{MiscellaneousPUB}{Production}{Health Group}{Unrestricted}

Publication No. 8H8439-01

2011-08-20

CARESTREAM VITA/VITA LE CR Systems

Safety and Regulatory Guide

© Carestream Health, Inc. 2011

MISCELLANEOUS PUBLICATION

CARESTREAM VITA/VITA LE CR Systems Safety and Regulatory Guide

Document No.: 8H8439-01
Copyright Carestream Health, Inc. 2011
All rights reserved. No part of this manual may be reproduced or copied in any form by any means–graphic, electronic
or mechanical, including photocopying, typing, or information retrieval systems–without written permission of
Carestream Health.

0086
Use of Manual
CARESTREAM CR Systems are designed to meet international safety and performance standards. Personnel
operating the unit must have a thorough understanding of the proper operation of the system. This manual has been
prepared to aid medical and technical personnel to understand and operate the system. Do not operate the system
before reading this manual and gaining a clear understanding of the operation of the system. If any part of this manual
is not clear, please contact your Carestream Health representative for clarification.

Authorized European Representative

Carestream France
1, rue Galilee
93192 NOISY-LE-GRAND CEDEX
France

Carestream Health, Inc.

150 Verona Street
Rochester, NY 14608
CARESTREAM is a trademark of Carestream Health.
© Carestream Health, Inc. 2011

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Table of Contents
Description Page

Safety and Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
General Safety Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Electrical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Explosion and Implosion Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Overheating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Vita CR Laser Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Device-Specific Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Health and Safety Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CE Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
IEC Symbols Used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Labelling Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Recycling the Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Publication History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

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 Safety and Regulatory Information

Section 1: Safety and Regulatory Information

Introduction
The information contained herein is based on the experience and knowledge relating to the subject matter gained by
Carestream Health prior to publication. No patent license is granted by this information.
Carestream Health reserves the right to change this information without notice, and makes no warranty, express or
implied, with respect to this information. Carestream Health shall not be liable for any loss or damage, including
consequential or special damages, resulting from any use of this information, even if loss or damage is caused by
Carestream Health’s negligence or other fault.

Document Conventions
In this document the CARESTREAM VITA / VITA LE CR SYSTEM will be referred to as VITA CR, CR Scanner, or
System.

Note
Notes provide additional information, such as expanded explanations, hints, or reminders.

Caution
Cautions point out procedures that you must follow precisely to avoid damage to the system or any of its components,
yourself or others, loss of data or corruption of files in software applications.

Important
Important highlights critical policy information that affects how you use this manual and this product.

General Safety Guidelines

• This product is designed and manufactured to ensure maximum safety of operation. Operate and maintain it in
strict compliance with the safety precautions and operating instructions contained in this manual.
• This product meets all the safety requirements applicable to medical equipment. However, anyone attempting to
operate the system must be fully aware of potential safety hazards.
• Aside from cleaning the phosphor screen and the system’s rollers, there are no user serviceable parts in this
system. The product must be installed, maintained, and serviced by qualified service personnel according to
procedures and preventive maintenance schedules in the product service manual. If your product does not
operate as expected, contact your Service Representative.
• Do not modify this product in whole or in part without prior written approval from Carestream Health.
• Personnel operating and maintaining this system should receive training and be familiar with all aspects of
operation and maintenance.
• To ensure safety, read all user manuals carefully before using the system and observe all Cautions, Importants,
and Notes located throughout the manual.
• Keep this manual with the equipment.
• Reading this manual does not qualify you to operate, test, or calibrate this system.
• Unauthorized personnel are not allowed access to the system.
• If the product does not operate properly or fails to respond to the controls as described in this manual:
– Follow the safety precautions as specified in this manual.
– Stop using the unit and prevent any changes to it.
– Immediately contact the service office, report the problem, and await further instructions.
• Use only legally marketed cassettes. Check periodically the quality of the cassettes, and replace them if any
defects are apparent.

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• The images provided by this system are intended as tools for the trained user. They are explicitly not to be
regarded as a sole incontrovertible basis for clinical diagnosis.
• Be aware of the product specifications and of system accuracy and stability limitations. Consider these limitations
before making any decision based on quantitative values. If you have any doubts, consult your Sales
Representative.
• This system is Class I continuous operated stationary equipment without applied parts and has one signal input/
output part.
• The appliance coupler of the flexible cord is used as a disconnecting device.
• In order to guarantee medical-grade leakage current, the computer that is connected to the system should be a
medical-grade computer or connected to the mains through a medical-grade isolation transformer.
• To achieve grounding reliability in USA installations, the equipment must be connected to an equivalent
receptacle marked “Hospital Only” or “Hospital Grade”.

