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User manual | Users Manual | 1.74 MiB | June 07 2017 | |||
1 | Cover Letter(s) | June 07 2017 | ||||||
1 | External Photos | June 07 2017 | ||||||
1 | ID Label/Location Info | June 07 2017 | ||||||
1 | Cover Letter(s) | June 07 2017 | ||||||
1 | RF Exposure Info | June 07 2017 | ||||||
1 | Test Report | June 07 2017 | ||||||
1 | Test Setup Photos | June 07 2017 |
1 | User manual | Users Manual | 1.74 MiB | June 07 2017 |
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 This page intentionally left blank. 1. DESCRIPTION This AURATM ICP Monitoring Kit (SP101-A) contains one AURATM Intracrani-
al 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. 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 qualified neurosurgeons in the direct monitoring of intracranial pressure in the parenchy-
ma for neurological patients. 1 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. AURA Monitor Kit Instructions for Use AURA Data Receiver Instructions for Use 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. 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 qualified health care provider. The health care provider should take appropriate steps and pro-
cedures 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 specified duration may result in patient harm or sys-
tem 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 specified indications may result in patient or operator harm. There are no user serviceable components within the AURA ICP Monitoring System. Any additions or modifications 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 0C to 50C (32F to 122F) storage range. Usage outside of specified 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. 2 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 condi-
tion. 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 fields 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 sourc-
es 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 detect-
able. Patients with metal implants should not receive medical treatments and diag-
nostic tests using effects caused by electrical fields, 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 clot-
ting factor should be conducted on patients before insertion. Decisions regard-
ing the possibility of hemorrhage at the site of placement are the sole responsi-
bility of the practitioner. 3 7. INSTRUCTIONS FOR USE INSPECT THE PACKAGING Visually inspect for mechanical and functional integrity of the packaging and its contents as well as the legibility and adherence of the AURATM ICP Sensor labels. If there is evidence of damage or tampering, do NOT use the product and contact Customer Service. Branchpoint Technologies will provide instructions for return. In-Package AURATM ICP Sensor Check:
Turn on the AURA Monitor. Select Sensor. Place the AURATM 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. for in-package check and place AURAAntenna over AURA ICP If In-Package Check is successful, AURA Monitor will display Sensor OK. If In-Package Check fails, AURA Monitor will display Sensor Check Failed. If this occurs, retry the In-Package Check. If the issue persists, use another AURA ICP Sensor and contact Branchpoint Technologies for further instruction. INSERTING THE AURA ICP SENSOR Shave, prep and drape the patients scalp. Make the necessary incision at Kochers point or other desired location (Fig-
ure 2). Insert the provided self-retaining scalp retractor to expose skull (Figure 3). Place the drill bit with collar into the chuck. While holding the drill handle in place, turn the chuck clockwise to tighten the bit. Figure 2 Figure 3 NOTE: To remove the drill bit from the collar, repeat this step, turning the chuck counterclockwise. Loosen the collar with the included hex wrench, and carefully slide the collar towards the tip of the bit until the desired skull depth is reached. It is import-
ant to note that the collar will not stop the drill. It is designed only to provide the surgeon with a marker for drilling depth. Tighten the collar in place with a hex wrench and begin drilling. CAUTION: Proceed gently through the inner table with care to avoid injury to the dura or parenchyma. 4 Check the patency of the burr hole prior to placing the AURA ICP Sensor. Fenestrate the dura prior to placing the AURA ICP Sensor. 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. Figure 4 Figure 5 Using the appropriate technique, close and dress the surgical site (Figure 6). Figure 6 PAIRING THE AURA ICP SENSOR TO THE AURA MONITOR Turn the AURA Monitor ON. Place AURA Monitor Antenna into Antenna Holster and affix the Antenna Holster to the scalp with provided adhesive backing on the Holster (Figure 7). Position the AURA Monitor Antenna overtop the AURA ICP Sensor insertion site to pair the AURA ICP Sensor with the AURA Monitor. Figure 7: AURA Antenna Holster being affixed onto scalp above AURA ICP Sensor. 5 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 ICP Sensor when the User is ready to reposition the AURA Monitor Antenna. NOTE: See AURA Monitor Kit Instructions for Use for related infor-
