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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 t

he AURA™ Monitor, read and follow all instructions, warnings, and 

precautions provided in the AURA™ Monitor Pack manual and in the manuals for 

the other system components. Manuals for the other system components are 

listed below.

 

 

AURA™ Sensor 

Tray Instructions for Use 

 

AURA™ Data Receiver Pack Instructions for

 Use 

These manuals are also made available on the Internet and can be found at 

www.auramonitor.com.

 

5.

 

WARNINGS 

There are no user-serviceable components inside this device. Refer servicing 

to authorized personnel only. Unauthorized servicing, modification, or internal 

access may be hazardous or damage the product.

 

Use only the Branchpoint Technologies supplie

d AURA™ Data Receiver and 

software ap

plication with the AURA™ Monitor.

 

No modifications of this equipment are allowed unless approved by Branchpoint 

Technologies. Additions or modifications may interfere with system 

performance.

 

T

he AURA™ Monitor is MR 

Unsafe 

 keep away from magnetic resonance 

imaging (MRI) equipment.

 

Do not subject the AURA™ Monitor to temperatures outside of the 0°C to 50°C 

(32°F to 122°F) storage range. Exposure to high temperatures may cause the 

AURA™ Monitor to 

overheat and may reduce its performance and service life.

 

The AURA

TM 

Monitor Pack components are only for use in non-condensing 

humidity conditions.

 

Do not discard the AURA™ Monitor in a fire or incinerate.

 

Do not immerse the AURA™ Monitor in liquid of any kind. AURA

TM 

Monitor will be 

permanently damaged if it is submerged in liquid. Continued usage after 

submersion may result in further damage. If the AURA™ Monitor gets wet, turn 

the device off, disconnect all cables, remove the battery, wipe the wet surfaces 

dry, and contact Branchpoint Technologies customer service. Do NOT attempt to 

dry the AURA™ Monitor in an oven, microwave, or

 dryer.

 

Only power the AURA™ Monitor with the provided lithium

-ion batteries. Using 

other sources of power may be hazardous or cause damage to the AURA™ 

Monitor. Only recharge the lithium-ion batteries with the provided charger and 

power supply (REF# WSA515MD). Using other sources of power may be 

hazardous or cause damage to the batteries.

 

The AURA™ Battery Charger should be positioned to allow immediate 

disconnection from the supply mains. Connection and disconnection can be 

established by plugging and unplugging the power supply from mains.

 

Always keep the spare battery charging while the other is in use to ensure 

continuous availability of power. Change batteries as needed.

 

Never use a damaged battery or damaged AURA™ Monitor. Doing so could 

result in user injury.

 

To avoid risk of electric shock, do not disassemble the AURA™ Monit

or, 

batteries, battery charger, power supply, or antenna.

 

Summary of Contents for AURA TK101-A

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

Page 2: ...This page intentionally left blank...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 34: ...This page intentionally left blank...

Page 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...

Page 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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