Orex Computed Radiography SCANGODEVICE RFID reader User Manual UG CS7600 Overview with new scan

Orex Computed Radiography Ltd. RFID reader UG CS7600 Overview with new scan

User mannual

CS 7600_User Guide (8J4071)_Ed01 3
2 CS 7600 System Overview
Introduction
CS 7600 is a scanner system for intraoral X-ray exposed imaging plates.
The CS 7600 is intended for digital dental radiography using an imaging plate (storage phosphor
plate) for radiographic diagnostic intraoral images. The CS 7600 system is used to scan and review
intraoral dental X-ray images. When scanning the X-ray exposed imaging plate a digital image is
previewed on the scanner’s LCD and saved to the scanner’s internal memory. After scanning, the
scanner erases the imaging plate and ejects it. The imaging plate is ready for re-use.
The exam acquisition’s scanned image is sent over the network to the workstation’s image Acquisition
interface. Using the image Acquisition interface the image is processed and reviewed.
The image Acquisition interface sends the images to the Kodak Dental Imaging Software, which
archives the acquired images.
The scanner connects directly to the network, or is connected peer-to-peer to the workstation.
The scanner can be optionally placed on a desk/counter top or mounted on a wall, using a special shelf
(adapter).
The system is composed of the following elements:
CS 7600 scanning device (page 4)
Smart imaging plates (page 6)
CS 7600 image Acquisition interface (page 11)
Scan & Go device (optional, page 9)
Note: The CS 7600 is intended for dental professionals. You are required
to have training to use the CS 7600.
Note: The scanner is supplied with a separate viewing and archiving
software package: Kodak Dental Imaging Software, approved by
Carestream Health.
Note: The CS 7600 User Guide is also provided as a PDF file on the
supplied CD-ROM.
4 Chapter 2 CS 7600 System Overview
CS 7600 Components Overview
Scanner Overview
The CS 7600 scanner performs the functions necessary for scanning and acquiring images from the
imaging plates.
Figure 1 CS 7600 Front View
13.5" QVGA color LCD (320 X 240 pixels, landscape matrix)
2Function buttons for scanner use and menu navigation
3On/Off button + LED power indicator.
On/Off button functions:
Turn scanner On: press for 1 second
Turn scanner Off (close application and files and then turn off): press for 2 seconds.
4Base
5Intraoral imaging plates tray
6Detachable insertion panel. The CS 7600 makes use of two insertion panel sizes according to
the inserted imaging plates size (0–3 or 4).
7Front cover
8Back covers
2
7
8
3
6
1
4
5
CS 7600_User Guide (8J4071)_Ed01 5
Figure 2 CS 7600 Rear View
Figure 3 Cables Compartment in Detail
1Service door
2Base
3Cables compartment for power supply connection and interface ports (RJ-45 Ethernet port)
4Back cover
1
4
3
2
1
3
2
4
1Power supply inlet
2RJ-45 Ethernet port (Ethernet
activity LEDs: yellow indicates
speed, green indicates link status)
3Service ONLY ports
4Compartment cover
6 Chapter 2 CS 7600 System Overview
Smart Imaging Plates Overview
The CS 7600 works with five imaging plate sizes: 0 to 4. The scanned image file size depends on the
imaging plate size and the scanning resolution set by the user.
The smart function of the imaging plates is utilized when using the Scan & Go device.
Table 1 Intraoral Imaging Plate Sizes
Size Illustration Application
0 Periapical exam (Pediatric dentistry)
1 Bitewing exam (Pediatric dentistry)
2 Periapical exam (Adult)
3 Bitewing exam (Adult)
4 Occlusal exam
CS 7600_User Guide (8J4071)_Ed01 7
The imaging plate has two sides: the active side for capturing the X-ray image and the inactive side.
The active side of the imaging plate includes an orientation mark ‘c’ to facilitate accurate positioning
within the patient’s mouth. The inactive side has a printed dot that corresponds to the location of the
orientation mark on the active side. This dot is visible through the transparent hygienic sheath and is
also helpful for positioning the imaging plate correctly in the patient’s mouth.
Hygienic Sheaths
For each imaging plate size there is a corresponding one-time use, disposable, hygienic sheath for
preventing cross contamination. The transparent side allows you to see the orientation mark for
positioning the imaging plate correctly in the patient’s mouth while the opaque side protects the active
Inactive side
Active side
Important: Use only Carestream imaging plates and hygienic
sheaths!