mation. REMOVING AND DISPOSING THE ANTENNA HOLSTER Press down the scalp around the Antenna Holster. Gently lift up the edges of the adhesive from the patients scalp. Carefully remove the Antenna Holster by peeling it away from the patients scalp. Dispose the Antenna Holster in accordance with applicable hospital policy and regulations. Prep and drape incision location in a sterile fashion. REMOVING AND DISPOSING THE AURA ICP SENSOR Open incision and carefully remove the AURA ICP sensor. Using an appropriate technique, close and dress the incision. NOTE: Disposal of explanted devices is subject to applicable laws and regulations. Dispose in accordance with appropriate hospital policy. 8. MAINTENANCE RECOMMENDATIONS SERVICE There are no user-accessible or user-serviceable parts or components in the AURA ICP Sensor. If any service, repair, or replacement of internal compo-
nents is needed, the AURA ICP Sensor must be returned to Branchpoint Tech-
nologies. For instructions and return packaging, contact Branchpoint Technolo-
gies using the information on the back cover of this manual. When requesting service, please provide information concerning the nature of the failure and the manner in which the equipment was used when the failure occurred. The model number and serial number should also be provided. MAINTENANCE CHECK Prior to each use, you should perform a visual inspection and verify the follow-
ing:
Mechanical and functional integrity of all components in the AURA ICP Monitoring Kit. Legibility and adherence of the AURA ICP Sensor labels. Perform In-Package Check before unpackaging. 9. TROUBLESHOOTING This section presents potential operational issues and recommended solutions of the AURA ICP Sensor and AURA Monitor. Contact Branchpoint Technol-
ogies using the information on the back cover of this manual for additional assistance. 6 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. 10. COMPLIANCE STATEMENTS EMI/RFI This equipment has been tested and found to comply with the applicable limits for medical devices, IEC 60601-1-2:2007 or Active Implantable Medical Device Directive 90/385/EEC. Although this testing shows the device to provide reasonable protection against harmful interference in a typical medical installation, there is no guarantee that interference will not occur in a particular installation. If the device does cause harmful interference the user is encouraged to try and correct the interference by the following measures:
Reorient or relocate the device Increase the separation between the devices Connect the equipment to an outlet on a different circuit Contact Branchpoint Technologies using the information on the back cover of this manual Federal Communications Commission (FCC) Compliance FCC ID: 2AJW6-BTAIS-01 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
This device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operation CAUTION: Changes or modifications not expressly approved by Branch-
point Technologies could void the users authority to operate the equip-
ment. 11. PRODUCT INFORMATION DISCLOSURE Branchpoint Technologies has exercised reasonable care in the selection of materials and the manufacture of these products. Branchpoint Technologies excludes all warranties, whether expressed or implied, including but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Branchpoint Technologies shall not be liable for any incidental or consequen-
tial loss, damage, or expense, directly or indirectly arising from use of these products. Branchpoint Technologies neither assumes nor authorizes any person to assume for it any other or additional liability or responsibility in connection with these products. Branchpoint Technologies intends that this device should be used only by physicians with educational and training background enabling the proper use of the device. 7 12. TECHNICAL SPECIFICATIONS Frequency Response The maximum frequency response of the AURA ICP Monitoring System, including the ICP readout display, at peak pressures of 10, 20, and 50 mmHg. Slew Rates The slew rates (the systems fastest output during a unit of time) from zero to peak and peak to zero for peak pressures of 10, 20, and 50 mmHg. Full-Scale Deflection The time constants for full-scale deflection of the sys-
tem, with both increasing and decreasing pressure. Pressure Range of the AURA Intracranial Monitor-
ing System. Accuracy of ICP range. mmHg:
10: TBD 20: TBD 50: TBD 10: TBD 20: TBD 50: TBD TBD X to Z mmHg X to Y mmHg: (TBD) mmHg Y to Z mmHg: (TBD)mmHg Length of time over which the device will maintain the specified accuracy. The size of the intracranial portion of the AURA ICP Monitoring System. 29 Days The size of the skull hole needed for safe insertion of the intracranial portion of the AURA ICP Monitor. The stability of the pressure measurements of the complete system, including any external transducers and strain gauges, over the temperature range of 20 to 39C (68 to 102F). The expected drift of the zero-point reading of the AURA ICP Sensor. The frequency with which the zero point should be corrected because of drift. The expected daily drift inaccuracy of the system. 6.3mm and 6.5 mm TBD First 24 hours (maximum): TBD TBD mmHg 29 days (average):
TBDmmHg TBD TBDmmHg per day Version Date of Revision Quality of Service (QoS) Transmission Frequency Software Wireless Specifications TBD TBD TBD TBD 8 Effective Power Operating Range Security 2.4 GHz 0 dBm TBD 13. PACKAGING AND DEVICE SYMBOLS The following symbols may be used on the AURA ICP Monitoring components. Symbol Specification Symbol Specification Consult instructions for use Temperature limita-
tions Manufacturer Date of Manufacture Atmospheric limita-
tions Sterilized using ethylene oxide Humidity limitations Do not resterilize Serial Number Reference/ Catalogue Number LOT Lot Number Use-by date Mark for Nationally Recognized testing for safety standards WEEE- Waste, Elec-
trical, and Electronic Equipment (WEEE). Indicates separate collection for elec-
trical and electronic equipment (i.e., do not throw this device in the trash). Federal Communi-
cations Commission
(FCC) Non-ionizing electromag-
netic radiation Caution Do not use if package is damaged Do not reuse, single-use device CE mark of conformity with the identification of the notified body autho-
rizing use of the mark Caution: Federal (USA) law restricts this device to sale by or on the order of a physician IPXX International Protection Rating 9 Type BF Applied Part Class II Electrical Appli-
ance Non-Pyrogenic NA NA 14. 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 10 PN I-0032 AURA ICP Monitoring Kit Sterile Packaging Label PN I-0037 AURA ICP Monitoring Kit Shipping Container Label 11 15. END-USER SOFTWARE LICENSE AGREEMENT IMPORTANT: This End User License Agreement (Agreement) is a legal agreement between you (either an individual or a legal entity) (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. IF YOU ARE ENTERING INTO THE AGREEMENT ON BEHALF OF A COMPANY OR OTHER LEGAL ENTITY, YOU REPRESENT THAT YOU HAVE THE AUTHORITY TO BIND SUCH ENTITY AND ITS AFFILIATES TO THE AGREEMENT, IN WHICH CASE THE TERMS YOU OR YOUR SHALL REFER TO SUCH ENTITY. PLEASE READ THESE TERMS AND CONDITIONS CAREFULLY AS THEY GOVERN YOUR USE OF THE SOFTWARE. If you do not agree to the terms and con-
ditions of this Agreement, please do NOT install the Software and immediately destroy any copies of the Software and Documentation in your possession. 1. GRANT OF LICENSE Branchpoint hereby grants to you a personal, limited, non-exclusive, non-sub-licensable, nontransferable, non-assignable license to use the Software, in machine executable object code form, and any related Documentation as follows:
If you opt for a machine license, at no cost, you may: (i) install one copy of the Software on a single computer for use by any number of authorized persons within your organization; and (ii) make one copy of the Software and Documentation for back-up and archival purposes only; provided such copy must contain all of the original Software and Documentations proprietary notices. If you wish to use additional copies of the Software, you must obtain additional licenses from Branchpoint for each computer on which the Software is installed. If you opt for a site license, at no cost, you may: (i) install copies of the Software on an unlimited number of computers within your organization; (ii) use the Software on such computers simultaneously; provided, that the number does not exceed the number entered on the license management system; (iii) make one copy of the Software and Documentation for back-up and archival purposes only; provided such copy must contain all of the original Software and Documentations proprietary notices. Disabling Mechanism Applicable to All Users Your license may allow you to use the Software only for a specific duration. THE SOFTWARE MAY CON-
TAIN A DISABLING MECHANISM THAT WILL PREVENT IT FROM BEING USED AFTER THE LICENSE PERIOD EXPIRES. YOU MUST NOT TAMPER WITH THE DISABLING MECHANISM OR THE SOFTWARE. 2. LICENSE RESTRICTIONS a) All rights not expressly granted are reserved. b) You may not: (i) permit other individuals or entities to use or have access to the Software except under the terms of this Agreement; (ii) modify, translate, reverse engineer, decompile, disassemble (except to the extent that this restriction is expressly prohibited by law) or create derivative works based upon the Software or Documentation; (iii) copy the Software or Documentation (except for back-up or archival purposes); (iv) rent, lease, lend, assign, or otherwise transfer rights to the Software or Documentation; or
