HHS Collimator Tests Rev 28

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HHS Collimator Tests

Collimator Tests

Important...X-Ray Protection WARNING X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein contained should be thoroughly read and understood by everyone who will use the equipment before you attempt to place this equipment in operation. The General Electric Company, Healthcare Technologies, will be glad to assist and cooperate in placing this equipment in use. Although this apparatus incorporates a high degree of protection against x-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator to take adequate precautions to prevent the possibility of any persons carelessly exposing themselves or others to radiation. It is important that anyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International Commission on Radiation Protection, and take adequate steps to protect against injury. The equipment is sold with the understanding that the General Electric Company, Healthcare Technologies, its agents, and representatives have no responsibility for injury or damage which may result from improper use of the equipment. Various protective materials and devices are available. It is urged that such materials or devices be used.

Language Policy Direction 2128126 - Language Policy For Service Documentation ПРЕДУПРЕЖ ДЕНИЕ (BG)

Това упътване за работа е налично само на английски език. • Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е да осигури превод. • Не използвайте оборудването, преди да сте се консултирали и разбрали упътването за работа. • Неспазването на това предупреждение може да доведе до нараняване на доставчика на услугата, оператора или пациентa в резултат на токов удар, механична или друга опасност.

警告

本维修手册仅提供英文版本。

(ZH-CN)

• 如果客户的维修服务人员需要非英文版本，则客户需自行提供翻译服务。 • 未详细阅读和完全理解本维修手册之前，不得进行维修。 • 忽略本警告可能对维修服务人员、操作人员或患者造成电击、机械伤害或其他形式的伤害。

警告

本服務手冊僅提供英文版本。

(ZH-HK)

• 倘若客戶的服務供應商需要英文以外之服務手冊，客戶有責任提供翻譯服務。 • 除非已參閱本服務手冊及明白其內容，否則切勿嘗試維修設備。 • 不遵從本警告或會令服務供應商、網絡供應商或病人受到觸電、機械性或其他的危險。

警告

本維修手冊僅有英文版。

(ZH-TW)

• 若客戶的維修廠商需要英文版以外的語言，應由客戶自行提供翻譯服務。 • 請勿試圖維修本設備，除非您已查閱並瞭解本維修手冊。 • 若未留意本警告，可能導致維修廠商、操作員或病患因觸電、機械或其他危險而受傷。

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Rev

Date

Reason for change

Pages

May 30, 2012

Update of REG0075 and REG0086

March 10, 2013

Update of REG0086

August 20, 2013

Update of REG0086 to add computation and test criteria, introduce Discovery IGS 740, add new P011 extract and change product name to DiscoveryTM IGS 730, DiscoveryTM IGS 740

September 4, 2013

Update of REG0086 to introduce Optima IGS320

September 4, 2014

Update of REG0086 to add Ruler.

Update of REG0075 and REG0086 to modify product name to “InnovaTM IGS 620” and “InnovaTM IGS 630”. 24

March 4, 2015

Update of REG0075 and REG0086 to introduce “Optima IGS 330” and change product name to “Optima IGS 320”.

June 15, 2015

Update of REG0086 for Magnus Maquet OR table craddle axis

July 5, 2017

Update of REG0075 and REG0086 to introduce “InnovaTM IGS 80 5”, “InnovaTM IGS 6”, “DiscoveryTM IGS 7” and “DiscoveryTM IGS 7 OR”.

January 2021

Updated of REG0075 and REG0086 to introduce "Allia™ IGS 7", "Allia™ IGS 7 OR", "Allia™ IGS Systems" and "Optima IGS Plus"

November 2021

Update of REG0075 and REG0086 to introduce "Allia™ IGS 3" and "Allia™ IGS 5".

