveresin

75

Resincontainingradionuclide

Construction

The nuclide is homogeneouslyincorporated in 1ml resin in a

plastic tube. The empty volumeis filled with inactive plastic. For

easy identification of theradionuclide the active volume is

colour coded.

ISO Classification

C.23233 Drawing: VZ-1236

Tolerances

The maximum deviation of thedelivered activity from the

nominal values stated is ± 20 %.

Availability

Within 3 - 4 weeks of receipt oforder.

Gamma counter checking sourcesTube type sources

Application

The sources are used either forenergy calibration of gammacounters (uncalibrated) or fordetector efficiency calibration

(calibrated). Calibrated sourcesare supplied with a certificate of

the German Calibration Service (DKD) and are traceable

to international standards.

ø 12

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Quality Assurance in Nuclear Medicine

Ordering information

Instrument Radionuclide Nominal activity Product code

EG & G Berthold I-129 12 x 2kBq ISRB6539Model LB21..series

Stratec PC-RIA.MAS I-129 12 x 1kBq ISRB2355

Construction

The nuclide is homogeneously incorporated in 1ml of resin in a plastictube and the empty volume is filled with inactive plastic. The set oftubes is mounted in a holder to match the measurement equipment.

ISO Classification

C.22212 Drawing: VZ-2417(Berthold)

Tolerance

The sources are selected so that the emission rate from any oneparticular source is less than 1% from the mean emission rate of all ofthe sources.

Note

These sources are intended for quality control checks only. Calibrationof the instruments should be performed using I-125 calibrated singletubes.

Availability

Please enquire.Approx. within 4 weeks of

receipt of order.

Gamma counter checking sourcesMultifinger checking sources

Application

These uncalibrated sources areused for convenient and rapid

testing of multi-well gammacounters.

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Quality Assurance in Nuclear Medicine

Description

C-Trak has been designed to detect trace quantities of radiolabelledcompounds in lymph nodes in the presence of high backgroundradiation from the injection site. The instrument consists of a surgi-cal probe and an Automatic Analyzer which work together to mini-mize the background and give high sensitivity for locating thelymph nodes.The probe consists of a CsI crystal mounted in the tip of a stainlesssteel tube which is angled for better manoeuvrability. The crystal isinside a tungsten collimator so that it is shielded from radiation stri-king the side of the tube. Patented additional collimators can besnapped onto the probe to change the field of view from wide (forsurveying) to narrow (for probe-guided resection), or to match thetissue or background radiation. A tungsten shielding plate is alsoavailable to further reduce the radiation from outside the selectedfield of view.

C-Trak® Surgical Guidance System for Sentinel Lymph Node Diagnostics*)

Application:

The C-Trak Surgical GuidanceSystem has been designed to be

used by a surgeon to detecttissues which contain a

radioisotope label. The heart ofthe system is a small, hand-heldgamma detector (probe), whichis specifically developed for usein surgery. With this probe, the

surgeon can also determinewhether surgically removed

tissue contains radioactivematerial and, by repeated assay,

can determine whether allradioisotope-containing

material has been removed fromthe operative site.

Features

• Self-calibrating Automatic Analyzer• 11mm OmniProbe™ with superior spatial and energy resolution• New laparoscopic probe• Only one probe with shielding and collimation for Tc-99m,

I-131 and In-111• High sensitivity to detect radioactivity in tissue• Commonly used isotopes selectable by simple push button functions• User adjustable window and threshold for specific isotopes• Co-57 check source included for quality assurance• Complies with Medical Device Directive, CE-marked and FDA cleared• Wide range of accessories available (e.g. Tungsten shielding plates)• Supplied in a roller case

*) The C-Trak Automatic Analyzer System is manufactured by CareWise Medical Products Inc.

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Quality Assurance in Nuclear Medicine

C-Trak® Surgical Guidance System for Sentinel Lymph Node Diagnostics

Technical data

Analyzer:

Energy range: 27keV – 600keVPower: Battery operated, 9V DC, Main and reserve

batteriesAudio: variable tone generator coupled to the

ratemeter, volume controlDisplay: LCD with 6-digit display of counts per second or

timed counts 4 range analog ratemeterDimensions: Height 17.8cm, Width 31.2cm, Depth 25.4cmWeight : approx. 4.5kg including full battery

complementExternal Ports: PHA out for external pulse-height analyzer

Printer outputExternal LED DisplayRemote for Footswitch

Omni Probe:

Energy range: 27keV – 400keVDimensions: Length 17cm, Tip 11mm

Tip of Tc Collimator 15mmTip of In Collimator 25mm

Weight: Probe 130gProbe with Tc Collimator 185gProbe with In Collimator 872g

Sterilization: A sterile sheath is recommended.

