Carestream DENTAL CS 1200 Owner's manual

CS 1200
Carestream Dental
A Division of Carestream Health, Inc.
150 Verona St.
Rochester, NY 14608
Safety & Regulatory Guide
9H1808 Ed01 2011-07
For more information, visit: www.carestreamdental.com
©Carestream Health, Inc., 2011.

Notice
©Carestream Health, Inc., 2017. The information in this document is subject to
change. Neither Carestream Health 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 Health, Inc.
Carestream Health is a trademark of Carestream Health, Inc.
All other 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: 03
Print Date: 2017-04

CS 1200 Intraoral Camera Safety, Regulatory, and Technical
Specifications User Guide (9H1808)_Ed03 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 Information. . .14
Recommended Separation
Distances . . . . . . . . . . .15
EMC Standards for Intraoral
Camera . . . . . . . . . . . . . .16
Electromagnetic Interference and
Electrostatic Discharge . . . . .16
Compliance with European and
International Standards . . . . . .17
Accessories. . . . . . . . . . . .18
Other Equipment . . . . . . . . .18
Chapter 3
Te chn ic a l
Specifications
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
User Guide (9H1808)_Ed03 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 camera is not intended to be used with high frequency
surgical equipment.
•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
User Guide (9H1808)_Ed03 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.
•Any other equipment not complying with IEC60601 shall be out
of patient environment.
•DO NOT remove the cover of any camera components. For any
repairs, contact a qualified Carestream service technician.
•DO NOT replace the power adapter provided with the camera
with any other power adapter. Substitutes may not provide the
required protection against electric shocks.
•If the equipment is faulty, turn it OFF, display an “Out of Service”
notice, and contact a qualified service technician.
•Using components, accessories, and spare parts other than
those specified, with the exception of those sold by the
manufacturer of the equipment, may result in a lower level of
security and may be hazardous.
•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.
To isolate the device from mains supply, unplug the
USB/AV/S-Video cables and the adapter from the power outlet.

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 m distance between the patient and the equipment.
•The camera is only intended to be connected to the computer
or monitor which is at least IEC 60950 or equivalent standards
certified. 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
User Guide (9H1808)_Ed03 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
User Guide (9H1808)_Ed03 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
User Guide (9H1808)_Ed03 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
Figure 3 CS 1200 Adapter Reference Label
SN
CS 1200
MODEL
655 9991
1
Intraoral Camera /
数字口腔观察仪
9G8687 REV D
Made in China by
Carestream Health, Inc.
150 Verona Street
Rochester, NY, USA, 14608
锐珂（上海）医疗器材有限公司
中国（上海）自由贸易试验区
川 桥 路 1510号 第 七 幢 通 用 厂 房
邮 编 ： 201206
中国制造
CS 1200
P/N 9G5398 REV E
Made in China by
Carestream Health, Inc.
150 Verona Street, Rochester, NY, USA, 14608
CS 1200
MODEL
SN
Intraoral Camera
5 V 1.5 A
INPUT :
TÜVRheinland
USC
CS 1200

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
User Guide (9H1808)_Ed03 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
•FDA Center for Devices & Radiological Health CDRH - Title 21
CFR 872.3661 (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.
Portable and mobile RF communications equipment can affect medical
electrical equipment.

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 intraoral camera should assure that it is used
in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
Group 1
Class B
The intraoral camera uses RF energy only for its
internal function. Therefore, its RF emissions are
low and are not likely to cause any interference in
nearby electronic equipment.
Harmonics Emissions
IEC 61000-3-2
Complies
The 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.
Voltage
Fluctuations/
Flicker Emissions
IEC 61000-3-3

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
User Guide (9H1808)_Ed03 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 intraoral camera should assure that it is
used in such an environment.
Immunity Test IEC 60601
Tes t Le ve l
Compliance
Level
Electromagnetic Environment -
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V(rms)
150 kHz to 80
MHz
3 V/m
80 MHz to
2.5GHz
3 V(rms)
3 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the CS
1200 intraoral camera, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d=1.17
d = 1.17 80 MHz to 800 MHz
d = 2.33 800MHz to 2.5GHz
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
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should
be less than the compliance level in
each frequency rangeb.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
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.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radios, AM and FM radio broadcasts, and TV
broadcasts 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 intraoral camera system is used exceeds
the applicable RF compliance level above, the intraoral camera should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the CS 1200 intraoral camera.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

14 Chapter 2 Regulatory Information
EMC Standards Information
Electromagnetic Immunity for Equipment and Systems Fully Compliant
with IEC 60601-1-2: 2007
The CS 1200 intraoral camera is intended for use in the electromagnetic
environment specified below. The customer or the user of the 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
+/- 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
+/- 1kV for
input/output lines
+/-2kV for power
supply lines
+/- 1kV for
input/output lines
+/-2kV for power
supply lines
Mains power quality
should be that of a
typical commercial or
clinical environment.
Surge
IEC 61000-4-5
+/- 1 kV line to line +/- 1 kV line to line
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
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) for25 cycles
<5% UT(>95%
dip in UT) for 5
sec.
<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) for25 cycles
<5% UT(>95%
dip in UT) for 5
sec.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Note: Most components
in the intraoral camera
are powered from an
uninterruptible power
supply.
IEC 61000-4-11 is
applicable only to the
intraoral camera.
Power frequency
(50/60Hz)
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.
Note: UTis the a.c. mains voltage prior to application of the test level.

CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications
User Guide (9H1808)_Ed03 15
Recommended Separation Distances
Recommended Separation Distance Between Portable and Mobile RF
Communications Equipment and the Intraoral Camera System
The CS 1200 intraoral camera is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the
intraoral camera can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communication equipment
(transmitters) and the CS 1200 intraoral camera as recommended below, according
to the maximum output of the communications equipment.
Rated Maximum
Output Power
of Transmitter
Watts
Separation Distance According to Frequency of Transmitter Meters
150 kHz to 80
MHz
d = 1.17
80 MHz to 800
MHz
d = 1.17
800 MHz to 2.5 GHz
d = 2.33
0.01 0.117 0.117 0.233
0.1 0.37 0.37 0.737
1 1.17 1.17 2.33
10 3.7 3.7 7.36
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the
recommended separation distance in meters (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.

16 Chapter 2 Regulatory Information
EMC Standards for Intraoral Camera
IEC 60601-1-2: 2007 EMC requirements and tests, Medical Electrical
Equipment including CISPR11:2003 +A1: 2004 + A2:2006 Group 1,
Class B.
NOTE: This equipment has been tested and found to comply 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 when the equipment is operated in a commercial
environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the
instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is
likely to cause harmful interference, in which case the user will be
required to correct the interference at his own expense.
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Electromagnetic Interference and Electrostatic
Discharge
According to CISPR11:2003 + A1:2004 + A2:2006 Group 1, Class B.
This Class A ISM device complies with Canadian ICES-001.