Eastman Kodak 81507E2537 User Manual

SAFETY MANUAL

See Pages 1-3 through 1-4 and 1-9 through 1-10

for compliance statements and modification warnings.

Kodak DryView

8150 Laser Imager

Safety Manual

Eastman Kodak Company 343 State Street Rochester, NY 14650

7F3779

Catalog number 1415014 Rev. A

Table of Contents

1 Safety and Related Information

Safety, Warnings, and Cautions........................................................................................................................1-1

Safety Labels.............................................................................................................................................1-5

Safety and Health Compliance..........................................................................................................................1-8

Safety........................................................................................................................................................1-8

EMC..........................................................................................................................................................1-9

EU Directives..........................................................................................................................................1-16

CE Marking....................................................................................................... ......................................1-17

Note........................................................................................................................................................1-18

September 27, 2004 i

Table of Contents

ii September 27, 2004

Safety and Related Information

Safety, Warnings, and Cautions

Please read and understand all instructions before using the Kodak

DryView 8150 Laser Imager.

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. Only an

Authorized Service Provider of Kodak products may perform

service maintenance on this equipment.

• 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.

• Do not operate equipment with the covers open.

WARNING:

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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Safety and Related Information

WARNING:

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

This equipment is intended to connect to other medical devices. Only an Authorized Service Provider of Kodak products or Customer’s Qualified Service Personnel may install this equipment.

CAUTION

Only an Authorized Service Provider of Kodak products may perform service maintenance on this equipment.

CAUTION

Do not use a cell phone within 2 meters (6.56 feet) of this equipment even if you are separated by a wall from this equipment.

CAUTION

Do not use a microwave oven within 4 meters (13.12 feet) of this equipment. 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.

1-2 7F3779 September 27, 2004

1.83 m

Safety and Related Information

CAUTION:

This equipment should not be located within the patient environment. Therefore, do NOT locate this equipment closer than 1.83 meters (6 feet) from a patient bed or chair.

CAUTION

This equipment 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 Eastman Kodak Company.

CAUTION

(USA Only) Federal law prohibits dispensing without a prescription.

CAUTION

FCC (USA Only) 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

September 27, 2004 7F3779 1-3

Safety and Related Information

instruction manual, 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:

Do not use isopropyl alcohol to clean the exterior surfaces of this equipment because alcohol can dissolve the exterior paint on the equipment.

CAUTION

Filters are considered to be non-hazardous waste according to the US Environmental Protection Agency Resource Conservation Recovery Act (RCRA). You may dispose of filters in a landfill or incinerator with energy recovery in a municipal, commercial or industrial facility. Contact your state or local government to determine if additional disposal requirements apply.

CAUTION

This equipment contains lead and mercury. The lead is located in the solder on the circuit boards. Mercury is located in the back light of the local panel. Disposal of components containing these materials may be regulated due to environmental considerations. For disposal or recycling information at the end of usable service, please contact your local authorities or visit the Electronics Industry Alliance Web site at: http://www.eiae.org.

LASER WARNING

The equipment uses a 50-milliwatt invisible laser. Laser radiation may be present behind this back panel. The back panel may only be removed by an Authorized Service Provider of Kodak products or Customer’s Qualified Service Personnel. EXPOSURE TO LASER ENERGY MAY RESULT IN EYE DAMAGE.

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Safety and Related Information

Safety Labels Safety labels are attached to this equipment in compliance with

international standards.

8150001

8150

7F1000 6551261

January 2004 100/120/230 V 12/10/7 A

50/60 Hz

Processor Drum Cover Labels

1 Processor Drum Cover label - Warns operators to avoid hot

surfaces when the processor drum cover is open.

2 Caution Hot Surface label - Warns operators to use care near the

processor drum to avoid possible burns.

3 Serial Plate label - Shows the serial number and model number of

this equipment along with several other important data items.

September 27, 2004 7F3779 1-5

Safety and Related Information

4 5

Rear Panel - Warning and Caution Labels

1 Invisible Laser Radiation Present When Open label - Warns

operators that invisible laser radiation is present under the panel where the label is attached. Only an Authorized Service Provider of Kodak products or Customer’s Qualified Service Personnel should attempt access.

2 Hazardous Voltage label - Warns operators that high voltage is

present under panels where the label is attached. Only the an Authorized Service Provider of Kodak products or Customer’s Qualified Service Personnel should attempt access.

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Safety and Related Information

3 Static Sensitive Equipment label - Identifies static-sensitive

components. Connect a personal grounding strap to appropriate ground before servicing this equipment. Only an Authorized Service Provider of Kodak products may perform service maintenance on this equipment.

4 Class 1 Laser Product - Indicates that this equipment complies with

IEC requirements for a Class 1 Laser Product.

5 Radio Frequency Energy - Indicates that this equipment can radiate

radio frequency energy. If not installed and used in accordance with the instructions, this equipment may cause harmful interference to radio communications.

6 Japanese Import License - Not safety-related.

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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 1040.10 Class I: FDA CDRH Code of Federal Regulations Title 21 Food and Drugs, Volume 8 - Food and Drugs, Part 1040 - Performance Standards for Light Emitting Products, Section 10 - Laser Products.

FDA 95-415 Premarket Notification 510(K): Regulatory Requirements For Medical Devices.

UL 60950-1: Safety of Information Technology Equipment. (3rd Edition) UL 60601-1-1: 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.

