ODYSSEY HF Series Operators Manual Rev Q

This manual is copyrighted and all rights are reserved. No portion of this document may be copied, photocopied, reproduced, translated, or reduced to any electronic medium or machine readable form without prior consent in writing from Quantum Medical Imaging, LLC. (QMI)

Copyright© 2010 QMI

Quantum Medical Imaging, LLC 2002-B Orville Drive North Ronkonkoma, NY 11779-7661 USA Phone: (631) 567-5800 Fax: (631) 567-5074 E-mail: [email protected] www.quantummedical.net

Made in U.S.A.

Revision History

REVISION

DATE

TYPE OF MODIFICATION

A

7/13/01

Initial Release.

B

7/30/01

Incorporated UL comments, added Model QG-50.

C

9/25/01

Added Model QG-40-3.

D

12/10/01

Added Model QG-65, incorporated ECO# 0619.

E

2/26/02

Incorporated ECO# 0714, 0742

F

10/9/02

Incorporated ECO# 0787, 0876

G

4/23/03

Incorporated ECO# 0923, 1028

H

7/11/03

Incorporated ECO# 1256

J

7/31/03

Incorporated ECO# 1269, 1272

K

2/5/04

Incorporated ECO# 1144, 1359

L

5/4/05

Incorporated ECO# 1607

M

5/12/08

Incorporated ECO# 1985

N

3/2/09

Added protection against harmful ingress of water, EU battery directive

P

9/21/09

Incorporated ECO# 2199

Q

9/13/10

Safety Notices enhancements

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4-1 to 4-16

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5-1 to 5-14

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HF Series X-ray Generators - Operator’s Manual Quantum Medical Imaging, LLC

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Table of Contents

CHAPTER 1 - SAFETY NOTICES GENERAL SAFETY INFORMATION ... 1-3 WARNINGS, CAUTIONS, NOTES ... 1-3 REGULATORY COMPLIANCE ... 1-5 CLASSIFICATION ... 1-5 INTENDED USE ... 1-6 COMPATIBILITY ... 1-6 INTENDED OPERATOR ... 1-6 TRAINING ... 1-6 ACCOMPANYING DOCUMENTATION ... 1-6 APPLICABLE STANDARDS ... 1-7 DISPOSAL OF BATTERIES AND ACCUMULATORS (DIRECTIVE 2006/66/EC) ... 1-8 ELECTROMAGNETIC COMPATIBILITY (EN 60601-1-2:2007/IEC 60601-1-2:2007) ... 1-8 ABBREVIATION DEFINITION ... 1-14

CHAPTER 2 - GENERAL INFORMATION OVERVIEW ... 2-3 INTENDED USE ... 2-4 KEY FEATURES ... 2-4 PERFORMANCE SPECIFICATIONS ... 2-5 ELECTRIC OUTPUT DATA ... 2-9 MAIN COMPONENTS ... 2-12 ACCESSORIES ... 2-13 CONTROLS AND INDICATORS ... 2-13 HELP SERVICES SCREEN ... 2-19

CHAPTER 3 - OPERATION OVERVIEW ... 3-3 POWER ON/OFF PROCEDURES ... 3-3 Power On Procedure ... 3-3 Power Off Procedure ... 3-4 Automatic Power Standby Mode ... 3-5 DAILY TUBE WARM-UP PROCEDURE ... 3-6 SETTING UP TO TAKE EXPOSURES ... 3-7 RECEPTOR SELECTION ... 3-7 MODE SELECTION ... 3-9 Manual Mode ... 3-11 AEC Mode ... 3-12 APR Mode ... 3-18 TAKING AN EXPOSURE ... 3-24

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Table of Contents

Exposures ...3-25 Instantaneous Exposures ...3-25 HEAT UNIT COMPUTER ...3-25 FAULT MESSAGES ...3-26 HELP SCREEN FEATURES ...3-31

CHAPTER 4 - APR EDITOR OVERVIEW ... 4-3 ACCESSING THE APR EDIT MODE ... 4-3 APR EDIT MODE ... 4-6 Editing a View Name ... 4-6 Editing Programmable Exposure Settings ...4-10 Making a Back Up Copy of the APR Program File ...4-20 Restoring APR Program from Back Up Copy ...4-21

