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1 - Introduction
1 - Introduction
Certifications The Intego™ PET Infusion System is equipped to operate at 100-240 VAC, 50/60Hz. Power
consumption is 250 VA for the INT SYS 100 and 300 VA for the INT SYS 200. The INT SYS
100 complies with EN/IEC 60601-1, 2nd Edition. The INT SYS 200 complies with EN/IEC
60601-1, 2nd and 3rd Editions.
Intended Use The Intego™ PET Infusion System is intended to deliver accurate doses of
18
F-
Fluorodeoxyglucose (
18
F-FDG) or
18
F-Sodium Fluoride (
18
F-NaF) radiopharmaceuticals and
commonly used flushing solutions to patients during molecular imaging (nuclear medicine)
diagnostic procedures. The Intego™ PET Infusion System is also intended to provide effective
radiation shielding to medical personnel from Fluorine-18 (
18
F) radiation exposure during
nuclear medicine diagnostic procedures.
Indications for Use The Intego™ PET Infusion System is indicated for the administration of
18
F-FDG,
18
F-NaF, and
commonly used flushing solutions to patients during molecular imaging (nuclear medicine)
procedures.
NOTE: The Intego™ PET Infusion System is intended for use with
18
F-FDG or
18
F-NaF.
Intego™ PET Infusion System disposables intended for use with
18
F-FDG may
be used to deliver
18
F-FDG or
18
F-NaF. Please contact MEDRAD for more
information.
Restricted Sale The United States Food and Drug Administration (FDA) restricts sale of this system to
physicians or those with written authorization from a physician.
Trademarks MEDRAD and Intego are trademarks of MEDRAD, INC. Unless otherwise indicated, all
trademarks are owned by MEDRAD, INC. Other trademarks that appear in this manual are the
property of their respective companies.
Disclaimers External wiring and modifications disclaimers: MEDRAD disclaims liability for any modifications
or interfaces with other equipment that are not in conformity with the specifications and
information contained within this manual.
Accessory equipment connected to the Intego™ PET Infusion System must be certified
according to IEC 60601-1 standard. Furthermore, all configurations shall comply with system
standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input or
output port configures a medical system and is therefore responsible to ensure that the
Intego™ PET Infusion System complies with the requirements of the standard IEC 60601-1-1.
To obtain on-site consulting or consulting references, contact MEDRAD.
This manual applies to the Intego™ PET Infusion System, Catalog Numbers INT SYS 200 and
INT SYS 100. Read all the information contained in this manual. Understanding this
information assists in operating the Intego™ PET Infusion System in a safe manner.
Required Training This device is intended to be used by individuals with training and experience in nuclear
imaging studies.
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