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General| Measurement Principle | Electrochemical sensor |
|---|---|
| Target Analyte | Nitric Oxide (NO) |
| Accuracy | ±5 ppb or ±10%, whichever is greater |
| Flow Rate | 50 mL/s |
| Connectivity | USB |
| Compliance | CE marked, FDA cleared |
| Weight | Approx. 1.5 kg |
| Power Supply | 100-240 V AC, 50/60 Hz |
| Measurement Range | 5-300 ppb |
| Display | LCD screen |
| Calibration | Automatic |
| Operating Temperature | 15°C to 30°C |
| Storage Temperature | 0°C to 50°C |
| Power | Rechargeable battery |
| Battery Life | Up to 8 hours |
| Display Type | Touchscreen |
| Data Storage | Internal memory |
| Operating Humidity | 10% to 90% non-condensing |
| Device Type | Fractional exhaled nitric oxide (FeNO) measurement device |
Instructions for healthcare professionals on operating the monitor and understanding safety information.
Details about the manual version, software compatibility, and amendment policy.
States compliance with CE marking and RoHS directives.
Provides mailing and visiting addresses for Circassia AB.
Crucial warnings about alcohol use, healthcare professional operation, and manual adherence.
Explains the device measures exhaled Nitric Oxide (FeNO) for asthma management in children and adults.
Lists and illustrates the included accessories and parts of the NIOX VERO system.
Identifies the main instrument components like buttons, ports, and display.
Describes the main view, settings view, menus, and symbols for navigation.
Details the components of the main view, including status bar and measurement controls.
Overview of the settings menu options for instrument configuration.
Instructions on activating the instrument from standby or sleep mode.
Guides on entering patient identification for measurements, considering privacy.
Detailed steps for performing a Fractional exhaled Nitric Oxide (FeNO) measurement.
Steps for preparing the device and patient before a FeNO measurement.
The actual procedure for a patient to perform a FeNO measurement using the device.
Explains how to use animated demonstrations to guide patients through measurement steps.
Instructions for performing an ambient Nitrogen Monoxide measurement, often for troubleshooting.
Guides on modifying instrument settings like time, date, and sound volume.
Steps to adjust the instrument's time and date settings.
How to adjust the audible alert volume on the instrument.
Instructions on accessing and viewing stored measurement results.
How to view system alerts and error codes for troubleshooting.
Accessing detailed information about the instrument and sensor status.
Procedure for safely powering down the NIOX VERO instrument.
Overview of the Quality Control process ensuring system accuracy.
Criteria and process for identifying and qualifying staff to perform QC.
Step-by-step guide for performing daily QC and qualification measurements.
How to review historical Quality Control measurement data.
Accessing information about qualified QC testers.
Procedure to delete data for a specific QC tester.
Safety warnings specific to using the NIOX Panel software.
System requirements and steps for installing the NIOX Panel PC application.
How to establish a wired connection between NIOX VERO and a PC.
Instructions for enabling and establishing a wireless Bluetooth connection.
Steps to start and access the NIOX Panel software on a PC.
Procedure for updating the instrument's firmware via USB.
Overview of using the NIOX Panel software for device operations.
How to modify instrument settings through the NIOX Panel software.
Accessing stored measurement data via the NIOX Panel software.
Reviewing system alerts and error codes through the NIOX Panel.
Options for performing QC measurements using NIOX Panel and database integration.
Lists common alert codes and recommended actions for resolving issues.
Guidelines for routine cleaning and maintenance of the instrument and handle.
Verifying the instrument's proper working condition before use.
Procedures for replacing consumable parts like filters and handles.
Step-by-step guide to replace the breathing handle.
Detailed instructions for safely replacing the NIOX VERO sensor.
Procedure for replacing the rechargeable battery of the instrument.
Information on the expected lifespan of the instrument, sensor, and filter.
Details the expected minimum operational life of the instrument.
Information on the sensor's operational life and expiry.
Shelf life and usage guidelines for the patient filter.
Operational life and expiry indicators for the breathing handle.
Guidance on the proper disposal of used instruments and accessories.
General safety warnings and precautions for using the NIOX VERO.
Important cautions regarding environmental factors and device operation.
Factors like respiratory maneuvers, food, and smoking that can affect FeNO readings.
Guidance on the device's compliance with electromagnetic immunity standards.
Information on the device's electromagnetic emissions and potential interference.
Recommended environmental and operational conditions for the NIOX VERO.
Lists and describes the function of various control buttons on the device.
Explains the meaning of symbols used in the status bar and other displays.
Provides definitions for various symbols and icons found in the manual.
Specifies the physical dimensions and weight of the instrument.
Details electrical safety classification, voltage, and power consumption.
Specifies the noise level of the instrument.
Performance specifications for exhaled Nitric Oxide measurements under various conditions.
Technical data on the linearity of the measurement.
Technical data on the precision of the measurement.
Technical data on the accuracy of the measurement.
Data comparing NIOX VERO measurements with other methods.
Specifications for patient inhalation during measurements.
Specifies exhalation time, flow rate, and pressure requirements.
Outlines the core functions and safety features of the NIOX VERO.
Information on the storage capacity for measurements.
Details about the disposable patient filter.
Technical specifications for the Bluetooth connectivity.
Information on the battery's capacity, lifetime, and charging.
Guidelines for safely transporting and storing the NIOX VERO instrument.
Lists the standard components included in the NIOX VERO package.
Lists optional accessories available for the NIOX VERO system.
Guidance on the device's electromagnetic immunity compliance and test results.
Guidance on the device's electromagnetic emissions compliance.
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