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Related Manuals for Norav Medical NR Series
Summary of Contents for Norav Medical NR Series
- Page 2 The information contained in this document is subject to change without notice. Norav is neither responsible for nor liable to anyone in connection with this document. Manufactured by: Norav Medical Inc. 601 N. Congress Ave, Suite 105 Delray Beach FL 33445...
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Page 3: Disclaimer
Any repairs made to the product that are not covered by the warranty shall be billed to the customer. For service or technical support contact your local supplier or Norav Medical. Document Number: NV-54/NR Rev: 3.1... -
Page 4: Table Of Contents
Norav Medical NR series - High Resolution ECG Device Contents Disclaimer ..............................2 Norav Limited Warranty ..........................2 Symbols and Notations Used in this Manual ....................4 Device Label Symbols ............................ 5 General Description ............................6 NR Feature Matrix ............................6 Intended Use .............................. -
Page 5: Symbols And Notations Used In This Manual
Norav Medical 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: Device Label Symbols
Norav Medical NR series - High Resolution ECG Device Device Label Symbols Symbol Description Applied part type BF Defibrillator-proof type CF applied part Defibrillation protection in patient cable Caution Refer to operation manual NOTE On ME EQUIPMENT "Follow instructions for use”... -
Page 7: General Description
NR series - High Resolution ECG Device General Description The NR series (here and later “NR”) is a digital device which allowing acquisition of ECG waveforms with further recording and/or transmitting the data to the external computer system. NR Feature Matrix The following table is showing the available features depending on the device model. -
Page 8: Warnings And Precautions
Norav Medical NR series - High Resolution ECG Device Warnings and Precautions • Models NR-314-T, NR-1207-E and NR-1207-3 are protected against the defibrillator, when a defibrillation protected patient cable is used. (see table: “ECG Cables and Accessories” with part numbers). - Page 9 Norav Medical NR series - High Resolution ECG Device • Store the NR device in an area free from water or humidity • Take care to avoid areas subject to high humidity, poor ventilation and direct sunlight; store the NR device in an area free from any adverse effects of surrounding air containing dust, sodium, and sulfur.
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Page 10: Device Controls And Indicators
Norav Medical NR series - High Resolution ECG Device Device Controls and Indicators Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E Figure 2 Element Description Patient ECG Cable connector Screen to display feedback from the NR device Enter, Event button... - Page 11 Norav Medical NR series - High Resolution ECG Device Model NR-314P Element Description Power ON/OFF or Event push button LED indicator Neck Strap assembly 5 Snap receptacles for standard adhesive electrodes NR-314P Dock station Detachable USB cable mini-USB to A-USB Document Number: NV-54/NR Rev: 3.1...
- Page 12 Norav Medical NR series - High Resolution ECG Device NR-314P Main Battery and Dock Station Overview NR-314P has an internal rechargeable lithium polymer battery that is not user replaceable. The NR-314P comes with a Docking Station and USB cable that attaches to PC for recharging and uploading Holter data.
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Page 13: Memory Card (Sd Card) Usage
Norav Medical NR series - High Resolution ECG Device Memory Card Usage (SD card) Models: NR-302, NR-314, NR-1207 and NR-1207-3 The SD (Secure digital) card is a memory card that is formatted (see note below) exclusively for recording biological information. This card is an IC card composed of electrically erasable, non-volatile IC memory referred to as “flash memory”. -
Page 14: Main Battery
Norav Medical NR series - High Resolution ECG Device Main Battery Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E The NR is powered by one 1.5 volt AA Alkaline battery (IEC-LR6), one 1.2 volt AA rechargeable Nickel- Metal Hydride (NiMH) battery (IEC-HR6), or one 1.5 volt AA Li-FeS2 Lithium battery (IEC-FR6). -
Page 15: Electrode Application Guide
Norav Medical 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 16: Electrode Placement Scheme
Norav Medical 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 17: Patient Cable Connection
Norav Medical 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 18: Screen Navigation
Norav Medical 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 uses various menus to set preferences and enter patient information. Four keys, left, right, up and down, are used to navigate the menus. The enter key is used to make a selection of a highlighted item. - Page 19 Norav Medical NR series - High Resolution ECG Device Brief descriptions of NR device screens (continue) 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) ■...
- Page 20 Norav Medical 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 21: Common Modes And Workflows
Norav Medical NR series - High Resolution ECG Device Common Modes and Workflows Holter mode (for NR-302/314/1207/1207-3 and NR-314P models) A basic workflow for “classic” Holter recording procedure. • Prepare NR device. • Enter patient information. • Hookup patient •... -
Page 22: Ecg Recording Procedure: Detailed Instructions
Norav Medical 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 23 Norav Medical NR series - High Resolution ECG Device Acquire ECG Online (for Holter+, ECG and ECG+ mode) In Holter+ recording mode the NR-1207-3 NR device is able to transmit the live ECG traces online. To acquire the live ECG waveforms online use the Resting ECG software application of PC-ECG 1200 package or the Mobile ECG application for Android OS.
- Page 24 Norav Medical NR series - High Resolution ECG Device • The NR device with installed battery and SD card, turned ON and ECG cable connector connected to the unit; and is left for 10 minutes without pressing any button of keypad, will start the test automatically (for Holter and Holter+ modes).
- Page 25 Norav Medical NR series - High Resolution ECG Device Switching Device ON/OFF To switch ON the NR-314P, push the button for 2 seconds and release it. LED will fast flash green. After NR-314P completes its internal initialization, the LED will be solid green light.
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Page 26: Maintenance And Cleaning
Norav Medical NR series - High Resolution ECG Device Maintenance and Cleaning Cleaning and Disinfection for devices and patient lead wires * Before the Cleaning and Disinfection process, remove the battery. Before cleaning any part of the equipment, disconnect the equipment from the power supply and disconnect the device from any other equipment or external devices. - Page 27 Use the NR device after all the items become accepted. Unit check shall be performed by each medical institution, or by Norav personnel, representative agent, or an authorized third party. For more details, do not hesitate to consult your dealer or Norav Medical personnel.
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Page 28: Storage
Call customer support before returning a NR device to make shipping arrangements. All repairs on products under warranty must be performed or approved by Norav Medical. Unauthorized repairs void the warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be performed by Norav Medical certified service personnel. -
Page 29: Troubleshooting
Norav Medical NR series - High Resolution ECG Device Troubleshooting Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E Symptom Solution ■ Ensure battery is inserted with correct polarity. No display or NR device ■ Install a new AA battery. does not power on ■... -
Page 30: Technical Specifications
Norav Medical NR series - High Resolution ECG Device Technical Specifications Models: NR-302, NR-314, NR-314-T, NR-1207, NR-1207-3 and NR-1207-E Conditions typical Unit Dimensions Width Height Without ECG cable Depth Weight Without battery Ingress protection against water With ECG cable connected, Battery IP22 door closed and sealing installed. - Page 31 Norav Medical NR series - High Resolution ECG Device Model NR-314P ECG Channels 3 channels Recording capacity Input impedance >10 Mohm CMRR >90 db Dynamic range 10mV p-p Maximum DC input 800mv p-p A/D bit resolution 12bit (24 bit acquisition) Pacemaker detection Analog detection, 2-700 mV at 0.1-2 ms...
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Page 32: Ecg Cables And Accessories
Norav Medical 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 33: Electromagnetic Emissions And Immunity Information
Norav Medical 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 34 Norav Medical NR series - High Resolution ECG Device 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 35 Norav Medical NR series - High Resolution ECG Device Table 7: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity Electromagnetic environment – guidance IMMUNITY test IEC 60601 TEST Compliance level 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.
- Page 36 Norav Medical NR series - High Resolution ECG Device Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency Band Service Modulation Immunity Test level (MHz) (MHz) (V/m) Pulse modulation 380 to 390 TETRA 400 18 Hz GMRS 460, ±...
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Page 37: Fcc Information
Norav Medical NR series - High Resolution ECG Device FCC Information For patients with a pacemaker, maintain a minimum of 6 inches (15 cm) between the NR device and pacemaker. Turn the NR device off immediately and provide appropriate patient care if you suspect the NR device affected the pacemaker. The... -
Page 38: Document History
Norav Medical NR series - High Resolution ECG Device Document History Version Date Updates Changed by 01/01/2016 Initial document Boris 18/06/2017 New Logo Alex 06/07/2017 Add models to NR device feature matrix table; Boris NR-1207-E and NR-314-T 24.09.2017 NR-1207-3 recording modes added Alex 30.04.2018...