AURA
Distributed by:
Branchpoint Technologies
1 Technology Drive, Suite I-811
Irvine, CA 92618
United States
Phone: +1 (949) 829-1868
MADE IN USA
IFU PN I-0033 rev. A
Branchpoint Technologies
AURA™ ICP Monitoring Kit
INSTRUCTIONS FOR USE
SP 101-A
©2017 Branchpoint Technologies, Inc.
Revised 2017-05-24
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1. DESCRIPTION
This AURATM ICP Monitoring Kit (SP101-A) contains one AURA
TM
Intracranial Pressure (ICP) Sensor, one drill bit with collar, one hex wrench, one scalp
retractor, one disposable antenna holster (AH101), four patient registration
card, and ve patient labels (Figure 1). The AURA™ Sensor can be placed with
standard surgical instruments.
Figure 1: AURA™ ICP Monitoring Kit.
The AURA™ ICP Monitoring Kit is provided sterile and is sterilized by ethylene
oxidation. This kit is part of the AURA™ Intracranial Monitoring Sytem (Figure
2) whose function is to determine safely, quickly, and accurately the level and
change in ICP.
Figure 1: AURA™ Intracranial Monitoring System.
CAUTION: Federal Law (U.S.A.) restricts this device to be sold by or on
the order of a physician.
2. INDICATIONS FOR USE
The Branchpoint AURA™ Intracranial Monitoring System is for use by qualied
neurosurgeons in the direct monitoring of intracranial pressure in the parenchyma for neurological patients.
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3. CONTRAINDICATIONS
• This device is not intended for any use other than that indicated.
• This device is not designed, sold, or intended for use as a therapeutic
device.
4. RELATED INFORMATION
Before using the AURA™ ICP Monitoring Kit, read and follow all instructions,
warnings, and precautions provided in the AURA™ ICP Monitoring Kit manual
and in the manuals for the other system components. Manuals for the other
system components are listed below.
• AURA™ Monitor Kit Instructions for Use
• AURA™ Data Receiver Instructions for Use
This manual is also made available on the Internet and can be found at
www.auramonitor.com.
5. WARNINGS
Sterile techniques should be used at all times when handling components of the
AURA™ ICP Monitoring Kit and inserting the AURA™ ICP Sensor.
Placement of the AURA™ ICP Sensor must be carried out by a qualied health
care provider. The health care provider should take appropriate steps and procedures to avoid infections and complications.
If monitoring is continued for more than 29 days, placement of a new system
under sterile conditions is recommended. The AURATM ICP Sensor must be
explanted from patient after usage or when implantation has reached 29 days.
Usage beyond maximum specied duration may result in patient harm or system malfunction.
The AURA™ ICP Sensor and the items included in the AURA™ ICP Monitoring Kit
are designed for SINGLE USE ONLY. DO NOT RESTERILIZE OR REUSE AURA™
ICP Sensor if it has previously been implanted in another patient. DO NOT
REUSE any portions of the kit that have been partially or totally implanted in a
patient. Disposal of parts must be in accordance with hospital policy. Improper
disposal may pose biohazards or environmental hazards.
All Branchpoint Technologies AURA™ components are designed for use with
the AURA™ ICP Monitoring System only. Usage of product outside of specied
indications may result in patient or operator harm.
There are no user serviceable components within the AURA™ ICP Monitoring
System. Any additions or modications to this system, except those supplied or
recommended by Branchpoint Technologies, are prohibited and may interfere
with system performance or result in a hazard or hazardous condition.
Do not subject the AURATM ICP Monitoring Kit components to temperatures out-
side of 0°C to 50°C (32°F to 122°F) storage range. Usage outside of specied
conditions may result in patient harm, packaging damage or system mal-
function. Allow the AURA™ ICP Sensor to reach room temperature before it is
inserted and before “In-Package Check” is performed.
Do not insert the AURA™ ICP Sensor after the “Use by” date on the package
label.
Do not modify, cut, kink, crush, stretch, drop, or otherwise damage any com-
ponent of the AURA™ ICP Sensor. Impairment to the AURA™ ICP Sensor may
result in device malfunction.
The AURA™ ICP Monitoring Kit is provided sterile in sealed packaging.
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DO NOT USE if the packaging is wet, punctured, opened, or otherwise dam-
aged. Usage of damaged products may result in a hazard or hazardous condition. Contact Branchpoint Technologies for instructions to return the AURA™ ICP
Monitoring Kit.
The use of the AURATM ICP Sensor around strong sources of electromagnetism
and electric elds should be avoided.
Compatibility of AURA™ ICP Sensor with magnetic resonance imaging (MRI) has
not been validated.
6. PRECAUTIONS
Patients should avoid devices or medical treatments that generate strong sources of electromagnetic interference (EMI). EMI may result in device malfunction
or damage.
Patients should avoid medical treatments and diagnostic tests in which an
electrical current is passed through the body, such as TENS, electrocautery,
electrolysis/thermolysis, electromyography, or nerve conduction studies.
Patients should avoid sources of therapeutic ultrasound. Therapeutic ultrasound
may damage the device, however, the damage may not be immediately detectable.
Patients with metal implants should not receive medical treatments and diag-
nostic tests using effects caused by electrical elds, such as diathermy.
Patients should avoid sources of ionizing radiation. Ionizing radiation may dam-
age the device, however, the damage may not be immediately detectable.
By design, the AURA™ ICP Sensor emits radio frequency energy in the 2.4
GHz band and is powered by the AURATM Antenna in the 13.56 MHz band. The
presence of other equipment operating in the same frequency bands used by
the AURA™ ICP Sensor may interfere with communication. This interference can
be reduced by increasing the distance between the interfering device and the
AURA™ ICP Sensor.
The AURA™ ICP Sensor shall not be placed in oxygen rich environments.
Cerebral Spinal Fluid leakage, hemorrhage, pain, infection and neurological
damage are potential complications of this procedure. Testing of the blood clotting factor should be conducted on patients before insertion. Decisions regarding the possibility of hemorrhage at the site of placement are the sole responsibility of the practitioner.
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