(v) remove any proprietary notices or labels on the Software or Documentation. Any such forbidden use shall immediately terminate your license to the Software and Documentation. c) You agree that you shall only use the Software and Documentation in a manner that complies with all applicable laws, regulations and the like in the jurisdictions in which you use the Software and Documen-
tation, including, but not limited to, applicable restrictions concerning medical uses and copyright and other intellectual property rights. d) The Software or the use of the Software may be subject to legal or regulatory provisions related to products used in the healthcare industry. Prior to using the Software, it is your responsibility to ensure that your use of the Software will not violate any legal or regulatory provisions. Please contact Branch-
point to determine the most recent information regarding legal and regulatory approvals. e) The use of the Software is intended only for use with properly authorized content. Content files, includ-
ing, but not limited to images, which are viewed using the Software, may be protected by copyright laws or other laws of any jurisdiction and are used at your own risk. f) You may only use the Software for your internal purposes. You may not use the Software in any way to provide, or as part of, any application service provider service or other similar commercial service or application in which third parties have access to the Software. 12 g) You shall pay all applicable sales, use, transfer and any other taxes (exclusive of Branchpoint income taxes), however designated, which are collected or levied against Branchpoint on account of this Agree-
ment. 3. UPDATES/ UPGRADES Branchpoint reserves the right at any time to, but is not obligated to provide Updates to the Software. Update shall mean a change to the Software and/or Products designed to correct defects, but does not materially change functionality. If any such Updates are provided to you by Branchpoint, such Updates will be considered a part of the Software and subject to the terms and conditions of this Agreement. You agree and understand that although Branchpoint takes steps to prevent errors, the Software may contain errors affecting proper operation. The license provided herein does not include Upgrades. Upgrade shall mean a change to the Software that adds functionality or otherwise implements substantial additional ca-
pability. You agree that you may not have access to such Upgrades without separate payment or through a separate support agreement. 4. TITLE Title, ownership rights, and intellectual property rights in and to the Software and Documentation shall remain in Branchpoint or its licensors, as applicable. The Software is protected by the copyright laws of the country where the Software is used and international copyright treaties. Title, ownership rights and intellectual property rights in and to any content used with the Software shall be retained by the applicable content owner and may be protected by applicable copyright or other law. Branchpoint, and its licensors, also retains all right, title, and interest in and to the trademarks, trade names, logos, and icons (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 Branchpoints licensor; and (ii) other trademarks are either registered trademarks or trademarks of their respective owners. 5. DISCLAIMER OF WARRANTIES THE SOFTWARE IS PROVIDED AS IS, WITHOUT WARRANTY OR REPRESENTATION OF ANY KIND, WHETH-
ER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, AND FITNESS FOR A PARTICULAR PURPOSE. NEITHER BRANCHPOINT NOR ITS LICENSORS REPRESENT OR WARRANT THAT THE SOFTWARE WILL SATISFY YOUR REQUIREMENTS OR THAT IT IS WITHOUT DEFECT OR ERROR OR THAT THE OPERATION THEREOF WILL BE UNINTERRUPTED OR ERROR FREE. BRANCHPOINT DOES NOT WARRANT THAT FUNCTIONS CONTAINED IN THE SOFTWARE WILL MEET YOUR REQUIREMENTS OR THAT THE OPERATION OF THE SOFTWARE WILL BE ERROR-FREE OR UNINTERRUPTED. BRANCHPOINT MAKES NO GUARANTEES REGARDING THE QUALITY, ACCURACY, COMPLETENESS, EFFECTIVENESS, RELIABILITY, OR USEFULNESS OF THE SOFT-
WARE OR RESULTS OBTAINED THEREFROM. NO ORAL OR WRITTEN INFORMATION OR ADVICE GIVEN BY BRANCHPOINT, ITS DIRECTORS, OFFICERS, EMPLOYEES, LICENSORS, SUPPLIERS, AGENTS OR ANYONE ELSE WHO HAS BEEN INVOLVED IN THE CREATION, PRODUCTION, LICENSING, SUBLICENSING, SUPPLY OR DELIVERY OF THE SOFTWARE WILL CREATE A REPRESENTATION, CONDITION, OR WARRANTY, AND YOU MAY NOT RELY ON ANY SUCH INFORMATION OR ADVICE. You agree that the sole and exclusive responsibility for any medical decisions or actions with respect to the patients medical care and for determining the accuracy, completeness, or appropriateness of any diagnostic, clinical or medical information provided by the Software resides solely with the health care pro-
