This manual and the information contained herein are
confidential and proprietary to Philips Medical Systems, Inc.
Only Philips or its Licensees have the right to use the
information. Any unauthorized use, disclosure or
reproduction is a violation of the licenses and/or Philips’s
proprietary rights and will be prosecuted to the full extent of
the Law.
The information contained in this manual conforms with the
configuration of the equipment as of the date of manufacture.
Revisions to the equipment subsequent to the date of
manufacture will be addressed in service updates distributed
to the Philips Technical Service Organization.
Philips Medical Systems assumes no responsibility for the
use, nor for any consequences which may result from the use
or interpretation of the information contained herein
subsequent to the date of manufacture by anyone other than
Philips employees or authorized representatives of Philips.
DISCLAIMER
Neither Philips Medical Systems, Inc., nor any of its
worldwide affiliates shall be obliged in any manner in respect
to bodily injury and/or property damage arising from this
product or the use thereof if the unit is not operated and
maintained in strict compliance with instructions and safety
precautions contained herein, in all supplements hereto and
according to all terms of warranty and sale relevant to this
product.
Starting the Biopsy Procedure ...................................................................... 9-8
Lesion Localization Process .......................................................................... 9-9
Radiation Information .................................................................................. 9-11
Scattered Radiation Information ................................................................. 9-12
TOC-6Mx8000 Series Operation Manual, Vol. 1
Appendix A – Using Windows
Appendix B – Image Performance Quality Assurance
Appendix C – User Information
Table of Contents
Mx8000 Series Operation Manual, Vol. 1TOC - 7
DOCUMENT EFFECTIVITY
E.C.O.REV.DATEDESCRIPTIONCHAP.PAGESAPPR.
E99139060Mar
1999
E130000030May
2000
E130000480Nov
2000
E130000670Apr
2001
E130000671Jun
2001
E130001110Nov
2001
New ReleaseAllAllS. Rubinstein
Update to V2AllAllS. Rubinstein
Update v2 with
Dual system
Update to v2.2 Beta edition
Release v2.2AllAllS. Rubinstein
Release v2.21AllAllS. Rubinstein
AllAllS. Rubinstein
AllAllS. Rubinstein
a
Diagnostic Imaging Systems
RADIATION WARNING
X-RAY AND GAMMA RAYS ARE DANGEROUS TO BOTH OPERATOR
AND OTHERS IN THE VICINITY UNLESS ESTABLISHED SAFE
EXPOSURE PROCEDURES ARE STRICTLY OBSERVED.
THE USEFUL AND SCATTERED BEAMS CAN PRODUCE SERIOUS OR
FATAL BODILY INJURIES TO PATIENTS AND PERSONS IN THE
SURROUNDING AREA IF USED BY AN UNSKILLED OPERATOR.
ADEQUATE PRECAUTIONS MUST ALWAYS BE TAKEN TO AVOID
EXPOSURE TO THE USEFUL BEAM, AS WELL AS TO LEAKAGE
RADIATIONFROMWITHINTHESOURCEHOUSINGORTO
SCATTERED RADIATION RESULTING FROM THE PASSAGE OF
RADIATION THROUGH MATTER.
THOSE AUTHORIZED TO OPERATE, PARTICIPATE IN OR SUPERVISE
THE OPERATION OF THE EQUIPMENT MUST BE THOROUGHLY
FAMILIAR AND COMPLYCOMPLETELY WITHTHE CURRENT
ESTABLISHEDSAFEEXPOSUREFACTORSANDPROCEDURES
DESCRIBED IN PUBLICATIONS, SUCH AS: SUBCHAPTER J OF TITLE
21 OF THE CODE OF FEDERAL REGULATIONS, "DIAGNOSTIC X-RAY
SYSTEMS AND THEIR MAJOR COMPONENTS," AND THE NATIONAL
COUNCIL ON RADIATION PROTECTION (NCRP) NO. 102, "MEDICAL
X-RAY AND GAMMA-RAY PROTECTION FOR ENERGIES UP TO 10
MEV-EQUIPMENT DESIGN AND USE, " AS REVISED OR REPLACED IN
THE FUTURE.
