# US 11,896,378 B2 · Integrity verification system for testing high channel count neuromonitoring recording equipment

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- Number: US 11,896,378 B2
- Document ID: US11896378B2
- Status: Granted
- Kind: B2
- Application number: 17/931,188
- Filed: 2022-09-12
- Published: 2023-03-09
- Granted: 2024-02-13
- Earliest claimed: 2018-11-09
- Applicants: Cadwell Laboratories, Inc.
- Inventors: Ethan Rhodes; Richard A. Villarreal; John A. Cadwell; Rose Rehfeldt
- Web page: https://patentgrep.com/patent/US11896378B2

## CPC

- A61B 5/291: for electroencephalography [EEG]
- A61B 5/31: for electroencephalography [EEG]
- A61B 5/383: Somatosensory stimuli, e.g. electric stimulation
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- A61N 1/08: Arrangements or circuits for monitoring, protecting, controlling or indicating {(for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925)}
- G01R 31/2812: {Checking for open circuits or shorts, e.g. solder bridges; Testing conductivity, resistivity or impedance (of connections G01R31/66)}
- G01R 31/2829: {Testing of circuits in sensor or actuator systems (testing of apparatus for measuring electric or magnetic variables G01R35/00; testing of indicating or recording apparatus G01D; in airbag systems B60R21/0173; checking gas analysers G01N33/007; monitoring or fail-safe circuits for electromagnets H01F7/1844)}
- A61B 5/4094: {Diagnosing or monitoring seizure diseases, e.g. epilepsy}
- A61B 2560/0276: Determining malfunction
- A61N 1/36025: {for treating a mental or cerebral condition}
- A61N 1/3603: {Control systems}
- A61N 1/3614: {based on impedance measurement}
- A61N 2001/083: {Monitoring integrity of contacts, e.g. by impedance measurement}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12)

## Abstract

Methods of performing diagnostic tests on electroencephalography (EEG) recording devices comprising at least one stimulator coupled with a plurality of EEG electrode recording channels and corresponding recording channel connectors are performed by a test fixture comprising a plurality of resistors coupled with one or more of the EEG electrode recording channels and corresponding recording channel connectors. The methods include performing an impedance test for determining if each EEG recording channel of the EEG recording device has a predefined impedance, performing a channel uniqueness test for each EEG recording channel, performing a test for verifying the state of a switch of the stimulator of the EEG recording device, and performing a test for verifying connector IDs of the recording channel connectors connecting the EEG electrodes to respective EEG recording channels.

## Claims

### Claim 1

A method of performing a diagnostic test on an electroencephalography (EEG) recording device, wherein the EEG recording device comprises at least one stimulator having a plurality of EEG electrode recording channels, the method comprising:
performing an impedance test to determine if each EEG recording channel of the plurality of EEG electrode recording channels has a predefined impedance;
performing a channel uniqueness test on each EEG recording channel of the plurality of EEG electrode recording channels; and
performing a test to verify a functionality for each EEG recording channel of the plurality of EEG electrode recording channels.

### Claim 2 (depends on 1)

The method of claim 1, wherein the impedance test is performed using a hardware testing device comprising a plurality of resistors, wherein each of the plurality of resistors is coupled with one or more of the plurality of EEG electrode recording channels.

### Claim 3 (depends on 1)

The method of claim 1, wherein the channel uniqueness test is performed using a hardware testing device comprising a plurality of resistors, wherein each of the plurality of resistors is coupled with one or more of the plurality of EEG electrode recording channels.

### Claim 4 (depends on 1)

The method of claim 1, wherein the functionality verification test is performed using a hardware testing device comprising a plurality of resistors, wherein each of the plurality of resistors is coupled with one or more of the plurality of EEG electrode recording channels.

### Claim 5 (depends on 1)

The method of claim 1, wherein the at least one stimulator comprises a constant voltage test stimulator.

### Claim 6 (depends on 5)

The method of claim 5, wherein the constant voltage test stimulator comprises a stimulator anode adapted to connect to a first set of switches of the at least one stimulator, a stimulator cathode adapted to connect to a second set of switches of the at least one stimulator, and a ground connect.

