Perma Pure O2asis User manual

Personal Humidifier
USER GUIDE
PP-19-1 REV. 15

2O2asis User Guide
Copyright © 2021 Perma Pure, LLC
Reproduction, adaptation, or translation in whole or in part in any form or medium without the
express written consent of Perma Pure, LLC. is prohibited. This documentation is intended for
informational use only.
TRADEMARKS
O2asis™ is a registered trademark of Perma Pure, LLC.
All other trademarks are the property of their respective owners
WARRANTY
The O2asis personal humidifier is designed for use with low flow oxygen delivery systems to
provide warmth and humidification to patients. Under normal operating conditions, Perma Pure
will warrant the base unit to be free from defects of workmanship or materials for a period of
one - (1) year, and the replacement water-well unit for a period of thirty - (30) days from the date
of receipt provided that the unit is properly operated and maintained in accordance with Perma
Pure’s operating instructions. Based on Perma Pure’s product evaluation, Perma Pure’s sole obli-
gation under the foregoing warranty is limited to making replacements, repairs or issuing credit
for equipment found to be defective within the stated warranty period. Should the O2asis base
unit or the replacement water well fail prematurely, the replacement base unit is warranted for
the remainder of the original base unit warranty period, or the replacement water well is warrant-
ed for the remainder of the original water well warranty period. This warranty extends only to the
buyer purchasing the equipment directly from Perma Pure or through Perma Pure’s designated
distributors and/or agents as new equipment.
Other replacement parts, consumables, and routine maintenance items are excluded from this
warranty. Perma Pure shall not be liable to the purchaser or other persons for incidental or
consequential damages or equipment that has been subject to abuse, misuse, misapplication,
alteration, negligence or accident.
PATENTS
Covered by U.S. patent: 11071842
Other patents pending
CONTACT INFORMATION
Please contact your care provider, licensed distributor, or Perma Pure if you have trouble setting
up or using the O2asis device. Should you need to contact Perma Pure directly, please use the
following contact information:
Perma Pure LLC
1001 New Hampshire Ave
Lakewood, NJ 08701 USA
Toll Free: 866-334-2447
www.o2asishumidifier.com
PP-19-1 REV. 15
5020967
MEDICAL
ELECTRICAL
EQUIPMENT

3O2asis User Guide
CONTENTS
Included with the System ................................6
Device Overview and Features ............................6
Features................................................7
Safety Features .........................................8
Setting Up the Device....................................8
Filling the Water Well Consumable Cartridge ...............8
Color-Coded Port Connections for the Water Fill Pump......9
Powering the Device .....................................11
Color-Coded Port Connections for the Oxygen Hose .......12
Connecting the Oxygen Source ..........................12
Connecting the Cannula.................................12
Adjusting the Heat Level ................................13
Pediatric Patients.......................................13
Use Without Electrical Power ............................14
Replacing the Water Well Consumable Cartridge ..........15
Checking for an empty Water Well .......................17
Cleaning and Disinfection ...............................18
Regular Cleaning .......................................18
Reprocessing and Disinfection Between Patients...........19
Moving the Device......................................20
Technical Specifications .................................20
Physical ...............................................20
Environmental .........................................20
Electrical ..............................................21
Use Durations ..........................................21
Standards Classification .................................21
Performance ...........................................22
Units of Measure: .......................................22
Estimated Humidification Output ........................22
Electromagnetic Compatibility...........................23
Emissions..............................................24
Immunity ..............................................24
Disposal ...............................................25
Troubleshooting........................................25
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4O2asis User Guide
INTENDED USE
The O2asis Humidifier is a device intended to add moisture to breathing gases before they reach
the patient to aid in the comfort of oxygen therapy.
INDICATIONS FOR USE
The O2asis Humidifier is indicated to add moisture and may warm breathing gases for administra-
tion to pediatric and adult patients in the home, hospital, and clinical settings. It is used with an
external gas source of up to 6 Lpm via nasal cannula.
IMPORTANT
Rx only. Caution: Federal law restricts this device to sale by or on the order of a physician. In order
to receive the safe and proper treatment prescribed for you, only use the parts and accessories that
came with the device or were supplied with the O2asis device or its licensed distributors.
WARNINGS
Warnings indicate that possible harm to the operator or user may occur.
