Carestream Health 6850 Image Transmitter User Manual urg 00544

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Date Submitted	2010-12-03 00:00:00
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DRYVIEW 6850 Laser Imager
Safety Manual
150 Verona Street
Rochester, New York 14608
© Carestream Health, Inc., 2010
CARESTREAM and DRYVIEW are trademarks of
Carestream Health, Inc.
Pub No. 2G8646
Rev. A
Table of Contents
Safety and Related Information
Safety, Warnings, and Cautions .....................................................................................................1
Safety Labels .............................................................................................................................5
Safety and Health Compliance .....................................................................................................11
Safety.......................................................................................................................................11
EMC ........................................................................................................................................12
EU Directives ..........................................................................................................................17
CE Marking .............................................................................................................................17
Please Note..............................................................................................................................18
Imager Specifications ...................................................................................................................18
Publication History.......................................................................................................................18
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.
• 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.
• Four 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 the United Kingdom
– 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.
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Safety and Related Information
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:
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 or
customer’s qualified service personnel may perform
installation and service maintenance.
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.
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Safety and Related Information
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 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. Go to the Carestream Health web site,
search for the Environmental Technical Summary document,
and refer to the End-of-Life-Management section.
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. EPA’s RCRA does not regulate disposal of this lithium
battery. Users should discard spent batteries in municipal trash
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2G8646
Safety and Related Information
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 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 of
Carestream Health, Inc. products. USE OF CONTROLS OR
ADJUSTMENTS, OR PERFORMANCE OF PROCEDURES
OTHER THAN THOSE SPECIFIED HEREIN, MAY RESULT
IN EYE DAMAGE.
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Safety and Related Information
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 safety
labels:
Symbol on label
Definition
Belt Path
Processor Drive Belt
Turn Around Belt
Transport Drive Belt
Media Path
Model Number
Serial Number
CAT Number
Manufactured Date
Manufactured By
Sorter Belt Path
Sorter Drive Belt
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Safety and Related Information
Symbol on label
Definition
Tension Drive Belt
Lower Drive-Roller Belt
Main Drive Belt
Cooling Roller Drive Belt
Processor Belt Path
Short Drive Belt
Cooling Section Drive Belt
Long Drive Belt
Drum Drive Belt
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Safety and Related Information
Labels - Locations and
Details
DryView Laser Imager
DryView 6800
August 2007, 2007 08
100/120/200/220/240V
68000501
12/12/7/7/7A
7F2301
50/60Hz
6551576
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.
Laser Radiation Warning Labels
2010-11-04
Class 3B invisible laser radiation. This label states that,
“When open and interlocks defeated, avoid exposure to
the beam.”
Hazard symbol.
2G8646
Safety and Related Information
Laser Specifications
Type
Scanning (moving) laser beam emitting
from a diode
Wavelength
810 +/- 10 nanometers
Maximum power
120 milliwatts
Beam divergence
from Laser Diode
Minimum: 6.8 degrees, maximum: 32
degrees
8E4621.E
8E4621.E
High Voltage Warning Label
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 of Carestream Health, Inc. products.
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Safety and Related Information
Agency Statements
2010-11-04
Product Label. This label states that the imager is a Laser
Imaging Printer.
Grounding Reliability. This label states that grounding
reliability can only be achieved when the equipment is
connected to an equivalent receptacle marked "Hospital Only"
or "Hospital Grade."
Agency Symbols and Class 1 Laser Safety.
High voltage: 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: 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. 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.
FCC Compliance. Provides FCC ID and describes compliance.
Japanese Import License.
2G8646
Safety and Related Information
8F41
8F3563 .31
Hot Surface Labels
10
Drum end cap hot surface. This label indicates to use
care near the processor drum end cap to avoid possible
burns.
Drum hinge hot surface. This label indicates to use care
near the processor drum hinge to avoid possible burns.
Drum hot surface. This label advises to use care near the
processor drum to avoid possible burns.
Processor flatbed hot surface. This warning label
advises to use care near the processor flatbed to avoid
possible burns.
