Carestream DENTAL CS 1200 Owner's manual

CS 1200
Safety & Regulatory Guide

Notice
© Carestream Dental LLC, 2019. The information in this document is subject to
change. Neither Carestream Dental LLC nor any of its subsidiaries shall be liable for
errors contained herein or for incidental damages in conjunction with the furnishing,
performance, or use of this material. No part of this publication may be reproduced
without the permission of Carestream Dental LLC.
All trademarks and registered trademarks are the property of their respective holders.
The CS 1200 is intended for professional use only.
US Federal law restricts this device to sale by or on the order of a dentist.
Manual Name: CS 1200 Intraoral Camera Safety, Regulatory, and Technical
Specifications User Guide
Part Number: 9H1808
Revision Number: 04
Print Date: 2019-02

CS 1200 Intraoral Camera Safety, Regulatory, and Technical
Specifications User Guide (9H1808)_Ed04 iii
Contents
Chapter 1
Safety Information
Conventions in This Guide . . . . . 1
Warnings. . . . . . . . . . . . . 2
Camera. . . . . . . . . . . . . 2
Computer . . . . . . . . . . . 4
Hygiene and Disinfection . . . . . 5
Cleaning and Disinfecting
the Camera . . . . . . . . . . . 5
General Warnings. . . . . . 5
Cleaning the Camera . . . . 6
Disinfecting the Camera . . . 6
Visually Inspecting the Camera
for Damage . . . . . . . . . . . . 7
Chapter 2
Regulatory
Information
Marking and Labeling Symbols . . 9
Label Locations . . . . . . . . . .10
Indications for Use . . . . . . . .11
Regulatory Information. . . . . . .11
Electromagnetic Compatibility
Precautions . . . . . . . . . . . .11
Guidance and Manufacturer’s
Declarations . . . . . . . . . .12
EMC Standards for Intraoral
Camera . . . . . . . . . . . . . .16
Electromagnetic Interference and
Electrostatic Discharge . . . . .16
Compliance with European and
International Standards . . . . . .16
Accessories. . . . . . . . . . . .18
Other Equipment . . . . . . . . .18
Chapter 3
Technical
Specifications
Factory . . . . . . . . . . . . . .19
Manufacturer . . . . . . . . . . .19
Model. . . . . . . . . . . . . . .19
Technical Specifications. . . . . .19
Minimum Computer System
Requirements . . . . . . . . . . .21

iv
Chapter 4
Contact Information
Manufacturer’s Address . . . . . .23
Authorized Representatives . . . .23

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 1
1 Safety Information
Conventions in This Guide
The following messages emphasize information or indicate potential risks
to personnel or equipment.
WARNING: Warns you to avoid injury to yourself or
others by following the safety instructions.
Important: Alerts you to a condition that might
cause problems.
Note: Emphasizes important information.
Tip: Provides extra information and hints.

2 Chapter 1 Safety Information
Warnings and Safety Instructions
Warnings
Camera
•You MUST read and understand this safety information before
using the camera.
•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.
•Before using the camera, check the outer surfaces of the
camera and any accessories to ensure there are no rough
surfaces, sharp edges, or protrusions which may cause a safety
hazard.
•The surface temperature of the LED window may rise to 40°C.
Do not allow the window to come in contact with the patient's
mouth for more than 10 minutes.
•You are responsible for the operation and maintenance of this
camera. You MUST have training to use the camera.
•DO NOT place objects within the field of operation of the unit.
•When the unit is not in use, ensure that the camera is turned
OFF.
•DO NOT use this camera in conjunction with oxygen-rich
environments. This unit is not intended for use with flammable
anesthetics or flammable agents.
•DO NOT pull or twist the cable.
•DO NOT drop the camera.
•DO NOT expose the camera to water spray or submerge it in
water.

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 3
•DO NOT expose the camera to high vibrations.
•DO NOT expose the camera to ultraviolet radiation for a long
period.
•DO NOT replace the cables provided with the camera with other
cables. Doing so may damage the camera and adversely affect
the safety protection and EMC performance of the camera.
•Any other equipment not complying with IEC60601 shall be
kept at least 1.83 meters away from the patient.
•DO NOT remove the cover of any camera components. For any
repairs, contact a qualified Carestream Dental service
technician.
•If the equipment is faulty, turn it OFF, display an “Out of Service”
notice, and contact a qualified service technician.
•Using components, accessories, cables, and spare parts other
than those specified or provided by the manufacturer of this
equipment may impair the safety protection of the camera and
may result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
•Do not stare at the LED emission window.
•No modification of this equipment is allowed.
•Additional multiple outlet strips or extension cords should not
be connected to the system.
•To power off the device, push the power button for 3 seconds.