Laparoscopic / endoscopic / minimally invasive probe:

Energy range: 27keV - 364keVDimensions: Total length 46.6cm

Shaft length 33.7cmØ10mm tip

Weight: 255gSterilization: Probe can be sterilized using ethylene oxide.

The Automatic Analyzer registers the level of radiation detected bythe probe. The analyzer has digital and analogue readouts, and anaudible signal. The frequency of the audible signal is proportional tothe radiation level so that the node can be located accurately. Forsurgery, the analyzer has simple push button operation, but there isalso a menu driven LCD display for more detailed options.A Co-57 check source is also included to ensure that the instrument isoperating correctly and is stable.

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Quality Assurance in Nuclear Medicine

Availability

Within 4 weeks from receipt of order.

Ordering information

Product CodeC-Trak Automatic Analyzer System

• with OmniProbe, standard- and Lechner collimatorfor Tc-99m, external LED display NIGB7900

• with OmniProbe, standard- and Lechner collimator for Tc-99m, external LED display; collimator and shielding for In-111 NIGB7901

• with MiniProbe™ and standard technetium collimator NIGB7902

• with laparoscopic probe NIGB10110

• with laparoscopic probe and OmniProbe with standard collimator for Tc-99m NIGB10111

NEW

NEW

NEWProduct Code

C-Trak – laparoscopic probe for Automatic Analyzer NIGB9252Printer, footswitch and tungsten shielding platefor NIGB7900 to NIGB7902, NIGB10110, NIGB10111 NIGB7918C-Trak OmniProbe Shield and collimator for In-111 NIGB7904C-Trak OmniProbe with standard collimator for Tc-99m NIGB7917C-Trak MiniProbe without collimator NIGB7916C-Trak MiniProbe - collimator for Tc-99m NIGB7915C-Trak Automatic Analyzer NIGB7914C-Trak printer and buffer system with cable NIGB7913Tungsten shielding plate NIGB7912C-Trak external LED display with 3m cable NIGB7919Probe cable NIGB7911Footswitch NIGB7910Probe and Analyzer Carrying Case NIGB7909C-Trak OmniProbe custom collimator Lechner 5mm NIGB7908Replacement Co-57 check source Nominal activity: 185kBq, uncalibrated CTRB7874

Accessories

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28

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Health PhysicsLow energy personal alarm dosimeter – Dose GUARD Plus

Features:

• Photon energy response 17keV to 6MeV• Sensitive to x and γradiation, β particles• Suitable for all commonly used radionuclides (including I-125, I-131,

Tc-99m, …)• Records whole-body and surface dose (Hp(10) and Hp(0.07))• Infra-red communication port available• Uses standard AA batteries

Application/Description:

The new DoseGUARD Plus personal alarm dosimeter has been designedto meet the requirement in hospitals to measure low energy photonsfrom medical X-ray machines and low energy photon emitters (forexample, the photons emitted by I-125 seeds).

The instrument is based on proven technology, and incorporatesmultiple PIN diodes so that the low energy photon and beta dose ratescan be determined. The case is lightweight (95 grams), and isconstructed from high impact ABS / polycarbonate. Protection againstexternal electromagnetic fields is greatly in excess of internationalstandards. The instrument uses a standard AA lithium battery (givingtypically 5 months continuous use) or an AA alkaline battery (typically55 days continuous use).

Audible alarms can be set on dose and dose rate. The alarm volume andpitch can be chosen so that patients are not disturbed if an alarmshould sound. There is also a ‘chirp’ alarm to give a continuous warningif a source is exposed.

The instrument meets the requirements of relevant internationalstandards (IEC1283, ANSI 13.11, 13.27 and 42.20).

Options

DoseGUARD Plus dosimeters use standard IrDA infra-red protocol to communicate with a computer or accesscontrol terminal from up to 1 metre distance. IrDA eliminates the need for special dosimeter readers. This new,fast communication allows issue and return times of under 1 second. An enhanced range of features includesuser settable alarms, with all display options switched via the PC to make the new DoseGUARD Plus as simple orcomplex as the user wishes. The infra-red detector is connected to the serial port of the PC and is supplied withthe neccessary communications software.

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Quality Assurance in Nuclear Medicine

Technical data

Radiation type: Beta, gamma and X-ray Photon energy range: Hp(10) 17keV to 1.5MeV better than +/- 20%

Hp(10) 1.5MeV to 6MeV better than +/- 30%Hp(0.07) 20keV to 6MeV better than +/- 30%

Dose rate range: up to 4Sv/h Dose range: up to 16SvAccuracy: Hp(10) Cs-137 +/-10%

Hp(0.07) Sr-90 +/-20% Display: Dose or dose rate

Whole body (Hp(10)) or surface (Hp(0.07))Alarms: 2 thresholds on each of dose/ dose rate (Hp(10))Chirp alarm: Can be set from 0.01mSv/chirp to 100mSv/chirpAlarm pitch / volume: High or low tone

7 volume levelsContinuous or intermittent soundMaximum volume 98dBA at 20cm

Power supply: Standard AA lithium battery (typically 5 months continuous use) or standard AA alkaline battery (typically 55 dayscontinuous use)

Dimensions: 85mm x 63mm x 19mm Weight: 93g including battery Case: High impact ABS / polycarbonate blend Clip: High impact plastic, easily renewed, Lanyard

available Operating temperature range: -10 to +40°C Storage temperature range: -25 to +70°CHumidity range: 20% to 90% relative humidity, non-condensing

*) The new DoseGUARD Plus is currently available in North America. For other countries, please enquire.

