Introduction; Certifications; Intended Patient Population; Indications For Use - Bayer HealthCare CERTEGRA MEDRAD Stellant FLEX Operation Manual

Operation Manual
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Introduction

This manual applies to the MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Stellant FLEX
with Certegra Workstation), also referred to as the system throughout this document, Catalog Numbers: FLEX. Read
all the information contained in this manual. Understanding this information will assist users in operating the
Stellant FLEX with Certegra Workstation in a safe manner.
NOTE: Operating specifications, options, accessories, and feature availability may vary by country. Check
with a local product representative for Bayer and country-specific operating instructions.

1.1 Certifications

This device is equipped to operate at 100-240 VAC, 50/60 Hz, 300 VA and is designed to comply with IEC 60601-1
rd
(3 Edition Amendment 1) and IEC 60601-1-2 (3
Special precautions regarding Electro-magnetic Compatibility (EMC) are required for installation and use of this
injection system. Detailed EMC information can be found in
and 4th Editions.

1.2 Intended Patient Population

This device is intended for use on the general patient population. Patient physiology and institutional guidelines
should be considered when selecting catheter sizes and injection protocol parameters.

1.3 Indications For Use

The MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation, including Stellant FLEX CT Syringe Kits
and Connector Tubing, is indicated for the specific purpose of injecting intravenous contrast media or saline into
humans for diagnostic studies in computed tomography (CT) applications.

1.4 Contraindications

None known.

1.5 Restricted Sales

Federal (USA) law restricts these devices to sale by or on the order of a physician.

1.6 Required Training

The device is intended to be used by trained personnel with experience in diagnostic imaging studies.

1.7 Disclaimers

External wiring and modifications disclaimers: Bayer disclaims liability for any modifications 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.
rd th
and 4 Edition) standards, including national differences.
18 - Addendum – Compliance to IEC 60601-1-2: 3rd
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