i
Notice
About This Edition
Publication number 989803160581
Edition 3; Printed in the USA
The information in this document applies to the HeartStart XL+
defibrillator/monitor software versions indicated below. This
information is subject to change without notice.
Philips 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.
This document describes features that may or may not be present on
your specific HeartStart XL+ defibrillator/monitor, depending on
the installed options.
Edition History
Copyright
Copyright © 2015, Koninklijke Philips N.V.
All rights are reserved. Permission is granted to copy and distribute
this document for your organization’s internal educational use.
Reproduction and/or distribution outside your organization in
whole or in part is prohibited without the prior written consent of
the copyright holder.
SMART Biphasic
®
is a registered trademark of Philips.
Other trademarks and trade names are those of their respective
owners.
WARNING: Radio frequency (RF) interference coming from
devices other than the HeartStart XL+ may degrade the performance
of the HeartStart XL+. Electromagnetic compatibility with
surrounding devices should be assessed prior to using the
defibrillator/monitor.
Use of supplies or accessories other than those recommended by
Philips may compromise product performance.
Medical Device Directive
The HeartStart XL+ complies with the requirements of the Medical
Device Directive 93/42/EEC and carries the
0123
mark
accordingly.
The HeartStart XL+ defibrillator/monitor is designed and tested for
use under the operating conditions and settings stated in the device’s
Instructions for Use. The expected useful life of the HeartStart XL+
defibrillator/monitor will depend on the actual operating conditions
and the degree of adherence to the maintenance schedule described
in this manual. Use of the HeartStart XL+ outside of the stated
operating conditions may shorten the useful life and void the
warranty. Proper maintenance is described in the HeartStart XL+
Instructions for Use (IFU) as well as this Service Manual.
Certain accessories, such as cables, lead sets, and batteries, can be
subject to wear and abuse. These accessories are not intended to last
the life of the defibrillator and should be proactively replaced as
stated in the IFU.
According to the American Hospital Association publication,
Estimated Useful Lives of Depreciable Assets, Revised 2008 Edition, the
estimated useful life for defibrillators is 5 years. (Please note:
Estimated Useful Life is provided for informational purposes only,
and is not a guarantee or warranty of any kind.)
Manufacturer:
Philips Medical Systems
3000 Minuteman Road
Andover, MA USA 01810-1099
(978) 687-1501
Authorized EU-representative:
Philips Medizin Systeme Böblingen GmbH
Hewlett Packard Str. 2
71034 Böblingen
Germany
Declaration of Conformity:
For the Declaration of Conformity Statement, please see the Philips
Healthcare web site at
http://incenter.medical.philips.com/PMSPublic.
Scroll over the Quality and Regulatory tab located in the upper left
corner of the window. Click to see the Regulatory by Business. Then
click to select Defibrillators and select the entry for Declaration of
Conformity (DoC).
Chemical Content:
REACH requires Philips Healthcare to provide chemical content
information for Substances of Very High Concern (SVHC) if they
are present above 0.1% of the product weight. Components
of/within electric and electronic equipment may contain phthalates
above the threshold (e.g. bis(2-ethyl(hexyl)phthalate), CAS nr.:
117-81-7). The REACH SVHC list is updated on a regular basis.
Therefore, please refer to the following Philips REACH website for
the most up-to-date information on products containing SVHC
above the threshold:
http://www.philips.com/about/sustainability/reach.page
Pub. Number Ed. S/W Version Print Date
989803160581
1 A.00 July, 2011
2 B.00 Aug, 2013
3 B.01 July, 2015
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