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Summary of Contents for Branchpoint Technologies AURA
- Page 1 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...
- Page 2 Branchpoint Technologies AURA™ ICP Monitoring Kit INSTRUCTIONS FOR USE SP 101-A ©2017 Branchpoint Technologies, Inc. Revised 2017-05-24...
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Page 4: Indications For Use
Pressure (ICP) Sensor, one drill bit with collar, one hex wrench, one scalp retractor, one disposable antenna holster (AH101), four patient registration card, and five patient labels (Figure 1). The AURA™ Sensor can be placed with standard surgical instruments. -
Page 5: Related Information
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™... - Page 6 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 AURA Antenna in the 13.56 MHz band.
- Page 7 Place the AURA Antenna over the marked portion of the box in proxim- ity to the AURA™ ICP Sensor. Another option is to remove the translu- cent pouch from the sales container and position the Antenna over the AURA™ ICP sensor visualized through the translucent pouch.
- Page 8 Place the tip of the AURA™ ICP Sensor in the parenchyma through the punc- • ture in the dura (Figure 4) until the AURA™ ICP Sensor body is flush with the outer table of the skull (Figure 5). CAUTION: To ensure accurate ICP measurement, position catheter tip orthogonal to the inner table of the skull.
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Page 9: Maintenance Recommendations
If no AURA™ Sensor is detected, reposition the AURA™ Monitor Antenna. If • no AURA™ ICP Sensor is detected for 30 seconds, the AURA™ Monitor will sit idle and request the user to push the symbol to pair the AURA™ Monitor to the AURA™... - Page 10 TROUBLE COMMUNICATING WITH THE AURA™ MONITOR AURA™ Monitor will indicate inability to communicate with AURA™ ICP Sen- sor with the alarm message “No Sensor Found.” Reposition AURA™ Antenna until good connection re-established between the AURA™ ICP Sensor and the AURA™ Monitor.
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Page 11: Technical Specifications
Length of time over which the device will maintain 29 Days the specified accuracy. The size of the intracranial portion of the AURA™ ICP Monitoring System. The size of the skull hole needed for safe insertion of ≥ 6.3mm and ≤ 6.5 mm the intracranial portion of the AURA™... - Page 12 Effective Power 2.4 GHz Operating Range 0 dBm Security 13. PACKAGING AND DEVICE SYMBOLS The following symbols may be used on the AURA™ ICP Monitoring components. Symbol Specification Symbol Specification Consult instructions Manufacturer for use Temperature limita- Date of Manufacture...
- Page 13 Class II Electrical Appli- Type BF Applied Part ance Non-Pyrogenic ASSOCIATED DEVICE LABELS PN I-0031 AURA™ ICP Monitoring Kit Sales Container Label PN I-0035 AURA™ ICP Monitoring Kit Patient Label PN I-0036 AURA™ ICP Monitoring Kit Patient Registration Card...
- Page 14 PN I-0032 AURA™ ICP Monitoring Kit Sterile Packaging Label PN I-0037 AURA™ ICP Monitoring Kit Shipping Container Label...
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Page 15: End-User Software License Agreement
(“you”, or “your,” as context requires) and Branchpoint, Inc. and, where appli- cable, its licensors (collectively “Branchpoint”) for the software (“Software”) and associated documentation (“Documentation”) used in connection with the AURA intracranial monitoring system. BY INSTALLING, COPYING, DOWNLOADING, ACCESSING, OR OTHERWISE USING THE SOFTWARE, YOU AGREE TO BE BOUND BY THE FOLLOWING TERMS AND CONDITIONS. - Page 16 (collectively, “Marks”) used in or identifying the Software or its features and you may not use such Marks without the prior written permission of Branchpoint. Without limiting the forgoing: (i) AURA™ logo is a trademark of Branchpoint’s licensor; and (ii) other trademarks are either registered trademarks or trademarks of their respective owners.
- Page 17 AGREEMENT OR THE USE OF OR INABILITY TO USE THE SOFTWARE OR DOCUMENTATION, EVEN IF BRANCHPOINT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. BRANCHPOINT’S TOTAL LIABLITY FOR ANY DIRECT DAMAGES TO YOU, OR ANY THIRD PARTY CLAIMING THROUGH YOU, SHALL NOT EXCEED THE AMOUNT PAID FOR THE SOFTWARE OR FIVE DOLLARS ($5.00), WHICHEVER IS HIGHER.
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- Page 20 For further information contact: Branchpoint Technologies 1 Technology Drive, Suite I-811 Irvine, CA 92618 Tel.: 949-829-1868 www.branchpt.com Covered by one or more of the following U.S patents: (patent pending). ©2017 Branchpoint Technologies, Inc. AURA is a registered trademark of Branchpoint Technologies, Inc.
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