Introduction; Installation; Important Safety Notice; Indications For Use - Bayer HealthCare MEDRAD 800 Module Operation & Installation Manual

Installation

Important Safety
Notice

Indications For Use

Certifications

Contraindications

Restricted Sale

Disclaimers

MEDRAD

1 - Introduction

This manual contains important information about use of the MEDRAD
Stellant Imaging System Interface (ISI) 800 Module (Catalog Number: ISI
800).
Read all the information contained in this manual. Understanding this
information will assist the user in safely operating the System.
Contact Bayer for Installation information.
The ISI 800 Module 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 800 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. The ISI 800 Module supports the Class 1 standard of
the CAN Open for add-on Medical Devices.
The ISI 800 Module option is indicated for the specific purpose of allowing an
injector to interface with a CT scanner.
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, and 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.
None.
Federal (USA) law restricts these devices for sale except by or on the order of
a physician.
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 Bayer for any modifications to the equipment.
Screen images in this manual are for illustration purposes only. Actual
screens may vary.
®
Stellant ISI 800 Module Operation Manual
3
®