Carestream Health 4901 DRYVIEW CHROMA Imaging System incorporating RFID User Manual 9G4259 en

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Document ID	1651256
Application ID	ruYWwqW/JmtTFssghXh07Q==
Document Description	Carestream DV CHROMA Manual-ST CONFIDENTIAL
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	73.45kB (918164 bits)
Date Submitted	2012-03-08 00:00:00
Date Available	2012-09-04 00:00:00
Creation Date	2012-02-08 15:37:39
Producing Software	Acrobat Distiller 9.4.6 (Windows)
Document Lastmod	2012-02-22 15:28:54
Document Title	9G4259_en.book
Document Creator	FrameMaker 7.0
Document Author:	L486095

SHORT TERM CONFIDENTIAL
DRYVIEW CHROMA Imaging System
H210_0843AC
Safety Manual
SHORT TERM CONFIDENTIAL
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608
United States
© Carestream Health, Inc., 2012
Printed in China.
CARESTREAM, CHROMA, and DRYVIEW are
trademarks of Carestream Health, Inc.
Pub No. 9G4259_en
Rev. C
SHORT TERM CONFIDENTIAL
Table of Contents
Safety, Warnings, and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
Safety Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4
Safety and Health Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7
Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7
EMC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7
EU Directives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14
CE Marking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14
Please Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
Imager Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
Publication History - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
SHORT TERM CONFIDENTIAL
SHORT TERM CONFIDENTIAL
Safety and Related Information
Safety, Warnings, and Cautions
Please read and understand all instructions before using the
DRYVIEW CHROMA Imaging System.
RISK OF ELECTRIC SHOCK:
This equipment is operated with hazardous voltage which can
shock, burn, or cause death.
•
Remove wall plug before servicing equipment. Never pull on
cord to remove from outlet. Grasp plug and pull to disconnect.
Do not attempt to service or repair the imager yourself to avoid
exposure to dangerous voltage or other danger. Always call a
qualified service provider for any service or repair.
•
•
•
Do not operate equipment with a damaged power cord.
•
•
•
Position the power cord so it will not be tripped over or pulled.
Do not use an extension cord to power this equipment.
Do not operate equipment with any of the safety interlocks
overridden.
Connect this equipment to a grounded wall outlet.
One power cord set is provided with this equipment.
You must use an Agency-approved power cord with a plug type
suitable for the country of use.
DANGER: This equipment contains moving parts that may be
accessible to the user. Loose clothing, jewelry, or long
hair may cause personal injury or damage to the
equipment.
• Do not operate equipment with the covers open.
DANGER: This equipment is not contained in a sealed cabinet.
Do not use this equipment in locations where it can
come in contact with liquids, including body fluids.
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Safety and Related Information
SHORT TERM CONFIDENTIAL
CAUTION:
Double pole/neutral fusing.
CAUTION:
Do not use a cell phone within 2 m of this device. This
proximity includes any imager behind a wall adjacent to your
location.
CAUTION:
Do not use a microwave oven within 4 m of this device.
Electromagnetic radiation from a microwave oven is only an
issue if after the oven door is closed and latched, the seal does
not maintain an electromagnetic tight fit between the oven
door and oven main housing. Determining if the seal has an
electromagnetic tight fit requires special detection equipment.
CAUTION:
Do not use in the presence of flammable anesthetics, oxygen,
or nitrous oxide. This equipment does not have a gas-sealed
electronics enclosure and could ignite any flammable or
explosive gases present in its environment.
CAUTION:
This equipment uses a DICOM network port, and is intended
to connect to other medical devices. It is not intended to be
connected directly outside the building. Only qualified
personnel may perform installation and service.
1.83 m
CAUTION:
This device is NOT to be located within the patient
environment. Therefore, the equipment must not be located
closer than 1.83 m from a patient bed or chair.
CAUTION:
This device can affect implantable pacemaker or implantable
cardioverter defibrillators at distances of less than 30.48 cm
(1.00 ft).
9G4259_en
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Safety and Related Information
SHORT TERM CONFIDENTIAL
CAUTION:
This device should not be used in close contact with MRI
devices, due to possible very high magnetic fields near an MRI
unit. The magnetic field in the area where this equipment is
installed must be less than 50 G.
CAUTION:
Do not substitute or modify any part of this equipment without
prior written approval of Carestream Health, Inc.