4 Chapter 1 Safety Information
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 meters distance between the patient and the
equipment.
•The camera is intended to be connected only to a computer that
has agency approval according to the latest edition of
applicable safety and EMC standards. Connecting the camera
to other equipment may be hazardous.
•See the installation guide for your computer for information
about the data processing system, computer, and screen. Leave
a sufficient amount of clear space around the computer to
ensure that it is properly ventilated.
•Position the screen to avoid light reflections from internal or
external lighting for maximum image quality and visual comfort.

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 5
Hygiene and Disinfection
Perform the following maintenance activities on your CS 1200 and
accessories regularly.
To ensure maximum hygienic safety for the patient, carefully follow the
instructions to prepare the CS 1200 for use.
To minimize the risk for cross-contamination, after each patient, clean
and disinfect the CS 1200. See “Cleaning and Disinfecting the Camera.”
Cleaning and Disinfecting the Camera
General Warnings
WARNINGS:
•Read and follow the warnings and personal
protection instructions provided in the Safety
Data Sheet (SDS) of the disinfectant before
use.
•The disinfectant should be approved by the
applicable competent authority for use on a
dental medical device.
•You must wear gloves while handling and using
the camera.
•Always protect the camera with a hygienic
barrier sheath before use.
•The camera should be disinfected with a U.S.
Environmental Protection Agency (EPA)-
registered or CE-marked intermediate-level
disinfectant solution with tuberculocidal activity
between patients.
•DO NOT use a disinfectant containing phenolics
or iodophors; doing so will damage the surface
coating of the camera.
•Never put the camera in a sterilizing device or
immerse it in water or the disinfectant solution.
•Excessive fluids can damage the camera.
•Not protected against water spray.

6 Chapter 1 Safety Information
Cleaning the Camera
If the camera is visibly contaminated with blood and/or body fluids, you
must clean the camera before disinfecting it.
To clean the camera, follow these steps:
1Dampen (do not soak) a lint-free cloth with lukewarm water.
2Remove the blood and/or body fluids with the dampened lint-free
cloth.
Disinfecting the Camera
After each patient, the camera must be thoroughly disinfected.
To adequately disinfect the camera, follow the disinfectant
manufacturer’s instructions for the appropriate contact time.
To disinfect the camera, follow these steps:
1Remove the protective sheath.
2Remove all visible soil (see “Cleaning the Camera” ).
3Dampen (do not soak) a lint-free cloth with 0.525% sodium
hypochlorite (1:10 dilution of household bleach), or use a
commercially prepared disinfectant wipe. For example: Clorox
Healthcare Bleach Germicidal Wipes, if in the USA.
4Thoroughly wet the surface of the camera with the disinfectant
solution. Allow the surfaces to remain wet for the time specified by
the disinfectant manufacturer.
5Allow to dry in the open air for a minimum of 5 minutes.
Important: If the camera is visibly soiled, it must be
thoroughly cleaned prior to disinfecting. See
“Cleaning the Camera.”
WARNING: Do not rinse.

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 7
Visually Inspecting the Camera for Damage
Visually inspect the camera for signs of deterioration, especially around
the buttons and the cable. If damage is noted, do not use the camera
and contact your representative.

8 Chapter 1 Safety Information

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 9
2 Regulatory Information
Marking and Labeling Symbols
Type BF applied part symbol classification in
accordance with IEC 60601standards.
Class II equipment
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.
Manufacturer’s address
Attention:
Consult accompanying documentation.
Refer to instruction manual/booklet.
Direct current