• The patient and caregiver should read and understand this entire guide before using the device.
• This device is not intended for life support
• This device has no user serviceable parts. Do not attempt to disassemble the unit as this
could cause injury and invalidate the warranty.
Do not use any parts, accessories, or materials not recommended with O2asis as degraded
performance can result.
• Use only power cords and accessories supplied with the O2asis device. Using other power
cords and accessories could damage the device and may result in decreased immunity or
increased emissions of the system.
• This device is not transit operable.
Do not pull on or stretch the heated line. This could damage the device or cause air leaks.
• Always route the power cord in a way that will avoid anyone tripping or anything otherwise
interfering with it.
Do not position the device in a way that would make it dicult to access the power supply
connection port. Doing so would prevent quick disconnection if needed in an emergency
situation.
• This device is turned on when the power cord is plugged in. There is no on/o switch.
• Keep the power cord and heated line away from sharp objects at all times
• Inspect power cord and heated line for damage or signs of wear before use and periodically
during use. If damaged, immediately discontinue use and contact your care provider, licensed
distributor, or O2asis Customer Service for a replacement.
Do not connect any part of the device to any other equipment not described in this user guide.
• Strangulation hazard! – Keep cords and hoses out of the reach of children. Arrange all tubing
so that it will not twist around the head or neck.
• Choking Hazard – Small parts. Keep away from children under 3 yrs.
Do not autoclave, gas-sterilize, or immerse any portion of the device. This may create an
electric shock hazard or damage internal components.
Do not cover the breathing tubes with a blanket or subject to any outside heat source. This
can aect the quality of treatment or injure the user.
Do not add any attachments or accessories to the device that are not listed in this user
guide as the device may not function correctly aecting the quality of therapy or injuring the
patient.
Do not use the device at an altitude above 3,100 m (10,171 ft.) above sea level or outside of
a temperature of 20°C to 35°C (68° - 95° F). Using the device outside of this temperature
range or above this altitude can aect the performance of the device which consequently
can result in patient harm.
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5O2asis User Guide
• To prevent disconnection of tubing during use, especially during ambulatory use, only tubes
in compliance with ISO 5367 or ISO 80601-2-74 should be used.
• This device contains a heater and should be not be used in a situation where prolonged
direct skin contact could occur. Do not rest any part of the heated portion of device onto
exposed skin.
• If the device has been dropped or mishandled, or if you otherwise notice any changes in the
performance of the device, disconnect the power cord and discontinue use. Contact your
care provider, licensed distributor, or O2asis Customer Service for repair or replacement.
• Inspect all tubing and parts for damage, wear, debris, or occlusion. Discard and replace as
necessary.
• No substances other than oxygen shall be administered or delivered while using the device or
through the device itself.
Do not attempt to sterilize or reuse the Water Well cartridge. It is labeled as single patient
use only and must be disposed of after 30 days of use on a single patient. Reuse of the
Water Well cartridge can result in diminished performance and harm to the patient.
Do not attempt to sterilize or reuse the nasal cannulas included with this device. They are labeled
for single patient use only and must be replaced after one (1) week of use. Failure to replace
the nasal cannulas as recommended can result in diminished performance and harm to the
patient.
Do not touch the surface plate while changing the Water Well consumable cartridge.
Do not use organic solvents or abrasive cleaners. These types of cleaners may create toxic
gasses when heated and may damage the device.
• Water fill pump is intended for single patient use only. It cannot be reprocessed. If the
pump becomes contaminated, discard and replace the pump before filling.
• The Water Fill Pump is only intended for use with the O2asis Humidifier. Do not attempt to
use with or connect to other medical equipment.
• This device is not intended for connection to a medical pipeline.
• This device is not intended for use with patients whose upper airways have been bypassed.
CAUTIONS
Cautions indicate that the device can be damaged
Do not place the device directly onto blankets, carpets, fabrics, or other flammable materials.
Do not place the device in or on any container that can collect or hold water.
Do not use extension cords with this device.
• The responsible organization is accountable for the compatibility of the humidifier and all of
the parts and accessories used to connect to the patient before use.
• The included cannula is validated for use with this device. Do not use with any other
breathing systems.
• Mobile RF communications equipment can aect medical electrical equipment.
• Use only distilled water with this device. Use of tap or filtered water will damage the device
and impair the quality of therapy it can provide.
Do not use this device near any moisture producing devices such as a tea kettle or nebulizer.
Increased moisture will reduce the eectiveness of the device and possibly cause moisture to
build up inside of the breathing tube.
Do not place the device on a surface that is above your nose to reduce the chances of
moisture build up in the cannula and heated line.
Do not place the device near any sources of heating or cooling such as fire places, radiators,
air conditioners, or forced air vents.
Do not overfill the water container. Use only the included Water Fill Pump to fill the device.
• Keep the device away from any children, pets, or pests as interaction with the device could
cause damage and degrade performance.
• Keep the device free of lint, dust, and dirt as these debris can damage the device and
degrade performance.
CONTRAINDICATIONS
• This device should not be used by patients who have undergone nasal surgery within the
past three months.
• This device should not be utilized to condition nebulized medicine or any gas with airborne
salt/saline.
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6O2asis User Guide
SYMBOLS AND MARKINGS
The symbols listed in the table below may appear on the device or its labeling:
Consult Instructions for Use Type BF Applied Part
Catalog Reference Number Temperature Limitation
Manufacturing Lot Number AC AC
Serial Number DC DC
Manufacturer Ingress Protection Rating (Drip
Proof)
Caution
Federal Law (USA) restricts this
device to sale by or on the order of
a physician
Date of Manufacture Warning
Single Patient Use Humidity
Instructions for Use Do not use if package is open or
damaged
DO NOT USE IF PACKAGE IS OPEN OR DAMAGED
Non sterile Keep dry
Expiration Pressure
WARNING: This product can expose
you to chemicals including acryloni-
trile, which is known in the state of
California to cause cancer. For more
information, go to www.p65warnings.
ca.gov
INCLUDED WITH THE SYSTEM
The O2asis Humidifier comes with the following parts:
NOTE: If any of the items listed above are missing or damaged, please contact
your care provider, licensed distributor, or O2asis Customer Service.
DEVICE OVERVIEW AND FEATURES
The O
2
asis personal humidifier is used with low flow oxygen therapy to provide
moisture and heat to the oxygen stream. This greatly increases the comfort level
of the oxygen therapy as oxygen is often very dry and can lead to discomfort.
Pressure
WARNING: This product can expose
you to chemicals including acryloni-
trile, which is known in the state of
California to cause cancer. For more
information, go to www.p65warnings.
ca.gov
• O2asis Humidifier Base and Water Well
Consumable Cartridge pre-installed
• Power Supply
• O2asis Humidifier Adult Cannula
• Living with an O2asis Humidifier
Pamphlet
• Water Fill Pump
• Quick Start Guide
• Reorder Card
• User Guide
• Replacing Water Well Guide
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7O2asis User Guide
FEATURES
1 O2asis Base Unit — The base of the humidifier that includes the heat con-
trol buttons and the connection to the power plug.
2 O2asis Water Well Consumable Cartridge — The top cartridge that in-
cludes the water reservoir and heated line. The cartridge lasts for 30 days
before it needs to be replaced.
3 Heat Control Buttons — The + and – buttons which allow the user to select
from three levels of heat.
4 Cartridge Latch — The hinged latch that locks the Water Well cartridge in
place onto the base unit.
5 Power Cord Connector — The connector that accepts the male connector
at the end of the power cord.
6
Heated Line — The heated tube attached to the Water Well cartridge that
heats the oxygen to prevent water droplets from collecting inside of the tubing.
7 Water Fill Port — The port on the Water Well cartridge used to fill the
water reservoir with distilled water.
8 Oxygen Connection Port — The port that accepts connection to the oxy-
gen input from an oxygen tank or concentrator.
9 Cannula Connection Port — The port at the end of the heated line where
the cannula is connected to.
q Water Fill Pump — The pump and tubing set that attaches to a bottle of
distilled water to be used to fill the Water Well cartridge reservoir.
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8O2asis User Guide
SAFETY FEATURES
The O2asis Humidifier has been designed with the following safety features to
limit temperature, power currents, and to cut o power of the device to ensure
patient and user safety:
• Power Supply and Accessories – Power is supplied to the device when
plugged in. The device does not have a Power Switch.
