1
1.
SYSTEM DESCRIPTION
This AURA
TM
Monitor Pack (TK101-A) contains one AURA
TM
Monitor (TX101-A),
two rechargeable batteries (TB101-A), one battery charger (TC101-A), one
power supply, and one antenna (TA101-A).
This pack is intended to be used with AURA
TM
Sensor Tray and AURA
TM
Data
Receiver Pack, which are part of the AURA
TM
ICP Monitoring System (Figure 1
and Table 1).
The AURA™ Monitor is a non
-sterile, non-implantable hand-held device powered
by rechargeable lithium ion batteries (included in this pack). The device has an
OLED display screen and is controlled by buttons on its control panel. The
AURA™ Monitor receives intra
-cranial pressure (ICP) data via RF telemetry from
a coupled AURA
TM
Sensor and relays the ICP waveform to a paired AURA
TM
Data
Receiver. The AURA™ Data Receiver makes it possible for the data obtained by
the AURA™ Monitor to be displayed onto bedside patient monitor.
The AURA
TM
Antenna is placed above the AURA
TM
Sensor to provide power and
receive data. It is held in place by the sterile Antenna Holster provided in the
AURA
TM
Sensor Tray (SP101).
Table 1: Components of the AURA™ ICP Monitoring System.
Component
Model #
AURA™ Sensor
SP101
AURA™ Monitor
TX101
AURA™ Antenna
TA101
AURA™ Data
Receiver
DG101
AURA™ Battery
TB101
AURA™ Battery Charger
TC101
Figure 1: AURA™ ICP Monitoring System.
2.
INDICATIONS FOR USE
The Branchpoint AURA™ ICP Monitoring System is
intended for use by a qualified
neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal
applications.
