Technical Manual Introduction

DOC. 726-722-G1
REV. F
ECN 4026
6/06
www.ge.com
www.gehealthcare.com
www.gemedicalsystems.com

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Revision History
Software
Revision Date ECN Reason for Release
Reference
A 4/5/04 3431 - New Release
B 4/30/04 3445 - Changes per John Lybrook
C 9/30/04 3554 - Updates on interface and dose calibration
D 4/15/05 3677 - Add information on system backup/restore
E 6/30/05 3772 - Update Backup/Restore Procedures
F 6/20/06 4026 V2006.05.12.xx Update the Add HIPAA Manual to back of
Appendix; Update Heliflex lens type in manual

List of Change Pages

Revision Page Number

A All
Intro (Revision History), Step 2 (Camera calibration section rewritten), Step 3 (Removed reference to
B
powering up monitors), Step 7 (Rewritten), Appendices (Updated Generator Compatibility list.)
Deleted Step 6 and reordered remaining steps. Step 1 (Changes to 2. Supplied Cables, deleted
C section 4.3.3), Step 2 (Rewrote entire section), Step 4 (Sections 2.2 – 2.6 rewritten), Step 8 (New
“Recommended Dose” chart), Eliminated Appendix D
Service Applications (Expanded IP settings section, added section 5 & 6 to explain backup/restore,
D added more detail about changing language settings in Utility section), Step 2 (4.2, 4.2 changed
factory % round field restrictor diaphragm to 32%)
E Service Application (Section 5 & 6, corrected per M.Smith), Added Appendix D (Troubleshooting)
Update Len replacement & calibration procedure to Heliflex type (affects step 1, 2, 4, 5, 6, PM, CM
F and Service App. Overview); add AEC (High, Med, Low) Control Settings, Appendix addition – Add
HIPAA Manual

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Table of Contents

Introductory Pages:
Revision History, List of Changed Pages, Table of Contents,
Using this Manual, Manual Scope, Manual Conventions,
Tools and Test Equipment, Trademarks, Safety Summary,
Power Requirements & Environmental Requirements,
Flat Panel Monitor Specifications, When Calling for Help / Service / Parts...,
Cleaning Instructions, System Shipment Information, Applicable Standards
Installation Report Form & Acceptance Tests Form

Service Applications Overview

System Installation Instructions:

Step 1 - Components & Cables
Step 2 - Camera Installation
Step 3 - Power Up/Power Down
Step 4 - Connect and Test the Generator Interface Module (GIM)
Step 5 - Set System Parameters
Step 6 - Camera Calibration Monitor Brightness/Contrast Adjustment & Calibration
Step 7 - System Testing Camera Calibration
Step 8 - Recommended Doses and Exposure FactorsSystem Testing

Preventive Maintenance Instructions

Component Installation Procedures

APPENDICES:
Appendix A – Symbols
Appendix B – Abbreviations / Terms / Definitions
Appendix C – Compatibility List
Appendix D – Troubleshooting Guides (Operators & Service Technicians)
Appendix E – Pulsed Fluoro Configuration
Appendix F – HIPAA Manual

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Using This Manual

All of the introductory pages of this manual MUST BE READ, before the system is
unpacked!

The system must be installed systematically. This manual details each step of the procedure in
the order in which it must be performed. Each step of the instructions must be followed in order
(Step 1, Step 2, Step 3, etc.). DO NOT JUMP AHEAD.

Preventive Maintenance Procedures should be performed every six (6) months.

Pay special attention to all Safety Warnings given at the front of this manual, and throughout the
instructions.

Manual Scope

This manual is intended for use by Service Engineers who have received training from GE to aid
in the Installation, Acceptance Testing, Preventive Maintenance and component replacement for
the Precision RXi. The system is designed to be used with many makes/models of x-ray
generators and hardcopy devices.

This manual includes data for the direct connection to the x-ray generator and DICOM Network
Server. Refer also to the x-ray generator manufacturer’s manuals during the installation
procedure.

For testing the functionality of the features as part of the Acceptance Testing, Preventive
Maintenance and Component Installation Procedures, refer to the User Manual.

Modem transmission Field Service support is available.

