ADD UPDATED PHOTO OF HEADSET

NeuroGeneces® RECALL Sleepband System

Instruction Manual
Rev. 03.01.2023

Copyright © 2023 by NeuroGeneces, Inc.

All rights reserved
About this Manual

This manual contains all of the information that is needed to set up and operate the NeuroGeneces
RECALL system, and does not assume prior knowledge or experience with operator-
programmable medical electronics devices. Retain this manual for future reference.

The information in this manual has been carefully checked and is believed to be accurate.
However, in the interest of continued product development, NeuroGeneces reserves the right to
make changes and improvements to this manual and to the product(s) that it describes, at any
time, and without notice or obligation.

Caution: THIS IS AN INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL LAW

TO INVESTIGATIONAL USE.

Mailing and Shipping Address NeuroGeneces, Inc.

1012 Marquez Place, #207A
Santa Fe, NM 87505

Telephone (505)780-8628

Web Site www.NeuroGeneces.com

Note: This manual is applicable to the RECALL device.

Instruction Manual i
 Table of Contents

Introduction ................................................................................................................................... 1
Description ................................................................................................................................................ 1
Indications for Use..................................................................................................................................... 1
The RECALL at a Glance ......................................................................................................................... 2
Description of Reusable Components........................................................................................................ 3
Description of Disposable Components .................................................................................................... 4
Description of Documentation and Software Components........................................................................ 5
Glossary of Symbols .................................................................................................................................. 6
Contraindications, Warnings and Cautions................................................................................ 7
Contraindications ....................................................................................................................................... 7
Warnings.................................................................................................................................................... 7
Cautions ..................................................................................................................................................... 8
Care and Maintenance ................................................................................................................ 10
Inspection ................................................................................................................................................ 10
Cleaning................................................................................................................................................... 10
Interference .............................................................................................................................................. 10

Usage Overview ........................................................................................................................... 12

Understanding RECALL ................................................................................................................... 12
New Patient Setup................................................................................................................... 13
Pack Supplies for Patient to Take Home ................................................................................................. 13
Familiarize User with the RECALL .................................................................................................... 13
Adjust System Setup & Discuss .............................................................................................................. 14

General System Setup and Operation ...................................................................................... 15

Charging RECALL ........................................................................................................................... 15
Booting the system ............................................................................................................................. 16
Accessing the System Menu ................................................................................................... 17

Sleep Report and Statistics Files ................................................................................................ 23

Generate Sleep Report and Statistics ....................................................................................................... 23
Uploading data ............................................................................. 24
About the Sleep Files ............................................................................................... 25

System Utilities ............................................................................................................................ 29

Display System Information .................................................................................................................... 29
Update Firmware ..................................................................................................................................... 30
Setting the Failed Sensor Alert ................................................................................................................ 31
Troubleshooting and Specifications ............................................................................................ 32
Troubleshooting ........................................................................................................................................

Legal Notices ..................................................................................................................... 35

Trademarks and Intellectual Property Right.........................................................................................

ii Instruction Manual
nstruction Manual
 1
Introduction
Description

The RECALL system is a high technology sleepband, developed by NeuroGeneces, which uses
state-of-the-art electroencephalography (EEG) hardware in combination with advanced signal
processing algorithms to collect high quality, objective, real-time sleep features and provide
audio stimulation synchronoized to the slow-oscillations (SO) of slow-wave sleep.. RECAL
was designed for use in the clinical or home environment.

The RECALL headband acquires the EEG signal necessary for sleep monitoring using four high
quality, self-stick, single-use, disposable EEG sensors (Neuroline 720S). The four sensors are
designed for easy, self-application by the subject with minimal skin preparation (gentle washing
of skin with soap and water and dry). The sensors are located completely outside of the hairline
with three sensors positioned on the forehead . One is placed above each eye (Fp1 Fp2 signals),
one in the middle (ground) and the fourth sensor placed on the mastoids (reference). Integrated
impedance measurement technology verifies the quality of the sensor connections immediately
prior to the start of monitoring to ensure high quality signals prior to use..

