Carestream CS 1500 Owner's manual

CS 1500
Carestream Dental
A Division of Carestream Health, Inc.
150 Verona St.
Rochester, NY 14608
USA
Safety & Regulatory Guide
For more information, visit: www.carestreamdental.com
To give documentation feedback, visit:
www.carestreamdental.com/documentationfeedback
9H0953 Ed01 2012-01©Carestream Health, Inc., 2012.

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 1500 is intended for professional use only.
US Federal law restricts this device to sale by or on the order of a dentist.
The CS 1500 intraoral camera is also marketed and sold as the WAVE PICT +
intraoral camera.
Manual Name: CS 1500 Intraoral Camera Safety and Regulatory Guide
Part Number: 9H0953
Revision Number: 04
Print Date: 2017-04

CS 1500 Intraoral Camera Safety and Regulatory Guide
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Contents
Chapter 1
Safety Information
Conventions in This Guide . . . . . 1
Warnings and Safety Instructions . 2
Camera . . . . . . . . . . . . . 2
Computer . . . . . . . . . . . . 4
Hygiene and Disinfection. . . . . . 5
General Warnings. . . . . . . . 5
Cleaning the Plastic Button
Ring Cover . . . . . . . . . . . 6
Cleaning and Disinfecting the
CS 1500 . . . . . . . . . . . . 6
Cleaning the Camera . . . . 6
Disinfecting the Camera . . . 6
Visually Inspecting the Camera
for Damage . . . . . . . . . . . . 7
Disposing of the Battery . . . . . . 8
Chapter 2
Regulatory
Information
Marking and Labeling Symbols . . . 9
Label Locations . . . . . . . . . 10
Wireless Connection . . . . . 10
Wired USB Connection . . . . 12
Indications for Use . . . . . . . . 14
Regulatory Information . . . . . . 14
Electromagnetic Compatibility
Precautions . . . . . . . . . . . 14
Guidance and Manufacturer’s
Declarations . . . . . . . . . 15
EMC Standards Information . . 17
Recommended Separation
Distances . . . . . . . . . . . 18

iv
EMC Standards for Intraoral
Camera . . . . . . . . . . . . . .19
Wireless: . . . . . . . . . . . .19
Electromagnetic Interference and
Electrostatic Discharge . . . . .20
Conforming with European and
International Standards . . . . .20
Communications Equipment . . . .22
Accessories . . . . . . . . . . . .22
Other Equipment . . . . . . . . .22
Cabling . . . . . . . . . . . . . .23
Chapter 3
Te chn ic a l
Specifications
Manufacturer . . . . . . . . . . .25
Model . . . . . . . . . . . . . . .25
Technical Specifications . . . . . .25
Minimum Computer System
Requirements . . . . . . . . . . .28
Chapter 4
Contact Information
Manufacturer’s Address . . . . . .29
Authorized Representatives . . . .29

CS 1500 Intraoral Camera Safety and Regulatory Guide
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1 Safety Information
Conventions in This Guide
The following special 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 precisely.
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.
•This 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 1500 Intraoral Camera Safety and Regulatory Guide
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•DO NOT expose the camera to high vibrations.
•DO NOT expose the camera to ultraviolet radiation for a
long period.
•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 cables provided with the camera
with other cables. Doing so may damage the camera.
•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 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 the 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 1500 Intraoral Camera Safety and Regulatory Guide
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Hygiene and Disinfection
Perform the following maintenance activities on the CS 1500 and accessories
regularly.
To ensure maximum hygienic safety for the patient, carefully follow the
instructions to prepare the CS 1500 camera for use.
To minimize the risk of cross-contamination, after each patient, clean and
disinfect the CS 1500. See “Cleaning and Disinfecting the CS 1500” on
page 6.
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 Plastic Button Ring Cover
Use a 75% Ethanol cleaning solution to prevent cracks, chips,
or other damage to the plastic button ring cover.
Cleaning and Disinfecting the CS 1500
Cleaning the Camera
If the camera is visibly contaminated with blood 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.
2 Remove the blood 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.
Caution: Do not use disinfectants containing
Diisobutylphenoxyethoxyethyldimethylbenzyl
ammonium chloride, Isopropanol, Ethylene
Glycol Monobutly Ether (2-Butoxyethanol), or
similar ingredients to clean the plastic ring cover.
Important: If the camera is visibly soiled,
it must be thoroughly cleaned prior to
disinfecting. See “Cleaning the Camera.”

