Carestream Health 5800 Laser Imager User Manual 2G0734

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Document ID	907529
Application ID	6XrZKkqrLVQZT2zydHFjGA==
Document Description	Safety manual
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Document Type	User Manual
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Date Submitted	2008-02-28 00:00:00
Date Available	2008-02-29 00:00:00
Creation Date	2007-06-07 10:26:56
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Document Lastmod	2007-06-07 10:31:00
Document Title	2G0734.book
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Document Author:	v965725

Kodak DryView 5800 Laser Imager
Safety Manual
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608
© Carestream Health, Inc., 2007
DryView is a trademark of Carestream Health.
Kodak is a trademark of Kodak used under license.
Pub No. 2G0734
Rev. A
Catalog No. yyyyyyyy
Table of Contents
Safety and Related Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
Safety, Warnings, and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
Safety Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -5
Safety and Health Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -8
Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -8
EMC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9
EU Directives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14
CE Marking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14
Please Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
Imager Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
June 7, 2007
2G0734
Safety and Related Information
Safety, Warnings, and Cautions
Please read and understand all instructions before using this
product.
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 laser imager yourself to
avoid exposure to dangerous voltage, laser beam, or other danger.
Always call an Authorized Service Provider of Carestream
Health, Inc. products 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.
Three power cord sets are provided with this equipment:
– power cord with plug for use in North America
– power cord with plug for use in China
– power cord with plug for use in Europe
All other countries must use an Agency-approved power
cord with plug type suitable for the country of use, or
contact an authorized Carestream Health, Inc. dealer.
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.
June 7, 2007
2G0734
Safety and Related Information
CAUTION:
Do not use a cell phone within 2 meters of a laser imager. This
proximity includes any imager behind a wall adjacent to your
location.
CAUTION:
Do not use a microwave oven within 4 meters of a laser
imager. 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 an Authorized
Service Provider of Carestream Health, Inc. products may
perform installation and service maintenance.
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 meters from a patient bed or chair.
2G0734
June 7, 2007
Safety and Related Information
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 Gauss.
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 userís authority to
operate the equipment.
CAUTION:
Do not use isopropyl alcohol to clean the exterior surfaces of
the laser imager. Isopropyl alcohol can dissolve the exterior
paint on the laser imager.
CAUTION:
In the U.S., exhausted filters are considered to be
non-hazardous waste according to the US Environmental
Protection Agency Resource Conservation Recovery Act
(RCRA). Municipality owned and licensed solid waste
management facilities are an appropriate disposal option.
Contact your local or state solid waste authorities to determine
if additional disposal requirements apply. In other regions,
contact local or regional solid waste authorities for proper
disposal guidance.
June 7, 2007
2G0734
Safety and Related Information
CAUTION:
Lithium batteries should only be replaced by an Authorized
Service Provider of Carestream Health, Inc. products. The
laser imager 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. EPAís 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.
LASER WARNING:
The Equipment uses a 50-Milliwatt invisible laser. Laser
radiation may be present when the machine operates without the
rear cover installed. Covers with this lavbel may only be
removed by an Authorized Service Provider of Carestream
Health, Inc. products. USE OF CONTROLS OR OTHER
ADJUSTMENTS, OR OTHER PERFORMANCE OF
PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN,
MAY RESULT IN EYE DAMAGE.
2G0734
June 7, 2007
Safety and Related Information
Safety Labels
Safety labels are attached to the laser imager in compliance with
international standards.
DryView Laser Imager ‚ ˚‰…⁄„ ‡ ˇæ ˙
5800
August 2007, 2007 08
100/120/200/220/240V
58000501
12/12/7/7/7A
8F2800
50/60Hz
xxxxxxx
311346
3JZT
Carestream Health, Inc.
Rochester, NY 14608
TM: DryView
7F3118.E
This label shows the serial number and model number of the Imager
along with other important data items.
8F4187.A
7F6587.A
7F6587.A
Laser Radiation Warning Labels
June 7, 2007
Class 3B invisible laser radiation. This label states that,
"When open and interlocks defeated, avoid exposure to the
beam."
Laser Hazard symbol.
2G0734
Safety and Related Information
Japanese Import Licence
Japanese Import Licence
Agency Statements
Hazardous Voltage. This warning label indicates that high
voltage is present under panels where the label is attached. Only
an Authorized Service Provider of Carestream Health, Inc.
products should attempt access.
Static Sensitive Equipment. This label identifies static-sensitive components. Connect a personal grounding strap to appropriate ground before servicing this laser imager. These panels
may only be removed by an Authorized Service Provider of
Carestream Health, Inc. products.
Radio Frequency Energy. This label indicates that the laser
imager can radiate radio frequency energy. If not installed and
used in accordance with the instructions, the laser imager may
cause harmful interference to radio communications.
Class 1 Laser. This label indicates that the laser imager complies with IEC requirements for Class 1 systems.
Japanese Import License.
2G0734
June 7, 2007
Safety and Related Information
2G0589.30
2G0590.30
Hot Surface Labels
June 7, 2007
Processor cover hot surface. This label indicates to use care
near the processor drum to avoid possible burns.
Processor heat shield hot surface. This label indicates to use
care near the processor heat shield to avoid possible burns.
2G0734
Safety and Related Information
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
21 CFR 1040.10 Class I
Code of Federal Regulations Title 21 Food and Drugs
Chapter I Food and Drug Administration, Department of Health and
Human Services
Volume 8 - Parts 800 to 1299
Subchapter J - Radiology Health
Part 1040 - Performance Standards for Light Emitting Products
Section 10 - Laser Products
FDA 21CFR 807 Premarket Notification 510(K): Regulatory
Requirements For Medical Devices.
UL 60950-1: Safety of Information Technology Equipment, including
Electrical Business Equipment (Bi-National Standard).
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements
for medical electrical systems, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user’s guide.
2G0734
June 7, 2007
Safety and Related Information
Canada
CAN/CSA - C22.2 NO 60950-1-03 Information Technology Equipment - Safety - Part 1: General Requirements. (Bi-National Standard,
with UL 60950-1).
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for safety, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user’s guide.
Europe
EN60950-1: Safety of Information Technology Equipment, including
Electrical Business Equipment (IEC 60950: 1991, Modified) (Includes
Amendment A1, A2, A3, A4, and A11).
EN60601-1: Medical electrical equipment - Part 1: General requirements for safety, Clause 19.
EN60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
Rest of World
IEC 60950-1: Safety of information technology equipment.
IEC 60601-1: Medical electrical equipment - Part 1: General requirements for safety, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
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: U725800
June 7, 2007
2G0734
Safety and Related Information
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: 7027A-5800
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
Guidance and Manufacturerís Declaration for Electromagnetic Emissions
The Kodak DryView 5800 Laser Imager is intended for use in the electromagnetic environment specified
below. The customer or user of the Kodak DryView 5800 Laser Imager should ensure that it is used in such
an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions:
Group 1
The Kodak DryView 5800 Laser 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 Kodak DryView 5800 Laser 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 Kodak DryView 5800 Laser 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 Kodak DryView 5800 Laser 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
10
2G0734
June 7, 2007
Safety and Related Information
Guidance and Manufacturerís Declaration for Electromagnetic Immunity
The Kodak DryView 5800 Laser Imager is intended for use in the electromagnetic environment specified
below. The customer or user of the Laser Imager 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.
<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
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.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Kodak DryView 5800 Laser
Imager requires continued operation during power mains interruptions, it is recommended that the
Kodak DryView 5800 Laser
Imager be powered from an uninterruptible power supply or a battery.
3 A/m
3 A/m
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
Voltage dips, short
interruptions and
voltage variations
on power supply
lines:
• EN61000-4-11
• IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic field:
• EN61000-4-8
• IEC 61000-4-8
NOTE: * Ut is the a.c. mains voltage prior to application of the test level.
June 7, 2007
2G0734
11
Safety and Related Information
Guidance and Manufacturerís Declaration for Electromagnetic Immunity
The Kodak DryView 5800 Laser Imager is intended for use in the electromagnetic environment specified
below. The customer or user of the Kodak DryView 5800 Laser Imager 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
Kodak DryView 5800 Laser 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 to 80 MHz
Radiated RF
3 v/m
IEC 61000-4-3
80 MHz to 2.5 GHz
3 Vrms
d = 1.17 P
3 v/m
d = 1.17 P
d = 2.33 P
80 MHz to 800 MHz
800 MHz to 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 survey a,
should be less than the compliance level in each
frequency range b.
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.
a See Note 1 on next page.
b See Note 2 on next page.
12
2G0734
June 7, 2007
Safety and Related Information
Guidance and Manufacturerís 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 Kodak DryView 5800 Laser
Imager is used exceeds the applicable RF compliance level above, the Kodak DryView 5800
Laser Imager should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Kodak
DryView 5800 Laser Imager.
Note 2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 v/m.
Recommended separation distance between portable and mobile RF communications equipment and
the Kodak DryView 5800 Laser Imager
The Kodak DryView 5800 Laser Imager is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Kodak DryView 5800 Laser Imager can
help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communication equipment (transmitters) and the Kodak DryView 5800 Laser 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)
150 kHz to 80 MHz
80 MHz to 800 MHz
d = 1.17 P
d = 1.17 P
800 MHz to 2.5 GHz
d = 2.33 P
0.01
0.1
10
100
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.
June 7, 2007
2G0734
13
Safety and Related Information
EU Directives
93/42/EEC Title: Council Directive Concerning Medical Devices.
99/05/EEC Title: Council Directive Concerning Radio and
Telecommunications Terminal Equipment.
73/23/EEC Title: Council Directive on the Harmonization of the Laws
of Member States Relating to Electrical Equipment Designed for Use
within Certain Voltage Limits.
89/336/EEC Title: Council Directive on the Approximation of the Laws
of the Member States Relating to Electromagnetic Compatibility.
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 Carestream Health, Inc.
representative or refer to www.kodak.com/go/recycle for additional
information on the collection and recovery programs available for this
product.
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 Deutschland GmbH
Hedelfinger Str. 60
70327 Stuttgart, Germany
Phone: ++49 711 406 2993
Fax: ++49 711 406 3513
14
2G0734
June 7, 2007
Safety and Related Information
Please Note
The information contained herein is based on the experience and
knowledge relating to the subject matter gained by Carestream Health,
Inc. prior to publication. No patent license is granted by this
information. Carestream Health, Inc. reserves the right to change this
information without notice and makes no warranty, express or implied,
with respect to this information. Carestream Health, Inc. 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 Carestream Health, Inc. negligence or other fault.
Imager Specifications
See the Site Readiness for the Kodak DryView 5800 Laser Imager,
2G0735.
June 7, 2007
2G0734
15
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608
© Carestream Health, Inc., 2007
DryView is a trademark of Carestream Health.
Kodak is a trademark of Kodak used under license.
Pub No. 2G0734
Rev. A
Catalog No. yyyyyyyy

---

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