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Contents

Contents

CHAPTER 1 Regulatory Information..............................................................................1

..................................................................................................................................... 2

HIPAA

...............................................................................................................................................3

CHAPTER 2 Statement of Intended Use.......................................................................5

Statement of intended use

.......................................................................................................... 6

Intended patient population

......................................................................................................... 6

Intended anatomy

..........................................................................................................................6

Intended user profile

..................................................................................................................... 6

Intended conditions for use, storage, or transportation

.......................................................... 7

Operating principle

........................................................................................................................ 7

CHAPTER 3 Cleaning Practices....................................................................................9

Approved disinfection agents

.................................................................................................... 10

Cleaning cautions

........................................................................................................................ 10

Best practices for removing dust from fans and heat sinks

................................................. 11

CHAPTER 4 Safety and Warranty Information............................................................ 13

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

Содержание nexus DR

Страница 1: ...Regulatory and Safety Manual 736 226 G1 Rev J...

Страница 2: ...Regulatory and Safety Manual 2 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...

Страница 4: ...r X ray imaging in medical scientific and industrial applications and also supplies X ray imaging products for cargo screening and industrial inspection Our products are built on an open platform that...

Страница 5: ...R 3 Cleaning Practices 9 Approved disinfection agents 10 Cleaning cautions 10 Best practices for removing dust from fans and heat sinks 11 CHAPTER 4 Safety and Warranty Information 13 Information symb...

Страница 6: ...quipment and systems 26 Table 8 Electromagnetic Immunity All equipment and systems not life supporting 26 Table 9 Emissions All equipment and systems not life supporting 27 Table 10 Separation Equipme...

Страница 7: ...oration in the United States and other countries Excel is a product of Microsoft Pleora is a brand and trade name of Pleora Technologies Inc Kanata Ontario Canada Optiplex and the Dell logo are regist...

Страница 8: ...front and back covers Added warnings and cautions for electromagnetic emissions immunity and separation distances D 2020 02 03 EC 00000271 Updated copyright EU representative CE mark and detector clea...

Страница 9: ...02 16 EC 0007571 The electronic instructions for use eIFU information was added to the Information symbols topic in Chapter 5 the following topics were updated Electromagnetic compatibility Emissions...

Страница 10: ...Chapter 1 Regulatory Information Topics Regulations on page 2 HIPAA on page 3 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J 1...

Страница 11: ...roup com Swiss Authorized Representative Arazy Group Swiss GmbH Bruderholzallee 53 4059 Basel Schweiz swiss ar arazygroup com Australian Sponsor Emergo Asia Pacific Pty Ltd 201 Sussex Street Darling P...

Страница 12: ...HIPAA HIPAA logging Varex Imaging Corporation support HIPAA Access Control Standards Unique user identification and automatic logoff are implemented through user configuration and the login logoff fe...

Страница 13: ...1 Regulatory Information 4 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...

Страница 14: ...d use on page 6 Intended patient population on page 6 Intended anatomy on page 6 Intended user profile on page 6 Intended conditions for use storage or transportation on page 7 Operating principle on...

Страница 15: ...poses of clarity the imaging system is also referenced as Nexus DR throughout this manual and other product related documentation Warning Do not modify this equipment without authorization from Nexus...

Страница 16: ...ex imaging system is to synchronize the image acquisition of the digital receptor with the X ray beam of the host X ray system to capture display and archive quality images of the intended anatomy wit...

Страница 17: ...2 Statement of Intended Use 8 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...

Страница 18: ...ing Practices Topics Approved disinfection agents on page 10 Cleaning cautions on page 10 Best practices for removing dust from fans and heat sinks on page 11 Nexus DR Regulatory and Safety Manual 736...

Страница 19: ...an Approved disinfection agents Use a hospital grade EPA registered agent classified as a low or intermediate level product for hard non porous surfaces and equipment CaviWipes is an example of this t...

Страница 20: ...e typically very dry and can be blown clean with compressed air available at most retail stores that sell electronics Observing ESD precautions use the compressed air to carefully remove all dust hair...

Страница 21: ...3 Cleaning Practices 12 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...

