Document Information for: 5475521TPH

Type Drawing Print

Name 5475521TPH
Revision 6
State Release
ECO 2156773
Description Brivo XR 115 Operator Manual
Originator 305018930_visveshvaren__ms

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2. 5475521TPH_s1_r6.docx
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Person Action Date and Time
305018930_visveshvaren__m s Approved 09/12/2013 09:01:58 am GMT
305025941_krupa__maria Approved 09/14/2013 05:08:17 am GMT
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 GE Healthcare

Brivo XR 115
Mobile X-Ray System

Operator Manual
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

5475521, Revision 6
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Brivo XR 115
Operator Manual, English
© 2013 General Electric Company
All rights reserved.

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 Brivo XR 115 complies with India regulations required for sale.

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

Contact Information
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Manufactured by:

Wipro GE Healthcare Private Ltd.,

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122 Part 1, EPIP, Whitefield,

Bangalore - 560066, India.

Web address:

www.gehealthcare.com

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 Table of Contents
Preface ....................................................................................................................... i-1

Important! ...................................................................................................................................................................................... i-2

Safety Conventions used in the Manual .......................................................................................................................... i-2
Important precautions for X-radiation protection ..................................................................................................... i-3

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

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

1.2. Purpose of the Manual ........................................................................................................................................... 1-2
1.3. Prerequisite skills ....................................................................................................................................................... 1-2
1.4. Equipment classification........................................................................................................................................ 1-3
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1.5. Safety information .................................................................................................................................................... 1-3

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

2.1 Indications for Use .................................................................................................................................................... 2-2

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2.2 Contraindication for Use ........................................................................................................................................ 2-2

2.3 Radiation safety and X-Ray Protection........................................................................................................... 2-3
2.3.1 Good operating practices ................................................................................................................................ 2-3
2.3.2 Monitoring of Personnel .................................................................................................................................... 2-5
2.4 User’s responsibility ................................................................................................................................................. 2-5
2.5 Electrical Safety .......................................................................................................................................................... 2-7
2.6 Mechanical Safety..................................................................................................................................................... 2-7
2.7 Patient Positioning Warnings .............................................................................................................................. 2-8
2.8 Regulatory Requirements ..................................................................................................................................... 2-8
2.9 General Disposal..................................................................................................................................................... 2-10
2.10 Pediatric Imaging ................................................................................................................................................... 2-10
2.10.1 Radiation Exposure Sensitivity............................................................................................................... 2-11
2.10.2 Parameters to be used .............................................................................................................................. 2-11
2.10.3 Suggestions for Minimizing Unnecessary Dose ............................................................................ 2-11
2.11 Markings and symbols ......................................................................................................................................... 2-12
2.11.1 Special Notices .............................................................................................................................................. 2-12

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 2.11.2 System Power ON/OFF and reset ......................................................................................................... 2-12
2.11.3 Electrical current .......................................................................................................................................... 2-13
2.11.4 Ground............................................................................................................................................................... 2-13
2.11.5 Collimator......................................................................................................................................................... 2-13
2.11.6 X-radiation ....................................................................................................................................................... 2-13
2.12 Identification and Rating plates ...................................................................................................................... 2-14

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

3.1 Overview and system description ..................................................................................................................... 3-2

3.1.1 Product features and highlights ................................................................................................................... 3-2
3.2 Component Identification ..................................................................................................................................... 3-3
3.3 System Console .......................................................................................................................................................... 3-5
3.4 Console Keys ............................................................................................................................................................... 3-5
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3.5 Hand-switch ................................................................................................................................................................ 3-7

3.6 Audible signals ............................................................................................................................................................ 3-8
3.7 Parameter selection ................................................................................................................................................. 3-8

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

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4.1 Locking and Unlocking the unit .......................................................................................................................... 4-2

4.2 Moving the unit........................................................................................................................................................... 4-2
4.3 Positioning the Swivel Arm ................................................................................................................................... 4-3
4.4 Turning the unit ON .................................................................................................................................................. 4-4
4.5 Positioning the Tube Head.................................................................................................................................... 4-5
4.5.1 Rotation of X-ray tube assembly .................................................................................................................. 4-6
4.5.2 Collimator adjustment ....................................................................................................................................... 4-6

Image Acquisition ................................................................................................... 5-1

5.1 General Image Acquisition.................................................................................................................................... 5-2

Troubleshooting ...................................................................................................... 6-1

6.1 Errors and Warnings ................................................................................................................................................ 6-2

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 Maintenance ............................................................................................................ 7-1

7.1 General ........................................................................................................................................................................... 7-2

7.2 Qualified Service ........................................................................................................................................................ 7-2
7.3 General Cleaning and Disinfecting ................................................................................................................... 7-2
7.4 User Maintenance/ Quality Checks .................................................................................................................. 7-3
7.5 Periodic Maintenance by Service Personnel ................................................................................................ 7-4
7.6 Shipping and Long term Storage ...................................................................................................................... 7-4
7.7 Caring for Your Equipment ................................................................................................................................... 7-4

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

A-1 Technical Specifications......................................................................................................................................... A-2

A-2 X-ray tube Head Specifications .......................................................................................................................... A-2
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A-3 Mechanical Dimensions and Weight ............................................................................................................... A-3

A-4 Mains Power Requirements ................................................................................................................................. A-3
A-5 Environmental Conditions ..................................................................................................................................... A-3

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

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B-2 Compatibility Tables................................................................................................................................................. B-2

B-3 Use Recommendations ......................................................................................................................................... B-5
B-4 Cable Shielding and Grounding.......................................................................................................................... B-5

APR values for Brivo XR 115 .................................................................................. C-1

C-1 Recommended APR values for Brivo XR 115 ............................................................................................... C-2

Installation Instructions ........................................................................................D-1

D-1 Damage in transportation ....................................................................................................................................D-2

D-2 Safety ..............................................................................................................................................................................D-2
D-3 Installation Process ..................................................................................................................................................D-2
D-3.1 System components ...........................................................................................................................................D-2
D-3.2 Site preparation.....................................................................................................................................................D-2
D-3.3 Installation Procedure ........................................................................................................................................D-3

Revision History

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5475521-1EN, Revision 6
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Brivo XR 115
Preface
Chapter i

i-1
 Preface

Important!
The purpose of this Operator manual is to provide instructions for the proper use of the
system. It is the responsibility of the user to read this manual carefully as it contains
information that is crucial to the safety of the operator and the patient.

All of the information contained herein is based on the current version of the system.
GE Healthcare reserves the right to improve and implement changes to the information
herein to reflect any changes that maybe necessitated by technological enhancements to
the system.

Safety Conventions used in the Manual

Specific symbols and conventions are used in the manual to emphasize the importance of
safety. Universal symbols are used to highlight warning, danger or caution notices. This
section also describes the purpose of a NOTE.
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DANGER Danger is used to identify conditions or actions for which a specific hazard is
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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.

NOTE A Note provides additional information that may emphasize certain

information regarding special tools or techniques, items to check before
proceeding or factors to consider about a concept or task.

5475521-1EN, Revision 6 Brivo XR 115 i-2

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 Preface

Important precautions for X-radiation protection

WARNING This X-ray unit must be used in strict compliance with the safety instructions
contained in this manual and must not be used for purposes other than those
for which it was intended.

X-Ray equipment if not properly used may cause injury. Accordingly, the instructions
contained herein should be thoroughly read and understood before you attempt to place
this equipment in operation. GE Healthcare or its authorized representatives will be glad to
assist and co-operate in installing and setting up this equipment for use.
Although the equipment incorporates a high degree of protection against diagnostically
irrelevant X-radiation, no practical design of equipment can provide or ensure complete
protection.
It is important to note that, no mandatory safety procedures can be implemented by GE
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Healthcare or its authorized representatives to ensure that the operator or other users 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.
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It is important that everyone having anything to do with X-radiation be fully acquainted with
the recommendations as per the local regulation recommendations. For India, refer to Atomic
Energy Research Board (AERB), India regulations and take adequate steps to insure
protection against injury.

WARNING 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, its agents, and
representatives have no responsibility for injury or damage which may result
from exposure to X-radiation

Various materials and devices are available for protection against radiation. It is urged that
such materials and devices be used to ensure safety of the user and patient.

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5475521-1EN, Revision 6
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Brivo XR 115
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i-4
 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
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5475521-1EN, Revision 6
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Brivo XR 115
Chapter 1
Introduction

1-1
 Introduction

1.1. Introduction
It is recommended to keep the Operator Manual accessible and readily available to the user
at all times. It is the responsibility of the facility owning the equipment to periodically review
the procedures and safety precautions provided in the manual. It is important to read and
understand the contents of this manual before attempting to use this product.
It is urged that the operating instructions be studied and followed carefully before any
operation is attempted.

1.2. Purpose of the Manual

This manual is written for health care professionals (namely, Radiology technologist,
technicians and doctors) to provide the necessary information relating to the proper
operation of this system. It is intended to guide the user on system components and features
necessary to use the equipment to its maximum potential.
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NOTE: The manual is not intended to teach radiology or to aid in making any type of clinical
diagnosis.

1.3. Prerequisite skills

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It is necessary for the operator to have sufficient knowledge to competently perform various
diagnostic imaging procedures.
The system should be used only by a qualified Radiology Technician, Radiology Technologist,
Radiology doctors and related Health Care Professionals.
Radiology Technologist/Technician shall be qualified as per AERB –India regulations and
should be trained in performing radiography on patients in the department/ward.
Radiology doctors who shall use the system shall complete medical graduation with a post-
graduation certificate or shall be undergoing post-graduation in Radiology Services and
should be trained in performing radiography on patients in the department/ward.