CHAPTER 5 - USER MAINTENANCE OVERVIEW ... 5-3 USER MAINTENANCE ... 5-3 SYSTEM SETTINGS ... 5-4 ACCESSING SERVICE MODE ... 5-4

CHAPTER 6 - WARRANTY INFORMATION WARRANTY STATEMENT ... 6-3 WARRANTY EXCLUSIONS ... 6-4 BUYER’S REMEDIES ... 6-5 WARRANTY RETURN PROCEDURE ... 6-5 EQUIPMENT IN TRANSIT ... 6-5 VOIDING WARRANTY ... 6-6

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Chapter

1

SAFETY NOTICES

1-1

Chapter 1 Safety Notices

GENERAL SAFETY INFORMATION Quantum products are designed to meet stringent safety standards. All medical electrical equipment requires proper installation, operation, and maintenance (particularly with regard to safety). It is vital that the user read, understand, note, and where applicable, strictly observe all Warnings, Cautions, Notes and Safety markings within this document and on the equipment, and that the user strictly follow all safety directions in this manual to help ensure the safety of users and patients. Every reasonable precaution has been taken during manufacture to safeguard the health and safety of persons who will operate this equipment. The following precautions must be observed at all times.

WARNINGS, CAUTIONS, NOTES The following samples show how warnings, cautions, and notes appear in this document. The text explains their intended use.

WARNING

Indicates injury or death is possible if the instructions are not obeyed. Instructs users to refer to documentation if displayed without warning text.

CAUTION

Indicates that damage to equipment is possible if the instructions are not obeyed.

NOTE

Notes provide advice and highlight unusual points. A note is not intended as an instruction.

The purpose of safety icons, such as those shown below, is to indicate at a glance the type of caution, warning or danger.

WARNING

Ionizing radiation: indicates the possibility of increased levels of radiation.

WARNING

Dangerous voltage: indicates the presence of high voltage.

WARNING

Warning, hot surface.

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Chapter 1 Safety Notices

WARNING Quantum Medical Imaging, LLC disclaims all responsibility from any injury resulting from improper application of this equipment. This equipment is sold to be used exclusively under the prescribed direction of a person who is licensed by law to operate equipment of this nature. This equipment must be used in accordance with all safety procedures described in this manual and must not be used for purposes other than those described herein. In the United States, Federal law restricts this device to sale, distribution, and use by or on order of a licensed physician. Quantum Medical Imaging, LLC cannot assume responsibility for any malfunctioning of this equipment resulting from improper operation, maintenance, or repair, or from damage or modification of its components. Failure to observe these warnings may cause serious injuries.

WARNING X-rays are hazardous to both patient and operator unless established safe exposure factors and operating instructions are observed. Only qualified and authorized personnel shall operate this system. In this context, qualified means those legally permitted to operate this equipment in the jurisdiction in which the equipment is being used, and authorized means those authorized by the authority controlling the use of the equipment. Full use must be made of all radiation protection features, devices, systems, procedures and accessories. It is important that everyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Suite 800, Bethesda, Maryland 20814-3095 (www.ncrp.com), and of the International Commission on Radiological Protection (www.icrp.org), and take adequate steps to protect against injury.

WARNING X-ray equipment may cause injury if used improperly. The instructions contained in this manual must be read and followed when operating this unit. Personal radiation monitoring and protective devices are available. You are urged to use them to protect against unnecessary X-ray exposure.