THOSE RESPONSIBLE FOR THE PLANNING OF X-RAY AND GAMMARAYEQUIPMENTINSTALLATIONSMUSTBETHOROUGHLY
FAMILIAR ANDCOMPLYCOMPLETELY WITH NCRPNO.49,
"STRUCTURALSHIELDINGDESIGNANDEVALUATIONFOR
MEDICAL OF X-RAYS AND GAMMA-RAYS OF ENERGIES UP TO 10
MEV," AS REVISED AND REPLACED IN THE FUTURE.
FAILURE TO OBSERVE THESE WARNINGS MAY CAUSE SERIOUS OR
FATAL BODILY INJURIES TO THE OPERATOR OR THOSE IN THE
AREA
.
b
Diagnostic Imaging Systems
MECHANICAL - ELECTRICAL WARNING
ALL OF THE MOVEABLE ASSEMBLIES AND PARTS OF THIS EQUIPMENT
SHOULD BE OPERATED WITH CARE AND ROUTINELY INSPECTED IN
ACCORDANCEWITHTHEMANUFACTURER'SRECOMMENDATIONS
CONTAINED IN THE EQUIPMENT MANUALS.
ONLY PROPERLY TRAINED AND QUALIFIED PERSONNEL SHOULD BE
PERMITTED ACCESS TO ANY INTERNAL PARTS.LIVE ELECTRICAL
TERMINALS ARE DEADLY; BE SURE LINE DISCONNECT SWITCHES ARE
OPENED AND OTHER APPROPRIATE PRECAUTIONS ARE TAKEN BEFORE
OPENING ACCESS DOORS, REMOVING ENCLOSURE PANELS, OR ATTACHING
ACCESSORIES.
DO NOT, UNDER ANY CIRCUMSTANCES, REMOVE THE FLEXIBLE HIGH
TENSION CABLES FROM THE X-RAY TUBE HOUSING OR HIGH TENSION
GENERATOR AND/OR THE ACCESS COVERS FROM THE GENERATOR UNTIL
THE MAIN AND AUXILIARY POWER SUPPLIES HAVE BEEN DISCONNECTED.
FAILURE TO COMPLY WITH THE ABOVE MAY RESULT IN SERIOUS OR FATAL
BODILY INJURIES TO THE OPERATOR OR THOSE IN THE AREA.
ELECTRICAL GROUNDING INSTRUCTIONS
THE EQUIPMENT MUST BE GROUNDED TO AN EARTH GROUND BY A
SEPARATE CONDUCTOR. THE NEUTRAL SIDE OF THE LINE IS NOT TO BE
CONSIDERED THE EARTH GROUND.ON EQUIPMENT PROVIDED WITH A
LINE CORD, THE EQUIPMENT MUST BE CONNECTED TO A PROPERLY
GROUNDED, THREE-PIN RECEPTACLE. DO NOT USE A THREE-TO-TWO PIN
ADAPTER
.
INSTALLATION AND ENVIRONMENT
EXCEPTFORINSTALLATIONSREQUIRINGCERTIFICATIONBYTHE
MANUFACTURER PER FEDERAL STANDARDS, SEE THAT A RADIATION
PROTECTION SURVEY IS MADE BY A QUALIFIED EXPERT IN ACCORDANCE
WITH NCRP 102, SECTION 7, AS REVISED OR REPLACED IN THE FUTURE.
PERFORM A SURVEY AFTER EVERY CHANGE IN EQUIPMENT, WORKLOAD,
OR OPERATING CONDITIONS WHICH MIGHT SIGNIFICANTLY INCREASE THE
PROBABILITY OF PERSONS RECEIVING MORE THAN THE MAXIMUM
PERMISSIBLE DOSE EQUIVALENT.
c
TO THE USER OF THIS MANUAL
THE USEROF THISMANUAL IS DIRECTEDTO READ AND
CAREFULLYREVIEWTHEINSTRUCTIONS,WARNINGSAND
CAUTIONSCONTAINEDHEREINPRIORTOBEGINNING
INSTALLATION OR SERVICE ACTIVITIES. WHILE YOU MAY HAVE
PREVIOUSLY INSTALLED OR SERVICED EQUIPMENT SIMILAR TO
THATDESCRIBEDINTHIS MANUAL,CHANGES INDESIGN,
MANUFACTURE OR PROCEDURE MAY HAVE OCCURRED WHICH
SIGNIFICANTLY AFFECT THE PRESENT INSTALLATION OR SERVICE.
