Branchpoint Technologies AURA TK101-A Instructions For Use Manual

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TK101-A

Revised 2018-09-13

Branchpoint Technologies

AURA

Monitor Pack

INSTRUCTIONS FOR USE

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1. SYSTEM DESCRIPTION

This AURA

Monitor Pack (TK101-A) contains one AURA

Monitor (TX101-A), two rechargeable batteries (TB101-A), one battery charger (TC101-A), one power supply, and one antenna (TA101-A).

This pack is intended to be used with AURA

Sensor Tray and AURA

Data

Receiver Pack, which are part of the AURA

ICP Monitoring System (Figure 1

and Table 1).

The AURA™ Monitor is a non-sterile, non-implantable hand-held device powered by rechargeable lithium ion batteries (included in this pack). The device has an OLED display screen and is controlled by buttons on its control panel. The AURA™ Monitor receives intra-cranial pressure (ICP) data via RF telemetry from a coupled AURA

Sensor and relays the ICP waveform to a paired AURA

Data

Receiver. The AURA™ Data Receiver makes it possible for the data obtained by the AURA™ Monitor to be displayed onto bedside patient monitor.

The AURA

Antenna is placed above the AURA

Sensor to provide power and receive data. It is held in place by the sterile Antenna Holster provided in the AURA

Sensor Tray (SP101).

Table 1: Components of the AURA™ ICP Monitoring System.

Component

Model #

AURA™ Sensor

SP101

AURA™ Monitor

TX101

AURA™ Antenna

TA101

AURA™ Data Receiver

DG101

AURA™ Battery

TB101

AURA™ Battery Charger

TC101

Figure 1: AURA™ ICP Monitoring System.

2. INDICATIONS FOR USE

The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.

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™ 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 supplied AURA™ Data Receiver and software application with the AURA™ Monitor.

No modifications of this equipment are allowed unless approved by Branchpoint Technologies. Additions or modifications may interfere with system performance.

The 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

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

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™ Monitor, batteries, battery charger, power supply, or antenna.

Tampering with the AURA

Battery could result in a hazard, such as fire,

explosion or shock.

By design, the AURA™ Monitor and its antenna emit radio frequency in the

13.56 MHz and 2.4 GHz bands. This may interfere with nearby medical or office

equipment. When using the AURA™ Monitor, closely monitor equipment in the

vicinity to verify normal operation.

The presence of other equipment operating in the same frequency bands used by the AURA™ Monitor may interfere with communication. Interference can occur even if the other equipment complies with the International Special Committee on Radio Interference (CISPR) emission requirements. This RF interference can be reduced by increasing the distance between the interfering device and the AURA™ Monitor. If communication problems persist, refer to the Troubleshooting section of this manual.

The use of any accessories with the AURA™ Monitor other than those specified

by Branchpoint Technologies in this manual may result in increased emissions

or decreased immunity of the AURA™ Monitor and may cause decreased functionality or unintended operational behavior of the AURA™ Monitor.

The use of the AURA

Monitor around strong sources of electromagnetism and

electric fields should be avoided.

For disposal of the AURA

Monitor Pack, follow applicable hospital procedures and local regulations or return the product to Branchpoint Technologies. Improper disposal of products may pose biohazards or environmental hazards.

During normal or single fault conditions, the AURA

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 detrimental clinical effects.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the AURA

ICP Monitoring System or AURA

Battery Charger, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

The Emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment.

6. PRECAUTIONS

Do not disassemble, alter, or modify any parts of the AURA™ Monitor or AURA™

Data Receiver.

The AURA™ Monitor Pack shall not be placed in oxygen rich environments. Use only the designated Branchpoint Technologies AURA™ Monitor and appropriate software application to communicate with the AURA™ Sensor and AURA™ Data

Receiver.

The AURA™ Monitor is intended for use by or under the direction of healthcare

professionals only.

