Philips ST80i Instructions For Use Manual page 4

Notices
PN 453564XXXXXX
June 2012
Edition 1
Printed in the USA
Edition History
Edition 1, June 2012
Applicable to ST80i, version
A01.00 and later.
Philips Medical Systems 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.
Copyright
©
Copyright 2012
Koninklijke Philips Electronics
N.V. All rights are reserved.
Andover, MA 01810-1099 USA
(978) 687-1501
Warranty
Philips Medical Systems 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.
Nothing contained within this
Instructions for Use is intended as
any offer, warranty, promise, or
contractual condition, and must not
be taken as such.
Responsibility of Manufacturer
Philips Medical Systems only
considers itself responsible for any
effects on safety, reliability, and
performance of the StressVue
system if:
– assembly operations, exten-
sions, re-adjustments, modifica-
tions or repairs are done by
persons authorized by Philips
Medical Systems, 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.
Authorized EU-representative
Philips Medizin Systeme
Böblingen GmbH
Hewlett Packard Str. 2
71034 Böblingen
Germany
European Directives
This product consists of hardware
and software. The hardware carries
the CE mark based on the
declarations provided in the User's
Guide for the IT hardware.
The ST80i software, the wireless
patient module, and the Philips
thermal printer are class IIa medical
devices under the Medical Device
Directive 93/42/EEC and carry
the 0123 mark accordingly.
CAUTION
THIS PRODUCT IS NOT
INTENDED FOR HOME USE. IN
THE U.S., FEDERAL LAW
RESTRICTS THIS DEVICE TO
SALE ON OR BY THE ORDER
OF A PHYSICIAN.
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.
Global Medical Device
Nomenclature (GMDN)
The 5-digit GMDN code adjacent to
the symbol is defined in the EN ISO
15225.
GMDN 36145
WARNINGS
As with all electronic equipment,
Radio Frequency (RF) interference
between the ST80i 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 Medical Systems assumes
no liability for failure resulting from
RF interference between Philips
Medical Systems medical
electronics and any radio frequency
generating equipment at levels
exceeding those established by
applicable standards.
Use of accessories other than those
recommended by Philips Medical
Systems may compromise product
performance.
Trademarks
Windows is a registered trademark
of Microsoft Corporation.
All other brand and product names
are trademarks or registered
trademarks of their respective
companies.