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Collimator Tests

Contents

Contents 1 Safety ...13 1.1 Safety ... 13

2 Collimator Test Requirements ...15 2.1 Collimator Test Requirements ... 15

3 Collimator Function...17 3.1 Introduction... 17 3.2 REG0071 - Functional Test - Auto Rad Collimator Version... 17 3.3 REG0072 - Functional Test - In-Table Fluoro Collimator Version... 18 3.4 REG0073 - Functional Test - Vascular Collimator Version... 19 3.5 REG0074 - Functional Test - Manual Rad Collimator Version ... 20

4 SID Test ...23 4.1 REG0075 - SID Test... 23

5 Light to X-Ray Field Test...25 5.1 REG0076 - Light to X-Ray Field Test... 25

6 Center to Center Test ...27 6.1 REG0077 - Center to Center Test for Bucky or Cassette Holder ... 27 6.2 REG0078 - Center to Center Test for SFD... 28 6.3 REG0079 - Center to Center Test for Film Changers ... 30 6.4 REG0080 - Center to Center Test for Digital Systems ... 32

7 Field Size Indicator (Pointers to Actual Size) Test ...35 7.1 REG0081 - Field Size Indicator Test ... 35

8 Size to Size Tests...37 8.1 REG0082 - Size to Size Test for Bucky or Cassette Holder ... 37 8.2 REG0083 - Size to Size Test for SFD... 39 8.3 REG0084 - Size to Size Test for Gantry - Mounted Film Changer ... 41 8.4 REG0085 - Size to Size Test for Digital Systems... 42

9 Fluoro Collimator to Image Intensifier Test...47 9.1 REG0086 - Fluoro Collimator to Image Intensifier Test... 47

10 Image Overlap Test for Fixed Cones or Cylinders ...69 10.1 REG0087 - Image Overlap Test for Fixed Cones or Cylinders ... 69

11 Collimator Light Field Intensity ...71 11.1 REG0088 - Collimator Light Field Intensity... 71

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1 1 Safety 1.1 Safety X-Ray Protection WARNING X-RAY EQUIPMENT IF NOT PROPERLY USED MAY CAUSE INJURY. ACCORDINGLY, THE INSTRUCTIONS HEREIN CONTAINED SHOULD BE THOROUGHLY READ AND UNDERSTOOD BY EVERYONE WHO WILL USE THE EQUIPMENT BEFORE YOU ATTEMPT TO PLACE THIS EQUIPMENT IN OPERATION. THE GENERAL ELECTRIC COMPANY, MEDICAL SYSTEMS GROUP, WILL BE GLAD TO ASSIST AND COOPERATE IN PLACING THIS EQUIPMENT IN USE. ALTHOUGH THIS APPARATUS INCORPORATES A HIGH DEGREE OF PROTECTION AGAINST X-RADIATION OTHER THAN THE USEFUL BEAM, NO PRACTICAL DESIGN OF EQUIPMENT CAN PROVIDE COMPLETE PROTECTION. NOR CAN ANY PRACTICAL DESIGN COMPEL THE OPERATOR TO TAKE ADEQUATE PRECAUTIONS TO PREVENT THE POSSIBILITY OF ANY PERSONS CARELESSLY EXPOSING THEMSELVES OR OTHERS TO RADIATION. IT IS IMPORTANT THAT EVERYONE HAVING ANYTHING TO DO WITH X-RADIATION BE PROPERLY TRAINED AND FULLY ACQUAINTED WITH THE RECOMMENDATIONS OF THE NATIONAL COUNCIL ON RADIATION PROTECTION AND MEASUREMENTS AS PUBLISHED IN NCRP REPORTS AVAILABLE FROM NCRP PUBLICATIONS, 7910 WOODMONT AVENUE, ROOM 1016, BETHESDA, MARYLAND 20814, AND OF THE INTERNATIONAL COMMISSION ON RADIATION PROTECTION, AND TAKE ADEQUATE STEPS TO PROTECT AGAINST INJURY. THE EQUIPMENT IS SOLD WITH THE UNDERSTANDING THAT THE GENERAL ELECTRIC COMPANY, MEDICAL SYSTEMS GROUP, ITS AGENTS, AND REPRESENTATIVES HAVE NO RESPONSIBILITY FOR INJURY OR DAMAGE WHICH MAY RESULT FROM IMPROPER USE OF THE EQUIPMENT. VARIOUS PROTECTIVE MATERIAL AND DEVICES ARE AVAILABLE. IT IS URGED THAT SUCH MATERIALS OR DEVICES BE USED. CAUTION United States Federal law restricts this device to use by or on the order of a physician. If you have any comments, suggestions or corrections to the information in this document, please write them down, include the document title and document number, and send them to: GENERAL ELECTRIC COMPANY MEDICAL SYSTEMS MANAGER – INFORMATION INTEGRATION, AMERICAS W–622 P.O. BOX 414 MILWAUKEE, WI 53201–0414