CAUTION:
Federal law prohibits dispensing without a prescription.
CAUTION:
This equipment has been tested and found to comply with the
limits for a Class A 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 User Guide and
other User Documentation, 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.
CAUTION:
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to
operate the equipment.
CAUTION:
Do not use isopropyl alcohol to clean the exterior surfaces of
the device.
CAUTION:
Lithium batteries should only be replaced by a qualified
service provider. The device uses a lithium battery to power
the clock and calendar circuitry. THERE IS A DANGER OF
EXPLOSION IF THE BATTERY IS REPLACED
INCORRECTLY. The battery must be replaced only with the
same or equivalent type. The U.S. EPA’s RCRA does not
regulate disposal of this lithium battery. Users should discard
spent batteries in municipal trash unless their community
offers a battery collection program. In other regions, contact
local or regional solid waste authorities for proper disposal
guidance.
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Safety and Related Information
SHORT TERM CONFIDENTIAL
Safety Labels
Safety labels are attached to the imager in compliance with international
standards.
English Text on Labels
Some names on the labels are shortened and in English. Below is a key
to understand the meanings of the shortened words on the safety labels:
Symbol on label
Definition
Model Number
Serial Number
CAT Number
Manufactured Date
Manufactured By
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Safety and Related Information
SHORT TERM CONFIDENTIAL
Labels—Locations and
Details
See “Safety and Health Compliance” on page 7 for the specific details
of the safety and health compliance.
This label shows the serial number and model number of the device
along with other important data items.
Front view of the imaging system
Serial number label
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Safety and Related Information
SHORT TERM CONFIDENTIAL
Back view of the imaging system
Additional labels for U.S.,
Canada, and Japan
Agency Statements
Product Label. This label states that the imager is a medical
imaging printer.
Static Sensitive Equipment. This label identifies
static-sensitive components. Connect a personal grounding strap
to the appropriate ground before servicing this device. These
panels may only be removed by a qualified service provider.
Radio Frequency Energy. This label indicates that the device
can radiate radio frequency energy. If not installed and used in
accordance with the instructions, the imager may cause harmful
interference to radio communications.
FCC ID and Intentional Radiation IC.
Japanese Import License.
9G4259_en
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Safety and Related Information
SHORT TERM CONFIDENTIAL
Safety and Health Compliance
This equipment has been tested for, and complies with, the following
Safety and Emissions Standards. Certificates of Compliance and
Declarations of Conformity have been issued as shown below.
Safety
United States
FDA 21CFR 807 Premarket Notification 510(K): Regulatory
Requirements For Medical Devices.
UL 60950-1, 2nd Ed.: Safety of Information Technology Equipment,
including Electrical Business Equipment (Bi-National Standard).
Canada
CAN/CSA - C22.2 NO 60950-1-07 Information Technology
Equipment - Safety - Part 1: General Requirements (Bi-National
Standard, with UL 60950-1, 2nd Ed.).
Europe
EN60950-1: Safety of Information Technology Equipment, including
Electrical Business Equipment (IEC 60950-1, 2nd Ed.).
Rest of World
IEC 60950-1, 2nd Ed.: Safety of information technology equipment.
EMC
United States
FCC Rules and Regulations, Title 47, Part 15, Subpart B, Class A:
Radio Frequency Devices: Unintentional Radiators.
This equipment has been tested and been found to comply with the
limits for a Class A digital device pursuant to part 15 of the FCC rules.
Those limits are designed to provide reasonable protection against
harmful interference in a residential installation.
FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio
Frequency Devices: Intentional Radiators. FCC ID for CHROMA
Imager: U724901.
2012-02-24
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Safety and Related Information
SHORT TERM CONFIDENTIAL
Canada
CAN/CSA-C108.6-M91, Class A: Limits and Methods of
Measurement of Electromagnetic Disturbance Characteristics of
Industrial, Scientific and Medical (ISM) Radio-Frequency
Equipment.
Intentional Radiation IC for CHROMA Imager: 7027A-4900.
This Class A digital apparatus complies with Canadian ICES-003.
CET APPAREIL NUM ENRIQUE DE CLASSE A EST
CONFORME A LA NORME NMB-003 DU CANADA.
