operator manual - brivo xr285amx

GE Healthcare

0459

Brivo XR285amxX-Ray System

Operator Manual

5400233-1ENRevision: 4GE does business as GE Healthcare

Brivo XR285amx

Operator Manual, English

5400233-1EN

Revision: 4© 2010 General Electric CompanyAll rights reserved.

5400233-1EN Rev 4 Brivo XR285amx TOC-1

Table of Contents

i Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .i-1

IMPORTANT!...X-RAY PROTECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-2

Medical Device Directive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-3

Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-4

Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i-5

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Manual Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Graphic Conventions and Legends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Software User Interface Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

2 Safety and Regulatory . . . . . . . . . . . . . . . . . . . . . . . . 2-1

X-Ray Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

FCC Statement of Conformance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Pediatric Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Pediatric Imaging Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Pediatric Imaging Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12Good Operating Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Know the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13IEC Equipment Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Radiation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14


Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Monitoring of Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Emergency Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Safe Operation Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18General Use Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18Patient Positioning Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19Pinch Points and Crush Hazard Summary . . . . . . . . . . . . . . . . . . . . . . . 2-19

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21Special Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21X-ray Tube Operational Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21System Power On and Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22Electrical Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22Electrical Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23Ground . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23Collimator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Identification and Compliance Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26Identification Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26NRTL Listed Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26Identification and Compliance Plate Locations . . . . . . . . . . . . . . . . . . . . 2-27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

System Identification Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28Standard Identification Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33X-Ray Tube Identification Plates . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36Collimator Identification Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36

Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37Disposal of Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38Pollution Control Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

Dose Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

3 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Quick Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2Productivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

4 Moving and Positioning . . . . . . . . . . . . . . . . . . . . . . 4-1

Turn Unit On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Unlock The Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3


Drive the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Position the Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8Mechanical Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Latch Lock Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8Adjust Column and Telescoping Arm . . . . . . . . . . . . . . . . . . . . . . . . . 4-8Rotate the Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9Adjust the Collimator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

5 Charging the System Batteries . . . . . . . . . . . . . . . . 5-1

Important Points To Remember . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3Emergency Capacity Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Recharge Recommended . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

System Battery Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

How to Re-Charge Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Main Power Circuit Breaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

6 Quick Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Hardware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Hand-switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Adjust the Tube Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2Rotate the Multi-Leaf Collimator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

Logon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Standard Logon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Invalid Password Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3Emergency Logon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

General Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

7 System Hardware Overview . . . . . . . . . . . . . . . . . . . 7-1

Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

Unit Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Hand Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7


8 Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

System Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

9 Image Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

Patient Dose Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4

Conduct an Exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

10 Set Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

Accessing Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2

System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3System Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3Drive Logon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4Dose Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6

Healthpage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6Logon Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7

11 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2Qualified Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2General Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2User Service and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3Periodic Maintenance by Service Personnel . . . . . . . . . . . . . . . . . . . . . 11-3

Qualified Service Available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4

A Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

System Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

X-ray Source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4X-ray Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

X-ray Tube Leakage Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4X-ray Tube Loading Factor Conditions . . . . . . . . . . . . . . . . . . . . . . . .A-4


Tube Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-5

High-voltage generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

Collimator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-7

Dose Area Product (DAP) Meter (Option) . . . . . . . . . . . . . . . . . . . . . . . . .A-7

User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-8

Drive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9

Safety and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10

Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11

Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-12

Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13

B EMC Compliance Statement . . . . . . . . . . . . . . . . . . . B-1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

Compatibility Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4Electromagnetic Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-4Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-5

Use Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9

Installation Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11Cable Shielding and Grounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11Subsystem and Accessories Power Supply Distribution . . . . . . . . . . . .B-11Stacked Components and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11Low Frequency Magnetic Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11Static Magnetic Field Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-11Electrostatic Discharge Environment and Recommendations . . . . . . . . .B-11

5400233-1EN Rev 4 Brivo XR285amx i-1

Preface

Preface


IMPORTANT!...X-RAY PROTECTIONX-Ray equipment if not properly used may cause injury. Accordingly the instructions herein contained should be thoroughly read and understood before you attempt to place this equipment in operation. The General Electric Company, Healthcare Division, will be glad to assist and cooperate in placing this equipment in use.

Although this apparatus incorporates a high degree of protection against x-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator or his assistant to take adequate precautions to prevent the possibility of authorized or unauthorized persons carelessly, unwisely, or unknowingly exposing themselves or others to direct or secondary radiation.

It is important that everyone having anything to do with x-radiation be fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Ave., Bethesda, MD 20814, and of the International commission on Radiation Protection, and take adequate steps to insure protection against injury.

It is assumed that all persons authorized to use the equipment are cognizant of the danger of excessive exposure to x-radiation and the equipment is sold with the understanding that the General Electric Company, Medical Systems Division, its agents, and representatives have no responsibility for injury or damage which may result from exposure to x-radiation.

Various protective materials and devices are available. It is urged that such materials and devices be used.

Preface


Medical Device DirectiveThis product complies with the following requirements:

Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:

The location of the CE mark label on the equipment is in the service system manual.

European registered place of business:

GE Healthcare SCS

Quality Assurance Manager

283 rue de la Minière

78530 BUC France

Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK).

Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.

Canadian Standards Association (CSA).

International Electrotechnical Commission (IEC), international standards organization, when applicable.

GE Healthcare reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation.

The original language of this manual is English.

Preface


Contact InformationManufactured by:

GE Medical Systems, LLC (GE Healthcare)

United States address:

GE Medical Systems, LLC (GE Healthcare)

3000 N Grandview Blvd.

Waukesha WI 53188 USA

Phone number:

United States: 262-544-3011

International: +1-262-544-3011

Web address:

www.gehealthcare.com

Preface


Revision HistoryTable i-1 Revision History

Revision History Revision Date Pages Affected Description of Change

1 13 July 2011 All Initial Release

2 4 October 2011 All Minor Revisions

3 7 November 2011 All Minor Revisions

4 17 November 2011 All Minor Revisions

5400233-1EN Rev 4 Brivo XR285amx 1-1

Chapter 1

Introduction

Introduction


IntroductionThe equipment is intended for use by qualified personnel only.

WARNING: United States Federal law restricts this device to sale by or on the order of a physician.

This Operator Manual should be kept with the equipment and be readily available at all times. It is important for you to periodically review the procedures and safety precautions. It is important for you to read and understand the contents of this manual before attempting to use this product.

This chapter explains the purpose and design of this Operator Manual. It provides information on the organization, chapter format, and graphic conventions that identify the visual symbols used throughout the manual.

Purpose Of This ManualThis manual is written for health care professionals (namely, the radiologic technologist) to provide the necessary information relating to the proper operation of this system. The guide is intended to teach you the system components and features necessary to use it to its maximum potential. It is not intended to teach radiology or to make any type of clinical diagnosis.

Prerequisite SkillsThis guide is not intended to teach radiology. It is necessary for you to have sufficient knowledge to competently perform the various diagnostic imaging procedures within your modality. This knowledge is gained through a variety of educational methods including clinical working experience, hospital based programs, and as part of many college and university Radiologic Technology programs.

Introduction


Safety InformationPlease refer to Chapter 2: Safety and Regulatory in this manual. The Safety chapter describes the safety information you and the physicians must understand thoroughly before you begin to use the system. Note that you will find additional safety information throughout this operator manual. If you need additional training, seek assistance from qualified GE Healthcare personnel. The equipment is intended for use by qualified personnel only. This guide should be kept with the equipment and be readily available at all times. It is important for you to periodically review the procedures and safety precautions. It is important for you to read and understand the contents of this guide before attempting to use this product.

Safety NoticesSafety notices are used to emphasize certain safety instructions. This guide uses the international symbol along with the danger, warning, or caution message. This section also describes the purpose of a Note.

DANGER: Danger is used to identify conditions or actions for which a specific hazard is known to exist which will cause severe personal injury, death, or substantial property damage if the instructions are ignored.

WARNING: Warning is used to identify conditions or actions for which a specific hazard is known to exist which may cause severe personal injury, death, or substantial property damage if the instructions are ignored.

CAUTION: Caution is used to identify conditions or actions for which a potential hazard may exist which will or can cause minor personal injury or property damage if the instructions are ignored.

Important! An Important comment calls your attention to items that affect your workflow or image quality but do not involve the safety of people or equipment.

NOTE: A Note provides additional information that is helpful to you. It may emphasize certain information regarding special tools or techniques, items to check before proceeding, or factors to consider about a concept or task.

Introduction


Manual OrganizationThe manual is organized by chapters to provide information about specific functions. The following list provides an overview of the chapters’ contents.

Introduction provides basic information about the Operator Manual itself. Safety and Regulatory contains the detailed safety information operators and the physicians

must understand thoroughly before using the system. Note that you will find additional safety information throughout the Operator Manual. If you need additional training, seek assistance from qualified GE Healthcare personnel.

General Information describes features and functions that apply to the whole system: such as start up, shutdown, and system messages.

Moving and Positioning Charging the System Batteries Quick Steps provides an overview of common tasks. System Hardware Overview describes the overall system, hardware, and available

accessories. Status Bar Image Acquisition describes the process of selecting and performing exams. Set Preferences describes the features and processes to configure the system. Maintenance describes the process to conduct checks on the system to ensure continued

image quality. Logon Administration describes how to administer the logon options of the system, such as

adding and removing users or groups. Specifications provides the technical specifications of the system. EMC Compliance Statement provides electromagnetic compliance information.

Introduction


Graphic Conventions and LegendsThe table below describes the conventions used when working with menus, buttons, text boxes and keyboard keys.

Table 1-1 Conventions for menus, buttons, text boxes, and keyboard keys

Example Describes

Select Marking an option in a group of check boxes or radial buttons

Choosing an option from a drop-down list

Activating a tab

Highlighting row items

Press [START EXAM] Pressing a button on a screen.

Press ENTER Pressing a key on the keyboard.

Press CTRL+ALT+DELETE Pressing a combination of keys on the keyboard. The key that should be pressed first is listed first.

Press and hold SHIFT Pressing and holding down a key on the keyboard.

In the Matrix text box,... The name of text box in which you can select or type text or the name of a drop-down list from which you select an option.

Type DICOMAE in the... Text you enter into a text box.

Select Preferences > Worklist. The path of selecting option(s) in a tree structure.


