TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 Neteera 130H/131H Instructions for use Reviewers Name Position Date Author Idan Yona Customer Engamenet Manager 22-Mar-2021 Reviewer Shahar Yaron VP Product 22-Mar-2021 Approver Rakefet Shohat QA Manager 22-Mar-2021 Signature Revision History Version Author Changes 0.7 Hanna Riezk First Issue 1.0 Hanna Riezk Initial Release 1.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 Table of Contents 1. Introduction 4 1.1 Acronyms and Terminology 4 1.2 About this product 5 1.3 Hardware requirements 5 2. HW installation 6 2.1 HW Technical description 7 2.2 Neteera 130/131H characteristics 7 2.3 The main unit – the Neteera130/131H radar 9 3. General Safety Guidelines 10 3.1 General Hazards 10 3.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 1. INTRODUCTION 1.1 Acronyms and Terminology Term Neteera130/131H VS HW SW HR RR BCG Description Neteera’s 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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 subject’s mild body movement. More information about these parameters is provided in chapter 5.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 2. HW INSTALLATION Neteera 130/131H consists of: Neteera 130/131H main unit USB 2.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 2.2.4 Electrical Characteristics Parameter Value Operating Voltage 5V +/-5% Power/Data Connector USB 2.0 Power Consumption, typical (130H) 4.5W Power Consumption, typical (131H) 3W Power Supply Options Charger 5V/1A or Type A USB 2.0 port of a host device 2.2.5 Physical Characteristics Parameter Value Dimensions (L x W x H) 3.22*1.22*2.36 in.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 Operating and storage Humidity 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
• • • • • • • TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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 system’s warranty. The patient should not have direct contact with the Sensing Unit.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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. Image 7: Wall mount 4.2 Installation types 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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” ➢ Patient’s ID - kindly use an up to a 22 digit number (only).
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 Image 15: Enter patient’s information • About 30 seconds after clicking “start session”, the vital signs will start streaming. As presented in the image below.
• TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 5.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
• TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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.
• TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 The session should last at least 30 seconds.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.1 6. VIEW RESULTS ON LOCAL DB • Recorded sessions are automatically uploaded to the local DB on the customer’s 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.
• TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 REVISION: 1.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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 chair’s back There is no interfering object between the patient’s/user’s torso and the sensor’s field of view.
TITLE: Neteera 130H/131H IFU RELEASE DATE: 22-Mar-2021 DEPARTMENT: Product EFFECTIVE DATE: 22-Mar-2021 NUMBER: IFU-000 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 How to fix Re-activate the Neteera software – follow the instructions on part 3.
