NEUROShield™

Medical Image Processing Software User manual

Software – NEUROShield™ v3.0

User manual

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
TABLE OF CONTENTS

1 INTRODUCTION ..............................................................................................................4

1.1 IMPORTANT RESTRICTIONS AND WARNINGS ............................................. 4

1.2 INTENDED USE ....................................................................................................... 4

1.3 NEUROSHIELD™ INTRODUCTION................................................................... 5

1.4 INSTRUCTIONS AND INSTALLATION .............................................................. 5

1.5 REGISTERED TRADEMARK ............................................................................... 6

1.6 SOFTWARE VERSION............................................................................................ 6

1.7 PATIENT TARGET GROUP ................................................................................... 6

1.8 INTENDED USER .................................................................................................... 6

1.9 INDICATIONS .......................................................................................................... 6

1.10 CONTRAINDICATIONS ......................................................................................... 7

1.11 CLINICAL BENEFITS............................................................................................. 7

1.12 CLINICAL SAFETY................................................................................................. 7

1.13 PERFORMANCE CHARACTERISTICS .............................................................. 7

1.14 PRECAUTIONS ........................................................................................................ 8

1.15 LIMITATIONS .......................................................................................................... 8

1.16 SIDE-EFFECTS ........................................................................................................ 9

1.17 USAGE FREQUENCY ............................................................................................. 9

1.18 NOTICE TO THE USER .......................................................................................... 9

2 QUICK GUIDE ..................................................................................................................9

2.1 OVERVIEW OF FUNCTIONS IN THE NAVIGATION PANEL ........................ 9

2.2 SCANNER SETTINGS ........................................................................................... 15

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
3 ANALYSIS ........................................................................................................................22

3.1 ANALYSING MRIS ................................................................................................ 22

3.2 WARNING STATUS ............................................................................................... 22

4 IMAGES ............................................................................................................................22

4.1 CREATE OR DELETE AN IMAGE ..................................................................... 22

4.2 IMAGE DETAILS ................................................................................................... 23

4.3 SAVE PATIENT’S DETAILS ................................................................................. 23

4.4 VISUALIZATION ................................................................................................... 23

5 THE NEUROSHIELD™ ANALYSIS ............................................................................23

6 ADMINISTRATION ........................................................................................................26

6.1 USER AUTHENTICATIONS ................................................................................ 26

6.2 UPGRADES ............................................................................................................. 26

7 DATA BACKUP ................................................................................................................26

8 TROUBLESHOOTING ...................................................................................................26

8.1 WRONG EMAIL ADDRESS ................................................................................. 26

8.2 SECURITY CONTROLS ....................................................................................... 26

8.3 HOW TO SAFELY DECOMMISSION AND DISPOSE OF THE SYSTEM: .. 27

9 CONTACT INFORMATION ..........................................................................................27

10 SYMBOLS.........................................................................................................................27

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 1 Introduction

1.1 Important restrictions and warnings

NEUROShield™ should only be used as a tool to assess the volume of the Hippocampus
brain structure. It is not a diagnostic tool and should not be used as a replacement of a
qualified physician or trained practitioner.
It is recommended to read and understand this user manual and observe the caution and
warnings stated.
Users should contact In-Med Prognostics immediately to analyze any incident or software
malfunction, such as software shutdown, that occurred because of using the
NEUROShield™ software as intended.
Quality and format of the imaging data should follow the guidelines in the section named
“Quick guide” in this user manual, otherwise In-Med Prognostics cannot guarantee the
result.
The accuracy of the results of the NEUROShield™ software output may decrease when the
subject brain includes pathological features that are not present in the normal brain or lacks
features normally present. Thus, In-Med Prognostics cannot guarantee for the quality output
for brains with tumours or other structural abnormalities.
NEUROShield™ has anonymization in built and does not require the USER to add another
layer of anonymization to ensure the patient's confidentiality. However, the trained USER
must ensure that correct details are uploaded and reflected for the patient for optimal output.

1.2 Intended use

The NEUROShield™ medical image processing software is intended for automatic
labelling, visualization, and volumetric quantification of the Hippocampus brain structure
from a set of MR images.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
1.3 NEUROShield™ introduction
NEUROShield™ is a medical image processing software intended for automatic
labelling, visualization, and volumetric quantification of the Hippocampus brain
structure from magnetic resonance images. NEUROShield™ is intended to automate
the current manual process of identifying, labelling, and quantifying the volume of
HC brain structure identified on MR images. NEUROShield™ is aimed to be a support
tool for clinicians in assessing structural MRIs. NEUROShield™ describes the
analysis in a self-explicative volumetric Analysis.

