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NR SERIES
NR SERIES
All content in this manual is proprietary to Norav Medical GmbH and is intended for operation, maintenance, or service of the NR Series Models. It is protected under copyright law and cannot be copied without consent. The information is for guidance only and subject to change without notice.
The NR Series digital recorders comply with EU and UK medical device regulations. They are restricted to sale by licensed healthcare providers. Contact information for Norav Medical GmbH in Germany, a UK representative, and a Swiss representative is provided.
This system is a decision support tool for trained medical professionals and should not be the sole basis for clinical decisions. Norav Medical GmbH offers a limited one-year warranty against manufacturing defects, excluding expendable items. The company disclaims all other warranties and liabilities.
Warnings indicate potential hazards, cautions protect against equipment damage, and notes provide important information for optimal performance. Device label symbols include defibrillator-proof type, IP protection class, and disposal instructions.
The NR Series are battery-powered digital recording devices for continuous ECG waveform acquisition. They support various diagnostic examinations and can detect pacemaker spikes. Data is stored on an SD card or transferred via USB to a computer for analysis.
The feature matrix outlines available features for different NR models, including ECG channels, patient input cables, and additional functionalities like pacemaker detection and Bluetooth interface.
Electrocardiography records the heart's electrical activity to diagnose conditions like arrhythmias and myocardial infarction. The NR Series is used for patients with symptoms such as chest pain, dizziness, or a family history of heart disease. It also evaluates therapeutic interventions and heart disease treatments.
Intended Use: The NR Series Models are intended for patients aged 10 years and older, weighing above 10 kg, with no gender restrictions. They are not intended for use by laypeople and should be prescribed and supervised by healthcare professionals.
Use Environment: These non-sterile, reusable devices are suitable for home use and clinical settings. They require standard disposable ECG electrodes, which are purchased separately.
Essential Performance: The devices must accurately acquire ECG signals, process data, and generate reports without being affected by electromagnetic interference. Data transmission is not considered essential under environmental disturbances.
Clinical Benefits: The devices provide continuous ECG recording, which is more effective than intermittent recording for detecting atrial fibrillation and other arrhythmias. They also offer better heart rate variability measurement compared to wristband devices.
Contraindications and Adverse Effects: There are no known contraindications or adverse effects associated with the NR Models for ambulatory ECG monitoring. The devices do not deliver electrical energy to the patient.
Warnings and Precautions: The document outlines several warnings, including the need to use certified SD Flash Memory Cards, avoid using the devices in emergency settings, and ensure proper electrode connection. It also highlights the importance of using defibrillation-protected cables when necessary.
Possible Hazards: Potential hazards include skin irritations, infection, overheating, and electrical shock. The document advises on proper storage and handling to mitigate these risks.
Device Controls and Indicators: The document describes the controls and indicators on the NR Series Models, including the patient ECG cable input connector, display, navigation buttons, and battery compartment.
The NR-314-P device features a non-user-replaceable rechargeable Lithium Polymer Battery, a Docking Station, and a USB cable for PC connection, recharging, and data upload. The battery recharges in 3.5 hours and supports up to 14 days of recording. Docking the device stops and closes the recording.
Battery and Charging
The device uses a 1.5 Volt Alkaline, 1.2 Volt NiMH, or 1.5 Volt Li-FeS2 Lithium battery. Batteries should not be reused for a second patient and must be disposed of according to local regulations. The Real-Time Clock is maintained by an internal rechargeable lithium cell, which is not user-replaceable.
Memory Card Usage
The device supports SD cards formatted as FAT16 or FAT32, depending on the card size. The memory card slot is a "push-push slot," and the card must be inserted or removed with the battery compartment open.
Electrode Application
High-quality wet gel electrodes are recommended. Skin preparation is crucial for good contact. Electrodes should be applied carefully, ensuring no contact with conductive objects. The device supports various electrode configurations, including 3, 5, 7, and 10 lead setups.