Canada

C22.2 NO 60950-1 CAN/CSA, Safety of Information Technology Equipment, Including Electrical Business Equipment (Gen Instr 1) (UL 1950-95).

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 (2000).

EN60601-1-1: Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems, Clause 19.

EN60825-1: Safety of laser products - Part 1: Equipment classification, requirements and user's guide.

1-8 7F3779 September 27, 2004

Rest of World

IEC 60950-1: Safety of information technology equipment. IEC 60601-1-1: 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.

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 commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, 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.

Safety and Related Information

FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio Frequency Devices: Intentional Radiators. “FCC ID: PA481507E2537"

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. (CISPR 11,Class A (EN55011)).

RSS-210, Issue 5:2001, Section 6.2.2(e): Low Power License-exempt Radio Communication Devices (All Frequency Bands), a Spectrum Management and Telecommunications Policy, Radio Standard Specification.

Intentional Radiation “IC: 1016B-8150”

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Safety and Related Information

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

European Telecommunication Standard (ETS) EN300 330: Electromagnetic Compatibility and Radio Spectrum Matters (ERM); Short Range Devices (SRD); Technical Characteristics and Test Methods for Radio Equipment in the Frequency Range 9 kHz to 25 MHz and Inductive loop Systems in the Frequency Range 9 kHz to 30 MHz.

European Telecommunication Standard (ETS) EN300 489-3: Electromagnetic Compatibility and Radio Spectrum Matters (ERM) Electromagnetic compatibility (EMC) standard for radio equipment and services - Part 3: specific conditions for short-range devices (SRD) operating on frequencies between 9 kHz and 40 GHz.

Rest of World

IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electrical compatibility Requirements and tests.

Japan

VCCI V.3/2001.04: Agreement of Voluntary Control Council for Interference by Information Technology Equipment Technical Requirements.

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Safety and Related Information

Europe and the Rest of the World

Guidance and Manufacturer’s Declaration for Electromagnetic Emissions

The Kodak DryView 8150 Laser Imager is intended for use in the electromagnetic environment specified below. The customer or user of the Kodak DryView 8150 Laser Imager should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions:

• 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

Group 1 The Kodak DryView 8150 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 8150 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 8150 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 8150 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.

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Safety and Related Information

Guidance and Manufacturer’s Declaration for Electromagnetic Immunity

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -

Guidance

Electrostatic discharge (ESD):

• 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

NOTE: * U

is the a.c. mains voltage prior to application of the test level.

Power frequency (50/60 Hz) magnetic field:

• EN61000-4-8

• IEC 61000-4-8

± 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

± 1 kV differential mode ± 2 kV common mode

± 2 kV for power supply

lines

± 1 kV for input/output

lines

± 1 kV differential mode ± 2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

<5% U U

40% U U

70% U U

<5% U U

* (>95% dip in

*) for 0.5 cycle

* (60% dip in

*) for 5 cycles

* (30% dip in

*) for 25 cycles

* (>95% dip in

*) for 5 sec.

<5% U U

40% U U

70% U U

<5% U U

* (>95% dip in

*) for 0.5 cycle

* (60% dip in

*) for 5 cycles

* (30% dip in

*) for 25 cycles

* (>95% dip in

*) for 5 sec.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Kodak DryView 8150 Laser Imager requires continued operation during power mains interruptions, it is recommended that the Kodak DryView 8150 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.

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Safety and Related Information

Guidance and Manufacturer’s Declaration for Electromagnetic Immunity

Immunity Test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 Test Level

3 Vrms 150 kHz to 80 MHz

3 v/m 80 MHz to 2.5 GHz

Compliance

Electromagnetic Environment - Guidance

Level

Portable and mobile RF communications equipment should be used no closer to any part of the Kodak DryView 8150 Laser Imager, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended Separation Distance:

3 Vrms

3 v/m 80 MHz to 800 MHz

d 1.17 P=

d 1.17 P= 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 survey

, should be less than the

compliance level in each frequency range 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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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 Kodak DryView 8150 Laser Imager is used exceeds the applicable RF compliance level on the previous page, the Kodak DryView 8150 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 8150 Laser Imager.

Note 2 Over the frequency range 150 kHz to 80 MHz, field strengths sho uld be le ss than 3 v/m.

1-14 7F3779 September 27 , 20 04

Safety and Related Information

Recommended separation distance between portable and mobile RF communications

equipment and the Kodak DryView Model 8150 Laser Imager

The Kodak DryView 8150 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 8150 Laser Imager can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the Kodak DryView 8150 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 800 MHz to 2.5 GHz

d 1.17 P=

d 2.33 P=

0.01

0.1 1

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.

September 27, 2004 7F3779 1-15

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.

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Safety and Related 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 Eastman Kodak Company, Health Imaging Systems European Representative at:

Kodak GmbH Product Safety 70323 Stuttgart Germany Phone: ++49 711 406 2993 Fax: ++49 711 406 3513

September 27, 2004 7F3779 1-17

+ 50 hidden pages

Eastman Kodak 81507E2537 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Safety and Related Information

Safety and Related Information

Safety, Warnings, and Cautions

Safety Labels Safety labels are attached to this equipment in compliance with

Safety and Health Compliance

Safety United States

EU Directives 93/42/EEC Title: Council Directive Concerning Medical Devices.

CE Marking Documents concerning the conformance of this product to Council