Indications for Use

The RECALL sleepband is a 2-channel, EEG acquisition and analysis system, designed for use
in the home or clinical environments for investigational purposes. The system is regarded as a
“Low Risk General Wellness Product” device in accordance with FDA guidance document
General Wellness: Policy for Low-Risk Devices - Guidance for Industry and Food and Drug
Administration Staff, issued September 27, 2019. Such products are not regulated by the FDA
as medical devices. The FDA guidance document defines a general wellness product as one
which “has an intended use that relates to maintaining or encouraging a general state of health
or a healthy activity”. A general wellness product is also described as “sustaining or offering
general improvement to functions associated with a general state of health that do not make any
reference to diseases or conditions”. The NeuroGeneces RECALL System meets this
definition. The FDA guidance document specifically lists general wellness claims relating to
mental acuity among the examples discussed. Memory enhancement is a type of mental acuity
improvement. Morningstar FDA Consultancy has issued an FDA Position Paper expressing
that in their professional opinion, NeuroGeneces headband to enhance slow-wave sleep to
enhance cognitive performance and stress resilience is “regulated by FDA as a Class II medical
device but it is exempt from pre-market notification.”

Introduction 1
The RECAL System at a Glance

INSERT PHOTO WITH LABELED PARTS

2 Introduction
Description of Reusable Components

The RECALL system may include some or all of the reusable items described below.

INSERT PHOTO OF
HEADBAND AND POD

RECALL Heaband and RECALL Charging Cable: RECALL Travel Case

Pod

Description of Disposable Components

The RECALL system may include some or all of the disposable items described
below.

RECALL Sensors
Neuroline 720S

Note: Appearances may vary.

Introduction 3
Description of Documentation and Software Components

The RECALL system may include some or all of the documentation and software items
described below.

User Guide (printed)

Introduction 4
 2
Contraindications, Warnings
and Cautions
Contraindications

• Do not use the RECALL on newborns, infants, or children. The RECAL sleepband has
only been tested on adults.

• Do not use the RECALL on subjects with a pacemaker, cardiac defibrillator, or other
medical electronic device.

• Do not use the RECALL on patients with fragile or damaged skin. The self-adhesive
sensors could damage fragile skin.

Warnings

• Do not use the RECALL in an oxygen rich or explosive atmosphere.

• Do not use the RECALL in conjunction with high frequency surgical equipment.

• Do not connect the RECALL to a patient undergoing cardiac defibrillation.

• Do not use the RECALL in an MRI environment.

• Do not open the RECALL enclosure for any reason. The RECALL contains no user
serviceable parts and service or repairs must be performed only by NeuroGeneces service
team members

Contraindications, Warnings and Cautions 5

Cautions

• Read and understand this entire manual before using the RECALL sleepband.

• Clinicians are advised to instruct patients on the proper use of the RECALL system..

• The RECALL contains an internal Lithium Ion battery; this battery is not user replaceable.
Following a full charge, if the RECALL fails to operate for at least 12 hours, then the
battery has reached end-of-life. Please contact NeuroGeneces for battery replacement.

• The RECALL sleepband employs high sensitivity amplifiers to acquire and analyze very low
amplitude EEG signals. As such, it is possible that there may be some unavoidable
interference from radio frequency magnetic fields, electrostatic discharges and low
frequency magnetic fields. This interference may alter the results from the RECAL system.
Transmitters, power transformers, motors and similar equipment that generate strong
electromagnetic fields should not be used in close proximity to the RECAL sleepband.

• Electric blankets should not be used with RECALL as this may interfere with the sensitive
EEG amplifiers.

• Do not allow the conductive parts of the RECALL sensors and connectors to contact other
conductive parts, including earth ground.

