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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

23

August 20, 2013

Update of REG0065 to introduce Discovery IGS 740 and 28 TM TM change product name to Discovery IGS 730, Discovery IGS 740

24

September 4, 2013

Update of REG0065 to introduce Optima IGS320

28

25

September 4, 2014

Update of REG0065 to change product name to “InnovaTM IGS 620” and “InnovaTM IGS 630”

28

26

March 4, 2015

Update of REG0065 to introduce “Optima IGS 330 and change product name to “Optima IGS 320”.

28

27

July 5, 2017

Update of REG0065 to introduce “InnovaTM IGS 5”, “InnovaTM IGS 6”, “DiscoveryTM IGS 7” and “DiscoveryTM IGS 7 OR”.

28

28

January 2021

Updated of REG0065 to introduce "Allia™ IGS 7", "Allia™ IGS 7 OR", "Allia™ IGS Systems" and "Optima IGS Plus"

28

29

November 2021

Update of REG0065 to introduce "Allia™ IGS 3" and "Allia™ IGS 5".

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Beam Quality Test

Contents

Contents 1 Beam Quality Test...13 1.1 Safety ... 13 1.2 REG0065 - Beam Quality Test ... 14 1.3 REG0066 - Beam Quality Test - Graphical Method ... 21

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1 1 Beam Quality Test 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 46-017562 Revision 29

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1.2 REG0065 - Beam Quality Test

Beam Quality Test

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).

1.2 REG0065 - Beam Quality Test Table 1-1 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

1

Not Applicable

30 minutes

Not Applicable

All diagnostic source assemblies at installation and whenever replacing tube unit insert, mylar window, collimator mirror, table top, or other absorption between source and patient. NOTE Refer to 46-017565 HHS MAMMOGRAPHY TESTS for Mammographic units. Discovery™ IGS 730, Discovery™ IGS 740 systems or Discovery™ IGS 7 and Discovery™ IGS 7 OR systems are also named Discovery™ IGS Systems. The procedure is applicable indifferently to Discovery™ IGS 730 or Discovery™ IGS 740 or Discovery™ IGS 7 or Discovery™ IGS 7 OR. Allia™ IGS 5 and Allia™ IGS 7 and Allia™ IGS 7 OR are also named Allia™ IGS Systems. The procedure is applicable indifferently to Allia™ IGS 5 or Allia™ IGS 7 or Allia™ IGS 7 OR.

Requirement 1.

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The half–value layer of useful beam at a given kVp shall not be less than that shown in the following table. These requirements are from 21CFR part 1020.30 (m). Specific test point is at 80 kVp, thus the minimum half–value layer requirement is 2.3 mm of aluminum for systems

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manufactured before June 10th, 2006. The minimum half–value layer for systems manufactured On or After June 10th, 2006 is 2.9 mm aluminum @ 80 kVp Table 1-2 Minimum Half-Value Layer

Below 51

51 to 70

Above 70

Selected kVp

Minimum Half-Value Layer (Millimeters of Aluminum)** For Systems manufactured before June 10th, 2006

Minimum Half-Value Layer (Millimeters of Aluminum)** For Systems manufactured on or after June 10th, 2006

30

0.3

0.3

40

0.4

0.4

50

0.5

0.5

51

1.2

1.3

60

1.3

1.5

70

1.5

1.8

71

2.1

2.5

80*

2.3

2.9*

90

2.5

3.2

100

2.7

3.6

110

3.0

3.9

120

3.2

4.3

130

3.5

4.7

140

3.8

5.0

150

4.1

5.4

NOTE * Specific test point. **Type 1100 aluminum, or better. 2.

