flyp fn2000m User manual

USER: READ THIS GUIDE BEFORE OPERATING THIS DEVICE.
SAVE THIS GUIDE FOR FUTURE REFERENCE.
Pocket Portable
Nebulizer
User Guide
Model fn2000m

2
The symbols that appear on the box and the Flyp™ nebulizer are
described below:
SYMBOL MEANING
Caution
Consult instructions for use
Keep dry
Do not place in dishwasher
-10ºC
+45ºC
only
DO NOT PLACE
IN DISHWASHER
-10ºC
+45ºC
only
DO NOT PLACE
IN DISHWASHER
SYMBOLS
-10ºC
+45ºC
only
DO NOT PLACE
IN DISHWASHER

3
Transient storage temperature limits -10˚C to 45˚C
(14˚F to 113˚F)
Federal law (USA) restricts this device to sale
by or on the order of a physician or licensed
practitioner.
Type BF applied part
IP22
Protected against insertion of ngers and will not
become damaged or unsafe during a test in
which it is exposed to vertically dripping water
when held at an angle.
Bluetooth enabled technology
-10ºC
+45ºC
only
DO NOT PLACE
IN DISHWASHER
-10ºC
+45ºC
only
DO NOT PLACE
IN DISHWASHER

4
This page left blank intentionally.

5
Important information
to prevent damage to your
Flyp™ nebulizer
Important safety information
regarding hazards that may cause
personal injury
Before using your Flyp nebulizer for the rst time, be aware of all
warnings and safety information. Only use accessories approved by
the manufacturer and referenced within this manual. If you do not fully
understand all the warnings, safety precautions, and operating instructions,
contact the Flyp customer service team at 844.FLYPNEB (359.7632) for
technical support. ALWAYS KEEP THIS USER GUIDE HANDY.

TABLE OF CONTENTS
Section 1: Introduction
Intended Use 8-9
Section 2: Safety Guidelines
Safety Guidelines 10-15
Section 3: Product Description
Features and Benets 16-17
Section 4: Flyp™ at a Glance
Names and Functions of Parts 18-20
Section 5: Using Flyp
About Flyp’s Battery 21-23
Filling Medication Reservoir with Prescription 24-25
Turning Flyp ON and OFF 26-27
Inhaling Prescribed Medication 28

Section 6: Cleaning and Disinfecting
Cleaning Parts 29-33
Disinfecting Parts 34-35
Section 7: Troubleshooting
Troubleshooting 36-37
Section 8: Support
Learning More 38
Section 9: Information
Technical Data 39
Specications 39-40
Aerosol Performance 41-42
Electromagnetic Compatibility 43-52
Disposal and Recycling 53
Warranty 53
Section 10: Replacement Parts and Accessories 54

8
INTENDED USE
Indications for use:
The Flyp™ nebulizer, for use by
adolescent and adult patients, is
intended to aerosolize healthcare
provider-prescribed solutions for
inhalation that are approved
for use with a general-purpose
nebulizer. Flyp is intended for
use at home or a medical facility,
such as a hospital or doctor’s ofce.
Intended user:
Flyp nebulizer, for use by
adolescent and adult patients,
should only be used by a patient
under the supervision of a qualied
medical expert, such as a doctor,
nurse, or respiratory therapist.
The user, or their actively assisting
caregiver, should be capable
of understanding all of the User
Guide’s contents. Flyp is intended
for use by a single user. Flyp is not
a life-saving device. Patients who
are in severe respiratory distress,
who are unconscious, or who
Section 1: INTRODUCTION

9
are not breathing spontaneously
should not use this device.
In an emergency, call 911
immediately for medical
assistance.
Caution:
Federal law (USA) restricts this
device to sale by or on the
order of a physician or licensed
practitioner.
Precautions:
All warnings and cautions
described in the User Guide should
be observed.
Service life:
The Flyp main unit has an
expected service life of 36 months.
*Note: The reservoir assembly
(HypersonIQ™ Cartridge) should
be replaced as needed, or every
3 months.
*Note: Charge only with Flyp
provided charger (EC 60601-1)
DO NOT Alter or modify this device.
The mouthpiece of this device is
removable.

10
SAFETY GUIDELINES
Read this section to learn how to
use Flyp™ safely and correctly
and to prevent risks and injuries
to you and others.
Keep this User Guide handy for
future reference.
Failure to follow these instructions
could result in serious injury or
damage to the device or other
property. Read all the safety
information below before using
the device.
Medical device:
Flyp is a medical device,
available only by prescription
and for prescribed medications.
Be sure to follow a qualied
medical expert’s instructions.
Direct exhaled medication away
from others.
If you are using Flyp to treat a
serious condition, a back-up
device is recommended.
Section 2: SAFETY GUIDELINES

