OEC Compact Series Operating and maintenance manual

Compact / Series 7600
Mobile Imaging System
Installation Procedure
Part Number: 00-879039-03
April 1997
OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City, UT. 84116
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Compact / Series 7600 Installation Procedureii
This manual contains descriptions, instructions and
procedures that apply to the Compact / Series 7600 Mobile
Digital Imaging System only.
Refer to the Installation Report/Checklist P/N 00-879038-03
when installing a 7600 system.
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Compact / Series 7600 Installation Procedure iii
Revision History
Rev Dash Date Change Description
Rev 1 -01 December 1995 Initial Engineering Release
Rev A -01 December 1995 Manufacturing Release
Rev B -02 July 1996 Added power supply tolerances, kV tracking
specifications, and resolution specifications
Rev C -03 April 1997 Add Series 7600 installation procedures
Rev D -03 November 1998 Drawing change only
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Compact / Series 7600 Installation Procedureiv
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Compact / Series 7600 Installation Procedure v
TABLE OF CONTENTS
Introduction................................................................................................................... 1
Responsibility.............................................................................................................................1
Safety Procedures......................................................................................................................1
Explosion Hazard...................................................................................................................................... 1
Electrical Safety......................................................................................................................................... 2
Accident Reporting.................................................................................................................................... 3
Unauthorized Modifications....................................................................................................................... 3
System Specifications.................................................................................................. 4
Technical Specifications............................................................................................................................ 4
System Classification .................................................................................................................4
Connector Output Power............................................................................................................4
C-Arm........................................................................................................................................................ 4
Input Power................................................................................................................................5
X-ray Source Assembly..............................................................................................................6
Fluoroscopy............................................................................................................................................... 6
Pulsed Fluorography Mode....................................................................................................................... 6
Radiography.............................................................................................................................................. 7
Accuracy ................................................................................................................................................... 7
Video Signal.............................................................................................................................................. 7
Dimensions ............................................................................................................................................... 8
Tube Data And Rating Charts.....................................................................................................8
General Tube Data.................................................................................................................................... 8
X-ray Generator Information.......................................................................................................9
Unpacking and Inspection ......................................................................................... 10
Remove Protective Shipping Material.......................................................................................10
De-pallet the System (Compact)...............................................................................................10
De-pallet the System (Series)...................................................................................................10
C-Arm...................................................................................................................................................... 10
Workstation............................................................................................................................................. 10
Installation................................................................................................................... 11
Site Requirements....................................................................................................................11
Installation Kit Contents............................................................................................................11
Cover Removal.........................................................................................................................12
C-Arm:..................................................................................................................................................... 12
Workstation:............................................................................................................................................ 12
Mechanical Checks ..................................................................................................................12
Inspection and Setup................................................................................................................12
Line Voltage Compatibility Check.............................................................................................13
Isolation Transformer Wiring.....................................................................................................13
Power ON System....................................................................................................................13
System Power Supply Voltages................................................................................................14
Measure Line Voltage Regulation.............................................................................................14
System Operational Verification ...............................................................................................15
Generator................................................................................................................................................ 15
Workstation............................................................................................................................................. 18
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Compact / Series 7600 Installation Procedurevi
Thermal Printer / Multiformat Camera........................................................................20
Fluoroscopic Image Tests.........................................................................................................21
Radiographic Beam Alignment Test..........................................................................................21
Setup....................................................................................................................................................... 21
Beam Alignment Verification................................................................................................................... 21
Complete Paper Work...............................................................................................................22
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Compact / Series 7600 Installation Procedure 1
Introduction
This manual describes the installation of the Compact / Series 7600 system
and a definition of the responsibilities and instructions for reporting, safety,
unpacking, moving and verifying system operation.
Responsibility
The customer must provide the labor and equipment necessary to unload the
system from the transport vehicle and move it to the final location. It is the
customer’s responsibility to obtain all permits necessary to meet all
requirements of state and local codes, regulations and ordinances with respect
to the installation and operation of the system.
A qualified service technician should perform the following:
•Installation Report/Checklist (00-879038-03).Safety procedures should be
in effect at all times during the installation process. By law, complete
reports within 15 days from the date of assembly (installation).
•Return the assembler's copy of the Report of Assembly of Diagnostic X-ray
(FDA form 2579), the Beam Alignment Radiographs (films), and the
Installation Report/Checklist to OEC Medical Systems, Inc., Attention:
Technical Support, in the stamped, manila envelope provided in the Field
Service Documentation Package.
•Distribute the various remaining copies of the Report of Assembly of
Diagnostic X-ray (FDA form 2579), following the documentation instructions
included in the Field Service Documentation Package.
•The OEC Medical Systems, Inc. Representative MUST sign the last page of
the Installation Report and Checklist, verifying Field Service acceptance of
the unit. If, for any reason, the installation remains incomplete, notify the
Hospital that the system is not yet ready for use.
Safety Procedures
Under no circumstances should the safety interlocks in the system be
bypassed, jumped or otherwise disabled. Never operate or store the system in
a location where conductive fluids such as water, saline solution, etc., can spill
on any part of the equipment unless you cover the system with a protective
waterproof draping.