WARNING Radiographic equipment must be operated only by qualified personnel and

only after sufficient training.

The equipment can be deployed in locations that may include Orthopedic Clinics, Radiology
Imaging Centers, hospital Radiology Departments, or hospital Orthopedic Departments, ICU
(Intensive Care Unit), NICU (Neonatal Intensive Care Unit), PICU (Pediatric Intensive Care

5475521-1EN, Revision 6 Brivo XR 115 1-2

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 Introduction

Unit), CCU (Critical care Unit), Emergency Room, Operating Room, Nursing Home, Radiology
department, Outpatient Surgery Clinic and Oncology clinics/hospitals.

1.4. Equipment classification

This product is a mobile general purpose radiographic X-ray system. The following
equipment classification is applicable to this product:
 Equipment classification with respect to protection from electric shock: Class I
 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: Non- Continuous with intermittent loading.

1.5. Safety information

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For information on safety and safety notices please refer to Chapter 2: Safety and
Regulatory of this manual. This chapter describes in detail, the safety information that has to
be understood by the operator before using the system.
NOTE: Additional information pertaining to safety will also be detailed in applicable sections
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throughout the Operator Manual.

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Introduction

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Brivo XR 115
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1-4
 Safety and Regulatory

Chapter 2
Safety and Regulatory
This chapter explains the indications and contraindication for use, safety considerations,
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equipment related and patient related precautions and symbols used for the safe and
successful operation of your equipment.
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5475521-1EN, Revision 6 Brivo XR 115 2-1

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 Safety and Regulatory

2.1 Indications for Use

Brivo XR 115 mobile radiographic imaging system is designed to generate diagnostic
radiographic X-rays that may be used to detect disease or injury early enough for a medical
problem to be managed, treated or cured.
X-rays are used in many types of examinations and procedures that include radiography to
find orthopedic damage, tumors, pneumonia and foreign objects.
The Brivo XR 115 Mobile X-Ray system is intended to take exposures utilizing film based
cassettes or Computed Radiography (CR) Cassette.
The system is indicated for use on neonates, pediatric, adult and elderly patients for general-
purpose diagnostic radiographic examinations and procedures. Indicated use of the system
is irrespective of gender, height and weight.
The mobility of the system enables general-purpose radiographic procedures throughout
the clinical environment, or as needed within the Emergency, Intensive care (ICU), Neonatal
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Intensive Care Unit, Cardiac and Operating departments, for patients who have limited
mobility or in cases where it is unsafe or impractical to move them to a traditional RAD room.
The Brivo XR 115 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
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in prone or supine position.

CAUTION Consult a physician if a Radiography test is to be done on a pregnant women

2.2 Contraindication for Use

The Brivo XR 115 is not intended for fluoroscopy, mammography and dental applications.

CAUTION The system is not intended for therapeutic use.

The system should not be plugged to the mains, during transportation. e.g., in
ambulance.
The system is not intended for any experimental or unapproved procedures.

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 Safety and Regulatory

WARNING It is forbidden to use this device to take exposures repeatedly and frequently
for the same patient.

2.3 Radiation safety and X-Ray Protection

Owing to the ionizing effects of X-radiation, elongated exposures to radiation may be
damaging to health. Some of the effects of X-ray radiation are cumulative and may extend
over a period of months or years.
NOTE: The best rule for safety of the X-ray operator is to 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 of the object material struck by the primary beam.
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Take protective measures to safeguard against it.

It is important that everyone associated with X-radiation be properly trained and fully
acquainted with the recommendations of AERB regulations. Additionally, all personnel must
take adequate steps for protection against injury.
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CAUTION Always provide necessary radiation protection for your patient, the operator
and bystanders when operating the unit.
Prior to taking an X-ray, ensure that necessary precautions are taken to
prevent injury or damage that may result from exposure to X-radiation.
It is the User’s responsibility to provide means for audio and visual
communication between the Operator and the patient

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.

2.3.1 Good operating practices

During the use of X-rays, personnel present in the room must comply with the
following rules concerning protection against ionizing radiation:
 Do not use a coupler device or a separable plug which makes the equipment
difficult to disconnect from the supply.

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 Safety and Regulatory

 When necessary, use protective shielding against radiation in addition to the

shielding already provided on the unit. Use protective aprons containing a
material equivalent to 0.25mm of lead.
 The best protection against radiation is distance. It is therefore recommended
that you stay as far as possible from the X-ray source and the exposure target.
For this purpose, use all of the cable length provided for the hand switch.
 Avoid walking or standing directly in the direction of the X-ray beam.
 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
 Always use the proper field size and technic factors for each procedure to
minimize X-ray exposure and produce the best diagnostic results
 Check the display carefully before making an exposure. Verify that the selected
technique is the intended technique for a specific radiograph/procedure.
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 Always use the smallest possible field of exposure by closing the collimator
diaphragms appropriate. The scatter dose produced depends principally on the
volume of the irradiated object.
 Ask visitors to step outside the room during an exposure
 When X-raying bed patients, move them away, as far as possible, from nearby
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patients.
 Use gonad shields for patients whenever possible.

CAUTION During an X-ray exposure, if people other than the patient and the operator,
are present in the room, it is the operator/ facility’s responsibility to ensure that
adequate safety practices are followed to prevent unwarranted exposure to x-
radiation.

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.

NOTE: Under most conditions, cumulative radiation dose to the operator will not exceed
recommended maximum permissible levels. However, a qualified radiation expert should

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 Safety and Regulatory

evaluate situations involving frequent exposures using high kVp and mAs technic to
determine if extra protection devices are necessary.

2.3.2 Monitoring of Personnel

It is the responsibility of the hospitals/clinics to regularly monitor personnel, to
determine the amount of radiation to which they have been exposed. This provides a
valuable cross check to determine whether implemented safety measures are
adequate. It may reveal inadequate/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 to use instruments that 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 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 Thermo- luminescent material enclosed within a holder that may be
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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.
See the GEHC Myworkshop System to determine the status of this document.

2.4 User’s responsibility

The operator is responsible for the use of the system in compliance with the applicable
standards concerning installation and use.

WARNING
This system shall not be used under flammable environment
Preventive maintenance or regular checks may not always help in
identifying potential failure or malfunction of components such as X-ray
tubes etc.
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.

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 Safety and Regulatory

 The system should not be operated when the system components or cable
insulations are damaged or when there is any system components that are loose and
free. Please contact service for safety.
 Perform periodic maintenance to ensure continued safe use of the equipment. Follow
recommended preventive maintenance as outlined in Chapter 7
 There are no operator serviceable parts or adjustments inside. Only trained service
personnel authorized by GE Healthcare may remove the unit covers and are
permitted access to the internal parts of the equipment and only in accordance with
the instructions contained in the Service Manual.
 GE Healthcare will provide necessary diagnostic diagrams, component part lists,
descriptions and calibration instructions to assist the service personnel in parts
repair.
 The X-ray system should be wheeled only into rooms or spaces that are sufficiently
bigger in dimension than the system itself. To prevent damage to the system or injury
to the operator, do not force the unit into areas that are too small to accommodate it.
 It is recommended that the minimum door size of the room is 6’ x 4’ and the room
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ceiling is at a minimum height of 3.0 meters.

NOTE: Installation instructions for Brivo XR 115 can be found in the Installation section
under Appendix D
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WARNING Electric Shock Hazard! Do not remove covers. The system contains high voltage
circuits for generating and controlling X-rays. Never touch the patient and any
exposed low safety circuits or connectors simultaneously. Serious injury may
occur.

CAUTION GE Healthcare is responsible for the safety of its products only when
maintenance have been performed by GE Healthcare or its own agreed
distributors.
GE Healthcare cannot be held liable for any malfunction, damage, or danger
resulting from improper use of the system or non-compliance with the rules of
proper maintenance.

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 Safety and Regulatory

2.5 Electrical Safety

This X-ray unit may only be used in environments or medical rooms in compliance with the
applicable IEC standards.

CAUTION Electric shock hazard! This equipment must only be connected to supply mains
with protective earth.
Do not remove covers or panels. The acquisition console and cabinets contain
high voltage circuits for generating and controlling X-Ray. Prevent possible
electric shock by leaving covers or panels on the equipment.
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
condition is to be used in proximity to this X-ray Unit.
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To prevent accidental exposures and/or injury ensure that the system safety
circuits and devices must not, for any reason, be moved, modified, or omitted.
The unit should not be used in areas where danger of explosion exists.

When used in conjunction with other apparatus, components, or modules,

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whose compatibility is uncertain, it is necessary to ensure the absence of any

danger to the patient or operator. Consult GE Healthcare for information.
Take precautions not to damage the system covers /cabinet that may lead to
reduction in electrical spacing of high voltage electronics.

2.6 Mechanical Safety

CAUTION After positioning the unit, engage the parking brakes. This prevents unintended
movement of the system.
For safe and easy operation, always use the handles provided for moving
and/or re-positioning the system and its components
Observe equipment limitations when moving the mobile system up or down on
an inclined plane. In the transport (parked) position the mobile system can be
driven up to a 10-degree incline.

Refer to Section 2.12 –“Incline limit label” for more information

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 Safety and Regulatory

2.7 Patient Positioning Warnings

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 appropriate protective materials
and patient positioning devices.

