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General| Category | Measuring Instruments |
|---|---|
| Impedance Check | Yes |
| Software | Embla RemLogic |
| Input Range | ±500 mV |
| Resolution | 24-bit |
| Noise Level | < 1 µV RMS |
| Common Mode Rejection Ratio (CMRR) | > 100 dB |
| Input Impedance | > 100 MΩ |
| Connectivity | USB, Ethernet |
| Weight | 2.5 kg |
| Power | AC/DC, Battery |
Details the design and variations of EEG/PSG amplifiers, including base units and breakout boxes.
Specifies the intended application as an electroencephalograph for acquiring, displaying, storing, and archiving electrophysiological signals.
Highlights how the devices aid in diagnosing brain and sleep disorders by collecting physiological data for physician treatment decisions.
States there are no known residual risks or side effects and advises users to read warnings and cautions before operation.
Describes the amplifier system, computers, cameras, isolation transformers, and carts as optional system components.
Defines essential performance and details potential causes and indicators of its degradation.
Covers policies for preventing unauthorized access and guidelines for secure network connectivity.
Details secure access methods and measures for data confidentiality and protection.
Describes the system components and how electrophysiological signals are acquired, digitized, and transmitted to the computer.
Explains the content of the manual and how to access copies of the user guide online or from Natus.
Lists the system's compliance with key safety standards like IEC 60601-1, ISO 80601-2-61, and IEC 62366.
Lists the electromagnetic compatibility (EMC) standards the system adheres to, including IEC 60601-1-2 and CISPR11.
Presents a table detailing RF emissions, harmonic emissions, and voltage fluctuations/flicker emissions compliance.
States that there are no known contraindications for using this device.
Explains the meaning of Warning and Caution labels used to identify potentially dangerous conditions and procedures.
Provides essential general warnings regarding system use, approved accessories, cable integrity, and maintenance.
Provides warnings regarding the use of approved equipment on trolleys/carts and caution against tilting the trolley/cart.
Refers users to the pulse oximeter sensor user manual for associated precautions and instructions.
Warns that mobile RF communications can affect the operation of this medical equipment.
Explains that in noisy environments, signal interpretation might be affected, but trained professionals can identify and disregard such signals.
Details techniques to reduce the incidence of component damage caused by static electricity during handling.
Defines conducted immunity and provides techniques to identify sources and increase immunity towards parasitic noise.
Lists and explains system-specific symbols for Body Position Connector and Patient Event Button Connector.
Explains how to connect the Natus base unit to the acquisition computer via network or USB and connect other system accessories.
Guides users on initial steps, including power failure handling, operator/patient placement, and component setup.
Explains how to initiate an EEG or Sleep study after system installation and patient connection.
Provides a step-by-step guide for safely powering down the system, including closing studies and unplugging the power cord.
Provides instructions on how to safely disconnect the system cables.
Guides users on attaching and connecting the 3D body position pod for gathering patient position and activity data.
Explains how to connect a nasal cannula to the Luer Lock port for airflow recording via a pressure sensor.
Outlines regular user maintenance tasks, including inspecting trolleys, cables, and electrical plugs.
Provides warnings and cautions related to transportation systems, emphasizing the use of Natus-approved equipment and avoiding tilting.
Lists electrical input voltage and isolation transformer details for different regions (EU, North America, Japan).
Lists the displayed oxygen saturation (SpO2) and pulse rate ranges.
Explains how the software indicates signal inadequacy, degradation, or probe faults for the SpO2 sensor.
Describes how Oximetry Sensors work and lists the Nonin reusable sensor model.
Advises users to refer to the provided instructions for use for each Nonin oximeter sensor.
Provides cleaning instructions for the amplifier pouch.
Lists critical warnings related to cleaning, including disconnecting cables, avoiding internal fluid seepage, and not using certain cleaning agents.
Provides a step-by-step checklist to diagnose and resolve waveform or signal issues.
Offers specific advice for missing or bad signals, suggesting cable swapping and running a channel test.
Advises documenting incidents and searching online documentation for solutions.
Details computer restart/shutdown procedures and steps for contacting technical support.
Details the pin assignments and definitions for the digital trigger input port.
Shows the pin layout for connecting a pre-wired headcap or assembly to the headcap connector.
Presents frequency response curves for Sample Rates of 256Hz and 512Hz.
