Carestream DENTAL CS 760 User manual

CS Imaging
Safety, Regulatory and Technical Specications
CS 7600

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 Dental, LLC.
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: 07
Print Date: 2019-02
The Brand names and logos reproduced in this Guide are copyright.
0086

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 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)_Ed07 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
The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio frequency communication services. The
user might need to take mitigation measures, such as relocating or reorienting the
equipment.
The system should be used in the hospital environment except for near active HF
SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for
magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the CS 7600, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they
are operating normally.
Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
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.

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 3
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.
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.
Connection of the PEMS to an IT-NETWORK that includes other
equipment could result in previously unidentified RISKS to
PATIENTS, OPERATORS or third parties.
 The RESPONSIBLE ORGANIZATION should identify, analyze,
evaluate and control these RISKS.
Subsequent changes to the IT-NETWORK could introduce new
RISKS and require additional analysis and changes to the
IT-NETWORK that include:
Changes in the IT-network configuration.
Connection of additional items to the IT-NETWORK.

4 Chapter 1 Safety Information
Disconnecting items from the IT-NETWORK.
Update of equipment connected to the IT-NETWORK.
Upgrade of equipment connected to the IT-NET.
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.
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.

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 5
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.
Cable
Description From To
Cable Type
(or Detail
model name
and
manufacturer
for this cable)
Cable
Length
USB cable Scan & Go
Device USB Port
PC USB
Port Shield 2 m
Network cable CS 7600 Network
Port
PC Network
Port Unshielded 3 m
Power cord Adapter AC inlet Mains Unshielded 1.5 m

6 Chapter 1 Safety Information
General Notice
Laser Safety Instructions
Hygiene and Disinfection
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.
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.

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 7
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.

8 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 Dental LLC may result in a lower level of
security for the entire system.
General mandatory action sign.
Refer to instruction manual / booklet.
Manufactured Date.
Manufacturer’s address.

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 9
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

10 Chapter 1 Safety Information
Label Locations
The following figure illustrates the label locations of the CS 7600 components.
TA1313 A
1) This device may not cause harmful
interference,
2) this device must accept any
interference received, including
interference that may cause undesired
operation.
Scanner FCC ID: 2ASFG-CR-SCANNER
IC: 24914-CRSCANNER
Manufacturer: Carestream Dental LLC
This device complies with Part 15 of the
FCC Rules. Operation is subject to the
following two conditions:

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 11
2 Regulatory Information
General Regulatory Information
The CS 7600 is an active device specifically intended for scanning of X-ray
diagnostic images. This device complies with the following regulations:
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.
Electro-magnetic Compatibility (EMC) directive 89/336/EEC, Group 1,
Class A
Radio Equipment directives 2014/53/EU
FCC rules part 15/EN 300 330 V2.1.1/47CFRp15sb.C/RSS/210 Issue 7
Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS).
21 CFR 1040.10
FDA Center for Devices & Radiological Health CDRH - Title 21 CFR
872.1800 (USA)
Medical Devices Regulations (Canada)
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
Compliance with European and International Standards
Compliance with European and International Standards
EN 60601-1 / IEC
60601-1
Medical Electrical Equipment, Part 1: General
Requirements for Basic Safety and Essential Performance
EN 60601-1-2 / IEC
60601-1-2
Medical Electrical Equipment, Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic Disturbances –
Requirements and tests.
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 15223-1
Medical devices – Symbols to be used with medical
device labels, labeling and information to be supplied –
Part 1: General requirements.
EN 1041 Information supplied by the manufacturer of medical
devices
EN 62304/IEC 62304 Medical device software - Software life cycle processes
EN 300 330
Short Range Devices (SRD); Radio equipment in the
frequency range 9 kHz to 25 MHz and inductive loop
systems in the frequency range 9 kHz to 30 MHz
EN 60825-1 / IEC
60825-1
Safety of laser products - Part 1: Equipment classification
and requirements
EN 62366 / IEC 62366 Medical devices - Application of usability engineering to
medical devices
EN ISO 10993-1 Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
ANSI AAMI
ES60601-1
Medical Electrical Equipment - Part 1: General
Requirements for Safety
CAN/CSA-C22.2
No. 60601-1
Medical Electrical Equipment - Part 1: General
Requirements for Safety

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 13
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 7600.
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 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

14 Chapter 2 Regulatory Information
Guidance and Manufacturer’s 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, other than 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
Not
applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Not
applicable
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
Level
Compliance
Level
Electromagnetic Environment
- Guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 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.

CS 7600_Safety, Regulatory & Technical Specifications (8J4070)_Ed07 15
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)
±2 kV line(s) to
earth
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
0 % UT; 0,5
cycle
At 0o, 45o, 90o,
135o, 180o,
225o, 270o and
315o
0 % UT; 1 cycle
and
70 % UT;
25/30a) cycle
Single phase:
at 0o
0 % UT;
250/300a) cycle
0 % UT; 0,5
cycle
At 0o, 45o, 90o,
135o, 180o, 225o,
270o and 315o
0 % UT; 1 cycle
and
70 % UT; 25/30a)
cycle
Single phase:
at 0o
0 % UT;
250/300a) cycle
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.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment
a) e.g 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
NOTE: UT is the AC mains voltage prior to the application of the test level.
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity (Continued)

16 Chapter 2 Regulatory Information
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 L e ve l
Compliance
Level
Electromagnetic Environment -
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms 150
kHz to 80 MHz
6 Vrms in ISM
bands between
150 kHz and 80
MHza)
3 V/m
80 MHz to 2.7
GHz
3 Vrms 150 kHz
to 80 MHz
6 Vrms in ISM
bands between
150 kHz and 80
MHza)
3 V/m
80 MHz to 2.7
GHz
Environment of a care facility professional
health.
WARNING: Portable RF communications
equipment (including peripherals such as
antenna cables and external antennas)
should be used no closer than 30 cm (12
inches) to any part of the CS 7600 including
cables specified by the manufacturer.
Otherwise, degradation of the performance
of this equipment could result.
a The ISM (industrial, scientific and medical) bans between 150 k Hz and 80 MHz to 6.795
MHz; 13.533 MHz to 13.567 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
NOTE 1: 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.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.