TES HT100 Clinical Outcomes - Clinical Validation of the TES HT100 Temnograph for Brain Injury Screening in Patients With Mild Head Trauma or Suspected Neurological Symptoms (TESCO)
Phase: NA
Conditions: Mild Traumatic Brain Injury, Intracranial Lesions, Neurological Symptoms Not Related to Head Trauma
Sponsor: B&B srl

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PROTOCOL
TES-HT 100 MEDICAL DEVICE CLINICAL INVESTIGATIONS
Title of the Study:
"TES HT100 Clinical Outcomes - Clinical 
Validation of the TES HT100 Temnograph for 
Brain Injury Screening in Patients with Mild 
Head Trauma or Suspected Neurological 
Symptoms" (TESCO)
Reference number or code
clinical investigation identifier:
CLV-01-TES HT
Protocol version number:
1.1
Date of issue:
02/07/2024
Promoter
Manufacturer and Sponsor: B&B S.r.l.
Fienile road, 1 - 80013 - Casalnuovo (NA)
+39 081-19189806
Scientific Responsible
DR.SSA CONTE MODESTINA ADRIANA
Investigators involved
Dr. Carmellino Salvatore, Dr. Perrone Anna
Dr. Localzo Angelo, Dr. Russo Esau, Dr. Antonia 
Sorbo
Centers involved:
EMERGENCY DEPARTMENT - PINETA GRANDE 
HOSPITAL
Contact Information
Promoter Contact Name.
Bruno Basile 
bruno.basile@temnografia.com
Name Contact for Vigilance 
Device
Daniele Giuseppe Gallo 
Daniele.gallo@temnography.com

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PROTOCOL APPROVAL.
The Investigators and the Promoter:
-
Approve this Protocol;
-
Declare that the study will be conducted in accordance with Good Clinical Practices, 
Standard UNI EN ISO 14155:2012 and as stated in this Protocol.
  02/07/2024
Date
Dr.
Date
Dr.
Date
Dr.
Date
Dr.

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Index
Medical device information
4
Information regarding the manufacturer
5
Intended use and population for which the device is intended
5
Detailed description of the device
5
Mechanism of action
8
Training required for the use of the medical device by users
8
Literature review and rationale for clinical investigation
9
Objectives of the study
10
Ethical considerations
10
Arrangements for obtaining informed consent
11
Preclinical evidence and previous clinical experience
11
Information regarding the clinical investigation
12
Description of the study
12
Primary and secondary objectives
13
Variables to be measured
15
Systematic errors - bias
15
Patient selection
15
Inclusion criteria
15
Exclusion criteria
15
Number of patients expected to enroll
16
Point of enrollment
16
Number of experimental medical devices expected to be used
16
Duration of the study
16
Medical and surgical procedures and study follow-up
17
Discontinuation and withdrawal of subjects from clinical investigation
17
Benefit-risk assessment
17
Statistics
18
Quality assurance, control procedures, data management and record keeping
19
Deviations from the clinical evaluation plan
20
Adverse events
20
Data publication policy
20
Bibliography
21

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Medical device information
Medical Device Identification.
TES HT model 100 devices are medical devices aimed at noninvasive detection of endocerebral lesions. 
It uses non-ionizing, ultra-low power electromagnetic waves in the frequency range 500- 6500 MHz.
TES HT devices are composed of the following parts:
●
Graphic console for measurement and data processing;
●
Battery charger/power supply.
The console inside includes the battery pack, radio frequency management and emission unit, 
processing unit, and a high-resolution display.
The indication of the presence of an intra-cranial lesion is of the 'on-off' type.
The positioning of the device is done manually by the operator (following the instructions in the 
Instruction Manual) as shown in Figure 1(a,b); the patient wears a disposable surgical-type headset 
while performing the examination, and the device never comes into direct contact with the patient's 
head.
The complete examination has a duration of 5 minutes.
Figure 1-(a) Correct positioning TES HT100
Figure 1-(b) Wrong positioning TES HT100