CAUTION Keep the patient in full view at all times and never leave the patient
unattended.
To avoid patient injury, always assist the patient as needed, from the
beginning to the end of an exam.
Make sure that patient connected lines; tubes, etc. do not become pinched or
pulled.
Thoroughly check there is no interference or possibility of collision between
the patient and other equipment.
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2.8 Regulatory Requirements

Brivo XR 115 complies with the following safety standards and code:
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 IS 7620(Part 1): 1986,

 IEC 60601-1:1988 +A1:1991+A:1995
 IEC 60601-1:2005 +CORR.1(2006) + CORR.2(2007)
 IEC 60601-2-7:1998.
 Atomic Energy Regulatory Board (AERB) Safety code no. AERB/SC/MED-2 (Rev.1)

GE Healthcare has tested this equipment and is in compliance with the applicable
regulations regarding EMC. Refer to Appendix B for information on Electromagnetic
Compatibility, Requirements and tests, which defines the maximum allowed emission levels
from electronic devices and the required immunity from interference caused by externally
generated electromagnetic fields.
It is not, however, possible to exclude radio signals coming from transmitters such as mobile
phones or similar mobile radio devices. These and other transmitting devices, including
those in compliance with the EMC standards, may influence the functioning of medical
apparatus when used in proximity with it.

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WARNING 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 result in performance outside the published
specifications.

CAUTION Mobile phones must be switched off in zones close to the unit. These rules must
be applied when the unit is switched on i.e. connected to the mains and ready
for use.
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
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

NOTE: This equipment generates, uses, and can radiate radio frequency energy. The equipment may
cause radio frequency interference to other medical, 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.
See the GEHC Myworkshop System to determine the status of this document.

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

a) Reorient or relocate the affected devices.

b) Increase the space separating the equipment and the affected device.
c) 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: 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.

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

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

CAUTION This system source assembly is designed to be used with only the Brivo XR 115
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.

2.9 General Disposal

In order to comply with applicable safety requirements, the system may be comprised of
materials that may be harmful to the environment (for example: tube head oil, protective
lead, circuit boards and electronic components).
The equipment must be disposed as per the WEEE (Waste of Electrical and Electronic
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Equipment) directive which states that the unit or its components must not be disposed as
unsorted municipal waste and must be collected separately.

Figure 2-1 Disposal of waste symbol

See the GEHC Myworkshop System to determine the status of this document.

Please contact an authorized representative of the manufacturer for information concerning

the decommissioning of your equipment.
To protect the environment, it is mandatory to follow proper disposal methods, according to
the regulations of the country where the unit is installed.

2.10 Pediatric Imaging

GE 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.

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2.10.1 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. 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.
Everyone shares the responsibility of minimizing pediatric 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.

2.10.2 Parameters to be used

It is recommended that the team of Radiologists, Medical Physicists and
Technologists work together to evaluate and deduce techniques that may reduce
radiation dose and provide adequate diagnostic information.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

2.10.3 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.
See the GEHC Myworkshop System to determine the status of this document.

 Properly Center All Patients: In addition to collimation, centering of intended

anatomy should be considered. Improper centering may lead to repeat exposure. (If
applicable)
 Check Technical Factors Before Exposure: Review the technical display carefully
before making an exposure to verify selected and intended techniques are the same.
Pay attention to the displayed 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.
 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.

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2.11 Markings and symbols

Markings and symbols on the system and in its accompanying documents are listed below.

2.11.1 Special Notices

Table 2-1 Special notices

Symbol Description

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.

2.11.2 System Power ON/OFF and reset

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Table 2-2 System Power and Reset symbols

Symbol Description
See the GEHC Myworkshop System to determine the status of this document.

The mains ON LED glows green when the Mains wall socket and system rocker
switch is switched ON.
The POWER ON button is used to turn ON the system.

The Power OFF button is used to turn the system OFF

The fault LED glows RED when there is an error in the system.

Pressing the Reset button will bring back the technique parameters to its
previously set values.

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2.11.3 Electrical current

Table 2-3 Electrical Current

Symbol Description

This symbol indicates the equipment is suitable for alternating current only.

Warning: Dangerous voltage.

2.11.4 Ground
Table 2-4 Ground

Symbol Description
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

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.
See the GEHC Myworkshop System to determine the status of this document.

2.11.5 Collimator
Table 2-5 Collimator

Symbol Description

Collimator lamp button for indicating radiation field by using light.

2.11.6 X-radiation
Table 2-6 X-ray emission

Symbol Description

Used to indicate that 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.

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2.12 Identification and Rating plates

Product identification and rating labels can be found on the system.
Table 2-7 Identification and Rating plates

DESCRIPTION LABEL / CONTENTS LOCATION

SYSTEM RATING
COLUMN
LABEL
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

Total Serial
Manufa Equipment Manufact. Model
unit No. of
cturer classification Date no.
weight system

COLUMN
INCLINE LIMIT
LABEL

Refer to Instructions The operating instructions

should be consulted to ensure
safe operation

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When not in the transport position, In the transport (parked)

do not drive the mobile system up position the mobile system
an incline greater than 5 degrees can be driven up to a 10-
degree incline.

X-RAY CONSOLE- CONSOLE

RADIATION
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

WARNING LABEL
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.
See the GEHC Myworkshop System to determine the status of this document.

TUBE HEAD
X-RAY TUBE HEAD
RATING LABEL ASSEMBLY

Caution: X-rays

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TUBE
IDENTIFICATION X-RAY TUBE
LABEL
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

LIGHT FIELD/ X- COLLIMATOR

RAY FIELD SIZE UNIT
LABEL
See the GEHC Myworkshop System to determine the status of this document.

The information specifying corresponding FOV in inches and

millimeters, for a specified SID can be found on the collimator.

COLLIMATOR
KNOB CONTROL COLLIMATOR
LABEL (x2) UNIT

Used for indicating lateral and longitudinal shutter positioning.

Each position (identified from 0 to 8) of the collimator knob control,
corresponds to its Light field/ X-ray field size as indicated in the
table above

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Note: Collimator knob on the tube head can either represent the
image as above (without graduation above the knob) or as below
image (with graduations above the knob).
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

COLLIMATOR COLLIMATOR
KNOB CONTROL UNIT
See the GEHC Myworkshop System to determine the status of this document.

LABEL (x2)

Used for indicating lateral and longitudinal shutter positioning.

Each position of the collimator knob control corresponds to its
Light field/X-ray field size indicated for 40 inch (100cm) and 72
inch (180cm) SID.

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FOCAL SPOT TUBEHEAD

LABEL
Represents the position of the focal spot inside the Tube head. This
is for information purpose only.

CAUTION- HOT COLLIMATOR

SURFACE LABEL UNIT
(x2)
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

The collimator enclosure may get hot during extended use. To avoid
burn injuries, exercise caution.
See the GEHC Myworkshop System to determine the status of this document.

TUBE BOTH SIDES OF

ANGULATION THE TUBE
REFERENCE BRACKET

LH Bracket RH Bracket

A tape is wound around each end of the bracket that holds the tube
head. The tape markings provide an indication of the degree to
which the tube assembly has been moved in the backward and
forward direction as shown in Figure 4-6b)

ONE LOGO ON
THE TUBE HEAD
GE LOGO AND TWO LOGO S
ON EITHER SIDE
OF THE CABINET.

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.
Safety and Regulatory

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Brivo XR 115
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2-19
 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.
Safety and Regulatory

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2-20
 General Information

Chapter 3
General Information
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

This chapter explains some of the basic operations and features of the Mobile X-ray Unit.
See the GEHC Myworkshop System to determine the status of this document.

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3.1 Overview and system description

This unit is a mobile X-ray system aimed to fulfill a wide range of clinical applications.
The system console provides the user the ability to control the acquisition technique
parameters (kV, mAs) manually.
It must be operated exclusively by qualified, trained personnel who have been informed of
the risks linked to the use of ionizing radiation.

3.1.1 Product features and highlights

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

 The compactness and maneuverability of the unit enables the operator to

navigate through obstacles such as doors, small rooms, narrow aisles and
elevators with ease and allows accurate positioning between patient beds.
 The ergonomic design of the unit allows the operator excellent visibility during
operation and movement.
 The perfectly balanced tube head arm allows free movement and positioning
even in the more awkward positions.
 The shape of the base allows easy positioning under the patient bed to reach any
part of patient anatomy.
 The position and shape of the four antistatic wheels make the system easy to
move even on coarse surfaces.
NOTE: Location and appearance of some of the system components is subject to change

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CAUTION The system does not belong to the category of equipment designed for
continuous operation.

3.2 Component Identification

Table 3-1 Component Identification
Item Description Item Description

1 Tube Head 7 Handle for transport

2 Handle to lift the Swivel arm 8 Holder for accessories

3 Swivel Arm 9 Cassette Bin

4 Hand Switch 10 Foot rest to tilt the unit across the

threshold
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

5 Parking Lock 11 Parking brake

6 Console

Figure 3-1a) Component identification

See the GEHC Myworkshop System to determine the status of this document.

4
6
3
7

8 2

9 1

10

11

NOTE: Location and appearance of some of the system components is subject to change.

