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
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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.

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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.

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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.”