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It is important to remember that the a chosen clinical protocols chosen often depend depends on the response of each patient, and the monitoring options available with equipment are based on clinical evidence found in literature. If in doubt, seek guidance from our technical support.

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The B4C System is designed to provide non-invasive monitoring of variation in intracranial pressure (ICP). The system ONLY monitors the intracranial pressure (ICP) curve pulse morphology, which can be shown as a surrogate ICP waveform on the brain4care application or, with the use of the optional receiver component, show the sensor waveform in a compatible multiparameter monitors that have Invasive Blood Pressure (IBP) or Invasive Pressure (IP) Module with sensitivities of 5 μV / Vex / mmHg or higher and have automatic amplitude window adjustment. This system does NOT monitor actual pressure in mmHg and, therefore, the signal shown in a on the mobile application or monitor should be assessed only by ICP its morphology and NOT by ICP absolute value. The BcSsPICNIW-1000 Sensor and B4C System is not intended for use as a standalone diagnostic tool; the surrogate ICP curve waveform is one element of a comprehensive clinical evaluation.

Info

ATTENTION - This sensor does NOT monitor ICP in mmHg and therefore the signal waveform shown in a monitor should be assessed only by its morphology and NOT absolute value.

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The B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and information for interpretationassociated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful pulses and cardiac pulse) for interpretation.

Refer to device labeling for more information regarding the derivation and interpretation of the output of the device.

Warning

WARNING - This sensor must only be operated by trained and qualified health professionals, who are responsible for knowing the protocol guiding use usage of the sensor as well as the care related to its purpose and use in patients.

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Allergic reactions due to hypersensitivity to sensor components.

3.1.4 contraindications

This system is contraindicated for use in pediatric patients.

The system is contraindicated for use in adult patients who have:

  • Undergone decompression craniectomy;

  • Cranial defects (portions of skull missing);

  • Any other conditions that the healthcare professional deems unsuitable for use of this device.

3.2 warnings and precautions

Warning

WARNINGS

  • The B4C System should only be used by trained and qualified health professionals.

  • The B4C System does not replace a comprehensive clinical evaluation. The waveform and report output should always be evaluated by the clinician in conjunction with other clinical parameters or analyses.

  • The BcSs-PICNIW-1000 Sensor and waveform and report output do not substitute ICP monitoring methods when measurement of the absolute value of ICP is required.

  • The medical professional is responsible for determining the additional clinical parameters or analyses required in addition to the BcSs-PICNIW-1000 Sensor waveform and report to make a clinically informed decision.

  • The appearance of a normal waveform morphology and report information does not eliminate the possibility of elevated intracranial pressure or irregularity in brain compliance.

  • Do NOT attempt to calibrate BcSs-PICNIW-1000 Sensor with your patient monitor. This may result in display of a misleading ICP value shown in the patient monitor that can be misinterpreted when making critical clinical decisions.

  • Make sure NO ICP value is shown in your patient monitor when the BcSs-PICNIW-1000 Sensor is connected. Make sure that the default question marks (? /?) or dashes (- / -) are shown instead.

  • MR Unsafe. The B4C System is not intended to be used in an MR (magnetic resonance) environment.

  • The type of protection of the sensor is IP00. So, keep the sensor and the receiver away from water or any type of liquids, to prevent any damage to the sensor or to the patient.

  • Do not leave the equipment near flammable chemicals such as alcohol, benzene, etc. Should they come in contact with electrical parts, this may result in fire or internal short circuit

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  • . The same is true with the use of some flammable disinfectants.

  • The clinician is reminded to assess the waveform morphology in real-time during a monitoring session. The B4C report is available for the clinician’s convenience to review associated waveform parameter estimates and other clinical observations entered in a past monitoring session.

Do not use this device on patients who have:

  • Multiple scalp injuries that make it impossible to correctly position the sensor;

  • Open head wounds;

  • Any other conditions the health practitioner deems to be unsuitable for use of this device.

Note

PRECAUTION

  • The position, or movement, of the patient and the BcSs-PICNIW-1000 Sensor is known to affect the signal being recorded. As a result, if multiple recording sessions are obtained on the same patient, consistent positioning of the patient and device will lead to more comparable recordings

  • Contact brain4care to receive training before operating the BcSs-PICNIW-1000 Sensor. The sensor may only be used by qualified individuals who have successfully completed training with a brain4care representative.

  • Read and understand the content of this user guide before use.

  • Manually clean and disinfect the device components before and after each patient’s monitoring session.

  • Do not subject the device to autoclave or other thermal disinfection or sterilization processes.

  • Perform corrective maintenance once a year, and if abnormal performance is observed.

  • All modifications and repairs must be exclusively performed by brain4care.