Patient Cable Connection
The Patient ECG Cable must be connected correctly to avoid damage. The device includes a cable connection sensor to alert users if the cable is not properly connected.
Screen Navigation
The device features menus for setting preferences and entering patient data, navigated using four keys. Users can set recording modes, check date and time, enter patient identification, and verify ECG signal quality. Various settings, including recording time, sample rate, and additional features like pacemaker detection, can be configured.
Cautions and Warnings
Users are cautioned against using sharp objects on the keypad, leaving batteries in the device for extended periods, and using non-certified SD cards. Proper disposal of batteries and adherence to safety standards for electrodes are emphasized.
- Time Settings: Configurable in 12 or 24-hour format.
- Display: Contrast adjustable between 20-90%, with rotation options of 0, 90, 180, and 270 degrees.
- Battery Types: Compatible with Alkaline, NiMH, and Lithium batteries.
- Language Support: Multiple languages including English, Español, Deutsch, Français, Italiano, Português, Nederlands, Polski, Русский, Ελληνική, and Türk.
- Modes: Holter, Holter+, ECG, and ECG+ (specific to NR-1207-3 model).
- Starting a New Test: Involves preparing the device, entering patient information, checking ECG leads, and starting the recording.
- Recording Modes: Different workflows for Holter, Holter+, ECG, and ECG+ modes, each with specific steps for setup, recording, and data management.
- Data Management: Includes downloading ECG data to a computer, erasing old data, and ensuring proper data transfer.
- Cleaning and Disinfection: Remove the battery before cleaning. Avoid chemicals entering connectors and do not use abrasive cleaners.
- Ingress Protection: IP22 for most models, indicating protection against light drips. NR-314-P has IP64, offering dust resistance and splash protection.
- Automatic test start feature if left idle for 10 minutes.
- Battery replacement within 1 hour is crucial to resume recording.
- Settings must be compatible with SD card capacity.
It is advised not to use alcohol, acetone, or certain ammonium chlorides for cleaning the recorder unit and holster, as these substances can damage the materials. Instead, use a soft, non-abrasive damp cloth with tap water and a mild enzymatic detergent for cleaning. Isopropanol 70% wipes should be used for disinfection. Ensure the device is disconnected from power before cleaning.
Device Handling and Storage
The device should not be autoclaved or sterilized with steam. If liquid penetrates the device, it should be turned off, the battery removed, and left to dry for 48 hours. Store the device in a dry, well-ventilated area away from chemicals and direct sunlight.
Maintenance and Checks
Regular checks should be performed to ensure the device is free from cracks, distortion, and corrosion. The battery compartment and SD card should be inspected for cleanliness and damage. Any non-compliant items should be addressed before use.
Service and Troubleshooting
For any issues, refer to the troubleshooting section. If further assistance is needed, contact customer support. Unauthorized repairs void the warranty, and all repairs should be conducted by certified personnel.
Technical Specifications
The document provides detailed technical specifications for various models, including dimensions, weight, ECG channels, input impedance, and power requirements. The device operates within specific environmental conditions and has wireless capabilities.
Conformance and Standards
The device complies with several IEC standards and is classified as a Type BF or CF applied part, depending on the model. It supports USB and Bluetooth communication.
Accessories
A list of compatible ECG cables and accessories is provided, detailing their applications and compatibility with different models.
This document outlines compliance with Industry Canada regulations for license-exempt radio devices. The device must not cause interference and must accept any interference received, even if it affects operation. It complies with CAN ICES-003 (B)/NMB-003(B) and CAN ICES-001/NMB-001 standards.
The device should only be used with the holster or pouch provided by Norav Medical. It must be installed parallel to the patient's body to ensure proper functioning.
Usage must strictly adhere to the manufacturer's conditions and statements. A minimum separation distance of 7 mm between the human body and the device, including the holster or pouch, is required.
