NM-700 Instructions for Use For software version: 4.51 Copyright © Norav, January 2024 All rights reserved. This manual contains proprietary information, which is protected by copyright, all rights reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws (e.g., educational purposes). United Kingdom [UK Representative]: The Old Malt House Willow Street Shropshire, SY11 1AJ United Kingdom Tel: (+44) 1691 676496 Mail: [email protected] Norav Medical GmbH Christof-Ruthof-Weg 10 55252 Mainz-Kastel Germany E-Mail: [email protected]...

Standards Compliance The software complies with Standards for Analysis of Ventricular Late Potentials Using High Resolution or Signal Averaged Electrocardiography, published in 1991 by the Task Force Committee of the European Society of Cardiology, the American Heart Association, and the American College of Cardiology. The NR ECG device is tested and certified for the following standards: Defibrillation protection: Built in for ECG cable lead wires with "Banana" and "Clip" ends. US Federal Law restricts this device to sale by, or on the order of, a physician

1. Introduction Document ConventionsWarnings Cautions and Notes Pay particular attention to specific points in a procedure when one of the following messages is displayed: 11 \ Warnings call attention to possible hazards involving potential damage or injury to Cautions refer to practices necessary to protect against potential damage to equipment or loss of equipment. Pay careful attention to instructions. Notes provide pertinent information to help obtain optimum software performance or signify an important step or procedure requiring special attention. Abbreviations and Acronyms Abbreviation

NM-700 is a PC-based ECG tracing system for up to 7 patients. ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in the following cases: • Patients with suspected cardiac abnormalities • Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is desired. The NR ECG device is intended for recording ECG Tests. The device has no contraindications or adverse events.

Safety Warnings and Precautions Warning ^ Electrosurgery — There is a risk of burns and injury to the patient. If an electrosurgical device is used, disconnect the ECG cable from the device. ^ Cables - Cables present a possible strangulation hazard. To avoid possible strangulation, route all cables away from the patient’s throat. ^ Conductivity — Electric shock or device malfunction may occur if electrodes contact conductive materials. Keep the conductive parts of lead electrodes and associated parts away from other conductive parts, including earth. Also make sure that no contact to other conductive...

^ Damage to Device from Battery Leakage — Batteries may leak if left in an unused device for a long period. If you intend to store the device for more than one week, remove the battery. ^ Cable Damage — Bending or wrapping the cable can damage it. When attaching and affixing the ECG cable, make sure not to bend it excessively. Avoid coiling the ECG cable around the device, as this can damage the cable. ^ Damage to Device — You may open only the battery compartment of the NR ECG device. Do not use force when handling the NR ECG device. Take care to prevent chemicals/liquids from entering the connectors...

Do not expose the ECG and SpO2 devices to water or any kind of liquid. Maintain in a dry place. Electrical Hazard — Improper handling during inspection or cleaning can result in electrical shock. To avoid potential shock, always observe the following guidelines: > Before inspecting or cleaning the system, turn it off, unplug it from AC power, and remove the battery. > Do NOT immerse any part of the equipment in water. Perform daily inspection, preferably before the equipment is first used each day. During inspection, make sure the device meets the following minimum conditions: • Device case is...

Close all Norav software applications (if any are running) before installing or updating the software. The software package works under Windows 10/11 operating system. 1. Launch the installation executable file. 2. Follow the onscreen instructions. 3. After installation is completed, restart the PC. This option is available with the D1 license. Follow the instructions from the previous section. X|\ The ECG and Sp02 devices are sensitive to electrical interference. To prevent possible injury, read this page carefully before installing the device. • ECG and SpO2 devices are designed to work only...

Installing NR-314-T or NR-1207-3 ECG Device Please, refer to the Norav NR Series Instruction for Use for detailed information about connecting patient cable and installing batteries NR-314-T or NR-1207-3 devices. Use only alkaline or NiMH rechargeable batteries. 1. Select NR ECG device or SpO2 oximeter. ◊ For NR ECG device, enter 12345 as the pass key. ◊ For SpO2 oximeter, enter the PIN code written on the device backside label. 3. After the device is paired, click Done. Connect the HASP dongle to the USB port. The new hardware has been identified. After the driver is installed, a red indication...

• Telemetry ECG real-time acquisition application • NEMS-A Database The following sections describe the operation of these interfaces.

Telemetry Session Window Patient Data Print ECG Opens the Patient Data dialog box to enable input or edit patient's details viewed in the active session window. Edit Remarks and Event comments. Displays the detected ECG events list. Permits writing comments for detected ECG Events or to write free text remarks; input fields to insert BP values. Click the button on the patient session window to print a current ECG screen. Controls starting and stopping the telemetry sessions. Blood Pressure Click to input the blood pressure. HR Click to adjust the Tachycardia and Bradycardia HR alarm thresholds....