8 Chapter 2 CS 7600 System Overview
side of the inserted imaging plate from light damaging effects. The foam strip is a stopper which
prevents inserting the hygienic sheath by mistake into the scanner (as long as the insertion direction is
correct).
Figure 4 Hygienic Sheath (front view)
1 Adhesive strip (for sealing the hygienic sheath)
2 Foam stopper
3 Sheath, transparent on one side and with a light protection barrier on the other side
3
1
2
CS 7600_User Guide (8J4071)_Ed01 9
Scan & Go Overview
Scan & Go is an optional device that enables you to link the imaging plate to a specific exam
acquisition (for example, patient) prior to acquisition. This information is retrieved by the scanner and
the imaging plate is scanned automatically according to this information (resolution, target workstation,
etc.). Scanned images are then routed automatically to the correct workstation, associated to the
correct exam acquisition and placed in the correct frame in the CS 7600 image Acquisition interface.
Figure 5 Scan & Go device (Before June 2012)
1USB 2.0 port
2On/Off button
3On/Off/Recording LED status indicator (blue)
Turning On/Off, 3 short flashes
Standby (intermittent flashing)
Recording data to the imaging plate (successive short flashes)
4Battery LED status indicator (amber):
Charging (static light)
Low battery (successive short flashes)
(light Off) battery charged
5Recording surface for imaging plate
6Mounting adapter
5
1
4
3
2
6
10 Chapter 2 CS 7600 System Overview
Scan & Go Overview (for Scan & Go models released from June 2012)
A new Scan & Go device is available from June 2012. The following improvements have been made to
the new Scan & Go device:
Faster scanning - Approximately 1/4 sec instead of 1 sec
No battery - Therefore no need for charging.
No on off switch - Turns on automatically when the USB is connected.
Figure 6 Scan & Go device (After June 2012)
1USB 2.0 port
2On/Off/Recording LED status indicator (blue)
Power Up: One Flash & Beep (Internal FW)
Beacon: Flashes blue every few seconds in idle mode (Not during Tagging)
Tagging OK: One flash (long) & 1 bleep (long)R
Tagging Fail: One Red flash (long) & 1 bleep (long)R
3Connected to USB: LED status indicator (green):
4Recording surface for imaging plate
5Mounting adapter
4
1
3
2
5
Carestream Health, Inc.
150 Verona Street
Rochester, NY 14 608, USA
0086
Reference:
HT022_20120424_EN
ATHT0296_20120424_EN
Note: To use this Scan & Go, you need to install Acquisition Interface V1.0 Rev 3
(or higher).
Unlike previous versions, this Scan & Go does not use batteries.
Note: If the Scan & Go LED lights up green and the USB icon appears red, there
is a possibility that the image acquisition version needs updating to V1.0.Rev 3
Note: This picture is for demonstration only and the Scanner version may
vary.
Note: If the scanner is already updated with Version 1.30, and you have
clicked Update Scanner, a message appears The scanner is already
updated then, click OK, close the Scanner Manager window.
Note: In the rare case that the Update Failed message appears, restart
the scanner, press and verify that the scanner version is 1.30.
Note: For more information, see the CS 7600 User Guide provided in the original
CD delivered with the system.
Intraoral Imaging Plate System
CS 7600
Safety, Regulatory & Technical
Specifications User Guide
Notice
The Regulatory Information & Technical Specifications User Guide for the CS 7600 includes
information on the safety instructions, regulatory information and the technical specifications of the
device. Please read and observe all warnings and instructions in this Guide and those marked on the
unit.
The information contained in this Guide may be subject to modification without notice, justification
or notification to the persons concerned. Make sure you have the most current version.
No part of this Guide may be reproduced without the express permission of Carestream Health, Inc.
U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.
This document is originally written in English.
Guide Name: Intraoral Imaging Plate System CS 7600 System Safety, Regulatory and Technical
Specifications User Guide
Part Number: 8J4070
Revision Number: 02
Print Date: 2012-06
The Brand names and logos reproduced in this Guide are copyright.
Manufacturer
Authorized Representative in the European Community
Carestream Health France
1, rue Galilée
93192 NOISY-LE-GRAND CEDEX
FRANCE
0086
Carestream Health, Inc.