Certified Electrical Contractor Statement All electrical installations that are preliminary to positioning of the equipment at the site prepared for the equipment shall be performed by licensed electrical contractors. In addition, electrical feeds into the Power Distribution Unit shall be performed by licensed electrical contractors. Other 46-017564 Revision 28

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1.1 Safety

Collimator Tests

connections between pieces of electrical equipment, calibrations, and testing shall be performed by qualified GE Medical personnel. The products involved (and the accompanying electrical installations) are highly sophisticated, and special engineering competence is required. In performing all electrical work on these products, GE will use its own specially trained field engineers. All of GE’s electrical work on these products will comply with the requirements of the applicable electrical codes. The purchaser of GE equipment shall only utilize qualified personnel (i.e., GE’s field engineers, personnel of third-party service companies with equivalent training, or licensed electricians) to perform electrical servicing on the equipment.

Damage in Transportation All packages should be closely examined at time of delivery. If damage is apparent, have notation “damage in shipment” written on all copies of the freight or express bill before delivery is accepted or “signed for” by a General Electric representative or a hospital receiving agent. Whether noted or concealed, damage MUST be reported to the carrier immediately upon discovery, or in any event, within 14 days after receipt, and the contents and containers held for inspection by the carrier. A transportation company will not pay a claim for damage if an inspection is not requested within this 14 day period. Call Traffic and Transportation, Milwaukee, WI (414) 827–3449 / 8*285–3449 immediately after damage is found. At this time be ready to supply name of carrier, delivery date, consignee name, freight or express bill number, item damaged and extent of damage. Complete instructions regarding claim procedure are found in Section “S” of the Policy & Procedure Bulletins (6/17/94).

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2 2 Collimator Test Requirements 2.1 Collimator Test Requirements Use theTable 2-1 Test Requirements (Notes 1, 2) on page 15 to determine the applicable tests for your system, and be sure to read the notes. It could save you a lot of extra work; do it now. These tests must be performed at installation and after any service that might affect the operation of the collimator with regard to the listed functions. The sole exception is when the tests have been performed in the factory, such as on the AMX-4. In such a case, you will have received separate instructions advising you of the factory tests and specifying other tests (sometimes called signature tests) which supersede the tests in this document. In the Table 2-1 Test Requirements (Notes 1, 2) on page 15, read across in the rows labeled Systems Types and examples to determine which column applies to your system. Table 2-1 Test Requirements (Notes 1, 2) System Types

Auto Coll. to Auto Bucky or Coll. to Cass. Holder SFD

Auto Coll. to I.I. (Fluoro)

Auto Coll. to Man. Coll. to Man. Coll. Cone/Cyl. Film Chang- any Recep. to Mobile to any er (Note 3) X–ray Receptor

Examples:

XT Suspension, Tube Stand Remote Table (Note 5)

RFX/SFX, Vascular, Remote Table, Stenoscop (Note 6)

Integral film changers such as AFM or L–U

RFX/SFX, Stenoscop (Note 6)

Table top film, free standing film changers

AMX, VMX

Tube Stand

Test Required SID

Light to X-ray

Center to Center

X (Note 7)

X (Note 4) (Note 7)

Field Size Indicators

X (Note 4)

Size to Size

Lamp Brightness

Image Overlap Fluoro Coll. to I.I.