Chapter 2

Safety and Regulatory

This chapter explains the safety considerations, general equipment and patient related precautions, and the symbols used for the safe operation of your equipment. This chapter also includes information about the emergency procedures.

This chapter presents the concepts necessary to successfully operate your system safely.



X-Ray ProtectionX-ray equipment if not properly used may cause injury. Accordingly, the instructions herein contained should be thoroughly read and understood by everyone who will use the equipment before you attempt to place this equipment in operation. GE Healthcare, will be glad to assist and cooperate in placing this equipment in use.

Although this apparatus incorporates a high degree of protection against x-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator to take adequate precautions to prevent the possibility of any persons carelessly exposing themselves or others to radiation.

It is important that everyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International Commission on Radiation Protection, and take adequate steps to protect against injury.

The equipment is sold with the understanding that GE Healthcare, its agents, and representatives have no responsibility for injury or damage which may result from improper use of the equipment.

Various protective material and devices are available. It is urged that such materials or devices be used.



FCC Statement of ConformanceThis device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.



Indications for UseThe GE Automatic Mobile X-Ray (AMX) Brivo XR285amx is intended to take exposures utilizing film or computed radiography.

Brivo XR285amx is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).

The Brivo XR285amx is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The Brivo XR285amx is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

The Brivo XR285amx is not intended for mammographic applications.

WARNING: United States Federal law restricts this device to sale by or on the order of a physician.



Pediatric Imaging

Pediatric Imaging UseGE Healthcare strongly suggests reducing radiation dose to As Low As Reasonably Achievable (ALARA) in all patients, especially pediatric and small patients, whenever it is determined that an x-ray is necessary. X-ray is an extremely valuable tool for diagnosing injury and disease, but its use is not without risk. This section discusses the importance of minimizing the radiation dose in children and small adults consistent with ALARA principles.

Considerations

Radiation exposure is a concern in both adults and children. However, children are more sensitive to radiation. Using the same exposure parameters on a child as used on an adult may result in larger doses to the child. X-ray settings can be adjusted to reduce dose significantly while maintaining diagnostic image quality.

Pediatric Imaging ConceptsThis section presents the concepts necessary to understand Pediatric x-ray imaging. The concepts you need to understand are:

Radiation Exposure Sensitivity Suggestions for Minimizing Unnecessary Dose Guidelines for Adjusting Individual Exposure Parameters by Patient Patient Dose Reporting Dose Index Reporting ConsiderationsEveryone shares the responsibility of minimizing pediatrics dose. There are several steps that can be taken to reduce the amount of radiation that pediatrics and small patients receive from x-ray examinations.

Radiation Exposure Sensitivity

Radiation exposure is a concern in all people of all ages, however, pediatrics are more sensitive to radiation exposure. Radiation risk is higher in the young as they have more rapidly dividing cells than adults. The younger the patient, the more sensitive they are.

Suggestions for Minimizing Unnecessary Dose

Image the Anatomical Region Indicated (Collimation): Collimation and anatomical coverage should be carefully considered prior to each exposure. Follow your facility imaging guidelines to determine appropriate collimation.

Properly Center All Patients: In addition to collimation, centering of intended anatomy should be considered. This is especially true when utilizing AEC/ion chambers. Improper centering over ion chambers may cause more or less than the desired dose which may lead to overexposure or repeat exposure. (If applicable)



Check Technique Factors Before Exposure: Review the technique display carefully before making an exposure to verify selected and intended techniques are the same. Pay particular attention to placement of decimal point in display of numerical values.

Use Pediatric Positioning Accessories: Approved Pediatric positioning accessories are often useful for certain patients and exams. These may be helpful in decreasing motion that may contribute to repeat exposure. Understand your facilities guidelines when implementing these devices.

Protective Apparel/Barriers/Shielding: When applicable, utilize proper protective measures as they comply with your facility guidelines.

Consider Patient Radiation Safety Protocols: Ensure understanding and conformance of Patient Radiation/Protection Safety and ALARA principles as required by your facility. This includes patient shielding to reduce exposure to unintended areas.

Patient Dose Reporting

Estimates of patient dose are calculated after each acquisition and displayed (optionally) as part of the image annotations (if applicable). Reference Patient Dose Reporting in this operator manual for more information.



ContraindicationsThis device is not intended for mammographic applications.



UsersThe targeted clinical users include qualified trained doctors, radiographers, or radiologic technologists (RTs) working in various locations. Locations may include orthopedic clinics, radiology imaging centers, hospital radiology departments, or hospital orthopedic departments.



SafetyThe electrical wiring of the relevant rooms complies with all national and local codes, as well as the Regulations for the electrical equipment of buildings published by the Institution of Electrical Engineers. All assembly operations, extensions, re-adjustments, or repairs must be carried out by qualified service representatives. Any modifications must be carried out by GE Healthcare Technologies authorized service representatives. The equipment must be used in accordance with the instructions for use.

WARNING: This X-Ray unit may be dangerous to patient and operator, unless safe exposure factors, operating instructions and maintenance schedules are observed.

To be used by authorized personnel only.

WARNING: Electric Shock Hazard! Do not remove covers. The system contains high voltage circuits for generating and controlling X-rays. Prevent possible electric shock by leaving covers on the equipment. There are no operator serviceable parts or adjustments inside. Only trained and qualified personnel should be permitted access to the internal parts of this equipment.

WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING: All assembly operations, extensions, re-adjustments, or repairs must be carried out by qualified service representatives. Any modifications must be carried out by GE Healthcare Technologies authorized service representatives.

WARNING: Electric shock hazard. To prevent possible electric shock, do not insert fingers inside the RJ 45 connector (Ethernet port).

WARNING: Radiographic equipment must be operated by qualified personnel and only after sufficient training.

WARNING: Do not use in an oxygen-rich environment or around other flammable or explosive gases.



WARNING: This equipment is not rated for use in the presence of flammable gases.

CAUTION: Always be alert to safety when you operate this equipment. You must be familiar enough with the equipment to recognize any malfunctions that can be a hazard. If a malfunction occurs or a safety problem is known to exist, do not use this equipment until qualified personnel correct the problem.

CAUTION: This mobile X-ray Unit is not normally connected to protective earth ground while in use. For the safety of the patient and operator, only devices that are certified to the appropriate safety standards for medical devices and in good working order are to be used in proximity to this X-ray Unit.

CAUTION: It is the User’s responsibility to provide the means for audio and visual communication between the Operator and the patient.

CAUTION: If you suspect any electromagnetic interference affecting or caused by the unit, call service. Portable and mobile RF communications equipment can affect medical electrical equipment.

CAUTION: Use only manufacturer recommended equipment and accessories.

CAUTION: Front bumper will stop movement of the mobile system when engaged. The system will stop when the release handle is released.

CAUTION: The connection of equipment or transmission networks other than as specified in these instructions can result in electric shock hazard. Alternate connections will require verification of computability and conformity to IEC/EN 60601-1-1 by installer.



CAUTION: There is a cable-counterpoise assembly in the tube support column which makes the tube easy to move and position. This assembly includes a mechanical safety device. In the unlikely event that the tube becomes very difficult to move vertically on the column, please contact your service personnel as the mechanical safety device may have been activated.

NOTE: If such an event occurs, it may be accompanied by a loud noise.

CAUTION: Observe equipment limitations when moving the mobile system up or down an incline. In the transport (parked) position the mobile system can be driven up to a 7-degree incline. When not in the transport position, do not drive the mobile system up an incline greater than 5 degrees.

Figure 2-1 Incline Limits



Good Operating Practices Wear a lead apron while performing an x-ray exam. Step back at least 2 meters from the tube or to the full extension of the hand switch cord

before making an exposure. Always use the proper field sizes and technique factors for each procedure to minimize x-ray

exposure and produce the best diagnostic results. GE Healthcare strongly suggests reducing radiation dose to As Low As Reasonably

Achievable (ALARA) in all patients, whenever it is determined that an x-ray exposure is necessary.

Check the digital display carefully before making an exposure: verify that the selected technique is the intended technique. Pay particular attention to the placement of the decimal point in the mAs setting to insure that whole numbers are not mistaken for an intended mAs fractional number.

Ask visitors to step outside the room during an exposure. Use gonadal shields for patients whenever possible. Be sure to read and follow the maintenance schedule outlined in the Maintenance and Service

section of this manual. Under most conditions, cumulative radiation dose to the operator will not exceed

recommended maximum permissible levels. However, as with all radiation-producing devices, a qualified radiation expert should evaluate situations involving frequent exposures using high kVp and mAs techniques to determine if extra protective devices are necessary.



Know the EquipmentRead and understand all of the instructions in this Operator Manual before attempting to use the product.

IEC Equipment ClassificationsThis product is a mobile general purpose radiographic x-ray system. The following equipment classifications are applicable to this product:

Equipment classification with respect to protection from electric shock: Class I Degree of protection from electric shock: Type B Degree of protection against ingress of liquids: IPX0 Degree of Safety in the presence of Flammable Anesthetics Mixture with air or with oxygen or

with nitrous oxide: Not suitable for use in the presence of Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide.

Mode of operation: Continuous with intermittent loading



Radiation SafetyAlways use the proper technical factors for each procedure to minimize X-ray exposure and to produce the best diagnostic results. In particular, you must be thoroughly familiar with the safety precautions before operating this system. Default techniques are designed to optimize the image processing parameters.

CAUTION: There should be no people other than the patient in the room during x-ray exposure. If circumstances require another person to enter the room while x-ray exposures are planned or possible, that person should wear a lead apron in accordance with accepted safety practices.



Radiation ProtectionBecause exposure to X-ray radiation may be damaging to health, use great care to provide protection against exposure to the primary beam. Some of the effects of X-ray radiation are cumulative and may extend over a period of months or years. The best safety rule for X-ray operator is “Avoid exposure to the primary beam at all times”.

Any object in the path of the primary beam produces secondary (scattered) radiation. The intensity of the secondary radiation is dependent upon the energy and intensity of the primary beam and the atomic number for the object material struck by the primary beam. Secondary radiation may be of greater intensity than that of the radiation reaching the film. Take protective measures to safeguard against it.