Important
When the System is not in use, disconnect the power cable from the electrical outlet.

Electrical Hazards

Caution
• Do not remove or open system covers or plugs. Internal circuits use high voltage capable of causing serious
injury.
• Fuses blown within 36 hours of being replaced by a qualified technician may indicate malfunctioning electrical
circuits within the system. Have the system checked by qualified service personnel. Do not attempt to replace
any fuse.
• Fluids that seep into the active circuit components of the system may cause short circuits that can result in
electrical fires. Therefore, do not place any liquid or food on any part of the system.

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 the
following documentation.
• 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 below 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 on other equipment. If adjacent or stacked use is
necessary, verify normal operation in the configuration in which the scanner will be used.
• Cable, Accessory and Transducer Information for the System.

Port
Port Type Description From To Cable Type Cable Length
Power AC Power VITA CR AC Mains Unshielded 3.00 m (9.84 ft.)
Signal USB VITA CR PC Shielded 3.00 m (9.84 ft.)

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Guidance and manufacturer’s declaration—electromagnetic emissions

The System is intended for use in the electromagnetic environment specified below. The customer or the user of
the System should assure 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
CISPR 11 function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class B The VITA CR is suitable for use in all establishments,
CISPR 11 including domestic establishments and those directly
connected to the public low-voltage power supply
Harmonics emissions Class A
network that supplies buildings for domestic purposes.
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3

Guidance and manufacturer’s declaration - electromagnetic immunity

The System is intended for use in the electromagnetic environment specified below. The customer or the user of
the Scanner should assure that it is used in such an environment.
Electromagnetic environment -
Immunity test IEC 60601 test level Compliance level guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or
discharge (ESD) ±8 kV air ±8 kV air ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast ±2 kV for power supply ±2 kV for power Mains power quality should be that
transient/burst lines supply lines of a typical commercial or hospital
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output environment.
lines lines
Surge ±1 kV line to line ±1 kV line to line Mains power quality should be that
IEC 61000-4-5 ±2 kV line to earth ±2 kV line to earth of a typical commercial or hospital
environment.
Voltage dips, < 5 % UT ( > 95 % dip < 5 % UT ( > 95 % dip Mains power quality should be that
short in UT) for 0.5 cycle in UT) for 0.5 cycle of a typical commercial or hospital
interruptions 40 % UT (60 % dip in 40% UT (60 % dip in environment. If the user of the
and voltage UT) for 5 cycles UT) for 5 cycles System requires continued
variations on operation during power mains
power supply 70 % UT (30 % dip in 70 % UT (30 % dip in interruptions, it is recommended
lines UT) for 25 cycles UT) for 25 cycles that the System be powered from an
IEC 61000-4-11 < 5 % UT ( > 95 % dip < 5 % UT ( > 95 % dip uninterruptible power supply.
in UT) for 5 sec. in UT) for 5 sec.
Power 3 A/m 3 A/m Power frequency magnetic fields
frequency (50/ should be at levels characteristic of
60 Hz) magnetic a typical location in a typical
field commercial or hospital environment.
IEC 61000-4-8
Note: UT is the AC mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration - electromagnetic immunity

The CR System is intended for use in the electromagnetic environment specified below. The customer or the
user should assure that it is used in such an environment.
Compliance
Immunity test IEC 60601 test level level Electromagnetic environment - guidance
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.
Recommended separation distance
Conducted RF IEC 3 Vrms 3 Vrms d = 1.17 divided by P
61000-4-6 15 kHz to 80 MHz
Radiated RF IEC 3 Vrms 3 v/m d = 1.17 divided by P 80—800 MHz
61000-4-3 80 MHz to
2.5 GHz
d = 2.33 divided by P 800 M Hz—2.5 GHz
where P is the maximum output rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
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 1: At 80 MHz and 800 MHz, 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.

a.Field 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 scanner is used exceeds the applicable RF
compliance level above, the scanner should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the scanner.
b. Over the frequency range 150 kHz—80 MHz, field strengths should be less than 3 v/m.

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Recommended separation distance between portable and mobile RF communications equipment and the
VITA CR
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.
W Rated maximum output
power of transmitter m Separation distance according to frequency of transmitter
150 kHz—80 MHz 80—800 MHz 800 MHz—2.5 GHz
d = 1.17 divided by P d = 1.17 divided by P d = 2.33 divided by P
0.01 0.117 0.117 0.233
0.1 0.37 0.37 0.737
1 1.17 1.17 2.33
10 3.7 3.7 7.36
100 11.7 11.7 23.3
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.