Since the standard test absorber is 2.5 mm, the procedure described below allows for radiation measurement tolerance with respect to rejection limits for systems manufactured before June 10th, 2006. The set of Aluminum Filters (46–194427P274) in the HHS kit allows for correct HVL test filtration thickness when added to the 2.5 mm standard test absorber. For Systems manufactured On or After June 10th, 2006 the default HVL test filtration is 3.1 mm of Aluminum unless specifically stated otherwise in the following table. Table 1-3 System Specific Details Standard Absorber Total Test Aluminum Filtration Be- Total Test Aluminum Filtration On or fore June 10th, 2006 in millimeAfter June 10th, 2006 in millimeters ters AMX

46–173632G2

2.5

3.0

Precision 500D 46–173632G1

2.5

3.0

Definium 8000 46–173632G1

2.5

3.0

Proteus

46–173632G1

2.5

3.0

Silhouette VR

46–173632G1

2.5

3.0

Other

46–173632G1

2.5

3.1

NOTE The following applies: 46-017562 Revision 29

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1 Beam Quality Test

Design Operating Range (Kilovolts Peak)

1.2 REG0065 - Beam Quality Test

Beam Quality Test

• HVL is very dependent on the actual kVp value. The kV accuracy test must have been performed prior to HVL measurement. • Record the data (apply any corrective factor if required and check final results are within acceptance criteria) and complete THE FDA 2579 FORM.

Procedure Summary: • Measure radiation level at prescribed exposure technic. • Add the standard absorber and measure reduced radiation level. This measurement must indicate 50% or more of initial reading. • If less than 50%, remove standard absorber and add fixed absorption to the beam. • It will be found, generally, that radiographic X-ray sources with collimators already include sufficient filtration (due to mirror in collimator), but that under table and other X-ray sources without light beams may require additional fixed filtration. 1.

NOTE The following applies: • On undertable tube systems, check factory documentation. In some cases, (H.L.A.), the correct filtration has been added at the factory, and only verification that filter is in place is required. • For alternate method, refer also to REG0066 - Beam Quality Test - Graphical Method on page 21. Position radiation probe as shown in the following illustration. NOTE Circular Field Collimators 46–246840G5 are shipped with 1 mm aluminum equivalent filtration at 150 KVP installed, and an additional 0.5 mm to be installed if needed. If the added filtration is NOT installed, affix the label from Label 2135807 which indicates that the collimator has 1 mm aluminum equivalence to the collimator. If the extra 0.5 mm filter is installed, affix the label from Label 2135807 which indicates that the collimator has 1.5 mm aluminum equivalence to the collimator. Both labels are attached to the same peel-off carrier for convenience. Discard the unused label. Reference: Labeling Instructions 2136680IDW.

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Figure 1-1 Half Value Layer - Good Geometry

1 Beam Quality Test

NOTE Common problems to avoid: • Useful beam smaller than active area of probe. • Useful beam significantly larger than active area of probe. • Probe not 12” from absorber. • Intensifier (or anything else) within 4” of probe. NOTE If table top is normally in the beam, then the half value layer shall be tested in that configuration. For fluoroscopic tests, use an exposure rate or exposure measuring instrument, and for radiographic tests use an exposure measuring instrument. Refer to the following illustration for a typical LU or LC gantry configuration.

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Beam Quality Test

Figure 1-2 Half Value Layer - Test Set-up

NOTE On systems that can be positioned so that the table top is not in the X-Ray beam, the half value layer must be tested in that configuration (i.e., table top not in beam). 2.

The optimum position for the standard absorber is midway between the focal spot and the radiation probe. Other positions will introduce reading errors. For example, if the absorber is placed close to the probe, then the probe will receive excess scatter and the absorber will appear to have absorbed less.

3.

Position image intensifiers or other equipment at least 4 away from probe to prevent radiation scatter errors.

4.

Set technic factors as follows: • Fluoroscopic: 80 kVp, 2 mA (use Spot-Film mode if possible). • Radiographic: 80 kVp, 50 to 100 mA, 1/2 to 1 second. mA and time should be adjusted so that reading in Step 6 contains three significant digits.

5.

NOTE For all Innova, Optima, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3, use X220 Fluoro Calibration Unit at 30 fps, in order to set the System in manual mode without spectral filtration and for appropriate technic factors. The test will be performed in Fluoro mode. Remove or dial out all filters that are removable by the operator and collimate slightly larger than active volume of probe using image system or light field. NOTE The following applies: • For Innova 2000 Systems, select the fixed point HHS1, center the probe while making exposures and collimate to probe volume. Then go to the Next Page and select row: 80 kVp, 0.0667 mAs, 10 ms, FS=0.6, Spectral filter=0. Leave field for LONG/LAT empty to keep previous collimator settings.