11
However, in a life-threatening
situation, NEVER rely on a
nebulizer. Call 911 immediately
for emergency medical
assistance.
Use by others:
For single patient use only.
If others use it, infection may
spread.
Medical use:
Flyp is intended solely to deliver
prescribed medication to treat
a respiratory condition. Using
Flyp for any other purpose is
dangerous, and neither the
distributor, manufacturer, nor
their afliates can be held liable
for any damage or injury caused
by improper use or misuse.
Supervision required:
Adult supervision is required when
the device is used by children and
the inrm. If someone swallows
small pieces, such as the Stopper,
consult a doctor immediately.
You should also be aware that
the USB Wall Charger presents a
potential choking hazard.
Cleaning:
Be sure to clean the Mouthpiece,
Medication Reservoir and Stopper
before using them for the rst

12
time and after each subsequent
use (refer to pages 29-32).
The Main Unit should be cleaned
every day, but it should
NEVER be
placed in water or washed in a
dishwashing machine.
ALWAYS
disconnect and unplug the USB
Wall Charger before cleaning
the Main Unit.
Do not drop medication on the
Main Unit or into its USB port. If
you drop medication on either
area, immediately wipe it off
with gauze.
Battery:
The battery is not replaceable.
Don’t attempt to replace the
battery yourself, as you may
damage it. Overheating and
injury could result. The lithium-
ion battery should be replaced
only by the manufacturer, and
it must be recycled or disposed
of separately from household
waste. NEVER incinerate the
battery. Incineration may cause
the battery to rupture. If an
ignition source exists, then re
and even an explosion could
result. NEVER immerse the
battery in water, as this may
cause the battery to rupture.

13
Electronic device:
Flyp complies with all applicable
electromagnetic compatibility
(EMC) standards. You should,
however, avoid operating it near
other electronic devices.
If you are not going to use the
unit for a long period of time,
disconnect the USB Wall Charger.
Charging:
Flyp contains an internal, lithium-
ion rechargeable battery that
cannot be removed.
Charge Flyp only with the USB
Wall Charger provided. NEVER use
the device when it is charging.
Battery life should exceed 500
charge cycles. All batteries
deteriorate over time if they are
not used or charged. Do not
store Flyp for long periods of time
without charging it periodically.
If Flyp is not used or charged
for a long period of time, the
battery may create a hazardous
condition.
Proper handling:
Flyp contains sensitive
components, including a
stainless steel disk. Do not drop,
crush, puncture, bend, heat,
incinerate, or apply strong shock
to the device or its parts.

14
periods of time. Keep the
device away from children,
pets, pests, lint and dust.
You may render the device
ineffective.
•Flyp is intended for use at home
or a medical facility, such as a
hospital or doctor’s ofce.
Using cords and ports:
NEVER force the USB Wall
Charger into the USB Port.
Check for obstructions in
the USB Port.
If you’re concerned about
dirtying Flyp™, you can carry it in
the Draw-String Bag.
•NEVER unscrew or open the
Main Unit.
•Do not disassemble, repair, or
modify Flyp. You may injure
yourself or render the device
ineffective.
•Keep the device away from
heated surfaces and extreme
heat and cold. Do not leave
Flyp in a car if it will be subjected
to signicant heat or cold.
•Do not expose the device to
direct sunlight for extended

15
If the USB Wall Charger and USB
Port don’t join with reasonable
ease, they probably don’t
match. Make sure that you
are using the USB Wall Charger
provided and that you have
positioned it correctly.
Disposing of Flyp properly:
If, after proper cleaning and
charging, Flyp takes longer than
10 minutes to deliver either 1
unit-dose of medication or 3
mL of normal saline (0.9%), the
HypersonIQ™ cartridge should
be cleaned or replaced.
Consult “Troubleshooting” on
pages 36-37 to see if corrective
steps can be taken. For
information about the proper
disposal of Flyp, including
other important regulatory
compliance information, see
“Disposal and Recycling” on
page 53.

16
FEATURES AND BENEFITS
Read this section to learn about
Flyp’s features and benets.
Small and convenient:
Flyp™ ts in your pocket.
There is no separate control unit,
compressor, mask, hose or cup.
And Flyp’s convenient
Draw-String Bag makes it
easy to carry with you.
Flyp is rechargeable with a
USB Wall Charger, like a cell
phone. There are no disposable
batteries.
Simple:
Flyp is designed for easy
operation and delivers all
medications approved for use
with general-purpose nebulizers.
Section 3: PRODUCT DESCRIPTION

17
Silent:
Flyp operates almost silently.
Fast and efcient:
Flyp is designed to shut off
automatically after 10 minutes to
conserve battery life.
After proper cleaning Flyp should
not take longer than 10 minutes
to deliver 3 mL of normal saline
(0.9%).
Self clearing function:
To active this mode, press and
hold power button for 5 seconds
to enter “clearing mode”.
Operate the unit for 1-2 minutes or
until the reservoir is empty.

18
NAMES AND FUNCTIONS
OF PARTS
Read this section to learn the
names and functions of the parts.
If any items are missing, contact
the store where you purchased
Flyp. You may also contact
Flyp
nebulizer customer service at
1-844-FLYPNEB
Section 4: FLYP™ AT A GLANCE

19

20
USB WALL CHARGER DRAW-STRING BAG
Note: the Draw-String Bag is
not intended to protect Flyp™. It is
provided for convenience only.