The AURA™ Sensor and Antenna Holster are type BF applied parts. The AURA™ Monitor, AURA

Antenna, batteries, battery charger, and AURA

Data Receiver

are accessible parts.

Mishandling (such as dropping or crushing) could damage the AURA™ Monitor.

If you suspect damage to the AURA™ Monitor, contact your Branchpoint

Technologies representative or the customer service department for instructions and return packaging.

The AURA™ Monitor has been classified with an International Protection Marking of IP43. The AURA™ Monitor is therefore not waterproof or explosion-proof and

cannot be sterilized. Do not use it in the presence of flammable gas mixtures containing anesthetics, oxygen, or nitrous oxide.

The AURA™ Monitor may be affected by electrostatic discharge (ESD). If ESD occurs 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 pediatric use.

Avoid sources of ionizing radiation. If ionizing radiation must be used, avoid focusing near the AURA™ Sensor placement site. Ionizing radiation may damage the device, however, the damage may not be immediately detectable.

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 AURA™ Monitor labels. If

there is evidence of damage or tampering, do NOT use the product. Contact Customer Service, and Branchpoint Technologies will provide instructions for return.

Package contents include:

• AURA™ Monitor (1)

• AURA™ Antenna (1)

• Lithium Ion 11V rechargeable batteries (2)

• Battery Charger (1)

• Power Supply (1)

CONTROL PANEL

Figure 2: AURA™ Monitor Controls.

INSERTING AND CHANGING THE AURA™ BATTERY

To remove the battery:

• Press the release buttons on the sides of the battery pack (Figure 3).

• Slide the battery pack towards the bottom of the AURA™ Monitor (Figure

4).

• Lift up to remove the battery pack from the AURA™ Monitor (Figure 5).

Figure 3: Press 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 sides of both the battery and AURA™ Monitor

(Figure 6).

• Insert the battery into the AURA™ Monitor.

• Slide the battery forward into the AURA™ Monitor until the locking

mechanism is activated (Figure 7).

Figure 6: Line up and insert battery at guide markers.

Figure 7: Slide battery into place.

CHARGING THE AURA™ BATTERY

Figure 8: Slide batteries into battery charger.

To charge a battery, gently slide it into the battery charger (Figure 8). The LEDs next to the batteries will illuminate according to Table 3 below.

Table 3: Battery charger LED indicator status and indication.

LED Indicator

Indication

LED Indicator does not illuminate

No battery is charging

LED Indicator is solid blue

The battery is charging

LED Indicator is solid green

The battery is fully recharged

LED indicator is blinking blue

An error with the battery has been detected

NOTE: Battery Status LED indicator blinking blue indicates 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 ensure ready availability of power for the AURA

Monitor.

Each battery will typically provide at least 8 hours of battery life.

TURNING THE AURA

MONITOR ON AND OFF

To turn on, press the power button.

To turn off, press and hold the power button for two seconds until the display screen is deactivated.

READING BATTERY LEVEL

The battery level icon located on the upper right corner of the screen indicates the remaining battery level (Figure 9). The icon will be empty and flashing when the battery level is critically low.

Figure 9: Battery level icon on the upper right corner of the AURA

Monitor screen.

CONNECTING AND DISCONNECTING THE AURA™ ANTENNA

To connect the AURA™ Antenna to the AURA™ Monitor, align the arrows on the cable and connector (Figure 10) and until they click together (Figure 11). To disconnect the AURA

Antenna, hold the cable by the plug and pull. Do not pull the cable. Pulling on the cable may damage it in a way that 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 unpacking the AURA

Sensor Tray box, the User can run in-package

check for the pre-implantation status of the AURA

Sensor.

To run in-package check:

• Plug the antenna cable into the AURA

Monitor.

• Turn the AURA

Monitor on and select the button for in-package check.

The AURA

Monitor will start searching for the AURA

Sensor.