This Class A digital apparatus meets all requirements of the Canadian
Interference-Causing Equipment Regulations.
Europe and the Rest of World
Under 60601-1-2, there are four tests for 61000-4-11. Three of the tests
were passed normally at the declared test voltages.
Compliance with one of the tests, a 60 % dip in voltage for 5 cycles
(which is approximately one tenth of a second) was not met due to a
technological limitation. The imager portion of the CHROMA Imaging
System will not function at the minimum nominal voltage of 100 V,
when it dips to 40 V. At 40 V, the imager stops and requires operator
intervention to be restored to full operation (Test Performance Criteria
“C”. However, the imager must meet Test Performance Criteria “B” or
“A”). Although the imager stops and intervention is required, no images
are lost by the imaging system.
The imager passes the 60 % dip test at 115 V nominal, dipping to 46 V.
No operator intervention is required, and there are no performance
degradation results due to the voltage dip (Test Performance
Criteria “A”).
The DICOM interface passes the 60 % dip test at 100 V nominal,
dipping to 40 V (Test Performance Criteria “A”). Therefore, the
DICOM interface may be plugged directly into a 100 V system, wall
outlet, and meets all the requirements of 61000-4-11 under 60601-1-2.
9G4259_en
2012-02-24
Safety and Related Information
SHORT TERM CONFIDENTIAL
Guidance and Manufacturer’s Declaration for Electromagnetic Emissions
The imager is intended for use in the electromagnetic environment specified below. The customer or user
should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment—Guidance
RF emissions:
Group 1
The imager 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.
Class A
The imager is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Class A
The imager is suitable for use everywhere, including those
establishments directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Complies
The imager is suitable for use everywhere, including those
establishments directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
• EN55011
• CISPR 11
RF emissions:
• EN55011
• CISPR 11
Harmonics emissions:
• EN61000-3-2
• IEC 61000-3-2
Voltage fluctuations and
flicker emissions:
• EN61000-3-3
• IEC 61000-3-3
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9G4259_en
Safety and Related Information
SHORT TERM CONFIDENTIAL
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The imager is intended for use in the electromagnetic environment specified below. The customer or user
should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environment—Guidance
Electrostatic
discharge (ESD):
± 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 %.
± 2 kV for power
supply lines
± 1 kV for
input/output lines
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Mains power quality should be that of a
typical commercial or hospital environment.
± 1 kV
differential mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common
mode
Mains power quality should be that of a
typical commercial or hospital environment.
• EN61000-4-2
• IEC
61000-4-2
Electrical fast
transient/burst:
• EN61000-4-4
• IEC
61000-4-4
Surge:
• EN61000-4-5
• IEC
61000-4-5
10
9G4259_en
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Safety and Related Information
SHORT TERM CONFIDENTIAL
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environment - Guidance
Voltage dips,
short
interruptions, and
voltage variations
on power supply
lines:
• EN61000-4-11
• 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*) for 25
cycles
<5 % Ut* (>95 %
dip in Ut*) for 5
sec.
<5 % Ut* (>95 %
dip in Ut*) for 0.5
cycle
70 % Ut* (30 %
dip in Ut*) for 25
cycles
<5 % Ut* (>95%
dip in Ut*) for 5
sec.
115 V (ac) 40 %
Ut* (60 % dip in
Ut*) for 5 cycles
40 % Ut* (60 %
dip in Ut*) for 5
cycles
Mains power quality should be that of a typical
commercial or hospital environment. If the
user requires continued operation during power
mains interruptions, it is recommended that the
imager is powered from an uninterruptible
power supply or a battery.
Under 60601-1-2, there are four tests for
61000-4-11. Three of the tests were passed
normally.
One of the tests is a 60 % dip in voltage for
5 cycles, which is approximately one tenth of a
second dip, to 40 % of the nominal voltage.
The imager portion of the CHROMA Imaging
System did not pass that test, at the planned
nominal voltage of 100 V, dipping to 40 V. At
that voltage, operator intervention was
required to restore the system to full operation
(Performance Criteria “C”. The system must
meet Performance Criteria “B” or greater). No
images were lost by the imaging system.
The imager passes the 115 V nominal test,
dipping to 46 V. No operator intervention is
required, and there is no performance
degradation (Test Performance Criteria “A”).
