Notice
About This Edition
Published by Philips
Medical Systems
Printed in USA
Publication number
453564164431
Edition History
Edition 1, June 2009
Software Revision
A.03.00 and higher
Edition 2, March 2010
Software Revision
A.04.01 and higher
Warranty
Philips Medical Systems
reserves the right to make
changes to both this
Instructions for Use and to
the product that it
describes. Product specifi-
cations 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.
Copyright
© 2010 Koninklijke
Philips Electronics N.V.
All rights are reserved. All
other product names are
the property of their
respective owners.
Reproduction in whole or
in part in any form, or by
any means, electrical,
mechanical or otherwise,
is prohibited without the
written consent of the
copyright holder.
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810 USA
(978) 687-1501
Unauthorized copying of
this publication may not
only infringe copyright
laws, but may also reduce
the ability of Philips
Medical Systems to
provide accurate and
current information to
users.
Compliance
The Philips Medical
Systems PageWriter TC70
cardiograph and Page-
Writer TC50 cardiograph
comply with all relevant
international and national
standards and laws. Infor-
mation on compliance will
be supplied on request by a
local Philips Medical
Systems representative, or
by the manufacturer.
Intended Use of this
Instructions for Use
This Philips product is
intended to be operated
only in accordance with
the safety procedures and
operating instructions
provided in this Instruc-
tions for Use, and in accor-
dance with the purposes
for which it was designed.
Installation, use, and oper-
ation 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 appli-
cable laws or regulations
that have the force of law.
Use of this product for
purposes other than the
express intended purpose
provided by the manufac-
turer, or incorrect use and
operation, may relieve the
manufacturer (or agent)
from all or some responsi-
bility for resultant non-
compliance, damage, or
injury.
United States federal law
restricts this device to use
by or on the order of a
physician. THIS
PRODUCT IS NOT
INTENDED FOR HOME
USE.
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 regula-
tions.
For further information on
available training on the
use of this product, please
contact a Philips Medical
Systems representative, or
the manufacturer.
Medical Device
Directive
The PageWriter TC70
cardiograph and Page-
Writer TC50 cardiograph
comply with the require-
ments of the Medical
Device Directive 93/42/
EEC and carries the
0123
mark accordingly.
Authorized EU-represen-
tative:
Philips Medizin Systeme
Böblingen GmbH
Hewlett Packard Str. 2
71034 Böblingen
Germany
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