NOTE: All OEC Medical Systems, Inc. systems comply with International
Electrotechnical Commission safety standard IEC-601. Do not connect any
external device to the system that does not meet the requirements of IEC-601.
Only devices provided by or approved by OEC Medical Systems, Inc. should be
connected to the system.
Explosion Hazard
Never operate the system in the presence of flammable anesthetics or other
flammable or explosive liquids, vapors, or gases. Vapors and gases can ignite
by electrical arcs that can occur during the normal operation of switches, circuit
breakers, push-buttons and other circuit components.
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Compact / Series 7600 Installation Procedure2
If flammable substances are present before you apply system power, do not
plug in or turn on the system.
If you detect flammable substances after the system has been turned on, do
not touch any of the controls, switches, knobs or cables. Evacuate all personnel
immediately, then ventilate the room to clear the air of the flammable vapor or
gas. Remove any volatile liquids that are producing flammable vapors to a safe
storage area.
Electrical Safety
Electrical circuits inside the equipment use voltages that are capable of causing
serious injury or death from electrical shock.
WARNINGS: This equipment contains high power electrical components and only
personnel familiar with the circuitry and its operation should provide
service. Some components may maintain a charge with the power cord
disconnected.
Observe safety precautions when measuring high voltage electronics.
Steps within this procedure produce x-rays. Use appropriate precautions.
Areas where hazardous voltages exist include:
Transformers - 100 - 240 volts
Video Monitors - 100 - 240 volts and High AC/DC Voltages
Image Intensifier - 50,000 volts
Generator - 110,00 volts
•Observe the following precautions when you remove system covers:
•Observe the two person rule when working near lethal voltages. A person
who is familiar with the emergency power removal procedure must be in
attendance. This person must remain clear of the machine and be prepared
to turn it off in an emergency.
•Be familiar with the components being serviced and the locations of
hazardous voltages in the assembly where you work.
•High voltage cables and capacitors can retain a charge even when you
remove all power from the system. Avoid touching these unless you are
certain the charge has dissipated to ground.
•Some high energy capacitors in the system should be shorted to ground
through an adequate resistance to avoid a burn hazard.
•A protective earth ground stud, located on the bottom left side of the
system base, and marked with the international symbol shown below on the
left. It also has a distinctly colored decal at the base of the stud as shown
below on the right.
el
Grn
PROTECTIVE EARTH SMBOL PROTECTIVE EARTH STUD
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Compact / Series 7600 Installation Procedure 3
Accident Reporting
The Medical Device Reporting Regulation, 21 CFR Part 803, requires that the
manufacturers of medical devices submit a report to the appropriate federal
agency containing specific information in the event of an accident resulting in
death or serious injury during the use or service of its medical devices. (In the
following paragraphs, labeling definitions include all instructional and
procedural text contained in the Operator's Guide and Periodic Maintenance
Procedures.)
A report is not necessary if:
•The potential for death or the type of serious injury that may result
appears in the labeling for the system.
•The malfunction and the routine service, repair, or maintenance in-
structions to correct the problems appear in the labeling for the system.
•The malfunction has occurred at or below its expected rate of frequency
and severity.
•The malfunction does not lead the manufacturer to undertake a remedial
action involving any other systems.
For OEC Medical Systems, Inc. to meet these reporting requirements, all users
of these systems, operators, and service technicians, must provide the QA
Manager of OEC Medical Systems, Inc. with the following information regarding
all reportable events as soon as possible:
1. Identify the model and the serial number.
2. Describe the event. Include whether any serious injury or death occurred,
the number of personnel injured, and any publication title and dates of any
articles in the scientific or medical literature describing the reported event.
3. Identify the person who is submitting the information, include their address,
to OEC Medical Systems, Inc.
4. Indicate whether additional information will be submitted, and if so, when.
5. Indicate whether the event being reported has occurred with greater
frequency or severity than is indicated in the labeling for the system, or is
unusual for this type of system.
Unauthorized Modifications
Unauthorized changes or modifications to any part of the system could have
hazardous consequences. Changes or modifications are forbidden unless
specifically authorized by OEC Medical Systems, Inc.
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Compact / Series 7600 Installation Procedure4
System Specifications
Technical Specifications
The policy of OEC Medical Systems, Inc. is one of continual product
development and improvement. For this reason, OEC Medical Systems, Inc.
reserves the right to change the operating characteristics and specifications of
newer products at any time, without prior notice, and without incurring any
obligation relating to previously manufactured items.
The specifications list limited to general performance and physical data.
Specifications of optional equipment provided by other manufacturers in the
applicable manuals provided with those options.
OEC Medical Systems, Inc. will make available, on request, circuit diagrams,
component part lists, descriptions, calibration instructions, or other information
that will assist properly trained and qualified technicians to repair those parts of
the system which are designated as repairable.
System Classification
Class I (as defined by IEC 601-1)
Type B
Ordinary protection against ingress of water
Non AP (Non-anesthetic proof)
Continuous operation
Connector Output Power
C-Arm
Footswitch: 15 VAC 30 milliamp current source
Handswitch: 15 VAC 30 milliamp current source
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