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1. SYSTEM DESCRIPTION
This AURA
Monitor Pack (TK101-A) contains one AURA
TM
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
Receiver Pack, which are part of the AURA
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
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
Antenna is placed above the AURA
TM
receive data. It is held in place by the sterile Antenna Holster provided in the
AURA
Sensor Tray (SP101).
TM
Table 1: Components of the 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.
Sensor and relays the ICP waveform to a paired AURA
Component
AURA™ Sensor
AURA™ Monitor
AURA™ Antenna
AURA™ Data Receiver
AURA™ Battery
AURA™ Battery Charger
Figure 1: AURA™ ICP Monitoring System.
Monitor (TX101-A),
TM
Sensor Tray and AURA
TM
ICP Monitoring System (Figure 1
TM
Sensor to provide power and
TM
Data
TM
Data
TM
Model #
SP101
TX101
TA101
DG101
TB101
TC101
1
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