X X

NOTE 1. All collimators require functional tests; see Chapter Collimator Function. 2. Mammo collimator tests are covered under 46–017565, HHS MAMMOGRAPHY TESTS. 3. Does not include mobile X-Ray units (AMX and VMX). 4. These are required by many state agencies but not by the FDA. 5. The Bucky of a remote table is similar to a SFD, and so the centering test is that of a SFD. Refer to REG0078 - Center to Center Test for SFD on page 28. 6. The stenoscop is a C-Arm with a SFD (optional).

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Collimator Tests

7. Centering requirements will be met provided the X-Ray and light fields are aligned and the cross-hairs are centered in the field.

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3 3 Collimator Function 3.1 Introduction This test is divided into four versions to suit different types of collimators. • Auto Rad Collimator Version • Undertable Fluoro Collimator Version • Vascular Collimator Version • Manual Collimator Version Certain collimators, which are part of specialized equipment, may have functional requirements in addition to the generalized requirements of this section. Refer to the applicable service manual. NOTE Functional tests of a collimator must be complete before performing tests of the remaining sections. There is an HHS requirement for a minimum distance of 30 cm between the focal spot and the patient for radiographic application, and 38 cm for fluoroscopic applications. Most collimators accommodate this requirement in the design of the collimator. However, in some cases a skin spacer or handle extension is used. Make sure that such features, if provided, are indeed attached to the collimator.

3.2 REG0071 - Functional Test - Auto Rad Collimator Version Table 3-1 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

Not Applicable

Table 3-2 Required conditions Condition

Reference

Effectivity

Requirements are defined in Collima- tor service manual.

SID scale and/or SID indication must be present.

Test data may be entered into the Laptop 3382 spreadsheet program, or if this is not available, it may be record in Form 3382.

46–017566, HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS

Procedure 1.

Check each mode of operation.

Verify that collimator enters correct mode when all conditions are met.

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3.3 REG0072 - Functional Test - In-Table Fluoro Collimator Version

Collimator Tests

Also, verify that collimator does not enter above mode if any of the required conditions are not met (change SID, remove cassette, etc.).

Check both table and wall receptors.

When collimator indicates an exposure inhibit condition, verify that exposures are not possible.

Blades must move to new position in less than 5 seconds. Refer to appropriate service manual for step-by-step procedure. Sentry III – Direction 46–001414 (SM D5303C), Chapter 4. ULTRANET SA - CG Y00W20L.04, Chapter 4. Siemens - 2260325-100 NOTE The FDA requires that, when the X-Ray beam is vertical, an automatic collimator must be in the AUTO mode at least between 90 cm (35.4”) and 130 cm (51.2”) SID. The collimator may go into the manual mode outside of that range.

Finalization No finalization steps.

3.3 REG0072 - Functional Test - In-Table Fluoro Collimator Version Table 3-3 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

Not Applicable

Table 3-4 Required conditions Condition

Reference

Effectivity

Test data may be entered into the Laptop 3382 spreadsheet program, or if this is not available, it may be record in Form 3382.

46–017566, HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS

Procedure 1.

Check conditions for mode and functions provided by mode as described in Table 3-5 Requirements in-table Fluoro Collimator Version on page 18. Table 3-5 Requirements in-table Fluoro Collimator Version Mode

Conditions Required for Mode

Function Required for Mode • Shutters limit beam to visual area in Fluoro.

AUTOMATIC 1. SFD switch in “AUTO”

• Shutters change automatically to full size of selected film when cassette transfers (if applicable).

2. Cassette in place (except Full Digital System)

• Shutters change automatically to full size of selected record format during record operation. • Collimator blades must move to any new position within 5 seconds.

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3.4 REG0073 - Functional Test - Vascular Collimator Version

Table 3-5 Requirements in-table Fluoro Collimator Version (Table continued) Mode

Conditions Required for Mode

Function Required for Mode

MANUAL

1. SFD switch in “MANUAL”

• Shutters may be controlled manually, but maximum beam is always limited to receptor size (Fluoro or Record format).