• Slowly move the AURA

Antenna around the marked area on the AURA

Sensor Tray box (Figure 12). The green light will illuminate on the antenna when the antenna is at the proper location. Hold the antenna at this location.

Figure 12: Positioning the AURA

Antenna at the sticker on the AURA

Sensor Tray box to run in-package check.

• If an AURA

Sensor is found, the AURA

Antenna will connect to the

AURA

Sensor and show its status.

• If no AURA

Sensor is found, the AURA

Monitor will display “No Sensor

Found.” Select the button to re-run the in-package check and try to

move the AURA

Antenna around the marked area again as the AURA

Sensor within the box may slightly shift during transportation. If failure

persists, please contact Branchpoint Technologies for further instruction.

• Another option to run in-package check is to remove the sterile pouch from

the AURA

Sensor Tray box and position the AURA

Antenna over the

AURA

Sensor visualized through the translucent side of the pouch.

CONNECTING TO AN AURA™ SENSOR

Ensure that an AURA

Antenna is connected and turn the AURA

Monitor on.

The device will display the following screen as it seeks an AURA

Sensor to

connect to.

CAUTION: DO NOT run an in-package check after the sensor has been inserted. This will lead to an erroneous failure message for functional sensors.

Place antenna directly over the AURA™ Sensor and into the Antenna Holster provided in the AURA

Sensor Tray (Figure 13). The Antenna Holster will hold

the AURA™ Antenna securely in place. The LED on the AURA

Antenna will

illuminate green upon successful connection to an AURA

Sensor.

Figure 13: Antenna Holster being affixed onto scalp above AURA™ Sensor.

CAUTION: Please ensure that the AURA

Antenna does not rest on or

contact the patient’s skin.

Upon successful connection, the AURA™ Monitor will display the sensor’s serial

number then begin to stream ICP data.

If an AURA™ Sensor is not found within 20 seconds, the screen will display the following screens:

Press to command the antenna to search for a sensor connection again.

NOTE: If is not pressed within 2 minutes, the AURA™ Monitor will turn off to save power.

After successfully pairing with the AURA™ Sensor, The AURA™ Monitor is now ready to pair with the AURA™ Data Receiver. Press button to start paring with the Data Receiver or open the menu and select “Pair Receiver.”

PAIRING WITH AN AURA™ DATA 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 AURA

Data Receiver is connected to the patient monitor

(Figure 14) and is calibrated (see AURA

Data Receiver Pack Instructions for

Use for directions).

Figure 14: AURA™ Data Receiver connecting into Patient Monitor IBP Port.

Press to continue pairing with a data receiver.

Select the serial number that matches the printed serial number on the label of the AURA™ Data Receiver being paired to (Figure 15).

Figure 15: Example of printed serial number on the label of AURA™ Data Receiver.

Select “Connect.”

The AURA

Monitor will start pairing with the AURA

Data Receiver.

After successfully paired with the AURATM Data Receiver, the AURATM Monitor will display the ICP.

NOTE: If the AURA

Data Receiver is not calibrated, after selecting

“Connect,” the screen will display reminders to calibrate receiver.

Calibrate receiver according to AURA

Data Receiver Instructions For Use.

After calibration for receiver is complete, the AURA

Monitor will

automatically display the ICP.

To unpair an AURA™ Data Receiver, press the Menu button and choose “Unpair Receiver” from the drop-down menu and then confirm unpairing. Unpairing will also occur when the AURA

Monitor is turned off. Note that if an AURA

Data

Receiver is briefly turned off and on, connection to the prior AURA

Monitor

may be automatically re-established.

SETTING ICP ALARM 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 disable the alarm, select “Disable.”

The User can set ICP alarm thresholds. To do so, select ICP High/Low Limit and use the Up and Down buttons to set the ICP threshold value. The LED light will flash when the alarm sounds for these thresholds as well.