• The RECALL system may not work adequately for some users, such as those with highly
fragmented sleep, or an abnormal EEG signal. Some medications that affect the EEG
signal could affect RECALL performance.

• In order for the RECALL to produce accurate results, and enhancement of slow-wave sleep
the user must have achieved some slow wave sleep.

• The RECALL is not protected against ingress of water or particulate matter. Care should
be exercised to avoid exposing the RECALL system to liquids or particulate matter.

• Do not immerse the RECALL sleepband in liquid to clean. Do not sterilize the RECALL
headband or accessories.

• Do not sterilize or wash the RECALL sleepband or sensors.

• The RECALL is designed for indoor use only.

• The function or safety of the equipment could be impaired if it has been subjected to
unfavorable conditions or mishandling. If, at any time, function or safety is thought to be
impaired, or any damage to the RECALL headband or accessories has been observed, the
device should be taken out of operation and secured against unintended use. Contact
NeuroGeneces for service or replacement.

• Some users may experience skin irritation or hypersensitivity from the sensors. If this
occurs, user should discontinue use and consult a healthcare provider.

8 Contraindications, Warnings and Cautions

 3
Care and Maintenance
Inspection

The RECALL system should be inspected regularly for damage to the system and accessories.
If, at any time, function or safety is thought to be impaired or any damage to the headband or
accessories has been observed, then the RECALL device should be taken out of operation and
secured against unintended use. Contact NeuroGeneces for information regarding service and
technical support.

Cleaning

The outer fabric surfaces of the RECALL may be cleaned as needed. Use a small amount of
water or isopropyl alcohol to dampen a soft cloth to remove dirt. Do not allow any liquid to
enter the electronic enclosure of the RECALL sleepband.

Interference

The RECALL Sleepband will continue to operate in the presence of radio frequency magnetic
fields (RF) and during electrostatic discharges according to the requirements specified in IEC/UL
60601-1-2.

RECALL employs high sensitivity amplifiers to acquire and analyze very low amplitude EEG
signals. As such, it is possible that there may be some unavoidable interference from radio
frequency magnetic fields, electrostatic discharges and low frequency magnetic fields. This
interference may alter the results from the RECALL system. Mobile phones, transmitters, power
transformers, motors and similar equipment that generate strong electromagnetic fields should not
be used in close proximity of RECALL. Electric blankets should not be used with the RECALL
sleepband..

Although the RECALL system meets the standards for electromagnetic compatibility, the device
may cause interference when used in close proximity with sensitive electrical equipment. It is
advised that if interference on sensitive electrical equipment is observed that the equipment is
switched off or moved from the proximity of RECAL..

10 Care and Maintenance

 4
Usage Overview
Preparing for sleep

Key steps to use the headband are:

1. Make sure that the headband has been fully charged with the micro-usb charging cord
provided. It takes ~ 4 hours to fully charge.

2. Wash and dry forehead with soap and water and behind the ear.

3. Dispose of any used senors and snap 4 new Neuroline sensors into the snaps on the headband.

4. About 30 minute before bedtime, peal the clear plastic covers off the three forehead sensors.
Clear away hair from the forehead. Align the headband so that two outside sensors are lined up
with each eye and the center sensor is lined up to the center of the forehead. The 4th sensor will
be dangling to the side. Put the headband on and tighten to a comfortable pressure that is secure.

5. Move the hair away from the behind the ear. Peel off the clear plastic cover from the 4th
sensor and adhere the sensor to mastoid behind the ear. See photo below for positioning:

Putting the headband on ~ 30 minutes before bed will allow sufficient time for the sensor gel to
soak into the skin and lower the sensor impedances without the use of an abrasive skin
preparation.

When in bed, turn on the bedside pod. When the RECALL and pod are both turned on, the
sensor connections and impedances will be checked. , and begin recording.