Ordering information *)

Product code

DoseGUARD Plus NIGB8000IR Connector and software NIGB8001

Availability

Within 2 weeks from receipt of order.

Page 32: Quality Assurance in Nuclear Medicine

30

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Health PhysicsPersonal electronic alarm dosimeter – DoseGUARD™

Application/ Decription

For ensuring doses are as low asreasonably practicable. A robustcost effective instrument, for use

where the low energy response(below 50keV) is not required.

The dose rate or cumulative doseis shown on an LCD display. The

dosimeter is normally used in thestand alone mode using the pre-

set configuration. A moreindividual configuration can be

set by using a reader head whichcan be connected to a PC.

Availability

Within 2 weeks from receipt of order.

Features

• Energy response matches most radionuclides used for diagnosis, therapy and quality control (eg, Tc-99m, In-111, Ga-67, Tl-201, I-131, Ir-192, Co-60, Cs-137)

• Three independent audible alarm systems (dose, dose rate, chirper function)

• Alarms can be switched off to avoid disturbing patients• Robust, splash proof casing• Battery operated using standard AAA size alkaline cell

Options

The DoseGUARD dosimeter canbe configured for particular

applications using a reader headconnected to a PC (not included)

via the serial port. With thereader head it is possible to:

• Prevent a user changingsettings using the pushbutton

• Obtain a hard copy printout ofthe recorded dose

• Prevent a user to reset the doseto zero level and to switch off

the dosimeter

• Customise the alarm settingsand chirp rate.

Technical data

Radiation type: Photons Energy range: 50keV to 3MeV Dose measurement range: 1µSv to 9.99Sv Dose rate measurement range: 5µSv/h to 3Sv/h Calibration accuracy: Better than ±5% at 662keV Dimensions: 78mm x 67mm x 22mm Weight: 80g (including battery)

Ordering information

Product code

Dosimeter DoseGUARD NIGB2000Dosimeter DoseGUARD S10 GB3000*)Dosimeter DoseGUARD S10 (special calibration) NIGB3001*)Reader Head ADR-1 and software ADR-1/50 NIGB4955Calibrated checking device for NIGB3000 and NIGB3001including 3.7MBq Cs-137 source CDRB7000

*) Für Kunden in Deutschland:Das Dosimeter ist unter der Bezeichnung DoseGUARD S10 zur innerstaatlichen Eichung zugelassen undist auch bereits geeicht unter der Bestellnummer NIGB3001 erhältlich. Die zugehörige radioaktiveKontrollvorrichtung wird bereits geeicht geliefert. Weitere Details sind auf Anfrage verfügbar.

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31

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Technical data

Radiation type: Photons Energy range: 60keV to 1.3MeV Dose measurement range: 0.01µSv to 99.9mSv Dose rate measurement range: 0.01µSv/h to 9.99mSv/h Calibration accuracy: Better than 5% at 662keV Dimensions: 130 x 80 x 29mm Weight: approx. 400g

Ordering information

Product code

Survey instrument 6150AD6 NIGB6001

Alpha-beta-gamma counting tube 6150AD17 with window NIGB4974

Gamma counting tube 6150AD18 (low dose tube) NIGB5945

Belt bag for 6150AD6 NIGB6248

Carry case for 6150AD6 survey meter and counting tube NIGB6242

Features

• Robust, waterproof, housing• Energy response matches most radionuclides used in diagnosis,

therapy and quality control• Analogue and digital display of dose rate• Averaging facility for accurate measurement of very low dose rates• Audible alarms on dose / dose rate

Availability

With 2 weeks from receipt of order.

Health PhysicsSurvey meter

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Health PhysicsContamination monitors

LB124 - Technical data

• Sensitive detector for gamma/ beta emitting radionuclides• Detector: Sealed Xenon filled proportional counter• Window area: 150cm area, protection grid with 80% transmission• Display: Monochrome LCD 192 x 64pixel, electro-luminescence

illumination• Power supply: 3 batteries type C (LR14)• Stored calibration factors for more than 50 radionuclides• Dimensions: 240mm x 140mm x 110mm• Weight:1620g with batteries

Availability

Please ask for more details andthe availability in your country

via your local distributor or AEATechnology QSA office.