NOTE: The factory default ICP low alarm trigger value is 7 mmHg and the default ICP high alarm trigger value is 20 mmHg. If the User changes these trigger values, they will persist across power cycles. Trigger values do not reset to factory settings if the device is turned off and on.

AUDIO TONES

The following table describes the audio output (including frequency, duration and tone) for different events.

Table 4: AURA™ Monitor Audio Output.

Event

Event Description

Audio

Startup

At power up.

880 Hz 250ms tone

Button Selection

Button (any except on/off) pressed.

880 Hz 50ms tone

Alarm (High Priority)

Enabled alarm condition detected. Audio pattern output repeatedly every 5 seconds until alarm cleared or user mutes the alarm.

A A A – A A | A A A – A A A = 440 Hz 100ms tone with 4

harmonics space indicates 50ms gap – indicates 250ms gap | indicates 2.5 second gap

Alarm (Medium Priority)

Enabled alarm condition detected. Audio pattern output repeatedly every 5 seconds until alarm cleared or user mutes the alarm.

A A A A = 440 Hz 150ms tone with 4

harmonics space indicates 150ms gap

Alarm (Low Priority)

Enabled alarm 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 indicates 200ms gap

Fault (Low Priority)

Fault condition detected. Audio pattern output repeatedly every 30 seconds until power off or user mutes the fault.

C A C = 523 Hz 200ms tone with 4

harmonics A = 440 Hz 200ms tone with 4 harmonics space indicates 200 ms gap

Sensor Pairing

The antenna pairs with the sensor.

D A D D = 587 Hz 100 ms tone A = 880 Hz 50 ms tone D = 1174 Hz 100 ms tone

space indicates 50 ms gap

Sensor Unpairing

The Antenna unpairs from the Sensor.

D A D D = 1174 Hz 100 ms tone A = 880 Hz 50 ms tone D = 587 Hz 100 ms tone space

indicates 50 ms gap

Data Receiver Pairing

The Monitor pairs with a receiver.

D D D = 587 Hz 100 ms tone D = 1174 Hz 100 ms tone

space indicates 50 ms gap

Data Receiver Unpairing

The Monitor unpairs from a receiver.

D D D = 1174 Hz 100 ms tone D = 587 Hz 100 ms tone space

indicates 50 ms gap

8. MAINTENANCE RECOMMENDATIONS

BATTERIES

If the AURA

Monitor will not be used for some time, remove batteries from the device and place in charging dock to ensure that fully-charged batteries are readily available when needed.

CLEANING

Keep AURA™ Monitor Pack devices and accessories away from dust and dirt. Clean the external surfaces of the devices immediately after each use and prior to re-use.

Do not use harsh chemicals, cleaning solvents, or strong detergents to clean any of the devices. Do not spray or pour cleaning solutions directly onto any devices or submerge them.

Recommended cleaning procedure:

1. Turn off the device.

2. Use a clean, soft, lint-free cloth dampened with isopropanol, Cidex® or

a non-staining chemical disinfectant to wipe the external surfaces of the devices.

3. Follow applicable hospital cleaning procedures and instructions on the

cleaning agent.

4. If the device came in contact with blood or bodily fluids, perform

intermediate disinfection per FDA and CDC guidelines.

5. Follow applicable instructions for the cleaning agent to remove excess

cleaning solution or residue. Otherwise, wipe devices using a clean, dry, lint-free 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, discontinue use and contact the Manufacturer.

SERVICE

There are no user-accessible or user-serviceable parts or components in the

AURA™ Monitor Pack. If any service, repair, or replacement of internal components is needed, the AURA™ Monitor Pack must be returned to

Branchpoint Technologies. For instructions and return packaging, contact Branchpoint Technologies 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

Perform a visual inspection and verify the following prior to each use:

• Mechanical and functional integrity of the AURA™ Monitor, cables, and

accessories.

• Legibility and adherence of the AURA™ Monitor labels.