10 Chapter 2 Regulatory Information
Label Locations
Figure 1 CS 1200 Camera Box Label
Figure 2 CS 1200 Camera Label

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 11
Indications for Use
The CS 1200 intraoral camera is indicated for use by health
professionals in viewing and capturing intraoral or extraoral color video
images for the purposes of:
•Allowing practitioners to view regions of the oral cavity.
•Assisting communications with the patient by providing a view
of treatment areas before and after a procedure.
•Providing images for documentation in patient records.
Regulatory Information
The CS 1200 intraoral camera complies with the following regulations:
•Medical Device directives 93/42/European Economic
Community (EEC), Class I following the rule 5 as amended by
2007/47/EEC
•Directive 2011/65/EU on the Restriction Of the use of certain
Hazardous Substances in electrical and electronic equipment
(ROHS)
•FDA Center for Devices & Radiological Health CDRH - Title 21
CFR 872.6640 (USA)
•Medical Devices Regulations (Canada)
Electromagnetic Compatibility Precautions
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC). Medical equipment must be
installed and put into service according to the EMC information provided
in this documentation.
Other equipment can interfere with communications with the intraoral
camera, even if the equipment complies with CISPR emissions
requirements.
Warning: Portable and Mobile 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 intraoral
camera, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.

12 Chapter 2 Regulatory Information
Guidance and Manufacturer’s Declarations
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The CS 1200 intraoral camera is intended for use in the electromagnetic environment
specified below. The customer or user of the CS 1200 intraoral camera should assure that
it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11 Group 1
The CS 1200 intraoral camera 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 B
The CS 1200 intraoral camera 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
Not
applicable
Voltage
Fluctuations/
Flicker Emissions
IEC 61000-3-3
Not
applicable

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 13
Guidance and Manufacturer’s Declaration -- Electromagnetic Immunity
The CS 1200 intraoral camera is intended for use in the electromagnetic
environment specified below. The customer or the user of the CS 1200 intraoral
camera 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
±1 kV for input/
output lines ±1 kV for input/ output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5 Not applicable Not applicable Not applicable
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
Not applicable Not applicable Not applicable
Power frequency
(50/60Hz)
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.

14 Chapter 2 Regulatory Information
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The CS 1200 intraoral camera is intended for use in the electromagnetic environment
specified below. The customer or the user of the CS 1200 intraoral camera 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
6 Vrms in ISM
bands between
150 kHz and
80 MHza
3 V/m
80 MHz to
2.7GHz
3 Vrms
150 kHz to
80 MHz
6 Vrms in ISM
bands between
150 kHz and
80 MHza
3 V/m
80 MHz to
2.7GHz
Environment of a professional
healthcare facility.
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 1200, including cables
specified by the manufacturer.
Otherwise, degradation of the
performance of this equipment could
result.
a The ISM (industrial, scientific and medical) bands between 150 k Hz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70 MHz.
NOTE: 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 1200 intraoral camera is used exceeds the applicable RF compliance level
above, the CS 1200 intraoral camera 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 1200 intraoral camera.

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
UserGuide(9H1808)_Ed04 15
Guidance and Manufacturer’s Declaration -
Electromagnetic Immunity
For the immunity to proximity fields from RF wireless communications
equipment, the CS 1200 intraoral camera is compliant with the test
levels specified below, according to IEC60601-1-2 standard. The
customer or user of the CS 1200 intraoral camera should assure that it
is used in such an environment.
Test Frequency
(MHz)
Band
(MHz) Immunity Test Levels
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470 FM, ±5 kHz deviation, 1 kHz sine,
28V/m
710
704-787 Pulse modulation 217Hz, 9V/m745
780
810
800-960 Pulse modulation 18Hz, 28V/m870
930
1720
1700-1990 Pulse modulation 217Hz, 28V/m1845
1970
2450 2400-2570 Pulse modulation 217Hz, 28V/m
5240
5100-5800 Pulse modulation 217Hz, 9V/m5500
5785

16 Chapter 2 Regulatory Information
EMC Standards for Intraoral Camera
IEC 60601-1-2: 2014 EMC requirements and tests, Medical Electrical
Equipment including CISPR 11:2009+A1:2010.
Electromagnetic Interference and Electrostatic
Discharge
According to CISPR 11:2009+A1:2010 Group 1, Class B.
Compliance with European and International
Standards
Europe and Other Countries:
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
IEC 60601-2-18: Medical Electrical Equipment, Part 2-18: Particular
requirements for the basic safety and essential performance of
endoscopic equipment
EN 62471 / IEC 62471: Photobiological safety of lamps and lamp
systems: Equipment classification, requirements, and User’s Guide
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 62366 / IEC 62366: Medical devices - Application of usability
engineering to medical devices
EN 62304 / IEC 62304: Medical device software - Software life cycle
processes