Branchpoint Technologies AURA Manuale utente

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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

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 ve 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 qualied

neurosurgeons in the direct monitoring of intracranial pressure in the parenchy-

ma for neurological patients.

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™ 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.

• AURA™ Monitor Kit Instructions for Use

• AURA™ Data Receiver Instructions for Use

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 qualied 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 specied 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 specied

indications may result in patient or operator harm.

There are no user serviceable components within the AURA™ ICP Monitoring

System. Any additions or modications 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 0°C to 50°C (32°F to 122°F) storage range. Usage outside of specied

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.

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 elds 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 elds, 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.

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 for in-package check and place AURA™Antenna over AURA™ ICP

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.

• 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 patient’s scalp.

• Make the necessary incision at Kocher’s 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.

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.

Figure 3

Figure 2

• 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 ush 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.

• Using the appropriate technique, close and dress the surgical site (Figure 6).

PAIRING THE AURA™ ICP SENSOR TO THE AURA™ MONITOR

• Turn the AURA™ Monitor “ON.”

• Place AURA™ Monitor Antenna into Antenna Holster and afx 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 afxed onto scalp above AURA™ ICP Sensor.

Figure 4 Figure 5

Figure 6

• 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 patient’s scalp.

 Carefully remove the Antenna Holster by peeling it away from the patient’s

scalp.

 Dispose the Antenna Holster in accordance with applicable hospital policy

and regulations.

REMOVING AND DISPOSING THE AURA™ ICP SENSOR

• Prep and drape incision location in a sterile fashion.

• 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.

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 modications not expressly approved by Branch-

point Technologies could void the user’s 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 tness 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.

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