DISPOSAL

To dispose of, return, or exchange an AURA™ Monitor, contact Branchpoint Technologies using the information on the back cover of this manual or dispose

in accordance with appropriate hospital policy. Do not dispose of the AURA™

Monitor in the trash or at electronics recycling facilities.

9. TROUBLESHOOTING

This section presents potential AURA™ Monitor operational issues and

recommended solutions. Contact Branchpoint Technologies using the information on the back cover of this manual for additional assistance.

TROUBLE CONNECTING WITH THE AURA™ SENSOR OR POOR QUALITY OF SERVICE

• The AURA™ Monitor will display the messages: “Sensor Connection Lost,”

“Reposition Antenna, Check Connections,” or “Sensor Error” to indicate an

AURA

Sensor connection issue.

• Reposition the AURA

Antenna and check connections until a good connection is re-established between the AURA™ Sensor and AURA™ Monitor.

NOTE: If the AURA™ Monitor cannot connect to an AURA

Sensor, try

repositioning the AURA

Antenna.

TROUBLE CONNECTING WITH THE AURA™ DATA RECEIVER OR POOR

QUALITY OF SERVICE

• The AURA

Monitor will state “No Receivers Found” if it does not find any

receivers ready for connection. In this case, verify that no other AURA

Monitor is already connected to the target AURA

Data Receiver.

• The AURA™ Monitor will display the words “Pairing Failed,” “Receiver Error,”

or “Connect Receiver” to indicate failure to connect with a selected AURA

Data Receiver. If the AURA

Monitor fails to communicate with the AURA

Data Receiver or determines there is a poor Quality of Service, it will automatically disconnect from the AURA

Data Receiver.

• Verify there are no potential sources of interference in close proximity to

the AURA™ Monitor or AURA

Data Receiver.

• Check the connection of the AURA

Data Receiver to the patient monitor.

• After verification, reset the AURA™ Monitor.

POINT MEASUREMENT MODE

In point measurement mode, the patient monitor displays ICP as a series of flat line values (10 to 30 seconds at each consecutive averaged value) instead of an ICP waveform. The point measurement mode allows the ICP monitoring system to operate in a low power state. When in this mode, try re-positioning the AURA

Antenna for better alignment with the AURA

Sensor. The system will automatically transition out of point measurement mode when the issue is resolved.

ALARMS

Table 5 lists all possible alarms that can be displayed to the User based on their significance, LED indicator status, and the audio alarm priority.

If a medium priority and a low priority alarm are active at the same time, the AURA

Monitor will only sound the medium alarm.

If two or more medium alarms are active at the same time, the AURA

Monitor will cycle through all of them and display the alarm text for each alarm as shown in Table 5.

Table 5: Alarms Condition, Display, LED status, and Audio Alarm output level.

Alarm Condition

Display

LED

Audio Alarm

Max. ICP Exceeded

Flashing “HI” text to left of ICP average

Medium

Min. ICP Exceeded

Flashing “LO” text to left of ICP average

Medium

In Package Check Failure

“Sensor Check Failure”

None

Monitor Over Temperature

“Monitor Cooling”

Medium

Battery Temperature High

Screen 1: “Battery Temp High”

Screen 2: “Change Battery, Check Manual”

Medium

Low Battery

Screen 1: “Battery Low”

Screen 2: “Change Battery”

Medium

Critically Low Battery

Screen 1: “Battery CRITICAL”

Screen 2: “Change Battery”

Medium

Receiver Not Calibrated

Screen 1: “Receiver Not Calibrated”

Screen 2: “Calibrate Receiver”

Low

Receiver Issue

Screen 1: “Receiver Error”

Screen 2: “Connect Receiver”

Low

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.

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

NOTE: “Harmful interference” is defined by the FCC as follows: Any emission, radiation or induction that endangers the functioning of a radio navigation service or of other safety services or seriously degrades, obstructs or repeatedly interrupts a radio communications service operating in accordance with FCC rules.

