Norav Users Guide PC-ECG 1200 For Models: 1200S/M/HR/W, Blue-ECG, NR-1207-E and NR-1207-3, software version: 5.986 Revision: 250406 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 is neither responsible for nor liable...

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 system, other than the original design or intended use thereof, is not advised and considered a misuse of the software product. Norav Limited Warranty Norav products are warranted to be free from manufacturing and material defects for a period of one (1) year from the date of shipment from Norav or the dealer...

This manual explains in detail how to install and use the PC-ECG 1200. At the beginning of each application chapter, there is a Quick Start section, which is a brief explanation of how to carry out a study, including the keyboard short-cuts for the main functions. If you are familiar with ECG procedures, you can use this Quick Start section to get up and running quickly. The software must be installed before the hardware. See Software Installation and Hardware Installation. Pay particular attention at specific points in a procedure when one of the following messages appears: Cautions refer to...

Equipment Symbols Symbol Description TYPE BF APPLIED PART TYPE CF APPLIED PART DEFIBRILLATION-PROOF TYPE BF APPLIED PART DEFIBRILLATION-PROOF TYPE CF APPLIED PART Class II equipment Non-ionizing radiation Refer to instruction manual / booklet NOTE On ME EQUIPMENT "Follow instructions for use” Complies with the Medical Device Directive of the European Union. Caution The recorder is not suitable for measurements conducted on children weighing less than 10 kg (formation of loops in the patient cable!). IP protection class Device Serial Number Device Reference Number Date of manufacture Disposal...

Indications for Use of the PC-ECG 1200 ECG Intended Use ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in adults and pediatric populations 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. QT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacological therapy. QT analysis is also used to...

Contraindications for Use and Adverse Effects The device has no contraindications or adverse effects.

The PC-ECG 1200 package contains the following elements: • Acquisition box — one of the following device models: • SD memory card (for NR-1207-3 model only) • Patient cable • Data USB cable or wireless RF adaptor (for 1200W) or Bluetooth USB transmitter (for Blue-ECG, NR-1207-E and NR-1207-3) • Software installation media with the PC-ECG 1200 package, including: 0 Measurements and Interpretation 0 Stress ECG • Software key (if optional software is included)

Each program has a specific purpose. The following is a brief description of when to use each one:

17 Safety Warnings and Precautions • ELECTROSURGERY - There is a risk of burns and injury to the patient. If an electro surgery 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 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...

Overview PATIENT SAFETY • A patient undergoing a test must be at a distance of at least (relates to the wired models only): □ 1.5 meters from the computer, printer and other peripherals, and □ 2.5 meters from the ceiling. • If such conditions cannot be fulfilled, the entire system needs to be connected to the A/C power supply through an Isolation transformer meeting the IEC/EN 60601-1 standard. OPERATION WITH OTHER DEVICES • Other devices which are part of the system must meet the requirements of the Standard for Information Technology Equipment (IEC/EN 60950-1) and the Standard for Electrical...

• DAMAGE TO THE DEVICE THROUGH BATTERY LEAKAGE -Batteries may leak if left in an unused device for prolonged periods. If you intend to store the device for longer than one week, remove the battery from it. • 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 THE DEVICE - You may only open the battery compartment of the recorder. Do not use force when handling the recorder. • SAFETY ONLY WITH APPROVED ACCESSORIES - Safe...

!Caution • Pacemaker - It is recommended that a minimum separation of 15 cm (6 inches) be maintained between the wireless models Blue-ECG/NR-1207-E/NR-1207-3/1200W and a pacemaker to avoid potential interference with pacemaker. Some studies have shown that wireless devices might interfere with implanted cardiac pacemakers if used within eight inches of the pacemaker. Pacemaker users may want to avoid placing or using a wireless device this close to their pacemaker. Patients with a pacemaker: o Should always keep the wireless Blue-ECG/NR-1207-E/NR-1207-3 unit at least 30 cm from their pacemaker...