Operator's Manual

Chapter 1 Introduction
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 10
1.1 CE statement
Marking by the above symbol indicates compliance of this device to the Medical Devices Directive (MDD)
93/42/EEC (as amended) and the Radio Equipment Directive (RED) 2014/53/EU (as amended). The CE
mark is accompanied by the number 0413 which is the reference number for the Notified Body who certify
RDT’s quality system.
The Tempus Pro is a class IIb device under the MDD and is a class I device (harmonised frequencies) under
the Radio Equipment Directive (RED) 2014/53/EU.
A Declaration of Conformity in accordance with the above regulations has been made and is on file with
RDT, see “RDT contact details”.
The wireless portion of this equipment may be operated in GB, France, Italy, Switzerland, Germany,
Holland, Portugal, Spain, Sweden, Norway, Denmark and Finland.
1.2 FDA prescription statement
Federal law (USA) restricts the use or sale of this device by, or on the order of, a physician.
1.3 Proprietary notice
Information contained in this document is copyright © 2013-2019 by Remote Diagnostic Technologies
Limited ('RDT') and may not be reproduced in full or in part by any means or in any form by any person
without prior written permission from RDT.
The purpose of this document is to provide the user with adequately detailed information to efficiently install,
operate, maintain and order spare parts for the Tempus Pro. Every effort has been made to keep the
information contained in this document current and accurate as of the date of publication or revision.
However, no guarantee is given or implied that the document is error free or that it is accurate with regard to
any specification. RDT reserves the right to change specifications without notice.
Tempus Pro, Corsium, Corsium Crew, RachBak, i2i and TempusNET are all trademarks of RDT.
The Bluetooth name and logo are owned by the Bluetooth SIG Inc. and any use of this name or mark is
under license.
The following trademarks are the property of Oridion Medical Ltd.: Oridion, Microstream, FilterLine,
(FilterLine Set; FilterLine H Set, Nasal FilterLine), CapnoLine (Smart CapnoLine, Smart CapnoLine O2,
Smart CapnoLine Plus, Smart CapnoLine Plus O2, Smart CapnoLine H Plus, Smart CapnoLine H Plus O)
and Integrated Pulmonary Index (IPI).
The following trademarks are the property of Masimo Inc, SET, PVI, Rainbow, FastSAT.
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any expressed or implied license to use the device
with unauthorized sensors or cables that would, alone, or in combination with this device, fall within the
scope of one or more of the patents relating to this device.
Masimo and the Masimo SET logo are the property of Masimo Inc.