ESSENTIAL PERFORMANCE

Essential performance is maintained as long as the AURA

ICP Monitoring System can be brought back into a functional state to measure and display ICP to the user without requiring surgical intervention to remove or replace the sensor.

The performance limit for ICP measurement accuracy is ± 2 mmHg for ICP values of 0 to 20 mmHg, and ± 10% for ICP values above 20 mmHg during normal and single fault conditions.

FEDERAL COMMUNICATIONS COMMISSION (FCC) COMPLIANCE

AURA

Monitor contains FCC ID T7V1740.

AURA

Antenna contains FCC ID 2AJW602. This product complies with Part 18

of the FCC rules.

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

Branchpoint Technologies could void the user’s authority to operate

the equipment.

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 consequential 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.

12. TECHNICAL SPECIFICATIONS

AURA™ ICP MONITORING SYSTEM

TECHNICAL AND PERFORMANCE 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.

10 mmHg: 34 Hz

20 mmHg: 38 Hz

50 mmHg: 23 Hz

AURA

Monitor displays a 1

second moving average.

Slew rates The slew rates (the system’s fastest output during a

unit of time) from zero to peak and peak to zero for peak pressures of 10, 20, and 50 mmHg.

10 mmHg: 0.79 mmHg/ms

20 mmHg: 1.68 mmHg/ms

50 mmHg: 2.06 mmHg/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

With decreasing pressure:

10 mmHg: 7.74 ms 20 mmHg: 8.99 ms 50 mmHg: 9.10 ms

Pressure range of the AURA™ ICP Monitoring System including display range.

-20 to 100 mmHg

Accuracy of ICP range.

-20 to 20 mmHg: ± 2 mmHg

20 to 100 mmHg: ± 10%

Length of time over which the device will maintain

the specified accuracy.

29 Days

Pressure stability over temperature.

The stability of pressure measurement is not affected by sensor temperature between

25°C to 39°C.

The expected drift of the zero-point reading of the AURA

Sensor.

First 24 hours: < 0 ± 2 mmHg per day

29 days:

< 0.3 mmHg per day

AURA™ MONITOR SPECIFICATIONS

Physical dimension and weight

Height

Width

Depth

Weight (with battery inserted)

7.8 inches

3.7 inches

1.8 inches

700 grams

Temperature limits

Operating

Storage

15°C to 30°C

0°C to 50°C

Humidity limits

Operating

Storage

20-85% R.H., non-condensing

Pressure limits

Operating

Storage

795 mmHg to 700 mmHg

795 mmHg to 375 mmHg

RF data transmission

(AURA

Monitor and AURA

Antenna)

Frequency range

2.40 - 2.48 GHz

Output power

0dBm (0.001 watts)

Modulation

GFSK FHSS

Wireless power

(AURA

Antenna)

Frequency range

13.553 - 13.567 MHz

Output power (variable)