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Table 3-2 Component Identification

Item Description Item Description

1 Rocker Switch 6 Tube Head bracket

2 Cable winder 7 Collimator with knob
3 Tube head handle 8 Collimator handle

4 Goniometer 9 Parking Lock

5 Tube head 10 Hand Switch

Figure 3-1b) Component identification

5
6 4

7
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

8 3

9
See the GEHC Myworkshop System to determine the status of this document.

10

CAUTION The system is not used in direct contact with the patient; however, accidental
contact of some unit parts with the patient and operator is possible
NOTE: Contact with the operator is strictly for reasons linked to the use of the equipment (normal
operation). Contact of the system with the patient is non-invasive

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3.3 System Console

The system console displays the currently selected kVp and mAs and system status messages or
errors.
Table 3-3 Control panel functions

Item Description Item Description

1 Mains ON Indicator 7 kV display field

2 Power ON Button 8 Fault indicator
3 Power OFF Button 9 System reset button
mAs increment/ decrement Exposure Ready Indicator/ X-ray ON
4 10
buttons Indicator

5 mAs display field

kV increment/ decrement 11 Collimator light switch

6
buttons
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Figure 3-3 Console key identification

11 10 9 8 7 6 5 4 3 1 2
See the GEHC Myworkshop System to determine the status of this document.

3.4 Console Keys

Table 3-4 Console key operation

Switch ON the system using Power ON button on the

Power ON button
console.

The green LED, when lit, indicates that the unit is

Mains Indication
connected to the Mains supply.

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To switch OFF the system, press the power OFF button.

Power OFF button
The power is disconnected to the system.

Collimator lamp ON/OFF button.

Collimator Lamp There are 2 collimator lamp switches – One on the
button console and the other on the tube head
(The collimator light ‘ON’ time is set for approximately 30
seconds)

When the system is in fault condition, Fault LED glows

Fault indication
RED.

Resets the system during fault condition. Previously set

System Reset parameters will be displayed.
button

NOTE: If the RESET key is pressed when the system is in stand-by condition (non-error condition); the
input voltage to the system “Vin” will be displayed on the console. This information is for use of
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

authorized Service Personnel only. Pressing the reset key again, will return the system to stand-by
mode.

kV + kV - To increment or decrement kV value

See the GEHC Myworkshop System to determine the status of this document.

mAs + mAs - To increment or decrement mAs value.

EXPOSURE
When the system is ready for exposure, the ‘Ready’ LED
READY
glows Green
Indicator

X-RAY ON When X-ray emission is in progress, the ‘Ready’ LED

Indicator glows yellow

NOTE:
a) The system needs a minimum room lighting of 60 to 80 lux for normal visibility to
move/or use the system inside the ward/ICU. Outside the room/ward, minimum lighting is
required to move the system within the hospital/ diagnostic center
b) If the system operating room lighting is more than 80 lux, the prep and exposure indications
may not be clearly visible

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3.5 Hand-switch
X-ray Exposures are made with the hand switch. The hand switch is a 2 relay, mechanical
switch which operates in 2 levels:
1. PREP
2. EXPOSE
Figure 3-3 Hand switch operation
1at level
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Hand Switch with 2 Level

1st Level “Prep” 2nd Level “Exposure”
Exposure
See the GEHC Myworkshop System to determine the status of this document.

LEVEL 1: Depressing the hand switch half way downwards until the READY indicator
glows green and an audible beep is heard, prepares the system to READY for exposure.
LEVEL 2: Depressing the hand switch button fully until the READY indicator turns from Green
to Yellow and an audible beep is heard, indicates that X-ray emission is in progress.
NOTE: The switch has to be released only at the end of the beep; which marks the
completion of exposure.

CAUTION
In case, an exposure does not terminate cut-off the power supply to the
equipment immediately.
If the prep and exposure LED does not light up during the procedure, do not use
the system. Log in a service call.
While taking an exposure, ensure that the hand switch passes through each
level of press one after the other, as described above. Pressing the hand switch
in quick succession before Prep is completed; results in a system inhibit error.
The system enters into fault mode (E25 On), with an error code display on the
console, a continuous beep and fault LED glowing red.

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NOTE: If the hand switch is released midway before the exposure could be completed, the
system displays the kV and mAs values up to which the exposure occurred. The system
identifies this as an error and goes into fault mode. Error “E57 Abt,” is displayed on the
console with a continuous beep and the fault LED glowing red.
The OFF position is when the Prep/Expose button on top of the hand switch is not in partially
or fully depressed state.

3.6 Audible signals

Table 3-4 Audible signals

Audible signal Scenario description

Single Beep Generated when the system is ready for exposure.
The ‘READY’ LED glows green
Exposure Generated when the X-ray emission is ON. The exposure beep will be continuously
Beep ON throughout X-ray ON time.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

The beep ON duration is equal to the duration of the X-ray ON time if it is greater
than 100msecs.
For all exposures with X-ray ON time less than 100msecs the beep ON duration is
100msecs
The ‘READY’ LED glows Yellow during exposure
See the GEHC Myworkshop System to determine the status of this document.

Long Beep Generated when the system is in fault condition, ‘FAULT’ LED glows RED.

CAUTION If the prep and exposure beep sounds are not heard, log a service call.
If the ambient sound, in the room where exposures are carried out, is greater
than 60dB, there is a possibility that the Prep and/or Exposure beeps may not
be heard.

3.7 Parameter selection

CAUTION The default technique factors for the system are 60kV and 10 mAs. These
values are placeholders only. No exposures should be made until the user
selects values appropriate for the patient size.

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Selection of kV and mAs parameters can be done in steps as detailed below

Table 3-5 Parameter selection

Radiographic
Step Range
parameter
Tube voltage (kV) 2 40kV to 70kV 70kV to 40 kV
Tube voltage (kV) 5 70kV to 100kV 100kV to 70kV
0.1 to 250mAs 250mAs to 0.1mAs
mAs Renard (0.1, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, (250, 200, 160, 125,100, 80, 63, 50,
6.5, 8, 10, 12.5, 16, 20, 25, 32, 40, 40, 32, 25, 20, 16, 12.5, 10, 8, 6.5,
50, 63, 80, 100, 125, 160, 200, 250) 5, 4, 3.5, 3, 2.5, 2, 1.5, 1, 0.5, 0.1)
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

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See the GEHC Myworkshop System to determine the status of this document. General Information

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3-10
 Moving and Positioning

Chapter 4
Moving and Positioning
This section describes how to move the unit and position the X-ray tube for image
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

acquisitions
See the GEHC Myworkshop System to determine the status of this document.

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 Moving and Positioning

4.1 Locking and Unlocking the unit

Locking and unlocking of the unit is to be done using the foot brakes that are located at the
base of the unit. The brakes, work in synchronization with each other and hence, either one
of the brakes can be activated for locking and unlocking.
To lock the unit in place, firmly press the brakes downwards (as indicated by the arrow) and
position it at an angle of approximately 45° (as shown in Figure 4-1a)
To unlock the unit, the brakes have to be positioned parallel to the base of the unit. To do
this, press firmly on the foot brake and position it as instructed (shown in Figure 4-1b)
Figure 4-1 a) Brakes locked Figure 4-1b) Brakes unlocked
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

4.2 Moving the unit

Brivo XR 115 is a manually driven equipment. A compact foot print makes maneuvering of
the system an easy task. To drive the Brivo XR 115, follow these steps:
a) Before transporting the unit, make sure that the swivel arm is properly positioned and
brought to the proper driving position as shown in Figure 4-2a)
b) After positioning the swivel arm in the proper driving position, simply grip the push
handle and steer the unit to your destination (Figure 4-2b).

WARNING Ensure that the parking brake is released and swivel arm is locked to the
park/transport position before attempting to move the unit. If not properly
latched, moving the Brivo XR 115 could cause the arm to slide and strike an
operator or patient.
Do not drive or position the Brivo XR 115 unless standing directly behind it.
Failure to do this may result in loss of control causing serious injury to the
operator and/or equipment damage.

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 Moving and Positioning

Figure 4-2a) Correct transport position Figure 4-2b) Push handle

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

WARNING While moving or maneuvering the unit through elevators, doorways or aisles do
not use the unit as an anchor to open doors or keep doorways blocked.
Constant and continuous impact of unwarranted forces on the tube head may
See the GEHC Myworkshop System to determine the status of this document.

lead to system damage or malfunction.

Potential Crush hazard: Take care not to drive the system over cables or over a
person’s foot.
Exercise caution that system wires/cables do not come in contact with moving
parts.
To prevent injury to the user due to spillage of liquids on the floor/pathway
exercise caution while moving the system.

4.3 Positioning the Swivel Arm

To release the swivel arm from its parking position (shown in Figure 4-2a), follow these steps:
a) Press the swivel arm downwards with one hand
b) Pull the parking lock (shown in Figure 4-3a) with the other hand
The parking pin will de-latch and release the arm from its parked position. The arm can now
be positioned at the desired SID, as shown in Figure 4-3b).

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NOTE: If the arm appears to sag after positioning at the desired SID, tighten the friction lock as
shown in Figure 4-3c), to maintain the required SID.

WARNING Potential Pinch Point: The area where the tube head connects to the swivel arm
may create a pinch point when the tube is raised. To avoid injury, the operator
should use the handles provided to raise the arm in up/down direction.