Страница 22: ...ranty Information Topics Information symbols on page 14 Product and equipment classification on page 15 Safety information on page 15 Warranty Information on page 21 Nexus DR Regulatory and Safety Man...

Страница 23: ...r is displayed with this symbol The procedure requires making X ray exposures and producing radiation Follow safety precautions when operating the X ray system Earthing terminal Grounding terminal War...

Страница 24: ...associated with the use of the X ray system General precautions All information and instructions contained in this document are intended to promote safe and effective installation service and maintena...

Страница 25: ...hat all mounting and fastening hardware is tightened properly and that all securing mechanisms on connectors and covers are properly latched Inspect all cabling mounting and securing mechanisms during...

Страница 26: ...d or marked as medical grade The Isolation Transformer is intended to electrically isolate components of the system from all other equipment on the site s AC supply circuits DO NOT connect any device...

Страница 27: ...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 traini...

Страница 28: ...uipment is in use DO NOT bypass or otherwise disable safety mechanisms provided by the X ray generator Take all available and appropriate measures to prevent unnecessary or unintentional radiation exp...

Страница 29: ...e appropriate measures to prevent the spilling of liquids or bodily fluids on or into the components of the Varex system Observe all cautions and warnings in the product manuals Failure to abide by th...

Страница 30: ...use abuse or misuse of the equipment regardless of intention Use of the equipment for purposes other than those for which it was designed See Statement of intended use on page 6 Use of the hardware or...

Страница 31: ...that appear on the packaging Allow all equipment to acclimate to the operational environment Flat panel detectors often require time to acclimate to the environment Check the manual shipped with the...

Страница 32: ...wer and Environmental Specifications Topics Power requirements on page 24 Environmental specifications on page 24 Electromagnetic compatibility on page 25 Nexus DR Regulatory and Safety Manual 736 226...

Страница 33: ...power to system components The following requirements must also be satisfied Peak impulse levels line to neutral must not exceed 100V peak above nominal voltage peak time interval 2ms or less The neu...

Страница 34: ...istance between portable and mobile RF communications equipment and the system as recommended below according to the maximum output power of the communications equipment The system has been tested for...

Страница 35: ...unlikely to cause any interference in nearby electronic equipment Harmonics IEC 61000 3 2 Class A Flicker IEC 61000 3 3 Dmax 4 Nexus DR is suitable for use in all establishments other than domestic a...

Страница 36: ...commercial or hospital environment Proximity Magnetic Fields IEC 61000 4 39 134 2 kHz at 65 A m 13 56 MHz at 7 5 A m 134 2 kHz at 65 A m 13 56 MHz at 7 5 A m RFID equipment should be used no closer t...

Страница 37: ...0 to 800 MHz D 3 5 E1 P Separation m 800 MHz to 2 7 GHz D 7 E1 P 0 01 0 11667 0 11667 0 23333 0 1 0 36894 0 36894 0 73785 1 1 1667 1 1667 2 3333 10 3 6894 3 6894 7 3785 100 11 667 11 667 23 3333 Guida...

Страница 38: ...1 kV 2 kV Common Mains power quality should be that of a typical commercial or hospital environment Voltage dips dropout EN IEC 61000 4 11 0 Dip 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 Dip 1 cy...

Страница 39: ...nces calculated or listed in the following table Warning Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12...

Страница 40: ...ax output power watts Separation m 150 kHz to 80 MHz D 3 5 V1 P Separation m 80 to 800 MHz D 3 5 E1 P Separation m 800 MHz to 2 7 GHz D 7 E1 P 0 01 0 11667 0 11667 0 23333 0 1 0 36894 0 36894 0 73785...

Страница 41: ...5 Power and Environmental Specifications 32 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...

Страница 42: ...ove dust 11 I information symbols 14 informative markings 14 installation inspect components 21 intended patient population 6 intended use statement 6 Introduction iv L labels symbols 14 M maintenance...

Страница 43: ...nded Use 6 symbols informational 14 T trademarks vii training installation and service 22 translated material vii U user profile intended 6 W warranty information 21 installation and service training...

Страница 44: ...Index 35...

Страница 45: ......

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