Carestream Health 6950 Laser Imager User Manual AB3145
Carestream Health, Inc. Laser Imager AB3145
User Manual
Publication No. AB3145_en
2014-06-09
Safety Manual
All rights reserved. No part of this manual may be reproduced or copied in any form by
any mean graphic, electronic, or mechanical, including photocopying, typing, or
information retrieval systems without written permission.
AB3145_en | 2014-06-09 i
Contents
Safety and Related Information
Safety, Warnings, and Cautions....................................................................................................... 1
Safety Labels ............................................................................................................................... 4
System Labels .............................................................................................................................. 5
Safety and Health Compliance ........................................................................................................ 8
Safety Standards ......................................................................................................................... 8
EMC Standards............................................................................................................................ 8
EU Directives ............................................................................................................................. 16
Publication History
AB3145_en | 2014-06-09 1
Safety and Related Information
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 manufacturer’s negligence or other fault.
For product specifications, see the User Manual.
Safety, Warnings, and Cautions
Please read and understand all instructions before using this product.
DANGER
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 for any service or repair.
• Do not operate equipment with a damaged power cord.
• Do not use an extension cord to power this equipment.
• Do not operate equipment with any of the safety interlocks overridden.
• Position the power cord so it will not be tripped over or pulled.
• Connect this equipment to a grounded wall outlet.
• A power cord is provided with this equipment. All countries must use an agency-approved
power cord with plug type suitable for the country of use. Contact a qualified dealer for help.
• Do not operate equipment with the covers open.
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.
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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.
Caution
The operator must not touch or have contact simultaneously with the patient and the laser
imaging system.
Caution
Do not use a cell phone within 2.0 m (6.6 ft) of a laser imager. This proximity includes any imager
behind a wall adjacent to your location.
Caution
Do not use a microwave oven within 4.0 m (13.1 ft) 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
over the network. It is not intended to be connected directly to other medical devices. Only
qualified personnel may provide installation and service.
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.
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AB3145_en | 2014-06-09 3
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.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
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 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.
Caution
Lithium batteries should only be replaced by an authorized service provider. 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. 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.
Laser Warning
The equipment uses an invisible laser beam with a maximum power of 120 milliwatts. Laser
radiation may be present when the machine operates without the rear cover installed. Covers
with this label may only be removed by an authorized service provider. USE OF CONTROLS OR
ADJUSTMENTS, OR PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN,
MAY RESULT IN EYE DAMAGE.
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Safety Labels
Safety labels are attached to the laser imager in compliance with international standards.
English Text on Labels
Some names on the labels are shortened and left in English. Below is a key to understand
the meanings of the shortened words on the labels:
Symbol on label Definition
Model Number
Serial Number
CAT Number
Part Number
Manufactured Date
Manufactured By
Operator must read the user documentation
Consult instructions for use
Attention! Consult accompanying documents
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System Labels
Laser Radiation Warning
Table 1: Laser specifications
High Voltage Warning
This warning label indicates that high voltage is present under panels or enclosures
where labels are attached. These panels may only be removed by an authorized service
provider.
1Class 3B invisible laser radiation. This label states: “When open and interlocks
defeated, avoid exposure to the beam.”
2Hazard symbol
Type Scanning (moving) laser beam emitting from a diode
Wavelength 810 ±10 nanometers
Maximum power 120 mW
Beam divergence from
Laser Diode
Minimum: 5 °, maximum: 32 °
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Back Panel and Agency Statements
Figure 1: Laser Imager Back Panel
Item Label Description
1 FCC compliance Describes compliance, if applicable for the country of installa-
tion.
2 Product States that the imager is a Laser Imaging Printer.
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Hot and Sensitive Surface Labels
Figure 2: Drum labels: Hot Surface and Sensitive Surface (No Sharp Objects in this Vicinity)
This label indicates that you must use care where the label is installed:
• Hot surface! Take care to avoid possible burns.
• Sensitive coating! Do not use abrasive or sharp objects around the drums.
3 Agency labels and
Class 1 Laser Safety
•High voltage. Indicates that high voltage is present
under panels where the label is attached. Only an autho-
rized service provider should attempt access.
•Static Sensitive Equipment. Identifies static-sensitive
components. Connect a personal grounding strap to the
appropriate ground before servicing this laser imager.
These panels may only be removed by an authorized
service provider.
•Radio Frequency Energy. 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. Indicates that the laser imager complies
with IEC requirements for Class 1 Laser systems.