AB100B - Technical data

• Sensitive detector for gamma/ beta emitting radionuclides• Detector: Sealed Xenon filled proportional counter• Window area: 12cm x 19cm• Display:4 digit LCD, backlit by LED’s• Power supply:3 batteries type C (LR14) located in the handle• Stored calibration factors for more than 25 radionuclides• Dimensions: 234mm x 140mm x 126mm• Weight:2200g with batteries

Instrument Product code

Beta/ Gamma contamination monitor AB100B

Wall mounting console including mains power supply LB122W

Sr-90 beta check source (nominal activity 220Bq) SIRB1011

Monitor set, including monitor, wall-mounted console,

power supply, beta check source SIRB5353

Ordering information

Instrument Product code

LB124 contamination monitor NIGB11532

Ordering information

Availability

Please ask for more details andthe availability in your country

via your local distributor or AEATechnology QSA office.

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33

Quality Assurance in Nuclear Medicine

Reference sources for surface contamination monitors

Features

• Traceable to national standards• Robust sealed sources• Suitable for functionality testing and calibration

Application

Surface contamination monitors should be checked and calibratedregularly, in accordance with national regulations. The sources shownbelow are a short selection from the wide range available; for furtherdetails, please see the Instrument Calibration catalogue available freeof charge from your local representative.

CoMo170 - Technical Data

• Sensitive detector for alpha/beta and gamma emitting radionuclides

• Detector type: thin-layer plastic scintillation detector with ZnS coating

• Detector size: 170cm2

• Display: large-area, graphical LC display 128 x 64pixels,with illumination

• Dimensions: 280mm x 125mm x 135mm• Weight: approx. 750g with batteries• Power supply: 2 batteries, Type AA (LR6) or corresponding

rechargeable batteries (NiCd, NiMH)

Ordering information

Instrument Product code

CoMo 170 Contamination monitor NIGB9820

Availability

Please ask for more details andthe availability in your country

via your local distributor or AEATechnology QSA office.

Page 36: Quality Assurance in Nuclear Medicine

Activearea

Ø 25

Ø 16

3.0

34

Quality Assurance in Nuclear Medicine

ISO classification

C.34645Drawings: VZ-626 and VZ-1366

Reference sources for surface contamination monitors

Construction

The activity is homogeneously incorporated into the anodized surfaceof an 0.3mm thick aluminium foil. The foil is mounted on an aluminium backing plate, 3mm thick. The source is calibrated by theGerman National Calibration Service (DKD) and is supplied with a DKDcertificate of measurement.

Availability

Within 6 weeks of receipt of order.

Ordering information – rectangular type sources

Radionuclide Nominal activity Appoximate particle Beta end-point Product code[kBq] emission rate [1/s] energy [MeV]

Co-57 3 0.122 (gamma) CTR06032I-129 3 0.297 (gamma) ISRB5895I-129 10 ISRB4180C-14 1 380 0.157 CFR06022Tc-99 1 490 0.294 TCR06022

Ordering information – disc type sources

Radionuclide Nominal activity Product code

Co-57 3kBq CTR01032I-129 1.85kBq ISR5016

3.0

100.0

120.0120.0

100.0

Activity

Page 37: Quality Assurance in Nuclear Medicine

35

Quality Assurance in Nuclear Medicine

Experiments that can be performed include:• The statistics of radioactive decay• Measuring the plateau of a detector• Determining the half life of Ba-137m• The absorption of gamma-rays in lead• The inverse square law• Estimating the activity of a radioactive source

A complete demonstration setincluding a radionuclide

generator has been developedby AEA Technology QSA for

illustrating the properties ofradioactivity in laboratorycourses and school lessons.

The ratemeter can be connectedto a PC via a serial port. All

experiments can be performedusing the PC.

AktivLab™Demonstration set for experiments on radioactivity

Ordering information

Instrument Product code

AktivLab CDRB5645

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Quality Assurance in Nuclear Medicine

General information

Applications

The sources in this catalogue areintended for quality control of

measurement devices andequipment in nuclear medicine

departments.The applications of the sources

are described in each section.

Certification

Each source is supplied with a certificate which states:• Reference time and date• Nominal activity of radionuclide• ISO Classification of source• Source serial number• Results and date of leakage test• Measured activity (calibrated sources only)• Overall uncertainty (calibrated sources only)

Uncertainties

Reported is the expandeduncertainty U=k*uc, with U

determined from a combinedstandard uncertainty uc (ie.

estimated standard deviation)and a coverage factor k=2.U=2uc defines an interval

having a level of confidence ofapproximately 95%.

Traceability

The sources are traceable tostandards held by national

laboratories such as thePhysikalisch-Technische

Bundesanstalt (Germany), theNational Physical Laboratory

(UK), the National Institute ofStandards and Technology

(USA), the Bureau National deMétrologie - LaboratoireNational Henri Becquerel(France), and many other

countries world-wide.

