Operator's Manual

Chapter 14 Specifications and standards
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 252
14.5 Tempus Pro device classification
The system is classified according to the requirements of EN60601-1:2006, the standard for Medical
Electrical Equipment, Part 1, General Requirements for Safety, as:
 The Tempus Pro is internally (battery) powered. The external power supply is class I (earthed) as
defined by the classification of the power supply specified and supplied by RDT. The battery charger is
class II (double insulated).
 Applied parts type CF defibrillator proof. All patient coupled connections from the Tempus are
designated as Patient Applied Parts per IEC60601-1.
 The Tempus Pro is rated IP66, protected against rainfall according to IEC60529. This means that the
device is proof against the ingress of talcum powder into the body of the device (into its case) and also
proof against the entry of water from a strong hose (akin to a garden hose) into the body of the device
(into its case). All other parts are rated IPXX. The device is rated IP66 with all connectors either mated
or unmated (except the Capnometer cannula which must be unconnected and its door clicked shut) and
with dust covers fitted or not fitted and with the battery mated or unmated.
 No parts supplied sterile or suitable for/requiring sterilising.
 Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide.
 Suitable for continuous use, for use with defibrillators and for use with electrosurgical systems.
 The expected service life of the device (excluding batteries) is 5 years. This can be extended through
maintenance of the device.
14.5.1 Standards compliance
The Tempus Pro complies with the applicable parts of the following standards:
Standard
Title
IEC 60601-1 3
rd
edition Medical electrical equipment -- Part 1-1: General requirements for
safety - Collateral standard: Safety requirements for medical electrical
systems
IEC 60601-1-2 4
th
edition Medical electrical equipment -- Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-6
Medical electrical equipment -- Part 1-6: General requirements for
safety - Collateral standard: Usability
EN 60601-1-8
Medical electrical equipment -- Part 1-8: General requirements, tests
and guidance for alarm systems in medical electrical equipment and
medical electrical systems
IEC 60601-2-49 Medical electrical equipment -- Part 2-49: Particular requirements for
the safety of multifunction patient monitoring equipment
ISO 80601-2-56 Medical electrical equipment -- Part 2-56: Particular requirements for
basic safety and essential performance of clinical thermometers for
body temperature measurement
EN 60601-2-34 Medical electrical equipment -- Part 2-34: Particular requirements for
the basic safety and essential performance of invasive blood pressure
monitoring equipment