Notice
PN 453564746991
October 2019, Revision C
Revision History
Revision A, November 2018
Revision B, March 2019
Revision C, October 2019
Philips Medizin Systeme Böblingen GmbH
shall not be liable for errors contained
herein or for incidental or consequential
damages in connection with the furnishing,
performance, or use of this material.
© 2019 Koninklijke Philips N.V. All rights are
reserved.
Proprietary Notice
This document and the information
contained in it is proprietary and
confidential information of Philips Medizin
Systeme Böblingen GmbH and may not be
reproduced, copied in whole or in part,
adapted, modified, disclosed to others, or
disseminated without the prior written
permission of the Philips Legal Department.
Use of this document and the information
contained in it is strictly reserved for current
Philips Medizin Systeme Böblingen GmbH
personnel and customers who have a
current and valid license from Philips for use
by the customer’s designated in-house
service employee on equipment located at
the customer’s designated site.
Use of this document by unauthorized
persons is strictly prohibited. Report
violation of these requirements to the
Philips Legal Department. This document
must be returned to Philips Medizin
Systeme Böblingen GmbH when the user is
no longer licensed and in any event upon
the first written request from Philips Medizin
Systeme Böblingen GmbH.
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Strasse 2
71034 Böblingen
Germany
Warranty
Philips Medizin Systeme Böblingen GmbH
reserves the right to make changes to both
this Instructions for Use and to the product
that it describes. Product specifications are
subject to change without notice.
Philips Medizin Systeme Böblingen GmbH
makes no warranty of any kind with regard
to this material, included, but not limited to,
the implied warranties or merchantability
and fitness for a particular purpose.
Responsibility of Manufacturer
Philips Medizin Systeme Böblingen GmbH
only considers itself responsible for any
effects on safety, reliability and
performance of the product if:
– assembly operations, extensions, read-
justments, modifications or repairs are
done by persons authorized by Philips
Medizin Systeme Böblingen GmbH, and
– the electrical installation of the relevant
room or vehicle complies with the IEC or
national requirements, and
– the instrument is used according to the
instructions for use presented in this
manual.
Responsibility of Customer
The user of this product is responsible for
ensuring the implementation of a
satisfactory maintenance schedule. Failure
to do so may cause undue failure and
possible health hazards.
Instructions for Use
This Philips Medizin Systeme Böblingen
GmbH product is intended to be operated
only in accordance with the safety
procedures and operating instructions
provided in this Instructions for Use, and in
accordance with the purposes for which it
was designed. Installation, use, and
operation of this product is subject to the
laws in effect in the jurisdiction(s) in which
the product is being used.
Users must only install, use, and operate this
product in such a manner that does not
conflict with applicable laws or regulations
that have the force of law.
Use of this product for purposes other than
the express intended purpose provided by
the manufacturer, or incorrect use and
operation, may relieve the manufacturer (or
agent) from all or some responsibility for
resultant non-compliance, damage, or
injury.
Training
Users of this product must receive adequate
clinical training on its safe and effective use
before attempting to operate the product as
described in this Instructions for Use.
Training requirements vary by country. Users
must ensure that they receive adequate
clinical training in accordance with local
laws or regulations.
For further information on available training
on the use of this product, please contact a
Philips Medizin Systeme Böblingen GmbH
representative.
Compliance
The Philips Medizin Systeme Böblingen
GmbH EarlyVue VS30 complies with all
relevant international and national
standards and laws. Information on
compliance will be supplied on request by a
local Philips Medizin Systeme Böblingen
GmbH representative, or by the
manufacturer.
CAUTIONS
THIS PRODUCT IS NOT INTENDED FOR
HOME USE.
Rx: IN THE U.S., FEDERAL LAW RESTRICTS
THIS DEVICE TO SALE ON OR BY THE
ORDER OF A PHYSICIAN.
Philips Medizin Systeme Böblingen GmbH
strongly recommends that your site not use
patient identification numbers that are
related to any other forms of identity, such
as social security number or driver's license
number. Using unique patient identification
numbers is part of best practices for any
information technology system as a way to
help health care providers and patients
avoid identity theft.
WARNING
As with all electronic equipment, Radio
Frequency (RF) interference between the
EarlyVue VS30 system and any existing RF
transmitting or receiving equipment at the
installation site, including electrosurgical
equipment, should be evaluated carefully
and any limitations noted before the
equipment is placed in service.
Radio frequency generation from
electrosurgical equipment and close
proximity transmitters may seriously
degrade performance.
Philips Medizin Systeme Böblingen GmbH
assumes no liability for failure resulting from
RF interference between Philips Medizin
Systeme Böblingen GmbH medical
electronics and any radio frequency
generating equipment at levels exceeding
those established by applicable standards.
Australia and New Zealand Sponsor
Philips Electronics Australia Ltd.
65 Epping Road
North Ryde
NSW 2113
Australia
Medical Device Directive
The EarlyVue VS30 complies with the
requirements of the Medical Device
Directive 93/42/EEC and carry the following
mark accordingly:
Global Medical Device Nomenclature
(GMDN)
The 5-digit GMDN code adjacent to the
symbol is defined in the EN ISO 15225
standard.
Trademarks
Product and company names mentioned
herein may be the trademarks or registered
trademarks of their respective owners.
Masimo and SET are federally registered
trademarks of Masimo Corporation.
Microstream, FilterLine, CapnoLine and
VitaLine are trademarks of a Medtronic
company.
GMDN
33586
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