Figure 4-3a) Figure 4-3b) Figure 4-3 c)

Parking lock Arm extended position Friction Lock

Manual Parking lock Friction lock

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

4.4 Turning the unit ON

a) Connect the system cable to the mains wall power socket and turn ON the mains power.
b) Turn ON the Rocker switch located at the bottom of the equipment. The rocker switch will
glow green, as shown in Figure 4-4 below

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 Moving and Positioning

Figure 4-4 Main power Rocker Switch

CAUTION Make sure that the other end of the power cord cable is connected to the
system as shown in the Figure 4-4.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

If the power cord is disconnected from the system, the input power supply will
be lost and the mains ON indicator on the console will not glow green.

c) Turn the system ON by pressing the power ON button, on the console. The system
will take few seconds to boot up. In this time, it performs a few diagnostic self-tests to
See the GEHC Myworkshop System to determine the status of this document.

ensure that the system electronics is functioning.

d) When the console display lights up with default technique values (as shown in
Figure 4-5), the unit is ready for operation.
Figure 4-5 Console on power up

4.5 Positioning the Tube Head

Positioning the tube head does not require the use of an active lock. With little effort that is
need to override friction, the tube head handles can be used, to position the tube to the

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 Moving and Positioning

desired angle. This section describes how to setup and position mechanical components of
the Brivo XR 115.

4.5.1 Rotation of X-ray tube assembly

Use the tube head handles to position the tube to the desired angle. The tube
assembly can be rotated in two directions:

Figure 4-6 Tube rotation

a) Clockwise and counterclockwise: b) Backwards: -45 degrees Forwards:
±180 degrees +180 degrees
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

NOTE: Always use both hands to grasp the tube head handles.
See the GEHC Myworkshop System to determine the status of this document.

A goniometer is present on the front face of the monoblock. The goniometer (shown
in Figure 4-7) is an angle indicator that indicates the degree to which the tube head
assembly is rotated in the clockwise or in the anti-clockwise direction as shown in
Figure 4-6 a) above.

Figure 4.7 Goniometer

4.5.2 Collimator adjustment

The Brivo XR 115 manual collimator , shown in Figure 4-8 , limits patient radiation
exposure to a desired area at a given distance from the X-ray tube focal spot.

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 Moving and Positioning

Figure 4-8 Collimator

Collimator

1. Two Collimator lamp switches are available- one on the console and the other on
the tube head assembly. To activate the light field lamp, press the collimator light
switch:
a. The collimator light field switch is a toggle: The light will turn ON with the first
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

press of the switch and will turn OFF with the second press of the switch. The
field light is timed and will automatically turn off 30 seconds after the first
press of the switch. To activate the field light for another 30 seconds, press
the button again.
See the GEHC Myworkshop System to determine the status of this document.

b. As long as the collimator light is ON, PREP cannot be started. Collimator light
should be switched off before initiating PREP.
c. The collimator light cannot be turned ON while the system is in prep mode.
NOTE:
a) Once the collimator lamp is switched ON, it takes approximately 7 seconds for the
light to reach its maximum intensity
b) Frequent use of the collimator light might lead to heating of the collimator back-
cover

CAUTION Take precaution not to direct the collimator light to the patient’s eye while
radiographing the skull/head. This light intensity may irritate the patient’s
eye. Instruct the patient to keep the eyes closed when the collimator light
is switched ON for positioning.

2. Using the collimator handles, the collimator can be rotated about its vertical axis
along +90° to -90°, as shown in Figure 4-9

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 Moving and Positioning

Figure 4-9 collimator rotation

CAUTION Make sure that no accessories or materials are located in the path of the
primary X-ray beam during exposure. This could result in bad image quality.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Always use the handles to rotate the collimator and tube head, and ensure that
the collimator is grasped in a way such that, the hand is not pinched or crushed
between the handles and the collimator.

While rotating the collimator or the tube head assembly to obtain the right
See the GEHC Myworkshop System to determine the status of this document.

collimation/exposure positions, be careful not to rotate beyond the allowed

angles. Rotation beyond the tolerance limits will cause the cable connecting
the top and the bottom of the tube head assembly to be twisted. This may
cause a communication error or put unnecessary strain on the cables.

WARNING Take precaution and check if the collimator is intact with the tube head
assembly. If the collimator assembly appears to be disconnected or has an
unintended movement with respect to tube head, do not use the system. Log
a service call.

3. Position the collimator and tube using the field light and cross hair shadow as
guides. The cross hair shows the field center.
4. Use the provided tape to measure SID (Source-to-Image Distance) in the
collimator.

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 Moving and Positioning

CAUTION Use the largest SID appropriate for the anatomy being imaged, to keep the
patient dose as small as possible

5. Collimate by adjusting the size of the field with the two control knobs located on
the collimator.
a. At a SID of 40” (102cms), field sizes starting from 0”x0” up to 17”x17” (43x43
cm) can be obtained.
b. The knob selectors indicate the field size for a selected SID.
c. Dial numbers on the calibrated scale are for 1000mm and 900mm SID.

NOTE: Dimensions of X-ray field (FOV) and SID are provided on the collimator. Make sure you
are using the right field of X-ray and SID for specific examination. Refer to Section 2.12 - Light
field/X-ray field label for details
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

6. To allow for optional use of spectral filters, the collimator is provided with an
accessory rail, where filters can be inserted.
See the GEHC Myworkshop System to determine the status of this document.

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
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4-10
 Image Acquisition

Chapter 5
Image Acquisition
This section details the process of acquiring images using the cassette.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

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 Image Acquisition

5.1 General Image Acquisition

1. Unlock the foot brake of the system and move the equipment to the patient location.
2. Lock the foot brake and gently push the swivel arm downwards, pull the parking pin
out and lift the swivel arm to the required Source to Image Distance (SID).

NOTE: Do not raise the swivel arm when the system is placed close to the bed. This
may cause the tube head to hit the patient bed. Raise the swivel arm before reaching
close to the patient bed.

3. Connect the power cable to the wall mains power socket and turn ON the power.

CAUTION Take precaution not to pull out the cable connector from the system,
while plugging the power cord to the mains AC outlet.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

A trip hazard could be created when the system’s power supply cord is
connected to the AC mains. Exercise caution while moving or walking in
the vicinity of the powered system.
To prevent damage to the system power supply cord, ensure that heavy
or sharp objects are not dropped on the cable
See the GEHC Myworkshop System to determine the status of this document.

4. Turn ON the rocker switch and the power ON button on the console
5. Position the cassette under the patient.
6. Unlock the foot brake and position the tube head in line to the patient and the
cassette. Confirm or adjust the SID as required using the measuring tape.
7. Set the Field of View to the required anatomy using the collimator knob.
8. Lock the foot brake.
9. Set the KV and mAs parameters as appropriate for the exam.
10. Instruct the patient appropriately before exposure.
11. Perform exposure using the hand switch.
a. Depress the hand switch partially (up to level I as shown in Figure 5-1 below) to
initiate prep. Wait until the READY LED glows green and a single audible beep is
heard.
b. This indicates that the system is ready to produce X-rays Press the switch
completely (up to Level II as shown in Figure 5-1 below) for exposure. X-ray ON
LED will glow yellow and will be continuously lit throughout the exposure time
along with an audible beep

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 Image Acquisition

Figure 5-1 Hand switch operation

Hand Switch with 2

1st Level “Prep” 2nd Level “Exposure”
Level Exposure

12. After exposure is completed, delivered KV and mAs values will be displayed for up to 5
seconds
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

CAUTION If there is an improper or no display before or after exposure, contact GE

service.

13. After each exposure is complete, the system enters into a cooling mode, indicated by
See the GEHC Myworkshop System to determine the status of this document.

the message “CLG Prd” which will be displayed in the KV and mAs display fields

CAUTION Do not power off the system while generator is in cooling mode. There is a
cooling mechanism incorporated inside the generator, which requires a
specific time, depending on the exposure time, to cool the generator
electronics before performing the next exposure.

Powering OFF of the system, or attempting to take exposures before the

cooling period elapses, may shorten the life span of the tube and other
component.

14. After the cooling period elapses, the system console will display previously set
technique parameters
NOTE: Cooling period for each exposure will vary depending on the set exposure time
with a duty cycle of 1:30.
15. If required to perform an exposure on the same patient, repeat the steps from 5.
16. To power off the system, press the power OFF button on the console and turn OFF the
rocker switch.

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 Image Acquisition

17. Power OFF the mains supply, unplug the cable from the mains socket and wind the
cable around cable winder on the system.

CAUTION Ensure that the power cord is completely wound around the cable winder.
If not, the cable can drop down, and can come under the wheels of the
system during transport.

18. Bring down the swivel arm to the park position.

19. Move the system back to the desired location and engage the brakes.
NOTE: Keep the system powered OFF, when not in use.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document. Image Acquisition

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5-5
 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document. Image Acquisition

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5-6
 Troubleshooting

Chapter 6
Troubleshooting

This section describes about the errors code, error display description along with the recommended
action that can be performed by the user before calling for service.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

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 Troubleshooting

6.1 Errors and Warnings

When the system is under fault condition and is not functioning as expected or error codes
are being displayed on the console, as given in Table 6-1, attempt using the recommended
actions that are provided in the same table, to help in rectifying these system faults.
Error codes are designated with a 2 digit code that is prefixed with “E”, displayed in the kV
field and a 3 character fault description that is displayed in the mAs field.

WARNING If the recommended action provided does not help in restoring the normal
functionality of the system, do not attempt to open the covers or repair the
system.

Only trained service personnel authorized by GE Healthcare may remove the

unit covers and only in accordance with the instructions contained in the Service
Manual.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Table 6-1 Error code, Error description and recommended actions

Sl. Error Error Error Description Recommended actions

No. Code Description
display
See the GEHC Myworkshop System to determine the status of this document.