1.4 Instructions and installation

NEUROShield™ has no extra hardware requirements. It can be used as a web-based
platform. It is known to work on the following browsers: Google Chrome or Safari.
It is compatible with Windows 7 and above and Mac OS.
Minimum supported web browser versions are:
Windows: chrome
100.0.4896.127 and above
MacOS:
Chrome is Version 101.0.4951.41 and above
Safari: Version 15.1 (17612.2.9.1.20) and above

It requires a stable internet connection and that the images that should be analysed
are in the computer where the NEUROShield™ Web Platform is accessible. If using
the web browser application, please ensure the firewall at the site has access to use
the NEUROShield URL. https://nsus.in-medprognostics.com/

The MRIs to be analysed using NEUROShield™ are marked during the scanning
process. The marked MRI will be sent through the established secure connection, and
the resulting segmented images and the NEUROShield™ Analysis can be viewed on
the NEUROShield™ viewer once processed.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 The following are security controls in place for three findings observed in VAPT:
1. NEUROShield™ has allowed the user to run the website on 443 ports or HTTPS
protocol.
2. NEUROShield™ software has provided an ability to apply and configure
Content- security- policy and X-Frame-Options headers in application code or
Web server configurations for application.
3. NEUROShield™ has allowed access to the AWS components only to In-Med
personnel through an internal AWS Virtual Private Cloud (VPC) network,
ensuring the privacy of the data.
4. The user needs to change the password using the “Forgot Password” feature
after initial login.

1.5 Registered Trademark

Ô

1.6 Software Version

NEUROShieldÔ Version 3.0

1.7 Patient target group

Only for patients between 55 to 90 years of age

1.8 Intended User

Neuroradiologists, Neurosurgeons, Trained Practitioners, Physicians & Clinicians

1.9 Indications
The NEUROShieldTM is indicated as a software tool to assist physicians in the diagnosis of
neurological conditions such as -
• Mild Cognitive Impairment (MCI),
• Dementia
• Alzheimer’s disease,

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
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 • Multiple Sclerosis,
• Epilepsy.

1.10 Contraindications
• Images for a patient who has undergone neurosurgery should not be uploaded and are
contraindicated.
• InMed Prognostics cannot guarantee for the quality output for brains with tumours or
other structural abnormalities.

1.11 Clinical benefits

Provides accurate and automated labelling, visualization, and volumetric quantification of
the Hippocampus brain structure, assisting clinicians in early detection, thereby reducing
diagnosis time and enabling the monitoring of the progression of neurological conditions.

1.12 Clinical Safety

● Ensuring patient data and medical images are securely stored, transmitted, and
accessed in compliance with data protection regulations.
● Implementation of robust error detection and recovery mechanisms to prevent adverse
events due to software malfunctions.

1.13 Performance characteristics

• NEUROShieldTM provides clinicians with specific data on brain volumes to evaluate
neurological conditions and monitor it over time.
• Fully Automated segmentation of structures and anomalies
• Volumetric Analysis of structures and anomalies
• Advanced Visualizations of Regions of interest
• Detection of atrophy at Initial Stage.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
1.14 Precautions
• If something unexpected occurs during the analysis which results in a failed process,
then an error message will pop up and the status will be “Failed”
• When the image being uploaded are not supported format the message stating “The
format of the case doesn’t seem correct, please upload a case with all the proper
DICOM files” shall be displayed.

1.15 Limitations
Summary of the requirements for the images provided to NEUROShieldTM software:
• 3D T1 MPRAGE or BRAVO or FFE images from a 1.5 or 3 T scanner.
• Thickness of the slices (a sub image that composes an MR image) should be as close
to 1 mm as possible (min. 0.9mm-max. 1.2 mm).
• There should be no gap between the slices.
• The quality of the picture should be good in the sense that the whole brain should be
present without any artifacts.
• Images for a patient who has undergone neurosurgery should not be uploaded and are
contraindicated.
Installation:
• Minimum supported web browser versions are:
o Windows – chrome 100.0.4896.127 and above
o Mac OS – chrome is version 101.0.4951.41 and above
o Mac OS – Safari version 15.1 (17612.2.9.1.20) and above
Data Format:
• The software only accepts uncompressed raw T1 3D GRE isometric DICOM image
format.
Create or delete an image:
• An image can be uploaded by a user. However, the NEUROShieldTM manager is the
only one that can delete an image, please contact the NEUROShieldTM manager as
soon as possible in such situations.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
1.16 Side-effects
• Delay in delivery of appropriate medical care leading to moderate injury.
• Not knowing the status of the report, unable to search the cases lead to inconvenience
to the user.
• Medical imaging can sometimes produce false positive results, leading to anxiety for
patients.

