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

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Introduction

This manual applies to the MEDRAD
(Stellant with Certegra Workstation), also referred to as the system throughout this document, System
Catalog Numbers: SCT-310, SCT-321, SCT-322. Read all the information contained in this manual.
Understanding this information will assist users in operating the Stellant with Certegra Workstation in a
safe manner.

1.1 Certifications

This device is equipped to operate at 100-240 VAC, 50/60 Hz, 180 VA (Single), 300 VA (Dual), 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 "Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions" of this
manual.

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
purpose of injecting intravenous contrast media 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.
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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.
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Stellant CT Injection System with Certegra
Stellant CT Injection System with Certegra
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Workstation is indicated for the specific
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Workstation
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