An effective protective measure is the use of lead shielding. To minimize dangerous exposure, use such items as lead screens, lead impregnated gloves, aprons, thyroid collars, etc. The lead screen should contain a minimum of 2.0 mm of lead or equivalent and personal protective devices (aprons, gloves, etc.) must contain a minimum of 0.25 mm of lead or equivalent. For confirmation of the local requirements at your site, please refer to your “Local Radiation Protection Rules” as provided by your Radiation Protection Advisor.

WARNING: While operating or servicing x-ray equipment, always keep a distance not less than 2 meters from the focal spot and X-ray beam, protect body and do not expose hands, wrists, arms or other parts of the body to the primary beam.



Monitoring of PersonnelMonitoring of personnel to determine the amount of radiation to which they have been exposed provides a valuable cross check to determine whether or not safety measures are adequate. It may reveal inadequate or improper radiation protection practices and potentially serious radiation exposure situations.

The most effective method of determining whether or not the existing protective measures are adequate is the use of instruments to measure the exposure. These measurements should be taken at all locations where the operator, or any portion of the body may be exposed. Exposure must never exceed the accepted tolerable dose.

A frequently used, but less accurate, method of determining the amount of exposure is the placement of film at strategic locations. After a specified period of time, develop the film to determine the amount of radiation.

A common method of determining whether personnel have been exposed to excessive radiation is the use of personal radiation dosimeters. These consist of X-ray sensitive film or thermoluminescent material enclosed within a holder that may be worn on the body. Even though this device only measures the radiation which reaches the area of the body on which they are worn, they do provide a reasonable indication of the amount of radiation received.



Emergency ProceduresIt is not always possible to determine when some components, such as the X-ray tubes, are nearing the end of their operating lives. These components could stop operating during a patient examination.

WARNING: The facility must establish procedures for handling the patient in case of the loss of system functions during an exam.



Safe Operation Precautions

General Use Warnings

WARNING: For continued safe use of this equipment, follow the instructions contained in this Operator Manual. Study this guide carefully before using the equipment and keep it at hand for quick reference. You may print this manual to have a paper copy available within the Radiology department.

WARNING: Only qualified personnel trained in the operation of this equipment should run this system. Read and become familiar with all instructions in this manual before using this equipment If further assistance is needed, please contact GE.

WARNING: It is the responsibility of the owner to make certain that only properly trained, fully qualified personnel are authorized to operate the equipment. A list of authorized operators should be maintained.

WARNING: Check for obstructions before moving the system; do not drive the system into or onto fixed objects.

WARNING: It is the responsibility of the operator to ensure the safety of the patient at all times. The patient should be monitored by visual observation, use of proper patient positioning, and the use of appropriate protective devices.

CAUTION: Keep the patient in full view at all times and never leave the patient unattended.

CAUTION: Please carefully monitor all equipment motion to prevent collisions. Pay attention during operation to prevent possible injuries that could result from collision of the power-driven equipment parts with other moving or stationary items likely to be in the environment.



WARNING: Perform periodic maintenance to ensure continued safe use of the equipment. Follow recommended preventative maintenance schedule as outlined in the documentation provided with your system.

CAUTION: Make sure any other accessories or materials are not located in the primary X-ray beam during exposure that could result in bad image quality.

CAUTION: Always use GEHC recommended accessories to ensure best performance and to avoid possible hazards.

WARNING: For accessories used in combination with diagnostic X-ray equipment, be aware of the possible adverse effect arising from materials located in the X-ray beam.

IMPORTANT! ESD Events may cause Control Panel indicator lights to briefly flash or change color. If this occurs it will be temporary and self-correcting. No user interaction is required.:

Patient Positioning Warnings

CAUTION: To avoid patient injury, always assist the patient as needed at the beginning or end of an exam.

CAUTION: Make sure that patient connected lines, tubes, etc. do not become pinched or pulled.

WARNING: Hot Surface! Take care not to burn yourself or the patient by contact with the x-ray tube housing or the collimator lamp housing during extended use.

Pinch Points and Crush Hazard SummaryThis section lists the potential pinch points or crushing hazards that exist for the system.

Table 2-1 Pinch Points and Crush Hazard Summary



Component Warning

SystemWARNING:Potential Crush Hazard: Take care not to drive the system over

cables or over a person’s foot.

Drive Handle WARNING:Potential Pinch Point: Always grasp the drive handle in such a way that neither hand can be pinched between the handle sections.

Park LatchWARNING:Hand Crush Hazard: Keep your extremities and the patient’s

extremities away from the Park Latch.

ColumnWARNING:Potential Pinch Points: The vertical column may create pinch

points during up and down motion.

Column ArmWARNING:Potential Pinch Points: The column arm may create pinch points

during motion.

X-ray Tube and Collimator

WARNING:Potential Pinch Point: The area where the tube connects to the arm may create a pinch point when the tube is rotated. Operators should keep their hands on the collimator handle and keep patient clear while rotating the tube.



SymbolsThis section explains the symbols used on this system and in its accompanying documents.

Special NoticesTable 2-2 Special notices

X-ray Tube Operational SymbolsThe table below describes the operational symbols for the system such as X-ray emissions and collimator locations.

Symbol Description

Dangerous voltage. This indicates an avoidable, dangerous, high voltage hazard.

This symbol on the equipment indicates the operating instructions should be consulted to ensure safe operation.

Hand crushing hazard. This symbol indicates that serious injury to the hand may occur.

Follow operating instructions. This symbol directs you to consult this manual for more information.

No stepping or standing on unit. The component on which the symbol appears cannot support the weight of a person. Damage to equipment or injury may occur if the unit is stepped or stood upon.

Maximum load. This symbol indicates that the component has a maximum weight limit. Damage to equipment or injury may occur if the maximum weight is exceeded.

Operating temperature. This symbol indicates that the component must be within a minimum and maximum temperature range in order to operate. Damage to equipment may occur if equipment is used at temperatures outside of the specified range.



Table 2-3 Operational symbols

System Power On and ResetThe table below describes the power controls of the system.

Table 2-4 Power controls

Electrical TypeThe table below describes the electrical protection rating based on system type.

Symbol Description

X-ray emission is used to indicate the X-ray tube head is emitting X-rays. Take adequate precautions to prevent the possibility of any persons carelessly, unwisely, or unknowingly exposing themselves or others to radiation.

X-ray source assembly is used to indicate a reference to an X-ray source assembly.

X-ray tube is used to indicate a reference to the X-ray tube, e.g., to mark the surface of a grid, which is to be oriented towards the X-ray tube.

Identifies controls or indicators associated with the selection of a small focal spot or the connection for the corresponding filament.

Identifies controls or indicators associated with the selection of a large focal spot or the connection for the corresponding filament.

Symbol DescriptionThe POWER ON button is used to turn on the power to the system.

ON: Green OFF: Dark POWER TRANSITION: Blue HARDWARE FAULT: Blinking Yellow



Table 2-5 Electrical type

Electrical CurrentThe table below describes the symbols for the different types of electrical current that may be used on your system.

Table 2-6 Electrical current types

GroundThe table below describes the different types of grounding that may be used in your system.

Table 2-7 Ground types

Symbol Description

Type B Equipment indicates the equipment provides a particular degree of protection against electrical shock regarding leakage current and protective earthing per IEC60601-1.

Symbol Description

Alternating Current indicates the equipment is suitable for alternating current only.

Direct Current indicates the equipment is suitable for direct current only.

Both direct and alternating currents indicate the equipment is suitable for both direct and alternating current.

Symbol Description

Functional Earth (ground) Terminal indicates a terminal directly connected to a point of a measuring supply or control circuit or to a screening part, which is intended to be earthed for functional purposes.

Noiseless (clean) earth (ground) identifies any terminal of a specially designed earthing system where noise from earth of leads will not cause a malfunction of the equipment.



CollimatorThe table below describes the collimator controls and the radiation field.

Table 2-8 Collimator descriptions

Protective earth (ground) identifies any terminal which is intended for connection of an external protective conductor to protect against electrical shock in case of a fault.

Frame or chassis identify the frame or chassis terminal.

Equipotentiality identifies terminals that bring the various parts of equipment or systems to the same potential when connected together. These terminals are not necessarily at earth (ground) potential. The value of the potential may be indicated next to the symbol.

Symbol Description

Symbol Description

Control for indicating radiation field by using light.

Identifies controls for opening the collimator blades, or indicates partially or fully open state.

Identifies controls for closing the collimator blades, or indicates closed state.

Indicates the collimator blades are closed. The controlled blades are shown in thicker lines.

Indicates the collimator blades are open. The controlled blades are shown in thicker lines.



Indicates the use of laser radiation.

Symbol Description



Identification and Compliance PlatesProduct identification labels can be found on the system. The types of system identification compliance plates are located below.

Identification PlateFigure 2-2 Typical identification plate

NRTL Listed LabelThe Nationally Recognized Testing Laboratory (NRTL) label indicates that the assembly is listed or recognized by a nationally recognized testing laboratory (i.e. ETL, UL, CSA).

Figure 2-3 ETL Listed Label



Identification and Compliance Plate LocationsFigure 2-4 System identification and compliance plate Locations



System Identification Plate

Figure 2-5 System Identification Plate

Table 2-9 System Identification Plate

Number Text1 GE Healthcare, LLC

2 3000 N. Grandview Blvd. Waukesha, WI USA

3 System Model Name

4 Model Number



Standard Identification Plate

Figure 2-6 Standard Identification Plate

Table 2-10 System Identification Plate

Number Text

1 General Electric CompanyMilwaukee, Wisconsin. Made In USA

2 Model

3 Serial Number

4 Manufactured

5 Description

6 1440 VA

7 100-240 VAC

8 50/60 Hz



Figure 2-7 System Label (CISPR 11)

Table 2-11 System Label (CISPR 11)

Figure 2-8 System Label (Chassis)

Number Text1 CISPR 11 / EN 55011

2 CLASS: A GROUP: 1

3 CLASSE: A GROUPE: 1

4 The operating instructions should be consulted to ensure safe operation.

5 Refer to Instructions (ISO 7010-M002)

6 RF transmitter (IEC 5140)



Table 2-12 System Label (Chassis)

Figure 2-9 System Identification Plate (ETL)

Table 2-13 System Identification Plate (ETL)

Figure 2-10 System Identification Plate (FCC)

Table 2-14 System Identification Plate (FCC)

Number Text1 Dispose of Separately

2 Weight of System

Number Text1 ETL Classified

2 Medical Equipment

Number Text1 Contains Transmitter Modules



Figure 2-11 System Advisory Label

Table 2-15 System Advisory Label

Figure 2-12 X-Ray Console Warning

Table 2-16 X-Ray Console Warning

Figure 2-13 X-Ray Console Warning (Canada)

Number Text1 The operating instructions should be consulted to ensure safe operation.