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• For Innova 2100-IQ/2121-IQ, Innova 3100/3100-IQ/3131-IQ, Innova 4100/4100IQ systems, Innova IGS 520, 530, 540, Innova™ IGS 5, Allia™ IGS 3, Allia™ IGS 5, Innova™ IGS 620, 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, Optima IGS 320 and Optima IGS 330, set the techniques below (and click Submit button), center the probe while making exposures and collimate to probe volume by reducing the Collimator LONG/LAT values (click Submit button to validate changes).

1

Exp.Mod e

Frame Rate

Focal Spot

kVp

mA peak

Fluoro

30

0.6

60

1

Pulse Width 2

Spectral Filter None

DLB Presence No

LONG LAT 4000/3000

Then, set the following technics (and click Submit button) for measurement phase: Table 1-5 Exp.Mod e

Frame Rate

Focal Spot

kVp

mA peak

Fluoro

30

0.6

80

6.67

Pulse Width 10

Spectral Filter None

DLB Presence Yes

LONG LAT See Note below

NOTE Let current values to keep collimator settings. 6.

Make an exposure and measure exposure or exposure rate with no added filters. Record readings. This represents 100% transmission level.

7.

Place the standard absorber 46–173632G1 in beam with additional required filtration for systems manufactured On or After June 10th, 2006. Absorber must be on tabletop or in collimator accessory rails. Repeat exposure and record reading.

8.

Compute the ratio (Dose with absorber over dose without absorber). Check the Table 1-6 on page 19 for action. Table 1-6 System Manufacture Date Before June 10th, 2006

If Ratio Is:

Fixed Filtration Must Be:

0.5 or greater* Left as is. No Change.

2.5 mm Aluminum minimum Less than 0.5

Added (mandatory)**

On or After June 10th, 2006 0.5 or greater* Left as is. No Change. 2.9 mm Aluminum minimum Less than 0.5

Added (mandatory)**

NOTE *The 0.5 minimum ratio is mandatory. However, above 0.57, there will be a noticeable reduction in radiation and loss of radiographic contrast. For all Innova, Optima, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3 the 0.57 ratio value may be exceeded on purpose and reach up to 0.7. NOTE **For Rad and R & F systems utilizing the Siemens Collimator, filtration cannot be added. The collimator design does not support this: • Verify kVp Accuracy. • Verify test setup is correct. This is the most common error.

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Table 1-4

1.2 REG0065 - Beam Quality Test

Beam Quality Test

• Verify test equipment is functioning properly and within calibration. • Issues reside at the system level interactions. Detailed analysis must be performed to identify root cause of failure. Collimators with mirrors usually require no additional filtration but, on the other hand, excess filtration may not be removed. Filtration may only be removed if separate sheets were previously added. The required change in filtration may be estimated as 0.5 mm for each desired 0.05 change in ratio. For example, if the ratio is 0.48 the addition of 0.5 mm of aluminum will raise the ratio by approximately 0.05 to a new ratio of approximately 0.53. Re–test the system after adding filtration. Fixed filters must be Type 1100 aluminum and should be mounted between the tube unit and collimator whenever possible. If not possible (example: lead fingers of collimator interfere), mount elsewhere between source and patient, but use piece large enough to intercept entire beam, and mount permanently. A good mounting area in the Sentry Collimator is the back of the mirror. Use a good quality adhesive such as contact cement or epoxy. Since the filter will be at a 45 angle to the beam, use only about 0.7 of the thickness of aluminum that is calculated. Recheck HVL before mounting permanently (use tape for temporary mounting). Table 1-7 Mini-Troubleshooting Guide Problem

Possible Cause

HVL too high [>0.57] or [>0.7 (for Innova, Optima, Discovery™ IGS Systems and Allia™ IGS Systems and Allia™ IGS 3)]

kVp incorrect (high) Meter error – probe saturation, see REG0066 - Beam Quality Test Graphical Method on page 21. Excessive anode wear. Excessive filter in beam. For incorrect conditions of INNOVA 2000, check that spectral filtration has not been used in the X220 input. For incorrect conditions of Innova 2100-IQ/2121-IQ, Innova 3100/3100IQ/3131-IQ, Innova 4100/4100-IQ, Innova IGS 520, 530, 540, Innova™ IGS 5, Innova™ IGS 620, Innova™ IGS 630, Innova™ IGS 6, Discovery™ IGS systems, Allia™ IGS Systems and Allia™ IGS 3, Optima CL320i/CL323i, Optima IGS Plus, Optima IGS 320 and Optima IGS 330, check that the spectral filter has been set to 'None’.

