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Summary of Contents for Norav Medical NR Series
- Page 1 2025-04-06 Document Number: NV-54/NR Rev: 3.4 Page...
- Page 2 Norav Medical Inc. Copyright Information All content in this manual is the proprietary information of Norav Medical Inc and is provided solely for purposes of operation, maintenance or service of the NR Series Models. This manual and the NR Series Models described in it are protected under copyright law under which they may not be copied, in whole or in part, without written consent of Norav Medical Inc.
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Page 3: Disclaimer
Norav Medical Inc offers a limited warranty Norav Medical Inc 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 Medical Inc or the dealer to the original purchaser. -
Page 4: Table Of Contents
Norav Medical Inc. NR Series – High Resolution ECG Device Contents Disclaimer ..............................2 Norav Medical Inc offers a limited warranty ....................2 Symbols and Notations Used in this Manual ....................4 Device Label Symbols ............................ 4 General Description ............................5 NR Feature Matrix ............................ -
Page 5: Symbols And Notations Used In This Manual
Norav Medical Inc. NR Series – High Resolution ECG Device Symbols and Notations Used in this Manual Warnings call attention to possible hazards involving potential damage or injury to persons. WA RN I NG Cautions refer to practices necessary to protect against potential damage or loss to equipment. -
Page 6: General Description
Model Number General Description The NR Series Models, hereinafter referred to as “NR” are battery powered Digital Recording Devices that allow the continuous acquisition, digitization, and real-time storage of ECG waveforms from a Patient’s heart during normal daily activities via disposable ECG Electrodes applied to the Patient’s chest. The different NR Models... -
Page 7: Intended Use/Purpose
Norav Medical Inc. NR Series – High Resolution ECG Device NR-302 3, 5, 7 ● ● ● ● NR-314 3, 5, 7 ● ● ● ● ● ● ● ● ● NR-314-T 4, 5 ● ● ● ● NR-314-P 3, 4, 5 ●... - Page 8 If symptoms tend to come and go, a regular ECG may not find a change in the heartbeat. Patients are then asked to wear a NR Series Model for several days (up to 14) during the normal daily activities. • Cardiological diagnostics in the Cardiologist Office by medical professionals: o 12-Lead Resting ECG Using the BlueTooth communication for an instant assessment of the Patient’s ECG Signal...
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Page 9: Clinical Benefits For Patients
Norav Medical Inc. NR Series – High Resolution ECG Device report for the test is generated and stored when the testing has been completed. Failure to transmit the data is a recoverable error and delayed transmission of the data does not result in additional unacceptable risk to the patient. -
Page 10: Contraindications And Potential Adverse Effects
Warnings and Precautions • Only use Norav Medical Inc certified SD Flash Memory Cards for recording. • It is the responsibility of the End User to properly configure the NR Series Model with settings compatible with the relevant ECG Analysis Software. - Page 11 Under no circumstances operate the device with a mains adapter – this could threaten the life of the Patient. • Any attempt to operate NR Series Models in an area where an MRI is operating, will mutually generate negative effects.
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Page 12: Possible Hazards For Patient (Acceptable Residual Risk)
Series Models in a place free from the harmful effects of ambient air containing dust, sodium, and sulfur. • Do not store the NR Series Models in an area where chemicals are kept, or which is exposed to chemical fumes or vapors. -
Page 13: Device Controls And Indicators
Norav Medical Inc. NR Series – High Resolution ECG Device Possible Hazard (acceptable Residual Risk) Possibly caused by --- Lack of Medical Data --- No output, irregular or incorrect output from Impaired equipment operation or equipment failure due to a chest module or wireless handheld device design flaw. - Page 14 Norav Medical Inc. NR Series – High Resolution ECG Device Fig. 4: Device Front, Back, and Docking Station Position Description Push button Power ON/OFF and Patient Event LED indicator light Mounting eyelet for Neck Strap 5 Snap Sockets for standard disposable Electrodes Docking Station Detachable USB Cable –...
- Page 15 Norav Medical Inc. NR Series – High Resolution ECG Device Push Down until NR-314-P is locked inside the Docking Station Correct direction Indicator Pull up to disconnect the NR-314-P from the Docking Station Memory Card Usage (SD card) Models: NR-302, NR-314, NR-1207 and NR-1207-3 The SD (Secure Digital) card, formatted for recording biological information, is an IC card with electrically erasable, non-volatile flash memory.
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Page 16: Main Battery
No t e automatically and the instrument switches off. • Use only a Norav Medical Inc Certified SD card for Recording. The NR device supports only SD cards formatted as follows: • FAT(FAT16) with cluster size = 64KB for SD cards ≤ 4G or FAT32 with cluster size = 64KB for SD cards >... -
Page 17: Rtc Back Up Battery
With a full charge, the clock is maintained for at least 4 months after the main battery is removed. The clock cell is not replaceable by the user, and in the case of suspected failure the NR should be returned to Norav Medical Inc for service. Page 16 of 39 Document Number: NV-54/NR Rev: 3.4... -
Page 18: Electrode Application Guide
Norav Medical Inc. NR Series – High Resolution ECG Device Electrode Application Guide Many ECG adhesive electrodes are suitable for use. As ECG electrodes from different manufacturers have different electrical properties, the choice of ECG electrodes can considerably affect the measurement results and quality. Ensure that only high-quality electrodes are used. -
Page 19: Electrode Placement Scheme
Norav Medical Inc. NR Series – High Resolution ECG Device Electrode Placement Scheme Suggested electrode placements are shown in the diagrams below. However, it is up to the physician to make the final placement determination. The NR device’s ECG display screen or Computer Analysis System that used Bluetooth communication can be used to verify a proper patient hookup. -
Page 20: Patient Cable Connection
Norav Medical Inc. NR Series – High Resolution ECG Device Patient Cable Connection Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E Connecting: Insert the Patient ECG Cable connector into ECG cable connector slot of the NR unit, as shown on the picture. Make sure to insert the Cable connector until there is no space between the Cable connector and the unit. -
Page 21: Screen Navigation
Norav Medical Inc. NR Series – High Resolution ECG Device Screen Navigation Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E The NR device features menus for setting preferences and entering patient data, navigated using four keys: left, right, up, and down. Selections are made with the Enter key. The device operation involves a sequence of steps: setting Record Mode, checking/setting Date &... - Page 22 Norav Medical Inc. NR Series – High Resolution ECG Device Screen Description Settings (continue) • System Settings Date\Time ■ Date (Month,Day,Year) ■ Date Format (MM/DD/YYYY, YYYY/MM/DD, DD/MM/YYYY, YYYY/DD/MM) ■ Time (Hour and Minute) ■ Time Format (12 or 24 hr) ...
- Page 23 Norav Medical Inc. NR Series – High Resolution ECG Device “Main” menu screen - explanation of menu navigation by using keypad buttons almost the same for the others menu screens. Menu Item[1]: Patient ID Recorder Date&Time Main Battery Indicator Menu Item[2]: Voice Record Selected Item is highlighted in current Menu Screen.
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Page 24: Common Modes And Workflows
Norav Medical Inc. NR Series – High Resolution ECG Device Common Modes and Workflows Holter mode (for NR-302/314/1207/1207-3 and NR-314-P Models) A basic workflow for “classic” Holter recording procedure. Prepare NR device. • • Enter patient information. Hookup patient •... -
Page 25: Ecg Recording Procedure: Detailed Instructions
Norav Medical Inc. NR Series – High Resolution ECG Device ECG Recording Procedure: Detailed Instructions Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E Starting New Test 1. Prepare NR device Open NR device battery compartment door. • Insert an SD card into NR device. -
Page 26: Data Downloading
Norav Medical Inc. NR Series – High Resolution ECG Device Add New Patient Marker (for ECG+ mode only) During an ECG Recording ('REC' flashing on Lead Check screen), press and hold the Enter button to increase the patient counter and add a voice note if enabled. -
Page 27: Stop Recording
Norav Medical Inc. NR Series – High Resolution ECG Device Model NR-314-P Start New Recording To start a new recording, connect the NR-314-P to the Docking Station and use the Setup Software on the Computer Analysis system to enter patient demographics and recording parameters. After downloading settings to the NR-314-P, disconnect it from the Docking Station and power it on. -
Page 28: Maintenance And Cleaning
Norav Medical Inc. NR Series – High Resolution ECG Device IP64 Instructions Model NR-314-P has an IP64 rating. Dust-resistant: Fully protected against dust. • Water-resistant, not waterproof: Resists splashes but must not be submerged. Avoid • swimming, bathing, or hot tubs. You may shower but avoid directly spraying water onto the device. -
Page 29: Maintenance
Use the NR device after all the items become accepted. Unit check shall be performed by each medical institution, or by Norav Medical Inc personnel, representative agent, or an authorized third party. For more details, do not hesitate to consult your dealer or Norav Medical Inc personnel. -
Page 30: Calibration
Norav Medical Inc. NR Series – High Resolution ECG Device All repairs on products under warranty must be performed or approved by Norav Medical Inc. Unauthorized repairs void the warranty. In addition, whether covered under warranty or not, any product repair shall exclusively be performed by Norav Medical Inc certified service personnel. -
Page 31: Technical Specifications
■ Ensure RTC set correctly via Computer Analysis System RED LED is ON when ■ Use only Norav Medical Inc USB cable, try replacing USB cable. connected to Docking Station ■ Try connecting USB cable to other USB port or to another computer BLUE LED is OFF when ■... - Page 32 Norav Medical Inc. NR Series – High Resolution ECG Device Dynamic Range Recording, Peak-to-Peak Derived Respiration Channels Sensing Electrodes Ch1(+) & Ch1(-) Exitation Current µA 27.3 Exitation Frequency Power Supply Voltage 1 x Battery, size AA Internally provided Voltage In RMS Current during = 1.5V...
- Page 33 Norav Medical Inc. NR Series – High Resolution ECG Device Model NR-314-P ECG Channels 3 Channels Recording capacity 2 GByte Input Impedance >10 MOhm CMRR >90 dB Dynamic Range 10mV Peak-to-Peak Maximum DC Input 800mv A/D Bit Resolution 12 Bit (24 Bit Acquisition) Pacemaker Detection Analogue Detection, 2 to 700 mV at 0.1 to 2 ms...
- Page 34 Norav Medical Inc. NR Series – High Resolution ECG Device IEC 60601-1-2 IEC 60601-2-47 IEC 60601-1-11 Classification: Type BF Applied Part Internally powered Medical Device Device for continuous operation Communication: USB 2.0 HS ...
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Page 35: Ecg Cables And Accessories
Norav Medical Inc. NR Series – High Resolution ECG Device ECG Cables and Accessories Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E Item Part Number NR Compatibility Application Defib. protected ECG Cables 3 Lead Patient Cable, Snap, AHA C3-S-U-EI 302, 314, 1207, 1207-3... -
Page 36: Electromagnetic Emissions And Immunity Information
Norav Medical Inc. NR Series – High Resolution ECG Device Electromagnetic Emissions and Immunity Information Refer to the following tables for specific information regarding NR device compliance to IEC 60601-1-2. Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E Table 1: Electromagnetic Emissions... - Page 37 Norav Medical Inc. NR Series – High Resolution ECG Device Table 4: Recommended Separation Distances The following table details the recommended separation distances between portable and mobile RF communications equipment and NR device. This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the device as recommended below, according to maximum output power of the communications equipment.
- Page 38 Norav Medical Inc. NR Series – High Resolution ECG Device Table 7: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity IMMUNITY test IEC 60601 TEST Compliance level Electromagnetic environment – guidance LEVEL Portable and mobile RF communications equipment should be used no closer to any part of the [ME EQUIPMENT including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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Page 39: Fcc Information
Norav Medical Inc. NR Series – High Resolution ECG Device GMRS 460, 430 to 470 ± 5 kHz deviation FRS 460 1 kHz sine LTE Band 13, Pulse modulation 704 to 787 217 Hz GSM 800/900, TETRA 800, Pulse modulation... -
Page 40: Ised Information
CAN ICES-003 (B)/NMB-003(B) / CAN ICES-001/NMB-001 Usage Conditions: It must be used only with the holder or pouch provided by Norav Medical in the package. The device must be used while installed parallel to the patient's body. Limitations of usage: Use of the product must be done exactly, as per the usage conditions and relevant statements provided by the manufacturer.
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