Safety and Related Information

Safety and Health Compliance

This equipment has been tested for and complies with the following Safety and Emissions Standards. Certificates of Compliance and Declarations of Conformity have been issued as shown below.

Safety

United States

21 CFR 900.12(e) Mammography Quality Standards Act; Quality Standards; Quality Assurance for Equipment.

21 CFR 1040.10 Class I

Code of Federal Regulations Title 21 Food and Drugs

Chapter I Food and Drug Administration, Department of Health and

Human Services

Volume 8 - Parts 800 to 1299

Subchapter J - Radiology Health

Part 1040 - Performance Standards for Light Emitting Products

Section 10 - Laser Products

FDA 21CFR 807 Premarket Notification 510(K): Regulatory Requirements

For Medical Devices.

UL 60950-1: Safety of Information Technology Equipment, including

Electrical Business Equipment (Bi-National Standard).

IEC 60601-1-1: Medical electrical equipment - Part 1: General

requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems, Clause 19.

IEC 60825-1: Safety of laser products - Part 1 : Equipment classification, requirements and user’s guide.

Canada

CAN/CSA - C22.2 NO 60950-1-03 Information Technology Equipment -

Safety - Part 1: General Requirements. (Bi-National Standard, with

UL 60950-1).

IEC 60601-1-1: Medical electrical equipment - Part 1: General

requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems, Clause 19.

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Kodak DryView 8900 manual Safety and Health Compliance, Canada

DryView 8900 specifications

The Kodak DryView 8900 is a state-of-the-art dry imaging system that revolutionizes medical imaging with its advanced technology and unparalleled performance. Designed primarily for the healthcare sector, this system delivers high-quality printed images for various diagnostic applications, making it an essential tool for hospitals, clinics, and imaging centers.

One of the standout features of the Kodak DryView 8900 is its exceptional image quality. The system utilizes advanced imaging algorithms and high-resolution printing capabilities to produce crisp, clear images that facilitate accurate diagnosis and enhanced patient care. This high fidelity is crucial in fields such as radiology, mammography, and other imaging modalities where precision is paramount.

Incorporating thermal imaging technology, the DryView 8900 eliminates the need for traditional wet processing chemicals, which is not only environmentally friendly but also simplifies the workflow in medical facilities. This dry imaging process results in faster turnaround times for print production, allowing clinicians quick access to essential imaging data.

The DryView 8900 also boasts a user-friendly interface, designed with healthcare professionals in mind. Its intuitive controls and straightforward operation minimize the learning curve, enabling users to navigate the system efficiently. Moreover, the printer supports a variety of film sizes and formats, providing flexibility to meet the diverse needs of medical imaging departments.

Another impressive characteristic of the Kodak DryView 8900 is its durability and reliability. Built with robust components, the system is designed to handle the rigorous demands of a busy clinical environment. Regular maintenance and servicing are streamlined, helping to maintain optimal performance and reduce downtime.

Additionally, the Kodak DryView 8900 incorporates connectivity options that allow seamless integration with existing imaging systems and PACS (Picture Archiving and Communication Systems). This connectivity ensures that the DryView 8900 can receive high-quality images directly from modalities, enhancing the overall efficiency of the imaging process.

In summary, the Kodak DryView 8900 is a cutting-edge imaging solution that combines remarkable image quality, user-friendly design, and reliable performance. With its dry imaging technology, broad compatibility, and environmental considerations, this system stands out as a vital asset in today’s medical imaging landscape, driving advancements in healthcare delivery and patient outcomes.