1.17 Usage Frequency

Reusable device

1.18 Notice to the User

In the event of malfunction of the device or changes in its performance that may affect
safety, or any serious incident that has occurred in relation to the device should be reported
to the manufacturer and the competent authority of the Member State in which the user
and/or patient is established.

2 Quick guide

2.1 Overview of functions in the navigation panel

Screenshots are available further in the guide.
1. Dashboard:
This is the NEUROShield™ platform dashboard

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 2. Login:
Login using ID and password provided.

3. Upload images:
User can upload the images by clicking on “Upload Study” located on the right panel.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 Click on “Browse” to select the images to be uploaded. The number of images that
can be uploaded depends on the skull size of the patient. The average number of
images is 250-300, but NEUROShield™ can support a maximum of 500 images
uploaded for a single study.
The user must fill in details like the patient’s age, sex, symptoms, condition etc.
After the details are filled in appropriately click on “upload”. Ensure the files
being uploaded are not more than 25 MB.

4. Reviewing cases: The User can review the past and new cases uploaded by them to
the NEUROShield™ platform, check the status of a case, open/download the
Analysis, view the segmentation in different planes.
Filter the cases using Patient ID, NSID, Gender and Age.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 Icons Description Dispy Area/Screen
Home Displays Worklist, Profile
Home/Worklist

Profile Displays Profile Worklist, Profile

Page

NEUROShield™ Logo Opens Home/Worklist Worklist, Profile

WorkList Opens WorkList Worklist, Profile, Report

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 Refresh Reloads WorkList Worklist

Upload Study Upload Patient Worklist

Details

Patient ID Search Filters results based Worklist

on Patient ID
search query

NSID Search Filters results Worklist

based on NSID
search query

Gender Search Filters results Worklist

based on Gender
search query
Age Search Filters results Worklist
based on Age
search query

Report (Action) Displays report of Worklist

corresponding
patient
View Opens viewer to Worklist
view the
segmentation image

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 Logout Logout from the Worklist, Profile
application

Download Report Downloads the Report

report in PDF
format
Next Page (>) Displays next page Worklist
of given table

Previous Page (<) Displays previous Worklist

page of given table

Sort Sorts the below fields: Worklist

• Patient ID
• Patient Name
• NSID
• Gender
• Age
• Current status
• Upload Source
• Uploaded Date
Reset Resets the entered Worklist
fields

Upload Uploads the patient Worklist

details

• Data format
The software only accepts uncompressed raw T1 3D GRE isometric DICOM image format.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
2.2 Scanner Settings
• 1.5 or 3 Tesla, pre-contrast 3D T1 Sagittal MPRAGE(Siemens), 3D T1 Sagittal
FFE(Philips), 3D T1 Sagittal Bravo (GE) protocol for the scanning settings to generate
MRIs. The protocol should be isometric.
• The scanner settings of the machines are given below: -

GE Healthcare 1.5T
Plane Sagittal

Mode 3D

Pulse seq SPGR

Pulse Sequence Zoom

Imaging Option EDR, IrP

TE Min Full
Prep Time (TI) 500 ms

Flip angle 10 deg

Bandwidth ~16 kHz
Frequency 256
Phase 256
Frequency Direction S/I

Nex 1

Phase fov 1
Shim Auto

Fov 25.0 - 29 cm

Slice Thickness 1. mm
Locs per Slab (Number of Slices) 160 - 170

Phased Array Uniformity Enhancement (PURE) On

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 Surface Coil Intensity Correction (SCIC) Off