1 E01 0Pn Cable Open Press RESET KEY. Generator will

return to standby state. If the
problem persists, request service call

2 E02 OLt OIL Hot These faults are generated when

defined operating specification/
conditions are not met. These faults
will be automatically cleared if
operating conditions comes back to
defined specifications.

3 E03 bAL KV Unbalance

4 E04 oUU Output Under Voltage (KV)
5 E05 OOU Output Over Voltage (KV)
Press RESET KEY. Generator will
6 E06 Hst Heat Sink Hot return to standby state. If the
7 E10 ASP Anode Spit problem persists, request service call

8 E11 CSP Cathode Spit

9 E12 IoC Inverter Over Current
10 E13 CoU Cathode Over Voltage

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 Troubleshooting

Sl. Error Error Error Description Recommended actions

No. Code Description
display
11 E14 AoU Anode Over Voltage
12 E15 bSC DC Bus Short Circuit Switch OFF mains power. Wait for 2
minutes. Switch ON mains power.
If the problem persists, request
service call.
13 E16 oCC Over Current Cathode
Press RESET KEY. Generator will
14 E17 oCA Over Current Anode
return to standby state. If the
15 E18 FoC Filament Over Current problem persists, request service call.

16 E22 fiL Filament Over Current (High

frequency)
17 E24 PrP Prep Switch is ON
18 E25 On X-ray ON switch ON
19 E26 CAL No calibration
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

20 E27 Abt Exposure Abort Press RESET KEY. Generator will

21 E29 NoP PFC not ON by Prep. return to standby state. If the
problem persists, request service call
22 E30 Nod PFC not received Power.
23 E33 NoC No PFC Communication
See the GEHC Myworkshop System to determine the status of this document.

24 E34 CAN CAN Communication Error

25 E35 NoC No PFC Communication
26 E36 PoC PFC Over Current Switch OFF mains power. Wait for 2
minutes. Switch ON mains power.
27 E37 PoU PFC Over Current (DC Bus) If the problem persists, request
service call.

28 E38 bUL DC Bus OFF Press RESET KEY. Generator will

return to standby state. If the
problem persists, request service call

29 E40 IuU Input under Voltage These faults are generated when
defined operating specifications/
conditions are not met.
30 E41 IoU Input Over Voltage These faults will be automatically
cleared if operating conditions
comes back to defined specifications
31 E42 CAP Calibration Problem
(Maximum Iteration
exceeded)
32 E43 oCC Over Current Cathode

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 Troubleshooting

Sl. Error Error Error Description Recommended actions

No. Code Description
display
33 E44 oCA Over Current Anode
Press RESET KEY. Generator will
34 E45 foC Filament Over Current
return to standby state. If the
35 E46 AoU Anode Over Voltage problem persists, request service call
36 E47 CoU Cathode Over Voltage
37 E48 ASP Anode Spit
38 E51 IoC Inverter Over Current
39 E53 CSP Cathode Spit
40 E54 Arc Tube Arc
41 E57 bSC DC Bus Short Circuit Switch OFF mains power. Wait for 2
minutes. Switch ON mains power.
If the problem persists, request
service call.
42 E58 Err Key Jam Error Shutdown and restart the system.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Ensure no switch including hand

switch is pressed during system
booting.
If the problem persists, request
service call.
See the GEHC Myworkshop System to determine the status of this document.

43 The unit does not power on when mains is switched Check if Power ON switch back light
ON illuminates
If not, there may be a loose contact
at the wall socket end or the wall
outlet is not receiving power.
Check local electrical circuit for trips.
If Power ON switch is illuminating:
(a) check that the Mains Cable is
properly connected to the power
socket on the system
(b) Switch off mains power. Wait for 2
minutes.
Switch ON mains power.
If the problem persists, call service.
44 No X-ray image even though the unit indicates In case of manual processing, verify
normal exposure. film development and storage
method. The films could be damaged
or the chemicals could be
contaminated. If these factors are
satisfactory, call for service.

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 Troubleshooting

In case of CR cassettes, read the

exposed cassette on the CR reader, if
no image appears, log a service call
to validate exposure quality.
45 Tube head assembly drifts with respect to swivel arm This can be due to normal wear and
axis tear or using excess force on the
tube head generator during its
rotation.
Tighten the Nylock nut or call service.
46 Collimator light not working Request a service call.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
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6-6
 Maintenance

Chapter 7
Maintenance
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

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 a part of this program

See the GEHC Myworkshop System to determine the status of this document.

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 Maintenance

7.1 General
In order to assure continued safe performance of this x–ray equipment, following are some
points to remember:
 Regular periodic maintenance can help identify any potential problem.
 Based on frequency of usage, it is the owner’s responsibility to ensure that periodic
maintenance is arranged.
 Apart from routine maintenance, any abnormal noise, vibration or unusual
performance should be reported immediately to a GE representative.
 Before calling for service, be sure the equipment is being operated in accordance
with the foregoing instructions.

WARNING Failure to perform periodic inspection and maintenance could allow

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

deteriorating conditions to develop without being detected. This could result in

equipment failures which could cause serious injury or equipment damage.

7.2 Qualified Service

See the GEHC Myworkshop System to determine the status of this document.

Safe equipment performance also requires the use of service personnel specially trained on
this medical x–ray equipment. 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.

7.3 General Cleaning and Disinfecting

This equipment should be cleaned frequently with a damp cloth and dried.

CAUTION Never use cleaners or solvents of any kind if you are uncertain of the nature of
the cleaning agent
Ensure that no liquid seeps into the unit, so as to avoid short-circuiting or
corroding the electrical and electromechanical parts.
Personal caution should be used when removing any accumulating foreign
Material/debris with live system components

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 Maintenance

NOTE:
a) The equipment need not be kept sterile.
b) Never use solvents or flammable solutions to clean hand switch.
c) Never use dripping cloth (or) immerse hand switch in water or cleaning solution.
d) Never use chemicals for cleaning the cables, as this may degrade the cable insulation

7.4 User Maintenance/ Quality Checks

GE X–ray equipment contains operating safeguards to ensure maximum safety. Before
calling for service, be certain that proper operating procedures are being followed.
Recommended Inspection checks by the user
It is important that the X-ray unit is inspected at periodical intervals to ensure equipment
and user safety. Please refer to the checklist below:

Summary of the Periodical Checks

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Daily Check functionality of beeps and indicators

Check for oil leakage from the tube head.

Check unusual noises in the tube head during X-ray emission
Check the X-ray tube and collimator centering
Weekly
See the GEHC Myworkshop System to determine the status of this document.

Check the hand switch for accumulation of dirt, contrast material, damage
to the plastic housing or loosening in the plastic housing
Check for any debris accumulation in the imaging pathway (collimator). If
any debris found, do not use the system. Call service.
Check effectiveness of the brakes
Every 6
months Check handle functionality – System push handle, Tube head handle,
Collimator handle, Friction lock, swivel arm handle and cassette bin handle
Repeatedly press the hand switch buttons (Prep and exposure) to check
that the switch moves smoothly from inactive to active positions.
Yearly
Log a service call with GEHC to replace the hand switch, if the buttons
motion is not smooth or if the buttons are getting stuck.

In the event of any observation of any fault, switch off the unit. Perform the checks as given
above.
NOTE: Please note that the System should be used only after the fault condition is reset.

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 Maintenance

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

7.5 Periodic Maintenance by Service Personnel

To insure the continued safe performance of your mobile system, establish a periodic
maintenance program with a qualified service representative.
For continued service support, ensure that you have entered into an annual maintenance
program. This will ensure that qualified engineers periodically keep a check on your
equipment.
It is advised that the unit be subject to a maintenance schedule once every year.

7.6 Shipping and Long term Storage

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

 Use the original packing box for shipping/transporting the unit.

 When not in use for a long time, cover the unit with dust proof covers and ensure that it
is stored under recommended environmental conditions as given in Appendix A, Section
A-5.
See the GEHC Myworkshop System to determine the status of this document.

 When re-starting the system after long storage (more than 3 months), perform the below
mentioned procedure to ensure the tube head operates at its optimum.
Step 1- Set the kV and mAs to the minimum value (40kV, 0.1mAS).
Step 2- Close the Collimator shutters.
Step 3- Take 5 exposures.
Step 4- Increase kV in steps of 10 kV and repeat step 3 till 100kV.

7.7 Caring for Your Equipment

CAUTION Do not hang external loads or weights on the tube head or swivel arm. The arm
and base units are designed for its own weight and may not hold an additional
weight.
Do not step or stand on the base unit. Damage to equipment or injury to
personnel may occur if the unit is stepped or stood upon.

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 Maintenance

 Do not allow the unit to impact with any hard surface.

 Schedule and carry out periodic maintenance checks.
 Place the tube head assembly to the parking position when not in use and during
transportation
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document. Maintenance

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7-6
 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document. Specifications

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Brivo XR 115
Appendix A
Specifications

A-1
 Specifications

A-1 Technical Specifications

Generator Type High Frequency, Microprocessor controlled, constant

Potential (DC)
High Voltage Range 40KV-100KV selectable (adjustable)
Accuracy of High Voltage <± 3%
High voltage Ripple Frequency >200kHZ
High Voltage Ripple <10%
Tube-head current range 10mA – 100mA
Maximum Exposure Time 5 seconds @230Vac input
Minimum Exposure Time 10mS
mAs range 0.1mAs to 250mAs,
mAs accuracy ± (5%+0.2) for > 1mAs and ± (10% +0.2) for < 1mAs
Maximum Input Current 16 Amps
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Duty Cycle 1:30secs

Total X-ray filtration ≥ 3.6mm Al equivalent
Minimum focus to skin distance 400mm
Maximum X-ray field 480mm X 480mm at 1 meter from focal spot
See the GEHC Myworkshop System to determine the status of this document.