2. Cassette in place (except Full Digital System)

• Maximum field size changes automatically when cassette transfers but shutters will not increase opening, beyond format size.

RECOMMENDATION: Collimator blades visible at edges of image in all fluoro and record modes for all table positions with controls in maximum open position.

Finalization No finalization steps.

3.4 REG0073 - Functional Test - Vascular Collimator Version Table 3-6 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

Not Applicable

Table 3-7 Required conditions Condition

Reference

Effectivity

X-Ray exposure must not be possible, except at proper SID or SID range. Collimator blades must move to any new position in 5 seconds or less.

Test data may be entered into the Laptop 3382 spreadsheet program, or if this is not available, it may be record in Form 3382.

46–017566, HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS

Procedure 1.

Check that exposure is prevented at incorrect SID, and permitted at correct SID (or range).

Check collimator shutters for response in 5 seconds or less.

Finalization No finalization steps.

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3 Collimator Function

• Collimator blades must move to any new position within 5 seconds.

3.5 REG0074 - Functional Test - Manual Rad Collimator Version

Collimator Tests

3.5 REG0074 - Functional Test - Manual Rad Collimator Version Table 3-8 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

Not Applicable

Table 3-9 Required conditions Condition

Reference

Effectivity

Manual collimators which bear an HHS certification label may be installed in the systems described in Table 3-10 Requirements, Manual RAD Collimator Version on page 20. If in doubt, contact your supervisor. This Table also includes any additional system requirements that apply.

Test data may be entered into the Laptop 3382 spreadsheet program, or if this is not available, it may be record in Form 3382.

46–017566, HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS

Procedure 1.

Verify that radiographic system using manual collimator fits one of the types described in Table 3-10 Requirements, Manual RAD Collimator Version on page 20. Table 3-10 Requirements, Manual RAD Collimator Version System Description

Additional Requirements

Mobile

None

Rapid Film Changer (only)

Coll. not used with table or wall bucky

Single Size Cassette & Fixed SID

• Means provided to limit beam to cassette size • Coll. interlocked to prevent operation at other SID's • Coll. not used with table or wall bucky

Room W/O Permanent Bucky (e.g. table top only)

None

Single purpose systems None (e.g. HYDRADJUST, UTILEX, FRANKLIN HEAD UNIT), ACS 1000

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3.5 REG0074 - Functional Test - Manual Rad Collimator Version

Table 3-10 Requirements, Manual RAD Collimator Version (Table continued) System Description Any radiographic system not described above

Additional Requirements As of 1993 the FDA dropped the positive beam limitation (PBL) requirement. It is now possible to sell a system with a Manual Collimator in applications where an auto-collimator would previously have been used. There is one absolute requirement: There must be documentation on site (preferably a system level operator's manual) indicating that the system may be used with a manual collimator.

Verify additional requirements noted, if any.

Finalization No finalization steps.

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3 Collimator Function

If a collimator and its associated receptor(s) are each capable of automatic collimation, then auto-collimation must be functional. However, it is permitted to replace an auto-collimator with a manual collimator provided there is an on-site operator's manual that describes system operation with a manual collimator.

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4 4 SID Test 4.1 REG0075 - SID Test Table 4-1 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

Not Applicable

Table 4-2 Required conditions Condition

Reference

Effectivity

The difference between the indicated SID and the actual SID may not exceed 2% of the indicated SID. Rejection limit is 1.8%.

Test data may be entered into the Laptop 3382 spreadsheet program, or if this is not available, it may be record in Form 3382.

46–017566, HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS

Procedure NOTE The procedure below uses no film. See 46–017560, HHS TOOLS if a film procedure is desired. 1.

Set the tube at a common SID using the operator’s indicator scale (on col. or bridge).

