Carestream Health KODAK1500H, KODAK1500 User Manual
8G8224-01
KODAK 1500 Intraoral Camera
Safety and Regulatory Guide
Notice
©Carestream Health, Inc., 2009. 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
with the permission of Carestream Health, Inc.
Carestream is a trademark of Carestream Health, Inc.
The Kodak trademark and trade dress are used under license from Kodak.
All other trademarks and registered trademarks are the property of their respective
holders.
US Federal law restricts this device to sale by or on the order of a dentist.
The Kodak 1500 intraoral camera is also marketed and sold as the STV Pro +
intraoral camera.
Manual Name: KODAK 1500 Intraoral Camera Safety and Regulatory Guide
Part Number: 8G8224
Revision Number: 01
Print Date: August 2009
Authorized Representative:
Handpiece:
FCC ID: U72KODAK1500H
IC: 7027A-KODAK1500
Docking Station
FCC ID: U72KODAK1500
IC: 7027A-KODAK 1500
Safety and Regulatory Information
Indications for Use
The KODAK 1500 intraoral camera is designed for use by health
professionals in viewing and capturing intraoral or extraoral color images
for the purpose of:
• Enabling practitioners to view and magnify all regions of the oral
cavity to assess overall dental health.
• 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 and wireless. The
wired camera is composed of a camera, a docking station, and
accessories. The wireless camera is composed of an additional charge
station and accessories.
Regulatory Information
The KODAK 1500 intraoral camera complies with the following
standards:
• 93/42/EEC European directive for medical devices including
EN 60601-1-2 and collaterals
• Electrical Safety and Electromagnetic Compatibility standards
(IEC) (CEM)
• Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 1
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.
Guidance and Manufacturer’s Declarations
Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions
The KODAK 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
RF Emissions
CISPR 11
Harmonics Emissions
IEC 61000-3-2
Voltag e
Fluctuations/
Flicker Emissions
Group 1
Class B
Class A
Complies
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.
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.
IEC 61000-3-3
2
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
The KODAK 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
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test Level
3 Vrms
150 kHz to 80
MHz
3 V/M
80 MHz to
2.5GHz
Compliance
Level
3 Vrms
3 V/M
Electromagnetic Environment Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Kodak 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
manufacture and is the
recommended separation distance
in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
should be less than the compliance
level in each frequency range
a
,
b
.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 3
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity (Continued)
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.
a Field strengths from fixed transmitters, such as base station 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 Kodak 1500 intraoral camera.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/M.
4
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