Carestream Health 5950 Film Printer for Medical Images using 13.56 MHz Transmitter RFID User Manual 5950 Safety

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Document ID	1784172
Application ID	Dud+tqpdAS0QCOcoLn0Qlw==
Document Description	User Manual II
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	72.15kB (901932 bits)
Date Submitted	2012-09-06 00:00:00
Date Available	2013-03-05 00:00:00
Creation Date	2012-07-24 15:14:25
Producing Software	Acrobat Distiller 9.5.1 (Windows)
Document Lastmod	2012-08-22 16:04:03
Document Title	5950-Safety.book
Document Creator	FrameMaker 10.0.1
Document Author:	L486095

SHORT TERM CONFIDENTIAL
Preliminary Safety Manual
Publication No. AA2205_en
2012-07-27
SHORT TERM CONFIDENTIAL
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.
1–2
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
Contents
1 Safety and Related Information
Safety, Warnings, and Cautions .................................................................................................... 2
Safety Labels ............................................................................................................................ 5
System Labels ........................................................................................................................... 5
Safety and Health Compliance ..................................................................................................... 9
Safety Standards ...................................................................................................................... 9
EMC Standards ....................................................................................................................... 10
EU Directives .......................................................................................................................... 15
CE Marking ............................................................................................................................. 15
Publication History
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
SHORT TERM CONFIDENTIAL
Safety and Related Information
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.
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
Safety and Related Information
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 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.
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 m of an imager. This proximity includes any imager behind a wall
adjacent to your location.
Caution
Do not use a microwave oven within 4 m of an 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.
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SHORT TERM CONFIDENTIAL
Safety and Related Information
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
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.
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 imager.
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Safety and Related Information
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 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.
Important
Install the printing system in a secure location to protect patient privacy rights if required by local
regulations.
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Safety and Related Information
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 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
Manufactured Date
Manufactured By
System Labels
Serial Number and Model Number
This label shows the serial number and model number of the imager along with other
important data items. (The label shown above is an example serial plate label.)
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SHORT TERM CONFIDENTIAL
Safety and Related Information
Laser Radiation Warning
Class 3B invisible laser radiation. This label states: “When open and interlocks
defeated, avoid exposure to the beam.”
Hazard symbol
Table 1:
Laser specifications
Type
Scanning (moving) laser beam emitting from a diode
Wavelength
810 ±10 nanometers
Maximum power
120 mW
Beam divergence from
Laser Diode
Minimum: 5 degrees, maximum: 32 degrees
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.
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Safety and Related Information
Back Panel and Agency Statements
Figure 1: Laser Imager Back Panel
Item
Label
Description
FCC compliance
Provides FCC ID and Industry Canada, describes compliance.
Product
States that the imager is a Laser Imaging Printer.
Agency labels 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 should attempt access.
•
Static Sensitive Equipment. Identifies static-sensitive
components. Connect a personal grounding strap to the
appropriate ground before servicing this imager. These
panels may only be removed by an Authorized Service
Provider.
•
Radio Frequency Energy. Indicates that the imager can
radiate radio frequency energy. If not installed and used in
accordance with the instructions, the imager may cause
harmful interference to radio communications.
•
Class 1 Laser. Indicates that the imager complies with IEC
requirements for Class 1 Laser systems.
Grounding
reliability
AA2205_en | 2012-07-27
States that grounding reliability can only be achieved when the
equipment is connected to an equivalent receptacle marked
“Hospital Only” or “Hospital Grade.”
SHORT TERM CONFIDENTIAL
Safety and Related Information
Item
Label
Description
Japanese import
license
Allows importation into Japan.
Power cord inlet
Covers the power cord inlet when shipped from
manufacturing. Shows the voltage at which the imager must
be operated. The label is removed or moved during installation.
Hot Surface
Figure 2: Hot Surface Labels
This label indicates that you must use care where the label is installed to avoid possible
burns.
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
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 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
•
ANSI/AAMI ES60601-1 (2005+C1+A2)
•
UL 60601-1 Ed. 2 (1998): 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 (2008): 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. 3 (2006): Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
•
EN60825-1 (2005+Corr:07): Safety of laser products - Part 1: Equipment classification,
requirements and user's guide.
Rest of World
•
IEC 60601-1 Ed. 2 (1998) - Medical electrical equipment - Part 1: General requirements
for safety.
•
IEC 60601-1 Ed. 3 (2005): Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
•
IEC 60825-1 (2005+Corr:07): Safety of laser products - Part 1: Equipment classification,
requirements and user's guide.
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
Safety and Related Information
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
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: U725950”
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-5950”
•
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.
10
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
Safety and Related Information
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.
Emissions Test
Compliance
Electromagnetic Environment— Guidance
RF emissions:
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 equipment.
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 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
Class A
Complies
The system 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.
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 system should ensure that it is used in such an environment.
Electromagnetic Environment—
Guidance
Immunity Test
IEC 60601 Test Level
Compliance Level
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
±2 kV for power
supply lines
±1 kV for
input/output lines
supply lines
±1 kV for
input/output lines
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
AA2205_en | 2012-07-27
11
SHORT TERM CONFIDENTIAL
Safety and Related Information
Immunity Test
IEC 60601 Test Level
Compliance Level
Surge:
±1 kV differential
±1 kV differential
•
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
1.
12
mode
mode
Electromagnetic Environment—
Guidance
Mains power quality should be that
of a typical commercial or hospital
environment.
±2 kV common
±2 kV common
mode
mode
<5 % Uτ1 (>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.
<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
Imager requires continued operation
during power mains interruptions, it
is recommended that the 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.
Uτ is the a.c. mains voltage prior to application of the test level
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
Safety and Related Information
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 system 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
3 Vrms
150 kHz–80 MHz
3 Vrms
d = 1.17 √ P
Radiated RF
IEC 61000-4-3
3 v/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 survey1,
should be less than the compliance level in each
frequency range2.
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.
1.
2.
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 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.
AA2205_en | 2012-07-27
13
SHORT TERM CONFIDENTIAL
Safety and Related Information
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
10.00
3.70
3.70
7.37
100.00
11.70
11.70
23.30
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
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.
14
AA2205_en | 2012-07-27
SHORT TERM CONFIDENTIAL
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
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.
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
AA2205_en | 2012-07-27
15
SHORT TERM CONFIDENTIAL
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Publication History
Publication History
Revision
Date
Reason for Change
2012-07-27
Preliminary - for Gate 2 (preliminary) review
AA2205_en | 2012-07-27
17
SHORT TERM CONFIDENTIAL
Carestream Health, Inc.
150 Verona Street
Rochester, NY 14608
United States
© Carestream Health, Inc., 2012
Printed in China.
CARESTREAM and DRYVIEW are trademarks of Carestream Health, Inc.
Pub No. AA2205_en
Rev A (preliminary)

---

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