Leakage radiation @ 1 meter <90mR/ Hour

A-2 X-ray tube Head Specifications

Tube Insert Model OX 105-2

Focal Spot (IEC 60336) 1.8mm
Anode Material Tungsten
Anode Angle 19°
Insert Inherent filtration 0.5mm Al equivalent
Anode Thermal Capacity 30 KJ
Anode Type Stationary Anode

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 Specifications

A-3 Mechanical Dimensions and Weight

Total Weight of System <120kgs
Type of painting Powder coated.
Rotation of Tube head on 360 °
horizontal arm
Overall width 600mm max.
Overall Height with arm 2500mm +/- 10mm
extended
Overall Length in parked 1280mm +/- 5mm
position
Ground Clearance 100mm in transport position.
Cassette Bin Suitable for 6 cassettes

A-4 Mains Power Requirements

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Power consumption 4KW max

Line Voltage range 230Vac ± 10%
Line frequency Nominal: 50Hz ±5%
See the GEHC Myworkshop System to determine the status of this document.

Electrical Classification Class I

Electrical Connection Line, Neutral and Earth (Earth is Mandatory)

A-5 Environmental Conditions

Operating conditions Temperature: +10 °C to +40 °C
Max temp gradient of +10°C /hour (Operating)
Humidity: 20% to 80% (RH) non condensing , 30%
Gradient/Hour (Operating)
Conditions for transport and Temperature: -20° C to +70° C ,
storage Max Allowable Temperature Gradient of +20°C/Hour
(Non-operating)
Humidity: 20% to 90% (RH) non Condensing, 30%
Gradient /Hour (Non-operating)

Pressure Operating : 700 to 1060 Hpa ;

Non-operating : 500 to 1060 Hpa

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document. Specifications

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Brivo XR 115
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A-4
 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

5475521-1EN, Revision 6
EMC Compliance Statement

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Brivo XR 115
Appendix B

B-1
EMC Compliance Statement
 EMC Compliance Statement

B-1 Introduction
This 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)
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

 Power the equipment from a source different from that of the affected device
 Consult the point of purchase or service representative for further suggestions
The manufacturer is not responsible for any interference caused by using other than
recommended interconnect cables or by unauthorized changes or modifications to this
See the GEHC Myworkshop System to determine the status of this document.

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.
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.

B-2 Compatibility Tables

This equipment complies with IEC/EN 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.

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 EMC Compliance Statement

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 Emission
Table B-1 Brivo XR 115 Electromagnetic Emission
Guidance and manufacturer’s declaration – Electromagnetic Emissions
The BRIVO XR115 is intended for use in the electromagnetic environment specified below.
The customer or the user of the BRIVO XR115 should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment Guidance

RF emissions, IEC/ EN These systems use RF energy only for its internal function.
Group 1 Therefore, the RF emissions are very low and are not likely to
55011
cause any interference in nearby electronic equipment.
These systems are intended for use in non-domestic
RF emissions, IEC/EN environments, and not directly connected to the Public Mains
Class A
55011 Network. These systems are intended for use (e.g. in hospitals)
with a dedicated supply system, and in an X-ray shielded room.

Electromagnetic Immunity
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Table B-2 Brivo XR 115 System Electromagnetic Immunity

Guidance and Manufacturer’s declaration – electromagnetic immunity.
The BRIVO XR115 is intended for use in the electromagnetic environment specified below.
The customer or the user of the BRIVO XR115 should assure that it is used in such an environment.
See the GEHC Myworkshop System to determine the status of this document.

IEC 60601-1-2 Test Electromagnetic

Immunity Test Compliance Level
Level Environment Guidance
Floors should be wood, concrete, or
Electrostatic
+/- 6 kV contact. +/- 6 kV contact. ceramic tile. If floors are covered
Discharge (ESD),
+/- 8 kV air +/- 8 kV air with synthetic material, the relative
IEC/EN 61000-4-2
humidity should be at least 30%.
+/- 2 kV for power +/- 2 kV for power supply Mains power quality
Electrical Fast
supply lines. lines. should be that of a typical
Transient/Burst,
+/- 1 kV for +/- 1 kV for input/output commercial or hospital
IEC/EN 61000-4-4
input/output lines. lines. environment
Mains power quality should be that
Surge, +/- 1 kV line(s) to line(s). +/- 1 kV line(s) to line(s).
of a typical commercial or hospital
IEC/EN 61000-4-5 +/- 2 kV line(s) to earth. +/- 2 kV line(s) to earth.
environment.
5% UT a, (> 95% dip in 5% UT a, (> 95% dip in UT) Because the systems draw 16 Amps
UT) for 0.5 cycle. for 0.5 cycle. per phase, the only test required is
Voltage Dips, to drop each phase out for 5
Short 40% UT, (60% dip in 40% UT, (60% dip in UT) seconds.
Interruptions and UT) for 5 cycles. for 5 cycles. Mains power quality should be that
Voltage of a typical commercial or hospital
70% UT, (30% dip in 70% UT, (30% dip in UT)
Variations on UT) for 25 cycles. for 25 cycles. environment. If the user of the
Power Supply system requires continued
Input Lines, operation during power mains
IEC/EN 61000-4- < 5% UT, (> 95% dip in < 5% UT, (> 95% dip in UT) interruptions, it is recommended
11 UT) for 5 sec for 5 sec that the system be powered from
an un-interruptible power supply or
a battery.

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 EMC Compliance Statement

Power frequency magnetic fields

Power Frequency
should be at levels characteristic of
(50/60 Hz)
3 A/m 3 A/m a typical location in a typical
Magnetic Field,
commercial or hospital
IEC/EN 61000-4-8
environment.
a) UT is the a.c. mains voltage prior to application of the test level.
b) UT is the a.c. mains voltage prior to application of the test level.

Table B-3 Brivo XR 115 System Electromagnetic Immunity (Continued)

Guidance and Manufacturer’s declaration - electromagnetic immunity.
The BRIVO XR115 is intended for use in the electromagnetic environment specified below.
The customer or the user of the BRIVO XR115 should assure that it is used in such an environment.
IEC 60601-1-2 Test Compliance
Immunity Test Electromagnetic Environment Guidance
Level Level
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.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Recommended Separation Distance

Conducted RF 3 Vrms,

IEC/EN 61000-4- 150 kHz to 80MHz 3V 80 MHz to 800 MHz

See the GEHC Myworkshop System to determine the status of this document.

6
800 MHz to 2.5GHz

where P is the maximum output power rating of

the transmitter in watts (W) according to the
10 V/m, 80 MHz to 2.5 3V/m transmitter manufacturer and d is the
Radiated RF GHz recommended separation distance in meters (m).
IEC/EN 61000-4- Field strengths from fixed RF transmitters, as
3 determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency range b.

Interference may occur in the vicinity of

equipment marked with the following symbol:

A Field 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.

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 EMC Compliance Statement

B Over 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.

Table B- 4 Recommended separation distance

Recommended separation distances between portable and mobile RF communications equipment and BRIVO
XR115
The BRIVO XR115 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 BRIVO XR115 as recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum Output Power (P) Separation distance according to frequency of transmitter (in meters)
of Transmitter Watts(W) 150 kHz to 80MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

10 3.8 3.8 7.3

100 12 12 23
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 EN
61000-4-6 test and E1 is the COMPLIANCE LEVEL for the EN 61000-4-3 test.
See the GEHC Myworkshop System to determine the status of this document.

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.

B-3 Use Recommendations

This product complies with IEC 60601-1-2 Edition 3.0 (2007-03) EMC standard for medical
devices and with radio frequency emission requirements per EN 55011 Group1 Class A
standard limits. The system is intended for use in hospitals.

B-4 Cable Shielding and Grounding

All 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.

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
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5475521-1EN, Revision 6
EMC Compliance Statement

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Brivo XR 115
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B-6
 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document. APR values

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Brivo XR 115
Appendix C

C-1
APR values for Brivo XR 115
 APR values

C-1 Recommended APR values for Brivo XR 115

View Recommended kV Recommended mAs

Skull AP 70 - 80kV 16 - 20mAs

Skull Lateral 70 – 80kV 10 - 16mAs

C. Spine AP 70 - 75kv 8 – 12.5mAs

C. Spine Lateral 70 - 75kv 6.5 – 10mAs

Chest AP/PA 56 - 62 kV 8 - 10mAs

Chest Lateral 60 - 70 kV 10 - 16mAs

Thoracic Spine AP 75 - 85kV 16 - 32mAs

Thoracic Spine Lateral 75 - 95kV 32 - 50mAs
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Abdomen AP 70 - 80kV 25 - 40mAs

L.S Spine AP 75 - 90kV 32 - 40mAs

L.S Spine Lateral 80 - 100kV 50 - 80mAs
See the GEHC Myworkshop System to determine the status of this document.

