Carestream DENTAL CS 7600 User manual

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

Notice
The Safety, Regulatory, and 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: CS 7600 Intraoral Imaging Plate System Safety, Regulatory, and Technical
Specifications User Guide
Part Number: 8J4070
Revision Number: 08
Print Date: 2023-03
The brand names and logos reproduced in this guide are copyrighted.
The CS 7600 complies with the Medical Device Regulation (EU) 2017/745 and UK Medical
Devices Regulations 2002 (SI 618) as subsequently amended by the EU Exit Regulations of
2019 (SI 791) and 2020 (SI 1478).

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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Contents
Chapter 1
Safety Information
Indications for Use . . . . . . . . 1
Clinical Benefits and Performance
Characteristics . . . . . . . . . . 1
Conventions in This Guide . . . . . 2
Warning and Safety Instructions . . 2
Scanner . . . . . . . . . . . . 3
Imaging Plates: . . . . . . . . . 5
Computer: . . . . . . . . . . . 6
Disposal . . . . . . . . . . . . 7
General Notice . . . . . . . . . . 8
Laser Warnings . . . . . . . . . . 8
Precautions Before Use . . . . . . 9
Cleaning and Disinfecting . . . . 9
Imaging Plate Care . . . . . . . 9
Cleaning and Disinfecting the
Imaging Plate . . . . . . . . . . 9
Disinfecting the Hygienic Sheath
and the Imaging Plate . . . . 9
Cleaning the Imaging
Plate . . . . . . . . . . . 10
Disposing of the Imaging
Plate . . . . . . . . . . . 11
Scanner Care. . . . . . . . . 12
Cleaning the Scanner
Body . . . . . . . . . . . 12
Marking and Labeling
Symbols. . . . . . . . . . . . . 16
Label Locations . . . . . . . . . 18
Chapter 2
Regulatory
Information
General Regulatory
Information . . . . . . . . . . . 19
Guidance and Manufacturer’s
Declarations . . . . . . . . . . 23
EMC Standards Information . . 25

iv
Compliance with International
Regulations . . . . . . . . . . . 27
Compliance with FCC Rules . . . 28
Chapter 3
Technical
Specifications
Model . . . . . . . . . . . . . . 29
CS 7600 Technical
Specifications . . . . . . . . . . 29
Power Supply . . . . . . . . . . 30
RF Information . . . . . . . . . . 30
Imaging Plate Technical
Specifications . . . . . . . . . . 31
Minimum Computer System
Requirements . . . . . . . . . . 33
Chapter 4
Contact Information
Manufacturer’s Address . . . . 35
Factory . . . . . . . . . . . . 35
Authorized Representatives . . 35
List of Importers for European
Union According to the
MDR 2017/745 . . . . . . . . 36
List of Importers for
Switzerland . . . . . . . . . . 37

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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1 Safety Information
Indications for Use
The CS 7600 is intended for use in dental digital radiography
using imaging plates (phosphor storage screens) for dental
intraoral X-ray imaging of pediatric and adult patients.
Clinical Benefits and Performance
Characteristics
The CS 7600 benefits healthcare professionals by enabling
them to acquire digital intraoral X-ray images of the
dento-maxillofacial area. These outcomes enable the healthcare
professional to support image diagnosis, establish a relevant
treatment plan, and thus improve clinical patient management.
The clinical benefit of the CS 7600 is the positive impact on
patient management.

2 Chapter 1 Safety Information
Conventions in This Guide
The following special messages emphasize information or
indicate potential risk to personnel or equipment.
Warning and Safety Instructions
There are no contraindications identified for the CS 7600.
When operating the device, observe the following warnings and
safety instructions.
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.
IMPORTANT: All known residual risks or
undesirable side effects are listed in this guide. If
any serious incident occurs in relation to the
device, you must report it to Carestream Dental
and to the competent authority of your Member
State in the European Union.

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WARNINGS
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 notices, 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.
DANGER OF ELECTRIC SHOCK
This is an electrical unit. Do NOT expose it to
water spray. Such action can cause an electric
shock or a malfunction of the unit.

4 Chapter 1 Safety Information
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 a 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

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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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.
Disconnecting items from the IT-NETWORK.
Update of equipment connected to the IT-NETWORK.
Upgrade of equipment connected to the
IT-NETWORK.
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 waterless
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

6 Chapter 1 Safety Information
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. Leave at least 1.83 m distance
between the patient and the unit. The computer and

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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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 a medical-grade power
supply. This is not relevant if the system is
connected to a laptop by USB through an isolator or
network cable.
Disposal
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 disposal or recycling center. For further
information on disposing of electrical and electronic waste,
contact the cognizant authority within the local jurisdiction.
To dispose of the unit or its components, contact a service
technician.