Less than 4.5W

Transmission distance

AURA

Antenna to AURA

Sensor

AURA™ Monitor to AURA

Data Receiver

1.5 cm

7 meters

Software

Version

BLE: SW-0008 rev. A

MCU: SW-0006 rev. C

AURA

ANTENNA SPECIFICATIONS

Physical dimension and weight

Height

Width

Depth

Weight

AURA

Antenna cable length

3.3 inches

1.8 inches

0.8 inches

63 grams

5 ft 0.2 inches

Transmission distance

AURA

Antenna to AURA

Sensor

AURA™ Monitor to AURA

Data Receiver

1.5 cm

7 meters

Wireless power

Frequency range

13.553 - 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

Physical dimension and weight

Height

Width

Depth

Weight

5.2 inches

3.4 inches

1.1 inches

400 grams

Temperature limits

Operating

Storage

15°C to 30°C

0°C to 50°C

Humidity limits

Operating

Storage

20-85% R.H., non-condensing

Pressure limits

Operating

Storage

795 mmHg to 700 mmHg

795 mmHg to 375 mmHg

AURA™ BATTERY CHARGER SPECIFICATIONS

Charger AC power supply input requirements

Voltage

Frequency

100 - 240 VAC

50-60 Hz

Charger Power Supply output

Voltage

Power

15 VDC

30W

Charging output

Voltage

Current

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

3.0 inches

375 grams

3.3 inches

2.8 inches

1.9 inches

450 grams

Temperature limits

Operating

Storage

15°C to 30°C

0°C to 50°C

Humidity limits

Operating

Storage

20-85% R.H., non-condensing

Guidance and Manufacturer’s Declaration - Emissions

The AURA™ Intracranial Monitor System and AURA™ System Battery Charger are

intended for use in the electromagnetic environment specified below. The customer or user of the AURA™ Intracranial Monitor System and AURA System Battery Charger should ensure that they are used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF 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 function. Nearby equipment may be affected.

Battery Charger

Group 1

The AURA™ System Battery Charger RF emissions are

very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class A

The AURA™ Intracranial Monitor System and AURA

System Battery Charger are suitable for professional establishments only.

Harmonics IEC 61000-3-2

Class A

Flicker IEC 61000-3-3

Complies

Guidance and Manufacturer’s Declaration – Immunity

The AURA™ Intracranial Monitor System and AURA™ System Battery Charger are

intended for use in the electromagnetic environment specified below. The customer or

user of the AURA™ Intracranial Monitor System and AURA™ System Battery Charger

should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

ESD IEC 61000-4-2

±4kV Contact ±8kV Air

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the r/h should be at least 30%

EFT IEC 61000-4-4

±2kV Mains

±1kV I/O’s

±2kV Mains ±1kV N/A

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1kV Differential ±2kV Common

Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips/ Dropout IEC 61000- 4-11

>95% Dip for

0.5 Cycle

>95% Dip for 1 Cycle

30% Dip for 25/30 Cycles

>95% Dip for 250/300 Cycles

>95% Dip for

0.5 Cycle

>95% Dip for 1 Cycle

30% Dip for 25/30 Cycles

>95% Dip for 250/300 Cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the

AURA™ System Battery Charger

requires continued operation during power mains interruptions, it is recommended

that the AURA™ System Battery

Charger be powered from an uninterruptible power supply or a battery.

Power Frequency 50/60Hz Magnetic Field IEC 61000- 4-8

3 A/m

3A/m

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

Guidance and Manufacturer’s Declaration – Immunity

The AURA™ Intracranial Monitor System and AURA™ System Battery Charger are intended for use in the electromagnetic environment specified below. The customer or

user of the AURA™ Intracranial Monitor System and AURA™ System Battery Charger

should ensure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

Conducted RF IEC 61000-4-6

0.15MHz-80MHz 6V

in ISM between

0.15MHz and 80MHz

80% AM at 1kHz

0.15MHz-80MHz 6V

in ISM between 0.15MHz and 80MHz

80% AM at 1kHz

PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT

Radiated RF IEC 61000- 4-3

3V/m 80MHz – 2.7GHZ 80% AM at 1kHz

PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT

r.m.s. before modulation is applied.

The ISM (industrial, scientific, and medical) bands between 0.15 MHz and 80 MHz are

6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and

40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are

1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.

Guidance and Manufacturer’s Declaration – Immunity

The AURA™ Intracranial Monitor System is intended for use in the electromagnetic environment specified below. The customer or user of the AURA™ Intracranial Monitor

System should ensure that it is used in such an environment.