Catalog excerpts
NR Series – High Resolution ECG Device Norav Medical GmbH Copyright Information All content in this manual is the proprietary information of Norav Medical GmbH 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 GmbH. Norav Medical is a trademark of Norav Medical GmbH. All other trademark names are the trademarks of their respective holders. The information in this...
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Norav Medical GmbH NR Series – High Resolution ECG Device 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 and considered a misuse of the software product. Norav Medical GmbH offers a limited warranty Norav Medical GmbH products are warranted to be free from manufacturing and...
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Norav Medical GmbH NR Series – High Resolution ECG Device
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Norav Medical GmbH 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. Pay careful attention to instructions. Notes provide pertinent information to help obtain optimum performance from the software or signify an important step or procedure that requires special attention. Device Label Symbols Symbol Description Applied part type BF Defibrillator-proof type CF applied...
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Norav Medical GmbH NR Series - High Resolution ECG Device 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 enable different signal processing for the respective diagnostic examinations, such as Resting-ECG, Cardiac Stress Test, or Ambulatory ECG Monitoring (so called Holter-ECG) and some can also be configured for...
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Norav Medical GmbH NR Series - High Resolution ECG Device Electrocardiography is the creation of an Electrogram, a recording of the electrical activity of the human heart. This is an Electrocardiogram (ECG or EKG) in which the Voltage of the heart’s electrical activity derived from electrodes attached to the Patient’s chest, is plotted against Time. These electrodes sense the small electrical changes that result from the depolarization of the heart muscle and subsequent repolarization during each cardiac cycle (heartbeat). An Electrocardiogram is carried out to check the heartbeat. It shows how...
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Norav Medical GmbH NR Series – High Resolution ECG Device • Analysis of Late Potentials in ECG • Analysis of QT Interval parameters • Clinical and epidemiological Research Studies Intended Purpose of NR Series Models The NR Models are intended for Patients who require: • Ambulatory ECG Monitoring (Holter ECG) 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...
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Norav Medical GmbH 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.
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Norav Medical GmbH NR Series – High Resolution ECG Device Contraindications and Potential Adverse Effects There is no risk of electric shock during an Electrocardiogram. The disposable adhesive electrodes applied to the chest of a Patient only sense the small electrical changes that result from the activities of the heart muscle during each cardiac cycle (heartbeat). NO electrical energy is delivered to the Patient. There are no known contraindications or adverse effects for the application of the NR Model for an Ambulatory ECG Monitoring (Holter-ECG). Report any adverse events to the manufacturer....
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Norav Medical GmbH NR Series - High Resolution ECG Device • The NR Series Models are not intended for use on infants weighing less than 10 kilograms (22 pounds). • The NR Series Models are not directly applicable to the heart. • The NR Series Models (NR-302, NR-314, NR-1207) are NOT protected against high-energy shocks from Cardiac Defibrillators. Remove those NR Series Models from the Patient BEFORE using a Cardiac Defibrillator. • Some of the NR Series Models (NR-314-T, NR-314-P, NR-1207-E, NR-1207-3) are protected against high-energy shocks from Cardiac Defibrillators when a Defibrillation-Protected...
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Norav Medical GmbH NR Series - High Resolution ECG Device • Store the NR Series Models in an area free from water or humidity. • Ensure to avoid areas with high humidity, poor ventilation, and direct sunlight. Store the NR 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. • Never attempt to modify or to disassemble the NR Series Models. • Do not open the NR Series Models housing. The housing may only be opened by Norav...
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Norav Medical GmbH NR Series - High Resolution ECG Device
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Norav Medical GmbH NR Series - High Resolution ECG Device NR-314-P features an internal non-user-replaceable rechargeable Lithium Polymer Battery. It includes a Docking Station and USB cable for PC connection, recharging, and Holter data upload. The battery fully recharges in 3.5 hours. Docking the NR-314-P during Holter recording stops and closes the recording. A fully charged battery supports up to 14 days of Holter recording, but charging before hooking up the next Patient is advised. Frequent users can keep the NR-314-P docked between uses. For less frequent use, remove the NR-314-P from...
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