Every patient will have unique EEG patterns that are related to their age, skull thickness, medical
history, medication use, etc. RECALL relies on a self-tuning algorithm which automatically
adjusts to the unique EEG patterns of each user. When the RECALL first begins recording with a
new user, the first night's data will be used to generate the user's unique parameters and sleep
profile.

12 Usage Overview
13
 5
General System Setup
and Operation
Charging the RECALL System

The RECALL headband and pod each have an internal battery, when fully charged and
operating within design parameters, can operate for at least 12 hours. It takes approximately
four hours to obtain a full charge.

To charge the RECALL headband:

i) Plug the charger into a wall outlet and plug the micro USB into the headband
ii) Charging will start and stop automatically when fully charged

UPDATE PHOTO
OF CHARGER
→

Plug the charger into a Insert the micro USB into

wall outlet the charging port on the
headset

Note: The charge cable connector can only be fully inserted when properly oriented.

Ensure that the RECALL headband is fully charged using it at night. Charge
the headband after each night of use.

The headband can safely remain connected to the charger until ready for use.

General System Setup and Operation 15

Booting the RECALL Pod

To boot the RECALL Pod:

i) Press and release the button.
ii) If the system battery has sufficient power, it will boot immediately. Otherwise,
charge the unit before turning it on.

Pair the device with the mobile app. The start screen will open. Select "Ready for Bed".
A reminder to take a saliva sample will pop up. Take one tube out of the box, and scan the
bar code on the tube. Follow the instructions provided to complete the saliva sample and
upon completion store the saliva sample in the collection box and put in the freezer. Click
on Saliva sample completed button.

A brief end-of-day survey will pop up.

Complete the survey and click the submit button.

The system will confirm that there is good EEG data signals being received from the headband.

16 General System Setup and Operation

Accessing the RECALL System Menu

General System Setup and Operation 17

18 General System Setup and Operation
General System Setup and Operation 19
20 General System Setup and Operation
General System Setup and Operation 21
22 General System Setup and Operation
Sleep Report and Statistics Files 23
Uploading data to the Cloud

The microSD card can only be ejected safely when the RECALL is off, at the Main Screen
(displaying either the sleeping puppy or sleep statistics) with the operating mode in the upper left
corner indicating ‘Ready’, or following report generation. Otherwise, loss of data can result.

i) Eject the microSD card by pressing inward on the edge of the card with your
fingertip/ fingernail and releasing. If the card was depressed sufficiently, upon
release, the card will protrude from the card slot sufficiently so as to allow it to be
withdrawn.

ii) Insert microSD card into the supplied USB-microSD Card Reader.
iii) Import data into your Zmachine Data Viewer software, or copy/paste files to your
computer manually.

24 Sleep Report and Statistics Files

Sleep Report and Statistics Files 25
26 Sleep Report and Statistics Files
Sleep Report and Statistics Files 27
28 Sleep Report and Statistics Files
 7
System Utilities

System Utilities 29
Update Firmware

Updates to the RECALL system firmware may be released by NeruoGeneces from time to time.

To install a firmware update on your system:

30 System Utilities
Setting the Failed Sensor Alert

Throughout the recording session, RECALL will periodically measure and limit test the sensor
impedance values. If the RECALL detects a failed sensor, it can either stay silent (default), or
can produce an immediate alert to the patient with instructions presented on the system display
indicating which sensor(s) need to be replaced. Regardless which setting is selected, the
detection of a failed sensor will always be noted in the report.

System Utilities 31
 8
Troubleshooting and
Specifications
Troubleshooting

Troubleshooting solutions for some problems you may encounter with the RECALL system are
listed below. If none of the corrective actions provided solve your problem or if your problem
is not listed, then discontinue use immediately and contact NeuroGeneces

Problem Solution

The RECALL can no longer run The battery has reached end of life. Contact NeuroGeneces
for at least 12 hours on a full to arrange for battery replacement.
charge.