  • When disinfecting the sensor pin be careful to not apply excessive force.

  • If the device functionalities are lost due to EM disturbances, the waveform may not be accurate.

  • Ensure that your mobile device is set up with a strong password, not used in root mode, nor with unverified applications installed.

  • Verify with your facility’s clinical engineering team which receiver will match the monitor module plug in your caregiving area.

  • If the Essential Performance is lost due to EM disturbances, the waveform may not be accurate.

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note

PRECAUTION -

  • Be cautious when handling the headband due to risk of strangulation. Also avoid touching simultaneously the patient and a non medical device due to risk of electrical shock

3.3 clinical performance

Three clinical studies demonstrated the safety and effectiveness of the B4C System and for its intended use.

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These results demonstrated a statistically significant correlation in the ICP signal and waveform parameters between the B4C System and the gold standard invasive ICP monitoring device measured over time. While the study had a limited sample size, and further data may be necessary to develop a mapping between the B4C and invasive ICP parameters, the study outcomes demonstrate comparable effectiveness between the Braincare device and commonly used invasive ICP devices for use in monitoring and assessing variations in ICP waveform parameters over time.

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waveform parameters over time.

3.4 regulatory compliance

Medical equipment biocompatibility standards ISO 10993-10: 2010, EN ISO 10993-10: 2013 and ISO 10993-5: 2009.

Designed and manufactured in accordance with ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012 + Emend 1 (2016) and its side standards IEC 60601-1-2: 2014, ABNT NRB IEC 60601-1-6:2011 (identical to IEC 60601-1- 6: Ed.1.1b:2013), ABNT NRB IEC 60601-1-9:2014 (identical to IEC 60601-1-9 ED. 1.1 B:2013) and ABNT NBR IEC 60601-1-11:2012 (identical to IEC 60601-1-11:2010).Medical equipment biocompatibility standards ISO 10993-10: 2010, EN ISO 10993-10: 2013 and ISO 10993-5: 2009.

Equipment tested under specification FCC 47 CFR Part 15 Subpart C, §15.209 Radiated emission limits and General requirements RSS-GEN, Issue 4, Nov.2014, section 8.9 Contains FCC ID: 2AA9B04

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The BcAc-DG-1000 receiver module (dongle) enables the captured waveform reproduction on a multiparameter patient monitor. This reproduction transmission is done by pairing the sensor, which transmits data via Bluetooth, and the receiver, which transmits the same data by connecting to the monitor’s invasive pressure input. There are several versions of receivers, each with the connector adapted for a monitor model, . Please see Appendix 2 for more options.

Figure 3.5-3 BcAc-DG-1000 Receiver Module.

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For any questions regarding monitor compatibility, contact our technical support team (item 9).

3.5.4 headband

The headband is used to position the sensor on the patient’s head. It consists of a turnbuckle and several sized bands to fit each head sizeseveral band sizes. In addition to positioning, this accessory is intended to transmit all perimeter cranial expansion to the sensor.

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Tip

TIP - Most adults will need an M or L headband size while children typically use S or XS headband size headband.

3.5.5 external battery charger

The charger supplies power to the sensor’s removable external battery. It is a device designed to enable the external battery to be charged in a timely manner before the sensor’s internal battery discharges, ensuring continuous use of the sensor.

With side magnetic connectors on the sides, the charger is capable of connecting with two other chargers, allowing for up to three batteries to be simultaneously chargedsimultaneous battery charging.

Figure 3.5-5 External battery charger.

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The brain4care app can be used on tablets or mobile phones running Android 7.0 or higher with a minimum of 2 GB of RAM and Bluetooth® 4.2 or 5.0. It is intended to connect with the BcSs-PICNIW-1000 sensor and the BcAc-DG-1000 receiver. The app allows for real-time visualization of the sensor waveform curve and trend, that along with patient data, are sent to the cloud system where a monitoring report is processed and generated.

Info

ATTENTION - Use the brain4care mobile app only on tablets or mobile devices that meet the requirements set out defined in ANNEX 3 and comply with IEC 60601-1. The Bluetooth module of the mobile device must be FCC approved.

The app can be downloaded and installed from the Google Play Store using the steps below:

Step 1. On an Android phonemobile device, open the Google Play Store (1).

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Note

PRECAUTION - Ensure that your mobile device is set up with a strong password, ; do not used use it in root mode, nor with unverified applications installed

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Step 10. To use the brain4care application it is necessary to have a brain4care account, and your organization . Your corporate account manager must enable activate your user to use allow usage of the application and system. For details, see technical support or refer to the portal user guide /wiki/spaces/B4CDOC/pages/1812463629.

Info

ATTENTION - The device should not be set to power save mode as this may affect the mobile device and mobile app performance and functionality.