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Manufacturer-related information
TES HT100 medical devices are mass produced by B&B S.r.l. Table 1 shows the information related to 
the manufacturer.
Table 1
Company Name
B&B S.r.l.
Company headquarters
Fienile road, 1 - 80013 - Casalnuovo (NA)
VAT number or tax code
06342121214
PEC
bandbroadcast@pec.it
Office Tel.
+39 081-19189806
E-mail
direzione@temnografia.com
Website
https://www.bandbsrl.com/
Intended use and population for which the device is intended
The TES HT100 medical device is designed to rapidly identify brain injury and/or potentially 
pathological changes in brain structure. TES HT models are designed to measure the interaction of 
electromagnetic waves with a person's brain under static conditions. They are intended for emergency 
units, such as ambulances, first aid stations, neurology, trauma and emergency medicine departments 
- including mobile ones. The devices can be used several times on the same patient without time 
limitation.
Detailed description of the device
The TES HT 100 device consists of Console and Charger. Table 2 describes the technical specifications 
of the TES HT100 device.
Table 2
Technical Specifications TES HT100
Specifications
Dimensions (mm)
420L x 400H x 340P
Weight (kg)
8.0
Power supply (V)
12V DC
Battery (mAh)
10000 mAh
Power (W)
60
Technical Specifications TES HT100
Specifications

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Radio Transmitter
Precision Analyzer
Radio wave frequency (MHz)
500 - 6500
Maximum power of radio waves (mW)
250
Screen
10.1"
Connection
Internal Modem - SIM
Maximum number of exams that can be stored
1000
Cable length (mm)
battery charger->console= 905
power supply->battery charger =1180
Power supply weight (kg)
0,35
Power supply (V)
220 A.C.-12 D.C.
The signaling of the presence of intra-cranial lesion or abnormality is of the 'on-off' type. In the case of 
positive detection, the LED light clusters will signal this event by emitting a flashing red light signal; on 
the other hand, in the case of no negative result, they will signal this event by emitting a flashing green 
light signal. The report produced in PDF format is stored in the instrument and can be sent via internet 
connection to the prepared center at the end of the examination.
In TES-HT 100 devices there are components such as electromagnetic transducers, the control module, 
the electronics for transducer management, the power button (amber in color), the examination 
start/stop button (blue in color), and two sets of optical indicators that signal the status of the system at 
each stage of operation.
In terms of user interaction, the TES-HT 100 offers full functionality through the integrated physical 
buttons and also features a graphical touchscreen display, which allows for a graphical visualization of all 
phases of device operation

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Figure 2- TES-HT 100 device
Table 3 shows the materials used in the manufacture of the TES-HT 100 device
Table 3 - Materials of the device
Materials Bulletin Device
●
Mechanical structure
●
2 electromagnetic transducers
●
Electronic control board
●
Cables
●
Button with integrated amber-colored LED
●
Button with integrated blue color led
●
Management electronic board
●
Processing unit
●
RF signal generation system

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●
Display module, Human Interface Device (HID)
●
Mechanical structure for containing the console
●
Lithium-ion battery 12V, 10 A/h
Mechanism of action
The technology of TES-HT devices is based on electromagnetic scattering over different dielectric 
tissues. Radiofrequency waves can easily penetrate the bone material of the cranial theca to reach the 
underlying tissues. Moreover, the dielectric composition of the brain is almost uniform, whereas blood 
and serum (for parenchymal lesions) have completely different "εr and σ (S/m)" dielectrics. This makes 
it possible to detect them within the brain with high contrast. Signal scattering in different frequencies 
and RF wave propagation are used in the specified range as 'radar' to detect abnormalities in the brain. 
The full range of frequencies used consists of hundreds of different frequencies. Each signal has a 
maximum sent power of less than 250 milliwatts. The full diagnostic examination takes four minutes, 
and in this short time the total energy applied is minimal and discontinuous.
Training required for the use of the medical device by users
TES-HT 100 devices are designed and manufactured to be used by medical professionals without 
specific expertise. They allow the return of an automatic on/off type result regarding the presence of 
endocelebral lesions.
The steps for setting up and properly performing the examination will be explained to the personnel 
who will use the device at dedicated training event.
Copies of the user manual and a quick user guide will be provided with the device.