The RECALL does not indicate a The wall charger may be faulty or the battery may have
full charge after 5 hours of reached end of life. Contact NeuroGeneces to arrange for
charging or the LCD indicates battery or charger replacement.
Charge Fault.

Sensor check indicates that one or Replace the failed sensors according to the Patient Guide. If
more sensors need to be replaced. the problem persists, then a faulty sensor cable may be the
cause. Contact NeuroGeneces to arrange for replacement.

RECALL system and/or cable are Discontinue use immediately and return to NeuroGeneces
damaged. for repair or replacement.

32 Troubleshooting and Specifications

RECALL Specifications

Input Characteristics
Type Fully differential
Coupling AC
Voltage (non-distorted) ±500 μV
Voltage (maximum) ±40 V
Highpass Filter Cutoff 0.5 Hz
Lowpass Filter Cutoff 380 Hz
Impedance 10GΩ || 800pF

Analog-to-Digital Conversion
Sampling frequency 2.5 kHz
Sampling resolution 16 bit
Linearity ± 1.5 LSB
Architecture SAR

Battery
Nominal Voltage 3.7 VDC
Chemistry / Cell type Lithium Ion / Secondary
Capacity 900 mAh @ C/5 Rate @ 23 degC (standard)
1800mAh @ C/5 Rate @ 23 degC (extended)
Runtime 12-18.5 hrs (standard battery)
24-29.5 hrs (extended battery)
Charge time ≤ 5 Hr (standard battery)
≤ 8 Hr (extended battery)

Current Consumption (Nominal)

Running ~70 mADC
Charging ~600 mADC
Sleeping ≤ 0.5 µADC

Standards
Electrical Safety IEC/UL 60601-1
Electromagnetics IEC/UL 60601-1-2
FCC 47 CFR 15, Subpart B

Troubleshooting and Specifications 33

 9
Clinical Performance

34 Clinical Performance
 10
Legal Notices
Trademark and Intellectual Property Rights

NeuroGeneces is a registered trademarks of NeuroGeneces Inc. RECALL has been designed

and developed by NeuroGeneces, Inc based in Santa Fe, NM USA. At the time this manual
was printed, the RECALL was protected by the following patents:

United States Patents:

Other patents pending

User Agreement
This User Agreement (“Agreement”) sets forth the terms of use by and between NeuroGeneces
Inc, a New Mexico corporation, whose address is 1012 Marquez Place, #207A, Santa Fe, NM
87505, and the user of the subject equipment (“User”). User agrees that the RECALL will at all
times be used and operated solely in the conduct of User’s business for the purpose for which it
was designed and intended and under and in compliance with applicable laws and all lawful acts,
rules, regulations and orders of any governmental bodies or officers having power to regulate or
supervise the use of such property. The RECALL contains certain pre-loaded computer software
which is licensed but not sold or otherwise transferred to User and is subject to the Software
License Agreement terms contained in this Manual. NeuroGeneces warrants that the RECALL
will be free from defects in workmanship or materials, when given normal, proper, and intended
usage for a period of two years (“Warranty Period”) from the date of its shipment to User.
Excluded from this warranty are expendable components and supply items such as, but not
limited to, sensors and sensor cables. NeuroGeneces' obligations under this warranty are to repair
or replace any warranted product (or part thereof) that the company reasonably determines to be
covered by this warranty and to be defective in workmanship or materials provided that the User
has given notice of such warranty claim within the Warranty Period and the warranted product is
returned to NeuroGeneces with freight prepaid. Repair or replacement of products under this
warranty does not extend the Warranty Period. To request repair or replacement under this
warranty, User should contact NeuroGeneces directly.

