3B RESmart CPAP User manual

RESmart®CPAP and Auto-CPAP
User Manual
Solutions in Sleep Therapy™
www.3Bproducts.com

Table of Contents
Symbols ............................................................................................................. 1
Indications for Use .......................................................................................... 2
Warning! ........................................................................................................... 3
Specifications .................................................................................................. 5
Unpacking the System .................................................................................. 7
Available Therapies ....................................................................................... 8
System features ............................................................................................... 9
First Time Setup (Patient) ............................................................................. 10
Install the Filter.................................................................. 10
Connect Power Cord..................................................... 10
Patient Menu Set-Up....................................................... 12
Selecting Patient Device Settings ................................ 13
Assembling the Circuit.................................................... 18
Adding a Humidifier........................................................ 19
Using Oxygen with Device............................................. 20
Routine use (Patient) ................................................................................... 21
Connecting the Circuit .................................................. 21
Adjusting the Circuit ....................................................... 21
Using the Ramp Button................................................... 21
Turning the System OFF .................................................. 22
Helpful Hints...................................................................... 23
Routine Maintenance ................................................................................. 24
Replacing the Filter......................................................... 24
Cleaning the System ...................................................... 24
Reordering........................................................................ 25
Service............................................................................... 25
Traveling with RESmart
®
.............................................................................. 26
Troubleshooting ............................................................................................ 27
EMC Requirements ...................................................................................... 28
Glossary ........................................................................................................... 32
Limited Warranty .......................................................................................... 34
iCode® is a trademark of BMC Medical Co., Ltd.
3B and Solutions in Sleep Therapy™are trademarks of 3B Products, LLC.
RESmart®is a registered trademark of BMC Medical Co., Ltd.

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RESmart®CPAP and Auto-CPAP User Manual
Symbols
CONTROL BUTTONS
PressureStartIStop
Ramp Start
Humidifier On I Off ( iCode® )
User Button
User Button
DEVICE
Attention, Consult Accompanying Documents
Type BF Applied Part
Class II (Double Insulated)
AC Power
IPX1 Drip-Proof, Vertical
SN Serial Number of the Product
Manufacturer

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RESmart®CPAP and Auto-CPAP User Manual
IMPORTANT!
Read and understand the entire User Manual before operating this
system. If you have any questions concerning the use of this system,
contact your home care provider or health care professional.
CAUTION!
Federal law restricts this device to the sale by or on the order of a
physician.
Indications for Use
The RESmart®CPAP and Auto-CPAP systems are intended to deliver
positive pressure for the treatment of Obstructive Sleep Apnea. The
optional integrated humidifier is indicated for the humidification
and warming of air from the flow generator device. These devices
are intended for single patient use by prescription in the home or
hospital/ institutional environment on adult patients.
Contraindications
TheRESmart
®
CPAPandAuto-CPAP device areNOTintendedforlife
support. Studies haveshown that the following pre-existing
conditions may contraindicate the use of positive airway pressure
therapy for some patients:
• Bullous Lung Disease
• Bypassed Upper Airway
• Pneumothorax
• Pathologically Low Blood Pressure
• Pneumocephalus has been reported in a patient using nasal
Continuous Positive Airway Pressure.
Caution should beused when prescribing CPAP for susceptible
patients such as those with: cerebral spinal fluid leaks,
abnormalities of the cribriform plate, prior history of head trauma,
and/or pneumocephalus. (Chest 1989: 96:1425-1426)
• The use of positive airway pressure therapy may be temporarily
contraindicated if you exhibit signs of a sinus or middle ear infection.
Contact your health care professional if you have any questions
concerning your therapy.