### Claim 7 (depends on 6)

The method of claim 6, wherein the first set of switches comprises high side switches and wherein the second set of switches comprises low side switches.

### Claim 8 (depends on 1)

The method of claim 1, further comprising performing a test to verify a state of a switch of the at least one stimulator of the EEG recording device.

### Claim 9 (depends on 8)

The method of claim 8, wherein performing the test adapted to verify the state of the switch of the at least one stimulator of the EEG recording device comprises performing a test adapted to verify a state of high side switches.

### Claim 10 (depends on 9)

The method of claim 9, wherein performing the test adapted to verify the state of the high side switches comprises:
connecting one of the high side switches with one of a plurality of resistors in a hardware testing device;
connecting the plurality of EEG electrode recording channels with the plurality of resistors of the hardware testing device;
injecting a stimulus into the one of the high side switches, wherein the stimulus is defined by a predefined voltage level or a predefined current level;
measuring a voltage on at least one of the plurality of EEG electrode recording channels; and
verifying that the one of the high-side switches is connected with at least one of the plurality of resistors if the measured voltage is equal to the stimulus.

### Claim 11 (depends on 10)

The method of claim 10, wherein inj ecting the stimulus comprises injecting a stimulus having a constant voltage or a stimulus having a constant current.

### Claim 12 (depends on 8)

The method of claim 8, wherein performing the test adapted to verify the state of the switch of the at least one stimulator of the EEG recording device comprises performing a test adapted to verify a state of low side switches.

### Claim 13 (depends on 12)

The method of claim 12, wherein performing the test adapted to verify the state of the low side switches comprises:
connecting a high-side switch to one of the plurality of resistors and one of the low-side switches to one of the plurality of resistors;
connecting at least one of the plurality of EEG electrode recording channels with at least one of the plurality of resistors;
injecting a stimulus into the high-side switch;
measuring a voltage on at least one of the plurality of EEG electrode recording channels; and
verifying that the one of the low-side switches is working if the measured voltage is at a ground potential.

### Claim 14 (depends on 13)

The method of claim 13, wherein injecting the stimulus comprises injecting a stimulus having a constant voltage or a constant current.

### Claim 15 (depends on 1)

The method of claim 1, wherein performing the channel uniqueness test comprises:
connecting a hardware testing device to the EEG recording device;
connecting at least one resistor to at least one of the plurality of EEG electrode recording channels; and
determining an electrode connected status for the at least one of plurality of EEG electrode recording channels.

### Claim 16 (depends on 15)

The method of claim 15, wherein performing the channel uniqueness test further comprises:
disconnecting one of the plurality of EEG electrode recording channels from one or more of the plurality of resistors; and
determining an electrode disconnected status for the disconnected one of the plurality of EEG electrode recording channels.

### Claim 17 (depends on 1)

The method of claim 1, wherein performing the impedance test comprises:
determining if measured impedance values match expected impedance values within a predetermined margin of error;
determining that one or more of the plurality of EEG electrode recording channels is not working as intended if the measured impedance values do not match the expected impedance values within the predetermined margin of error; and
verifying that the one or more of the plurality of EEG electrode recording channels are working as intended if the measured impedance values match the expected impedance values within the predetermined margin of error.

### Claim 18 (depends on 17)

The method of claim 17, wherein the predetermined margin of error is +/−30% of the expected impedance value.

### Claim 19 (depends on 1)

The method of claim 1, wherein performing the test for verifying the functionality of the electrode connections comprises:
connecting a hardware testing device to the EEG recording device; and
detecting a presence or absence of connector identification circuitry with respect to predefined groups of the plurality of EEG electrode recording channels, wherein the detected connector identification circuitry comprises numbers and wherein each of the numbers uniquely corresponds to predefined groups of the plurality of EEG electrode recording channels.

### Claim 20 (depends on 19)

The method of claim 19, wherein each of the predefined groups comprises 4 recording channels.