Legal Notices 35
THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY FOR
NUEROGENECES' PRODUCTS, EXTENDS ONLY TO THE USER THAT HAS
PURCHASED THE RECALL FROM NEUROGENECES, AND IS EXPRESSLY IN LIEU
OF ANY OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING WITHOUT
LIMITATION ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. NEUROGENECES' MAXIMUM LIABILITY ARISING OUT
OF THE SALE OF THE PRODUCTS OR THEIR USE, WHETHER BASED ON
WARRANTY, CONTRACT, TORT, OR OTHERWISE, SHALL NOT EXCEED THE
ACTUAL PAYMENTS RECEIVED BY NEUROGENECES IN CONNECTION
THEREWITH. NEUROGENECES SHALL NOT BE LIABLE FOR ANY INCIDENTAL,
SPECIAL, OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE (INCLUDING
WITHOUT LIMITATION LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING
FROM THE SALE, INABILITY TO SELL, USE OR LOSS OF USE OF ANY PRODUCT.
EXCEPT AS SET FORTH HEREIN, ALL PRODUCTS ARE SUPPLIED “AS IS”
WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED.

36 Legal Notices
Software License Agreement
The computer software (“Licensed Software”) loaded on the RECALL (the “System”) is
licensed, not sold, for your use under the terms of this license. NeuroGeneces reserves any rights
not expressly granted to the user. While User may possess the System, NeuroGeneces retains all
ownership rights and title to the Licensed Software. You shall not transfer the Licensed Software
in any manner from the System to any other computer or system without the prior written consent
of NeuroGeneces. You shall not distribute copies of the Licensed Software or its related
documentation to others. You shall not modify or translate the Licensed Software or its related
documentation without the prior written consent of NeuroGeneces. The Licensed Software is
proprietary; you may not decompile, reverse engineer, disassemble, or otherwise reduce the
Licensed Software to a human-perceivable form. If you transfer the System, you have the right
to transfer the Licensed Software provided that the transferee agrees to be bound by the terms and
conditions of this License Agreement. This License remains effective until terminated. This
License will terminate automatically without notice from NeuroGeneces, if you fail to comply
with any term or provision of this License. Upon termination of this License, you may not make
any further use of the Licensed Software.

Legal Notices 37
Privacy Policy
For purposes of this Agreement (“Agreement”), the following terms have the following
meanings:
“User” means anyone using the RECALL system (described in this manual), or any associated
systems or software.
“De-identified Information” shall mean Information that has been de-identified in accordance
with the requirements for de-identification of protected health information under 45 CFR
§164.514(b).
“Information” shall mean written or electronic health information or data received by GSC from a
User and includes Information or data provided in any form, including De-Identified Information
and Limited Data Sets.
“Limited Data Set” shall have the same meaning as the term “limited data set” in 45 CFR
§164.514(e), and shall include Protected Health Information that excludes the following direct
identifiers of the individual or of relatives, employers, or household members of the individual:
names, postal address information (other than town or city, state, and zip code), telephone
numbers, fax numbers, electronic mail addresses, social security numbers, medical record
numbers, health plan beneficiary numbers, account numbers, certificate/license numbers, vehicle
identifiers and serial numbers (including license plate numbers), device identifiers and serial
numbers, web universal resource locators (URLs), internet protocol (IP) address numbers,
biometric identifiers (including finger and voice prints), full face photographic images, and any
comparable images.
“Protected Health Information” or “PHI” shall have the same meaning as the term “protected
health information” in 45 CFR § 164.501.

GSC has created and established a data repository to receive and store Information received from
a User. The Information submitted by a User, may be stored by NeuroGeneces in in one or more
data repositories. De-identified Information from the data repositories may be moved to a
separate data repository for use as set forth herein. User agrees that NeuroGeneces may use such
De-identified Information for any purpose. User agrees that NeuroGeneces is the exclusive
owner of the De-Identified Information. User licenses to NeuroGeneces data identified as PHI
for the purposes of carrying out the operations as requested by User. Unless otherwise permitted
in this Agreement, no User shall have direct access to Information in the data repository.
Requests, if any, from User to access or amend PHI shall be referred to NeuroGeneces.

38 Legal Notices