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RESmart®CPAP and Auto-CPAP User Manual
Warning!
Indicates the possibility for Injury to the user or the operator
• The instructions in this manual are not intended to supersede
established medical protocols.
• This device is intended for adult use only
• This device is not intended for life support
• CPAP devices have the potential to allow rebreathing of exhaled air.
• Contact your health care professional if symptoms of sleep apnea
recur.
• Using the RESmart
®
CPAP and Auto-CPAP at an incorrect elevation
setting could result in airflow pressures higher than the prescribed
setting. Always verify the elevation setting when traveling or relocating.
To reduce this potential, observe the following:
• Use BMC circuit accessories.
• Do not wear the mask and headgear for more than a few minutes
while the device is not operating.
• Do not block or try to seal the vent holes in the exhalation port.
• As with most CPAP devices: At low CPAP pressures, some exhaled gas
(C0
2
) may remain in the mask and be rebreathed.
• If the room temperature is warmer than 95 ℉ (35 ℃ ), the airflow
produced by the RESmart
®
device may exceed 106 ℉ (41 ℃ ). The room
temperature must be kept below 95 ℉ (35 ℃ ) while the patient uses the
device.
• This equipment is not suitable for use in the presence of a flammable
anesthetic mixture in combination with oxygen or air, or in the presence
of nitrous oxide.
• If you notice any unexplained changes in the performance of the
RESmart
®
CPAP and Auto-CPAP. If it is making unusual or harsh sounds,
if it has been dropped or mishandled, if the enclosure is broken, or if
water has entered the enclosure, disconnect the power cord and
discontinue use. Contact your home care provider.
• To avoid electrical shock, disconnect the power cord before cleaning.
DO NOT immerse the device in any fluids.
• To remove AC power, disconnect the power cord from the electrical
outlet.
• The use of accessories other than those specified or recommended by
the manufacturer may adversely impact performance of the device.
• Inspect the power cord often for any signs of damage. Replace a
damaged cord immediately.
• DO NOT use the RESmart
®
CPAP and Auto-CPAP if the display is erratic.
Contact your home care provider for further instructions.

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RESmart®CPAP and Auto-CPAP User Manual
CAUTION!
Makesurethe RESmart
®
CPAP and Auto-CPAP isaway from any
heating or cooling equipment (e.g., forced air vents, radiators, air
conditioners). Also make sure that bedding, curtains, or other items
are not blocking the filter or vents of the device. Air must flow
freely around the device for the system towork properly.
Indicates the possibility of damage tothe device
• Tobacco smoke may cause tar build-up within the RESmart
®
CPAP and
Auto-CPAP that may result in the device malfunctioning.
IMPORTANT!
Additional warnings and cautions are located throughout
this manual as they apply.
WARNING!
DO NOTconnect any equipment to the RESmart
®
CPAP
and Auto-CPAP unless recommended by BMC oryour
health care provider.
CAUTION ！
Ifthe RESmart
®
CPAP and Auto-CPAP hasbeenexposedto
either very hot or very cold temperatures, allow it to adjust
to room temperature (approximately 2 hours) before
beginning setup.
WARNING!
DO NOTusethe RESmart®CPAP and Auto-CPAP if the display
is erratic. Contact your home care provider for further
instructions.

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RESmart®CPAP and Auto-CPAP User Manual
Specifications
Device Size
Dimensions: 8.66 × 7.6 × 4.4” (220 x 194 x 112mm),
12.3” (313 x 194 x 112mm) (with Integrated Heated Humidifier)
Weight: 3.5 lbs. (1.6 kg), 5.3 lbs. (2.4 kg) (with Integrated Heated
Humidifier)
Product Use, Transport and Storage
Operation Transport and Storage
Temperature: 41˚F to 95˚F (5 to 35˚C) -4˚F to 131˚F (-20 to 55˚C)
Humidity: ≤ 80% Non-condensing ≤ 93% Non-condensing
Atmospheric Pressure: 860 to 1060 cmH2O 500 to 1060 cmH2O
Mode of Operation
Continuous
Work Mode
CPAP, Auto
SD Card Capacity
2G bytes
AC Power Consumption
100 –240V AC, 50/60Hz, 1.0A max
Type of Protection Against Electric Shock
Class II Equipment
Degree of Protection Against Electric Shock
Type BF Applied Part
Degree of Protection Against Ingress of Water
IPX1 –Drip-Proof, Vertical
Pressure Range
4 to 20 cmH2O (in 0.5 cmH2O increments)
Pressure Stability
4 to 20 cmH2O (±1 cmH2O)
Altitude setting
Auto-CPAP: Manual setting: level 0 - 2
CPAP: Manual setting 0- 10000 ft.
Automatic altitude compensation for therapy pressure

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RESmart®CPAP and Auto-CPAP User Manual
Sound Pressure Level
<30 dB, when the device is working at the pressure of 10 cmH2O
Maximum Flow
Test Pressure (cmH2O)
4
8
12
16
20
Average flow at the
patient connection
port(L/min)
70.1
73.6
75.9
73.0
73.4
Accessories
The RESmart®CPAP and Auto-CPAP are not sold with mask, tubing or
bacterial filters.
Accessories may be purchased separately. The RESmart®product
line is designed to accommodate standard CPAP tubing (22mm) for
easy interconnectibility of masks and air tubing.
WARNINGS AND CAUTION
1. This device is restricted to sale by or on the order of a
physician.
2. Ensure that the SD card is inserted into the device
before you turn on RESmart®CPAP or Auto-CPAP
device.
3. In order to avoid impairing SD card or the data saved
in it, please do not insert or pull out the SD card when
the device is connected to a power source.

