Operator's Manual

Chapter 2 Warnings and cautions
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 14
WARNING
Operating high frequency electrosurgical equipment in the vicinity of the monitor can
produce interference in the monitor and cause incorrect measurements.
WARNING
Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the
function of the monitor may be disturbed.
WARNING
This system is intended for use by healthcare professionals only. This system may
cause radio interference or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures, such as re-orienting or relocating the Tempus
or shielding the location.
CAUTION
Tempus has been tested in a “heavy” wireless environments consisting of different wireless
technologies (Bluetooth, WiFi 802.11 b and cellular communications) with multiple
transmitters used simultaneously. Users deploying the Tempus in environments where
other wireless technologies are being used should evaluate the potential risk of interference
and aggregate spectrum usage.
2.3 Indications for use
The Tempus Pro is a portable vital signs monitor intended to be used by clinicians and medically qualified
personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-
hospital care applications. The device is indicated for: 3-, 4- and 5-lead ECG monitoring; 12-lead ECG
recording with interpretation; real-time arrhythmia detection/alarming; QT measurement/alarming and ST
measurements/alarming; impedance pneumography; non-invasive blood pressure (NIBP); end-tidal CO2
(ETCO2) and respiration rate; pulse oximetry (SpO2); contact temperature; and invasive pressure and
extended pulse oximetry capability including; carboxyhaemoglobin (SpCO), methaemoglobin (SpMet), total
haemoglobin (SpHb) and total oxygen content (SpOC) measurements.
The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting
patient data to other medical professionals located elsewhere).
The device is indicated for adults, paediatrics and neonates.
The monitor can be used to display images from Interson 3.5 MHz General Purpose (GP) and 7.5 MHz
Small Parts/Vascular (SR) USB ultrasound probes or a Karl Storz C-MAC S USB video laryngoscope. The
monitor can also be used to display the following readings from a Masimo ISA OR+ gas module*: end-tidal
and fractionally inspired CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane.
These optional accessories are to be used in accordance with their indications for use.
* Not cleared for use with the Tempus Pro in Canada or the USA.
2.3.1 Contraindications
The Tempus Pro does not replace a physician’s care. The device is not an apnoea monitor.
The Tempus Pro is not intended to be used in strong magnetic or electro-magnetic fields which are
generated for medical purposes e.g. MRI.