Insert a cassette into the Bucky and measure the distance between the focal spot locator decal and the film plane using a pocket tape measure. Be careful that the Bucky does not drop down out of its normal position when you make the measurement, and remember that the film plane is half way down into the cassette. NOTE For a manual collimator and table top film, or for a mobile unit, this is a trivial test. Just make sure that the SID indicated by the collimator tape (with tab extended) agrees with your Sears tape measure. You’re done, skip the remainder of this section, record the data.

Enter the results in the data record. Refer to table Bucky example below. Figure 4-1 SID Test, Auto RAD Collimator to Table Bucky

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4.1 REG0075 - SID Test

Collimator Tests

NOTE At most one vertical and one horizontal measurement are required. Horizontal test required only for system with detent. Compliance at maximum SID is verified if the indicator tracks with a tape measure, i.e., 10” tube travel = 10” change in indicated SID. All indicators, collimator tape, etc., must agree with measured SID. 4.

Move the tube to maximum SID and verify that the actual distance traveled equals the travel shown by the operator’s indicator scale. Note compliance in the data record form.

If so equipped, check that the collimator tape agrees with the previous measurements. If there’s a tab on the end of the tape, it must be extended.

If the current tube and receptor can be angulated, then angulate them and repeat the test. However, if when angulated, the only operator indicator is the collimator tape, then the test need not be repeated for that receptor. NOTE Innova 3100/3100-IQ/3131-IQ, Innova 4100/4100-IQ, Innova IGS 530, 540, Innova™ IGS 5, Allia™ IGS 3, Allia™ IGS 5, Innova™ IGS 630, Innova™ IGS 6, Discovery™ IGS 730, Discovery™ IGS 740, Discovery™ IGS 7, Discovery™ IGS 7 OR, Allia™ IGS 7,Allia™ IGS 7 OR, Optima CL320i/CL323i, Optima IGS Plus and Optima IGS 330 (Prerequisite SID Calibration done): • Remove the Tube Cover (Collimator side) • At minimum and maximum SID, measure the distance between the collimator output window and the Anticollision sensor windows. (With a Tape measurement tool) • Add 37 cm to this value and compare it to the displayed value.

Finalization No finalization steps.

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5 5 Light to X-Ray Field Test 5.1 REG0076 - Light to X-Ray Field Test Table 5-1 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

Not Applicable

Table 5-2 Required conditions Condition

Reference

Effectivity

The total misalignment of the X–Ray and light fields in either the lateral or longitudinal directions may not exceed 2% (rejection limit is 1.8%).

Test data may be entered into the Laptop 3382 spreadsheet program, or if this is not available, it may be record in Form 3382.

46–017566, HHS FORMS, COMPLETING THE FDA 2579 AND GE DATA RECORD FORMS

REG0092 - Light to X-Ray Field Test This test is normally performed at tabletop, or at the surface of a wall unit, and so it is most convenient to use the Long Afterglow Phosphor tool, part no. 2120565. However, the test can also be performed by utilizing a cassette in the image receptor, including a digital receptor. To utilize a cassette in a bucky, or cassette holder or digital device use the alternative procedure.

Procedure 1.

Beam angulation is irrelevant, set for convenience. Use common SID.

Select manual collimator mode. On some systems (e.g. remote tables) this may require first selecting AUTO, then one on one format, and then going into override or OBL mode.

Place the phosphor tool on the table (or tape to wall unit).

Adjust the light field to a 25 cm square (12.5 cm in each direction), center the pattern as necessary. Refer to example below: system software defaults to 12.5 cm for light field, but you may change these values if necessary. Figure 5-1 Light to X-Ray Field Test

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5.1 REG0076 - Light to X-Ray Field Test

Collimator Tests

Select non–AEC mode and use the technique indicated on the phosphor tool (2 exposures of 125 kV and 200 mAs each, with 10 second delay between exposures).

With minimum lighting, remove phosphor plate from holder and quickly mark edges of field with pencil (the covering on the phosphor is erasable). Now turn on room lights and read scales.

Enter the data on form 3382. The light field readings should all be 12.5 if you followed the instructions; if necessary you may change the default readings on the light field.

Finalization No finalization steps.

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