4 Grounding reliability States that grounding reliability can only be achieved when
the equipment is connected to an equivalent receptacle
marked “Hospital Only” or “Hospital Grade.”
5 Japanese import
license
Allows importation into Japan.
6 Serial plate Shows the serial number and model number of the imager
along with other important data items.
7 Power cord inlet Covers the power cord inlet when shipped from manufactur-
ing. Shows the voltage at which the laser imager must be
operated. The label is removed or moved during installation.
8 Safety sign
ISO 7010–M002
Indicates that the operator must read the user documenta-
tion.
Item Label Description
Safety and Health Compliance
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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 Standards
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
• UL 60601-1:2003 - Medical Electrical Equipment. General Requirement for Safety.
• ANSI/AAMI ES60601-1:2005 - Medical Electrical Equipment. Part 1: General
requirements for basic safety and essential performance.
Canada
CSA C22.2 NO 60601-1 CAN/CSA:2008 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.
Europe
EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance.
International
• IEC 60601-1:1988 - Medical Electrical Equipment. General Requirement for Safety.
• IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance.
• IEC 60825-1:2007 - Safety of laser products - Part 1: Equipment classification and
requirements.
EMC Standards
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
Safety and Health Compliance
AB3145_en | 2014-06-09 9
provide reasonable protection against harmful interference in a commercial or light
industrial installation.
• FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio Frequency Devices:
Intentional Radiators. “FCC ID: U726950”
RF Exposure Guidance: This equipment complies with FCC radiation exposure limits
set forth for an uncontrolled environment. This transmitter must not be co-located or
operating in conjunction with any other antenna or transmitter, except in accordance
with FCC multi-transmitter product procedures.
Canada
• CAN/CSA-C22.2 NO. 60601-1-2-08 Medical Electric Equipment - Part 1-2: General
requirements for safety - Collateral standard: Electromagnetic compatibility -
Requirements and Tests.
• Intentional Radiation “IC: 7027A-6950”
• This device complies with Industry Canada licence-exempt RSS standard(s). Operation
is subject to the following two conditions: (1) this device may not cause interference,
and (2) this device must accept any interference, including interference that may
cause undesired operation of the device.
• Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions
suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de
l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est
susceptible d'en compromettre le fonctionnement.
•Under Industry Canada regulations, this radio transmitter may only operate using an
antenna of a type and maximum (or lesser) gain approved for the transmitter by
Industry Canada. To reduce potential radio interference to other users, the antenna
type and its gain should be so chosen that the equivalent isotropically radiated power
(e.i.r.p.) is not more than that necessary for successful communication.
• Conformément à la réglementation d'Industrie Canada, le présent émetteur radio
peut fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur)
approuvé pour l'émetteur par Industrie Canada.
• This Class A digital apparatus complies with Canadian ICES-003 (A).
• CET APPAREIL NUM ENRIQUE DE CLASSE A EST CONFORME A LA NORME NMB-003
(A) DU CANADA.
• This Class A digital apparatus meets all requirements of the Canadian
Interference-Causing Equipment Regulations.
Europe
EN60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility - Requirements and Tests.
Rest of World
IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility - Requirements and Tests.
•
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Guidance and Manufacturer’s Declaration for Electromagnetic Emissions
The system is intended for use in the electromagnetic environment specified below. The
customer or user of the system should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The system 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.
Emissions Test Compliance Electromagnetic Environment— Guidance
RF emissions:
• EN55011
•CISPR 11
Group 1 The system 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 equip-
ment.
RF emissions:
• EN55011
•CISPR 11
Class A The system is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies build-
ings used for domestic purposes.
Harmonics emissions:
• EN61000-3-2
• IEC 61000-3-2
Class A
The system is suitable for use everywhere, including
those establishments directly connected to the public
low-voltage power supply network that supplies build-
ings used for domestic purposes.
Voltage fluctuations and
flicker emissions:
• EN61000-3-3
• IEC 61000-3-3
Complies
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic Environ-
ment— Guidance
Electrostatic dis-
charge (ESD):
• EN61000-4-2
• IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, con-
crete, or ceramic tile. If floors
are covered with synthetic
material, the relative humid-
ity should be at least 30 %.
Electrical fast tran-
sient/burst:
• EN61000-4-4
• IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power sup-
ply lines
±1 kV for input/out-
put lines
Mains power quality should
be that of a typical commer-
cial or hospital environment.
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Surge:
• EN61000-4-5
• IEC 61000-4-5
±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 commer-
cial or hospital environment.
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
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 commer-
cial or hospital environment.
If the user of the laser imager
requires continued operation
during power mains interrup-
tions, it is recommended that
the laser imager be powered
from an uninterruptible
power supply or a battery.
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 commer-
cial or hospital environment.
* UT is the a.c. mains voltage prior to application of the test level
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic Environ-
ment— Guidance
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12 AB3145_en | 2014-06-09
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The system 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.
Portable and mobile RF communications equipment should be used no closer to any part
of the system, including cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Immunity Test IEC 60601 Test Level
Compliance
Level Electromagnetic Environment— Guidance
Conducted RF
IEC 61000-4-6
3Vrms
150 kHz–80 MHz
3Vrms d=1.17√P
Radiated RF
IEC 61000-4-3
3v/m
80 MHz–2.5 GHz
3 v/m d = 1.17 √ P 80 MHz to 800 MHz
d = 2.33 √ P 800 MHz to 2.5 GHz
where 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*, should be less than the compliance
level in each frequency range†.
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:
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.
* Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and land mobile radios, ama-
teur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electro-
magnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the laser imager is used exceeds the applicable RF compliance level above, the 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 laser imager.
† Over the frequency range 150 kHz–80 MHz, field strengths should be less than 3 v/m.
Safety and Health Compliance
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Additional Guidance and Manufacturer’s Declaration–Electromagnetic
Emissions/Immunity
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 document.
Communications Equipment
Portable and mobile radio frequency (RF) communications equipment can affect medical
electrical equipment EMC performance.
Replacement of Cables, Accessories, or Transducers
The use of cables, accessories or transducers other than those specified in this document
with the exception of transducers or cables sold by the manufacturer of the equipment
as replacement parts for internal components, may result in increased emissions or
decreased immunity of the medical equipment.
Other Equipment
The System should not be used adjacent to or stacked with other equipment. If adjacent
or stacked use is necessary, the System should be observed to verify normal operation in
the configuration in which it will be used.
Shielded Locations
The System is fully compliant with the requirements of IEC 60601-1-2 without being
located in a shielded room.
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External Cables Listing
Description Length Shielded?
Cable, Category 5E, Shielded RJ45 to RJ45, Patch Cord, 4
Pair
2.1 m (7.0 ft) Yes
Cord Assembly, Power, China 2.5 m (8.2 ft) No
Cord Assembly, Power, Continental Europe Schuko 2.5 m (8.2 ft) No
Cord Assembly, Power, India/South Africa 2.5 m (8.2 ft) No
Cord Assembly, Power, North American 3.0 m (10.0 ft) No
Cord Assembly. Power, UK, Fused 2.5 m (8.2 ft) No
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AB3145_en | 2014-06-09 15
Recommended Separation Distance Between Portable and Mobile RF
Communications Equipment and the System
The system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communication equipment (transmitters) and the system as recommended
below, according to the maximum output of the communications equipment.
Rated Maximum Output
Power of Transmitter (P) Separation Distance (d) According to Frequency of Transmitter
Watts Meters
150 kHz–80 MHz
d=1.17√P
80 MHz–800 MHz
d=1.17√P
800 MHz–2.5 GHz
d=2.33√P
0.01 0.12 0.12 0.24
0.10 0.37 0.37 0.74
1.00 1.17 1.17 2.33
10.003.703.707.37
100.00 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended sepa-
ration distance d in meters (m) can be estimated using the equation applicable to the fre-
quency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Note
At 80 MHz and 800 MHz, the separation distance for 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.
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EU Directives
• 93/42/EEC Title: Council Directive Concerning Medical Devices.
• 1999/5/CE Title: Council Directive Concerning Radio Equipment and
Telecommunications Terminal Equipment.
Figure 3: Recycling Label
In the European Union, this symbol indicates that when the last user wishes to discard
this product, it must be sent to the appropriate facilities for recovery and recycling.
Contact your local authorized representative for additional information.
Authorized European Representative
Carestream Health France
1, rue Galilée
93192 NOISY-LE-GRAND CEDEX
FRANCE
Importer for European Union
Carestream Health Netherlands B.V.
Bramenberg 12
3755 BZ Eemnes
The Netherlands
AB3145_en | 2014-06-09 17
Publication History
Revision Date Reason for Change
A 2014-04-30 First release
B 2014-06-09 Draft, with additional FCC and RF guidance.
Added cables listing.
Carestream Health
150 Verona Street
Rochester, NY 14608
USA
© Carestream Health, Inc., 2014
Made in the USA.
Pub. No. AB3145_en
Rev. B