GE Healthcare 3T
Plane Sagittal
Mode 3D

Pulse seq SPGR

Pulse Sequence Zoom

Imaging Option EDR, IrP

TE Min Full

Prep Time (TI) 600 ms

Flip angle 8 deg

Bandwidth ~31 kHz

Frequency 256

Phase 256

Frequency Direction S/I

Nex 1
Phase fov 1
Shim Auto

Fov 25.0 - 29 cm

Slice Thickness 1. mm

Locs per Slab (Number of Slices) 160 - 170

Phased Array Uniformity Enhancement (PURE) On

Surface Coil Intensity Correction (SCIC) Off

Philips 1.5T
FOV 240 - 256 mm
RFOV 100%

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 Matrix scan 192

Scan percentage 100%

Stacks 1

Slices 160 - 170

Slice thickness 1. mm

Slice orientation sagittal

Scan mode 3D
Technique FFE
Contrast enhancement T1

Fast Imaging mode TFE

TFE shot interval 2300 ms

Echoes 1
TE 4 ms

Flip angle 8 deg

TR shortest

TFE prepulse delay / TI 1000 ms

Water fat shift maximum

Gradient mode default

CLEAR On

Philips 3T
FOV 240 - 256 mm
RFOV 100%

Matrix scan 192

Scan percentage 100%

Stacks 1
Slices 160 - 170

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
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 Slice thickness 1. mm

Slice orientation sagittal

Scan mode 3D

Technique FFE

Contrast enhancement T1

Fast Imaging mode TFE

TFE shot interval 3000 ms

Echoes 1
TE shortest

Flip angle 8 deg

TR shortest
TFE prepulse delay / TI shortest
Water fat shift 1.8 pix

Gradient mode maximum

CLEAR On

Siemens 1.5T
Orientation Sagittal

Mode 3D

Sequence MPRAGE

Gradient Mode Fast*

Magn. Preparation Non-sel. IR

RF pulse type Fast

Excitation Non-sel.
TR 2400 ms

TE minimum
TI 1000 ms

In Med Prognostics
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 Flip Angle 8 deg

Bandwidth 180 Hz/pix

Base resolution 192

Averages 1

Concatenations 1

Phase Oversampling 0%

Slice Oversampling 0%
FOV phase 100%
FOV read 250 - 290 mm

Slice Thickness 1. mm

Slices per Slab (Number of Slices) 160 - 170

Filter None
Parallel Acquisition Technique (iPAT) Off

Prescan Normalize On

Siemens 3T
Orientation Sagittal
Mode 3D

Sequence MPRAGE

Gradient Mode Fast

Magn. Preparation Non-sel. IR

RF pulse type Fast

Excitation Non-sel.
TR 2300 ms
TE minimum

TI 900 ms
Flip Angle 9 deg

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
 Bandwidth 240 Hz/pix

Base resolution 192

Averages 1

Concatenations 1

Phase Oversampling 0%

Slice Oversampling 0%

FOV phase 100%

FOV read 250 - 290 mm
Slice Thickness 1. mm

Slices per Slab (Number of Slices) 160 - 170

Filter None
Parallel Acquisition Technique (iPAT) Off
Prescan Normalize On

Summary of the requirements for the images provided to NEUROShield™ software:

• 3D T1 MPRAGE or BRAVO or FFE images from a 1.5 or 3 T scanner.
• Thickness of the slices (a sub image that composes an MR image) should be as close to
1 mm as possible (min. 0.9mm-max. 1.2 mm),
• There should be no gap between the slices.
• The quality of the picture should be good in the sense that the whole brain should be
present without any artifacts.
• Images for a patient who has undergone neurosurgery should not be uploaded and are
contraindicated.

Good quality pictures are characterized as the image below:

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
Data Analysis
● Once a patient’s scans get uploaded, there are different statuses of the case: Processing,
Complete and Failed.
● After the status changes to “Complete”, the scan can be viewed using the viewer built in
the application and volumetric analysis can be downloaded as a PDF file.

In Med Prognostics
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CONFIDENTIAL. Original document. Effective date: 28.08.2023
 3 Analysis

3.1 Analysing MRIs

While running, the software displays the name of the different steps of the analysis in the
“status” column.
When the analysis is done, the image will have “Complete” as a status.

3.2 Warning status

If something unexpected occurs during the analysis which results in a failed process, then
an error message will pop up and the status will be “Failed”.
Common Errors:
1. When the images being uploaded are not supported format the message stating “The
format of the case doesn’t seem correct, please upload a case with all the proper
DICOM files” shall be displayed.

4 Images
4.1 Create or delete an image
An image can be uploaded by a user. However, the NEUROShield™ manager is the only
one that can delete an image, please contact the NEUROShield™ manager as soon as
possible in such situations.