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Chapter 1 Safety Notices

REGULATORY COMPLIANCE This certified Quantum Medical Imaging, LLC medical device has been designed, manufactured, and calibrated to comply with governing Federal Regulations 21 CFR Subchapter J and the performance standards attendant thereto. Upon installation, all certified products require the filing of Form FD-2579 "Report of Assembly of a Diagnostic X-ray System" by the assembler (i.e., the installer) with the appropriate agencies; the "Installation Quality Assurance Checklist" must also be completed and properly distributed upon installation. A copy of each form (pink copy) is provided to the user. The installation report is completed by the installer and returned to Quantum Medical Imaging, LLC. Those responsible for the planning of X-ray equipment installations must be thoroughly familiar and comply completely with NCRP Report No. 49, "Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of Energies up to 10 MeV", as revised or replaced in the future. Those authorized to operate, test, participate in or supervise the operation of the equipment must be thoroughly familiar and comply completely with the currently established safe exposure factors and procedures 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 NCRP Report No. 102, “Medical X-ray, Electron Beam and Gamma Ray Protection for Energies Up to 50 MeV-Equipment Design and Use” as revised or replaced in the future. The ODYSSEY™ High-Frequency (HF) Series X-ray Generator, hereinafter referred to as the HF Series X-ray Generator, must only be used in rooms that comply with all applicable laws or regulations that have the force of law, concerning electrical safety for this type of equipment. Scheduled maintenance is essential to the assurance of continued integrity of this equipment with respect to regulatory compliance. The continuance of certified performance to the regulatory standard is incumbent upon the user's diligent conformance to recommended maintenance instructions. Do not use this equipment until you are sure that the planned maintenance program is up to date. CLASSIFICATION This product has been classified as Class I by Underwriters Laboratories, Inc. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide. Protection against Harmful Ingress of Water (Ordinary), enclosed equipment without protection against ingress of liquids. MEDICAL ELECTRICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE, MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1 AND CAN/CSA C22.2 NO. 601.1 98UA

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Chapter 1 Safety Notices

The following symbols may be used for marking on this equipment or equipment documentation: Earth (ground)

Dangerous Voltage

Protective Earth (ground)

Attention, consult accompanying documents

Power ON (part of equipment)

Power OFF (part of equipment)

Stand By

Non-ionizing radiation

Ionizing radiation

Alternating current

COMPATIBILITY The equipment described in this manual must only be used in combination with other equipment or components if these are expressly recognized by Quantum Medical Imaging, LLC as compatible. INTENDED OPERATOR The HF Series X-ray Generator is intended to be installed, used and operated only in accordance with the safety procedures given within this manual for the purpose for which it was designed. Before attempting to work with this equipment, read, understand, note and strictly observe all warnings, cautions and safety markings on the equipment. Users include those persons who actually handle the equipment and those who have authority over the equipment. TRAINING Users of HF Series X-ray Generator shall have received adequate training on its safe and effective use before attempting to work with the equipment. Training requirements may vary from country to country. The User shall make sure that training is received in accordance with local laws or regulations that have the force of law.

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Chapter 1 Safety Notices

ACCOMPANYING DOCUMENTATION The documentation consists of a User manual (this document) and related documentation: •

Service Manual P/N DC30-011: Contains technical and service documentation for this product, including installation and configuration instructions to be performed by qualified persons

The documentation shall be kept with the system for easy reference. APPLICABLE STANDARDS HF Series X-ray Generators comply with the following regulatory standards: •

FDA Center for Devices and Radiological Health (CDRH) - Title 21 CFR Subchapter J

•

EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996

•

IEC 60601-2-7: 1998(E)

•

CAN/CSA-C22.2 No. 601.1-M90, 2005 (Medical Electrical Equipment, part 1: General Requirements for Safety)

•

UL 60601-1, 1st Edition, 2006-04-26 (Medical Electrical Equipment, part 1: General Requirements for Safety)

•

IEC 60601-1 Medical electrical equipment, Part 1: General requirements for safety

•

IEC 60601-1-2: 2007

•

EC Directive 93/42/EEC for Medical Devices

EU Authorized Representative: Medizintechnik Berlin GmbH Altentreptower, Strasse 59 12683 Berlin - Germany Phone: +49-302-82 4726 Fax: +49-302-82 6382 E-mail: [email protected]

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DISPOSAL OF BATTERIES AND ACCUMULATORS (DIRECTIVE 2006/66/EC) In accordance with the European Directive 2006/66/EC, batteries and accumulators are labeled to indicate that they are to be collected separately and recycled at end of life. The label on the battery may also include a chemical symbol for the metal concerned in the battery (Pb for lead, Hg for mercury and Cd for cadmium). Users of batteries and accumulators must not dispose of batteries and accumulators as unsorted municipal waste, but use the collection framework available to customers for the return, recycling, and treatment of batteries and accumulators. Participation is important to minimize any potential effects of batteries and accumulators on the environment and human health due to the potential presence of hazardous substances.