THE INSTALLATION AND SERVICE OF EQUIPMENT DESCRIBED
HEREIN IS TO BE PERFORMED BY AUTHORIZED, QUALIFIED PHILIPS
MEDICAL SYSTEMSPERSONNEL.ASSEMBLERSAND OTHER
PERSONNEL NOT EMPLOYED BY NOR DIRECTLY AFFILIATED WITH
PHILIPS MEDICAL SYSTEMS TECHNICAL SERVICES ARE DIRECTED
TO CONTACT THE LOCAL PHILIPS OFFICE BEFORE ATTEMPTING
INSTALLATION OR SERVICE PROCEDURES.
This document prepared and distributed by
Technical Communications Department.
Address inquiries regarding this document to:
PHILIPS MEDICAL SYSTEMS, INC.
TECHNICAL COMMUNICATIONS DEPARTMENT
595 Miner Road
Highland Heights, Ohio 44143
Phone: (440) 483-3000
Fax: (440) 483-7209
d
CAUTION
Use of controls or adjustments or performance of
procedures other than those specified herein may
result in hazardous radiation exposure.
CAUTION
CAUTION
CAUTIONCAUTION
LASER RADIATION – DO NOT
STARE INTO BEAM
DIODE LASER – MAX OUTPUT POWER 1.0mW
650 NM EMITTED WAVE LENGTH
“CLASS II LASER PRODUCT”
e
PUBLICATION IMPROVEMENT RECOMMENDATION
Users of this publication are encouraged to report errors, omissions, and their recommendations for
improving this publication. This sheet is published for that purpose. To file a Publication
Improvement Recommendation, fill in the information requested below, fold, tape, and mail this
prepaid business reply form.
Appendix A – Using Windows ................................................
1
2
3
4
5
6
7
8
9
A
Appendix B – Image Performance Quality Assurance............
Appendix C – User Information.............................................
B
C
Chapter 1
Safety Guidelines
General
Warning
The x-ray unit may be dangerous to patient and operator unless
safe exposure factors and operating instructions are observed.
Caution
United States Federal Law restricts this device to sale,
distribution and use by or on the order of a physician.
1. This product was designed and manufactured to ensure maximum
safety of operation. It should be operated and maintained in strict
compliance with the safety precautions, warnings and operating
instructions contained herein
1
2. This product should be installed, maintained and serviced by Philips
personnel or other qualified personnel approved in writing by Philips
according to procedures laid down by Philips.
3. The system in whole or in part should not be modified in any way
without prior written approval by Philips.
4. The owner should make certain that only properly trained and fully
qualified personnel are authorized to operate this equipment. An
authorized operators list should be maintained.
5. It is important that this manual should be kept at hand, studied
carefully and reviewed periodically by the authorized operators.
6. Philips makes no representation, however, that the act of reading this
manual renders the reader qualified to operate, test or calibrate the
system.
Mx8000 Series Operation Manual, Vol. 11 - 1
Safety Guidelines
7. Unauthorized personnel should not be allowed access to the system.
8. Under no condition shall the patient be left unobserved within the
9. If the product does not operate properly or if it fails to respond to the
10. The images and calculations provided by this system are intended as
region of study.
controls described in this manual, the operator should:
A. Ensure the safety of the patient and then the safety of the
equipment.
B. Follow safety precautions as specified in the safety chapter.
C. Freeze the situation and prevent any changes.
D. Immediately contact the nearest Philips field service office,
report the incident and await further instructions.
tools for the competent user. They are explicitly not to be regarded
as a sole incontrovertible basis for clinical diagnosis. Users are
encouraged to study the literature and reach their own professional
conclusions regarding the clinical utility of the system
11. The user should be aware of the product specifications and of system
accuracy and stability limitations. These limitations must be
considered before making any decision based on quantitative values.
In case of doubt, please consult a Philips office.
12. The system has been designed to meet all the safety requirements
applicable to medical equipment. However, anyone attempting to
operate the system must be fully aware of potential safety hazards.
Warnings, Cautions and Notes are used throughout this manual.
• Warnings indicate precautions and instructions which, if not
followed, may result in personal injury or even death.
• Cautions indicate instructions which, if not followed, may
result in damage to the equipment or to the quality of clinical
studies.
