Bayer HealthCare MEDRAD SCT 110, Operation And Installation Manual

Page: 7 / 30

1
Introduction The MEDRAD
®
Stellant Imaging System Interface (ISI) 700 Module (Catalog Number: ISI 700)
is an option that allows an injector from Bayer to interface with a CT scanner. It obtains its
power from a hospital grade wall outlet. It interacts with an injector and scanner through direct
cable connection. Once the ISI module is installed and configured on the injector, it allows the
scanner and injector to interact with each other and provide functionality as outlined in this
manual.
Read all the information contained in this manual. Understanding this information will assist
you in operating the ISI module option in a safe manner.
Installation Contact Bayer for Installation information.
Certifications This device is equipped to operate at 100-120 / 200-240 VAC, 50/60 Hz, 40 VA, and is
designed to comply with IEC 60601-1 (2nd and 3rd Edition Amendment 1) and IEC 60601-1-2
(2nd, 3rd, 4th Edition) standards, including national differences. Special precautions regarding
Electro-magnetic Compatibility (EMC) are required for installation and use of this injection
system. Detailed EMC information can be found in Appendix A of this manual.
Indications For Use The ISI module option is indicated for the specific purpose of allowing an injector to interface
with a CT scanner.
Contraindications The ISI module is not to be used for any other use for which the device is not indicated. This
device is not to be used for drug infusion, chemotherapy, or any other use for which the device
is not indicated. The ISI module is not intended for portable use.
Restricted Sale Federal (USA) law restricts these devices for sale except by or on the order of a physician.
Disclaimers External wiring and modifications disclaimers: Bayer disclaims liability for any modifications to
this product or interfaces with other equipment that are not in conformity with the specifications
and information contained within this manual.
Anyone who connects additional equipment to the device or configures a medical system is
responsible that the system complies with the relevant requirements of IEC 60601-1. Any
accessory or equipment connected to the device must be certified to either IEC 60601-1
(Operator or Patient Environment Use) or, outside the patient environment, the level of safety
must be equivalent to equipment complying with their respective IEC or ISO safety standards,
e.g. IEC 62368-1 or IEC 60950-1 (Operator Environment Use Only), and must comply with the
relevant requirements according to IEC 60601-1. Consult with Bayer for any modifications to
the equipment.
Screen images in this manual are for illustration purposes only. Actual screens may vary.