2 Refer to Instructions (ISO 7010-M002)

3 Do not drive the system on a grade greater than 5 degrees with the arm extended.

4 It is OK to drive the system on a grade less than 7 degrees with the arm latched in the park position.

Number Text

1WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed. To be used by authorized personnel only.



Table 2-17 X-Ray Console Warning (Canada)

X-Ray Tube Identification Plates

Figure 2-14 X-Ray Tube Identification Plate 1

Table 2-18 X-Ray Tube Identification Plate 1

Number Text

1

WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed. To be used by authorized personnel only.CAUTION: X-RAYSATTENTION: RAYONS X

Number Text1 Manufactured

2 Unit Model

3 Serial Number

4 Insert Model

5 Serial Number

6 Supplementary Symbol



Figure 2-15 X-Ray Tube Regulation Label

Table 2-19 X-Ray Tube Regulation Label

Figure 2-16 X-Ray Tube Caution Label (Cable)

Table 2-20 X-Ray Tube Caution Label (Cable)

7 Stator

8 Maximum Voltage

9 Focal Spot

10 Permanent Filtration

11Toshiba Electron Tubes & Devices Co., Ltd.1385, Shimoishigami, Otawara-shi, Tochigi 324-850, JapanMade in Japan

Number Text

Number Text1 This label is valid for the Fire Service Law in Japan.

Number Text1 Always have service personnel install or remove the high-tension cable.



Figure 2-17 X-Ray Tube Caution Label (End Caps)

Table 2-21 X-Ray Tube Caution Label (End Caps)

Figure 2-18 X-Ray Tube Caution Label (Fragile)

Table 2-22 X-Ray Tube Caution Label (Fragile)

Number Text

1CAUTION: Housing end caps must always be mounted to the tube housing assembly properly and correctly for X-ray protection and safety. In any case, the X-ray tube shall not be energized without fixing the cap in such a manner as directed.

Number Text1 CAUTION: Do not impact on this fragile face.



Collimator Identification Plate

Figure 2-19 Collimator Identification Plate

Table 2-23 Collimator Identification Plate

Number Text

1GE Hualun Medical systems Co. Ltd.Number 1 Yongchang Bei RoadBDABeijing, PR China 100176

2 Made in China

3 Description: Manual Collimator

4 Model: 5129498

5 Serial Number

6 Manufactured

7 Input Rating: 21VDC, 8A

8 Total Filtration: between 3.1mm and 3.7mm Al Equivalence @ 70kV

9 Complies With DHHS Radiation Performance Standards 21 CFR Subchapter J



Regulatory RequirementsNOTE: This equipment generates, uses, and can radiate radio frequency energy. The equipment

may cause radio frequency interference to other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, this product complies with emission limits for Group 1 Class A Medical Devices as stated in EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular installation.

NOTE: If this equipment is found to cause interference (which may be determined by switching the equipment on and off), you (or qualified service personnel) should attempt to correct the problem using one or more of the following measures:

Reorient or relocate the affected devices. Increase the space separating the equipment and the affected device. Power the equipment from a source different from that of the affected device. Consult the point of purchase or the service representative for further suggestions.

NOTE: The manufacturer is not responsible for any interference caused either by the use of interconnect cables other than those recommended or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user’s authority to operate the equipment.

NOTE: To comply with the regulations applicable to an electromagnetic interface for a Group 1 Class A Medical Device, all interconnect cables to peripheral devices must be shielded and properly grounded. The use of improperly shielded and grounded cables may result in the equipment causing radio frequency interference in violation of the European Union Medical Device directive and Federal Communications Commission regulations.

NOTE: Do not use devices which intentionally transmit radio frequency (RF) signals (cellular phones, transceivers, or radio controlled products) in the vicinity of this equipment, as it may cause performance outside the published specifications.

Keep the power to these type devices turned off when near the equipment.

The medical staff in charge of this equipment is required to instruct technologists, patients, and other people who may be around this equipment, to fully comply with the above requirement.

Installation instructions for this device may be found in Brivo 285amx Installation Manual 5389169-1EN, which is included with this equipment.

This product complies with the following requirements:

Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:

Figure 2-20 CE mark



Disposal of WasteThis symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.

Figure 2-21 Disposal of waste symbol

Battery DisposalThe separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery must be recycled or disposed of in accordance with local or country laws. The letters below the separate collection symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are contained in the battery. To minimize potential effects on the environment and human health, it is important that all marked batteries that you remove from the product are properly recycled or disposed.

For information on how the battery may be safely removed from the device, please consult the service manual or equipment instructions. Information on the potential effects on the environment and human health of the substances used in batteries is available at this URL: http://www.gehealthcare.com/euen/weee-recycling/index.html

Figure 2-22 Battery Disposal symbol

Pollution Control LabelThe following product pollution control information is provided according to SJ/T11364-2006 Marking for Control of Pollution caused by Electronic Information Products.



Figure 2-23 Pollution control symbol

This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ/T11363-2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products. The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is Year.

In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual, and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly.

Consumables or certain parts may have their own label with an EFUP value less than the product. Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures.

This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning.



Dose Chart

Use the table below to compare film speed to dose values.

Table 2-24 Dose Chart

CAUTION: Use the largest possible focal spot-to-skin distance to keep the patient absorbed dose as small as possible.

CAUTION: If no technical factors are present in the system for any view, the default settings are:

kV = 80 mAs = 1.0These values are placeholders only. No exposures should be made until the user selects values appropriate for the patient size.

CAUTION: This system source assembly is designed to be used with only the Brivo XR285amx tube and collimator. Replacement of either of these components with different types may render the system non-compliant to applicable radiation safety standards and regulations.

Expected receptor Default Dose (μGy) at 80 kVp is less than: Equivalent Film Speed

16.00 100

12.90 125

10.00 160

8.00 200

6.25 250

5.00 320

4.00 400

3.20 500

2.50 640

2.00 800

1.60 1000



CAUTION: Certified diagnostic x-ray components (e.g., x-ray tube, collimator, or high-voltage generator) shall not be modified such that the component fails to comply with any applicable provision of 21CFR Subchapter J or an exemption under 534(a)(5) or 538 (b) of the Federal Food, Drug, and Cosmetic Act is granted.


Chapter 3

General Information

This chapter explains some of the basic operations and features of the Mobile X-ray Unit.

General Information


Quick Highlights

User Interface Optimized GUI System Health dashboard for system status Independent system status and system battery charge indicators

Productivity Exposures can be taken while the unit is plugged in and charging Smart Charge automatic charging algorithms allow the system to be re-charged even if

batteries are not fully drained System can be driven within 4 seconds of activation


Chapter 4

Moving and Positioning

This section describes how to drive the unit and position the x-ray tube for acquisitions.



Turn Unit On1. Turn the main power circuit breaker to the ON position.

Figure 4-1 Main power circuit breaker

Table 4-1 Main power circuit breaker

2. Press and release the on/off button to turn system on.

The unit performs diagnostics (self-tests to make sure everything is working correctly). This process takes up to 30 seconds.

3. The unit is ready for operation when the on/off button ring is green.

Number Description1 ON position

2 OFF position

3 Trip lever



Unlock The UnitIf the Drive Log In feature has been turned ON in Preferences, you must enter the correct four-digit code to the right of the screen to drive the unit. See Control Panel on page 7-6.

To unlock the unit:

1. Press any of the digit buttons to illuminate all four of the digit buttons.

The lock button below the four digit buttons will be blue if the unit is locked.2. Press the four digits of the code and press the lock button.

The lock button will turn green. You are now able to drive the unit. If the digit buttons start to flash and the lock button does not change color, then the four-

digit code you entered is not correct.3. To lock the unit when you are finished, press the four digits of the code and press the lock

button.

The lock button will turn blue. The unit is now locked. If the digit buttons start to flash and the lock button does not change color, then the four-

digit code you entered is not correct.



Drive the UnitA compact design and dual motor assembly makes driving and maneuvering the Brivo XR285amx an easy process.

If moving down hallways or just traveling from one room to another, first make sure that the telescoping arm is properly positioned and securely latched.

Then, simply grip the drive handle and steer the unit to your destination.

Figure 4-2 Drive handle

WARNING: Movement of the Brivo XR285amx x-ray unit could cause the horizontal arm to slide and strike an operator or patient if not latched properly. Latch telescoping arm properly before moving the unit.

WARNING: Do not drive or position the Brivo XR285amx unless standing directly behind it. Failure to do this may result in loss of control causing serious injury and equipment damage.



Figure 4-3 Proper driving position

The drive automatically adjusts to your pace, and can be pushed forward, turned or pulled in reverse at speeds of up to 5.0km per hour (3.1 m.p.h.).

Figure 4-4 Front Bumper

A self-stopping bumper at the front of the unit automatically activates the brakes and turns off the drive motors upon impact, to help prevent accidents. If the bumper is engaged, simply grip the drive handle and pull the unit in reverse. (As with any mobile equipment, however, when driving the unit be sure to exercise reasonable care.)

With the telescoping arm extended for a patient exam, the Brivo XR285amx pivots on the spot, rotating and maneuvering easily for exact positioning. Again, grip the drive handle and turn the unit to the desired position.

Brivo XR285amx maneuvering speed is automatically reduced by 50 percent when the telescoping arm is extended or not parked.



To drive the Brivo XR285amx, follow these steps:

1. Unplug the unit from the AC wall outlet and retract the cord, if necessary.

NOTE: Unit cannot be driven when plugged into the AC wall outlet.

