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Fixed Non-Float-Top Enclosed Base Radiographic Table: Installation and Operation Manual
Fixed Non-Float-Top Enclosed Base Radiographic Table: Installation and Operation Manual
Fixed Non-Float-Top
Enclosed Base Radiographic Table
K 2016-12-22 Added data plate on product, EMC warning, refer to manual symbol,
type B description, and updated ETL symbol, and translated some
warnings into French after English version.
SAFETY NOTICES
GENERAL SAFETY INFORMATION ............................................................ v
WARNINGS, CAUTIONS, NOTES .............................................................. v
REGULATORY COMPLIANCE ....................................................................vi
CLASSIFICATION .............................................................................vii
COMPATIBILITY ............................................................................. viii
INTENDED OPERATOR .................................................................... viii
TRAINING ...................................................................................... xiv
DOCUMENTATION .......................................................................... xiv
APPLICABLE STANDARDS ................................................................ xiv
ENVIRONMENTAL PROTECTION ............................................................ xiv
ELECTROMAGNETIC COMPATIBILITY
(EN 60601-1-2:2007/IEC 60601-1-2:2007) ............................................. xiv
ABBREVIATION DEFINITION ..................................................................xx
CHAPTER 1 - INTRODUCTION
OVERVIEW .......................................................................................... 1-3
INTENDED USE ............................................................................. 1-3
APPLIED PART ............................................................................... 1-3
MAIN COMPONENTS ...................................................................... 1-4
CHAPTER 2 - SPECIFICATIONS
PHYSICAL SPECIFICATIONS ........................................................... 2-3
Tabletop Specifications ............................................................. 2-3
Table Base Specifications ......................................................... 2-3
Table Specifications ................................................................. 2-3
Other Specifications ................................................................. 2-3
OPTIONS ................................................................................ 2-4
PERFORMANCE SPECIFICATIONS ................................................... 2-5
Image Receptor Travel Specifications ........................................ 2-5
System Operating Environment ................................................. 2-5
CHAPTER 4 - OPERATION
RADIOGRAPHIC TABLE OPERATION ..................................................... 3-3
CASSETTE TRAY OPERATION ......................................................... 3-3
Loading Cassette Tray (Midwest Type) ...................................... 3-3
Loading Cassette Tray (Poersch Type) ...................................... 3-5
CHAPTER 5 - MAINTENANCE
OVERVIEW .......................................................................................... 5-3
USER MAINTENANCE ..................................................................... 5-3
Cleaning ................................................................................. 5-4
RECEPTOR CABINET LOCK RELEASE LEVER
ADJUSTMENT PROCEDURE ............................................................ 5-4
REPLACEMENT PARTS AND ORDERING INFORMATION .................... 5-5
ORDERING INFORMATION ............................................................. 5-7
The purpose of safety icons, such as those shown below, is to indicate at a glance the
type of caution, warning or danger.
L’objectif des icônes de sécurité, telles que celles représentées ci-dessous, est de per
mettre à l’utilisateur de reconnaître d’un seul coup d’oeil le type d’avertissement, de
mise en garde ou de danger.
WARNING
AVERTISSEMENT
Carestream Health, Inc. disclaims all responsibility from any injury result-
ing from improper application of this equipment.
Carestream Health, Inc. décline toute responsabilité pour les blessures
résultant d'une utilisation incorrecte de cet équipement.
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.
Cet équipement doit être exclusivement utilisé sous la supervision d'une
personne légalement autorisée à manipuler du matériel de cette nature.
Toutes les règles de sécurité décrites dans ce manuel doivent être
respectées. L'équipement ne doit pas être utilisé pour d'autres usages que
ceux décrits dans le présent document. Les lois fédérales américaines
restreignent la vente, la distribution ou l'utilisation de cet appareil par des
médecins ou sur prescription d'un médecin habilité.
Carestream Health, Inc. cannot assume responsibility for any malfunction-
ing of this equipment resulting from improper operation, maintenance, or
WARNING
WARNING
AVERTISSEMENT
X-ray equipment may cause injury if used improperly. The instructions con-
tained 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.
L’utilisation incorrecte du matériel de radiographie peut provoquer des
blessures. Les instructions du présent manuel doivent être lues et appli-
quées lors de l’utilisation de l’appareil. Des dispositifs de protection contre
les radiations et de surveillance de l’irradiation sont disponibles. Il est
indispensable que vous les utilisiez pour vous protéger contre une exposi-
tion aux rayons X inutile.