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Explosion and Implosion Hazards

Caution
• Do not operate the equipment in the presence of explosive liquids, vapors, or gases.
• Do not plug in or turn on the system if hazardous substances are detected in the environment. If these
substances are detected after the system has been turned on, do not attempt to turn off the unit or unplug it.
Evacuate and ventilate the area before turning off the system.

Overheating

Caution
Do not block the air circulation around the unit. Always maintain at least 15 cm (6 in.) clearance around the unit to
prevent overheating and damage to the system.

VITA CR Laser Safety Instructions

The System is classified as a Class 1 Laser Product (with the outer cover in place).

Laser Warning
• The System contains a Class 3 laser. During normal operation, always keep the unit enclosed in its protective
cover.
• Do not attempt to remove the cover. Only a qualified technician may remove the cover to service this product.

Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24,
2007.
Class 1 Laser Product, and IEC/EN 60825-1.
Class 1 Equipment.
Intended for continuous operation.
Product is provided with ordinary protection against the harmful ingress of water.
Not suitable for use in the presence of a flammable anesthetics mixture with air or with oxygen or with nitrous oxide.
The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead
to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:
• Use of the accessory in the patient vicinity.
• Evidence that the safety certification of the accessory has been performed in accordance with IEC 60601-1 or
the system to IEC 60601-1-1 or local equivalent.

Device-Specific Safety Information

LIFTING HAZARD

The System weighs < 36 kg (79 lb). Do not try to lift the unit by yourself.
Always seek assistance from another person. Lifting equipment that is
too heavy may result in serious injury and/or damage to equipment.

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Health and Safety Compliance

Regulatory Information
The System was examined for compliance and has classifications and licenses as follows:

Safety

USA UL 60601-1: 2003 Medical Electrical Equipment

Canada CAN/CSA 22.2 No. 601.1-M90—Medical Electrical Equipment (R2001)
CAN/CSA 22.2 No. 601.1S1-94—Supplement No. 1-94 to Medical Electrical Equipment (R1999)
CAN/CSA 22.2 No. 601.1B-90—Amendment 2 to Medical Electrical Equipment (R2002)
International IEC 60601-1: 1988, +A1 (1991), +A2 (1995) Medical Electrical Equipment
IEC 60825-1: 1993 +A1:1997 + A2:2001 Safety of Laser Products
European EN 60601-1-1: 2001—Medical Electrical Equipment
Union EN 60601-1: 1990 +A1: 1993, +A2: 1995, +A13: 1996—Medical Electrical Equipment
EN 60825-1: 1994 +A1: 1997 + A2: 2001 Safety of Laser Products

EMC
IEC 60601-1-2: 2005 Medical Electrical Equipment—Electro-Magnetic Compatibility Requirements & Tests.
IEC 60825-1-2: 2001 Safety of Laser Products—Part 1: Equipment Classification, Requirements and User’s Guide.

CE Conformity
This product conforms to the requirements of Council Directive 93/42/EEC. The System bears the following mark of
conformity.

0086

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IEC Symbols Used

The system may have labels with one or more of the following symbols. These symbols indicate the IEC standards
to which the system conforms.

Caution – consult accompanying documents

Protective earth points

Power On

Power Off

Caution – Electrical shock hazard

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 Safety and Regulatory Information

Labelling Summary

External Labels

Product data plate

Internal Safety Labels

Laser-emitting product

Class 3B laser product inside

unit

High voltage

Protective earth point (chassis

stud)

Recycling the Scanner

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 representative for additional information on the
collection and recovery programs available for this product.

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Publication History

Publication Publication ECO Changed

Date No. No. Pages File Name Notes
2010-06-27 8H8439 POC_SafetyAndRegulatory_PDF.book New Publication
2010-12-20 8H8439-01 Cover, 2, POC_SafetyAndRegulatory_PDF.book Updated title,
7, 9, this Updated CE
page markings.
Updated
Authorized
European Agent
information, new
dataplate
graphic.
2011-08-20 8H8439-01 all POC_SafetyAndRegulatory_PDF.book updated for v3.2
 CARESTREAM and VITA are trademarks of Carestream Health, Inc.

Printed in U.S.A.
Carestream Health, Inc.
150 Verona Street
Rochester, N.Y. 14608