2. Lock the telescoping arm into the park/transport position, if necessary.

In the park/transport position the telescoping arm is: completely pushed in; centered over the control panel (collimator skin spacers within well); and securely latched.

Figure 4-5 Telescoping arm latched

3. Enter your drive login code if necessary to allow movement of the system.

4. Grip the drive handle to activate the motors and disengage the brakes. Now simply steer the unit, like a shopping cart, to your destination.

When climbing inclines or moving over carpeting or other rough surfaces the drive motors will automatically adjust to the floor surface.

5. To stop the unit and activate the brakes, slow the unit to a stop and then release your grip on the drive handle. Remember that the self-stopping bumper, upon impact, will turn off the drive motors and activate the brakes.

To reverse the unit, grip the drive handle and pull backwards. If the self-stopping bumper is engaged, after a brief pause reverse the unit.

To turn a sharp corner or rotate the unit, push one side of the drive handle (to the right or left) and pull on the other. The unit will turn or pivot easily.

If the drive motors should fail, press and hold the BRAKE RELEASE button, located just below the DRIVE HANDLE on the right bracket. Manually relocate the unit, and call service.



Figure 4-6 Brake release button

Figure 4-7 Brake release button location

NOTE: The unit may be driven while the system software is booting up.



Position the TubeThis section describes how to setup and position mechanical components of the Brivo XR285amx. Steps for mechanical positioning are organized in the following way.

Adjustment of column and telescoping arm Rotation of x-ray tube unit, and Adjustment of collimator

Mechanical SetupFollow these steps to release the latch, vertical column and telescoping arm locks from the park/transport position.

Make sure that the unit is turned ON.

Latch Lock Release

1. Grip the collimator handles to activate the switch. (You should hear a clicking sound.)

Note that you only need to grip one of the collimator handles to activate the lock release system.

NOTE: Unlatching the tube will activate the monitor. The monitor turns off when the tube is latched to conserve system battery power.

Figure 4-8 Lock release mechanism

Adjust Column and Telescoping Arm

In the following steps you can free the Brivo XR285amx components for positioning in one of two ways: by gripping the collimator handle(s) to keep the lock system released or, whenever necessary, overriding the lock system with slight force.

When possible, we recommend that you use the lock release system.



1. Rotate the arm and vertical column assembly to horizontally position the telescoping arm. The vertical column can be rotated 270 degrees clockwise or counterclockwise (detent at 0 degree park location).

2. Raise the arm on the vertical column to the desired height.

3. Extend the retractable arm to the desired length and release.

Figure 4-9 Extending the retractable arm

Rotate the Tube

Because the tube assembly is counterbalanced, no active lock is required. And little effort is needed to override friction and rotate the tube.

1. Use the collimator handles to position the tube to the desired angle.

You may rotate the tube in two directions: clockwise and counterclockwise +180 degrees (detents at every 90 degrees), or backwards -10 degrees and forwards +100 degrees (detent at 0 degree).

Figure 4-10 Tube rotation



Table 4-2 Tube rotation

Adjust the Collimator

The Brivo XR285amx manual collimator limits patient radiation exposure to a desired area at a given distance from the x-ray tube focal spot. The collimator field light will not turn on when the x-ray tube is in the parked position. The Collimator Lamp Switch on the side of the handswitch toggles the collimator field light.

1. Press the collimator field light button (on either the collimator face or hand switch) to activate the high-intensity collimator field lamp. The cross-hair beam shows the collimator field center

The collimator field light is timed and automatically turns off 30 seconds after you press the switch. To adjust the collimator field light on time, contact your service representative. The time the collimator field light will remain On during Prep is not configurable.

To activate the collimator field light for another 30 seconds, press the button again when the light goes out. (You may keep the collimator field light on for up to 4 minutes. After 4 minutes, the collimator field light will turn off for cooling and remain inactive for 5 minutes.)

You may take an exposure while the collimator field light is on; the light will automatically turn off at the end of the exposure.

The collimator field light switch is a toggle: The collimator field light will go on with the first press of the switch and will go off with a second press of the switch.

2. Position the collimator and tube using the collimator field light and cross-hair as guides. The cross-hair shows the collimator field center.

3. Use the tape measure on the side of the collimator to measure the SID (source-to-image distance).

4. Collimate by adjusting the size of the collimator field with the two control knobs located on the front of the collimator.

The left knob controls the transverse dimension of the blades. A diagram on the face of the collimator shows which knob controls which dimension.

collimator field size from 0x0 inches and up to 17x17 inches (43x43 cm) at the 40 inch (102 cm) SID can be obtained. The knob selectors indicate the collimator field size for a selected SID.

Dial numbers on the calibrated scale are for a 40 inch (100 cm) and 72 inch (180 cm) scale SIDs.

Number Description1 Collimator rotation knob

2 X-ray tube

3 Retractable arm

4 110° (Forward)

5 -10° (Backward)

6 0° Detent



Figure 4-11 Collimator controls

5. You may rotate the collimator about its vertical axis (that is, to the right or left) in two ways: by a simple 90° detent method or by a manual lock method for an angle other than 90°.

90-degree detent method: Pull out the knob and rotate the collimator to the desired 90° detent position. The detent will snap in place and lock.

Manual lock method: Pull out the knob, position the collimator to the desired angle (other than 90° detent), and turn the knob clockwise to secure. (Turn the knob counterclockwise to unlock the collimator and reposition.)

collimator field light The collimator field light will not turn on when the x-ray tube is in the parked position. The Collimator Lamp Switch on the side of the handswitch toggles the collimator field light.

The collimator field light will turn on with the first press of the Collimator Lamp Switch and will turn off with the second press of the Collimator Lamp Switch.

The collimator field light can be turned on while in prep to see the patient better. If the collimator field light is on when the prep is started the collimator field light will stay on

until the end of the exposure to have better visibility of the patient when taking an image. There is a time limit of 30 seconds from the start of prep before the collimator field light

turns off. The time limit of 30 seconds may be adjusted by a Service Engineer.

If the collimator field light is on for over 4 minutes, the collimator field light will be automatically turned off to prevent the collimator from overheating. You may activate the collimator field light in about 5 minutes.


Chapter 5

Charging the System Batteries



Important Points To Remember Charge the batteries anytime, any level of charge up to full capacity. System can be plugged in

and left plugged in all the time - this will not harm the batteries performance. If you need to, you can plug in the Brivo while taking exposures.



OverviewSystem battery charging is as easy as driving the Brivo to a correctly rated wall outlet and plugging the unit in. Ratings are as follows:

Table 5-1 Wall socket rating by model number

The time required to fully recharge the Brivo batteries will vary according to system battery charge level as indicated on the system battery status display.

During recharge the Brivo capacity gauge increases as the unit is charged. To recharge from 10% to 100% typically requires 4 hours.

The Brivo capacity gauge visually displays the remaining capacity using a 12 segment bar graph display. At or near full charge, all segments are illuminated. The system battery status display approximates the remaining system battery charge, and should only be used to determine the relative state of charge.

Emergency Capacity FeatureWhen the Brivo capacity gauge drops to 0%, inhibiting x-ray exposures, the system will allow 10 minutes for transport to a safe area for charging of the batteries. After 10 minutes the system will shut down if the system is not plugged in.

Models RatingAll 100-240V nominal, 15A, 50 /60 Hz operation



Recharge RecommendedWhen system battery charge dips below approximately 10%, recharge is recommended.

As the Brivo is used in its various modes of operation, the number of segments lit will slowly decrease.

It’s important to note that you do not have to raise your kVp and mAs value to compensate for low system battery capacity.



System Battery DrainThe figure below shows how much of the system battery capacity is used for the various Brivo operating modes in a relative basis.

Figure 5-1 System Battery drain

As the figure above demonstrates, the majority of the system battery pack’s capacity is used for drive and idle. Thus, reducing the amount of drive time by parking the Brivo in a central location and plugging in the Brivo when not in use will make more capacity available for x-ray generation.

When the system is not in use, park the x-ray tube. When the x-ray tube is parked the monitor will turn off after four minutes of inactivity, also saving battery charge.

NOTE: The monitor will also turn off by itself after periods of inactivity, regardless of whether the x-ray tube is parked or not.

Idle Field LightGenerationX-ray X-ray PrepDrive



How to Re-Charge Batteries

Follow these steps to recharge the batteries.

CAUTION: When recharging the batteries, always locate the unit in a well ventilated area.

CAUTION: Keep the power cord clear of aisles or work areas to eliminate a tripping hazard.

1. Drive the Brivo to a correctly rated wall outlet. Position the unit within 8.5 feet of the outlet so there is no stress on the retractable cord.

2. To plug in, firmly grip the plug located on the front of the unit, and pull the retractable cord straight out until it is fully extended. Set the cord by a slow pull-release action. Plug into a correctly rated wall outlet.

Figure 5-2 Battery charging cord

3. When the charge is complete, all Battery Indicator segments are illuminated green, the batteries are fully charged (at 100% of capacity).

4. Unplug the unit from the outlet, giving the plug a slight tug to release from take-up reel.

Main Power Circuit BreakerThe main power circuit breaker is located on the front left side of the unit.



Figure 5-3 Main power circuit breaker

Table 5-2 Main power circuit breaker

If the system battery charge is too low, or in the event of an overload in the high-voltage system, the circuit breaker will trip (interrupt power to the x-ray unit).

Should the circuit breaker trip, the control panel lights will go out and you will be prevented from operating the unit. To resume operation, flip the circuit breaker up to the ON position. If necessary, recharge the unit or (if the system battery is adequately charged) try the procedure again.

If the system battery is within operating condition (as indicated by the system battery status and message displays) and power interruptions are frequent, there may be a fault in the high voltage system. If a fault is indicated, have the unit checked by a qualified service representative.

If the unit will not turn off, isolate the unit to prevent unauthorized operation, use the circuit breaker to remove power from the unit, and have the unit checked by a qualified service representative.

Number Description1 ON position

2 OFF position

3 Trip lever



Replacing the BatteriesThe batteries will start to lose charge at a faster rate when they are nearing their end of life. This time cannot be determined because usage is different for all sites. Contact GE service if you think your batteries might need replacing.