150 Verona Street
Rochester, NY 14 608, USA
EC REP
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 iii
Contents
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Indications for Use . . . . . . . . . . . . . . . . . . . . . .1
Conventions in this Guide . . . . . . . . . . . . . . . . . . .1
Warning and Safety Instructions . . . . . . . . . . . . . . . .2
General Notice . . . . . . . . . . . . . . . . . . . . . . . .4
Laser Safety Instructions . . . . . . . . . . . . . . . . . . .5
Hygiene and Disinfection . . . . . . . . . . . . . . . . . . .5
Marking and Labeling Symbols . . . . . . . . . . . . . . . .6
IEC Symbols Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Safety Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Label Locations . . . . . . . . . . . . . . . . . . . . . . . .8
Declaration of Conformity . . . . . . . . . . . . . . . . . . .9
Regulatory Information . . . . . . . . . . . . . . . . . . . . . . 11
General Regulatory Information . . . . . . . . . . . . . . . 11
Compliance with International Regulations . . . . . . . . . . 18
Compliance with FCC Rules . . . . . . . . . . . . . . . . . 18
Technical Specifications . . . . . . . . . . . . . . . . . . . . . . 19
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . 19
Model . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
CS 7600 Technical Specifications . . . . . . . . . . . . . . 19
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Imaging Plate Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
RF Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
CS 7600 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . 21
Imaging Plates Environmental Requirements . . . . . . . . . . . . . . . . . 22
Minimum Computer System Requirements . . . . . . . . . . 23
iv
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 1
1 Safety Information
Indications for Use
The CS 7600 is intended for digital dental radiography using an imaging plate
(storage phosphor screen) for radiographic diagnostic intraoral images.
Conventions in this Guide
The following special messages emphasize information or indicate potential risk to
personnel or equipment.
WARNING: Warns you to avoid injury to
yourself or others by following the safety instructions
precisely.
Important: Alerts you to a condition that might
cause problems.
Tip: Provides extra information and hints.
Note: Emphasizes important information.
2 Chapter 1 Safety Information
Warning and Safety Instructions
WA R N I N G S
Scanner
Read and understand this safety information before using the CS
7600.
To ensure safety, read all user guides carefully before using the
system and observe all Warnings, Important and Notes located
throughout the guides.
Keep this guide with the equipment.
You are responsible for the operation and maintenance of this device.
You are required to have training to use the CS 7600. When
necessary, have a trained authorized service technician carry out
inspection and maintenance operations.
The CS 7600 is Class I, continuous operated stationary equipment
without applied parts and has one signal input/output part. Product
is provided with ordinary protection against the harmful ingress of
water.
DO NOT use this device in the presence of a flammable anesthetics
mixture with air or with oxygen or with nitrous oxide.
DO NOT remove or open system covers or plugs. Internal circuits
use high voltage capable of causing serious injury. Fuses blown
within 36 hours of being replaced by a qualified technician may
indicate malfunctioning electrical circuits within the system. Have
the system checked by qualified service personnel. Do not attempt to
replace any fuse. Fluids that seep into the active circuit components
of the system may cause short circuits that can result in electrical
fires. Therefore, do not place any liquid or food on any part of the
system. Access to the rear inspection cover is allowed, as an
exception, according to the instructions for Retrieval of the imaging
plate in the Troubleshooting section of the user guide.
DO NOT operate the device if there is the threat of an earthquake.
Following an earthquake, ensure that the device is operating
satisfactorily before using it again. Failure to observe this precaution
may expose patients to hazards.
DO NOT place objects within the field of operation of the device.
Connect this equipment ONLY to a mains power supply with
protective ground to avoid any risk of electric shock.
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 3
The appliance coupler/inlet of the flexible power cord is used as a
disconnecting device from the mains.
To dispose of the device or its components, contact a service
technician.
No modification of this equipment is allowed.
DO NOT block air circulation around the unit. Always maintain at
least 15 cm clearance around the unit to prevent overheating and
damage to the system.
The scanner should be positioned so that there is always easy access
to the mains power supply socket.
Imaging Plates:
To prevent damage to the imaging plates and the possibility of image
artifacts, avoid contact between the imaging plates and the following
materials/solutions/solvents: Isopropyl alcohol, hydrogen peroxide
and other peroxides, citrus-based cleaners, hand lotions and
water-less hand sanitizers, as well as surfactants and lubricants.
The imaging plate contains Barium and should be considered
hazardous or special waste in specific conditions at the end of its
useful service life. For disposal or recycling information, contact
your local authorities.
Do not soak the imaging plate in any cleaning or disinfecting
solutions. Do not autoclave; autoclaved imaging plates must be
discarded.
Imaging plates should be stored in their original packing or storage
box when they are not in use. Always store imaging plates in a dark
and dry place.
Do not expose the imaging plates to light for long periods as this can
have a degrading effect.
Do not store imaging plates in hot or moist conditions.
