Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Medrad™ Intego Vial Shield ReferenceThis document is not intended to replace the Medrad™ Intego Operation Manual. The Operation Manualshould be considered the main source of information on the system and should be read by a user beforeoperation.

NOTE: Radiation Shielding performance is achieved by using the vial shield designed by Bayer (or itsequivalent).

WARNING: Patient injury may result from using vials with other than a 20 mm diametercap. Use of vials other than a 20 mm diameter cap may create a particulate hazard.

WARNING: No modification of this equipment is allowed.

WARNING: Biological contamination may occur if aseptic techniques are not followed.Follow facility guidelines to disinfect the vial shield.

WARNING: Radiation Exposure Hazard. The Medrad™ Intego PET Infusion System Vial Shieldsmust be transported in a container that complies with applicable transportation regulations.

CAUTION: If using an absorbent disc, place no more than one disc in the vial shield beforeinstalling an RP vial. Additional absorbent discs may result in improper fit and potentialdamage to the vial.

CAUTION: If using an absorbent disc, do not expose the absorbent disc to cleaningsolutions or other fluids. Discard and replace the absorbent disc if it has been exposed to anyfluid. Failure to replace the absorbent disc that has been exposed to fluid may result inimproper fit and potential damage to the vial.

CAUTION: If using an absorbent disc, discard and replace the absorbent disc after each use.Failure to replace the absorbent disc may result in improper fit and damage the vial.

CAUTION: Do not place labels, tags, or other materials on the exterior of the vial shieldsurface. Application of labels, tags, or other materials may cause the vial shield to fitincorrectly in the needle insertion device and result in improper fit and functioning of the system.

CAUTION: Ensure that the needle insertion guide is clean and free of debris. Debris maycause the vial shield to fit incorrectly in the needle insertion device and result in improper fitand functioning of the system.

NOTE: Table 1 represents the vials and compatible vial shiels for use with the Medrad™ Intego PETInfusion System. For additional vials not specified in this table, please contact Bayer Service.

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

3017469 Silver 8.6 kg 30-35 mL 30H 36 ± 0.5 mm 62.8 ± 0.7 mm 20 mm3038383 (18 lbs) (1.417 ± 0.020") (2.472 ± 0.027") (0.787")

3025071 Blue 8.6 kg 20-25 mL 20R 30 ± 0.25 mm 55 ± 0.7 mm 20 mm3038384 (18 lbs) (1.181 ± 0.009") (2.165 ± 0.027") (0.787")

3027139 Gold 8.6 kg 20-25 mL 20H 32 ± 0.45 mm 58 ± 0.6 mm 20 mm3038385 (18 lbs) (1.259 ± 0.017") (2.285 ± 0.023") (0.787")

3025939 Green 8.6 kg 10-15 mL 10R 24 ± 0.2 mm 45 ± 0.5 mm 20 mm3038382 (18 lbs) (0.944 ± 0.007") (1.771 ± 0.020") (0.787")

3025040 Brown 8.6 kg 10-15 mL 15R 24 ± 0.25 mm 60 ± 0.5 mm 20 mm3038386 (18 lbs) (0.944 ± 0.009") (2.362 ± 0.020") (0.787")

25 ± 0.25 mm----- (0.984 ± 0.009")

3028305 Black 8.6 kg 10-15 mL 10H 25.4 ± 0.4 mm 53.5 ± 0.5 mm 20 mm3038387 (18 lbs) (1.944 ± 0.009") (2.106 ± 0.020") (0.787")

25.5 ± 0.25 mm----- (1.003 ± 0.009")

21.25 ± 0.2 mm 51 ± 0.5 mm(0.837 ± 0.007") (2.008 ± 0.020")

3037589 Violet 8.6 kg 10 mL -----21.75 ± 0.25 mm 52 ± 0.5 mm

20 mm(18 lbs)

(0.856 ± 0.009") (2.047 ± 0.020")(0.787")

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 1: Vial Shield and Vial Specifications - Summary

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 2: Vial Shield and Vial Specifications - Silver

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

3017469 Silver 8.6 kg 30-35 mL 30H 36 ± 0.5 mm 62.8 ± 0.7 mm 20 mm3038383 (18 lbs) (1.417 ± 0.020") (2.472 ± 0.027") (0.787")

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 3: Vial Shield and Vial Specifications - Blue

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

3025071 Blue 8.6 kg 20-25 mL 20R 30 ± 0.25 mm 55 ± 0.7 mm 20 mm3038384 (18 lbs) (1.181 ± 0.009") (2.165 ± 0.027") (0.787")

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 4: Vial Shield and Vial Specifications - Gold

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

3027139 Gold 8.6 kg 20-25 mL 20H 32 ± 0.45 mm 58 ± 0.6 mm 20 mm3038385 (18 lbs) (1.259 ± 0.017") (2.283 ± 0.023") (0.787")

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 5: Vial Shield and Vial Specifications - Green

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

3025939 Green 8.6 kg 10-15 mL 10R 24 ± 0.2 mm 45 ± 0.5 mm 20 mm3038382 (18 lbs) (0.944 ± 0.007") (1.771 ± 0.020") (0.787")

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 6: Vial Shield and Vial Specifications - Brown

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

3025940 Brown 8.6 kg 10-15 mL 15R 24 ± 0.25 mm 60 ± 0.5 mm 20 mm3038386 (18 lbs) (0.944 ± 0.009") (2.362 ± 0.020") (0.787")

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 7: Vial Shield and Vial Specifications - Black

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

25 ± 0.25 mm----- (0.984 ± 0.009")

3028305 Black 8.6 kg 10-15 mL 10H 25.4 ± 0.4 mm 53.5 ± 0.5 mm 20 mm3038387 (18 lbs) (1.944 ± 0.009") (2.106 ± 0.020") (0.787")

25.5 ± 0.25 mm----- (1.003 ± 0.009")

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Bayer reserves the right to modify the specifications and features described herein, or discontinuemanufacture of the product described at any time without prior notice or obligation. Please contactyour authorized Bayer HealthCare representative for the most current information.

Bayer, the Bayer Cross, and Medrad™ are trademarks of the Bayer group of companies.

© 2014 Bayer

Bus-MI-14-06284 March 2014

Table 8: Vial Shield and Vial Specifications - Violet

Source: Medrad™ Intego PET Infusion System operator manual – Appendix D

Vial Shield Vial(s)

Bayer Part Collar Weight Volume ISO 8362- Body Diameter Glass Height CapNumber Color Range 1:2003 Diameter

ISO 8362-4:2003 SizeSpecification

21.25 ± 0.2 mm 51 ± 0.5 mm(0.837 ± 0.007") (2.008 ± 0.020")

3037589 Violet 8.6 kg 10 mL -----21.75 ± 0.25 mm 52 ± 0.5 mm

20 mm(18 lbs)

(0.856 ± 0.009") (2.047 ± 0.020")(0.787")