Mobile ECG Instructions for Use Revision: 001 Copyright © Norav, December 2022 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). Norav Medical GmbH Christof-Ruthof-Weg 10 D55252 Mainz-Kastel Germany E-Mail: [email protected] 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...

• Defibrillation protection: Built in for ECG cable lead wires with "Banana" and "Clip" ends.

Pay particular attention to specific points in a procedure when one of the following messages is displayed: /1 \ Warnings call attention to possible hazards involving potential damage or injury to persons. ! 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.

AV The NR ECG device uses battery for main power supply (unless connected via f ■ \ the USB port). It is also sensitive to electrical interference. To prevent possible ^ . injury, read this page carefully prior to installing the device. • US Federal Law restricts this device to sale by, or on the order of, a physician. • Other devices which are part of the system must meet the requirements of the Standard for Information Technology Equipment (IEC 60950) and the Standard for Electrical Medical Devices (IEC 60601-1) • Computers and printers used with Medical Devices should be evaluated for EN 60950-1,...

• Operation only by trained medical staff. • This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: a. This device may not cause harmful interference. b. This device must accept any interference received, including interference that may cause undesired operation. The manufacturer is not responsible for any Radio or TV interference caused by unauthorized modifications to this equipment. Such modifications may invalidate user authority to operate the equipment. Install hardware only after software installation. ECG is intended to disclose either...

Installing the app requires permission to install files from unknown sources. Clearing the Unknown sources checkbox after installation is recommended. To install the app on the mobile device: 1. On the mobile device settings (see Figure 4), scroll down, tap , and then tap More settings Install apps from external sources 2. Please refer to third party app installation: https: / /www.makeuseof.com/tag/how-to-manually-install-side-load-apps-on-your-android-device /. Now, you must toggle the Unknown Sources option on a per-app basis, instead of globally. This allows sideloading from certain apps...

3. Tap an APK file (see following figure). You are prompted to install the APK file. If your Operaing System is Android 8 - Oreo or newer, make sure granting permission to the cloud storage app to install apps. 7.4 MB. modified 4 weeks ago nh_1 0 O.debug apk 30 I MB. modified S months ago camera_nx_v7 3.1 _Z.xhromloop com apk

is displayed on the mobile device apps screen (see Figure 2). Music Netflix Norav Mobile Notepad (I Q ^ TSf Optimizer Outlook PalGate PayBox Phone Phone Clone Photo PIP Photos Figure 2: Norav Mobile ECG App Shortcut The pairing procedure establishes connection between the mobile device and the NR ECG device. 1. Insert a battery into the NR ECG device (see Figure 3 - Back View). 2. Attach the ECG cable to the NR ECG device (see Figure 3 - Front View).

This pairing procedure is necessary for initial setup of mobile device and NR ECG device. 4. Open Settings on the mobile device and turn ON Mobile network More connections Home screen & wallpaper Display & brightness Figure 4: Settings on Mobile Device 5. To find nearby Bluetooth® connected devices, tap on the Bluetooth® menu (see Figure 5).

All Bluetooth® devices are displayed (see Figure 6). 6. Select the name of the NR ECG device (see Figure 7). To pair with nr-1207-e type the devices required PIN 7. Type the default PIN Code 12345 and tap OK (see Figure 7). Now the mobile device and the NR ECG device are paired (see Figure 6). 8. To complete the connection between the mobile device and the NR ECG device, see Section Device Settings (page 49).

The Select Device to Connect Dialog Box is displayed (see Figure 8). select a device to connect No devices have been paired Figure 8: Select Device to Connect Dialog Box When the NR ECG device is connected, 3. Select the NR ECG device (see Figure 9). Paired Devices Figure 9: Select NR ECG Device

Figure 11: Home Screen ♦ Start New Test — Run a new test (see Chapter 4 - Running a Test (page 20). ♦ Test Archive — View archived test results (see Chapter 5 - Managing Archive Tests (page 35). ♦ Settings — App settings (see Chapter 6 - Managing Settings (page 36).

This chapter reviews the tasks associated with running a test and includes the following sections: • Attaching NR ECG Device Leads to Patient (page 21) • Entering Patient Information (page 23) • Monitoring Test (page 24) • Viewing Test Report (page 25) • Report Screen Options (page 27) • Adding Remarks to ECG Report (page 27) • Sharing Report (page 29) • Uploading Report to Cloud (page 29) • Manual Measurements (page 30) • Starting New Test for New Patient (page 31) • Starting New Test for Existing Patient (page 32) • Recalculating MEANS Measurements & Interpretation for Record (page 32) • Printing...

Document Title: NV-700.217.018 Document Rev.: 001 Document Date: 29.12.2022 Entering Patient Information To enter patient information: 1. Tap on the Home Screen (see Figure 11). The Enter Patient Details Dialog Box is displayed (see Figure 14). Figure 14: Enter Patient Details Dialog Box 2. To enter patient details, tap the relevant field and then type. To add the Gender and Date of Birth fields (see Figure 14 - right) to the Patient Details Dialog Box, see Section Showing Personal Info (page 63). Note 3. Tap The Test Screen with ECG waves is displayed (see Figure 15). Figure 15: Test Screen