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RESmart®CPAP and Auto-CPAP User Manual
Unpacking the System
Includedwithyour RESmart
®
unit:
No. Item Number
1 RESmart®CPAP or Auto-CPAP 1
2 Power Cord 1
3 Carrying Case with shoulder strap 1
4 User Manual 1
5 Provider Instructions 1
6 Extra Filter (M1020) 1
7 Humidifier Plug 1
8 SD Card 1
SN Record Serial Number
IMPORTANT!
Ifanyofthe above partsare missing,contact your homecare
provider.
To order any accessories not included with this system, contact your
home care provider.
Home Care Provider Contact Information

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RESmart®CPAP and Auto-CPAP User Manual
Available Therapies
The RESmart®is available intwo models: CPAP (white) and Auto-CPAP
(black). The two models deliver the following therapies:
Shown with humidifier
CPAP:
DeliversContinuousPositiveAirway Pressure;CPAP maintains a
constant level of pressure throughout the breathing cycle. If your
health care professional prescribed ramp for you, you can press
the Ramp button to reduce the pressure andthen gradually
increase the pressure to the therapeutic pressure setting sothat you
canfall asleep more comfortably.
Shown with humidifier
Auto-CPAP:
Automatically adjustsCPAPtherapy pressurewithinthe pressure
range determined byyour physician or healthcare provider.

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RESmart®CPAP and Auto-CPAP User Manual
System features
Display Screen: All system settings, total operating time, and therapy
hours will appear here.
User Buttons: These buttons can be used to turn on/off the system and
change the system settings.
Humidifier Controller: This controller turns the Integrated Heated
Humidifier on/off and allows the heat setting to be adjusted. This
button allows access to iCode®data when the device is turned off.
Air Outlet: Connect the flexible tubing (coaxial 22 mm) here.
Humidifier Power: This socket provides the power to the Integrated
Heated Humidifier.
Handle: This handle is for lifting and carrying the device.
Medical Product Note: For ease at airport security stations, there is a
note on the bottom of the RESmart®CPAP and Auto-CPAP stating
that it is medical equipment. It may help if you also take this manual
with you when you travel.
AC Inlet: Connect/disconnect the AC power cord here.
SD Card Slot: Used to insert the SD card. As a memory medium, the SD
card can record and save all patient treatment data.
Communications Connector: For clinical use with the Data
Management Software. Connect the communications cable here.
Filter Cap & Filters: The foam filter screens out normal household dust
and pollens. The filter cap is designed to reduce the noise from the
RESmart
®
CPAP and Auto-CPAP.

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RESmart®CPAP and Auto-CPAP User Manual
First Time Setup (Patient)
WARNING!
Do not use the RESmart®CPAP and Auto-CPAP system until an
appropriate professional adjusts the settings.
Note to home care provider: Before beginning setup, be sure that
you have available the RESmart®Setup Instructions. Clinician’s
(Provider’s) Setup instructions are not included in this manual.
DO NOT connect any equipment to the RESmart®CPAP or Auto-
CPAP unless recommended by BMC or your health care provider.
CAUTION!
If the RESmart®CPAP or Auto-CPAP has been exposed to either very
hot or very cold temperatures, allow it to adjust to room temperature
(approximately 2 hours) before beginning setup.
Place the RESmart®CPAP or Auto-CPAP on a firm flat surface
Install the Filter
Place the foam filter into the filter area on the back of the RESmart®
CPAP and Auto-CPAP with the blue side facing out.
CAUTION! The foam filter must be in place at all times when the
RESmart® CPAP and Auto-CPAP is operating.
IMPORTANT! To remove AC power, disconnect the power cord from
the electrical outlet.
WARNING! Inspect the power cord often for any signs of damage.
Replace a damaged cord immediately.
Attach the integrated Heated Humidifier
Please see the RESmart®Integrated Heated Humidifier User Manual
enclosed with your device.
Connect Power Cord
Plug the socket end of the power cord into the AC inlet on the back
of the RESmart®CPAP and Auto-CPAP. Plug the pronged end of the
power cord into an electrical outlet. System status will appear on the

