Carestream Health 6950 User Manual

Safety Manual

Publication No. AB3145_en
2014-06-09

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.

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

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Safety and Related Information

DANGER

DANGER

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.

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.

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, Warnings, and Cautions

DANGER

Caution

Caution

Caution

Caution

Caution

Caution

Caution

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.

The operator must not touch or have contact simultaneously with the patient and the laser
imaging system.

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.

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.

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.

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.

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.

Do not substitute or modify any part of this equipment.

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Safety, Warnings, and Cautions

Caution

Caution

Caution

Caution

Caution

Laser Warning

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.

Changes or modifications not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.

Do not use isopropyl alcohol to clean the exterior surfaces of the laser imager.

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.

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.

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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