FCC ID: 2AYVONETEERA130PLUS Respiratory and cardiac rate monitor

TITLE: IFU 130H-Plus US DEPARTMENT: Product NUMBER: IFU-0002 REVISION: 1.0 Confidential Neteera technologies, Ltd P. 1 of 8 Neteera 130H-Plus/131H-Plus Instructions for Use Reviewers Name Position Date Signature Author Amatzia Mass Product Manager 22-Dec-22 Reviewer Rakefet Shohat VP Quality & Regulations 22-Dec-22 Approver Shahar Yaron VP Product 22-Dec-22 * Release date is same as last signature date Revision History Version Author Changes 1.0 Amatzia Mass First Issue (based on IFU 130H US Rev 3.0) * This page should not be included in the printed version. User Manual 130H-Plus/131H-Plus Registered Manufacturer:

Neteera Technologies Ltd at:

Prof. Rakah 3 St. Jerusalem Israel 9139002

[+972] (0)2-580-8733 US Importer:

Hudson Scientific 103 W Main Street Hudson, MI 49247

(517) 212-4047 Product name/model:

Neteera 130H-Plus/131H-Plus Device Description:

The Neteera device is a contactless vital signs monitor for measurement, data collection, and display of Heart Rate and Respiratory Rate. Neteeras device is based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting physiological parameters (Respiration Rate (RR), Heart Rate (HR)) during rest or while monitoring a persons mild body movement. Neteeras novel micro- radar-based solution enables remote measurement, in real-time, in a non-

invasive and contact-free manner. The system works by measuring only the micro-movements of the skin (BCG) through non-conductive materials such as furniture and clothing at a high resolution, and it has several different mounting options and measuring ranges. The presented product, the Neteera 130H-Plus/131H-Plus, contains a Wi-Fi component that enables communication and data transfer over the internet to the Neteera cloud, HealthGate. Intended Use:

The Neteera System, Neteera 130H-Plus/131H-Plus device, is intended for spot and continuous measurement of heart rate and respiration rate in adult patients in healthcare facilities. The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera monitoring system is not intended to be used as an alarm system for potentially life-

threatening situations in which medical intervention is necessary (e.g., ICU). Neteera Technologies Ltd. Confidential P. 1 of 7 Contra-Indications:

Neteera 130H-Plus/131H-Plus is contraindicated for use in:

People for whom proper positioning cannot be achieved or maintained. A combustible environment or in the presence of flammable anesthetics or gases. Situations where a dry environment cannot be ensured. A Magnetic Resonance Imaging (MRI) environment. Any other system or environment which was not authorized by Neteera Technologies LTD. Company. General Hazards:

Do not use a damaged Neteera 130H-Plus/131H-Plus device cracked/broken plastic case, cracked/broken lens, defective USB connection, or any other indication of physical damage to the Neteera 130H-Plus/131H-Plus device. The use of a damaged Neteera 130H-Plus/131H-

Plus device might result in the malfunction of the system. Handle the Neteera 130H-Plus/131H-Plus device with care. Do not drop, knock, or shake the unit. Rough handling can damage the internal circuit boards. The sensor is intended for indoor operation only. Avoid any contact with water or any other chemical. Cleaning is only allowed using a damp clean cloth, without harsh detergents, or per healthcare facility procedures. A damaged Neteera 130H-Plus/131H-Plus device should not be disposed of as unsorted municipal waste. Contact your local distributor for unit disposal. Changes or modifications not expressly approved (in writing) by Neteera technologies could affect the safety or effectiveness of the Neteera 130H-Plus/131H-Plus device performance and void the warranty. The Neteera 130H-Plus/131H-Plus device is designed with reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible that high levels of such interference due to proximity or strength of a source might impact the performance of the Neteera 130H-

Plus/131H-Plus device. Additionally, interference from emitters such as diathermy or electrocautery devices or wireless power transfer devices (e.g., wireless phone chargers) may impact performance of the Neteera 130H-Plus/131H-Plus device. Neteera Technologies Ltd. Confidential P. 2 of 7 Warnings and Cautions:

If the device does not operate properly, contact Neteera Support. Use only the supplied accessories and parts. In case a part or accessory should need to be replaced, please contact Neteera support. Do not attempt to replace parts or accessories without prior consultation by Neteera support. When using the Neteera system, do not share the chair/bed being monitored with another person or pet during Neteera 130H-Plus/131H-Plus device recording session. o Sharing the chair or bed could affect the effectiveness of the system and the accuracy of the measurements. Avoid using heated blankets, or any other metal-containing heating item located between the Neteera 130H-Plus/131H-Plus device and the monitored person. The use of heating blankets could affect the effectiveness of the Neteera 130H-Plus/131H-Plus and void the systems warranty. The monitored person should not have direct contact with the Unit a minimum distance of 5cm should be maintained. Neteera 130H-Plus/131H-Plus device is not intended to be a replacement for monitoring high-risk situations where ECG monitoring is required. The most reliable method of monitored person monitoring combines the close personal surveillance with the correct operation of the monitoring equipment. The Neteera 130H-Plus/131H-Plus technology and parameters have not been studied on any specific monitored person or group, nor has it been studied as a diagnostic tool for any specific disease or medical condition. It is meant to be an adjunctive tool only for measuring respiratory rate, heart rate. The device has not been validated in a pediatric population or in individuals with arrhythmia. The device is not intended for ambulatory conditions. As with all medical equipment, carefully route and secure Neteera 130H-Plus/131H-Plus device cables and connections to reduce the possibility of entanglement or strangulation. Interconnection of this equipment to other equipment not described in the instructions for use is prohibited. The Neteera 130H-Plus/131H-Plus monitoring system is not intended to be used as an alarm system for potentially life-threatening situations in which medical intervention is necessary. The device is not intended to be used as a real-time monitor or apnea monitor. Do not rely on the respiration monitoring for detection of cessation of breathing and always follow hospital guidelines and best clinical practices, including monitoring additional parameters that indicate the patients oxygenation status. Prior to delivering medical treatment based on a high heart rate reading (120 to 160 bpm), the subject should be asked to remain still for several minutes to allow the reading to be verified under no motion conditions. Neteera Technologies Ltd. Confidential P. 3 of 7 EMC Warnings:

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING: The use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Neteera 130H-Plus/131H-Plus, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING: Neteera 130H-Plus/131H-Plus needs special precautions regarding EMC and needs to be installed and put into service according to the specific instructions for maintaining basic safety and essential performance with regard to electromagnetic disturbances for the expected service life. Refer to System Compliance Appendix for further details on EMC safety conditions. RF EXPOSURE STATEMENTS Exposure to radiofrequency during wireless operation: based on the FCC RF exposure compliance requirements, the separation distance between a wireless antenna and any persons body must be at least 2 inches / 5 cm. Maintenance and Cleaning The Neteera 130H-Plus/131H-Plus is designed to provide trouble-free and maintenance-

free operation. The only maintenance required is to keep the system clean and dry and to verify that there is no physical damage to the Sensor. Gently wipe the Neteera 130H-Plus/131H-Plus device lens using a soft, damp cloth/wipes containing anti-septic substances. Wipes containing alcohol, Chlorhexidine, and bleach material can be used. Please ensure that the Neteera 130H-Plus/131H-Plus device is dry before re-use. Neteera Technologies Ltd. Confidential P. 4 of 7 Specifications Indications Rx Use Sterile The device is intended to perform measurements in healthcare settings. The data provided by the device is intended to be reviewed and interpreted by healthcare practitioners to assess a persons medical condition. The device is contact-free and does not need to undergo sterilization. Multiple Use The device is intended for multiple uses, spot, and continuous monitoring. Measured Parameters HR Heart Rate Range 40 to 160 BPM (Beats Per Minute) Maximal HR change speed HR output rate 4 BPM/ sec Every 1 sec RR Respiration Rate Range 5 to 40 BrPM (Breaths Per Minute) Maximal RR change speed RR output rate 1 BrPM/ 3 sec Every 1 sec Respiratory Amplitude scale 1 (low) to 5 (high) arbitrary units Respiratory Amplitude output rate Every 1 sec IE ratio scale Low RR (respiration rate) Occupancy Operation Specifications Mounting Options Integration mounting options Positive numbers Less than 5 BrPM No respiratory numeric values and trends are displayed while detected No numeric values and trends are displayed while not occupied Mounted in the front of a chair, or above a bed. Range: 860 in. / 20-150 cm Mounted in the back of a chair, or below a bed. Range: 28 in. / 5-20 cm Applicable patient positioning Sitting, laying (according to installation guidelines) Neteera Technologies Ltd. Confidential P. 5 of 7 Electrical Characteristics Operating Voltage Power/Data Connector 5V +/-5%

USB 2.0 type A + power supply Power Consumption, typical 2.9W Power Supply Options Charger 5V/1A or Type A USB 2.0 port of a host device Physical Characteristics Dimensions (L x W x H) 3.22 x 1.22 x 2.36 in. / 8.2 x 3.1 x 6 cm Weight 2.7 Oz / 76 gr. Data Connectivity Wired Wireless DataProtocol Handling and Storage USB 2.0 Wi-Fi 2.4GHz 802.11 b/g Neteera MQTT for wireless communication, CDC transfer protocol for wired communication Operation Temperature 32 to +104 F/ 0 to +40 C Storage Temperature

-40 to +176 F/ -40 to +80 C Operating and StorageHumidity Up to 75% (non-condensing) MR Compliance Not MR compliant Atmospheric Pressure 700-1060 hPa Service Life The device service life is 5 years. Neteera Technologies Ltd. Confidential P. 6 of 7 Symbols FCC ID: 2AYVONETEERA130PLUS This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate this equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. The maximum output power of our Wi-Fi module ESP-WROOM-32DC (FCC ID:2AC7Z -

ESPWROOM32DC), is limited, to 19 dBm. IFU-0002 130H-Plus/131H-Plus Rev 1.0 Neteera Technologies Ltd. Confidential P. 7 of 7

Labeling Representation LBL-0002 Rev 1.1 Confidential & Proprietary Confidential & ProprietaryPurpose & ScopeoThe following document presents all Neteeras device labels. General2ReviewersNamePositionDateSignatureAuthorYoniLeviProduction Manager22-Dec-22ReviewerRakefetShohatVP QA/RA22-Dec-22ApproverShaharYaronVPProduct22-Dec-22RevisionHistoryVersionAuthorChanges1.0YoniLeviInitialRelease(included210Hlabelsonly)1.1YoniLeviECO#2022-04Renamed210/211to130H-Plus&131H-Plus 130H-Plus US - 210-00-101-00 Device Label: 210-12-101-00 Rev 1.1 Confidential & Proprietary 3 131H-Plus US - 211-00-101-00 Device Label: 211-12-101-00 Rev 1.1 Confidential & Proprietary 4

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6466579.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case TCB GRANT OF EQUIPMENT AUTHORIZATION Certification Issued Under the Authority of the Federal Communications Commission By:

TCB Telefication B.V. Edisonstraat 12a Zevenaar, NL-6902 PK Netherlands Date of Grant: 04/22/2021 Application Dated: 04/21/2021 ESPRESSIF SYSTEMS (SHANGHAI) CO., LTD Suite 204, Block 2, 690 Bibo Road, Zhang Jiang Hi-Tech Park, Shanghai, 201203 China Attention: Mia Zhou NOT TRANSFERABLE EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below. FCC IDENTIFIER:

Name of Grantee:

Equipment Class:

Notes:

2AC7Z-ESPWROOM32DC ESPRESSIF SYSTEMS (SHANGHAI) CO., LTD Part 15 Spread Spectrum Transmitter Wi-Fi Module Grant Notes FCC Rule Parts 15C Frequency Range (MHZ) 2412.0 - 2462.0 Output Watts 0.079 Frequency Tolerance Emission Designator Class II Change: This change (a) incorporates this Wi-Fi module of ESPRESSIF SYSTEMS (SHANGHAI) CO., LTD in to Neteera technologies Ltd. portable host Respiratory and cardiac rate monitor. Any configuration other than the one described will require a separate approval. End end-users must be provided with specific operating instructions for satisfying RF exposure compliance requirements. The maximum conducted output power of the ESP32 module is limited to 19 dBm by the end user. Modular approval. Output power listed is conducted. This grant is valid only when the module is sold to OEM or OEM integrators. Modular approval for use as a module in mobile-only RF exposure conditions. Only those antenna(s) tested with the device or similar antenna(s) with equal or lesser gain maybe used with this transmitter. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and not be co-located with any other transmitters, except in accordance with FCC multi-transmitter product procedures. Compliance of this device in all final host configurations is the responsibility of the Grantee. End-users must be provided with specific information required to satisfy RF exposure compliance for the final host device. Installation of this device into portable RF Exposure category host devices requires the submission of a Class II permissive change or new application. Certificate No.:

212180398/AA/00 Mark Chung Product Assessor

Measurement Report Albatross for Antennas for 1 Antennas for Albatross The measurements were performed on package substrate. RF probes were used to contact TX and RX antennas. A four patch-array is used as transmit and receive antenna for Albatross B0. 1.1 Substrate Figure 1 Picture of package substrate with antennas. 1.2 Antenna specification Parameter Min Typ Max Unit Remarks Condition

Frequency range Total Efficiency Gain Tx (E-Plane) Gain Tx (H-Plane) Gain Rx (E-Plane) Gain Rx (H-Plane) Antenna aperture 116 55 8 8 8 8 123 GHz 68 11 11 11 11

dBi @ Theta=0 deg dBi @ Theta=0 deg dBi @ Theta=0 deg dBi @ Theta=0 deg 10 10 10 10 60 horizontal Antenna aperture vertical Boresight deviation plane) Boresight deviation plane)

(E-

-10

(H-

-10 60 0 0

+10

+10 S-Parameters (Port1: Tx-

Antenna, Rx-

Antenna) Port2:

Dimension Tx (x/y) Dimension Rx (x/y) Polarization

-19

-12

-5 dB 1.76/

1.76 1.76/

1.76 mm Patch array without feeding line mm Patch array without feeding line Linear Measurement Results 1.3 RX antenna measurements Figure 2 RX antenna gain vs frequency. 1.4 TX antenna measurements Figure 5 TX antenna gain vs frequency.

Covered list attestation FCC application letter Kiwa RF_755_02 Page 1 of 2 15-02-2023 Certification Application Attestation Statements Neteera Technologies LTD Prof. Rakah 3 St Jerusalem 9139002 Israel Subject: FCC ID: 2AYVONETEERA130PLUS To Whom It May Concern:

Statement for 47 CFR section 2.911(d)(5)(i) Neteera Technologies LTD certifies that as of the date of the application the equipment for which authorization is sought is not covered equipment1 prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. If the equipment for which the applicant seeks authorization is produced by any of the entities identified on the current Covered List, including affiliates or subsidiaries of the named companies, the applicant must include an explanation on why the equipment is not covered equipment. Additional Explanation: <N/A>

Statement for 47 CFR section 2.911(d)(5)(ii) Neteera Technologies LTD (the applicant) certifies that, as of the date of the filing of this application, the applicant

- is /

- is not (3) identified on the Covered List as an entity producing covered equipment. Date:

City:

Name(2) :

Function:

Telephone number:

Email address:

9-Feb-2023 Jerusalem Shahar Yaron VP Product

+ 972526809220 Shahar.yaron@neteera.com Signature:

1 - The Commissions Covered List is published by the Public Safety and Homeland Security Bureau and posted on the Commissions website. This Covered List, which is periodically updated, identifies particular equipment, produced by particular entities, that constitutes covered equipment. https://www.fcc.gov/supplychain/coveredlist .

(2): For FCC it must be the Grantee Code owner or the authorized agent.

(3): double click on the appropriate box and select checked then OK Covered list attestation FCC application letter Kiwa RF_755_02 Page 2 of 2 15-02-2023 Revision Record Sheet:

Revision Section Page Date Remark(s) number number 07-02-2023 1st version 01 02 issued by RvM 1 15-02-2023 Changed Applicant to Company RvdM and added Subject: FCC ID:

Issued/modified by Function Revision Date

: Richard van de Meer

: Certification assessor

: 02

: 15-02-2023 Verified by Function Date

: Willem Jan Jong

: Team Lead

: __-02-2023 Released by Function Date of release:

: Axel Gase

: Manager Quality Assurance

: __-02-2023

FCC, Request for non-disclosure RF_501, Issue 9 Date: 08-Oct-2021 Page 1 of 1 Company Name: Neteera Technologies LTD Address:

City:

Israel Country:

Prof. Rakah 3 St., Jerusalem 9139002 To: Telefication B.V., Dept. FCC TCB Wilmersdorf 50 7327 AC Apeldoorn The Netherlands Subject: Request for confidentiality FCC ID: 2AYVONETEERA130PLUS Reference number: 47235 Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application:

Bill(s) of Material Block Diagrams Operational Description Schematic Diagrams Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with the marketing regulations in 47 CFR 2.803 and the importation rules in 47 CFR 2.1204, applicant hereby requests Short-Term Confidential treatment of the following materials (See notes below):

Internal Photos Users Manual Test Set-up Photos External Photos Justification: The above information may assist competitors in understanding the system archtecture and major components, which may hurt our competitive advantage and help competitors with designing competing products Date: March 22, 2023 Name and signature of applicant: Shahar Yaron Notes:

1) A document or type of document can only have ONE type of confidentiality!

2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)!

The planned date should stated in the RF731 application form. 3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this!

5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period

RF_160, Issue 04

(On manufacturers company letter heading) Declaration of Authorization We Name:

Address:

City:

Country:

Declare that:

Neteera Technologies Ltd. Prof. Rakah 3 St.. Jerusalem 9139002. Israel . Name Representative of agent: . (1) Agent Company name:

Address:

City:

Country Hermon Laboratories Ltd. Harakevet Industrial Zone Binyamina 30500 .. Israel . . is authorized to apply for Certification of the following product(s):

Product description: Respiratory and cardiac rate monitor . Type designation:

Trademark:

Validity/ expiry date February 07, 2024 1) Neteera 130H-Plus 2) Neteera 131H-Plus NA . on our behalf. Date:

City:

Name:

February 07, 2023.. Jerusalem .. Shahar Yaron.. (2) Function:

VP product. Signature:

... Notes:

(1): Required for FCC application

(2): For FCC it must be the Grantee Code owner or the authorized agent.

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 03/10/2023 Ref: Attestation Statement Part 2.911(d)(7) Filing FCC ID: 2AYVONETEERA130PLUS Neteera Technologies Ltd. certifies that, as of the dates of this application, Americas Compliance Consulting LLC dba iCertifi iCertifi is our designated U.S. agent for service of process for the above referenced FCC ID. Neteera Technologies Ltd. accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any commission-related proceeding involving the equipment. iCertifi accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service process for the above referenced FCC ID. Designated U.S. Agent Information:

Name: Americas Compliance consulting, LLC dba iCertifi FCC FRN: 0033399411 Address: 1001 SW Disk Drive, Suite 250, Bend, Oregon 97702 Contact Person: Paul Preston Tel: 866-885-4575 Email: fccagent@icertifi.com Sincerely, Manufacturer Name Americas Compliance Consulting LLC dba iCertifi Manufacturer Contact Paul Preston Signature V02072023 Neteera Technologies Ltd.Rakefet Shohat