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RESmart®CPAP and Auto-CPAP User Manual
RESmart® CPAP and Auto-CPAP screen.
The RESmart®CPAP and Auto-CPAP is powered on for use when the
power cord in connected. The Pressure Start Stop Button turns the
blower on/off.
CAUTION!
Make sure the RESmart®CPAP and Auto-CPAP is away from any
heating or cooling equipment (e.g., forced air vents, radiators, air
conditioners). Also make sure that bedding, curtains, or other items
are not blocking the filter or vents of the device. Air must flow freely
around the device for the system to work properly.
Standby
When you plug the device into a power source it will be in Standby
mode. The blower will not engage unless you put your mask on or you
press the start/stop button. After power on, system status will appear
on display screen as described below.
Display Screen: LED screen where all device settings will appear as
well as iCode®data and last night’s sleep report.
User Buttons: These 4 buttons can be used when entering the Patient
and Clinician’s menus to change the RESmart®CPAP and Auto-CPAP
settings.
+/- User Buttons are used to go to the previous/next option and
operate as up and down keys to change the settings.
Ramp Button is used to confirm the setting change.
Start/Stop Button will allow you to exit the Setup Menu without
saving，will turn on/off the blower.
Pressure Start/Stop Button: Use this button to start/stop the airflow. DO
NOT start the airflow until the circuit tubing is connected.
Heated Humidifier Button: Use this button when the optional
Integrated Heated Humidifier has been prescribed. This button will
control the optional heated humidifier’s output. This button will also
provide iCode®data when the device is in the standby state.
IMPORTANT!
The humidifier button is active only when an Integrated Heated
Humidifier is connected. Refer to the Integrated Heated Humidifier’s
instruction for additional information.
Ramp Button: When the airflow is turned on, use this button to restart
the ramp cycle (which lowers the airflow pressure and then gradually
Increases it). This will allow you to fall asleep more comfortably. When

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RESmart®CPAP and Auto-CPAP User Manual
the airflow is turned off, use this button to access the patient menu
and to retrieve previous night’s sleep data.
Note: The ramp feature is not prescribed for all users.
Ramp Starting Pressure (Ramp P): The starting pressure after blower is
turned on. Default setting is 4 cmH2O.
Treatment Pressure: This setting (Min APAP) is the minimum pressure of
the therapy pressure range in Auto mode. This setting (Treat P) is the
designated fixed prescription pressure setting in CPAP mode. Default
setting is 7 cmH2O.
RampTime: The ramp time from starting pressure to prescription
pressure. This enables the patient to comfortably move from
wakefulness to sleep and can be adjusted in 5 minute increments.
Default setting is 10 minutes.
IMPORTANT!
Pressing the ramp button (when the airflow is turned on) will lower the
airflow pressure, if prescribed, and then will gradually increase it.
Patient Menu Set-Up
Depress the Ramp button for 3 seconds
(The airflow must be turned OFF)
You are now in the Patient Menu Set-up. You will need to press the
Ramp Button to enter change status and go through each option by
pressing the + or - Button. The cursor will blink, and values may be
changed using the User Buttons (+/-). Confirm the setting by pressing
the ramp again and the cursor will stop blinking.
IMPORTANT!
If at any time you wish to exit the setup menu, press the Pressure
Start/Stop Button and the display will go back to the system standby
screen.
Ramp 10
4.0--7.0
Ramp Time
Treatment
Pressure
Ramp Starting
Pressure

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RESmart®CPAP and Auto-CPAP User Manual
Selecting Patient Device Settings
IMPORTANT!
Press the Ramp Button to enter change status and press +/- User
Buttons to change the setting. Press the Ramp Button again to
confirm the setting.
Press +/-User Buttons to access the next setting. Proceed through the
following settings:
(1) Heater, (2) Altitude, (3) Auto On, (4) Auto Off, (5) Light, (6) Alert,
(7) Reslex, (8) RampTime, (9) Delay, (10) Date, (11) Time, (12) Save
(1) Setting the Humidifier (Heater)
When the optional Integrated Heated Humidifier is used, this setting
can change the temperature and humidity of airflow between level
0 to 5. Default setting is 3.
(2) Setting the Altitude
For Auto-CPAP: The altitude setting can be changed between level 0
to 2. Default setting is 0.
0 = less than 2,460 ft. (<750 m)
1 = 2,460 to 4,921 ft. (750 m to 1500 m)
2 = 4,924 to 8,202* ft. (1501 m to 2500 m)
*over 8,202 ft. = Measurement of air leakage may not be accurate.
For CPAP: The altitude setting can be changed between 0000ft and
Heater
3
3
Altitude
0
0
Heated
Humidifier
Button
Display
Screen
Ramp
User Button (+)
User Button (-)
Pressure Start/Stop
Button

