TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 Neteera 130H/131H Instructions for use Reviewers Name Position Date Signature Author Idan Yona Customer Engagement Manager 22-Apr-2021 Reviewer Shahar Yaron VP Product Approver Rakefet Shohat QA Manager 22- Apr -2021 22- Apr -2021 Revision History Version Author 0.7 1.0 1.1 Hanna Riezk Hanna Riezk Idan Yona Changes First Issue Initial Release Added Part 15 of the FCC Rules claims. Confidential Page 1 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 Neteera 130H/131H Instructions for use Copyright 2021 Neteera Technologies Ltd. All rights reserved worldwide. These instructions for use are proprietary of Neteera Technologies Ltd. Unauthorized use, disclosure or reproduction is prohibited. Neteera Technologies Ltd assumes no responsibility for errors that may appear in these instructions for use. Neteera Technologies Ltd reserves the right to make changes without notice to these instructions for use and the products described herein. Contact and Support Information For any question or help during installation/operation of the system, contact your FAE representative or support@neteera.com You may contact Neteera Technologies Ltd at:
BLDG 1.1, High-Tech Village, Hebrew University of Jerusalem, Givat Ram Campus, Jerusalem, Israel 9139002 Confidential Page 2 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 Table of Contents 1. Introduction 1.1 1.2 Acronyms and Terminology About this product 1.3 Hardware requirements 2. HW installation 2.1 HW Technical description 2.2 Neteera 130/131H characteristics 2.3 The main unit the Neteera130/131H radar 3. General Safety Guidelines 3.1 General Hazards 3.2 Contraindications for Use 3.3 Warnings and Cautions 4.Device installation 4.1 Mounting accessories 4.2 Installation types 4.3 Installation instructions 5. Software Instructions 5.1 Connect to an external device PC/Laptop/Tablet 5.2 Starting a monitoring session 5.3 Parameters displayed 6. View results on local db 7. Patient/user preparation 8. Maintenance and Cleaning 9. Troubleshooting 4 4 5 5 6 7 7 9 10 10 10 10 12 12 13 14 15 15 15 19 23 25 25 26 Confidential Page 3 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 1. INTRODUCTION 1.1 Acronyms and Terminology Term Neteera130/131H VS HW SW HR RR BCG Description Neteeras System (Micro-Radar Based system) Vital Signs Hardware Software Heart rate Respiratory rate Ballistocardiograph Image 1: Explanation of system labels FCC ID: 2AYVO-NETEERA1301 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. Confidential Page 4 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 1.2 About this product Neteera device is a contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting a variety of parameters: Respiration Rate
(RR), Heart Rate (HR), during rest or subjects mild body movement. More information about these parameters is provided in chapter 5.3 - parameters displayed. The Neteera device is intended for contactless monitoring of HR and RR, for spot and continuous monitoring by healthcare professionals (in healthcare facilities and home monitoring). The indications provided are to be used by health care practitioners and are intended to be reviewed and interpreted by clinicians to assess patients medical situation. 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 novel micro radar-based solution enables to measure remotely, in real-time, in a non-
invasive, non-contact manner, only the micro-motions 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 as detailed below. The presented product is divided into two different configurations:
130H: contains a Wi-Fi component that enables communication and data transfer over an internet network. 131H: enables P2P communication only through a USB connection between the device and an external Windows device. 1.3 Hardware requirements The Neteera 130/131H has a hardware component (the case housing the radar itself) and the software that operates it and runs over the device. To collect the data from the device and to display it, an external device is needed that will communicate with the device. The requirements for such a device as below:
PC/tablet with:
Windows 10 USB 2.0 port Core i3 8 GB RAM display resolution HD SSD 64GB Wi-Fi 2.4GHz 802.11b/g Confidential Page 5 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 2. HW INSTALLATION Neteera 130/131H consists of:
Neteera 130/131H main unit USB 2.0 cable Power supply (130H) Image 2: system parts When the installation is complete (according to the instructions found below), it should look like this:
The data is sent to a PC via the USB cable/Wi-Fi Vital signs are displayed on the screen. Image 3: Neteera 130/131H system operation Confidential Page 6 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 2.1 HW Technical description Component Description Neteera130/131H Main unit Full p2p radar-based system with PLL working at 116-123 GHz USB cable Standard 2.0 USB cable 2.2 Neteera 130/131H characteristics 2.2.1 Vital signs Parameter Value HR Heart Rate Range 40 to 160 BPM (Beats Per Minute) HR output rate Maximal HR change speed Every 1 second 4 BPM/sec RR Respiration Rate Range 5 to 40 BrPM (Breaths Per Minute) RR output rate Maximal RR change speed HR accuracy RR accuracy RA scale 2.2.2 Operation Specifications Every 2 second 2 BrPM/sec Up to 10% deviation Up to 10% deviation, or up to 2 BrPM 1 (low) to 5 (high) Parameter Value Measuring Range to the Subject 0.160.65 ft./5-20cm: Mounted in back. 0.65-4.92 ft./20-150cm: Mounted in front. Mounting Options Mounted in the back/front of a chair 2.2.3 SensorCharacteristics Parameter Value Maximum Radiated Power(E.I.R.P) Up to 20 dBm Field of View (-6dBBeam Width) Polarization 13 deg Linear Confidential Page 7 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 2.2.4 Electrical Characteristics Parameter Value Operating Voltage Power/Data Connector Power Consumption, typical (130H) Power Consumption, typical (131H) Power Supply Options 2.2.5 Physical Characteristics 5V +/-5%
USB 2.0 4.5W 3 W Charger 5V/1A or Type A USB 2.0 port of a host device Parameter Value Dimensions (L x W x H) 3.22*1.22*2.36 in. /82*31*60mm Weight 0.661 lb./300 gr. 2.2.6 Occupancy detection characteristics Parameter Value Accuracy Response time 96%
Up to 5 sec 2.2.7 Data Connectivity Parameter Value Wired Wired data protocol Wireless(optional) Wireless dataProtocol USB 2.0 CDC transfer protocol Wi-Fi 801.22 b/g NeteeraMQTT 2.2.8 Environmental Characteristics Parameter Value symbol Operation Temperature 32 to +122 F/ 0 to +50 C Storage Temperature
-40 to +176 F/ -40 to +80 C Confidential Page 8 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 Operating and storageHumidity Up to 75% (non-condensing) MR compliance Not MR compliant Atmospheric pressure 700-1060 hPa 2.3 The main unit the Neteera130/131H radar Radar lens Main unit outer casing Image 4: Neteera 130/131H main unit The main unit has a lens, outer casing, and a mounting accessory. The unit will be mounted on a chair seat (as will be detailed below). In case there is a need to install it on a bed, kindly contact the support team. PLEASE NOTE: ONLY mount and use this unit assembled as originally received. DO NOT try to disassemble the black casing may compromise device safety and proper functionality. Confidential Page 9 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 3. GENERAL SAFETY GUIDELINES 3.1 General Hazards Do not use a damaged sensor. The use of damaged components might result in the malfunctioning of the system. Handle the sensing unit with care. Do not drop, knock, or shake the sensing 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 sensor should not be disposed of as unsorted municipal waste. Contact your local distributor for unit disposal. Changes or modifications not expressly approved by Neteera technologies could affect the safety or effectiveness of the Neteera 130/131H performance and void the warranty. The Neteera 130/131H standard 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 disrupt the performance of this device. 3.2 Contraindications for Use Neteera 130/131H is contraindicated for use in:
Patients in whom proper positioning cannot be achieved or maintained. An explosive atmosphere 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 the Neteera Technologies Company 3.3 Warnings and Cautions If a sensor does not operate properly, contact Customer Support. Use only the supplied accessories and parts. In case a part or accessory should be replaced, contact Neteera support. Do not attempt to replace parts or accessories without prior consultation by Neteera support. Do not share the chair with another person or pet during Neteera 130/131H recording session. Sharing the chair could affect the effectiveness of the system and the accuracy of the measurements. Confidential Page 10 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 Avoid using heating blankets, or any other metal-containing heating item located between the chair and the patient. The use of heating blankets could affect the effectiveness of the Neteera 130/131H and void the systems warranty. The patient should not have direct contact with the Sensing Unit. The Neteera 130/131H is not intended for monitoring high-risk situations where ECG monitoring is required. The most reliable method of patient monitoring combines close personal surveillance with the correct operation of the monitoring equipment. The Neteera 130/131H technology and parameters have not been studied on any specific patient group, neither has it been studied as a diagnostic tool of any specific disease or medical condition. It is meant as an adjunctive tool only for measuring respiratory rate, heart rate. As with all medical equipment, carefully route sensor cables and connections to reduce the possibility of entanglement or strangulation. The Neteera 130/131H monitoring system is not intended to be used as an alarms system for potentially life-threatening situations in which medical intervention is necessary. Interconnection of this equipment to other equipment not described in the instructions for use is prohibited. RF EXPOSURE STATEMENTS Exposure to radio frequency 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 (5cm). Confidential Page 11 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 4.DEVICE INSTALLATION 4.1 Mounting accessories There are three mount devices supplied by Neteera to perform installations. The mount devices are supplied to the customer as a kit according to request. 1. Tripod part number: 130-00-903-00 The tripod is not part of the product, meaning it can be supplied in small quantities to test the technology or for demonstrations. The tripod is supplied with a ball-joint for easy adjustment. Image 5: Tripod mount 2. Table / Pole mount part number: 130-00-901-00 The table/pole mount is part of the product, meaning this can be supplied in large quantities. This device is supplied with a ball-joint ( and hinge for assembly) for easy adjustment. Image 6: Table/Pole mount Confidential Page 12 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 3. Wall mount - part number: 130-00-902-00 The wall-mount is part of the product, meaning this can be supplied in large quantities. 4.2 Installation types Image 7: Wall mount 130/131H product can be installed in front of the measured subject. The mounting devices mentioned above can be installed while the subject is sitting on a chair or lying on a bed. Chair installation: the product will be installed on a table using a tripod or table mount as presented below. Image 8: tripod installed on a table Image 9: table mount installed on a table Bed installation: the product will be installed above the subject using a wall mount or pole mount as presented below:
Image 10: pole mount installed above bed Image 11: wall mount installed Confidential Page 13 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 4.3 Installation instructions Please read the instructions carefully before beginning installation The first step is to install the HW. Before you begin, please make sure you have:
All the required HW parts - main unit (130/131H) and the USB 2.0 cable. An external device - PC/Tablet with the needed requirements. Neteera SW (supplied by Neteera) on the external device. Installation steps:
Front installations can be done within a minimum distance of 20 cm and up to 150 cm from the subjects body (0.65-4.92 ft.). Back installations can be done within a minimum distance of 5 cm and up to 20 cm from the subjects body (0.160.65 ft.). The lens located at the center of the product main unit should point to the center of mass of the subjects body. Meaning that it towards the subjects torso. The main unit should be parallel as possible to the subjects body. The device should be installed on a stable surface/location to avoid performance disruptions. NOTE: Back installation are possible and are defined as integration projects. The minimum distance of a back installation is 5 cm (0.16 ft.) from the subject. The path of the Radar to the subjects body should be clear from metal parts Confidential Page 14 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 5. SOFTWARE INSTRUCTIONS 5.1 Connect to an external device PC/Laptop/Tablet Use the supplied USB 2.0 cable to connect the Neteera 130/131H main unit to the external device. Make sure that the blue LED illuminates steadily after 10 seconds of connecting the system. This is an indication that the system is receiving voltage and can operate properly. 5.2 Starting a monitoring session Run the Neteera software (supplied with the system) by double-clicking the Neteera_run.bat file. The Neteera UI will appear. Image 12: the icon of Neteera software Click once on the start button. Image 13: the system is ready to start the monitoring session Confidential Page 15 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 If there is a USB image flashing on the screen, or if there is no play symbol the main unit is not connected properly, check the USB cable connection. Image 14: main unit is not connected properly, check the USB cable A menu will appear insert patient info PatientsID-kindly use an up to a22 digitnumber (only).This number should be anonymous, asfornow,thecloud is not GDPR/HIPAA certified(pending for future version). Patientsweight(Kg) Patientsbody temperature(Celsius) Patientsage Patientsblood pressure (systolic and diastolic) When finished inserting therequired info -click start session. Confidential Page 16 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 Image 15: Enter patients information About 30 seconds after clicking start session, the vital signs will start streaming. As presented in the image below. Image 16: Neteeras streaming vital signs Confidential Page 17 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 If Neteera 131H signal is compromised due to excessive movement of the subject, the message will change to Low signal reliability which means that the received vital signs should be discarded. Image 17: message on the screen In case the subject is leaving the devices field of view, the UI will indicate it by display Empty-seat Image 18: message on the screen Confidential Page 18 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 5.3 Parameters displayed The left part of thescreen displays HR and RR trends:
Image 19 Left part of the screen: a streaming wave of HR and RR trends The right part of the screen shows the real-time results for HR, RR, and RA and the timer as well:
Image 20 right part of the screen Confidential Page 19 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 5.4 Finishing the monitoring session To terminate the session, click the Stop button:
Image 21 terminating monitoring session Session results will appear on the screen, together with a reference info menu. Image 22 session results and reference info Confidential Page 20 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 In case the session quality was low a suitable message will be displayed. No data will be saved from this session for later review. Image 23 Low Session Quality message If a reference device for heart rate, respiratory rate, and saturation levels was used during the session, please enter the recorded values in the appropriate places (this is an optional step if no reference was used, click cancel):
Image 24 session results and reference info Confidential Page 21 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 The session should last at least 30 seconds. In case it was terminated before 30 seconds had passed, the RR and HR will have a negative value:
Image 25 session too short Confidential Page 22 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 6. VIEW RESULTS ON LOCAL DB Recorded sessions are automatically uploaded to the local DB on the customers side (once an hour). To access this information double-click on the Neteera_local_DB icon. Image 26: the icon of local DB After pressing it the following web window will appear with all the sessions that were recorded by the customer. Image 27 Recorded sessions summary On the top right side, the customer can filter by different parameters Image 28 search parameters Confidential Page 23 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 Parameters on the top menu:
Session ID session numbering (automatically numbered by Neteera this number can be used as a reference in case a specific session requires support or investigation by the Neteera team) Customer session ID future feature Patient -A_ID - the anonymous ID that was entered at the beginning of the session System # - the device identifier Date session recording date HR/RR med, min, max Heart rate and respiratory rate median, minimal and maximal values. Customer sensors/reference customers reference results (manually entered by the customer) Single session view To see more information about a particular session, click the relevant session line. The next screen will follow:
Image 29 Single recorded sessions detailed information Confidential Page 24 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 7. PATIENT/USER PREPARATION Before beginning the monitoring session, make sure that:
The patient/user is sitting comfortably in the chair, facing forward. The patient/user sits upright (not slouching), and his back is leaning against the chairs back There is no interfering object between the patients/users torso and the sensors field of view. The patient/user is at rest, and not moving or speaking Neteera 130/131H is properly mounted to the chair 8. MAINTENANCE AND CLEANING The Neteera 130/131H is designed to provide a 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 radar 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 sensor is dry before re-use. Confidential Page 25 of 26 TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Apr-2021 DEPARTMENT: Product NUMBER: IFU-000 EFFECTIVE DATE: 22-Apr-2021 REVISION: 1.1 9. TROUBLESHOOTING Issue The screens of the UI are greyed out and no vital sign is demonstrated Possible reason Software launch issue After clicking the start button, Neteeras UI is not displaying any vital signs The main unit connection issue Low signal quality The signal is not stable or reliable Heart rate or respiratory rate (or both) are not streaming on the right part of the screen, and some numeric parameters related to them are not displayed Session failed Error description:
Low session quality, please restart the session message displayed instead of session results (after the session was stopped) Session failed Error description:
Session was too short, please restart the session message displayed instead of session results (after the session was stopped) USB symbol is flashing on the screen USB cable connection Session too short issue How to fix Re-activate the Neteera software follow the instructions on part 3.2 operating the software in this manual Check the cable connection to the Neteera 130/131H and the PC/laptop, and then re-activate the Neteera software follow the instructions on part 3.2 operating the software in this manual The Signal was not reliable Usually due to excessive patient motion) Session running time was shorter than 30 seconds Check the USB connection and inspect the cable for damage. In case the USB cable needs to be replaced, kindly contact the Support team, as a new configuration should apply. For any question or help during the installation/operation of the system, contact our FAE representative or support@neteera.com Confidential Page 26 of 26