Quality assurance and quality control

The sources are calibrated at AEA Technology´s DKD accreditedmeasurement laboratory in Braunschweig, Germany. Themanufacturing facility operates a Quality Management System whichhas been independently audited and approved to ISO9001:2000.

CE Marking

All medical devices and accessories to medical devices sold in Europemust comply with the Council Directive 93/42/EEC of 14th June 1993(as enacted in national regulations).

The directive classifies medical devices in four classes I, IIa, IIb and III.The classification depends on the intended purpose of the device and isbased on the vulnerability of the human body taking account of thepotential risks associated with the technical design and manufacture ofthe devices. The conformity assessment for class I devices can be carriedout under the sole responsibility of the manufacturer whereas class IIand class III need the intervention of a Notified Body.

To indicate conformity with the directive, the devices should bear theCE mark.

AEA Technology’s radiation sources for quality assurance in nuclearmedicine have always been manufactured according to the latestquality standards and also comply with the new European regulationsand are CE marked.

According to the classification rules of the directive the radiationsources concerned are classified as class I medical devices. The CE markappears on the outer packaging and on the sealed source certificate(test report).

A conformity declaration is available on request.

Ordering information

Please see page 40f.

Recommended working life(RWL)

The Recommended working life(RWL) is the maximum period

within AEAT expects the sourceto meet it’s design requirementsunder proper conditions of envi-

ronment and usage. A sourceshould be replaced within the

RWL or a proper assessmentshould be made to verify it‘s sui-

tability for continued use.

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37

Quality Assurance in Nuclear Medicine

ISO classification

The International Organization for Standardization (ISO) has proposeda system of classification of sealed radioactive sources based on thesafety requirements for typical uses (see ISO2919:1999). This systemprovides a manufacturer of sealed radioactive sources with a set oftests to evaluate the safety of his products. It also assists a user of suchsealed sources to select types which suit the application in mind. The tests to which specimen sources are subjected are listed in thefollowing table.Each test can be applied in several degrees of severity. Test results areexpressed as a five figure code to indicate the severity of the tests.These figures are preceded by the letter C or E to show whether thesource activity is less than or greater than certain limits. These limitsdepend upon the toxicity, solubility and reactivity of the activecomponent of the source.C indicates that the activity level of the source does not exceed theprescribed limit andE that the limit is exceeded.

Test Class 1 Class 2 Class 3 Class 4 Class 5 Class 6

Temperature No test -40oC (20min) -40oC (20min) -40oC (20min) -40oC (20min) -40oC (20min)+80oC (1h) +180oC (1h) +400oC (1h) +600oC (1h) +800oC (1h)

and thermal shock and thermal shock and thermal shock400oC to 20oC 600oC to 20oC 800oC to 20oC

External No test 25kPa absolute 25kPa absolute to 25kPa absolute to 25kPa absolute to 25kPa absolute topressure to atmospheric 2MPa absolute 7MPa absolute 7MPa absolute 170MPa absolute

Impact No test 50g from 1m 200g from 1m 2kg from 1m 5kg from 1m 20kg from 1m

Vibration No test 3 x 10min 3 x 10min 3 x 30min25kHz to 500Hz 25Hz to 50Hz 25Hz to 80Hzat 5g peak at 5g peak at 1.5mm amplitude amplitude and amplitude peak

50Hz to 90Hz to peak andat 0.635mm 80Hz to amplitude peak 2000Hz at 20gto peak and 90Hz peak amplitudeto 500Hz at 10g peak amplitude

Puncture No test 1g from 1m 10g from 1m 50g from 1m 300g from 1m 1kg from 1m

Technical appendicesQuality control

Classification of sealed radioactive source performance standards according to ISO 2919

Page 40: Quality Assurance in Nuclear Medicine

38

Quality Assurance in Nuclear Medicine

Quality control

Leakage and contaminationtests

Stringent tests for leakage are anessential feature of radioactive

sources production. They arebased on ISO9978. Some

standard methods used fortesting radiation sources are

listed.

Wipe test I (A)

The source is wipedwith a swab or tissue,moistened withethanol or water; theactivity removed ismeasured.

Limit 185Bq

Immersion test II (L)

The source isimmersed in asuitable liquid at 50°Cfor 4 hours and theactivity removed ismeasured.