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Manual Conventions

NOTE: Notations are made for information which requires specific consideration,
but for which there is no risk of damaging the system.

CAUTION: Caution statements are given before any procedures, which if

performed incorrectly could cause damage to the system, danger
to the operator or patient, or loss of patient or image data.

WARNING: Warning statements are placed wherever the information given is

critical to proper operation of the system within UL, IEC, and FDA
guidelines.

Tools and Test Equipment

Digital Volt-Ohm meter (20,000 ohm/Volt)

Phillips screwdrivers (small, medium, large)
Flat blade screwdrivers (small, medium, large)
Metric Hex key set (1.5mm to 6mm)
Socket set (to one inch with appropriate driver)
Dose Meter
Ruler
ESD wrist strap with alligator clip
X-ray phantoms:
Line Pair Resolution
15 cm Lucite (homogeneous density)

Trademarks

® is a trademark of Microsoft Corporation.

DICOM by Merge.

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Safety Summary

• This manual is for the express use of QUALIFIED SERVICE PERSONNEL ONLY!
• The Precision RXi has been designed and tested to meet FDA, Radiological Health
regulations. To ensure personnel and patient safety, all procedures, warnings and
precautions must be strictly observed during all phases of operation and service of this
instrument.
• Failure to comply with these safety statements could result in injury and/or death to
service personnel, operator, or patient. GE assumes no liability for failure to comply.

This Equipment is classified:

• Protection Against Electric Shock – Class I
• Degree of Protection Against Electric Shock – Type B
• Degree of Protection Against Ingress of Water – Ordinary
• Mode Of Operation – Continuous
.
This system is not intended for use in an environment with flammable
WARNING: anesthetics mixture with air or with Oxygen or Nitrous Oxide
Consult GE regarding defective spare parts. An RMA (Return Materials
WARNING: Authorization) must be issued to return parts.

At the decommissioning of the system consult GE for the proper disposal

WARNING: of parts or contact your local regulatory agency.

Use of any hardware and/or software not provided by GE is strictly

WARNING: prohibited. To do so may void the warranty.
Do not access the operating software without prior service training in the
WARNING: maintenance of the Precision RXi product line. To do so may corrupt files
and cause improper functioning of the Precision RXi.
Do not attempt to alter any system hardware unless the procedure is given
WARNING: in the Preventive/Corrective sections of this manual, or supplied with a part
provided by GE. Doing so could disrupt the functioning of the system and
result in loss of images.
Do not bypass the safeties provided by the X-ray generator during the
WARNING: installation or servicing of the system hardware or software. Doing so
could expose personnel to unnecessary radiation.
THIS INSTRUMENT MUST BE GROUNDED! A three-conductor AC
WARNING: power cable is supplied with this instrument (at the Isolation Transformer)
to provide the proper electrical ground. To minimize the shock hazard the
power cable must be plugged into an approved, Hospital-grade, three
contact electrical outlet.

The Precision RXi system must be powered through the Isolation

WARNING: Transformer unit supplied with the system (Part #735-272-G14 for 120V,
735-272-G15 – 230V, 735-272-G16 – 100V). The Isolation Transformer
must NOT be positioned on the floor (see note below).

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NOTE: “In accordance with IEC 60601-1-1, the isolation transformer should not be placed on
the floor. The isolation transformer is considered a Multiple Portable Socket Outlet
(MPSO) by the international standards. MPSOs should be mounted in such a way as
to prevent ingress of liquids and avoid mechanical damage during normal use and
transportation. The transformer should be placed in accordance with the prevailing
electrical and fire codes.”

Plugging GE-supplied equipment directly into the wall outlet will not
WARNING: provide adequate isolation. This may result in improper operation of the
system, thus voiding all factory warranties.

DO NOT connect additional multiple portable socket-outlet or extension

WARNING: cords to the system.

Plugging equipment not supplied by GE specifically for the system into the
WARNING: GE-supplied isolation transformer may result in an overdraw of current.
This may result in improper operation of the system, thus voiding all
factory warranties.