8 Chapter 1 Safety Information
General Notice
Laser Warnings
WARNINGS
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.
WARNINGS
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.
WARNING
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.

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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Precautions Before Use
Cleaning and Disinfecting
Perform the following cleaning and disinfection activities on your
product and accessories before use.
Imaging Plate Care
If used with care, Carestream Dental imaging plates can be
used repeatedly. The imaging plates will show wear over time,
due to continuous use. Inspect the imaging plates regularly, and
replace them if they are scratched and/or show signs of
excessive wear.
Cleaning and Disinfecting the Imaging Plate
Disinfecting the Hygienic Sheath and the Imaging Plate
After removing the hygienic sheath from the patient’s mouth and
before extracting the imaging plate from within it, you must
thoroughly disinfect the hygienic sheath.
Warning: 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 waterless
hand sanitizers; as well as surfactants and
lubricants.
Warning: Do not soak the hygienic sheath
in any cleaning or disinfecting solutions.
The hygienic sheath must be discarded
after use (single-use component).

10 Chapter 1 Safety Information
Cleaning the Imaging Plate
If the imaging plate is visibly contaminated with dirt, dust
particles, or fingerprints, you must clean the imaging plate with
the following cleaning materials before disinfecting it:
Clean, dry, non-abrasive, lint-free wipes or cloths.
Carestream X-OMAT Screen Cleaner (ask your Carestream
Dental LLC representative).
To clean the imaging plate, follow these steps:
1Fold a non-abrasive, lint-free wipe or cloth, and dampen
with a small amount of the solution. Be careful not to pour
the solution directly on the imaging plate. Excessive
amounts of the screen cleaner may damage the imaging
plate.
2Wipe the imaging plate thoroughly dry with a clean, dry,
non-abrasive, lint-free cloth to remove residual cleaner. DO
NOT leave the imaging plate to air-dry. Apply pressure to
remove persistent dirt, if necessary.
The imaging plate must be disinfected after each scan.
To disinfect, use a commercially prepared product that adheres
to the following specifications and restrictions:
A commercially prepared equivalent solution of diluted
bleach that does not contain any ingredients (isopropyl
alcohol; hydrogen peroxide and other peroxides;
citrus-based cleaners; hand lotions and waterless hand
Warning: To prevent cross-contamination,
use a new hygienic sheath for each new
patient.

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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sanitizers; as well as surfactants and lubricants) that
can cause damage to the hygienic sheaths and imaging
plates.
To disinfect the sheaths and imaging plates, follow these steps:
1Follow the disinfectant manufacturer’s instructions for
disinfecting the sheaths and imaging plates.
2The sheaths and plates should be kept visibly wet for the full
contact time specified on the disinfectant label.
3Wipe with a non-abrasive, lint-free cloth after keeping it wet
for a specified period of time.
Disposing of the Imaging Plate
Warning: 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 local authorities.
Note: Do not soak the sheath or imaging
plate in the disinfectant solution.

12 Chapter 1 Safety Information
Scanner Care
Cleaning the Scanner Body
Use disinfectant wipes for medical equipment to clean the
scanner body thoroughly from all sides.
Cleaning the Detachable Insertion Panel
The CS 7600 makes use of three insertion panel sizes
according to the inserted plates size (0, 1–3, and 4). The
cleaning procedure is identical for all insertion panels.
WARNING
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.
Warning: It is the user’s responsibility to
disinfect the detachable insertion panel
daily to prevent cross contamination.
Warning: Do not autoclave; an autoclaved
detachable insertion panel must be
discarded.
Warning: Do not use a chemical vapor
sterilizer for disinfecting the detachable
insertion slot panel.

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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To clean and disinfect the insertion panels, follow these steps:
1Remove the installed insertion panel by inserting a finger in
the designated removal depression at the bottom of the
insertion panel (A) and lifting out the insertion panel (B).
2Use disinfection wipes for medical equipment to clean the
detachable insertion panels thoroughly from all sides,
including the slot.
3The scanner displays a prompt to insert a size 0 (left figure
in prompt), size 1-3 (middle figure in prompt), or a size 4
(right figure in prompt) insertion panel.
4Install the cleaned and disinfected insertion panel by
positioning the insertion panel at a 45 degree angle to the
right side of the insertion panel’s housing (A) and pressing

14 Chapter 1 Safety Information
the insertion slot panel in from right to left (B) until it is
completely inserted (C).
The scanner displays an insertion confirmation.
5For size 0, press the left function button to
confirm and return to the main screen.
6For size 1-3, press the right function button to
confirm and return to the main screen.

CS 7600_Safety, Regulatory, and Technical Specifications User Guide
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If insertion Panel 4 is inserted, the scanner displays the
following insertion confirmation.
7For size 4, press the middle function button to
confirm and return to the main screen.

16 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
Medical device
Name of the European authorized representative
and address of the registered place of business.