vider. Branchpoint assumes no responsibility for how such information is used and the choice with regard to when and how to use such information is the health care providers responsibility. You understand and agree that the responsibility for the medical treatment rests with the health care provider and revolves around the health care providers judgment and the health care providers analysis of the patients condi-
tion. Information provided by the Software is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the health care providers judgment and analysis of the patients condition. By using the Software, health care provider agrees that the Software is not intended to suggest or replace any medical decisions or actions with respect to the patients medical care and that the sole and exclusive responsibility for determining the accuracy, completeness or appropriateness of any diagnostic, clinical or medical information provided by the Software resides solely with the health care provider. Branchpoint assumes no responsibility for how such materials are used and disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, or suitability of this information and product for any particular purpose. 6. LIMITATION OF LIABILITY REGARDLESS OF THE SOURCE OF THE LIABILITY, OR THE LEGAL THEORY (INCLUDING, WITHOUT LIMITA-
TION, NEGLIGENCE, CONTRACT, BREACH OF WARRANTY, ABSOLUTE LIABILITY IN TORT, MISREPRESENTA-
TION OR OTHERWISE) UNDER WHICH IT IS ESTABLISHED, IN NO EVENT SHALL BRANCHPOINT OR ITS LI-
CENSORS BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE, OR OTHER DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS, SERVICE INTERRUPTION, LOSS OF INFORMATION, OR OTHER PECUNIARY LOSS) ARISING OUT OF THIS 13 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. BRANCHPOINTS 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. BECAUSE SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION(S) MAY NOT APPLY TO YOU. IN SUCH STATES AND JURISDICTIONS, BRANCHPOINTS LIABILITY SHALL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW. THIS SECTION SHALL SURVIVE THE TERMINATION OF THE AGREEMENT. 7. INDEMNIFICATION The Software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people that have been appropriately trained in the functions, capabilities and limitations of the Software. You agree to hold harmless, indemnify and defend Branchpoint, its licensors, officers, directors and employees, from and against any losses, damages, fines and expenses (including attorneys fees and costs) arising out of or relating to your use of the Software. THE ENTIRE RISK ARIS-
ING OUT OF YOUR USE OF THE SOFTWARE AND DOCUMENTATION REMAINS WITH YOU. 8. TERMINATION This Agreement will automatically terminate at the end of the license period or if you fail to comply with any term hereof including failure to make any required payment when due. No notice shall be required from Branchpoint to effect such termination. You may also terminate this Agreement at any time by noti-
fying Branchpoint in writing of termination. Without prejudice to any other rights, upon any termination of this Agreement, you shall immediately discontinue use of the Software and Documentation and shall with-
in three (3) days return to Branchpoint, or certify destruction of, all full or partial copies of the Software, Documentation and related materials. 9. MISCELLANEOUS This Agreement shall constitute the complete and exclusive agreement between the Parties, notwith-
standing any variance with any other written instrument submitted by you, whether formally rejected by Branchpoint or not. Failure or delay on the part of Branchpoint to exercise any right, power, privilege, or remedy will not constitute a waiver of, or bar the later exercise of, that or any other right, power, privilege, or remedy of Branchpoint. The terms and conditions contained in this Agreement may not be modified except in a writing duly signed by you and an authorized representative of Branchpoint. This Agreement is personal to you, and may not be assigned, sublicensed or transferred without Branchpoints express written consent. Any such attempted assignment, sublicense, or transfer will be null and void. Branchpoint may terminate this Agreement in the event of any such attempted assignment, sublicense, or transfer. If any provision of this Agreement is held to be unenforceable for any reason, such provision shall be reformed only to the extent necessary to make it enforceable, and such decision shall not affect the enforceability