The power source used for the system must meet the Power Supply
WARNING: requirements. Use of the system outside of these limitations will void the
Product Warranty.
The cable connections for each of the items in the system must conform to
WARNING: GE policy regarding component placement, use of approved extension
cables, and component power connections to the Isolation Transformer.
Use of the system outside of these limitations will void the Product
Warranty.
The PC cabinet should not be positioned within the patient vicinity (must be
WARNING: outside 6 foot radius of x-ray table).

The Precision RXi should not be operated such that a patient could come
WARNING: into contact with any part of the system.

There are no operator-serviceable parts within the Precision RXi.

CAUTION: Operators should not attempt to remove any panels or replace any parts.
Refer all servicing to qualified personnel trained in the maintenance of the
Precision RXi.
High voltages capable of causing death are present within this instrument.
WARNING:
The system is interfaced to x-ray generating equipment. Be certain to
CAUTION: follow the x-ray manufacturer’s instructions and specifications for wearing
proper shielding when in the presence of x-ray generating equipment.
All personnel must wear Dosimeters during every phase of installation,
CAUTION: operation and maintenance of the system.

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Do not position or use this system in a location where it may be subject to

WARNING: splashed or spilled liquids!

During installation of the system, care must be taken to prevent the

WARNING: potential risk of electromagnetic interference between this equipment and
other devices. The device has been tested for EMC compliance, but
interference can still occur in an electomagnetically noisy environment.
Attempt to maintain a suitable distance between electrical devices to
prevent cross-interference. The PC cabinet should be as far as possible
from any such device to prevent noise from affecting the image video
signal.

WARNINGS: In addition to the

! label, the following additional
Warnings appear in English on the Isolation Transformer:

THESE OUTLETS OUTPUT 120VAC

50/60Hz AT 8AMPS MAXIMUM
POWER FACTOR 0.8 +/- 10%
THE AMBIENT OPERATING TEMPERATURE
RANGE OF THIS SYSTEM IS 18-30 C

CAUTION
The imaging system and isolation transformer
(735-045) must be used together.
Do not plug any components of the system
directly into this wall outlet.

GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN CONNECTED

TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL GRADE.

CAUTION: TO REDUCE THE RISK OF ELECTRICAL SHOCK, DO NOT

REMOVE COVER. REFER SERVICING TO QUALIFIED SERVICE
PERSONNEL.

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Power Requirements

System Power Specifications

120 VAC - 50/60 HZ
8.0 AMPS

Power Phase Voltage Hz Amps

Single 90-132 50/60 8
Single 198-242 50/60 4

NOTES: Power must be from a dedicated A.C. line and be free of noise, spikes, surges, and
brownouts, which exceed the nominal voltage by +10%. If these conditions cannot be
met, the optional Power Conditioner is required.

• A dedicated A.C. outlet is required. Dedicated is defined as no other branch circuits

exist and where the outlet is powered directly from a circuit breaker in the local A.C.
distribution panel.

• Peak impulse levels (line to neutral) are to be under 100 volts peak above nominal
(peak time interval 2 mSec. or less).

• The neutral wire should be the same gauge as the line wire.

• Frequency requirements: for 60 Hz system: 60 Hz +0.5 Hz

for 50 Hz system: 50 Hz +0.5 Hz

• Neutral to ground potential: 2 V p-p or less.

• For European applications where the system will be powered by 230 VAC, an
approved male plug must be used on the isolation transformer provided it has ratings
of 250 VAC, 5A or greater.

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Environmental Requirements

For proper operation, and to keep the System Warranty valid, be sure that all components of the
Precision RXi system are always within these environmental limits.

Temperature Humidity Atmospheric Pressure

700 - 1060 hPA
Operation 64.4o to 86o F 20% - 80% Altitude to 3000 M above sea level
(Ambient) 18 o to 30 o C noncond (9842 feet)

700 - 1060 hPA

Transport and -40o to 140 o F 10% - 80% Altitude to 120000 M above sea
Storage -40o to 60o C noncond level (39,370 feet)

Flat Panel Monitor Specifications

A flat panel monitor must meet the following specifications in order to be used with the
Precision RXi:

Resolution 1280X 1024

Input Signal SVGA Analog Interface (75Hz progressive)
(Composite or Non-Composite)
SVGA Composite BNC
SVGA Non-Composite 15 pin DSub
Aspect Ratio 5:4
Contrast Ratio >=600:1
Brightness >=700 cd/m2 Max (White Luminance)
Response Time Tr=20 mS (black to white) Tf=5mS (black to white)
Regulatory UL/C-UL (Medical Safety), CE

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Video Output Signals

The normal video output from the Precision RXi is as follows:

• 60 Hz Progressive
• Aspect Ratio = 5:4
• Resolution – 1280 x 1024
• Non-composite SVGA **

**Composite and non-composite outputs are available.

An optional 525 line, 60 Hz or 625-50 Hz interlaced composite video is available for use with
VCRs in systems equipped with the scan converter option. The composite signal is 1 V p-p;
ratio is 4:3 (see figure below). The composite sync is carried by the green-channel and this
3-wire system is referred to as RGsB or SOG for sync-on-green, also known as RS-170.
Monitors are designed to work specifically with RGsB and the sync must be removed from
green.

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When Calling for Help . . .

Call the GE On Line Center to obtain the correct Service Engineer for your
location and to log your service call.

You will need to provide information when calling:

Have the unit Serial Number, Software Version Number and Copyright date ready.

Serial Number (S/N) is shown on:

• The Status Screen
• The Identification Tag on the rear of the computer.

Software Version Number and Copyright Date is shown on:

• The Status Screen

For Service, see information below for your location:

Diagnostic Imaging
Division Phone # More Info.

TiP Applications Support 800-682-5327

Service: On-Site 800-437-1171

Click Here;
Service: Parts 800-558-2040
www.gemedicalsystems.com
Sales: Accessories/Supplies 800-558-5102
Sales: New Equipment 800-886-0815
Sales: New Equipment
888-526-5144
LOGIQBook Compact Systems
Click Here;
Sales: Service 262-312-7399
www.gemedicalsystems.com
Click Here;
Canada 800-668-0732
www.gemedicalsystems.com
Click Here;
Latin America 305-269-4000
www.gemedicalsystems.com
Europe Click Here; www.gehealthcare.com
Middle East / Africa Click Here; www.gehealthcare.com
Click Here;
Asia
www.gemedicalsystems.com

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Canadian Contact Information

Products Diagnostic Imaging
General Electrics, CGR, Lunar, SMV,
Yokogawa Medical Systems (YMS),
Brand OEC
Johnson and Johnson, Technicare,
Elscint, Diasonics
Accessories &
800-668-0732 x3 800-668-0732 x3
Supplies
On-Site Service 800-668-0732 x1 800-668-0732 x1
Service Parts 800-668-0732 x2
New Equipment
800-668-0732 800-668-0732
Sales

To obtain your software information:

At the upper portion of the Clinical Interface:

1. Click on button at the Main Image screen.

2. A new Status screen will display.

3. Click on Tab labeled .

4. A new Version screen will display.

5. The S/N will be in format: PL1-xxxx-xxxx.

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Sample
Information

Version Information Screen

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Cleaning Instructions

No routine cleaning of the Precision RXi system is required. However, should the components
become dusty or dirty use the following procedures for cleaning the items.

CAUTION: Do not expose any system component surface to water or any corrosive
cleaners.

PC Use a clean, soft cloth to wipe off any dirt or dust on the outside of the cabinet.
Cabinet

Monitor The monitor screen can be cleaned with ordinary household glass cleaner.
Screen Anti-static wipes are also available commercially to clean monitor screen.
Be sure to remove power from the monitor and spray the cleaner onto a lint free
cloth so the fluid doesn't leak into the electrical components inside the monitor.
Vacuum off any dust that has settled on top of the monitor, and make sure no
books or papers have been placed on the air vents. Obstructed monitor vents can
cause the monitor to overheat or even catch on fire.
Refer also to the manual provided with the monitor by the manufacturer.

Keyboard Clean the keyboard by using compressed air contained in a can with a very long
nozzle. Aim the air between the keys and blow away all the dust and debris that
has gathered there. A vacuum cleaner can be used, but make sure the keyboard
doesn't have "pop off" keys that could possibly be sucked up by the vacuum.