Pelvis/Hip AP 70 - 75kV 20 - 32mAs

Hip Lateral 75 - 80kV 20 - 32mAs

Femur AP 56 - 60kV 10 - 20mAs

Femur Lateral 60 - 64kV 12.5 - 20mAs

Knee AP 50 - 56kV 8 - 12.5mAs

Knee Lateral 48 - 54kV 8 - 10mAs

Leg AP 48 - 54kV 6.5-10mAs

Leg Lateral 48 - 50kV 6.5 - 8mAs

Ankle AP 48 - 54kV 6.5 - 10mAs

Ankle Lateral 48 – 54V 5 - 8mAs

Foot AP/Oblique 44 - 48kV 6.5 - 8mAs

Foot Lateral 46 - 50kV 6.5 - 10mAs

Shoulder AP 54 - 60kV 6.5 - 10mAs

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 APR values

Humerus AP 48 - 54kV 6.5 - 10mAs

Humerus Lateral 48 - 54kV 10 - 16mAs

Elbow AP 44 - 46kV 4 - 8mAs

Elbow Lateral 46 - 50kV 4 - 8mAs

Forearm AP 44 - 46kV 4 - 6.5mAs

Forearm Lateral 46 - 48kV 4 - 6.5mAs

Hand AP 40 - 42kV 2 - 4mAs

Hand Lateral 42 - 44kV 4 - 6.5mAs

NOTE: The above mentioned exposure techniques are for reference only. It is the
responsibility of the radiographer to make sure the exposure factors are correct before
exposing
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Exposure factors are determined depending on the patient size and exposure conditions
(with grid or without grid).

The techniques guided above are without the use of a grid, on a Computed Radiography (CR)
system. If a gridded cassette is used, the exposure technique has to be increased to one step
See the GEHC Myworkshop System to determine the status of this document.

higher than that recommended above.

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C-4
 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

5475521-1EN, Revision 6
Installation Instructions

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Brivo XR 115
Installation Instructions

D-1
Appendix D
 Installation Instructions

D-1 Damage in transportation

All packages should be closely examined at the time of delivery. If damage is apparent, write
“Damage In Shipment” on ALL copies of the freight or express bill BEFORE delivery is
accepted or “signed for” by a GE representative or Hospital receiving agent.

D-2 Safety
Please refer to Chapter 2 Safety and Regulatory provided in this Operator Manual.

CAUTION Take necessary safety precautions while lifting or moving heavy objects during
installation.

D-3 Installation Process

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

D-3.1 System components

The packaging box of Brivo XR 115 contains the following components:
 Brivo XR 115 system
See the GEHC Myworkshop System to determine the status of this document.

 Operator Manual ( Installation instruction is embedded in to OM)

 Packing list

D-3.2 Site preparation

Installing The unit is designed for indoor usage.
Environment •It shall not be subject to direct sunlight for expanded duration.
•Place it away from sources of liquid ingress.
•If the X-Ray unit is stored below 10 ° C, time must be allowed for X-
Ray unit to reach room temperature (by keeping the system in room
temperature) before connecting it to the mains supply.
Electrical Ensure that there is a wall socket available near the installation
Outlets & location. The power requirements are as detailed in Appendix A,
Requirements Section A-4 of the Operator Manual
•The mains outlet shall have a good Earth connection. Grounding of
the system must be checked before connecting the System.
•The mains cord shipped with the unit shall not be extended further
using extension boxes or wires. In case extra wiring is required, ensure
that this is done by a qualified electrician.
•The mains outlet should be capable of supplying 230V ac and 16A of

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 Installation Instructions

current. It shall have Fuse protection or provided with a circuit breaker

of 16A (230V) or more.
•It is recommended to have an ELCB (Earth Leakage Circuit Breaker) or
RCCB (Residual Current Circuit Breaker) for protection against earth
leakage

D-3.3 Installation Procedure

Follow these steps for Installation
1. Unpack the system
2. Power ON the system
3. Initial testing
4. Installation Checklist

1. System Unpacking procedure

The Brivo XR 115 unit will arrive at the site in package as shown in Figure D.1
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

Figure D.1
See the GEHC Myworkshop System to determine the status of this document.

a. Remove the shrink wrap and cut and remove the straps
b. Remove the top cover of the package

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 Installation Instructions

c. Remove the plastic routers from the sides of the package

d. Remove the cover of the package
e. Remove the shrink wrap and packing materials from the system
f. Remove 4 screws of the ramp as shown in Figure D.2 and position it on the floor
Figure D.2
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

g. Unscrew the fasteners and take out the metal clamp on the front side of the
system as shown in Figure D.3
See the GEHC Myworkshop System to determine the status of this document.

Figure D.3

h. Remove the bolts and take out the metal clamp in the front of the positioner as
shown in the Figure D.4

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 Installation Instructions

Figure D.4

i. Remove the 2 rear blocks by tilting the system on either sides as shown in Figure
D.5
Figure D.5
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

j. Tilt the system as shown in Figure D.6 to remove the blocks below the base of the
positioner.
Figure D.6

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 Installation Instructions

k. Release the break and unload the system from the pallet by pulling it over the
ramp as shown in Figure D.7
Figure D.7

l. Visually inspect the system and components for any damage that might have
occurred during shipping.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

- If no damage is observed, continue with the installation.

- If damage is found, contact GE Service or the installation specialist

2. Turning ON the system

See the GEHC Myworkshop System to determine the status of this document.

 Check & ensure that the Power supply at the Wall Outlet is as per
recommendation in Appendix A, Section A-4 of the Operator Manual.
 Ensure that the Neutral to Earth (Ground) voltage is less than 3 Volts. Connect the
Power Cord to the Wall supply.
 Switch on the mains power and the Rocker switch located at the bottom of the
equipment. The rocker switch will glow green
 Turn the system ON by pressing the power ON button, on the console. The system
will take few seconds to boot up. In this time, it performs a few diagnostic self-
tests to ensure that the system electronics is functioning.
 When the console display lights up with default technique values (60KV and
10mAs) the unit is ready for operation.

3. Initial testing
a. Movements and Positioning
 Check for arm balancing in all positions
b. Collimator

 Open collimator shutters using the two knobs provided on the collimator.
 Press the collimator light switch to turn on the light field.

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 Installation Instructions

 Adjust the light field on the area to be irradiated, using the collimator knobs
 The set light field will be the X-ray field while taking an X-ray. There is an
automatic timer of 30 seconds for collimator light. This will switch off the light
after 30 seconds.
 If the light field adjustment is still required, press the collimator light switch
again. To switch off the light field, press the collimator switch.

CAUTION Check for debris in image chain path (Switch on the light and
visually check for any debris in the Collimator)

c. Exposure
NOTE: When re-starting the system after long (more than 3 months) storage,
take the unit through a ‘seasoning’ procedure to ensure the tube head
operates at its optimum. Follow the seasoning procedure as given in Section
7.6 Shipping and Long storage of this Operator Manual.
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

If the date of installation is less than 3 months, skip the seasoning procedure.
 Set the technique parameters to 40kV and 0.1mAs.
 Close the collimator shutters and depress the hand switch partially (up to level
1 as shown in Figure D.8,) to initiate prep. Wait until the READY LED glows
See the GEHC Myworkshop System to determine the status of this document.

green and a single audible beep is heard.

Figure D.8

Hand Switch with 2 1st Level “Prep” 2nd Level “Exposure”

Level Exposure
 This indicates that the system is ready to produce X-rays. Press the switch
completely (up to Level II as shown in Figure D.8) for exposure. X-ray ON LED
will glow yellow and will be continuously lit throughout the exposure time
along with an audible beep.
 Feedback kV and mAs values will be displayed on the console.

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 Installation Instructions

4. Installation Checklist

No. ITEM SIGN OFF

1. Power cables connected and tightened?

2. Product locator cards collected?

3. Missing components and/or options?

4. List of any installation deviations (all deviations should be signed by

customer and reviewed by the installation specialist).

5. Packing materials disposed off ?

6. Have all functional checks been completed?

7. Have all protective tape/coverings been removed?

8. Are there any cosmetic issues?

State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

9. Are there any system issues?

10. Are there any functional limitations?

11. Has system documentation been given to the customer?

See the GEHC Myworkshop System to determine the status of this document.

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 State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.
See the GEHC Myworkshop System to determine the status of this document.

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Installation Instructions

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Brivo XR 115
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D-9
 Revision History
Release/
Rev. Description of Content Reason for change or Change
Page Author Effectivity
No changed Control Number
Date
As per My
1 All Initial Release N/A Lalitha V
Workshop
Error codes and regulatory
Updated figures, error codes As per My
2 All contents were not mentioned in Lalitha V
and regulatory contents Workshop
Rev.1
Alignment and formatting Alignment and formatting error As per My
3 All Lalitha V
maintained in the manual of the text in Rev.2 Workshop
Manufacturers address and
Updated System Rating Label As per My
4 2-14 WEEE symbol updated in Lalitha V
image Workshop
system Rating Label
Collimator knob label (Rear
State: RELEASE - Document is released and under formal Change Control. Changes are subject to the ECR/ECO Process.

and Front shutter) with As per SCR, the collimator knob As per My
2-17 Lalitha V
graduations included in label is updated Workshop
5 Sec.2.12
Updated System Rating Label ISI mark to be included in the As per My
2-14 Lalitha V
image with ISI Mark System Rating Label Workshop

Manufacturers address As per My

See the GEHC Myworkshop System to determine the status of this document.

6 2-14 Entity name change Lalitha V

updated Workshop

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