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023
4.2 Image details
The only information needed from the patient is his/her age, gender, and patient ID.

4.3 Save patient’s details

All patients’ data (age, gender, and patient ID) are saved immediately after being retrieved
or entered.

4.4 Visualization
NEUROShield™‘s visualization tool allows the user to look at the uploaded and analyzed
images. The viewer shows the image in 3 planes. It specifies the left and right, with the
possibility to choose the radiological or neurological convention of image visualization.
You can also choose to see the crosshairs on the image so you can easily identify the point
of focus on the image in the three plans.

5 The NEUROShield™ Analysis

The Analysis can be divided into 5 distinct sections as displayed on the platform.

1) The NEUROShield Volumetric Analysis (NVA): This includes the information

concerning the user and the image analyzed. This section contains the patient details
entered during case upload by the USER:
- Patient ID
- Patient Name
- Patient Contact
- Patient Condition
- Patient Age
- Ref Physician
- Site Name
- Patient Gender
- Exam date

In Med Prognostics
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 2) Brain Volumetric Analysis: Provides volume of the Hippocampus brain structure.

There is no confidential information concerning the patient included in the report.

In Med Prognostics
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 The NEUROShield™ downloadable report:

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 6 Administration
6.1 User authentications
The user is provided with username and password at the time of the onboarding process.
They are requested to update this upon first logging into the NEUROShield™ platform.

6.2 Upgrades
The upgrades to the newer version of NEUROShield™ will be managed via the web
browser and the customer does not have to perform any steps to upgrade their version of
the product. A notice of a new version being launched will be communicated to the user
via email prior to release. After the release of the newer version logging into the platform
using the supported browser will directly be available to use the latest version of
NEUROShield™.

7 Data backup

All the data uploaded and entered in the web interface are saved to the server.

8 Troubleshooting

8.1 Wrong email address

• If you notice a mistake in the provided email ID, you must:
Contact tech support at In-Med Prognostics.
• The account which has the incorrect email address will be deactivated and deleted upon
your indication.
• Another account must be created using the correct information.

8.2 Security Controls

NEUROShield™ has the following controls in place:
• To mitigate information disclosure NEUROShield™ has a session token expiration set
for 60 minutes or 1 hour.

In Med Prognostics
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 • NEUROShield™ is running on an https protocol to provide security mechanism to
encrypt data and reduce chances of data interception.
• To mitigate the clickjacking vulnerability In-Med Prognostics has applied and
configured Content-security-policy and X-Frame-Options headers in application code
for NEUROShield™.

8.3 How to safely decommission and dispose of the system:

Steps for decommission:
• About the product’s decommissioning the existing customers will be informed via
email.
• All data, files, reports, and user information, including backed-up data, will be kept in
archive for a period of 10 years.
• The user can request their data from In-Med using the steps provided in the notification
email.

9 Contact information

For any further questions or need of technical support, contact us on:

Email: [email protected]
Address:
6th Floor, Awfis, The Kode 2, Baner Pashan Link Road, Baner, Pune, 411021, Maharashtra, India.
Website: https://inmed.ai/

10 Symbols

Symbol Name Symbol Symbol Description

Address: 6th Floor, Awfis, The Kode 2,

Baner Pashan Link Road, Baner, Pune,
Manufacturer
411021, Maharashtra, India.
Email: [email protected]

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 Symbol Name Symbol Symbol Description

Website: https://inmed.ai/
Ph. No.: 9673396831

Name: AMSTERMED B.V.

Authorized Address: Saturnusstraat 46-62, Unit 032, 2132

HB Hoofddorp, The Netherlands
representative in
Phone: +31235656337
the European
Community / Email: [email protected]

European Union Website: www.amstermed.nl

Manufacturer’s
Logo of Inmed Prognostics
Company Logo

Version 3.0 Version of software

Indicates the date when the medical

Date of
device was manufactured. &
manufacture
Including the Country of manufacture

Consult Indicates the need for the user to

instructions for use consult the instructions for use.

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Symbol Name Symbol Symbol Description

Medical device Indicates the item is a medical device

Unique Device Indicates a carrier that contains

Identifier Unique Device Identifier information

Once the Notified Body is

CE mark with the Notified Body
CE Mark finalized, we will mention the CE
number
mark with specified number

In Med Prognostics
NEUROShield Version 3.0 User Manual IMP-NS-SDLC-25-V01
CONFIDENTIAL. Original document. Effective date: 28.08.2023