Do not fold, crease, or bend the imaging plates.
Avoid touching the imaging side of the imaging plates and be careful
not to drag the imaging side of the imaging plate across any surface
as this will damage the imaging plate.
Do not leave imaging plates where they can become damaged by
liquid or chemical spills.
Read and follow the instructions in Material Safety Data Sheets
(MSDS) for the CS Screen Cleaner.
4 Chapter 1 Safety Information
If a commercially prepared equivalent solution of diluted bleach is
used, it should be used according to its manufacturer’s instructions.
Computer:
DO NOT place the computer and the peripheral equipment
connected to it in the immediate vicinity of the patient in the unit.
Leave at least 1.83 m distance between the patient and the unit. The
computer and the peripheral equipment must conform to the
IEC60950 standard.
See your computer installation guide for details of the data
processing system and screen. Leave a sufficient amount of clear
space around the CPU to ensure that it is properly ventilated.
To obtain maximum image quality and visual comfort, position the
screen to avoid direct light reflections from internal or external
lighting.
In order to guarantee medical-grade leakage current, the computer
connected to the system should be a medical-grade computer or
connected to the mains through medical-grade power supply. This is
not relevant if the system is connected to a laptop by USB through an
isolator or network cable.
General Notice
WA R N I N G S
If the product does not operate properly or fails to
respond to the controls as described in the product
accompanying documentation:
Follow the safety precautions as specified in this guide.
Stop using the unit and prevent any changes to it.
Immediately contact the service office, report the
problem, and await further instructions.
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 5
Laser Safety Instructions
Hygiene and Disinfection
WA R N I N G S
The CS 7600 is a CLASS 1 Laser product.
During normal operation, always keep the unit enclosed in
its protective cover to prevent the outside area from being
exposed to laser radiation.
During normal operation, do not remove the cover. Only
authorized service personnel may remove the cover.
Do not operate the system while the service door is open
Access to the rear inspection cover is allowed, as an
exception, according to the instructions for Retrieval of the
imaging plate in the troubleshooting section of the user
guide.
WA R N I N G
Laser radiation when cover is removed. Avoid direct exposure
to beam.
Class 3B laser inside. Do not operate the system while the
service door is open.
WA R N I N G S
Do not use chemical autoclave for disinfecting the
detachable insertion slot panel.
To prevent cross-contamination, use a new hygienic sheath
for each new patient.
WA R N I N G
Do not operate the equipment in the presence of 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 unplug it. Evacuate and
ventilate the area before turning off the system.
6 Chapter 1 Safety Information
Marking and Labeling Symbols
Label Description
In the European Union, this symbol indicates: DO
NOT discard this product in a trash receptacle; use an
appropriate recovery and recycling facility.
Contact your local sales representative for additional
information on the collection and recovery programs
available for this product.
Warning: General warning sign
Using accessories other than those specified in this
document with the exception of those sold by
Carestream Health may result in a lower level of
security for the entire system.
General mandatory action sign.
Refer to instruction manual / booklet.
Manufactured Date.
Manufacturers address.
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 7
IEC Symbols Used
The system may have labels with one or more of the following symbols
Safety Labels
Label Description
Caution—consult accompanying documents
Power On/Off
Caution—Electrical shock hazard
Label Description Location
Caution—Electrical
shock hazard PM board
Laser-emitting product Optical head
Class 3B laser product
inside scanner
Optical head and on the scanner
back cover
8 Chapter 1 Safety Information
Label Locations
The following figure illustrates the label locations of the CS 7600 components.
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 9
Declaration of Conformity
10 Chapter 1 Safety Information
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 11
2 Regulatory Information
General Regulatory Information
Compliance with European and International Standards
EN 60601-1 / IEC
60601-1
Medical Electrical Equipment, Part 1: General
Requirements for Safety
EN 60601-1-2 / IEC
60601-1-2
Medical Electrical Equipment, Part 1-2: Electromagnetic
Compatibility
EN 60601-1-6 / IEC
60601-1-6
Medical Electrical Equipment, Part 1-6: General
requirements for basic safety and essential performance -
Collateral Standard: Usability
EN ISO 14971 Medical devices - Application of risk management to
medical devices
EN 980 Symbols for use in the labeling of medical devices
EN 1041 Information supplied by the manufacturer of medical
devices
EN 62304/IEC 62304 Medical device software - Software life cycle processes
EN 300 330-2 Electromagnetic Compatibility and Radio Spectrum
Matters
WARNING: Any changes or modifications not
expressly approved by the party responsible for
compliance could void the user’s authority to operate
this equipment.
12 Chapter 2 Regulatory Information
Electromagnetic Compatibility Precautions
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC).
CS 7600 must be installed and put into service according to the EMC
information provided in this document.
Communication Equipment: Portable and mobile Radio Frequency (RF)
communications equipment can affect the Electromagnetic Compatibility
of CS 7600s.
CS 7600 may be interfered with other equipment even if that other
equipment complies with CISPR emission requirements.
Classification in Accordance with EN/IEC 60601-1
Type of protection against
electric shock
Class 1 equipment
Degree of protection against
electric shock
Type B – No Applied Parts
Protection against harmful
ingress of water
Ordinary equipment, IPX0
Operation mode Continuous operation
Conformity with EN/IEC 60601-1-2
Electromagnetic Compatibility Precautions
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 13
Guidance and Manufacturers Declaration - Electromagnetic
Emissions (IEC 60601-1-2)
The CS 7600 is intended for use in the electromagnetic environment specified
below. The customer or the user of the CS 7600 should assure that it is used in such
an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11 Group 1
The CS 7600 uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11 Class A
The CS 7600 is suitable for use in all
establishments, including domestic
establishments and those directly connected to the
public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Vo l t a g e
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
The CS 7600 is intended for use in the electromagnetic environment specified
below. The customer or the user of the CS 7600 should assure that it is used in such
an environment.
Immunity Test IEC 60601
Test L evel Compliance 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.
14 Chapter 2 Regulatory Information
Surge
IEC 61000-4-5
±1 kV line(s)
to line(s)
±2 kV line(s)
to earth
±1 kV
line(s) to
line(s)
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC
61000-4-11
< 5 % UT
( > 95 % dip
in UT)
for 0.5 cycle
40 % UT
(60 % dip in
UT)
for 5 cycles
70 % UT
(30 % dip in
UT)
for 25 cycles
< 5 % UT
( > 95 % dip
in UT)
for 5 s
< 5 % UT
( > 95 % dip
in UT)
for 0.5 cycle
40 % UT
(60 % dip in
UT)
for 5 cycles
70 % UT
(30 % dip in
UT)
for 25 cycles
< 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 CS
7600 requires continued operation
during power mains interruptions, it
is recommended that the CS 7600 be
powered from an uninterruptible
power supply or a battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital environment
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity (Continued)
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 15
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity (IEC 60601-1-2)
The CS 7600 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CS 7600 should assure that it is used in such an
environment.
Immunity
Test
IEC
60601
Test
Level
Compliance
Level
Electromagnetic Environment -
Guidance
Conducted
RF
IEC
61000-4-6
Radiated RF
IEC
61000-4-3
3 Vrms
150 kHz
to 80
MHz
3 V/m
80 MHz
to 2.5
GHz
[V1]= 3 V
[E1]= 3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the CS 7600, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
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
survey 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:
d(3.5
V1
-------)P=
d(3.5
E1
-------)P 80 MHz to 800 MHz=
d(7
E1
------)P 800 MHz to 2.5 GHz=
16 Chapter 2 Regulatory Information
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 CS 7600 is used
exceeds the applicable RF compliance level above, the CS 7600 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the CS 7600.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity (IEC 60601-1-2) (Continued)
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 17
Recommended Separation Distances between Portable and Mobile
RF Communications Equipment and the CS 7600
(IEC 60601-1-2)
The CS 7600 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the CS 7600
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
CS 7600 as recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance (m) According to Frequency of
Transmitter
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GHz
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.
d(3.5
V1
------- )P=
d(3.5
E1
-------)P=
d(7
E1
------)P=
Note: The communication without disruption has
been determined to be essential performance with
regard to electromagnetic compatibility.
18 Chapter 2 Regulatory Information
Compliance with International Regulations
The product conforms to the following safety standards: IEC 60601-1:2005 -
Medical Electrical Equipment - Part 1: General requirements for safety and essential
performance, EN/IEC 60825-1:94 + a1(97) + a2(01) + Cor1(02), EN
60601-1:06/IEC 60601-1:05, UL 60601-1:03, rev. 06, IEC
60825-1:93+A1:97+A2:2001 (for LED module), IEC 60825-1:2007 (for laser
module CAN\CSA-C22.2 No. 601.1-M90, JIS T 0601-1:1999.
This device complies with 21CFR 1040.10.
Medical Device Directives 93/42/ European Economic Community
(EEC), Class IIa follow the rule 16 as amended by 2007/47/EEC.
