TechVision Remote QG Series Operators Manual Rev B

THE ORIGINAL VERSION OF THIS MANUAL DATED HAS BEEN DRAFTED IN THE ENGLISH LANGUAGE BY QUANTUM MEDICAL IMAGING 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 (QMI).

Copyright© 2011 QMI

Quantum Medical Imaging A Division of Carestream 2002-B Orville Drive North Ronkonkoma, New York 11779 USA Phone: (631) 567-5800 Fax: (631) 567-5074 E-mail: info@qmiteam.com www.quantummedical.net

Made in U.S.A.

Revision History

REVISION

DATE

TYPE OF MODIFICATION

A

11/11/10

Initial Release, ECO 2314

B

3/11/11

Incorporated ECO 2314 (software update 3.0 R4)

Page Number

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i - iv

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1-1 thru 1-14

B

2-1 thru 2-8

B

3-1 thru 3-24

B

4-1 thru 4-10

B

5-1 thru 5-6

B

Page Number

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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 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 ABREVIATIONS ... 1-14

CHAPTER 2 - GENERAL INFORMATION OVERVIEW ... 2-3 KEY FEATURES ... 2-4 INTENDED USE ... 2-4 SPECIFICATIONS ... 2-4 PHYSICAL SPECIFICATIONS ... 2-4 CONTROLS AND INDICATORS ... 2-5 Push Button Switches: ... 2-5 Indicators: ... 2-5 DISPLAY SCREEN AND TOUCH PANEL ... 2-5 ELECTRICAL SPECIFICATIONS ... 2-5 SYSTEM OPTIONS ... 2-5 SYSTEM OPERATING ENVIRONMENT ... 2-6 NON-OPERATING ENVIRONMENT ... 2-6 MAIN COMPONENTS ... 2-7

CHAPTER 3 - OPERATION OVERVIEW ... 3-3 GENERAL OPERATION ... 3-3 THE TECHVISION DISPLAY SCREEN ... 3-4 GENERAL OPERATION NOTES ... 3-6 STATUS ICONS/BUTTONS ... 3-7 ERROR MESSAGES ... 3-8 TECHVISION/GENERATOR COORDINATION ... 3-9 OPERATING TECHVISION (Generator Mode) ... 3-10 GENERATOR STATUS ICONS/MESSAGES ... 3-11

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Table of Contents

MANUAL MODE EXPOSURE SETTINGS ...3-13 AEC MODE EXPOSURE SETTINGS ...3-14 APR MODE EXPOSURE SETTINGS ...3-15 TUBE SUPPORT DEVICE OPERATION ...3-17 Overhead Tube Crane (Model RS-580) Overlay Switches ...3-17 Universal System (Model QV-800) Overlay Switches ...3-20 Floor-Mounted Tube Stand (Model QS-550) Overlay Switches ...3-23

CHAPTER 4 - USER MAINTENANCE OVERVIEW ...4-3 USER MAINTENANCE ...4-3 Cleaning ...4-4 OPERATOR CONFIGURABLE SYSTEM SETTINGS ...4-4 ACCESSING OPERATOR SERVICE OPTIONS ...4-4 Set Date Time ...4-8

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

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Chapter

1

SAFETY NOTICES

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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

CAUTION NOTE

Indicates injury or death is possible if the instructions are not obeyed. Indicates that damage to equipment is possible if the instructions are not obeyed. Indicates essential information that should be read to avoid incorrect operation.

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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WARNING Quantum Medical Imaging 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 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.

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Chapter 1 Safety Notices

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.

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. This equipment 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.

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

Attention, consult accompanying documents

Protective Earth (ground)

Non-ionizing radiation

Ionizing radiation 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 This equipment 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 this equipment 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. ACCOMPANYING DOCUMENTATION The documentation consists of a User manual (this document) and related documentation: •

Service Manual P/N DC30-049: 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.

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Chapter 1 Safety Notices

APPLICABLE STANDARDS This product complies with the following regulatory standards: •

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

•

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

•

CAN/CSA-C22.2 No. 601.1-M90, 2005 (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

The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: •

Use of the accessory in the PATIENT VICINITY

•

Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.

•

IEC 60601-1-2: 2001(E)

•

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: Medizintechnik.Berlin.GmbH@t-online.de

Recognized under the Component Recognition Program of Underwriters Laboratories Inc.

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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) TechVision is intended for use in the electromagnetic environment specified below. As such, TechVision must be installed and put into service according to the information provided in the accompanying Service Manual. 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 of X-ray generators (including TechVision option) are intended for use in the electromagnetic environment specified below. The customer or the user of the HF Series of Xray generators (including TechVision option) 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 of X-ray generators (including TechVision option) use 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

TechVision Control Panel - Operator’s Manual Quantum Medical Imaging, LLC

The HF Series of X-ray generators (including TechVision option) 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 of X-ray generators (including TechVision option) are 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

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 of X-ray generators (including TechVision option) requires continued operation during power mains interruptions, it is recommended that the HF Series of X-ray generators (including TechVision option) 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 of X-ray generators (including TechVision option) are 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 Model 006, 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 of X-ray generators (including TechVision option) 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 of X-ray generators (including TechVision option). b Over the frequency range 150 kHz to 80 kHz, field strengths should be less than 3 V/m.

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

The HF Series of X-ray generators (including TechVision option) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HF Series of X-ray generators (including TechVision option) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HF Series of X-ray generators (including TechVision option) 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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ABREVIATIONS °C

Degrees Celsius

A/m

Amperes per meter

AEC

Automatic Exposure Control

APR

Anatomical Programmed Region

CCW

Counter Clockwise

Cd

Cadmium

CISPR International special committee on Radio Interference* cm

Centimeters (thickness)

CSA

Canadian Standards Association

CW

Clockwise

DR

Digital Receptor

ESD

Electrostatic Discharge

GHz

Gigahertz

Hg

Mercury

hPa

Hectopascal

IEC

International Electronic Commission

kVp

Tube voltage (kilovolt peak)

Ma

Tube current (milliampere)

mAs

Time-current product

MHz

Megahertz

OCP

Operator Control Panel

Pb

Lead

RF

Radio Frequency

SID

Source Image Receptor Distance

UT

A.C. mains voltage prior to application of test level

Vrms

Average DC voltage

W

Watts

* Note: French to English Translation for Comite’ International Spe’cial des perturbations Radioe’lectriques

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Chapter

2

GENERAL INFORMATION

2-1