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Feature #4756

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General Test cases - ADM 4 Channel EEG devices

Added by Sudalaimani C 9 days ago. Updated 9 days ago.

Status:
New
Priority:
Normal
Start date:
07/29/2026
Due date:
08/03/2026 (4 days late)
% Done:

0%

Estimated time:
Planned Due Date:

Description

Hardware:
1. Make V 1.1 EEG devices - 2 Nos
2. Test cases: Prepare the spec: Signal Quality, SNR - Identify the calculation (Ratio-based testing), CMRR, Impedance (Measure), Sampling rate, Gain, Number of Channels - Check their performance
3. Make the test report by repeating the tests using different signal sources (CDAC-developed source, Axxonet source)
4. Simultaneous recording of EEG data along with Axxonet and Natus by alternating the electrode placement of the device at the same time
5. Test the signal quality at various sampling rates
6. Tests based on IEC6060 - 1
1.
Basic Safety & Essential Performance – ME equipment must function safely under normal and fault conditions per IEC 60601-1.
2. Risk Management – A documented risk assessment process must identify, evaluate, and mitigate potential hazards.
3. Electrical Safety – Protective measures like insulation, grounding, and leakage current limits must prevent electric shock.
4. Mechanical Safety – Devices must withstand handling, vibrations, and sterilization without compromising functionality.
5. Environmental Conditions – Equipment should tolerate temperature, humidity, and electromagnetic interference within specified limits.
6. Marking & Documentation – Proper labels, symbols, and manuals must be provided for safe operation and compliance.

Embedded coding Module (Firmware):

1. Test cases for filters and sampling rate

Anesthesia Software Module:
1. Anesthesia Depth Score algorthm
2. Reliability of Software (Crash)
3. Packet loss

Actions #1

Updated by Sudalaimani C 9 days ago

  • Due date set to 08/03/2026
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