Contact GE service for replacement batteries. Do not try to change batteries yourself. System performance can change if the approved GE batteries are not used.


Chapter 6

Quick Steps

This section provides an overview of common tasks.

Quick Steps


HardwareThe following lists the basic processes for working with the system hardware.

Hand-switch1. Position your patient for the procedure.

2. Place the Cassette behind the patient.

3. Position the X-ray tube.

4. Turn on the collimator lamp and position the patient.

5. Confirm proper SID.

6. Press the Prep/Expose button to the PREPARE position.

7. Press the Prep/Expose button to the EXPOSE position.

8. Release the Prep/Expose button after the exposure is completed.

Adjust the Tube Position1. Rotate the tube about the short axis (cranial to caudal) to the desired angle.

2. Rotate the tube about the vertical axis of the telescopic column to the desired position.

Rotate the Multi-Leaf Collimator1. Grasp the multi-leaf collimator with both hands.

2. Rotate it to the desired angle and direction.

WARNING: Always grasp the multi-leaf collimator in such a way that neither hand can be pinched or crushed between the handles and the collimator.

Quick Steps


LogonThis following sections apply if the system is configured for Logon ability in the Service User Interface. Refer to Logon Administration for information on administering the login function.

Standard LogonThe Logon screen appears when the system is started, reset, or after a user logs off.

Figure 6-1 Standard Logon Screen

1. Start up the system.

2. Type in your Logon Name, if necessary.

3. Type in your Password.

4. Click [LOGON].

Invalid Password Message

Your Password must be entered correctly for you to log in. If the password you entered is not the correct password for the selected Username, an error message will appear in the top portion of the Logon screen.

If you see the error message, do the following:

1. Make sure that the correct Logon Name is displayed in the field. Depending on the configuration, the login name may be case sensitive. That is, “aBc“ is not the same login name as “ABc“.

2. Retype your Password carefully. Your password is case sensitive; that is, “xYz“ is not the same password as “Xyz“.

Quick Steps


3. Click [LOGON].

Contact your technical support group if you still are not able to login.

Emergency LogonEmergency Logon is a HIPAA required function to allow quick access to medical systems in the event of an emergency. Depending on the system’s configuration, this option may not be available. Refer to Logon Administration to configure the Emergency login function.

CAUTION: The Emergency Logon function should NOT be used when there is time to login normally, when there is time to receive assistance from technical support, or if there is no emergency situation. Your facility may track the use of this function.

Figure 6-2 Emergency Logon Screen

1. Press [EMERGENCY LOGIN].

2. You are prompted to enter your name. Enter your name and click [LOGON].

3. The Acquisition screen appears.

Quick Steps


General Acquisition

This section outlines the basic acquisition process.

1. Position the patient as appropriate..

2. Make technique adjustments as necessary: kVp and mAs.

3. Collimate and shield as appropriate for the exam.

4. Make exposure using the hand-switch.

5. Make additional exposures as needed.


Chapter 7

System Hardware Overview



ConfigurationsThe Brivo XR285amx system is available in four configurations:

S2000TA - 15KW International S2000TB - 30KW International S2000TC - 15KW China Package S2000TD - 30KW China Package



Unit FeaturesSince the Brivo XR285amx is battery operated, there’s no need to plug in your mobile x-ray unit before taking exposures. Battery operation makes the Brivo XR285amx easily adapted to operating, intensive care, and emergency room applications. Exposures can also be taken while the unit is charging.

Because of a dual-motor drive, driving and positioning the Brivo XR285amx requires minimum effort. And the control panel’s cut-away design permits optimum visibility for steering down crowded corridors.

The self-stopping bumper, one of many built-in safety devices, helps prevent unwanted mobility—the motors stop and the brakes activate upon contact with another object.

Figure 7-1 Brivo XR285amx back



Figure 7-2 Brivo XR285amx front

Table 7-1 Brivo XR285amx features

Description

Tube head.

Collimator controls.

Collimator skin spacing bars.

Tube latch mechanism. Locks the tube head down during transport.

Telescopic arm. The arm extends for tube placement.

Column. The column rotates for tube placement. The tube moves vertically on the column.

LCD touch screen. The screen provides the means to take x-rays.



On/Off Switch.

ON: Green OFF: Dark POWER TRANSITION: Blue HARDWARE FAULT: Blinking Yellow

Display and control panel. Displays the status of the system battery charge. When in acquisition mode, displays the currently selected kVp and mAs and any system status messages or errors.

Hand switch for initiating exposures.

Drive handle. Grasp the drive handle and squeeze the release bar to move the unit.

USB port.

Cassette bin. Provides a space to keep the Cassette and grid.

Front wheels.

Battery charging cord. The cord is retracted into the body before moving the Mobile X-ray Unit.

Main power circuit breaker.

Bumper. Automatically activates the brakes and turns off the drive motors upon contact, to help prevent accidents.

Description



Control PanelDisplays the status of the system battery charge. When in acquisition mode, displays the currently selected kVp and mAs and any system status messages or errors.

Figure 7-3 Control panel

Table 7-2 Control panel functions

Item Description

1 Control Panel

2 System Battery Capacity Indicator

3 On/Off Switch

4 Drive Logon Keypad

5 Drive Lock/Unlock



Hand SwitchExposures are made with the console hand switch. The Prep/Expose button on this switch has three positions: OFF, PREP, and EXPOSE.

Figure 7-4 Hand switch

Table 7-3 Hand switch buttons

Table 7-4 Hand switch button positions

Position Description

1 PREP

2 EXPOSE

3 Collimator lamp switch


OFF

The OFF position is when no pressure is applied to the Prep/Expose button on top of the hand switch.

PREPPREP is the next position on the hand switch. When it is partially pressed, it brings the rotor up to speed and heats the filament. PREP also checks the system interlocks and verifies the system is ready to make an exposure. The button returns to the OFF position if released.



EXPOSEThe EXPOSE position is when the button on the hand switch is fully depressed. This produces X-rays that are recorded. Release the Prep/Expose button after the exposure is completed.



Chapter 8

Status Bar

Status Bar


OverviewFigure 8-1 Status Bar

Table 8-1 Status Bar Icons

Item Description

1Inhibits Bar

A system inhibit icon will display within the Inhibit Bar when an Inhibit message is present The Inhibit Bar will display only when there are Inhibits availble

2

XRAY ON icon

1. X-ray OFF

2. X-ray ON

3 System Battery

4 Time

5 Heat Units Remaining

7 System Message Bar

Status Bar


System BatteryTable 8-2 System Battery Icons

Icon Description

Discharging System Battery - 12 bars - 100% capacity



Discharging System Battery - 1 bar - 8% capacity


Charging System Battery - 12 bars - 100% capacity



Charging System Battery - 1 bar - 8% capacity

Status Bar



Icon Description


Chapter 9

Image Acquisition

This section details the process of acquiring images using the cassette.

Image Acquisition


OverviewThe Acquisition screen is where the exam is set up and exposure details are adjusted.

Figure 9-1 Acquisition screen

Table 9-1 Image Acquisition functions

Function Description

[LOG OFF]

If the Logon function is enabled, pressing this button logs the current user off of the system.

DAP:Displays the measured entrance dose. Only available if the DAP option is installed.

Image Acquisition


kVpAdjusts the kV.

The up/down buttons on the right of the field adjust the kV by one unit.

The buttons on the left of the field adjust the kV by 5 units.

The kVp selection range is 50-125, in1 kVp increments.

mAs If in FIXED mode, adjusts the mAs.

The mAs selection is in Renard steps. The available selections are: 0.20, 0.25, 0.32, 0.40, 0.50, 0.63, 0.80, 1.0, 1.25, 1.6, 2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8.0, 10.0, 12.5, 16.0, 20.0, 25.0, 32.0, 40.0, 50.0, 63.0, 80.0, 100.0, 125.0, 160.0, 200.0, 250.0, 320.0, 400.0, 500.0, 630.0.

NOTE: Not all mAs selections are available at all kV settings.

Function Description

Image Acquisition


Patient Dose ReportingWith the optional Dose Area Product (DAP) meter, estimates of patient dose are calculated after each acquisition and optionally displayed as part of image annotations.

Entrance Dose (unit: dGy-cm2) is an estimate of entrance dose (air-kerma) at a distance from the patient surface to the tube focal spot.

Image Acquisition


Conduct an ExamThe Cassette Exam function takes an x-ray without digital image acquisition and storage or electronic information sending and retrieval. This is for use with a traditional Film Screen or CR cassette.

Figure 9-2 Cassette exam Acquisition screen

Follow this process to conduct an Exam.

1. For film and CR cassette work, use your site’s routine techniques as with any other mobile system. For ease of use, these techniques can be programmed into the protocol database.

2. Make technique adjustments as necessary for the appropriate body part being imaged: kV and mAs.

3. Collimate and shield as appropriate for the exam.

4. Have the patient suspend respiration, if required.

5. Make exposure using the hand-switch.

6. Process the cassette as necessary, depending on the media.


Chapter 10

Set Preferences

Preferences allow a super-user with the appropriate level of access to customize the system. This chapter explains the Preferences available to you and how to activate or change the preferences for your facility.

Set Preferences


Accessing Preferences

Preferences are set on the Utilities screen (Figure 10-2), which is accessed by pressing the [UTILITIES] button.

Figure 10-1 Utilities button

NOTE: You must be logged in as a user with the appropriate level of access in order to set preferences.

Figure 10-2 System Utilities screen

Set Preferences


System

System UtilitiesFigure 10-3 System Utilities screen

Table 10-1 System Utilities screen buttons

Function Description[LOG OFF]

This button will take the current user back to the Secure Logon screen.

[SERVICE]Access to Service tools.

Set Preferences


Drive LogonFigure 10-4 System - Drive Logon

Figure 10-5 System - Drive Logon - Settings

Enter a four-digit code for the Drive Logon.

Set Preferences


Dose ReportingFigure 10-6 System - Dose Reporting

Dose reporting is available when DAP is installed on the system. In Excel CSV format No date range to specify Export the report to a USB device For all exams the report will include:

kVp mAs Focal spot Date and time of exposure DAP

Set Preferences


PreferencesThis section provides instructions for setting your system preferences for the Health Page and Logon Management.

Figure 10-7 Preferences Menu

Healthpage

Figure 10-8 Healthpage

Set Preferences


Table 10-2 Healthpage

Logon Management

User Logon ManagementFigure 10-9 User Logon Management

If you are logged on as an administrator, you may change the user password:

1. Enter the old password.

2. Enter the new password.

3. Enter the new password once again in the Confirm Password box.

4. Select [SAVE].

Number Text1 Number of times the circuit breaker has been tripped either by a person or a short circuit

2 Number of times the circuit breaker has been tripped by the system due to a low battery condition

Set Preferences


Admin Logon ManagementFigure 10-10 Admin Logon Management

If you are logged on as an administrator, you may change either the user password or the administrator password:

1. Enter the old password.

2. Enter the new password.

3. Enter the new password once again in the Confirm Password box.

4. Select [SAVE].

If you are logged on as an administrator, you may change whether Emergency Login is enabled or disabled.

1. Click in the State box under Emergency Login.

2. Choose either Enabled or Disabled.

3. Select [SAVE].


Chapter 11

Maintenance

This chapter explains the Maintenance process for your system. To assure continued performance of this X-ray equipment, a periodic inspection program must be established. Daily functional checks should be part of this program.

Maintenance


Maintenance

GeneralIn order to assure continued safe performance of this x–ray equipment, a periodic maintenance program must be established. Functional Checks will not indicate that this x–ray system is performing to specifications. Only regular periodic maintenance can locate potential problems. It is the owner’s responsibility to arrange for this service.

Inspection intervals are based on average daily use of one eight hour shift. More frequent inspection is appropriate where equipment use is above average.

Aside from routine maintenance, any abnormal noise, vibration or unusual performance should be reported immediately to a GE representative. Before calling for service, however, be sure the equipment is being operated in accordance with the foregoing instructions.

WARNING: Failure to perform the periodic inspection and maintenance could allow deteriorating conditions to develop without being detected. This deterioration could result in equipment failures which could cause serious injury or equipment damage.

Qualified ServiceSafe equipment performance also requires the use of service personnel specially trained on the medical x–ray apparatus. GE and its associates, maintain a world–wide organization of stations from which one may obtain skilled x–ray service. If desired, arrangements can usually be made to furnish periodic and/ or emergency service on a contract basis. A GE representative will be glad to discuss this plan.

General Cleaning and Disinfecting

CAUTION: In the event of equipment contacting broken skin or being used with infected or immune compromised patients, the equipment should be cleaned using EPA cleared and EPA registered high-level disinfecting agents.

NOTE: Be sure to follow the label instructions and pre-cautions for use, storage, and disposal of all disinfecting agents.

Approved Cleaners

These cleaners are approved for the body of the system, including the handle, collimator, x-ray tube, and grid:

Bleach - 50 % mix with water (5-8% household Bleach) Glutaraldehyde <5%, Polyethylene Glycol <20% (tested as Cidex Plus 28)

Maintenance


Isopropyl Alcohol 70% concentration Hydrogen Peroxide 15-40% concentration

User Service and MaintenanceGE x–ray equipment contains operating safeguards to ensure maximum safety. Before calling for service, be certain proper operating procedures are being used.

This equipment should be cleaned frequently, particularly if corroding chemicals are present. Use a cloth slightly moistened in warm, soapy water (use mild soap) to clean the trim, table top and operator’s controls. Wipe with a cloth slightly moistened in clean water. Do not use cleaners or solvents of any kind as they may dull the finish or blur the lettering.

CAUTION: Only trained and qualified service personnel should be permitted access to the internal parts of the equipment.

Once a month inspect patient safety and support devices for signs of excessive wear, improper adjustment, or other indications that adjustment, repair, or replacement is required. In case of doubt about condition of this equipment, contact a GE Service representative.

CAUTION: Personal caution should be used when removing any accumulating foreign material.

Periodic Maintenance by Service PersonnelTo insure the continued safe performance of your Mobile X-ray Unit, establish a periodic maintenance program with a qualified service representative.

Periodic maintenance checks are required thirteen months after installation and every year thereafter. A periodic maintenance schedule and a sample mAs or kVp accuracy chart are provided on the following pages.

Qualified Service Available

GE Healthcare and its associates maintain a worldwide organization of service personnel specially trained on medical x-ray equipment. Consult your GE representative to find out more about all the available service programs.

Maintenance Schedule

Refer to 5389170-1EN Brivo 285amxPM Checklist

Maintenance


Table 11-1 Periodic Maintenance Schedule

Maintenance/Checks Frequency

Verify no movement between collimator and tube unit

Every 12 months, verify that there is no movement between the collimator and X-ray tube. If any movement is detected, you MUST remove the collimator and inspect all related fasteners.

Extension arm inspection Every year

Collimator general inspection and adjustment Every year

Filament and rotor interlocks Every year

X-ray tube anode rotation Every year

Column and carriage assembly inspection Every year

mAs accuracy Every year

kVp accuracy Every year

Operator displays Every year

Cross hair Every year

Collimator alignment Every year

Field size indicator Every year

Rotational detent Every year

Verify all cable ties are tight and secure Every year

Exposure tone is audible and x-ray on indicators light up when hand switch depressed to expose position

Every year

Auxiliary items (system battery charger, HV cables, etc.) Every year

Inspect monitor for damage/wear Every year

Touch screen calibration Every year

5400233-1EN Rev 4 Brivo XR285amx A-1

A Logon Administration

Logon Administration

5400233-1EN Rev 4 Brivo XR285amx A-2

Logon and Logout

The login feature requires you to login to access the system and can be turned on or off by your administrator or Field Engineer.

How your site uses this feature depends on if your site has a central user repository to which the system is connected. Sites with networks are referred to as Enterprise systems, those without are referred to as stand-alone systems. This feature can be used with either configuration, although some features are more applicable to enterprise systems.

1. At the login screen, type your assigned login name.

This name is assigned by your system administrator.NOTE: If you need to log in quickly for emergency purposes only, press [Emergency Logon].

NOTE: Logging off does not prohibit other users from logging in. Logout is designed to protect patient privacy, not stop approved users from logging in. When you or another user logs back in, the system returns to its last known state.

2. Press in the Password area and type in your password.

3. Press [Logon].

Figure A-1 Logon Window

4. To logout of the system, press the [LOG OFF] button.

You are immediately logged off..

5400233-1EN Rev 4 Brivo XR285amx B-1

B Specifications

Specifications


Power Capable of 100-240V nominal, 50 /60 Hz operation Power Consumption: 1440 Volt-Amperes System battery status display

Specifications


System Battery Independent component power management and system battery charging algorithms to

maximize usage time Typical charge time of 4 hours to go from 10-100%

Specifications


X-ray Source Accuracy of the radiation output: 5%

X-ray Tube Nominal Voltage (Radiographic): 40 to 150 kV (System 50 to 125kV) Permanent Filtration = 0.9mm Al / 75kV Maximum Continuous Heat Dissipation: Without Air-circulator: 170W (238 HU/s) Normal Operating Range of X-ray Tube Housing (end caps): 16 - 74° C Nominal Focal Spot size (IEC 60336):

Large Focus: 1.2 Small Focus: 0.6

Anode Rotation Speed (minimal): 3200/min Maximum X-ray Tube Current

Large Focus: 500 mA Small Focus: 200 mA

Refer to the Toshiba X-ray Tube manual for tube cooling curves and rating charts.

X-ray Tube Leakage Radiation

< 1mGy/hr at 1m from focal spot (125kV, 250mAs)

X-ray Tube Loading Factor Conditions

Nominal X-ray Tube Voltage With Highest X-ray Tube Current: Large Focus: 100 KV, 300 mA Small Focus: 100KV, 150 mA

Highest X-ray Tube Current With Highest X-ray Tube Voltage: Large Focus: 60 KV, 500 mA Small Focus: 50 KV, 200 mA

Highest Electric Power: Large Focus: 100 KV, 300 mA Small Focus: 100 KV, 150 mA

NOMINAL ELECTRIC POWER (KW) at 0.1 s exposure time: Large Focus: 30 KW see Highest Electric Power above Small Focus: 15 KW

Minimum mAs: Large Focus: 12.5 mAs Small Focus: 0.2 mAs

Nominal Shortest Irradiation Time In Automatic Exposure Control: N/A - no AES used

Specifications


Tube Positioning The column may be rotated up to ± 270° from the park position Tube Angle display and SID measuring tool Maximum focal spot 200cm (78.7 in): Height Minimum focal spot 62.5cm (24.6 in): Height Vertical travel 137.5 cm (54.1 in) Minimum horizontal extension center of column rotation to centerline of tube: 71.3 cm (28.1 in) Maximum horizontal extension center of column rotation to centerline of tube: 111.4cm (43.9

in) Travel Range of at least 40.1 cm (15.8 in)

Specifications


High-voltage generator Power (kW): 15 standard, 30 optional kVp: 50 to 125 in ±1 kVp steps mA: 300 maximum mAs: 0.2 to 630 in 24 steps (25% up, 20% down) Accuracy:

KVp accuracy = ±10% mAs accuracy = ±(10%, +0.2mAs)

Less than 2% low frequency ripple Frequency: greater than 100 kHz Super resonant inverter with varying frequency Minimum exposure time: 4.0 msec

Specifications


Collimator

A pair of independent collimator blades controls the x-ray field 180 lux (1000 (Lumen/mt2) light field lamp The collimator rotates ±180 degrees with detents at -180, -90, 0, +90, and +180 degrees Full 43cm x 43cm (17 in) coverage at a 100 cm SID Accessory rail for use with optional Al or Cu spectral filters or optional DAP meter Aluminum Equivalent Filtration: 3.1 to 3.7mm at 70kVp

Dose Area Product (DAP) Meter (Option) Aluminum Equivalent Filtration: 0.2mm at 70kVp

Specifications


User Interface Integrated 15 in (38.1 cm) touch-screen user interface Monitor matrix size 1024 x 768 pixels USB outlets for external drive, barcode reader, service mouse and keyboard

Specifications


Drive Battery operated Self propelled single drive handle control Variable speed of up to 5 km/h (3.1 mph) forward and reverse, automatically adjusts to the

operator’s pace; variable to adjust to the operator’s pace. Capable of climbing an incline of 7°

