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The AURA

Monitor Instructions For Use intends to provide all

necessary information for proper operation of all AURA

Monitor

models.

Do not operate any component of the AURA

ICP Monitoring System

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

United States

Tel.: +1 (949) 829-1868

www.branchpt.com

See www.branchpt.com/patents for patent information.

of Branchpoint Technologies, Inc.

Содержание AURA TK101-A

Страница 1: ...TK101 A 2017 Branchpoint Technologies Inc Revised 2018 09 13 Branchpoint Technologies AURATM Monitor Pack INSTRUCTIONS FOR USE...

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Страница 3: ...RF telemetry from a coupled AURATM Sensor and relays the ICP waveform to a paired AURATM Data Receiver The AURA Data Receiver makes it possible for the data obtained by the AURA Monitor to be display...

Страница 4: ...RA Monitor to overheat and may reduce its performance and service life The AURATM Monitor Pack components are only for use in non condensing humidity conditions Do not discard the AURA Monitor in a fi...

Страница 5: ...normal or single fault conditions the AURATM Antenna may reach a maximum temperature of 43 C There is a safety cutoff to prevent temperature from exceeding this value and mitigate the likelihood of d...

Страница 6: ...urs and the AURA Monitor s functionality is affected attempt to reset the AURA Monitor or contact Branchpoint Technologies for instructions AURA ICP Monitoring System has not been evaluated for pediat...

Страница 7: ...ress locking buttons simultaneously to release battery Figure 4 Slide battery to guide markers Figure 5 Lift and remove battery To insert the battery into the AURA Monitor Line up guide markers on the...

Страница 8: ...ndicates there is an error with the battery Try to remove then re insert the battery If problem persists replace the battery or contact Customer Service Charge the spare battery when not in use to ens...

Страница 9: ...at is not visibly detectable Figure 10 Align the arrow markings on the antenna cable and the AURA Monitor Figure 11 Plug antenna cable into AURA Monitor RUNNING IN PACKAGE CHECK FOR AURA SENSOR Before...

Страница 10: ...y No Sensor Found Select the button to re run the in package check and try to move the AURATM Antenna around the marked area again as the AURATM Sensor within the box may slightly shift during transpo...

Страница 11: ...URA Antenna securely in place The LED on the AURATM Antenna will illuminate green upon successful connection to an AURATM Sensor Figure 13 Antenna Holster being affixed onto scalp above AURA Sensor CA...

Страница 12: ...RECEIVER After pressing to start pairing the AURA Monitor with the AURA Data Receiver the screen will ask the user to plug the AURA Data Receiver into the patient monitor Ensure that the target AURATM...

Страница 13: ...The AURATM Monitor will start pairing with the AURATM Data Receiver After successfully paired with the AURATM Data Receiver the AURATM Monitor will display the ICP NOTE If the AURATM Data Receiver is...

Страница 14: ...RM LIMITS AND ALARM To enable an alarm when the acquired ICP reaches the high or low limit set by the user select the Menu button to get to the following screen Select Alarm Status and then Enable To...

Страница 15: ...m condition detected Audio pattern output repeatedly every 20 seconds until alarm cleared or user mutes the alarm C A C 523 Hz 200ms tone with 4 harmonics A 440 Hz 200ms tone with 4 harmonics space in...

Страница 16: ...ee cloth 6 Visually inspect the devices to ensure surfaces are free of residue and soil Inspect for any signs of wear or damage to the devices such as discoloration and cracking If damage is detected...

Страница 17: ...RATM Monitor fails to communicate with the AURATM Data Receiver or determines there is a poor Quality of Service it will automatically disconnect from the AURATM Data Receiver Verify there are no pote...

Страница 18: ...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 c...

Страница 19: ...SCLOSURE Branchpoint Technologies has exercised reasonable care in the selection of materials and the manufacture of these products Branchpoint Technologies excludes all warranties whether expressed o...

Страница 20: ...g ms Time constants The time constants for full scale deflection of the system with both increasing and decreasing pressure With increasing pressure 10 mmHg 5 75 ms 20 mmHg 5 62 ms 50 mmHg 8 03 ms Wit...

Страница 21: ...n condensing Pressure limits Operating Storage 795 mmHg to 700 mmHg 795 mmHg to 375 mmHg RF data transmission AURATM Monitor and AURATM Antenna Frequency range 2 40 2 48 GHz Output power 0dBm 0 001 wa...

Страница 22: ...13 567 MHz Software Version BLE SW 0008 rev A MCU SW 0002 rev D AURA BATTERY SPECIFICATIONS Battery Type Li ion rechargeable Capacity 5600 mAh Charge duration Operating 8 hours typical Voltage 11 1 V...

Страница 23: ...12 6 VDC per charging bay 895 mA per charging bay Physical dimensions and weight Charger Height Width Depth Weight Charger Power Supply Height Width Depth Weight with cable 5 8 inches 5 8 inches 3 0...

Страница 24: ...F Emissions CISPR 11 System Group 2 The AURA Intracranial Monitor System uses Group 2 limits The AURA Intracranial Monitor System must emit electromagnetic energy in order to perform its intended func...

Страница 25: ...ypical commercial or hospital environment Surge IEC 61000 4 5 1kV Differential 2kV Common 1kV Differential 2kV Common Mains power quality should be that of a typical commercial or hospital environment...

Страница 26: ...Hz 6V1 in ISM be tween 0 15MHz and 80MHz2 80 AM at 1kHz PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT Radiated RF IEC 61000 4 3 3V m 80MHz 2 7GHZ 80 AM at 1kHz 3V m 80MHz 2 7GHZ 80 AM at 1kHz PROFESSIO...

Страница 27: ...820 CDMA 850 LTE Band 5 Pulse modulation2 217 Hz 2 0 3 28 1720 1845 1970 1700 1900 GSM 1800 CDMA 900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation2 217 Hz 2 0 3 28 2450 2400 2750 WLAN 802 11 b...

Страница 28: ...not use if package is damaged Use by date Do not reuse single use device Mark for Nationally Recognized testing for safety standards Conforms to AAMI STD ES60601 1 IEC STD 60601 1 6 IEC STD 60601 1 8...

Страница 29: ...27 14 ASSOCIATED DEVICE LABELS PN T 0020 AURA Battery Charger Label PN T 0032 AURA Battery Label PN T 0012 AURA Monitor Label PN T 0039 AURATM Antenna Label...

Страница 30: ...28 PN T 0019 AURA Monitor Pack Sales Container Label PN T 0022 AURA Monitor Pack Shipping Container Label...

Страница 31: ...ction 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 le...

Страница 32: ...BRANCHPOINT MAKES NO GUARANTEES REGARDING THE QUALITY ACCURACY COMPLETENESS EFFECTIVENESS RELIABILITY OR USEFULNESS OF THE SOFTWARE OR RESULTS OBTAINED THEREFROM NO ORAL OR WRITTEN INFORMATION OR ADVI...

Страница 33: ...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 d...

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Страница 35: ...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...

Страница 36: ...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 T 0027 rev B...

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