Limit 185Bq

Nuclear decay scheme data for selected radionuclides

Radionuclide half-life Decay mode Beta energy Intensity Photonenergy Intensity[MeV] [%] [MeV] [%]

Co-57 271.4d ec 100.0 0.014 9.60.122 85.50.136 10.70.692 0.2

Ge-68 270.82d ec 100.0 0.009 - 0.010 44% X-rays

via Ga-68 1.13h ec 11.0 1.077 3.0in equilibrium β+ 0.822 1.0

1.899 88.0

Mo-99 2.75d β- 0.436 16.6 0.041 1.10.848 1.2 0.140 4.91.214 82.0 0.181 6.1

0.366 1.20.740 12.20.778 4.3

via Tc-99m 6.02h it 100.0 0.140 89.0in equilibrium

Tc-99m 6.02h it 0.140 89.00

I-125 60.1d ec 100.0 0.035 6.70.028 140% X-rays

I-129 1.57x107y β- 0.150 100.0 0.040 7.50.030 65% X-rays

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Quality Assurance in Nuclear Medicine

Nuclear decay scheme data for selected radionuclides

Radionuclide half-life Decay mode Beta energy Intensity Photonenergy Intensity[MeV] [%] [MeV] [%]

I-131 8.04d β- 0.248 2.1 0.080 2.60.304 0.6 0.284 6.10.334 7.4 0.364 81.20.606 89.4 0.637 7.30.807 0.4 0.723 1.8

via Xe-131m 11.9d it 100.0 0.164 2.0

Ba-133 10.52y ec 100.0 0.053 2.20.080 2.60.081 34.10.161 0.60.223 0.40.276 7.20.303 18.30.356 62.10.384 8.9

Cs-137 30.00y β- 0.512 94.61.173 5.4

via Ba-137m 2.55m it 0.662 85.1in equilibrium 0.033 7% X-rays

Gd-153 242.0d ec 100.0 0.070 2.40.075 0.10.083 0.20.089 0.10.097 29.50.103 21.1

Tl-201 3.04d ec 100.0 0.031 0.30.032 0.30.135 2.80.166 0.20.167 10.6

Quality control

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Quality Assurance in Nuclear Medicine

Ordering information

For customers in North America

In the USA and Canada persons or organizations purchasing, possessing,processing, using or selling radioactive materials must be licensed by anational authority and/or state government agency. Users ofradioisotopes should familiarize themselves with all applicableregulations. In the United States, a person who wishes to employradioactive material must possess an appropriate USNRC or AgreementState, or Licensing State License. In Canada all users must possess an CNSC license.The licensing of radioactive material in the United States is handled bymore than one regulatory agency; the regulatory agency that hasjurisdiction in any particular instance depends on the type of radioactivematerial.The Nuclear Regulatory Commission (NRC), a federal agency, hasjurisdiction for the types of radioactive materials known as by-product,source and special nuclear material. The NRC may delegate this authorityto states that have developed programs that meet NRC guidelines.These states are commonly known as ‘Agreement States’.There is another broad category of radioactive material which is notregulated by the NRC. It is known as ‘NARM’ – Naturally-occuring andAccelerator-produced Radioactive Materials. Regulations on thelicensing and use of NARM are published and enforced by individualstates. Examples of some NARM nuclides are cobalt-57, sodium-22,yttrium-88, radium-226 and bismuth-207.AEA Technology QSA must have written certification that a customer ispermitted to possess the type, form and quantity of radioactive materialbeing ordered. This information or the customer’s license or registrationnumber, name of the licensing agency and expiration date of thelicensing document must be on file before a shipment of radioactivematerial can be made.An address listing of federal and state licensing authorities can beobtained by contacting AEA Technology QSA.In Canada purchasers of radioactive material should possess aradioisotope license which can be obtained from:

A l’attention des clients francais

La fabrication des sources parAEA Technology QSA est faite

sous programme assurancequalité certifié par le label

ISO9001-1994. Une copie ducertificat délivré par un

organisme indépendant estdisponsible sur simple demande.

Pour la France uniquement:Toute commande livrable en

France est soumise àl’approbation de la CIREA et doit

être accompagnée d’uneDemande de Fournitures

dûment complétée et signée,exceptions faites des

établissements du C.E.A et quelque soit l’établissement, des

sources scellées d’activitéinférieure aux limites du décretde 1986 (EURATOM). Il en est demême des sources non scellées.

Conditions Particulièresd’Autorisation:

en sont dispensées les sourcesscellées d’activité inférieure à

5kBq (groupe 1), 5MBq (groupe2 et 3), 50MBq (groupe 4) àusage d’étalonnage ou de

calibration.

N’hésitez pas à contacter AEATechnology QSA France si vous

avez des doutes.

FranceAEA Technology QSA

12 avenue des TropiquesHightec Sud-Bâtiment B

Courtaboeuf Cedex 91955

Téléphone: 01 64 86 22 22Télécopie: 01 69 86 10 65e-mail: jeanrene.caramelle

@aea-technology.fr

Canadian Nuclear SafetyCommission280 Slater StreetP.O. Box 1046Ottawa, Canada K1P559Tel.: (613) 995-5894Fax: (613) 992-2915e-mail: [email protected]

United States & CanadaAEA Technology QSA, Inc.40 North AvenueBurlington, MA 01803Tel.: (781) 272-2000Fax: (781) 359-9179Toll-free: (888) 272-2242

Page 43: Quality Assurance in Nuclear Medicine

41

Quality Assurance in Nuclear Medicine

For customers in other countries

In most countries regulations exist which control the use of radioactivematerials. Users or potential users of AEA Technology´s Isotrakstandardized solutions or other reference sources must ensure thatthey fully understand and comply with their local regulations beforeplacing any order with AEA Technology QSA or its local representative.

AEA Technology QSA is represented in most countries worldwide. Ifyou do not know your local AEA Technology QSA representative,please enquire via one of the above-mentioned sales offices.

Für Kunden in Deutschland

Voraussetzungen für den Bezugvon radioaktiven Stoffen:

Der Umgang mit radioaktivenStoffen ist in der BundesrepublikDeutschland gemäß Atomgesetz

genehmigungspflichtig. DieGenehmigungsbedingungen für

den Umgang mit den in diesemKatalog aufgeführtenProdukten sind in der

Strahlenschutzverordnung(StrlSchV) in der jeweils gültigen

Fassung geregelt.Für den Bezug von Produkten,mit denen nur aufgrund einer

Genehmigung umgegangenwerden darf, senden Sie uns

bitte mit der ersten Bestellungeine Kopie Ihrer gültigen

Umgangsgenehmigung zu.Verfügen Sie über keine

Umgangsgeneh-migung undmöchten Produkte beziehen, für

die der Umganggenehmigungspflichtig ist,

informieren wir Sie gern überdie für Sie zuständige

Aufsichtsbehörde und sind beider Beantragung einer

Umgangsgenehmigungbehilflich.

For customers in the UK

Anyone possessing, transporting, selling or using radioactive materialmust ensure that they fully comply with The Radioactive SubstancesAct 1993 (RSA’93) and The Ionising Radiations Regulations 1999(IRRs’99).

Prior to receiving and using radioactive material, users will normallyrequire a registration from the Environment Agency. Some categoriesof low activity sealed reference sources used for checking and testingmeasurement instruments are exempt from registration under RSA’93.Details can be found in The Radioactive Substances (TestingInstruments) Exemption Order 1985.

Other categories of radioactive substances of low activity used ineducational establishments may also be exempt from registrationunder RSA’93. Details can be found in The Radioactive Substances(Schools etc.) Exemption Order 1963.

New users should also normally notify their local office of The Healthand Safety Executive (HSE) prior to undertaking work with radioactivematerial for the first time. For small quantities of radioactivity,notification may not be necessary. For details of notification limits,users should refer to Schedule 1 and Schedule 8 of the IRRs’99.

If users or potential users of AEA Technology’s Isotrak™ products are inany way unclear about whether registration and notification of use isrequired, they should contact their local Environment Agency office, orAEA Technology QSA for advice.

Ordering information

Page 44: Quality Assurance in Nuclear Medicine

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Quality Assurance in Nuclear Medicine

Notes

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Notes

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Notes

Page 47: Quality Assurance in Nuclear Medicine

SwedenLaborel SverigeKungsgatan 109SE-753 18 Uppsala

tel +46 18 14 83 00fax +46 18 14 83 01

NorwayLaborel ASCaspar Stormsvei 2Postboks 109 Alnabru0614 Oslo

tel +47 2305 1930fax +47 2263 0751

FinlandSonar OyTaivalmäki 11Niittykumpu02201 Espoo

tel +358 9 542 5420fax +358 9 452 2523

Distributors for isotrak products

AustriaMedPro Vertrieb für medizinisch-diagnostische Produkte GesmbHGersthofer Str. 91180 Viennatel +43 1 479 15690fax +43 1 479 835217

Netherland / DenmarkCanberra Eursiys Benelux NVResearch ParkPontbeeklaan 57B-1731 ZellikGeneral +32 2 481 8530tel NL +31 (0) 187 63 0176fax NL +31 (0) 187 63 05850tel DK +43 69 9051fax DK +31 (0) 187 63 0580

SwitzerlandUehlinger Pfiffner AGPicardiestraße 35040 Schöftland

tel +41 62 721 2281fax +41 62 721 5170

United KingdomHigh Technology Sources Ltd.Unit 6, MoorbrookSouthmead Industrial EstateDidcot, OxfordshireOX11 7HPtel +44 1235 514 200fax +44 1235 514 219

JapanChiyoda Technol Corporation7 - 12, 1-chomeYushima Bunkyo-kuTokyo, 113 - 8681tel +81 3 3816 7965fax +81 3 5803 1939

KoreaHan Mac Engineering Co. Ltd.305-335, 451-7, 2F Gung-dongYusung-Gu, DeajeonSouth Koreatel +82 42 822 7315fax +82 42 822 7316

TaiwanKerma Inc.1-5, Alley 2, Lane 129Ershjung Road, ShindianTaipei 231tel +886 2 8667 5320fax +886 2 8667 5321