Specifications


Safety and Compliance Drive Inhibit keypad access for JCAHO compliance Password protected access to patient information for compliance with confidentiality

regulations Automatic safety brake: Operator must press drive controls to allow system movement Integrated front bumper stops unit and activates brakes when activated

Specifications


Mechanical Characteristics Overall Width 54.1cm/21.3in (Includes front bumper) Overall Height 193.2cm/76.1in Tube Height in Transport (lookover) 138.0cm/54.3in Overall Length 122.3cm/48.1in Weight: 436kg/960lbs

Specifications


Environmental Conditions

System

Temperature

Operating +10° C to +35° C

Non-Operating System -10° C to +45° C

Humidity

Operating 30% to 75% RH, non-condensing (maximum change 30% per hour)

Non-Operating 25% to 85% RH, non-condensing (maximum change 30% per hour)

Altitude

Operating -30 m to +3,000 m relative to sea level

Non-Operating -30 m to +3,000 m relative to sea level

Atmosphere Pressure

Operating 106 kPa to 70.1 kPa

Non-Operating 106 kPa to 70 kPa

Audible Noise

Operating 60 dBA maximum audible noise at any point 1 meter from system

Idle 50 dBA maximum audible noise at any point 1 meter from system

Specifications


Options30 kw Generator

Available 30 kW (nominal) optionDose Area Product Meter

5400233-1EN Rev 4 Brivo XR285amx C-1

C EMC Compliance Statement

EMC Compliance Statement


IntroductionThis equipment complies with IEC 60601-1-2 Edition 3.0 (2007-03) EMC standards for medical devices.

This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and radio communications.

To provide reasonable protection against such interference, this product complies with the radiated emission standard limits as per CISPR11 Group1 Class A standard limits. However, there is no guarantee that interference will not occur in a particular installation.

If this equipment is found to cause interference (which may be determined by turning the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s):

Reorient or relocate the affected device(s) Increase the separation between the equipment and the affected device (see recommended

separation distances in Table B-4) Power the equipment from a source different from that of the affected device Consult the point of purchase or service representative for further suggestionsThe manufacturer is not responsible for any interference caused by using other than recommended interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the users' authority to operate the equipment.

All interconnect cables to peripheral devices must be shielded and properly grounded, except when technologically prohibited. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference.

These systems are intended for use in non-domestic environments, and not directly connected to the Public Mains Network that supplies buildings used for domestic purposes.

Mobile X-ray machines are susceptible to Electromagnetic Interference (EMI) from radio frequencies, magnetic fields, and transient in the air wiring. They also generate EMI. The Brivo XR285amx complies with limits as stated on the EMC label. However there is no guarantee that interference will not occur in a particular installation. Possible EMI sources should be identified before the unit is installed.

Electrical and electronic equipment may produce EMI unintentionally as the result of defect. These sources may include:

CT scanner MRI scanners High frequency surgical devices Diathermic devicesThe presence of a broadcast station or broadcast van may also cause interference.

The magnetic field environment from a MRI device located nearby is a risk of interference.

All of the above are required to achieve the Electromagnetic Compatibility for a typical installation of the system. Further detailed data and requirements are described in the Use Recommendations and Installation Recommendations sections.



Compatibility TablesThis equipment complies with IEC 60601-1-2 Edition 3.0 (2007-03) EMC standards for medical devices. These systems are suitable to be used in an electromagnetic environment, as per the limits and recommendations described in the tables hereafter:

Brivo XR285amx Electromagnetic Emission (Table B-1). Brivo XR285amx System Electromagnetic Immunity (see Table B-2 and Table B-3).NOTE: Note: This system complies with above mentioned EMC standard when used with

supplied cables. If different cable lengths are required, contact a qualified service representative for advice.



Electromagnetic EmissionTable C-1 Brivo XR285amx Electromagnetic Emission

Guidance and manufacturer’s declaration – Electromagnetic Emissions

These systems are intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment Guidance

RF emissions, CISPR 11 Group 1

These systems use RF energy only for its internal function. Therefore, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions, CISPR 11 Class A

These systems are intended for use in non-domestic environments, and not directly connected to the Public Mains Network. These systems are intended for use (e.g. in hospitals) with a dedicated supply system, and in an x-ray shielded room.

Harmonic Emissions, IEC 61000-3-2

Voltage Fluctuations/Flicker Emissions, IEC 61000-3-3

<16 A per phase Based on IEC 60601-1-2, IEC 61000-3-2 and IEC 61000-3-3.



Electromagnetic ImmunityTable C-2 Brivo XR285amx System Electromagnetic Immunity

Guidance and Manufacturer’s declaration – electromagnetic immunity.

These systems are intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.

Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance

Electrostatic Discharge (ESD), IEC 61000-4-2

+/- 6 kV contact.

+/- 8 kV air.

+/- 6 kV contact.

+/- 8 kV air.

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast Transient/Burst, EC 61000-4-4

+/- 2 kV for power supply lines.

+/- 1 kV for input/output lines.

+/- 2 kV for power supply lines.

+/- 1 kV for input/output lines.

Mains power quality should be that of a typical commercial or hospital environment

Surge, IEC 61000-4-5

+/- 1 kV line(s) to line(s).

+/- 2 kV line(s) to earth.

+/- 1 kV line(s) to line(s).

+/- 2 kV line(s) to earth.

Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines, IEC 61000-4-11

< 5% UT a, (> 95% dip in UT) for 0.5 cycle.

< 5% UT b , (> 95% dip in UT) for 0.5 cycle.

Because the systems draw 16 Amps per phase, the only test required is to drop each phase out for 5 seconds.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the system requires continued operation during power mains interruptions, it is recommended that the system be powered from an un-interruptible power supply or a battery.

40% UT, (60% dip in UT) for 5 cycles.




< 5% UT, (> 95% dip in UT) for 5 sec.

< 5% UT, (> 95% dip in UT) for 5 sec.

Power Frequency (50/60 Hz) Magnetic Field, IEC 61000-4-8

3 A/m 3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.



aUT is the a.c. mains voltage prior to application of the test level.bUT is the a.c. mains voltage prior to application of the test level.

Table C-3 Brivo XR285amx System Electromagnetic Immunity (Continued)

Guidance and Manufacturer’s declaration - electromagnetic immunity. These systems are suitable for use in the specified electromagnetic environment. The customer or the user of the system should assure that it is used in an electromagnetic environment as described below.

Immunity Test IEC 60601-1-2 Test Level

Compliance Level Electromagnetic Environment Guidance

Conducted RF, IEC 61000-4-6

3 Vrms, 150 kHz to 80 MHz V1 = 3Vrms Portable and mobile RF communications

equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.

Recommended Separation Distance

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.

Radiated RF IEC 61000-4-3

3 V/m, 80 MHz to 2.5 GHz E1 = 3V/m



Table C-4 Recommended Separation Distances

Interference may occur in the vicinity of equipment marked with the following symbol:

aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above, the system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the system.

bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than V1.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Guidance and Manufacturer’s declaration - electromagnetic immunity. These systems are suitable for use in the specified electromagnetic environment. The customer or the user of the system should assure that it is used in an electromagnetic environment as described below.

Immunity Test IEC 60601-1-2 Test Level

Compliance Level Electromagnetic Environment Guidance

Recommended separation distances between portable and mobile RF communications equipment and the system

The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.

Rated Maximum Output Power (P) of Transmitter Watts (W)

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

Separation Distance meters

80 MHz to 800 MHz


800 MHz to 2.5 GHz


0.01 (10 mW) 0.12 0.12 0.23



0.1 (100 mW) 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the separation distance can be estimated using the equation in the corresponding column, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. V1 is the COMPLIANCE LEVEL for the IEC 61000-4-6 test and E1 is the COMPLIANCE LEVEL for the IEC 61000-4-3 test. V1 is in V and E1 is in V/m.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.



Use RecommendationsThis product complies with IEC 60601-1-2 Edition 3.0 (2007-03) EMC standard for medical devices and with radio frequency emission requirements per CISPR11 Group1 Class A standard limits. The system is intended for use in hospitals.

Do not use devices which intentionally transmit RF signals (cellular phones, transceivers, or radio controlled products) in the vicinity of this equipment as it may cause performance outside the published specifications. Keep the power to these types of devices turned off when near this equipment.

Adhering to the distance separation recommended in Table B-4, between 150 kHz and 2.5 GHz, will reduce disturbances recorded at the image level but may not eliminate all disturbances. However, when installed and operated as specified herein, the system will maintain its essential performance including safe x-ray acquisition and patient positioning, proper error reporting, and integrity of patient and image data.

For example, a 1W mobile phone (800 MHz to 2.5 GHz carrier frequency) shall be put 2.3 meters apart from the system (in order to avoid image interference risks).

The use of accessories, transducers, and cables other than those specified may result in degraded ELECTROMAGNETIC COMPATIBILITY of the system.

The medical staff in charge of this equipment is required to instruct technicians, patients, and other people who may be around this equipment to comply fully with the above equipment requirements.



Installation RecommendationsThis system complies with above mentioned EMC standard when used with supplied cables up to maximum lengths referenced in the system’s Pre-Installation Manual.

In order to minimize interference risks, the following requirements shall apply.



Cable Shielding and GroundingAll interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference.

Subsystem and Accessories Power Supply Distribution All components, accessories subsystems, systems which are electrically connected to the system, must have all AC power supplied by the same power distribution panel and line.

Stacked Components and EquipmentThe system should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the system should be tested and verified in order to ensure normal operation in the configuration in which it will be used. Consult qualified personnel regarding device/system configurations.

Low Frequency Magnetic FieldNot applicable.

Static Magnetic Field LimitsIn order to avoid interference on the system, static field limits from the surrounding environment are specified.

Static field is specified less than <1 Gauss around the unit.

Electrostatic Discharge Environment and RecommendationsIn order to reduce electrostatic discharge interference, install a charge dissipative floor material to avoid electrostatic charge buildup.

The relative humidity shall be at least 30 percent.

The dissipative material shall be connected to the system ground reference, if applicable.

operator manual - brivo xr285amx

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