Integra Codman 901001ESUO Instruction Manual page 16

EN - ENGLISH
TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS
Service and Repair
The manufacturer will provide schematics, parts list, and other technical information to authorized service centers. For service, repair
or replacements, contact your local Integra representative. Equipment under warranty should be returned to Integra LifeSciences
Corporation. It will be repaired or replaced without charge to the purchaser.
End of Useful Life
The Generator contains electrical components. Consider recycling at the end of service life. The product can be returned to Integra for
recycling. Dispose of the equipment in accordance with local ordinances.
PRODUCT INFORMATION DISCLOSURE
INTEGRA LIFESCIENCES CORPORATION ("INTEGRA") HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE
MANUFACTURE OF THESE PRODUCTS . INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO THE PRODUCT LIMITED
WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR APPLICABLE PRODUCT CATALOG . THIS WARRANTY IS EXCLUSIVE, AND
INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE . INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL
OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THESE PRODUCTS . INTEGRA
NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN
CONNECTION WITH THESE PRODUCTS .
Field Maintenance and Repair
Equipment under warranty should be returned to Integra LifeSciences Corporation. It will be repaired or replaced without charge to the
purchaser. Annual safety and functional checks are recommended.
Guidance and Manufacturer's Declaration
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the
EMC information provided in the tables below.
NOTE: Portable and mobile RF communications equipment can affect medical electrical equipment.
Table 2 —Guidance and Manufacturer's Declaration—Emissions
All ME Equipment and ME Systems
Guidance and Manufacturer's Declaration-Emissions
The Generator is intended for use in the electromagnetic environment specified below. The customer or user of the Generator should
ensure that it is used in such an environment.
Emissions Test
Radiated RF Emissions
CISPR 11
Conducted RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Emissions of voltage
fluctuations/flicker IEC
61000-3-3
NOTE: The Generator must be installed and operated according to the EMC regulations laid out in this document.
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If it is used
in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
IEC 60601-1-2, 3rd edition
Compliance Level
Group 2
Class A
Class A
Complies
IEC 60601-1-2, 4th edition
Compliance Level
Group 2
Class A
Class A
Complies
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Electromagnetic Environment-Guidance
The Generator must emit
electromagnetic energy in order to
perform its intended function. Nearby
electronic equipment may be affected.
The Generator 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.