ELECTROMAGNETIC COMPATIBILITY (EN 60601-1-2:2007/IEC 606011-2:2007) The HF Series X-ray Generator is intended for use in the electromagnetic environment specified below. As such, the generator must be installed and put into service according to the information provided in the accompanying Service Manual. The HF Series X-ray Generator complies with the requirements of applicable EMC standards. Portable and mobile RF communications equipment can affect medical electrical equipment. It is therefore recommended that the operation of equipment of this type, such as mobile telephones, cordless microphones and other similar mobile radio equipment, be restricted from the vicinity of this device. Use of accessories, transducers and cables, other than those specified in the accompanying documents, may result in increased emissions or decreased immunity of the equipment. Guidance and manufacturer's declaration - electromagnetic emissions

The HF Series X-ray Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the HF Series X-ray Generator should assure that it is used in such an environment. Emissions test RF emissions CISPR 11

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Compliance Group 1

Electromagnetic environment guidance The HF Series X-ray Generator uses RF energy only for their internal functions. Therefore, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

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Chapter 1 Safety Notices

Guidance and manufacturer's declaration - electromagnetic emissions RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

HF Series X-ray Generators - Operator’s Manual Quantum Medical Imaging, LLC

The HF Series X-ray Generator is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

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Guidance and manufacturer's declaration - electromagnetic immunity

The HF Series X-ray Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the HF Series X-ray Generator should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

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

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines ±1 kV for input/output lines

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

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common mode

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

Voltage dips, short interruption, and voltage variations on power supply input lines IEC 60601-4-11

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

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

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

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

70% UT (30% dip in UT) < 5% UT (> 95% dip in UT) for 5 s

70% UT (30% dip in UT) < 5% UT (> 95% dip in UT) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the HF Series X-ray Generator requires continued operation during power mains interruptions, it is recommended that the HF Series X-ray Generator be powered from an uninterruptible power supply or battery.

3 A/m

3 A/m

Power frequency (50/60 Hz) IEC 61000-4-8

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

NOTE: UT is the A.C. mains voltage prior to application of the test level.

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Chapter 1 Safety Notices

Guidance and manufacturer's declaration - electromagnetic immunity

The HF Series X-ray Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the HF Series of X-ray generators (including TechVision option) should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the HF Series X-ray Generator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80MHz

3 Vrms

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

d  1,2 P d  1,2 P

, 80 MHz to 800 MHz

d  2,3 P

, 800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

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Guidance and manufacturer's declaration - electromagnetic immunity NOTE 1 At 80 MHz and 800 MHz, 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. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land 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 HF Series X-ray Generator is used exceeds the applicable RF compliance level above, the HF Series of X-ray generators (including TechVision option) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HF Series X-ray Generator. b Over the frequency range 150 kHz to 80 kHz, field strengths should be less than 3 V/m.

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Chapter 1 Safety Notices

Recommended separation distances between portable and mobile RF communications equipment and the HF Series X-ray generators (including TechVision option)

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

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

d  1,2 P

80 MHz to 800 MHz

d  1,2 P

800 MHz to 2,5 GHz

d  2,3 P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,73

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. 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.

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ABBREVIATION DEFINITION The following abbreviations and acronyms may be found in this document. Their definition is explained below. ADC

Analog-to-digital converter

AEC

Automatic Exposure Control

APR

Anatomical Programmed Region

cm

Centimeters (thickness)

HF

High Frequency

HSS

High-speed starter

kVp

Tube voltage (kilovolts peak)

LCD

Liquid crystal display

m

meters

mA

Tube current (milliampere)

mAs

Time-current product

MHz

MegaHertz

OCP

Operator Control Panel

RF

Radiofrequency

SE

Stored Energy

sec

Expose on time (seconds)

W

Watts

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Chapter

2

GENERAL INFORMATION

2-1