Test Frequency

Band

Service

Modulation

Maximum Power

Distance

Immunity Test Level

MHz

Meters

(V/m)

385

380-390

TETRA 400

Pulse modulation

18 Hz

1.8

0.3

450

430-470

GMRS 460,

FRS 460

FM3 ± 5 kHz deviation 1 kHz sine

0.3

710 745 780

704-787

LTE Band 13, 17

Pulse modulation

217 Hz

0.2

0.3

810 870 930

800-960

GSM 800/900, TEETRA 800, iDEN 820,

CDMA 850,

LTE Band 5

Pulse modulation

217 Hz

0.3

1720 1845 1970

1700- 1900

GSM 1800;

CDMA 900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

Pulse modulation

217 Hz

0.3

2450

2400- 2750

WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

Pulse modulation

217 Hz

0.3

28 5240

5500 5785

5100 – 5800

WLAN

802.11a/n

Pulse modulation² 217 Hz

0.2

0.3

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

¹ For some services, only the uplink frequencies are included.

² The carrier shall be modulated using a 50 % duty cycle square wave signal.

³ As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

13. PACKAGING AND DEVICE SYMBOLS

The Following symbols may be used on the AURA™ Monitor, its accessories, and their packaging.

Symbol

Specification

Symbol

Specification

Consult instructions for

use

Manufacturer

Temperature limitations

Date of Manufacture

Atmospheric limitations

Sterilized using ethylene oxide

Humidity limitations

Do not resterilize

Serial Number

Non-ionizing electromagnetic

radiation

Reference/ Catalogue

Number

Caution

Lot Number

Do 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

Non-sterile

WEEE- Waste, Electrical,

and Electronic Equipment

(WEEE). Indicates separate

collection for electrical and electronic equipment (i.e., do not throw this device in

the trash).

Caution: Federal (USA) law restricts

this device to sale by or on the order

of a physician

Federal Communications

Commission (FCC)

IPXX

International Protection Rating

Type BF Applied Part

Class II Electrical Appliance

Non-Pyrogenic

Contains Lithium Ion Batteries

MR Unsafe

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 AURA

Antenna Label

PN T-0019 AURA™ Monitor Pack Sales Container Label

PN T-0022 AURA™ Monitor Pack Shipping Container Label

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 Technologies, Inc. and, where applicable, its licensors (collectively “Branchpoint”) for the software (“Software”) and associated documentation (“Documentation”) used in connection with the AURA ICP Monitoring System.

BY 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 conditions of this Agreement, please do NOT use the software.

1. GRANT OF LICENSE

Branchpoint hereby grants to you a personal, limited, non-exclusive, non-sub-licensable, nontransferable, nonassignable license to use the Software as installed on your purchased product.

Disabling Mechanism Applicable to All Users Your license may allow you to use the Software only for a specific duration. THE SOFTWARE MAY CONTAIN 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 Documentation, 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 Branchpoint 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, including, 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.

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 Agreement.

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 capability. 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 Branchpoint; 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, WHETHER

EXPRESS, IMPLIED, OR STATUTORY, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF NONINFRINGEMENT, 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 SOFTWARE 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

patient’s 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 provider. 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 provider’s responsibility. You understand and agree that the responsibility for the medical treatment rests with the health care provider and revolves around the health care provider’s judgment and the health care provider’s analysis of the patient’s condition. 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 provider’s judgment and analysis of the patient’s 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 patient’s 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 LIMITATION, NEGLIGENCE, CONTRACT, BREACH OF WARRANTY, ABSOLUTE LIABILITY IN TORT, MISREPRESENTATION OR OTHERWISE) UNDER WHICH IT IS ESTABLISHED, IN NO EVENT SHALL BRANCHPOINT OR ITS LICENSORS 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 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.

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, BRANCHPOINT’S 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 ARISING 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 notifying 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 within 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, notwithstanding 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 Branchpoint’s 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 Branchpoint’s 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 Branchpoint’s 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, Branchpoint’s licensors shall be third party beneficiaries under this Agreement. This Agreement will not be governed by the United Nations Convention on Contracts 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.

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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

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

Branchpoint Technologies AURA TK101-A Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual