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NIOX FeNO VERO - Important Information and Safety Precautions; Before Using the NIOX VERO Monitor; Warnings and Compliance

NIOX FeNO VERO
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Chapter 1 Important information
000191-16 NIOX VERO
®
User Manual English 3
1 Important information
1.1 Before using NIOX VERO® Airway Inflammation
Monitor
NIOX VERO® may only be operated as directed in this manual by trained
healthcare professionals. Trained status is achieved only after careful reading
of this manual. Read the entire instructions for use and make certain that you
fully understand the safety information.
1.2 About this manual
NIOX VERO® User Manual-item number 000191, version 16, was released
May 2023. The software version number installed in the instrument can be
found by viewing the settings. For instructions on how to view the software
version number installed in the instrument,
see section 5.6.5, View instrument
information.
Information in this document is subject to change. Amendments will be made
by Circassia as they occur. The User Manual provides instructions on how to
operate NIOX VERO®. It contains numbered step-by-step instructions with
screens and illustrations. Choices within steps are displayed with bullet points.
1.3 Compliance
NIOX VERO® is CE-marked according to In Vitro Diagnostics Directive
98/79/EC.
NIOX VERO® is RoHS compliant.
1.4 Responsible manufacturer and contacts
Mailing address:
Circassia AB
P.O. Box 3006
SE-750 03 Uppsala, Sweden
Visiting Address:
Hansellisgatan 13
SE-754 50 Uppsala
www.niox.com
1.5 Warnings
• Do not use substances containing alcohol on or close to the
NIOX VERO® instrument. This includes any cleaning agents used to
clean the facility, or other equipment in the area, as well as alcohol wipes
or sprays used on patients.
• NIOX VERO® should only be operated by healthcare professionals.
• Operate NIOX VERO® as stated in this manual. Circassia accepts no
responsibility for damaged equipment or faulty results, if the equipment is
not handled according to this manual.
• NIOX VERO® can be operated with two different exhalation times,
10 seconds and 6 seconds. Incorrect use of the 6 second exhalation mode
may result in falsely low FeNO values, which can lead to incorrect clinical
decisions.
Symbol Description
WARNING
Indicates a potentially hazardous situation that, if not
avoided, can result in bodily harm or injury.
CAUTION
Indicates a potentially hazardous situation that, if not
avoided, can damage a product or system, cause loss of
data or harm to business.
Note Alerts the reader to important information on the proper
use of the product, user expectations, error situations,
and actions related to these.

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