• Notes are used in italics to provide information helpful in
obtaining optimal performance from the equipment.
1-2Nov 2001
General Hazards
Electrical Shock Hazard
Do not remove or open system covers or plugs. Internal circuits use high
voltage capable of causing serious injury.
Electrical Fire
Conductive fluids that seep into the active circuit components of the consoles
may cause short circuits that can result in electrical fires. Therefore, do not
place any liquid or food on any part of the consoles or other modules of the
system.
Explosion Hazard
Do not operate the equipment in the presence of flammable or explosive
liquids, vapors or gases. Do not plug in or turn on the system if hazardous
substances are detected in the environment. If these substances are detected
after the system has been turned on, do not attempt to turn off the unit or to
unplug it. Evacuate and ventilate the area before turning off the system.
Safety Guidelines
1
Implosion Hazard
Do not subject the system to serious mechanical shock, as the cathode ray tube
(CRT) can fracture if struck or jarred. This may result in flying pieces of glass
and phosphor coating that can cause serious injury.
Potential Pacemaker Hazard
Though the possibility of interference with pacemakers is small, the operator
should be alert to such a potential hazard from any equipment using a high
frequency electrical signals.
Mx8000 Series Operation Manual, Vol. 11 - 3
Safety Guidelines
IEC-601 Classification
1. Type of protection against electric shock:
Class I equipment.
2. Degree of protection against electric shock:
Type B equipment.
3. Degree of protection against harmful ingress of water:
Ordinary equipment.
4. Possible Interference with other Equipment:
IEC 601-1-2 Class B Device for both Emission and Susceptibility.
5. Mode of operation:
Continuous mode with short time loading.
Electrical Ratings
Voltage
(VAC)
380350/60890
400350/60890
420350/60890
440350/60890
460350/60890
480350/60890
1-4Nov 2001
PhaseFrequency
(Hz)
Power Consumption
(KVA)
Continuous
mode
Short time
loading
Environmental Protection
Philips is committed to the protection of the environment and natural resources.
Our devices are manufactured under strict guidelines to prevent contamination
of the surrounding water, ground and air.
The majority of the materials in this product (for example, metals, covers,
electronics, etc.) are recyclable. Philips encourages its customers to dispose of
the product at the end of its useful life, for recycling.
The following materials are hazardous to the environment. They must be
segregated and disposed of properly:
1. All batteries: according to local regulations.
2. X-ray tubes.
Owner's Responsibility
It is the owner’s responsibility to ensure that anyone using the system reads
and understands the Operation Manual and other relevant literature, and fully
understands them.
Safety Guidelines
1
The owner should ensure continuous power supply to the system, with voltage
and current according to Philips's specifications. If power outages are not
infrequent, a UPS (Uninterruptible Power Supply) should be installed on the
computer power line to avoid loss of data.
System Operation and Maintenance
The system should be operated and maintained in strict compliance with the
operating instructions contained in this manual.
Mx8000 Series Operation Manual, Vol. 11 - 5
Safety Guidelines
Safety Precautions
1. The system in whole or in part may not be modified in anyway
without prior written approval by Philips.
2. If there is any sign of danger to the patient, press any one of the three
red STOP buttons located on the Scan Panel of the Operation Station
and on both sides of the Gantry front cover.
3. Familiarize yourself with the manual Table Release procedure.
Practice it several times in order to be ready to react immediately in
a real emergency.
4. If the product does not operate properly or if it fails to respond to the
controls as described in this manual, proceed according to the
appropriate following measures:
• To stop all scanner motions and X-ray generation, press on
any red
front cover and on the Scan Panel.
STOP button located on both sides of the Gantry
• If the patient's body comes in contact with the Gantry and if
there is danger to the patient’s safety, then press the red
STOP button and release the patient manually as described in
the section on Safety Devices and Procedures.
• If the patient is safe and if there is no dangerous contact with
the scanner, return the system to normal operation according
to section Returning the System to Normal Operation below.
• If there is any indication that X-rays are not turned off after
scan, press the
STOP button and switch off the power by
turning off the main switch on the wall.
• Release the patient after stopping all Gantry and table
motions.
• Immediately contact the nearest Philips field service office,
report the incident and await further instructions.
5. Only qualified service personnel are authorized to change fuses.
1-6Nov 2001
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