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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 900.12(e) Mammography Quality Standards Act;
Quality Standards; Quality Assurance for Equipment.
FDA 21CFR 807 Subpart E - Premarket Notification
Procedures.
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: Medical electrical equipment - Part 1: General
requirements for safety.
IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1:
Equipment classification, requirements and user’s guide.
Canada
CAN/CSA - C22.2 NO 60601-1 Ed. 2 - Medical electrical
equipment - Part 1: General requirements for safety.
IEC 60825-1 Ed. 2 (2007): Safety of laser products - Part 1:
Equipment classification, requirements and user’s guide.
Europe
EN60601-1 Ed. 2 - Medical electrical equipment - Part 1:
General requirements for safety.
EN60825-1: Safety of laser products - Part 1: Equipment
classification, requirements and user's guide.
Rest of World
IEC 60601-1 Ed. 2 - Medical electrical equipment - Part 1:
General requirements for safety.
IEC 60825-1: Safety of laser products - Part 1: Equipment
classification, requirements and user's guide.
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11
Safety and Related Information
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: U726850”
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-6850”
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
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.
12
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Safety and Related Information
Europe and the Rest of World
Guidance and Manufacturer’s Declaration for Electromagnetic Emissions
The DRYVIEW 6850 Laser Imaging System is intended for use in the electromagnetic environment specified
below. The customer or user of the 6850 Laser Imager should ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions:
Group 1
The 6850 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 6850 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 6850 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 6850 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
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Safety and Related Information
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The 6850 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
± 6 kV contact
Electrostatic
discharge (ESD): ± 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
• EN61000-4-4 ± 1 kV for
input/output lines
Mains power quality should be that of a
± 2 kV for power
typical commercial or hospital
supply lines
± 1 kV for input/output environment.
lines
± 1 kV differential
mode
• EN61000-4-5
± 2 kV common
• IEC
mode
Mains power quality should be that of a
± 1 kV differential
typical commercial or hospital
mode
± 2 kV common mode environment.
<5% Uτ * (>95% dip
in Ut*) for 0.5 cycle
40% Uτ * (60% dip
in Uτ *) for 5 cycles
70% Uτ * (30% dip
in Uτ *) for 25
cycles
• EN61000-4-11
<5% Uτ * (>95% dip
• IEC
in Uτ *) for 5 sec.
<5% Uτ * (>95% dip
in Uτ *) for 0.5 cycle
40% Uτ * (60% dip in
Uτ *) for 5 cycles
70% Uτ * (30% dip in
Uτ *) for 25 cycles
<5% Uτ * (>95% dip
in Uτ *) for 5 sec.
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the 6850
Laser Imager requires continued
operation during power mains
interruptions, it is recommended that
the 6850 Laser Imager be powered
from an uninterruptible power supply
or a battery.
Power frequency 3 A/m
(50/60 Hz)
magnetic field:
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:
• IEC
61000-4-4
Surge:
61000-4-5
Voltage dips,
short
interruptions and
voltage
variations on
power supply
lines:
61000-4-11
• EN61000-4-8
• IEC
61000-4-8
NOTE: * Uτ is the a.c. mains voltage prior to application of the test level.
14
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Safety and Related Information
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The 6850 Laser Imager is intended for use in the electromagnetic environment specified below. The
customer or user of the 6850 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 6850
Laser Imager, including cables, than
the recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.17 P
Radiated RF
IEC 61000-4-3
3 v/m
80 MHz to 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
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.
See
Note 1 on next page.
See Note 2 on next page.
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15
Safety and Related Information
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 6850 Laser Imager is used exceeds the applicable RF
compliance level above, the 6850 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 6850 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 6850 Laser Imager
The 6850 Laser Imager is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the 6850 Laser Imager can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communication equipment (transmitters) and the 6850 Laser Imager as recommended below,
according to the maximum output of the communications equipment.
Rated maximum output Separation distance (d) according to frequency of transmitter
power of transmitter (P) in meters (m)
in Watts (W)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.17 P
d = 1.17 P
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.
16
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Safety and Related Information
EU Directives
93/42/EEC Title: Council Directive Concerning Medical Devices.
1999/5/CE Title: Council Directive Concerning Radio Equipment and
Telecommunications Terminal Equipment.
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
LES MERCURIALES
40, rue Jean Jaures
93176 BAGNOLET CEDEX
France
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2G8646
17
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 guide for the 6850 Laser Imager, 8H5321.
Publication History
Revision
18
Date
2010-11-04
2G8646
Reason for Change
First release
2010-11-04
150 Verona Street
Rochester, New York, 14608
© Carestream Health, Inc., 2010
CARESTREAM and DRYVIEW are trademarks of
Carestream Health, Inc.
Pub No. 2G8646
Rev. A

---

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