Belgium / LuxemburgCanberra Packard Benelux N.V./S.A.Research ParkPontbeeklaan 571731 Zelliktel +32 (0) 2 481 8530fax +32 (0) 2 481 8550

PolandBiker Ltd.ul. Sekocinska 3 m 202-313 Warszawa

tel +48 22 823 3269fax +48 22 823 3269

Czech Republic/ Slowac RepublicM.G.P. spol. s.r.o. (Ltd)Kvitkova 157576001 Zlin

tel +420 67 721 1539fax +420 67 721 1724

HungaryIzotop - Institute of Izotopes Co., LtdKonkoly Thege M. ut. 29-331121 Budapest

tel +36 1 39 10 815fax +36 1 39 59 247

BulgariaElectroncommerce LtdSamokovsko Shose 11738 Sofia

tel +352 9 75 4106fax +352 9 75 3360

Croatia / Slovenia / RomaniaBiomedica Ges.mbHOffice GrazKärntner Str. 1878053 Graztel +43 316 38 1782fax +43 316 38 17823

ItalyCampoverde SRLVia Quintiliano 31Milan20138

tel +39 02 5803 9020fax +39 02 5803 9021

SpainNuclear IbericaHierro 928045 Madrid

tel +34 91 530 6611fax +34 91 539 4330

EireParlamar Ltd.33 GranitefieldRochestown AvenueDun LoaghaireDublintel +353 1 285 3659fax +353 1 285 4338

New ZealandLife Sciences New Zealand Ltd.PO Box 33 109TakapunaAukland 9tel +64 9 480 7775fax +64 9 480 7757

AustraliaANSTO Australian RadioisotopesLucas HightsMenaiNew South Walestel +61 2 9717 3111fax +61 2 9543 7179

Please contact the German salesoffice of AEA Technology QSA.

Other countries

MexicoVicont, S.A. de C.V.Cuauhtemoc No. 178Col. El Carmen TotoltepecToluca, Edo. de MexicoC.P. 50200tel +527 2221 16041 fax +527 2221 65770

IsraelEldan Electronic instruments6 Hashiloch st.Kiryat MatalonPetach Tikvatel +972 3 9371 154fax +972 3 9371 144

Saudi ArabiaAbdulla Fouad Company LimitedP.O. Box 257Damman 31422

tel +966 3 834 0032fax +966 3 835 1181

Page 48: Quality Assurance in Nuclear Medicine

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AEA Technology QSA offices

United KingdomHeadquarter AEA Technology QSA329 HarwellDidcotOxfordshire OX 11 0QJ

USASales Office for: North and South America,Middle East, Australia,New ZealandAEA Technology QSA Inc.40 North AvenueBurlington, MA 01803tel +1 (888) 272 2242, Ext. 259tel +1 (781) 505 8259 fax +1 (781) 359 9179

China / Hong KongSouth East Asia Sales OfficeAEA Technology QSA Inc.Suite 3503, 35 / FloorChina Resources Building26, Harbour Roadtel +852 2596 7711tel +852 2596 7722fax +852 2586 1600

FranceSouthern European Sales OfficeAEA Technology QSA12 avenue des TropiquesHightec Sud - Bâtiment BF 91955 Courtaboeuf Cedextel +33 (0) 1 64 86 22 22fax +33 (0) 1 69 86 10 65

GermanySales Office for:Europe, Africa, India, JapanAEA Technology QSA GmbHGieselweg 1D-38110 Braunschweigtel +49 (0) 5307 932 555fax +49 (0) 5307 932 194

AEA Technology QSA’s radiation sources business brands:

ISOTRAK™ • Calibration sources • Sources for Nuclear medicine• Calibration Service• Instruments for measuring radioactivity

SOURCES™ • Radiation sources• Industrial applications• Smoke detectors

SENTINEL™ • Products and services for non-destructive testing

Internet: http://www.isotrak.dehttp://www.aeat-qsa.com

Email: [email protected]

© AEA Technology plc 2004. All rights reserved.AEA Technology plc. AEA Technology QSA, 329 Harwell, Didcot, Oxfordshire OX11 0RA,United KingdomAll goods and services are sold subject to the terms and conditions of sale ofthe company within the AEA Technology group which supplies them. A copy of these terms and conditions is available on request.

isotrak, AktivLab, C-Thru DoseGUARD and DoseGUARD Plus are trademarksof AEA Technology plc..C-Trak is a registered trademark of CareWise Medical Products.OmniProbe and MiniProbe are trademarks of CareWise Medical Products.ECAT is a registered trademark of CTI PET Systems, Inc. (CPS).ART is a trademark of CTI PET Systems, Inc. (CPS).E.CAM and ECAT EXACT are trademarks of Siemens Medical Systems, Inc..Theracap is a trademark of Amersham Health plc..