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Appendix B - Specifications
Protection Against the Ingress of Fluids
Per IEC 60529, the Intego™ PET Infusion System has been classified as drip proof. This is
indicated by the IPX1 designation.
Mode of Operation
Per EN60601-1, the mode of operation for the Intego™ PET Infusion System is continuous
operation. The system is capable of operation under normal load for an unlimited period,
without excessive temperature being developed.
Fluid Delivery
Ground continuity < 0.2 Ohms Measured from power cable
ground terminal to the system
power and grounding points. See
note below.
NOTE: Per IEC 60601-1, the Intego™ PET Infusion System is designated as a Class 1
medical device with a type BF applied part.
Nominal Value Notes
RP Vial
Maximum vial activity for
shielding effectiveness
27.8 GBq (750 mCi) ---
Maximum vial activity for dose
preparation
25.9 GBq (700 mCi) System will not move fluid if vial
activity exceeds this level.
Maximum RP vial volume 30 ml 30H vial. See note below.
Unextractable RP volume 0.64 ml 30H vial
Patient doses/vial 11 Based on 25.9 GBq (700 mCi) in
vial, 555 MBq (15 mCi) patient
doses and 30 minute interval
between doses.
NOTE: A wide variety of vials from 10 ml to 30 ml are compatible with the system, with use
of one of six different Vial Shields. See the "Appendix D - Vials and Vial Shields."
Concentration
Maximum RP concentration 3.7 GBq/ml (100 mCi/ml) ---
Minimum RP concentration 12.3 MBq/ml (0.33 mCi/ml) ---
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