Mouse 1. Remove the bottom cover. Arrows on the cover

indicate the direction in which the cover should be
rotated.

2. Place two fingers on the mouse cover and

push in the direction of the arrows.
3. Once the cover has rotated about an inch, rotate the mouse into its normal
position covering the bottom of the mouse with one hand.
The bottom should fall off and the mouse ball should be accessible.
4. Once the bottom cover and the ball are removed, three rollers located within
the mouse will be visible.
5. Use your finger/fingernail to move the rollers in a horizontal direction.
This action will loosen up any debris in the middle or the roller for removal.
6. Once any dirt has been removed, place the ball back inside the mouse and
replace cover.

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System Shipment Information

The Precision RXi system shipment consists of several cardboard boxes (approximately two to
six, depending on system configuration), which are banded to a standard wooden pallet.

A Packing List is attached to the outside of one of the boxes. Refer to this Packing List when
first receiving the shipment, or if the items have been removed from the pallet when they are
delivered to the x-ray room.

It is recommended that the pallet/boxes be kept in the upright position at all times.

CAUTION! The Precision RXi system is composed of sensitive electronic devices.

Follow all CAUTION stickers regarding Careful Handling, Do Not Drop, etc.

Applicable Standards

• FDA (Food and Drug Administration)

• UL 2601 (Underwriters Laboratories) – Second Edition
• FCC (Federal Communications Commission)
• IEC 60601.1 (International Electro-technical Commission)
• CE Mark
• CAN/CSA C22.2 No. 601-1
• CFR (Code of Federal Regulations), Title 21, Chapter J, part 1020.30 – “Diagnostic X-ray
systems and their major components”

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Installation Report
This form must be completed by a Service Engineer and returned within thirty-(30) days of first clinical
use. All blanks must be completed. Enter N/A if not applicable.

Installation: New Reinstalled Used Date: / /

System Serial Number:

Site Information Distributor Information

Name: Name:

Street Street:

City, State, Zip City, State, Zip

Department Administrator: Service Engineer:

Phone: Phone:

E-mail address E-mail address:

Survey Completed by (print)

Signed: Date:

Room Configuration:
Mounting Port Used: Radial (Side)____ Axial (Top)____

Fluoro Imaging?____ Spot Imaging?____

Continuous Pulsed Yes No

Camera ABC in Use? Yes____ LC____

High Resolution Monitor Make: Model:

Control Station In: Exam Area_____ Control Area_____

Are all interface cables clearly labeled? Yes_____ No_____

Distance from PC to patient area:

Modem Telephone Number:

X-Ray Generator
Manufacturer:
Model Number:
Image Intensifier Sizes:
Dose Measurement Normal MAG1 MAG2 MAG3
Fluoro rate mR/minute
Photospot rate uR/exposure

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Installation Notes:

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Acceptance Tests

After completion of each test or procedure, note date that test was completed as well as the
results of test or any other pertinent information. Some items listed are optional and may not be
installed. Please enter N/A for these lines.

Failure of any test or inability to perform system function constitutes failure of the system. Refer
to Steps 8 of the Technical Manual for instructions.

Procedure Pass Fail N/A

Baseline data on previously installed digital system
System calibration completed. Document image quality parameters,
including noise, resolution, uniformity and signal range
System configuration complete
System powers up
Review of test images with image processing, including W/L/I, edge,
mask with reregistration, zoom
Acquisition of fluoro images – integration, edge, W/L/I, fluoro store, LIH
Acquisition of fluoro loops – loop acquire, loop replay, store loop –
Acquisition of spot images – single shot, rapids
LIH – store, W/L/I, edge
Review of acquired images – W/L/I, edge, mask with reregistration,
zoom with pan, AIO
Hardcopy – different formats
Digital Host Control or DICOM hardcopy
Export / Import of data via DICOM
System diagnostics

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For QA Use Only: Log #:

System Serial Number: Installation Date:

Were any parts damaged in Yes_____ No_____

shipment?

If Yes, record all components that were removed and/or replaced:

Removed Component Replacement Component

Part Name IPN S/N Part Name IPN S/N

Comments:

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