HVL too low

kVp incorrect (low). Not enough filtration.

Acceptance Criteria for Vascular Systems (not applicable to Innova, Optima, Discovery IGS Systems and Allia IGS Systems and Allia™ IGS 3) 1.

If you have used a kVp meter RMI 230 or equivalent kVp–meter which allows 1 kVp accuracy, the DOSE RATIO measured for 80 kV must stand between the Min Ratio and the Max Ratio value according to the measured kVp value (refer to the following table). Table 1-8

2.

Measured kVp

75

76

77

78

79

80

81

82

83

84

85

Min Ratio

.519

.523

.526

.529

.533

.536

.540

.543

.546

.550

.553

Max Ratio

.545

.549

.552

.555

.559

.562

.566

.569

.572

.576

.579

If a 1 kVp accuracy kVp meter was not used, the acceptance criteria is: • CDRH REQT @ 80 KV: DOSE RATIO > 0.52

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• IMAGING REQT: DOSE RATIO < 0.57

Recording Data Record the data (apply any corrective factor if required and check final results are within acceptance criteria):

1

1.

The ratio of two readings using the standard absorber (after all fixed absorbers have been installed).

2.

The amount of fixed absorber added or removed from each source.

Beam Quality Test

Finalization No finalization steps.

1.3 REG0066 - Beam Quality Test - Graphical Method Table 1-9 Personnel requirements Required persons

Preliminary requirements

Procedure

Finalization

1

Not Applicable

Not Applicable

Not Applicable

Many Field Engineers have inquired about the graphical method of determining half value layer used by the FDA, and so we are presenting that method here. The graphical method will provide the actual value of the half value layer as opposed to the pass/fail result of the test shown earlier in this section. Either method is acceptable for our purposes. NOTE For Mammography see 46–017565 HHS MAMMOGRAPHY TESTS. The exposure rate at any given point is approximately a logarithmic function of the thickness of filtration in the X–Ray beam. Therefore, if exposure readings are taken with various thicknesses of added filtration in the beam, including zero added filtration, and the results are plotted on semi–log paper as a function of the added filtration, then the result will be a straight line. The point where this line crosses the 50% relative exposure level corresponds to the half value layer. In practice the exposure readings are normalized, (each reading is divided by the exposure with zero added filtration), before being plotted. In this way we plot relative exposure vs filter thickness.

Procedure 1.

Follow the standard set up procedure as described earlier in this section, and take exposure readings with zero, 1 mm, 2 mm, 3 mm, and 4 mm of added filtration. Take several exposures at each filter thickness and obtain an average exposure for each filter.

2.

Divide each reading by the exposure value obtained with zero added filtration. Express the results as percentages. The reading with zero added filtration then becomes 100%.

3.

Plot the data on semi–log paper, with the filter thickness being the standard axis and the relative exposure values being the logarithmic axis. (Refer to the following illustration for

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Beam Quality Test

example of a graph for half value layer.) You should be able to draw a straight line through the points. Figure 1-3

NOTE If you can’t draw a straight line that goes through the 100% point and comes within 2% or 3% of each of the other data points, then something changed during the course of the test. Check for stable kVp, mA, meter or probe saturation, good reproducibility, or a change in position of the probe.

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4.

1.3 REG0066 - Beam Quality Test - Graphical Method

Mark the point where the line of Step 3 crosses the 50% relative exposure line. Read the filter thickness corresponding to this line. This is your half value layer. NOTE You must have at least one data point on each side of the 50% relative exposure.

1 Beam Quality Test

Finalization No finalization steps.

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