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Varex Imaging nexus DR Safety Manual

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Regulatory and Safety Manual
736-226-G1, Rev. J

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Summary of Contents for Varex Imaging nexus DR

  • Page 1 Regulatory and Safety Manual 736-226-G1, Rev. J...
  • Page 2 Regulatory and Safety Manual 2 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...
  • Page 3 ©2016, 2024, Varex Imaging Corporation (121 Metropolitan Drive, Liverpool, NY 13088. All rights reserved.) Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 3...
  • Page 4 Welcome Varex Imaging Corporation, headquartered in Salt Lake City, Utah, is a premier supplier of tubes, digital detectors, and workstations for X-ray imaging in medical, scientific, and industrial applications and also supplies X-ray imaging products for cargo screening and industrial inspection.

  • Page 5: Table Of Contents

    Information symbols........................14 Product and equipment classification..................15 Safety information........................15 Warranty Information........................21 CHAPTER 5 Power and Environmental Specifications..........23 Power requirements........................24 Environmental specifications..................... 24 Electromagnetic compatibility....................25 Index............................33 Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | v...
  • Page 6 Table 12: Electromagnetic Immunity — All equipment & systems not life-supporting............29 Table 13: Emissions — All equipment and systems not life-supporting.................. 30 Table 14: Separation — Equipment not life-supporting......................31 vi | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...
  • Page 7 IT/software terminology. Each translated item that Varex commissions is based on the original English version release created by Varex. At times, a translated manual may not be the same revision as its English counterpart. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | vii...

  • Page 8: Table 1: Revision History

    About this documentation Note: For the purposes of clarity, the imaging system is also referenced as Nexus DR throughout this manual and other product-related documentation. Revision history The following table shows when this document has been revised and a description of the major updates for each revision.
  • Page 9 (eIFU) information was added to the Information symbols topic; in Chapter 5, the following topics were updated: Electromagnetic compatibility; Emissions, immunity, and separation distances; and Guidance and manufacturer's declaration. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | ix...

  • Page 10: Chapter 1 Regulatory Information

    Chapter Regulatory Information Topics: • on page 2 Regulations • on page 3 HIPAA Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 1...

  • Page 11: Regulations

    Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1020.10. Any optical disk storage devices (reader and writer) comply with Radiation Performance Standards of 21 CFR Subchapter J, applicable Section 21 CFR 1040.10. 2 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 12: Hipaa

    Clinical Mode. HIPPA Audit Control Standards are used in the Settings Mode logs to record user actions. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 3...
  • Page 13 1. Regulatory Information 4 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 14: Chapter 2 Statement Of Intended Use

    6 Intended anatomy • Intended user profile on page 6 • on page 7 Intended conditions for use, storage, or transportation • on page 7 Operating principle Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 5...

  • Page 15: Statement Of Intended Use

    Intended patient population Because Nexus DR relies on ionizing radiation to generate images, it is not recommended for use on patients who are or may be pregnant. Nexus DR is approved for use on all other patients. When imaging pediatric patients, Varex provides the following recommendations: •...

  • Page 16: Intended Conditions For Use, Storage, Or Transportation

    X-ray beam. A host X-ray system generates the X-ray beam, which passes through a patient and strikes the detector the Nexus DR digital imaging system. The detector converts the X-ray energy to digital image data that is then passed to the Nexus DR digital imaging system computer.
  • Page 17 2. Statement of Intended Use 8 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 18: Chapter 3 Cleaning Practices

    Cleaning Practices Topics: • on page 10 Approved disinfection agents • on page 10 Cleaning cautions • on page 11 Best practices for removing dust from fans and heat sinks Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 9...

  • Page 19: Approved Disinfection Agents

    It is important to use the proper cleaning practices when maintaining the system to avoid damaging the equipment. The Nexus DR digital X-ray imaging system is designed and suitable for use in typical clinical environments. During use, protect the system, all peripherals, and the detector from fluids. The system should not require disinfection beyond routine cleaning as part of preventive maintenance of the equipment.

  • Page 20: Best Practices For Removing Dust From Fans And Heat Sinks

    Even in a clinical environment, dust and other contaminants accumulate around fans and heat sinks inside the Varex imaging system computer. Special attention must be paid to these areas so that the airflow that cools the electronics can pass freely through the computer case and heat sinks.
  • Page 21 3. Cleaning Practices 12 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 22: Chapter 4 Safety And Warranty Information

    Safety and Warranty Information Topics: • on page 14 Information symbols • on page 15 Product and equipment classification • on page 15 Safety information • Warranty Information on page 21 Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 13...