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To disinfect the camera, follow these steps:
1Remove the protective sheath.
2 Remove all visible soil (see “Cleaning the Camera” on page 6).
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.
4 Thoroughly wet the surface of the camera with the disinfectant solution.
Allow the surfaces to remain wet for the time specified by the disinfectant
manufacturer.
5 Allow to dry in the open air.
Visually Inspecting the Camera for
Damage
Visually inspect the camera for signs of deterioration, especially around the
buttons or the cable. If damage is noted, do not use the camera and contact
your representative.
Warning: Do not rinse.

8 Chapter 1 Safety Information
Disposing of the Battery
The battery is a user-replaceable part ordered directly from the distributor or
dealer.
To dispose of the battery, follow these steps:
1Press the Battery Release button (A) and gently pull the battery out.
2 Hold the camera in one hand, and use your other hand to push the new
battery into the bottom of the camera.
3 Make sure the battery is locked into place.
4 To make sure that the battery and all the cables are inserted correctly,
press the ON/OFF for 3 seconds to power ON the camera.
When the battery has reached the end of its useful life, properly dispose of the
battery following all local regulations. Your community may offer a battery
collection program. Check with program sponsors for participation details.
A

CS 1500 Intraoral Camera Safety and Regulatory Guide
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2 Regulatory Information
Marking and Labeling Symbols
Type BF applied part symbol classification in
accordance with IEC 60601standards.
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.
Non-ionizing radiation
Class II equipment
Attention:
Consult accompanying documentation.
Refer to instruction manual/booklet.
Direct current
Manufactured date
Manufacturer’s address
Serial number

10 Chapter 2 Regulatory Information
Label Locations
Wireless Connection
Figure 1 CS 1500 Camera Wireless Shipping Label, Battery Label
Figure 2 CS 1500 Camera Wireless Label
SN
MODEL
1
REF
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
SN
MODEL
USC
This device complies with Part 15 of
the FCC Rules. Operatio n is sub ject
to the following two conditions: (1)
this device may not cause harm ful
interference, and (2) this device
must accept any interference
received, including interference that
may cause undesired operatio n.
This Class A ISM device
complies with Canadian ICES-001.
Cet appareil numérique de la classe A
est conforme à la norme NMB-001
du Canada. P/N 2G5818 REV B
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 1500 Intraoral Camera Safety and Regulatory Guide
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Figure 3 CS 1500 Camera Wireless Charge Station Label
Figure 4 CS 1500 Camera Wireless FCC Canadian Statement,
Handpiece Label
Figure 5 CS 1500 Camera Battery Label
Figure 6 CS 1500 Camera Wireless Charge Station Insert Indicative
Label
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
MODEL
FCC ID:U72KODAK1500H
IC:7027A-KODAK1500
SN

12 Chapter 2 Regulatory Information
Wired USB Connection
Figure 7 CS 1500 Camera Wired USB Shipping Label
Figure 8 CS 1500 Camera Wired USB System Label
SN
MODEL
1
REF
USC
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
VIDEO CLASS

CS 1500 Intraoral Camera Safety and Regulatory Guide
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Figure 9 CS 1500 Camera Rapid USB Cable Label

14 Chapter 2 Regulatory Information
Indications for Use
The CS 1500 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.
There are two configurations for the camera: wired USB and wireless. The
wireless configuration is composed of a camera, a docking station, a charge
station, and accessories. The wired USB is composed of a camera only.
Regulatory Information
The CS 1500 intraoral camera complies with the following regulations:
•93/42/EEC European directive for medical devices including EN
60601-1-2 and collaterals
•Electrical Safety and Electromagnetic Compatibility standards (IEC)
(EMC)
•Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions
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.

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Guidance and Manufacturer’s Declarations
Guidance and Manufacturer’s Declaration -
Electromagnetic Emissions
The CS 1500 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 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
Complies

16 Chapter 2 Regulatory Information
Guidance and Manufacturer’s Declaration -
Electromagnetic Immunity
The CS 1500 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
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 1500 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 ÖP
d = 1.17 ÖP 80 MHz to 800 MHz
d = 2.33 ÖP 800MHz to 2.5GHz
where P is the maximum output 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 radio, 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 1500
intraoral camera.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.