• Power to the Base Unit is shut o when the Water Well is removed.
• Water Well consumable cartridge (and Locking Latch) – Power to the
Heating System is terminated when the Water Well consumable cartridge is
removed.
• Main Board PCB – Controls, Heaters and Settings to device performance
and safety specifications
• Heated Line Power Levels
• Water Heater Temperature Levels
• Water Heater power turned o when Heated Line is not detected
• LED Indicator Lights – (3) LED Indicator Lights (low, medium, high)
• User Interfaces:
• Temperature Control Buttons - (2) Buttons (plus (+), minus (-)) to con-
trol temperature
SETTING UP THE DEVICE
Place the device on a firm, flat surface within easy reach of where you will use
it. Do not place the device near any sources of heating or cooling such as
fire places, radiators, air conditioners, or forced air vents.
Note: If an uncomfortable amount of rainout is occuring, try to place the de-
vice above your nose.
FILLING THE WATER WELL
CONSUMABLE CARTRIDGE
To fill the device, complete the following steps:
What You Will Need
O2asis
Humidifier
Water Fill
Pump
NOT INCLUDED
Distilled Water
Tap or filtered water
will damage device
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9O2asis User Guide
Warning: Make sure that the device is not plugged in to an electrical outlet
before filling.
Warning: Make sure that the Water Well consumable cartridge is secured to
the base unit with blue latch closed before filling.
Warning: Do not fill the water reservoir with anything other than distilled
water. Adding dierent water or other substances can damage the device
and degrade performance.
Warning: Do not overfill the water reservoir. Use only the included Water
Fill Pump to fill the device.
Warning: The Water Fill Pump is only intended for use with the O2asis
Humidifier. Do not attempt to use with or connect to other medical
equipment.
Note: Make sure to position the device on a flat, stable surface before filling.
Note: You should expect a full Water Well reservoir to hold 135 ml (4.6 oz)
of distilled water and last 24 hours under normal use at 2 lpm flow rate. For
additional reservoir durations, please refer to the Performance section of
this manual.
Note: The device will detect when the Water Well is empty and will shut
down. The three LED lights will flash until the device is filled.
Color-Coded Port Connections
for the Water Fill Pump
The Water Fill Port is color-coded to aid the patient/
user when connecting the Water Fill Pump to the
Water Fill Port (1COLOR CODED IN PURPLE).
FLOW
RATE
0.5-3 LPM
3-6 LPM
6 LPM
6 LPM
HEAT
SETTING
POWER OFF
HEATED LINE
POWER
OXYGEN PORT
3
4
2
FILL PORT
1
1Obtain a one-gallon bottle or jug of distilled water (available at many
pharmacies and grocery stores) and set the bottle on a hard, flat, and
stable surface.
2Remove the cap from the water bottle and insert the
Water Fill Pump into the top of the bottle. The pump
can rest on top of the water gallon. You do not need
to twist the pump collar onto the water gallon.
Note: If the container of distilled water is filled to the top, water
may overflow when the Water Fill Pump is inserted. Pour some
water into the sink to avoid overflow.
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10 O2asis User Guide
3The first time using the Water Fill Pump:
Hold the pump collar in one hand. Use the other hand
to twist pump head COUNTER-CLOCKWISE.
Twist until the pump SPRINGS UP.
4A Push (1) and then twist (2) the connector
at the end of the Water Fill Pump hose
to the Water Well fill port.
4B Slowly push down on the water fill pump handle 5 times
to fill the Water Well.
As needed, remove Water Well to visually check water
level, see section Checking for an empty Water Well,
page 18. To prevent over-filling, the pump should not
be used while the Water Well is disconnected from the
Base Unit.
Confirm that the electrical port is dry and reattach the
device to an electrical outlet. If the device is overfilled,
the soft portion of the Water Well may balloon, create
diculties in closing the blue latch, and cause it to dis-
connect from the base unit. If this happens, unplug the
device and allow it to run for several minutes without
power. When the ballooning has subsided, the device
can be reconnected to power and used normally
x5
4C Remove the Water Fill Pump hose from the fill port. Set
aside the gallon and Water Fill Pump until need to refill.
Collar
2
1
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11O2asis User Guide
POWERING THE DEVICE
To connect the device to AC power, complete the following steps:
1Ensure the blue latch is closed.
2Plug the prongs of the power supply into a standard electrical outlet.
3Plug the barrel connector of the power supply into the
2POWER cord connector on the latch side of the
device.
4When the device is powered on, one or more of the LED lights will be
illuminated.
Warning: Be sure to periodically inspect the power adapter cord for signs
of damage or wear. Immediately discontinue use and replace if damaged
Contact your care provider, licensed distributor, or O2asis Customer Service
for replacement.
Note: Make sure that the Water Well consumable cartridge is securely
latched to the base unit before plugging in the power cord.
Note: The O2asis Humidifier device will continue to humidify the airflow
even when disconnected from the power supply. Heating functions will not
be available without power. Therefore, without power, it will be possible to
get condensation in the breathing tube.
Note: The O2asis Humidifier device does not have a power button. In the
event of a malfunction, unplug the device to disconnect power.
Note: In the event of a power failure, unplug the device from the outlet until
power is restored. Then plug the unit back in and check to make sure the
device is functioning properly. The device will work to humidify the oxygen
supply without power. However, no heat will be supplied to the gas path-
way.
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12 O2asis User Guide
CONNECTING THE OXYGEN SOURCE
To connect your oxygen source, complete the following steps:
1Find the connector at the end of the hose or line coming from your
oxygen source.
2Push the connector on to the oxygen input port
on the latch side of the device until snug.
Note: Make sure that the connector forms
a seal around the oxygen input port on
the device. If you hear air coming out of
that connection, push the connector further
onto the port until it seals.
Note: Color-Coded Port Connections for the Oxygen Hose
The table below includes an image of the green color-coded O2asis Humidifier
Port Label and an image of the Oxygen Connection Port.
CONNECTING THE CANNULA
To connect the cannula to the device, complete the following steps:
Warning: Use only the cannula included with the device. Use of other
cannulas can degrade the performance of the device.
1Remove the cannula from its plastic bag.
2Connect the tube end to the connector at
the end of the 4blue heated line until
snug.
heated line
cannula
3Position cannula on face as directed by your care provider.
4Check for appropriate flow rate setting from oxygen source (concentra-
tor, tank, etc.) and confirm that oxygen is flowing through the cannula.
Note: Small amounts of condensation may build up in the device during
periods when it is not being used. In these cases, let oxygen flow through the
Color-Coded Port Connections
for the Oxygen Hose
The Oxygen Connection Port is color-coded
to aid the patient/user when connecting the
oxygen input to the Oxygen Connection Port
(3GREEN COLOR CODED).
FLOW
RATE
0.5-3 LPM
3-6 LPM
6 LPM
6 LPM
HEAT
SETTING
POWER OFF
HEATED LINE
POWER
OXYGEN PORT
3
4
2
FILL PORT
1
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13O2asis User Guide
device for 5 to 10 seconds to clear condensation before positioning on face.
Note: During use, the device status should be checked every 4 hours. If the
lights are o or flashing, consult the Troubleshooting section of this guide.
Note: The nasal canula can be contaminated with discharge from the nose
during use and if left unchecked portions of the O2asis tubing within the
heating tube and cartridge may also be contaminated. If visible contamination
is observed, the nasal cannula and any other contaminated parts should be
disposed of and replaced.
ADJUSTING THE HEAT LEVEL
To adjust the temperature level applied to the oxygen flow, complete the
following steps:
1Select the appropriate heat level for the prescribed oxygen flow as shown in
the table below:
2Above 2lpm of oxygen flow, begin your oxygen therapy on the first level
of heat. When the device receives power, the left most LED light will
illuminate, signifying that the device is on level one. Try this level first
before adjusting to a higher heat level as indicated by the table above.
3The heat level can be adjusted by pressing the ‘+’ and ‘-‘ buttons on
either side of the LEDs.
Note: When the power cord is disconnected, the device will return to the
previous heat level when power is restored.
Condensation: Regularly check for visual condensation in the cannula. If
excessive amounts of condensation are present, reduce the heat setting to the
lowest level or unplug the device. If the problem persists, discontinue use of
the O2asis Device.
Flow Rate Heat Setting
0.5 lpm – 2 lpm Power o
2 lpm – 6 lpm – Low
4 lpm – 6 lpm – Medium
5 lpm – 6 lpm – High
1 Light = Low 2 Lights = Medium 3 Lights = High
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14 O2asis User Guide
PEDIATRIC PATIENTS
Setup and use for pediatric patients are consistent with all other instructions
within this manual, except as follows:
Adult Caregiver: This device shall only be used with pediatric patients under
close adult supervision.
Cannula: For pediatric patients, utilize the appropriate cannula as indicated in
the table below, along with the supplied tubing connector
Patient Age range* Cannula Source
Pediatric 2 years to < 21 years HU412 Separate purchase
Adult 21 years + HU401 1 pc. Included in kit
*Ages according to the Federal Food, Drug, and Cosmetic Act
Initial Heat Setting: Follow the instructions in “Adjusting the Heat Level” sec-
tion of this document.
Condensation: Regularly check for visual condensation in the cannula. If
excessive amounts of condensation are present, reduce the heat setting to the
lowest level or unplug the device. If the problem persists, discontinue use of
the O2asis Device.
USE WITHOUT ELECTRICAL POWER
The O2asis Humidifier will continue to provide humidity even when disconnect-
ed from the power supply. For use without power, simply unplug the power
supply from the electrical outlet on the wall, then unplug the power adapter
cord from the O2asis device.
Without power, the device will not provide warmth, and humidification perfor-
mance will be diminished. Use without power may also lead to additional con-
densation, particularly if unplugged after a period of use with electrical power.
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15O2asis User Guide
REPLACING THE WATER WELL
CONSUMABLE CARTRIDGE
What You Will Need
O2asis
Humidifier
Replacement
Water Well Power Supply
O2asis Cannula Water Fill
Pump
NOT INCLUDED
Distilled Water
Tap or filtered water
will damage device
To replace the Water Well consumable cartridge, complete the following steps:
1Unplug the power adapter cord from the latch side of the device.
2Unplug the oxygen source line from the oxygen
connector. Leave the blue heated line in place.
3Unplug the canula from the end of the heated
line.
4Open the base latch by prying the top of the
latch o of the Water Well consumable cartridge
and swinging it down.
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16 O2asis User Guide
5Lift the latch side of the Water Well consumable
cartridge and rotate out of the base.
Do Not have any sharp objects around the Water
Well consumable cartridge to prevent punctures to
bladder.
6Dispose of the entire Water Well consumable cartridge in accordance
with local plastic recycling guidelines. Do not attempt to separate the
water bladder from the Water Well.
7Open the new consumable cartridge from its packaging.
8Insert the non-port side of the cartridge into
the button side of the base and push in until the
cartridge sits flush with the base.
9Swing the base latch up and snap it onto the
cartridge to lock it in place.
10 Fill the Water Well using the Water Fill Pump and distilled water as
outlined on pages 9 - 10, Filling the Water Well Consumable Cartridge.
11 Plug your cannula into the end of the heated line.
12 Plug in your oxygen source tubing to the oxygen
input port on the cartridge.
13 Plug in the power adapter cable to the power
input port on the base.
Water Well
Reverse side of
Water Well
Do not
remove water
bladder
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17O2asis User Guide
Warning: You must replace the Water Well consumable cartridge every 30
days to ensure device safety and performance. Failure to replace the car-
tridge can result in degraded device performance and risk of serious patient
injury.
Note: The entire gas pathway is contained within the Water Well
consumable cartridge and can become contaminated with bodily fluids. If
visible contamination is present or performance degradation is suspected,
dispose of and replace the Water Well consumable cartridge.
Warning: Do not touch the surface plate while changing the Water Well
consumable cartridge. Surface plate may be hot.
CHECKING FOR AN EMPTY WATER WELL
1Remove connections:
A: Remove power and oxygen connections
(leave blue line in).
B: Remove cannula from heated line.
2Remove Water Well:
A: Open blue latch to unlock.
B: Lift up to remove water well.
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18 O2asis User Guide
3Check Water in Water Well: If low or empty,
refill water well.
5Reinstall Water Well: After ensuring water,
install water well into base unit.
6Close Latch: Close blue latch to secure the
waterwell
CLEANING AND DISINFECTION
Regular Cleaning
Clean the device periodically and when dirt or debris is visible on the out-
side of the device. To clean the device base, disposable cartridge, or water fill
pump, use a lint free cloth dampened with water and a few drops of dish soap.
