Circassia NIOX VERO Manuel utilisateur
000190-09 (EPM-000165) NIOX VERO®User Manual US
April 2017
NIOX VERO® Airway Inflammation Monitor
User Manual
510(k) 133898
Remember
It is important to adhere to the following specified conditions:
• Ambient temperature: 50°F to 95°F
• Humidity: 20% to 80% RH (non-condensing)
• Mobile phones, cordless phones and gas emitting appliances might
interfere with the instrument and should therefore be kept away from
the instrument. Interference could make it impossible to perform a
measurement.
•Exhaled breath contains water vapor which can condense
inside the instrument. When excessively used in a short period,
there is a risk for condensation of water inside NIOX VERO.
Normally a maximum of 10 exhalations/hour can be performed with
NIOX VERO during continuous use. However, it is possible to
perform 20 exhalations in one hour if the instrument is paused for a
minimum of 30 minutes prior to the next session of exhalations.
Exhalations include failed and successful measurements.
• Avoid spilling water or other fluids on the instrument or Sensor.
• Always use a closed case or bag (NIOX VERO®bag recommended)
for transportation and storage of NIOX VERO.
• It is recommended, after inserting a new sensor, to wait for three
hours with the instrument switched on before performing a
measurement.
• Operational life-time NIOX VERO®Instrument: Minimum 5 years at
time of delivery, or 15, 000 measurements.
• Operational life-time NIOX VERO®Sensor: Maximum 12 months
after opening package and installed in NIOX VERO or expiration
date as stated on the Sensor, whichever comes first.
WARNING!
Use of substances containing alcohol close to the
NIOX VERO®instrument may cause erroneous measure-
ment results.
DO NOT clean the instrument or handle with products con-
taining alcohol. This includes sprays or wipes containing
alcohol!
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.
CAUTION!: Do not use NIOX VERO®in the proximity of areas where
volatile substances such as organic fluids or disinfectants are being
used. Special attention should be paid to aerosols and disinfection
baths, either open vessels or ultrasonic baths.
Table of contents
1
1 Important information ...............................................................3
1.1 Before using NIOX VERO®Airway Inflammation Monitor ........ 3
1.2 About this manual..................................................................... 3
1.3 Compliance .............................................................................. 3
1.4 Responsible manufacturer and contacts.................................. 3
1.5 Warnings .................................................................................. 3
1.6 Indications for use .................................................................... 4
2 Product description ..................................................................5
2.1 NIOX VERO®accessories and parts........................................ 5
2.2 Instrument ................................................................................ 5
3 Installation and set up ..............................................................6
4 User interface ..........................................................................10
4.1 Main and settings view........................................................... 10
4.2 Main View............................................................................... 10
4.3 Settings view .......................................................................... 11
5 Using NIOX VERO® ..................................................................11
5.1 Start the instrument from power save mode .......................... 11
5.2 Register patient ID (optional).................................................. 11
5.3 Measure FeNO....................................................................... 12
5.4 Demonstration mode.............................................................. 14
5.5 Measure ambient NO ............................................................. 15
5.6 Change settings ..................................................................... 15
5.7 Turn off the instrument ........................................................... 17
5.8 External Quality Control (QC) procedure ............................... 18
6 Using NIOX VERO®with NIOX®Panel ...................................23
6.1 Warnings................................................................................ 23
6.2 Installation of NIOX®Panel .................................................... 23
6.3 Connect to a PC via USB....................................................... 24
6.4 Connect to a PC via Bluetooth............................................... 24
6.5 Setup...................................................................................... 24
6.6 Firmware update .................................................................... 26
6.7 Using NIOX®Panel ................................................................ 26
7 Troubleshooting ...................................................................... 28
7.1 Alert codes and actions.......................................................... 28
8 Preventive care ....................................................................... 33
8.1 General care .......................................................................... 33
8.2 Change disposables .............................................................. 34
8.3 Operational life-time............................................................... 36
8.4 Disposal of instrument and accessories ................................ 36
8.5 Return shipments................................................................... 37
9 Safety information .................................................................. 37
9.1 Warnings................................................................................ 37