The DICOM interface passes the test at 100 V
nominal, dipping to 40 V (Performance
Criteria “A”).
If the imager is to be powered by a 100 V
system, an uninterruptible power supply (UPS)
must be placed in the power circuit, between
the wall outlet and the imager, to ensure the
imager will meet the minimum requirements of
this test (Performance Criteria “B”).
The DICOM interface may be plugged directly
into a 100 V system wall outlet and meets the
requirements of 61000-4-11.
Power frequency
(50/60 Hz)
magnetic field:
• EN61000-4-8
• IEC 61000-4-8
3 A/m
3 A/m
Mains power quality should be that of a
typical commercial or hospital environment.
NOTE: * Ut is the a.c. mains voltage prior to application of the test level.
2012-02-24
9G4259_en
11
Safety and Related Information
SHORT TERM CONFIDENTIAL
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The imager is intended for use in the electromagnetic environment specified below. The customer or user
should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment—Guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the imager, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz–80 MHz
Radiated RF
3 v/m
IEC 61000-4-3
80 MHz–2.5 GHz
3 Vrms
d = 1.17 P
3 v/m
d = 1.17 P
d = 2.33 P
80 MHz–800 MHz
800 MHz–2.5 GHz
d is the recommended separation distance in
meters (m).
P is the maximum output rating of the transmitter
in watts (W) according to the transmitter
manufacturer.
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:
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
aSee
NOTE 1 on the top of the next page.
See NOTE 2 on the top of the next page.
12
9G4259_en
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Safety and Related Information
SHORT TERM CONFIDENTIAL
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
NOTE 1
Field strengths from fixed transmitters, such as base station 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 imager is used
exceeds the applicable RF compliance level above, the imager should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the imager.
NOTE 2
Over the frequency range 150 kHz–80 MHz, field strengths should be less than 3 v/m.
Recommended separation distance between portable and mobile RF communications equipment and
the imager
The imager is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communication equipment (transmitters) and the imager
as recommended below, according to the maximum output of the communications equipment.
Rated maximum
output power of
transmitter (P) in
Watts (W)
Separation distance (d) according to frequency of transmitter in meters (m)
0.01
0.12
0.12
0.24
0.1
0.37
0.37
0.74
1.17
1.17
2.33
10
3.70
3.70
7.37
100
11.70
11.70
23.30
150 kHz–80 MHz
80 MHz–800 MHz
800 MHz–2.5 GHz
d = 1.17 P
d = 2.33 P
d = 1.17 P
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
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.
2012-02-24
9G4259_en
13
Safety and Related Information
SHORT TERM CONFIDENTIAL
EU Directives
93/42/EEC Title: Council Directive Concerning Medical Devices.
1999/05/EC Title: Council Directive Concerning Radio and
Telecommunications Terminal Equipment.
2006/95/EC Title: Council Directive on the Harmonization of the Laws
of Member States Relating to Electrical Equipment Designed for Use
within Certain Voltage Limits.
Recycling Label
In the European Union, this symbol indicates that when the last user
wishes to discard this product, it must be sent to appropriate facilities
for recovery and recycling. Contact your local authorized representative
for additional information.
CE Marking
Documents concerning the conformance of this product to Council
Directive 93/42/EEC of 14 June 1993 concerning Medical Devices can
be obtained from the Carestream Health, Inc. European
Representative at:
Carestream Health France
1, rue Galilée
93192 NOISY-LE-GRAND CEDEX
FRANCE
14
9G4259_en
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Safety and Related Information
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Please Note
The information contained herein is based on the experience and
knowledge relating to the subject matter gained by the manufacturer
prior to publication. No patent license is granted by this information.
The manufacturer reserves the right to change this information without
notice and makes no warranty, express or implied, with respect to this
information. The manufacturer shall not be liable for any loss or
damage, including consequential or special damages, resulting from the
use of this information, even if loss or damage is caused by the
negligence of the manufacturer or other fault.
Imager Specifications
See the User’s Guide, 9G4260.
Publication History
Revision
2012-02-24
Date
2011-05-05
2011-08-19
2012-02-24
9G4259_en
Reason for Change
First release
Page 13 - Added values to the table.
Added Caution about implantable
pacemakers/implantable cardioverter
defibrillators, updated the FCC ID.
15
SHORT TERM CONFIDENTIAL

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