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Literature review and rationale for clinical investigation
Mild head trauma
Mild traumatic brain injury (mTBI) is a significant medical condition that requires detailed analysis to fully 
understand its clinical, epidemiological, and management implications. This type of trauma represents a major 
cause of disability and mortality worldwide, with an incidence that varies significantly, reaching up to 694 cases per 
100,000 population per year (1). Despite the term "mild," head trauma of this type can lead to serious short- and 
long-term consequences, underscoring the importance of accurate diagnosis and appropriate treatment (2)
The assessment of head injury severity is commonly based on the Glasgow Coma Scale (GCS), which classifies 
injuries into mild (GCS 13-15), moderate (GCS 9-12) and severe (GCS <8) (3). In Italy, each year, approximately 250 
patients per 100,000 inhabitants require hospitalization due to head trauma, with a bimodal distribution by age, 
peaking between 16-35 years of age and over 70 years of age (4).
The diagnosis of mild head trauma is 
mainly based on clinical manifestations 
such as loss of consciousness, amnesia, 
confusion, and altered mental status. The 
most 
common 
symptoms 
include 
confusion, amnesia, headache, dizziness, 
nausea and vomiting (5,6,7). Computed 
tomography (CT) is considered the gold 
standard for the diagnosis of head trauma 
(8).
To improve diagnostic accuracy and reduce 
unnecessary radiation exposure, clinical 
scores such as the Canadian CT Head Rule 
(CCHR), the New Orleans Criteria (NOC), 
and the
National Emergency X-Radiography Utilization Study II (NEXUS II) criteria to identify patients in need of CT (9,10). 
However, a systematic review of the literature estimated a prevalence of CT abnormalities of 5% among patients 
with GCS = 15 and 30% for those with GCS = 13 (11).
Importantly, despite the classification of mild head injury, this condition may hide important short- and long-term 
risks for the patient, underscoring the importance of more thorough evaluation and management of patients with 
this condition(12).
Other neurological conditions that may manifest with symptoms similar to those of mild head injury are given by:
Syncope, for example, represents a temporary loss of consciousness due to transient cerebral hypoperfusion, and 
its prevalence in the general population is estimated to be around 3 percent per year (13).
Spatial disorientation and loss of balance can result from various neurological conditions, including stroke, 
vestibular diseases, and neurodegenerative disorders. It is estimated that about 30 percent of elderly patients aged 
65-74 years and up to 50 percent of those over 75 years have balance disorders (14). These symptoms, if neglected, 
can lead to serious complications, underscoring the importance of timely and accurate evaluation.
Speech disturbances, such as aphasia, and facial hemi-paresis are characteristic symptoms of stroke. Early 
intervention within 3-4.5 hours after symptom onset can significantly improve functional outcomes and reduce the 
risk of permanent disability (15). Stroke is a major cause of disability and mortality, with a huge impact on both 
individual health and overall health care expenditures (16).
Approximately 30% of stroke patients have visual disturbances (17). Detailed assessment of these symptoms

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is essential to determine the underlying cause and plan appropriate treatment in order to preserve visual function 
and prevent further neurological damage.
Head trauma can cause several neurological disorders, including memory loss, particularly when associated with 
traumatic brain injury (TBI). It has been shown that even a single traumatic event can cause structural and 
functional damage to the brain, thereby impairing short- and long-term memory (18). Head trauma has been 
shown to increase the risk of developing neurodegenerative diseases, such as Alzheimer's disease, which is often 
associated with cognitive deficits, including memory loss.
In recent decades, several technological solutions have been explored for the development of portable, 
noninvasive devices aimed at detecting endocranial injury and/or stroke. [19,20] Among the many options, the 
technology that has demonstrated clinically relevant results is on the use of electromagnetic fields at microwave 
frequencies. Extensive studies have shown the ability of this approach in detecting lesions such as internal bleeding 
and edema by exploiting the dielectric contrast between different tissue types [21].
As highlighted in [22], the use of radar imaging technology allows the detection of hot spots where there is 
inhomogeneity of electromagnetic features, such as the presence of blood in the brain parenchyma. Recording 
these variations, combined with the use of an appropriate imaging algorithm and a hybrid method for reducing 
reflections generated by surface structures (e.g., such as the skin) allows one to distinguish healthy tissue 
(dielectric values of various human tissues have been widely characterized in the literature) from diseased tissue 
[23].
Rationale for the investigation
The objective of this clinical investigation is to validate the effectiveness of the TES HT100 device as a screening 
tool for the presence of brain injury in both mild head injury patients and on patients with neurological symptoms 
not related to head injury. Having at one's disposal a rapid diagnostic address tool, only 5 minutes per examination, 
portable, nonoperator dependent, and most importantly harmless because it uses very low energy nonionized 
radio frequencies, that would allow rapid objective screening for the presence of brain injury would allow for 
improved management of such patients afferent to the emergency department. Such instrumentation would allow 
rapid identification of patients, who even if not in critical situations, need further diagnostic investigation. The 
literature supports the need for advanced diagnostic tools that can assist clinicians in the rapid and accurate 
assessment of complex neurological conditions. The rationale for this investigation is based on the need to improve 
the quality of care provided to patients with mTBI and other neurological conditions. The TES HT100 device 
interposes itself as an initial screening tool for the detection of brain lesions and potentially related neurological 
disorders, potentially enabling targeted management of patients. In addition, the adoption of the TES HT100 could 
lead to greater efficiency in the area of healthcare resources, reducing waiting times for diagnosis and optimizing 
the use of diagnostic equipment. This could result in better utilization of hospital resources and an overall 
improvement in the quality of care provided to patients.
Study Objectives.
Clinical validation of the ability of TES HT 100 to identify brain lesions or alterations in brain structure in 
patients with:
•
mild head trauma
•
Neurological symptoms not attributable to trauma but not in critical condition

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.
Ethical considerations
The TES-HT device clinical trial is performed in compliance with the Code of Good Clinical Practice (GCPs) 
and all other applicable regulations and administrative requirements.
The sponsor declares compliance with the Code of Good Clinical Practice for the Planning and Conduct 
of Clinical Investigations of Medical Devices (UNI EN ISO 14155:2012 STANDARD) and in compliance 
with EU Regulation 2017/745.
Arrangements for obtaining informed consent
Subject participation in this clinical study is voluntary.
Informed consent is obtained prior to the use of any experimental device, required by the study 
and/or test procedures or data collection.
Obtaining and documenting informed consent must be in accordance with the principles of ICH/GCP, 
the Declaration of Helsinki, and ISO 14155.
B&B S.r.l. will provide researchers with a specific Informed Consent Template for volunteers 
participating in this study. Any changes by the Sponsor require acceptance by B&B S.r.l. prior to use of 
the Template. The Template must be in a language understandable to the subject.
The process for obtaining informed consent includes:
• be conducted by personnel assigned or authorized to conduct the trial;
• include a description of all aspects of the clinical trial that are relevant to the subject's decision to 
participate in the entire clinical trial;
• avoiding any coercion or undue influence of subjects to participate;
• not waive or give the impression of waiving the subject's legal rights;
• use language that is simple and understandable to the subject or the subject's legal representative;
• provide time for the subject to consider participation and ask questions if necessary.
This Form must always be personally signed and dated by the subject or legal representative and the 
investigator and/or authorized designee. The original signed copy will be retained by the Sponsor. 
Failure to obtain subject consent will be reported by the Sponsor to the appropriate regulatory body 
as required by them.
Preclinical evidence and prior clinical experience
The TES-HT100 device was initially subjected to a series of validation tests using phantoms designed to 
accurately replicate the properties of the human tissues of interest. For the generation of such 
phantoms, which replicate the dielectric characteristics of the head, the following were adopted

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the values found in the specialist literature [24]. As demonstrated in previously published studies, the use 
of such phantoms allow laboratory replication of close-to-reality clinical situations of injuries such as 
hematomas, contusions, and diffuse damage Laboratory experimental results validated the device's 
ability to successfully detect alterations in endocranial dielectric properties, with high specificity and 
sensitivity. These data are available as Internal data from B&B s.r.l.
For the fulfillment of essential safety requirements in accordance with European Regulation MDR 
745/2017, a campaign was conducted to analyze, assess, and manage risks arising from the intended, 
reasonably foreseeable, and unforeseen use of the TES-HT100 device. Controls were defined and 
implemented to mitigate the identified risks. Residual risks are found to be acceptable in accordance 
with international standards and guidelines for risk management (ISO IEC 14971:2022). To ensure 
mechanical and electrical safety, the device was tested at laboratories for compliance with IEC 60601-1 
standards, which cover general requirements for basic safety and essential performance of 
electromedical devices. These tests included checks for mechanical strength, electrical safety, protection 
against fire and electric shock hazards, and general robustness of the device. The device underwent 
electromagnetic compatibility testing according to IEC 60601-1-2 standards. These tests ensure that the 
TES-HT100 does not interfere with other medical devices and is resistant to electromagnetic 
interference. Validation fates of the software and the Usability of the graphical user interface were 
conducted. Next The device was tested on a group of 98 volunteers at the Magnolia Clinic. in a real-world 
clinical setting. The volunteers were monitored for the presence of neurological symptoms and brain 
lesions using TES-HT100. The data collected indicated high accuracy an excellent tolerability of the 
device, with no significant adverse effects. [25] Currently, TES-HT100 is the subject of a clinical 
investigation, conducted according to Good Clinical Practice ISO 14155, to EU Regulation 2017/745 
following the clinical investigation guidelines MEDDEV 2.7/1 rev. 4. This study was approved by the 
Regional Ethics Committee for Clinical Trials of Tuscany-Italy Region on 17/04/2023. Preliminary data 
from that study, on 20 patients presented as an oral communication at the SIMEU congress (abstract ID 
018) show that the device a near 100% congruity with CT outcome. [26]
Information regarding clinical investigation
TES-HT devices are capable of detecting brain lesions. The answer is YES/NO. Three different steps 
must be considered during the clinical investigation:
1) Data collection - In order to achieve the target number established with the Reference 
Sponsor.
2) Data processing and comparison - At this stage, data are processed for each patient using 
appropriate ID and the result is linked to the respective diagnosis by the

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relevant personnel at the institution hosting the survey.
The purpose of the clinical investigation is to commercialize the device on a national/international scale.
Description of the study
The single-center, open-label study that aims to clinically validate the TES HT100 as a screening tool 
for noncritical care patients attending the emergency department either for mild head injury or with 
neurological symptoms. The study involves the enrollment of two separate cohorts of patients:
1) 425 Patients with mild head trauma
2) 425 Patients with neurological symptoms not related to head trauma and not in a critical or life-
threatening condition such as:
•
Syncope
•
Spatial disorientation and loss of balance
•
Speech disturbance and facial hemi-paresis
•
Visual impairment
•
Lack of memory and confusional state
All patients will follow the normal diagnostic-therapeutic procedure with priority access to CT 
examination according to severity and to which, as described below, only the examination with TES 
HT100 will be added, which has a maximum duration of 5 min (examination duration 4 min for 
acquisition and 1 min for data processing):
Patients with mild head trauma:
* the patient with mild head trauma following Acceptance Acceptance will be assisted and evaluated 
at Triage and will have a CT scan within 1 hr or more, followed by performing the temnographic 
examination with TES HT100, after signing the informed consent for participation in the study;
Patients with neurological symptoms:
* the patient following Acceptance Acceptance will be assisted and evaluated at Triage and a CT scan 
will be performed in order to exclude the possible presence of stroke and possible transfer via 118 to 
the Stroke Unit U.O.S.D. | A.O.S.G. Moscati. Temnographic examination with TES HT100 will be 
performed after the CT scan during the CT reporting phase, after signing the informed consent for 
participation in the study.
Information on the data collection form (Appendix A) will be collected for each patient.
Primary and secondary objectives

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Primary objectives
•
Assess the diagnostic accuracy of the TES HT100: Measure the sensitivity and specificity of the 
device in identifying brain lesions and structural brain changes in the cohorts of patients 
included in the study.
•
To establish the safety of the TES HT100: To monitor the incidence and type of possible adverse 
events associated with the use of the medical device during the study.
Secondary Objectives.
•
To evaluate the benefit of clinical use of the TES HT100: To measure the efficiency of the 
device in improving the management of patients and hospital resources in the emergency 
department setting during patient screening.
•
To evaluate the diagnostic accuracy of the TES HT100 in various subgroups of patients:
o
Young patients (<65 years old)
o
Elderly patients (>65 years)
o
Patients with or without prior injury or undergoing brain surgery
o
Patients with or without neurodegenerative 
diseases Primary end points
•
Receiver Operating Characteristic-Area under curve (ROC-AUC) processing, depending on the 
sensitivity and specificity calculated by comparing the TES HT100 exam result versus the CT scan 
report.
•
In order to establish the safety of the medical device, the rate of adverse events related to the 
use of TES HT100 will be calculated as provided in Regulation 2017/745 (MDR) (CNCCE Circular No. 
4/2022)
Secondary endpoints:
•
Descriptive evaluation of the potential benefits of using TES HT100 calculated according to the 
possible benefit applicable to each patient, in terms of operator time, procedures, and costs, that 
would be obtained by performing examination with TES HT 100 with the aim of directing the patient 
to the most appropriate diagnostic pathway.
•
Analysis of the diagnostic performance of TES HT100 as a function of sensitivity and specificity 
calculated by comparing the result of the TES HT100 examination versus the CT scan report in 
subgroups of patients
Expected Results.
From a health care perspective of rationalizing resources, the TES HT 100 tool could be

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useful to identify early on patients on whom to prioritize the diagnostic pathway avoiding delays and 
at the same time avoiding dispersion of resources in terms of economics and staff time for the 
management of patients who do not need further diagnostic investigation. We assume a diagnostic 
reliability of TES HT 100 greater than or equal to 90% and a sensitivity and specificity greater than 
80%.
Technological evolution in the medical field reflects the need to enhance the diagnostic fieldwith the 
introduction of diagnostic tools that are increasingly accessible, objective, fast and reliable, and 
above all harmless to the patient and health care providers.
Variables to be measured
TES HT examinations should be performed within 24 hours before or after the CT examination.
Systematic errors - bias
Systematic errors that may occur during the study are mainly related to the marked movement of 
the patient, who should avoid abrupt movements throughout the scan in order to reduce motion 
artifacts.
Patient selection
Patient inclusion criteria:
Group 1:
- age over 18 years
- acquisition of informed consent
- Patients referred to the emergency department for mild head injury
Group 2:
- age greater than 18 years
- acquisition of informed consent
- Patients afferent to the emergency department not for head trauma and not in a critical condition, 
with one of the following neurological symptoms:
•
Syncope
•
Spatial disorientation and/or loss of balance
•
Speech disturbance and/or facial hemi-paresis
•
Visual alterations
•
Lack of memory and/or confusional state

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Exclusion criteria for both cohorts:
- age less than 18 years
- pregnant women
- Metal plates or metal prostheses installed in the skull cap
- severe head trauma and/or with extensive lacerated contused areas
- patient in critical condition
- skull theca fracture
- failure to sign informed consent
The TES-HT device cannot be used in cases of metal plates or metal prostheses installed in the skullcap 
because their presence alters the outcome of the TES HT100 examination.
Number of patients expected to enroll
Considering that it is intended to prove the primary hypothesis that TES HT 100 succeeds in achieving a 
sensitivity and specificity of 90% when comparing to the outcome of the CT scan report, an AUC of 0.90 
is obtained, a value indicative of its excellent reliability. Assuming that TES HT100 meets this 
performance, a sample size of about 384 subjects is needed to obtain a maximum error of 3% on the 
confidence interval in the 95% two-tailed test on AUC. In other words, the target AUC and sample size 
should allow 95% confidence that the AUC is within the range [0.87;0.93]. Given a 10% drop-out rate, a 
sample size of 425 subjects for each patient cohort is considered necessary. Although the sample size 
calculation was performed as was previously explained, we believe it is fair to consider, in the case 
where there is a large imbalance between positive and negative outcomes, a small adjustment on the 
precision of the AUC estimate. Specifically, we will consider a precision of 0.02 instead of 0.03.
Point of enrollment
Patients will be enrolled in the study within the emergency department of Pineta grande hospital. 
The patient is considered to be enrolled in the clinical trial from the moment he or she meets all the 
inclusion criteria of the study and after signing the Informed Consent Form.
Number of experimental medical devices expected to be employed
The number of TES HT100 devices that will be employed for this study is one.
Duration of the study
The study is planned to last for 12 months.

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P1
L1
L2
Medical and surgical procedures and study follow-up
After positioning the device and the patient at the correct height, the authorized health care 
personnel, to start the measurements, presses the P1 button (Figure 3).
The device signals the measurement status through the L1 and L2 indicator, which emits a flashing 
blue light optical signal.
After the first measurement, the device gives the result of injury detection. After the end of the 
measurement operation, the user can remove the device and the examination is finished. To turn off 
the device, the user presses the appropriate button. After using the device, the user stores the 
device in a safe environment with the following requirements:
●
temperature 0°-+50° and humidity max 90%;
●
the device does not require cleaning agents, but simply follow the instructions in the 
Common Cleaning Manual;
●
the patient can wear a disposable surgical cap.
Discontinuation and withdrawal of subjects from the clinical investigation
In case of premature discontinuation of studies, a Written Statement as to the reason for premature 
discontinuation of the trial must be produced. Community and regulatory authorities, as appropriate, 
will be informed. Detailed information on how enrolled subjects will be handled will be provided later. 
In the event that the Sponsor discontinues participation in the study, TES-HT staff and regulatory 
authorities, as appropriate, will be informed in writing.
Benefit-risk assessment.
In consideration of risk/benefit, the TES-HT device appears to be absolutely harmless to both patient 
and operator. In fact, throughout its operation, the electromagnetic emission values are well below 
the electromagnetic emission values for professional

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professional electromedical devices.
The benefits that emerge from the use of the device can be divided into:
1) Ease of use-The device is easy to set up and its use does not require specialized personnel.
2) Low risk to the patient - The device does not emit ionizing radiation (as with CT scanning) and 
emission levels are well below reference limits.
3) Short scan duration - The duration of one measurement is 4 minutes.
4) Small size and easily transportable - The small size makes TES HT a device that can be used in 
all emergency situations and in places where rapid transport to a First Aid Center is difficult.
Thus, the device demonstrates positive cost-benefit and timely and beneficial results.
Statistics
To evaluate the performance of the device, statistical sensitivity and statistical specificity will be 
calculated. Statistical sensitivity indicates the device's ability to correctly identify positive cases, i.e., 
patients with brain injury (prior or post injury) and/or structural alteration of brain tissue. Statistical 
specificity indicates the ability of the
device to correctly identify negative cases, i.e., patients with no brain injury (new or previous) and no 
structural alteration of brain tissue. All TES HT examinations will be compared with the CT scan report, 
which will sanction the actual presence or absence of structural alterations of brain tissue. Comparison 
criteria such as Receiver Operating Characteristic-Area under curve (ROC-AUC), sensitivity and 
specificity will be used as statistical validation tools. To this end, it is intended to demonstrate the 
primary hypothesis regarding a diagnostic performance of TES HT 100 not less than 90% ROC-AUC 
compared to the outcome of the CT report, while maintaining sensitivity and specificity of at least 80%. 
The minimum threshold of 90% is indicative of excellent instrument reliability.
To calculate the statistical sensitivity and specificity, the following data will be used:
Brain injury 
present
Brain injury 
absent
Positive test
TP (True Positive)
FP (False Positive)
Negative Test
FN (False Negative)
TN (True Negative)
Total
TP+FN
FP+TN
•
Number of true positive cases (TP): number of patients with brain injury (prior or 
posttrauma) and/or structural alteration of brain tissue identified

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correctly by the device and confirmed by CT scan
•
Number of false-negative (FN) cases: number of patients with brain injury (prior or 
posttrauma) and/or structural alteration of brain tissue not identified by the device but 
confirmed by CT scan
•
Number of false-positive (FP) cases: number of patients without brain injury (prior or 
posttrauma) and/or structural alteration of brain tissue identified as positive by the device but 
confirmed as negative by CT scan
•
Number of true negative cases (TN): number of patients without brain injury (prior or 
posttrauma) and/or structural alteration of brain tissue identified correctly by the device 
and confirmed by CT scan
Statistical sensitivity is calculated as TP/(TP+FN), while statistical specificity is calculated as TN/(TN+FP).
It will also be calculated:
-
the positive predictive value: probability that the disease is present when the test is positive 
calculated as TP/(TP+FP)
-
the negative predictive value: probability that the disease is not present when the test is negative 
as TN/(FN+TN)
Specificity and sensitivity will also be evaluated for different subgroups of patients enrolled such as:
-
Young patients <65 years old
-
Elderly patients >65 years old
-
Patients with or without prior injuries or who have undergone brain surgery
-
Patients with or without neurodegenerative diseases.
An interim analysis is planned for the respective cohorts of study patients when the thresholds of 150 
and 300 patients enrolled in each cohort are reached.
Quality assurance, control procedures, data management and record keeping
Subject data will be recorded in a secure electronic data capture (EDC) with limited access. All 
changes made to clinical data will be captured in an electronic audit trail and available for review by 
the Sponsor or its representative. The software and database associated with data acquisition and 
storage have been designed to meet compliance with applicable laws and regulations, regarding 
data processing. Data collected on study subjects are in accordance with the ICH/GCP Guidelines 
valid in the European Union. Records must be kept for ten years after the completion of the device 
trial.
Each data collected should contain:

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●
ID of the examination performed on TES-HT (ID generated by TES-HT for each examination);
●
Location where the examination takes place (emergency district or other), time, date and 
operator.
●
Anonymous patient history
Deviations from the clinical evaluation plan
An investigator must not make changes or deviate from this Protocol except to protect the life and 
physical well-being of an emergency subject. An investigator must notify both the Sponsor and the 
manufacturer of any major deviation from the investigative plan designed to protect the life or 
physical well-being of a subject in an emergency.
Such notice will be given as soon as possible, but no later than 5 working days after the emergency 
occurs.
All deviations from the investigation plan, with the reason for the deviation must be collected in the 
appropriate document, which must contain:
●
patient data;
●
place, date and time;
●
signature of the investigator.
Deviations will be reviewed and evaluated on an ongoing basis, and corrective and preventive 
procedures will be applied if necessary.
Deviations will be classified according to the following definitions:
•
Type A - Diversion to protect the life or physical well-being of a patient in an 
unforeseen emergency.
•
Type B - Deviation based on medical judgment.
•
Type C - Deviation due to misunderstanding of Protocol requirements.
•
Type D - Deviation due to an out-of-control situation.
•
Type E - Deviation due to oversight, error or noncompliance of the Protocol.
Adverse Events
The TES-HT device is a model of a temnographic device already in use in different settings for which 
no adverse events have been observed.
Any adverse events should be appropriately recorded and reported to the device production staff in 
the manner and timeframe stipulated in Article 90 of EU Regulation 201/745.
Data publication policy
B&B S.r.l. will submit a study of results for publication (regardless of the outcome of the 
investigation) after its conclusion or termination. B&B S.r.l. adheres to the established collaboration 
criteria of the International Committee of Medical Journal Editors (ICMJE; http://www.icmje.org ).

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