9.2 Cautions................................................................................. 37
9.3 Substances disturbing FeNO measurement .......................... 38
9.4 Electromagnetic immunity...................................................... 39
9.5 Emission of electromagnetic energy ...................................... 40
9.6 Operating conditions .............................................................. 40
10 Reference information .......................................................... 41
10.1 Buttons and descriptions...................................................... 41
10.2 Symbols and descriptions .................................................... 41
10.3 Symbol explanation.............................................................. 42
Table of contents
2
11 Technical data .......................................................................43
11.1 Dimensions and weight ........................................................ 43
11.2 Electrical data....................................................................... 43
11.3 Noise level............................................................................ 43
11.4 Exhaled NO - performance data........................................... 43
11.5 Linearity................................................................................ 43
11.6 Precision............................................................................... 43
11.7 Accuracy............................................................................... 43
11.8 Method comparison.............................................................. 43
11.9 Inhalation parameters........................................................... 43
11.10 Exhalation parameters ....................................................... 44
11.11 Essential performance........................................................ 44
11.12 Memory capacity ................................................................ 44
11.13 Patient filter ........................................................................ 44
11.14 Bluetooth ............................................................................ 44
11.15 Rechargeable battery capacity........................................... 45
11.16 Instructions for transport and storage................................. 45
12 NIOX VERO®parts and accessories ....................................46
12.1 Parts included in NIOX VERO®package
(Article No. 12-1200) .................................................................... 46
12.2 Accessories.......................................................................... 46
13 Medical Device Reporting (MDR) .........................................47
14 Guidance and manufacturer's declaration - Electromagnetic
immunity and electromagnetic emissions ...............................48
Chapter 1 Important information
000190-09 NIOX VERO®User Manual US 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 - US 000190 (EPM-000165), version 09,
April 2017, for instruments with software version 1D1x-xxxx. X can be any
number between 0 and 9 or a character. For instructions on how to view the
software version number installed in the instrument, see page 17.
Information in this document is subject to change. Amendments will be made
by Circassia AB 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.
For clinical and performance characteristics, refer to the NIOX VERO®
Labeling Summary/Package Insert 000249 (EPS-000069).
1.3 Compliance
NIOX VERO® is CE-marked according to In Vitro Diagnostics Device Direc-
tive 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, Sweden
www.circassia.com
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.
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.
Chapter 1 Important information
4 000190-09 NIOX VERO®User Manual US
• When selecting an accessory for your NIOX VERO®product keep in
mind that an accessory not recommended by Circassia may result in
loss of performance, damage to your NIOX VERO®product, fire, electric
shock, injury or damage to other property. The product warranty does
not cover product failure or damage resulting from use with non
approved accessories. Circassia takes no responsibility for health and
safety problems or other problems caused by the use of accessories not
approved by Circassia.
• NIOX VERO®should not be used adjacent to or stacked with other
equipment.
• Only use the power supply provided. Pull the plug when disconnecting
NIOX VERO®from the power outlet.
• Use only the breathing handle supplied by Circassia.
• No modification of NIOX VERO®instrument, handle or Sensor is
allowed.
• Do not drop the instrument or subject it to strong impact.
• Do not use a damaged NIOX VERO® instrument or damaged
components.
• Keep the instrument and Sensor out of water. Ensure that no liquid is
spilled or dropped on the instrument or Sensor.
• Do not heat or dispose of the instrument or Sensor in fire. Refer to
“Disposal of instrument and accessories” on page 36.
• NIOX VERO® and the NO scrubber in the breathing handle contains
potassium permanganate. Used or expired instruments and breathing
handles should be disposed of as hazardous waste in accordance with
local waste disposal regulations.
• The breathing handle must not be used after the expiration date.
• Patient filters should be used immediately after opening.
• NIOX VERO®Sensor contains chemicals that could be harmful if
swallowed.
• Do not touch or clean the white Sensor membrane.
• Do not clean the sensor. Cleaning of the Sensor with ethanol or similar
disinfectant might destabilize it for a non-predicable time period.
• After inserting a new Sensor it is recommended to wait for three hours
with the instrument switched on before performing a measurement.
• Do not reuse the patient filters.
• Do not use NIOX VERO®in the proximity of areas where volatile
substances such as organic fluids or disinfectants are being used.
