Operator's Manual

Chapter 2 Warnings and cautions
Tempus Pro User/Operator Manual - 41-2001EN-00 – Page 18
WARNING
Ensure patient cabling or tubing is carefully routed on device to reduce the
possibility of patient entanglement or strangulation.
WARNING
All numerical, graphical and interpretive data should be evaluated with respect to the
patient's clinical and historical picture.
WARNING
Do not attempt to insert any connections from the Tempus Pro (including patient
cables) directly into an electrical outlet. (IEC60601-2-34:2011, 2011).
WARNING
Failure of Operation: If the Tempus Pro fails to respond as described in this user
guide; DO NOT use it until approved for use by qualified personnel.
WARNING
Reuse, disassembly, cleaning, disinfecting or sterilizing of any single use items (such
as the Capnometer cannula) may compromise functionality and system performance
leading to a user or patient hazard. Performance is not guaranteed if an item labelled
as single patient use is reused.
WARNING
Do not touch the patient at the same time as touching the body or contacts of any of
the medical or communications or power connectors.
WARNING
The USB connection must only be connected to non-mains powered peripherals
(such as a mouse or keyboard) or to interface accessories provided by RDT (such as
the USB-Serial Cable part number 01-1022). Any connections made to the USB port
must be to medical or IT peripherals or communications systems which comply with
the applicable IEC safety standard (i.e. IEC60601-1 or IEC60950). Any connection
arrangements must be made in a manner compliant with IEC60601-1-1 or IEC60601-
1:2005.
WARNING
The alarm functions of the Tempus are intended to be used by the attendant user
only. If the device is connected to a Response Centre this is for the purpose of
sharing vital signs data in real time, between two users for the purpose of obtaining
additional clinical support. The system is not a distributed alarm system (e.g. nurse
monitoring station system) in the terms of IEC60601-1-8. The i2i system at the
Response Centre is not equipped with alarm silencing or suspending controls.
WARNING
When connected to a PC running the i2i application at a Response Centre, streamed
data, such as the waveforms displayed on the Tempus Pro, will be transmitted and
displayed automatically on that PC’s display. Users are advised that streamed data
are transmitted using the UDP protocol. The UDP protocol includes error checking
but does not retransmit data. Therefore, any data that is dropped, lost or delayed
during the streaming process will not be retransmitted. In the event that packets of
waveform data are lost, they will appear as gaps in the waveform that is displayed on
the i2i interface.
WARNING
Medical data (vital signs data, photos, ECG recordings, patient details, TCCC cards
etc.) are transmitted using TCP/IP, this includes error checking and retransmission so
missing or dropped packets are therefore retransmitted.