  • Page 23: Information Symbols

    4. Safety and Warranty Information Information symbols Informational symbols are used in Nexus DR documentation and on some labeling. Table 2: Informative markings: Documents and equipment Symbol Title/Meaning Notice. An important aspect of Varex imaging system operation is presented. Caution.

  • Page 24: Product And Equipment Classification

    Authorized representative in Switzerland. Electronic instructions for use (eIFU). Product and equipment classification The Varex imaging system has been evaluated by a duly-authorized regulatory body and is classified as follows: Table 3: Product and equipment classification Protection against electric shock...
  • Page 25 Warning: Internal power supplies contain capacitors that may remain charged for a period of time after source power is removed. Before performing work inside any system component enclosure, allow at 16 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...
  • Page 26 Use only those cables provided or specifically approved by Varex. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 17...
  • Page 27 Only authorized and trained personnel may access patient records stored on the Nexus DR system or use Nexus DR for clinical imaging of patients. Proper operation and care are critical to maintaining system performance and optimal image quality. On-site training is available and may be scheduled by contacting Varex.
  • Page 28 Consult site documentation or personnel to determine the presence of and hazards posed by gases in the vicinity of the system. Do not open the receptor module as it may expose you to toxic materials. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 19...
  • Page 29 DANGER: The system must not be powered up or used in the presence of a flammable or explosive atmosphere, including certain gases used for anesthesia. Electric motors and other electrical 20 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 30: Warranty Information

    If damage to packaging or contents is apparent, contact Varex immediately. Do not proceed with installation or service if any component or cable is missing or damaged. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 21...
  • Page 31 Installation, maintenance, or service of by untrained or unauthorized personnel may void the product warranty, result in additional service or support charges, or both. Evidence of training must be provided on request. 22 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 32: Chapter 5 Power And Environmental Specifications

    Chapter Power and Environmental Specifications Topics: • on page 24 Power requirements • on page 24 Environmental specifications • on page 25 Electromagnetic compatibility Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 23...

  • Page 33: Power Requirements

    All system components are expected to be powered from the same dedicated circuit. Dedicated is defined as having no other branch circuits, providing power only to the Nexus DR components, and being supplied directly from a breaker in the local AC distribution panel.

  • Page 34: Electromagnetic Compatibility

    30 cm (12 inches) to any part of the MODEL OR TYPE REFERENCE of the ME EQUIPMENT or ME SYSTEM, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 25...

  • Page 35: Table 7: Emissions - Nexus Dr Equipment And Systems

    Differential ± 0,5 Differential ± 0,5 environment. kV, ± 1 kV, ± 2 kV kV, ± 1 kV, ± 2 kV Common Common 26 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 36: Table 9: Emissions - All Equipment And Systems Not Life-Supporting

    80 % AM at 1 kHz should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 27...

  • Page 37: Table 10: Separation - Equipment Not Life-Supporting

    Nexus DR is suitable for use in all establishments other 61000-3-2 than domestic and those directly connected to public low- voltage power supply network that supplies buildings used for Flicker IEC 61000-3-3 Dmax = 4 % domestic purposes. 28 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 38: Table 12: Electromagnetic Immunity - All Equipment & Systems Not Life-Supporting

    0° at 0° Power frequency 50/60 30A/m Power frequency magnetic 30A/m Hz magnetic field EN/ fields should be that of a IEC 61000-4-8 typical commercial or hospital environment. Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 29...

  • Page 39: Table 13: Emissions - All Equipment And Systems Not Life-Supporting

    Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter. 30 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 40: Table 14: Separation - Equipment Not Life-Supporting

    800 MHz to 2.7 GHz Max output power (watts) D=(3.5/V1)(√P) D=(3.5/E1)(√P) D=(7/E1)(√P) 0.01 0.11667 0.11667 0.23333 0.36894 0.36894 0.73785 1.1667 1.1667 2.3333 3.6894 3.6894 7.3785 100. 11.667 11.667 23.3333 Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 31...
  • Page 41 5. Power and Environmental Specifications 32 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...

  • Page 42: Index

    15, 16, 16, 18, 18, 18, 19, inspect components service precautions intended patient population software precautions intended use statement Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J | 33...
  • Page 43 Index specifications electromagnetic compatibility Statement of Intended Use symbols informational trademarks training installation and service translated material user profile intended warranty information installation and service training Welcome 34 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J...
  • Page 44 Index , , | 35...

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