Special attention should be paid to aerosols and disinfection baths,
either open vessels or ultrasonic baths. Do not use the instrument in the
presence of flammable anesthetic, vapors or liquids.
1.6 Indications for use
NIOX VERO®measures Nitric Oxide (NO) in human breath. Nitric Oxide is
frequently increased in some inflammatory processes such as asthma. The
fractional NO concentration in expired breath (FeNO), can be measured by
NIOX VERO according to guidelines for NO measurement established by
the American Thoracic Society.
Measurement of FeNO by NIOX VERO is a quantitative, non-invasive, sim-
ple and safe method to measure the decrease in FeNO concentration in
asthma patients that often occurs after treatment with anti-inflammatory
pharmacological therapy, as an indication of the therapeutic effect in patients
with elevated FeNO levels. NIOX VERO is suitable for children, approxi-
mately 7 - 17 years, and adults 18 years and older.
FeNO measurements provide the physician with means of evaluating an
asthma patient’s response to anti-inflammatory therapy, as an adjunct to the
established clinical and laboratory assessments in asthma. The NIOX VERO
is intended for prescription use and should only be used as directed in the
NIOX VERO User Manual by trained healthcare professionals. NIOX VERO
cannot be used with infants or by children approximately under the age of 7,
as measurement requires patient cooperation. NIOX VERO should not be
used in critical care, emergency care or in anesthesiology.
Chapter 2 Product description
000190-09 NIOX VERO®User Manual US 5
2 Product description
2.1 NIOX VERO® accessories and parts
(A) Breathing handle and handle cap, (B) Sensor (supplied separately),
(C) Instrument (including stand), (D) Rechargeable battery, (E) NIOX®Apps
USB memory stick, (F) USB cable, (G) Power adapter and power cord,
(H) Patient filter (supplied separately)
Note: Only accessories and parts supplied by Circassia may be used.
2.2 Instrument
H) ON/OFF button, (I) Power adapter port, (J) USB port
(K) Battery LED - lit when battery is charging, (L) Standby LED - blinking in
Standby/Sleep mode, (M) Touch panel Display
Chapter 3 Installation and set up
6 000190-09 NIOX VERO®User Manual US
(N) Breathing handle holder, (O) Breathing handle port
3 Installation and set up
Open the package with care. Prior to installation, check that the package
contains all the parts. (See page 5). A screwdriver is required for opening the
compartment lid and installation of Sensor and battery. Remove the plastic
film from the display.
1. Carefully place the instrument with the display facing down on a flat and
clean surface, then unscrew and remove the compartment lid. There is
a taper on the side of the lid for better grip when opening.
2. Open the Sensor can.
Chapter 3 Installation and set up
000190-09 NIOX VERO®User Manual US 7
WARNING! Open the Sensor can with care. The inside of the opening may
have sharp edges.
3. Open the Sensor package.
WARNING! Do not touch or clean the white Sensor membrane.
CAUTION! The Sensor should only be stored in its original unopened
package or installed in a NIOX VERO®instrument.
4. Insert the Sensor and turn the swivel clockwise until locked.
5. Open the battery package.
Note: Only use the correct rechargeable battery supplied by Circassia.
Type No BJ-G510039AA, Article No 12-1150
6. Insert the rechargeable battery and replace the lid. Tighten the screw by
using a screwdriver.
Chapter 3 Installation and set up
8 000190-09 NIOX VERO®User Manual US
7. Take the breathing handle tube and push the end of the tube into the
breathing handle port slowly until the triangle is no longer visible.
The breathing handle and the patient filter are Applied parts Type B.
Note: Only attach the breathing handle supplied by Circassia.
Article No 12-1010
Note: Use care not to bend the handle tube.
Note: The triangle should not be visible when assembled correctly.
8. Attach the power adapter to the instrument and then to the power outlet.
When installing the unit, either use a socket outlet with a readily
accessible power switch, or connect the AC cord plug to an easily
accessible socket outlet near the equipment. If a fault should occur
during operation of the unit, use the power switch to cut the power
supply, or remove the AC cord plug.
Note: Only use the power adapter supplied by Circassia with the
instrument. Article No 12-1120.
9. Position the instrument with the stand folded out.
Autres manuels pour NIOX VERO
2
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