NASONEB 7070 User manual

Instructions for Use
NasoNeb, Inc.
153 Industrial Blvd Plattsburgh, NY 12901 USA
Telephone: [phone]
www.nasoneb.com
MODEL 7070 NasoNeb Sinus Therapy System
MODEL 7080 NasoNeb Sinus Therapy System Supply Kit
European English - EU

Table of Contents
INTRODUCTION.....................................................2
IMPORTANT SAFEGUARDS............................................3
SYSTEM COMPONENTS ..............................................3
SET UP AND OPERATION .............................................4
CLEANING AND STORAGE ............................................6
REPLACE THE FILTER.................................................6
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
SPECIFICATIONS ....................................................8
GUIDANCE AND MANUFACTURERS DECLARATION ......................9
WARRANTY.......................................................13
Protected under US PATENTS 9,440,020; 9,402,947; 8,925,544; 8,162,921;
8,146,587; D689,185; others pending
INTRODUCTION
The NasoNeb® Sinus Therapy System is designed to deliver nasal safe solutions or
medication to the nasal and paranasal sinus cavities. The System can also be used
to clean the nasal pasages with our proprietary NasoNeb® Moisturizing Solution.
If you have any questions or concerns, please contact the NasoNeb, Inc. Customer
Experience Team toll-free in the US at 1-866-960-9833 or send us an email to
[e-mail]. A customer experience agent will be happy to help you!
Caution – Read all warnings and instructions before use.
Caution – Do not use with medications that are incompatible with
polycarbonate.
Caution – The NasoNeb Sinus Therapy System is designed for single person use.
Do not share the NasoNeb Sinus Therapy System with others. Doing so risks the
spread of infection.
Intended Use: The NasoNeb Sinus Therapy System is designed to deliver
medications formulated for inhalation to the nasal and paranasal sinus cavities.
2

SYSTEM COMPONENTS
IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE USING
WARNING – To reduce the risk of injury:
• Use the NasoNeb Sinus Therapy System only for its intended use
as described in this manual
• Use only with NasoNeb-brand accessories
• Never drop or insert any object into any opening or hose
• Do not use outdoors. This NasoNeb Sinus Therapy System is for indoor use only
3
Power Supply
NasoNeb Compressor
On/O Switch
Tubing
Holder
Power Connection
Filter Holder
Outlet
NasoNeb Cup
Assembly
NasoNeb Supply Tubing
NasoNeb Filters

SET UP AND OPERATION
Follow these simple steps to prepare and operate the NasoNeb Sinus Therapy System.
SET UP
Unpack the NasoNeb Sinus Therapy System and assemble by following these steps:
1. Unpack the Supply Tubing and Filters
2. Set the Filters aside for safekeeping
3. Connect one end of the Supply Tubing to
the outlet of the NasoNeb Compressor
4. Connect the loose end of the Supply
Tubing to the air inlet of the Cup
5. Place the Insert into the Cup to
form the Cup Assembly
6. The Insert and Cup t together in
only one orientation. If the Insert
does not seat, rotate the Insert 180 degrees
7. Place the Supply Tubing in the tubing holder
to hold the Cup Assembly upright
8. Plug the power supply into the Compressor
9. Plug the power supply into the wall
Insert
Cup
Supply Tubing
4

SET UP AND OPERATION
HOW TO USE
1. Place half of the medicine into the Cup Assembly
2. Place the Cup Assembly into one nostril, aim it straight in or slightly away
from the septum (the middle of your nose that divides your nostrils)
3. Turn on the Compressor
4. Turn o the Compressor when empty
5. Repeat steps 1-4 for the other nostril
TIP: You may need to tilt your head more or less to nd the best angle for your nose.
TIP: You may need to adjust the location of the Cup forward or backward to nd the
best location for medication delivery.
TIP: Stopping after the rst few seconds to blow your nose may improve delivery.
NOTE: Do not turn on the Compressor until the Cup Assembly is in position in the
nose. Do not remove the Cup Assembly from position without rst turning o the
Compressor. Doing so may result in being sprayed in the face.
5

6
CLEANING AND STORAGE
After each use, clean the NasoNeb Sinus Therapy System.
1. Unplug the Compressor
2. Disconnect the Cup Assembly from the Supply Tubing
3. Disassemble the Cup Assembly and wash the Cup and Insert in warm soapy water
4. Wipe the Supply Tubing and Compressor with a damp cloth
5. Set components aside to dry between uses
6. You may rinse the Cup and Insert with hydrogen peroxide or isopropyl alcohol
Replace Supply Tubing and Cup Assembly with a Model 7080 NasoNeb Sinus Therapy
System Supply Kit every 6-12 months or every 730 cleaning cycles. Store the NasoNeb
Sinus Therapy System in a dry place.
Caution – Avoid the use of harsh detergents or cleaning agents. These may damage
the plastic components, cause fogging or other undesirable eects. Do not wash in
the dishwasher.
Caution – Do not allow water to enter the Supply Tubing.
Caution – If water enters or condensation forms in the Supply Tubing, connect
one end of the Supply Tubing to the Compressor and run the Compressor until the
condensation evaporates.
REPLACE THE FILTER
The Compressor has a lter installed in the Filter Holder. There are additional lters
included in the system. Check the lter every 6 months or 720 minutes of use. If it is
dirty, replace the lter. Additional lters can be acquired from NasoNeb, Inc. or where
you purchased the NasoNeb System.
1. Pull the Filter Holder out of the compressor (the Filter Holder pulls straight out)
2. Remove the lter from the Filter Holder
3. If the lter is discolored, replace with a new lter, otherwise, put the lter back
into the Filter Holder
4. Insert the Filter Holder back into the compressor before using

7
TROUBLESHOOTING
Problem Possible Cause Resolution
No mist is created Insert not in place Ensure Insert is in place
No uid in Cup Check for uid in Cup
Supply Tubing not connected Check Supply Tubing
to device or Compressor connections
Compressor Compressor not Plug Compressor into
doesn’t turn on plugged in a power outlet
Power cord not connected Remove and insert
to Compressor power cord into Compressor
Power outlet not active Check that outlet has power
Compressor Pressing side of power switch Press straight down on the
doesn’t turn o does not engage switch center of the power switch
Particle Size Distribution
Performance information may not apply to drugs supplied in suspension or high viscosity
form. In such cases, information should be sought from the drug supplier.
Normalize Count (%)
0 20 40 60 80 100
Size (µm)
15
10
5
0

SPECIFICATIONS
Specications and appearance are subject to change without notice.
Components may be substituted at the will of NasoNeb, Inc.
NASONEB Compressor
Electrical DC 12V 1.5A, 180 VA
Sound Pressure 55 dB
Free ow 6 l/min nominal
Compressor Pressure Range ≥200 kPa (≥29 psi)
Operating Temperature Range 10° to 40°C (50° to 104°F)
Storage Temperature Range -21° to 70°C (-13° to 158°F)
Relatives Humidity Range 10 to 95 % RH (non-condensing)
Dimension (L x W x H) 136 x 126 x 56mm (5.3 x 5.0 x 2.2 in.)
Weight 445g (15.6 oz.)
NASONEB Cup Assembly
Dimension (L x W x H) 53 x 56 x 42 mm (2.1 x 2.2 x 1.64 in.)
Weight 16g (0.55 oz.)
Capacity 15 ml (0.5  oz.)
Phthalate-Free. Not manufactured with any natural latex products.
Supply Tubing
Length 1.98 m (6.5 ft)
Phthalate-Free. Not manufactured with any natural latex products.
Accessories
Model 7080 NasoNeb Sinus Therapy System Supply Kit
– Includes Cup, Insert and Supply Tubing
8
Tipo BF Classe II
IPX0

9
1Guidance and manufacturer’s declaration – electromagnetic emission
2The NasoNeb Compressor is intended for use in the electromagnetic environment
specied below. The customer or the user of NasoNeb Compressor should assure
that it is used in such an environment.
3Emissions Test Compliance Electromagnetic environment - guidance
4 RF emissions
CISPR 11
Group 1 The NasoNeb Compressor uses no RF energy
for its function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment
5 RF emissions
CISPR 11
Class B The NasoNeb Compressor is suitable
for use in all establishments, including
domestic establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
6 Harmonic
emissions
EN 61000-3-2
N/A
7 Voltage
Fluctuations/
icker emissions
EN 61000-3-3
N/A
Guidance and manufacturers declaration - electromagnetic emission
– for all EQUIPMENT AND SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic immunity
The NasoNeb Compressor is intended for use in the electromagnetic environment specied below.
The customer or the user of the NasoNeb Compressor should assure that it is used in such an environment.
Immunity Test EN 60601 test level Compliance Level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
EN 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or
ceramic tile. If oors are covered
with synthetic material, relative
humidity should be at least 30%
Electrostatic
transient /
burst
EN 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
N/A
Mains power quality should be that
of a typical commercial or hospital
environment
Surge
EN 61000-4-5
± 1 kV dierential
mode
±2 kV common mode
N/A
Mains power quality should be that
of a typical commercial or hospital
environment
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
EN-61000-4-11
0% UT; 0.5 cycle g)
At 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% UT; 1 cycle and
70 %UT; 25/30 cycles
at 0°
0% UT; 250/300 cycle
N/A
Mains power quality should be
that of a typical commercial or
hospital environment. If the user of
the NasoNeb Compressor requires
continued operation during
power mains interruptions, it is
recommended that the NasoNeb
Compressor be powered from an
uninterruptible power supply or
a battery.
Power
frequency
(50/60 Hz)
magnetic eld
EN-61000-4-8
30 A/m 30 A/m Power frequency magnetic
elds should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment
NOTE: UTis the a.c. mains voltage prior to application of the test level
Guidance and manufacturer’s declaration – electromagnetic immunity
– for all EQUIPMENT and SYSTEMS
10

Guidance and manufacturer’s declaration – electromagnetic immunity
– for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The NasoNeb Compressor is intended for use in the electromagnetic environment specied below. The customer
or the user of the NasoNeb Compressor should assure that it is used in such an environment.
Immunity Test EN 60601 test
level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
EN 61000-4-6
Radiated RF
EN 61000-4-3
3 Vrms
150 kHz – 80 MHz
3V/M
80 MHz to 2.5 GHz
N/A
10 V/m
Portable and mobile RF communications
should be used no closer to any part of the
NasoNeb Compressor, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance:
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Where pis the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres (m).b
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures,
object and people.
aField strengths from xed tr ansmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and T V broadc ast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an elec tromagnetic site survey should be considered. If the
measured eld strength in the location in which the NasoNeb Compressor is used exceeds the applicable RF compliance level above, the NasoNeb Compressor should be obser ved to verify
normal operation. If abnormal performance is obser ved, additional measures may be necessary, such as re¬orienting or relocating the NasoNeb Compressor
bOver the frequency r ange 150 kHz to 80 MHz, eld strength should be less than 3 V/m
d=[ — ]√– P
3.5
V1
d=[ — ]√– P
3.5
E1
d=[ — ]√– P
7
E1
11

Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM
– for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between portable and mobile
RF communications equipment and the NasoNeb Compressor
The NasoNeb Compressor is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the NasoNeb Compressor
can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the NasoNeb
Compressor as recommended below, according to the maximum output power of the
communications equipment
Rated maximum
output of transmitter
W
Separation distance according to the frequency of transmitter
m
150kHz to 80 Mhz 80 MHz to 800 MHz 800MHz to 2.5 GHz
0.01 l0.12 0.23
0.1 l0.38 0.73
1l1.2 2.3
10 l3.8 7.3
100 l12 23
For transmitters rated at a maximum output not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects and people.
d=[ — ]√– P
3.5
V1d=[ — ]√–
P
3.5
E1d=[ — ]√–
P
7
E1
12

WARRANTY
NasoNeb, Inc. warrants the NasoNeb Sinus Therapy System Compressor to be free from material
defects in workmanship and materials for a period of twenty four (24) months from the date of
purchase and the Supply Tubing and Cup and Insert to be free from material defects in workmanship
and materials for a period of three (3) months from the date of purchase (the “Warranty Period”).
This warranty is limited to the original purchaser of the NasoNeb Sinus Therapy System and is
non-transferable. Any defective parts or assembly will be repaired or replaced, at the sole discretion
of NasoNeb, Inc. if the unit has not been misused or tampered with during the Warranty Period.
Repair or replacement of defective parts shall not extend the term of any applicable warranty and
the original term of such warranty shall remain in eect. Shipping charges, if any, shall be paid by the
purchaser.
THIS LIMITED WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT EXPRESSLY
SET FORTH HEREIN, WHETHER EXPRESSED OR IMPLIED, WRITTEN OR ORAL, BY OPERATION OF LAW
OR OTHERWISE INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTIES ARISING FROM A COURSE OF DEALING
OR USAGE OR TRADE. NASONEB, INC. IS NOT RESPONSIBLE FOR HANDLING, STORAGE, CLEANING
AND STERILIZATION OF THE PRODUCT, AS WELL AS OTHER FACTORS RELATING TO THE PATIENT,
DIAGNOSIS, TREATMENT, MEDICAL PROCEDURES, AND OTHER MATTERS BEYOND NASONEB, INC.’S
CONTROL, DIRECTLY AFFECT THE PRODUCT OR THE RESULTS OBTAINED FROM ITS USE. THIS LIMITED
WARRANTY DOES NOT EXTEND TO ANY ABUSE OR MISUSE OF THE PRODUCT (INCLUDING, WITHOUT
LIMITATION, OFF-LABEL USE), ACCIDENT TO OR NEGLECT OF THE PRODUCT, FAILURE TO FOLLOW ANY
INSTRUCTIONS OR SPECIFICATIONS PROVIDED WITH THE PRODUCT (INCLUDING, WITHOUT LIMITATION,
ANY RE-USE, RE-PROCESSING OR RE-STERILIZATION OF THE PRODUCT NOT IN ACCORDANCE WITH
SUCH INSTRUCTIONS OR SPECIFICATIONS), IN EACH CASE WHETHER CAUSED OR CARRIED OUT BY
CUSTOMER OR BY ANY THIRD PARTY. THIS WARRANTY DOES NOT COVER PROVIDING A LOANER SYSTEM,
COMPENSATING FOR COSTS INCURRED OR FOR LABOR COSTS INCURRED OR REPLACING DEFECTIVE
PART(S). NASONEB, INC. NEITHER ASSUMES, NOR AUTHORIZES ANY OTHER PERSON TO ASSUME FOR
IT, ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THIS WARRANTY.
NASONEB, INC. SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL LOSS,
DAMAGE OR EXPENSE DIRECTLY OR INDIRECTLY ARISING FROM USE OF THE COMPRESSOR OR ITS
COMPONENT PARTS.
You may contact the NasoNeb, Inc. Service Center at [phone] for more information.
13

14

15

NasoNeb and the NasoNeb Logo are trademarks of NasoNeb, Inc.
Manufactured in the USA
Date of revision 2021/11/03
Reference Number 300-532105-01
NasoNeb, Inc.
153 Industrial Blvd
Plattsburgh, NY 12901
[phone]
[phone]
www.nasoneb.com
MDSS GmbH
Schigraben 41
30175 Hannover
Germany
Tel.: [phone]
Fax: [phone]
EC REP