WARNING
AVERTISSEMENT
To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
Pour éviter le risque du choc électrique, Cet équipement ne doit être conne
cté qu'à un réseau d'alimentation avec la protection de la terre.
WARNING
AVERTISSEMENT
The user is responsible for ensuring that other equipment used with the
CARESTREAM Radiographic Table does not compromise the patient contact
rating of the CARESTREAM Radiographic Table.
Il incombe à l’utilisateur de vérifier que les autres équipements utilisés
avec le système CARESTREAM Table radiographique ne compromettent pas
l’agrément contact patients du système.
The user is also responsible for safety and EMC compliance of any non-Car-
estream Health recommended, installed, or supplied accessory equipment.
L’utilisateur est également responsable de la sécurité et de la conformité
électromagnétique des équipements accessoires qui n’ont pas été recom-
mandés, installés ou fournis par Carestream.
The use of accessory equipment and/or hardware not complying with the
equivalent product safety and EMC requirements of this product may lead
to a reduced level of safety and / or EMC performance of the resulting sys-
tem.
L’utilisation d’accessoires et/ou de matériel non conformes aux critères de
ce produit en matière de sécurité et d’émissions électromagnétiques peut
entraîner une baisse du niveau de sécurité et/ou des performances électro-
magnétiques du système.
Consideration relating to the choice of accessory equipment used with this
product shall include:
Les éléments suivants doivent être pris en compte lors du choix des acces-
soires à utiliser avec ce produit:
• Use of the accessory in the patient’s vicinity.
• Utilisation de l’accessoire à proximité du patient.
• Evidence that the safety certification of the accessory has been
performed in accordance with applicable coordinated harmonized
product safety standards per IEC 60601-1-1.
• La certification de sécurité de l’accessoire a été établie en conformité
avec la norme nationale harmonisée CEI 60601-1-1 en vigueur.
• Evidence that applicable emission certification of the accessory has
been performed.
• La certification concernant les émissions des accessoires a été établie
en conformité avec les normes applicables.
CAUTION
ATTENTION
Observe all safety precautions recommended by the accessory equipment
manufacturer in the user documentation provided with the equipment.
Observe any laser precautions.
Respectez toutes les précautions en matière de sécurité recommandées par
le fabricant des accessoires dans la documentation utilisateur fournie avec
l’équipement. Observez les précautions relatives au laser.
The hardware specified for use with the DR System has been selected,
tested, and verified by Carestream Health, Inc. to meet the intended appli-
cations. All specified hardware meets applicable regulatory agency require-
ments for those countries where it is offered for sale with respect to its
intended applications. Consult the user documentation included with the
equipment for specific information relating to product safety and EMC com-
pliance.
Le matériel utilisable avec le système Table radiographique a été sélec-
tionné, testé et vérifié par Carestream Health, Inc. dans le but de répondre
aux objectifs visés. Tout matériel spécifié est conforme aux exigences des
organismes de réglementation en vigueur dans les pays où il est disponible
à la vente en ce qui concerne ses applications prévues. Consultez la docu-
mentation qui accompagne le matériel pour obtenir des informations sur la
sécurité et la conformité électromagnétique du produit.
REGULATORY COMPLIANCE
This certified Carestream Health, Inc. medical device has been designed, manufac-
tured, and calibrated to comply with governing Federal Regulations 21 CFR Subchap-
ter 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 (that is, the installer) with the appropriate agencies; the
“Installation Quality Assurance Checklist” must also be completed and properly distrib-
uted 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 Carestream Health,
Inc..
Those responsible for the planning of X-ray equipment installations must be thor-
oughly 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, par-
ticipate in or supervise the operation of the equipment must be thoroughly familiar
and comply completely with the currently established safe exposure factors and pro-
cedures described in publications such as Subchapter of Title 21 of the Code of Fed-
eral Regulations, “Diagnostic X-ray Systems and Their Maor Components,” and NCRP
Report No. 102, “Medical X-ray, Electron Beam and Gamma Ray Protection for Ener-
gies 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 perfor-
mance 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.
Complies with FDA Center for Devices and Radiological Health (CDRH) - Title 21 CFR
Subchapter .
EU Authorized Representative:
Carestream Health France
1, rue Galilée
93192 NOISY-LE-GRAND CEDEX
France
The following symbols may be used for marking on this equipment or equipment
documentation:
COMPATIBILITY
The equipment described in this manual must only be used in combination with
other equipment or components if these are expressly recognized by Carestream
Health, Inc. 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 equip-
ment.
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 require-
ments 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.
DOCUMENTATION
The user documentation for this device is contained in this manual, and it shall be
kept with the system for easy reference.
APPLICABLE STANDARDS
This equipment complies with the following regulatory standards:
• EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996
• IEC 60601-2-32: 1994
• 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
ENVIRONMENTAL PROTECTION
This equipment contains certain materials and chemical compounds incidental to
the manufacture of electrical and electronic equipment, and improper “end-of-life”
disposal of such equipment can result in environmental contamination. Therefore,
this equipment should not be disposed of as ordinary household waste, but
should instead be delivered to a designated electrical and electronic waste dis-
posal or recycling center. For further information on disposing of electrical and
electronic waste, contact the cognizant authority within the jurisdiction.
The Radiographic Table is intended for use in the electromagnetic environment specified below.
The customer or the user of the Radiographic Table should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment -
guidance
The Radiographic Table is intended for use in the electromagnetic environment specified below. The customer
or the user of the Radiographic Table should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environ-
test level level ment - guidance
Electrical fast ±2 kV for power supply ±2 kV for power supply Mains power quality should be
transient/burst lines lines that of a typical commercial or
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output hospital environment.
lines lines
NOTE: UT is the A.C. mains voltage prior to application of the test level.
The Radiographic Table is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of the Radiographic Table should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic environment - guid-
test level level ance
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 Radiographic Table 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 per-
formance is observed, additional measures may be necessary, such as re-orienting or relocating the Radio-
graphic Table.
b Over the frequency range 150 kHz to 80 kHz, field strengths should be less than 3 V/m.
The Radiographic Table is intended for use in an electromagnetic environment in which radiated RF dis-
turbances are controlled. The customer or the user of the Radiographic Table can help prevent electro-
magnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Radiographic Table as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1,2 P d = 1,2 P d = 2,3 P
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation dis-
tance 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, obects and people.
ABBREVIATION DEFINITION
The following abbreviations and acronyms may be found in this document. Their defi-
nition is explained below.
°C Degrees Celsius
°F Degrees Fahrenheit
Al Aluminum
CE conformité européenne
EN European Norme
hPa Hectopascal
kg kilogram
kHz Kilohertz
mm Millimeter
RF Radio Frequency
UL Underwriters Laboratory
W Watts
INTRODUCTION
1-1
1-2
Chapter 1 Introduction
OVERVIEW
This manual provides information for installing, operating, and maintaining Care-
stream's Fixed, Non-Float-Top, Radiographic Table, Model QT-730 (hereinafter
referred to as the Radiographic Table). It is imperative that all safety procedures
described in this manual be strictly adhered to in order to ensure the safety of both
patient and user.
APPLIED PART
The tabletop of QT-730 is an applied part that in normal use comes into physical
contact with the patients.
MAIN COMPONENTS
See Figure 1-1. The Model QT-730 Radiographic Table contains:
1. Tabletop
2. Receptor Cabinet
3. Receptor Cabinet Lock Lever
4. Compliance Label
5. Table Base
1
3
2
4
5
SPECIFICATIONS
2-1
2-2
Chapter 2 Specifications
PHYSICAL SPECIFICATIONS
The following are physical specifications for the Radiographic Table (see
Figure 2-1):
Tabletop Specifications
Length*: 1879.6 mm (74.0 in.)*
Width: 711.2 mm (28.0 in.)
Height: 806.5 mm(31.8 in.)
Material Type: Fiber Resin (phenolic)
Density: less than 1.0 mm Al
Tabletop-to-Film
plane distance: from 2.3—2.9 in. (58.4—73.7 mm)
Table Specifications
Total Table Weight: 79 kg (175 lb)
Maximum patient
weight capacity: 295 kg (650 lb)
Other Specifications
Receptor Types: 355.6 x 431.8 mm (14.0 x 17.0 in.) fixed grid
355.6 x 431.8 mm (14.0 x 17.0 in.) bucky
Bucky Weight (w/grid
and cassette tray): 14 - 18 kg (35 - 40 lb) typical
Collimator
compatibility: Manual, Selectable or Automatic
PERFORMANCE SPECIFICATIONS
The following are performance specifications for the Radiographic Table:
Image Receptor Travel Specifications
Longitudinal Travel
(with grid cabinet)**: 1098.6 mm (43.3 in.)
Longitudinal Travel
(with bucky cabinet)**: 1016 mm (40 in.)
ASSEMBLY &
INSTALLATION
3-1
3-2
Chapter 3 Assembly & Installation
OVERVIEW
This chapter describes the steps required to assemble the Radiographic Table and
how to install the completed assembly in your facility, including making all required
electrical connections.
To assemble and install the Radiographic Table, refer to Figures 3-1 through 3-
10.
Table Assembly
The table typically is shipped with the Table Top Frame already attached
to the Table Base, in which case you can skip to step 3. However, the fol-
lowing steps are provided in the event it is not.
1. Position the Table Base (see Figure 3-1) under the collimator, in
the approximate location where it is to be mounted.
2. Place Table Top Frame on Table Base and secure using four (4)
1/4-20 x 3/4” hex-head screws, 1/4” flat washers, and 1/4” lock
nuts.
3. If not already installed, install the Receptor Cabinet as follows:
a. Loosely attach the two (2) Front Receptor Bearing Brackets
to the Receptor Cabinet, as shown in Figure 3-2, using three
(3) 1/4-20 x 3/4” pan head screws (bracket with handle
mounts to right side of cabinet).
TABLE BASE
RECEPTOR BEARING
BRACKET (2X)
FRONT RECEPTOR
BEARING BRACKET
WHEELS ON RAIL
Figure 3-6. Position Receptor Cabinet for Rear Receptor Bracket Installation
e. Slowly roll the Receptor Cabinet along the bearing rails while
checking for smoothness. The mounting holes on the Recep-
tor Bearing Brackets are slotted to provide adjustment.
Adjust the brackets as required until receptor travel is satis-
factory (smooth and even through full travel), then fully
tighten all bracket screws.
BUCKY POWER
CABLE
13. If system is equipped with Automatic Exposure Control (AEC), note that Ion
Chamber gain potentiometers can be accessed through slot at rear side of
grid cabinet as shown in Figure 3-10.
Final Installation
1. Connect #10AWG yellow/green ground wire between Radio-
graphic Table’s ground stud (on back side of Table Base) and the
x-ray generator.
2. Connect #16AWG yellow/green ground wire between Receptor
Cabinet ground stud and the Table Base ground stud.
3. Attach Phenolic Tabletop to Table Top Frame.
OPERATION
4-1
4-2
Chapter 4 Operation
RECEPTOR CABINET
LOCK RELEASE LEVER
1. Pull cassette tray from Receptor Cabinet using tray handle (see
Figure 4-2).
2. Pull back on front cassette grip (opens both grips).
SLIDE GUIDES
TRAY HANDLE
CLAMP HANDLE
TRAY HANDLE
MAINTENANCE
5-1
5-2
Chapter 5 Maintenance
OVERVIEW
This chapter is designed to assist the system user in maintaining the proper operation
of the table. This product has been factory tested to assure its required performance
in an X-ray system.
USER MAINTENANCE
The user is responsible for performing certain routine maintenance and inspection
procedures. Aside from routine maintenance, any abnormal noise, vibration, or
unusual performance should be investigated by a qualified service representative.
Preventive maintenance or any repair service should be performed only by quali-
fied service personnel.
User maintenance consists of the following activities, which should be performed
on a daily basis:
• Visually inspect the table for wear and cleanliness
• Clean the tabletop, cassette tray, and exterior painted surfaces of the table
• Disinfect the table top surface after each use in accordance with facility
requirements.
Cleaning
The system user is responsible for the basic cleanliness of the equipment. On
a regular basis, the table surface should be wiped clean. Painted metal sur-
faces should be cleaned using a clean cloth slightly moistened in warm soapy
water (use mild soap). Wipe with a clean wet cloth, then dry. Never use abra-
sive polish on this equipment.
RECEPTOR CABINET LOCK RELEASE LEVER ADUSTMENT PROCEDURE
This procedure provides the steps necessary to properly adjust the Receptor Cab-
inet Lock Release Lever. Refer to Figure 5-1 and proceed as follows:
SOCKET HEAD
CAP SCREW
DELRIN
BRAKE
4. Re-check operation of Receptor Cabinet Lock Release Lever over entire travel
of Receptor Cabinet. Repeat adjustment if necessary.
REPLACEMENT PARTS AND ORDERING INFORMATION
Table 5-1 below provides a list of replaceable parts for the Radiographic Table.
Figures 5-2 through 5-4 show the locations of the replaceable parts in the system.
Use only original replacement parts as supplied or recommended by Carestream
Health, Inc..
ORDERING INFORMATION
To order replacement parts for the Radiographic Table, contact the Service
Department at:
Carestream Health, Inc.
150 Verona Street, Rochester, NY, USA 14608
www.carestream.com