The CS 7600 is an active device specifically intended for scanning of
X-ray diagnostic images.
ElectroMagnetic Compatibility (EMC) directive 89/336/EEC, Group
1, Class A
Radio and Telecommunications Terminal Equipment directives
1999/5/EEC
FCC rules part 15/EN 300 330-2 V1.3.1/47CFRp15sb.C/RSS/210:07
Issue 7
Compliance with FCC Rules
This equipment has been tested and found compliant with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that the
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference
that may cause undesired operation.
.
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 19
3 Technical Specifications
Manufacturer
Carestream Health, Inc.
150 Verona Street
Rochester,
New York - USA 14608
Model
CS 7600
CS 7600 Technical Specifications
System Specifications
* For external AC/DC power supply medical grade, complies with IEC 601-1
Components CS 7600
Dimensions
(without bracket) 267 mm (H), 237 mm (W), 260 mm (D)
Weight Approximately 6 kg
Power supply* SL Power Model #: MW174KB2403F01
100 – 240 V (ac), 50/60 Hz, 1.5 A
Laser wavelength 635 – 660 nm (Class 3B)
Laser power Up to 12 mW
20 Chapter 3 Technical Specifications
Imaging Plate Specifications
Imaging Plate Dimensions
Imaging Plate Scanning Resolution
*LP/mm: Line pairs per millimeter (measured on grid resolution target, in scan
direction)
Imaging
Plate
Size
01234
Height
(mm) 22 24 31 27 57
Width
(mm) 35 40 41 54 76
Super high
resolution
(SHR)
Height
(pixels) 1356 1476 1500 1802 2800
Width
(pixels) 2052 2298 2000 3009 3750
High
resolution
(HR)
Height
(pixels) 772 841 860 1026 1580
Width
(pixels) 1169 1308 1150 1713 2122
High
speed (HS)
Height
(pixels) 435 474 480 578 900
Width
(pixels) 659 738 640 966 1200
Resolution Level Practical Resolution (LP/mm*)
Super high resolution (SHR) 17
High resolution (HR) 14
High speed (HS) 8
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 21
RF Information.
CS 7600 Environmental Requirements
Ambient Operating Conditions
Storage and Transport Conditions
RF Information
Scan & Go standard ISO15693
Frequency 13.56 MHz
Ambient Operating Conditions
Temperature 5 – 35 °C
Relative humidity 30 – 85 % Non-condensing
Atmospheric pressure 700 – 1060 hPa
Ambient Storage Conditions (in packaging)
Temperature -10 – 60 °C
Relative humidity 10 – 95 % Non-condensing
Atmospheric pressure 700 – 1060 hPa
22 Chapter 3 Technical Specifications
Imaging Plates Environmental Requirements
Ambient Operating Conditions
Storage and Transport Conditions
Ambient Operating Conditions
Temperature 5 – 35 °C
Relative humidity 30 – 85 % Non-condensing
Atmospheric pressure 700 – 1060 hPa
Ambient Storage Conditions (in packaging)
Temperature -10 – 60 °C
Relative humidity 10 – 95 % Non-condensing
Atmospheric pressure 700 – 1060 hPa
CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed02 23
Minimum Computer System Requirements
Item Viewing and Acquisition Comments
CPU
2 GHz Intel® Dual Core™
or
AMD Athlon or higher
For best performance it is
recommended to use an
Intel® Dual Core™
processor.
RAM 1 GB ( 2 GB recommended ) RAM has a major impact on
system performance.
Hard disk drive
4 GB for software
installation
80 GB minimum ( 250
GB recommended ) free
space to use the software
Graphic board
Nvidia/ATI based board
supporting Open Glide 1.2 with
256 MB of video RAM
The video RAM has major
impact on system
performance.
Monitor
1 monitor
17" or larger
1024 x 768 minimum
screen resolution, 32-bit
color mode
Your monitor is a vital
component in displaying
quality images. Low-quality
monitors will impede proper
diagnoses and treatment.
Operating system
Windows 7
Ultimate/Professional
with SP1, 32/64-bit
Windows XP Professional
with SP3
Windows Vista Ultimate
with SP2, 32-bit
Ethernet interface 100/1Gb LAN card
USB 2.0 3 ports 4 ports recommended
CD/DVD drive DVD-ROM drive Required to install the
product software
Audio speakers 1 speaker
To enable hearing audible
alarms initiated by the system
and the Scan & Go option.
24 Chapter 3 Technical Specifications

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