Wipe all exterior surfaces. If visible soil is present, use a wetted soft nylon bris-
tle brush to remove visible soil, paying close attention to seams and crevices
in the device. Wipe again with dish soap and water. Dry with a lint free cloth.
Ammonia-free disinfecting wipes, such as Super Sani-Cloth® can be used on
the outside of the device or pump.
Note: If the device or pump becomes noticeably dirty and regular cleaning
does not remove soil, the device should be discarded and replaced.
Warning: Do not try to clean or disinfect the inside of the Water Well
consumable cartridge. It is designed and tested to be single patient use
for 30 days, after which it must be replaced.
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19O2asis User Guide
Reprocessing and Disinfection Between Patients
The O2asis Humidifier Base must always be cleaned and disinfected between
patients. The entire Water Well consumable cartridge, including its blue heated
line, is disposable and no disinfection is required. Follow these steps to ensure
a clean and disinfected device:
1Unplug the O2asis Humidifier Base from the power supply.
2Remove and discard the Cannula ( single-patient use).
3Remove and discard the Water Well consumable cartridge ( single-
patient use).
4Examine for visible soil. If visible soil is present, use a wetted soft nylon
bristle brush or Super Sani-Cloth® to remove all visible soil, paying close
attention to seams and crevices in the device.
5Wet all surfaces of the base unit with another Super Sani-Cloth®. Keep
the surface wet for at least two minutes. Use additional Super Sani-
Cloth® if needed.
6Allow the device to air dry completely.
7If Power Supply is exposed to the patient, disconnect from the O2asis
device and wall. Repeat steps 4 through 6, and let thoroughly dry.
Warning: Do not use organic solvents or abrasive cleaners. These types of
cleaners may create toxic gasses when heated and may damage the device.
Warning: Water fill pump is intended for single patient use only. The
Water Fill Pump should not be used between multiple patients. It cannot be
reprocessed. If the pump may have been contaminated, replace or provide
patient with new pump.
The Super Sani-Cloth® Germicidal Disposable Wipe is a premoistened nonwo-
ven durable wipe containing a quaternary ammonium chloride/alcohol-based
solution. It is recommended for use in hospitals and other critical care areas
where the control of the hazards of cross-contamination between treated
surfaces is required, and it is designed to be compatible with hard nonporous
surfaces and equipment made of plastic, Formica® laminate, glass and more.
Some organisms are removed from the surface by thoroughly wiping the sur-
face with the wipe. Most remaining organisms are killed within two (2) minutes
by exposure to the liquid in the wipe.
The Super Sani-Cloth Wipe is registered with the Environmental Protection
Agency (EPA) under (EPA #9480-4). In accordance with 21 CFR 880.6890,
the Super Sani-Cloth Wipe is regulated by the FDA as a Class I, 510(k) Exempt,
General Purpose Disinfectant under Product Code (LRJ).
PP-19-1 REV. 15

20 O2asis User Guide
MOVING THE DEVICE
To move the device to a new location, it is recommended that the power
adapter plug be disconnected from the humidifier base. When moving with the
device, make sure to secure the unit and route the tubing such that you will not
get tangled in or trip on it.
TECHNICAL SPECIFICATIONS
Physical
Dimensions ............................ 187 x 102 x 30mm (7.4 x 4.0 x 1.2 in.)
(Not including 1118mm (44 in.) long heated line)
Weight ...................0.7 lbs. 65lbs. (295 g) empty, 10.95 lbs. (430 g) full
Distilled water reservoir . . . . . . . . . . . approx. capacity: 135 ml or 4.6 oz (> 115 ml)
Environmental
Ambient Operating Conditions
Temperature ..................................20° to 35° C (68° - 95° F)
Humidity ................................... 15% - 90%, non-condensing
Atmospheric Pressure Range . . . . . . . . . . . . . . . . . . . . . . . . 650 hPa – 1060 hPa
Transport and Storage Conditions
Temperature ...................................5° to 40° C (41° - 104° F)
Humidity ................................... 15% - 90%, non-condensing
Atmospheric Pressure Range ........................650 hPa – 1060 hPa
PP-19-1 REV. 15