of such provision under other circumstances, or of the remaining provisions hereof under all circumstances. The parties specifically acknowledge and agree that this Agreement be drafted and fully enforceable as written in the English language. This Agreement shall be governed by the laws of the State of California, without regard to conflicts of law provisions. Any dispute between you and Branchpoint regarding this Agreement will be subject to the exclusive jurisdiction of the state and federal courts sitting in Orange County, California. Your remedies in this Agreement are exclusive. Any claim brought by you must be brought within one year of the date the cause of action has accrued or be forever waived. To the extent that you have breached or have indicated your intention to breach this Agreement in any manner which violates or may violate Branchpoints or its licensors intellectual property rights, or may cause continuing or irreparable harm to Branchpoint or its licensors (including, but not limited to, any breach that may impact Branchpoints or its licensors intellectual property rights, or a breach by reverse engineering), Branchpoint or its licensors may seek injunctive relief, or any other appropriate relief, in any court of competent jurisdiction. To that extent, Branchpoints licensors shall be third party beneficiaries under this Agreement. This Agreement will not be governed by the United Nations Convention on Con-
tracts for the International Sale of Goods, the application of which is hereby expressly excluded. No rule of strict construction shall apply against or in favor of either party in the construction and interpretation of this Agreement. 14 This page intentionally left blank. This page intentionally left blank. The AURATM ICP Monitoring Kit Instructions For Use intends to provide all necessary information for proper operation of all AURA Sensor models. Do not operate any component of the AURA Intracranial Monitoring Sys-
tem without completely reading and understanding these instructions. CAUTION:
FEDERAL LAW (U.S.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. For further information contact:
Branchpoint Technologies 1 Technology Drive, Suite I-811 Irvine, CA 92618 USA 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.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2017-07-06 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2017-07-06
|
||||
1 | Applicant's complete, legal business name |
Branchpoint Technologies, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0025921552
|
||||
1 | Physical Address |
1 Technology Dr
|
||||
1 |
Irvine, California 92618
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1 |
United States
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|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@intertek.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AJW6
|
||||
1 | Equipment Product Code |
BTAIS-01
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K******** H******
|
||||
1 | Telephone Number |
94924********
|
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1 | Fax Number |
94982********
|
||||
1 |
k******@branchpt.com
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app s | Technical Contact | |||||
1 | Firm Name |
Branchpoint Technologies, Inc.
|
||||
1 | Name |
K******** H******
|
||||
1 | Physical Address |
1 Technology Dr
|
||||
1 |
Irvine, California 92618
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|||||
1 |
United States
|
|||||
1 | Telephone Number |
94924********
|
||||
1 |
k******@branchpt.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Branchpoint Technologies, Inc
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||||
1 | Name |
N**** H******
|
||||
1 | Physical Address |
1 Technology Dr
|
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1 |
Irvine, California 92618
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1 |
United States
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1 |
n******@branchpt.com
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app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 12/31/2017 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | AURA ICP Sensor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power is EIRP | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Intertek Testing Services NA, Inc.
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1 | Name |
G****** L******
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1 | Telephone Number |
949-4********
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1 | Fax Number |
949 4********
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1 |
g******@intertek.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | IT | 2402.00000000 | 2480.00000000 | 0.0002360 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC