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Norav User Guide

Norav User Guide
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Norav User Guide

Product catalog summary
Standards Compliance
This device is restricted to sale by or on the order of a physician. It complies with international standards IEC60601-1 and IEC 60601-2-27, ensuring safety and performance in medical environments.

Manufacturer and Contact Information
Norav Medical Ltd, based in Israel, is the manufacturer. They have authorized representatives in the EU, UK, and Switzerland for support and service.

Disclaimer
The system is a decision support tool for trained medical professionals and should not be used as the sole basis for clinical decisions. Misuse of the system is not advised.

Warranty
Norav products have a one-year warranty against manufacturing defects, excluding expendable items like electrodes and cables. Modifications or damage by the customer void the warranty.

Device Specifications
The ECG-USB1D-EX and ECGUSB1D-EXR models offer defibrillation protection and low patient leakage current. They support a 3-lead ECG configuration with specific input ranges and bandwidths.

Indications for Use
The ECG-USB1 device is designed to add ECG/Respiration capabilities to host systems via USB. It requires custom software development by the host owner.

Safety Instructions
Ensure the device is connected to an isolated system and use only original cables. Discontinue use if performance changes are observed.

Operation
Instructions include connecting the device via USB, attaching patient cables, and ensuring proper electrode placement for optimal signal quality.

Maintenance
The device is not waterproof and should be kept dry. Clean with a soft cloth and avoid harsh chemicals. Regularly inspect and replace worn cables.

Technical Specifications
Details include protection features, input ranges, bandwidth, and environmental operating conditions. The device is compliant with safety and environmental standards.

Troubleshooting
Common issues like noisy ECG signals are addressed with corrective actions such as ensuring proper electrode application and checking for electrical interference.
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Catalog excerpts

Norav User Guide-1

Norav User Guide ECGUSB1D-EX / ECGUSB1D-EXR

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Norav User Guide-2

Norav User Guide Norav User Guide For Models: ECGUSB1D-EX, ECGUSB1D-EXR Copyright © Norav, October 2024. All rights reserved. Document Number: NV-54/ECG-USB1 Revision 07 No part of this publication may be reproduced in any material form (including photocopying or storing it in any medium by electronic means whether or not transiently or incidentally to some other use of this publication) without the prior written permission of the copyright owner, or under the terms of a license issued by the copyright owner. The information contained in this document is subject to change without notice. Norav...

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Norav User Guide-3

Norav User Guide The ECG-USB1 has been tested and certified for compliance with the following standards (including device features regulated by these standards): IEC60601-1: Protection type and class: Defibrillation protection: Disclaimer This system is intended as a decision support system for persons who have received appropriate medical training, and should not be used as a sole basis for making clinical decisions pertaining to patient diagnosis, care, or management. Any application of medical information from the program, other than the original design or intended use thereof, is not advised...

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Norav User Guide-5

Norav User Guide Page Document Conventions Notes and Cautions Pay particular attention at specific points in a procedure when one of the following messages appears: Warnings call attention to possible hazards involving potential damage or injury to persons. WA RN ING Cautions refer to practices necessary to protect against potential damage or loss to equipment. Pay careful attention to instructions. Notes provide pertinent information to help obtain optimum performance from the system or signify an important step or procedure that requires special attention. No te Equipment Symbols Symbol Type...

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Norav User Guide-6

Norav User Guide Page Medical device

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Norav User Guide-7

Norav User Guide The ECG-USB1 device provides a single channel ECG for host systems that require an external unit in order to add ECG\Respiration capabilities in an easy and fast way to their platform. The host owner should write its own software application that communicates with the device via USB port using the Norav USB driver and SDK. The device has no contraindications or adverse effects. Connect the ECG-USB1 only to a system that is isolated from the electric power supply. It is also sensitive to electrical interference. To prevent possible injury, read this page carefully prior to installing...

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Norav User Guide-8

Norav Users Guide Cautions refer to practices necessary to protect against potential damage or loss to equipment. 1. Connect the standard A-type plug of the USB cable (Figure 2, detail 1) to the USB connector of the host. 2. Connect the Mini-B type USB plug of the USB cable (Figure 2, detail 2) to the input of the ECG-USB1 acquisition device (Figure 1, detail 1). 3. Connect plug of detachable patient cable (Figure 4, detail 3) to the round connector on ECG-USB1 (Figure 1, detail 2) 4. Apply the leads to the patient (Right Arm, Left Arm and Right Leg) according to their markings (R(RA), L(LA)...

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Norav User Guide-9

Norav Users Guide The ECG traces quality depends very much on the stability and conductivity of the electrodes during the test, especially during high stages when the patient movements can cause artifacts. Here are some basic rules to ensure good electrical contact: 0 Shave hair at the electrode contact points 0 Use high quality liquid gel electrodes 0 Make sure that the lead wires do not swing Attach the leads as shown in Figure 5. Use the detachable ECG 3-lead cable, each lead 100 cm long, with clip connectors at the patient end, designed for use with disposable ECG electrodes. Figure 5: Electrode...

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Norav User Guide-10

Norav Users Guide Refer to Appendix B for examples of improper patient preparation results. The device is not waterproof. Do not expose the device to water or any kind of liquid. Maintain in a dry place. The exterior of the Recorder may be wiped clean with a soft cloth. Do not use harsh cleaning agents to clean the unit. Do not immerse the unit in any liquid. Clean the cables with a hospital approved cleaning procedure such as those recommended by AAMI or AORN. Wiping the cables with a solution of soap and water followed by a rinse with water is a simple yet effective method to clean the cables....

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Norav User Guide-11

Norav Users Guide APPENDIX A: TECHNICAL SPECIFICATIONS

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Norav User Guide-12

Norav Users Guide “Noise” refers to any degradation of the ECG signal that makes it difficult to accurately detect and classify beats. Causes of noise, such as artifact and electrical interference, should be avoided whenever possible. Some common causes of noisy ECG signals include: • Poor skin prep. • Muscle artifact caused by shivering, movement or tremors. • Baseline wander caused by excessive chest movement, or the electrical differences between two brands of electrodes. • Respiration artifact caused by thoracic or abdominal movement of both spontaneous and ventilated breathing patterns....

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.
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