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RESmart®CPAP and Auto-CPAP User Manual
10000ft manually. The increment is 1,000 ft. Default setting is 0000ft.
*over 10,000 ft. = Measurement of air leakage may not be accurate.
IMPORTANT!
The RESmart® deviceisequippedtofunctionwithautomatic
adjustment oftherapypressuretocompensateforchanges in
altitude.Evenwithout settingthealtitude,the RESmart® devicecan
stilldeliverproper pressureinanyaltitudeworldwide.However,the
correctsetupofaltitude will prevent the device giving out a false
alert.Generally, a false alert is caused by calculation of leakage
at thewrong range of altitude settings.
(3) Setting Auto On
When the RESmart®CPAP and Auto-CPAP is instandby mode and you
are wearing your mask. Your deep breath will start airflow
automatically.
Default setting is On.
(4) Setting Auto Off
When the mask is removed, the RESmart®CPAP and Auto-CPAP will
stop airflow automatically.
Default setting is Off.
(5) Setting the LCD Light
This setting allows you to adjust the LCD light among Auto, On and
Off. Default setting is Auto.
Auto: LCD light will turn on when any button is pressed and dim
after few seconds.
On: LCD light will always beturned ON.
Off: LCD light will always bedimmed.
(6) Setting the Alert
This setting allows you to turn on/off the patient disconnect alert.
When a large, continuous air leak (such as mask removal) has
been detected in the circuit, this setting enables/disables the
audible alert (a beeping sound). This setting is only effective
when the Auto Off setting is off.
Defaultsetting isOff.
Auto On
On
Auto Off
Off
Light
Auto
Alert
Off

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RESmart®CPAP and Auto-CPAP User Manual
(7) Setting the Reslex
The Reslex setting displays the Reslex level set by your home care
provider. This setting allows you to adjust the level of air pressure relief
that you feel when you exhale during therapy. Your home care
provider will have already set a Reslex level. If this is not comfortable
for you, you can increase or decrease the setting. The setting of “1”
provides a small amount of pressure relief. Use the + and –keys to
increase or decrease the pressure relief provided on exhalation.
Default setting is 0 (disable).
(8) RampTime
This setting is the ramp time from starting pressure to prescription
pressure. The device gives airflow at the relative lower pressure of
Ramp P from start point of ramp time, and increases the output
pressure to the prescription pressure gradually during ramp. Setting
range is 0-60mins with the adjustment step of 5mins. Default setting is
10mins. The device reduces the output pressure and counts down to
zero every time the Ramp key is pressed.
(9) Setting the Delay
When the optional Integrated Heated Humidifier is used, this setting
allows the air flow to continue for about 15 minutes at very low
pressure (about 2 cmH2O) after RESmart®CPAP and Auto-CPAP is
turned off. This will blow off the residual vapor and protect the
RESmart®CPAP and Auto-CPAP.
Default setting is Off.
(10) Setting the Date
The current date is displayed and can be modified if needed.
Note: Check and confirm this Date Setting frequently to ensure that
compliance data reporting is accurate.
Reslex
0
Delay
Off
Date
13 01 04
RampTime
10

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RESmart®CPAP and Auto-CPAP User Manual
(11) Setting the Time
The current Time is displayed and can be modified if needed.
Note: Check and confirm this Time Setting frequently to ensure that
compliance data reporting is accurate.
(12) Save and Exit the Settings
All changes to settings must be saved. Confirm the saved settings by
hitting the ramp button once. This will exit the patient menu.
Save
Time
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RESmart®CPAP and Auto-CPAP User Manual
Ability to Use Smartphone Apps
For use with all RESmart®CPAP and Auto-CPAP models. As simple as
taking a picture. Absolutely free of charge. Take a photo of the
display and generate a sleep report. Auto email physician or provider.
View Your Sleep Report with iCode®
Step 1: Press the humidifier button to retrieve your iCode®string.
Continuously pressing the humidifier button steps through all
iCode®values (iCode®1 day, iCode®7 day, iCode®30 day,
iCode®60 day,etc.)
Step 2: To generate a report, go to www.bmc-iCode.com. There
are three mandatory fields required to generate a report: device
serial number, retrieval date, and iCode®string. All other fields are
optional and may be entered depending on the requirement for
the report.
For instructions on viewing your sleep report go to the Patient
Portal at WWW.3bproducts.com.
Reviewing Sleep Data
The RESmart® allows review of the prior night’s sleep data. To
access your data, make sure that the blower is not running by
pressing the start / stop button.
Press the Ramp Start button and scroll through the display using
the +/- buttons. The data displayed consists of completion
time(Compl), P95(95th percentile of the airway pressure over time),
Mean P, AHI(apnea-hypopnea index), and SNI(snore index).
Quit reviewing the sleep data by pressing the start / stop button.

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RESmart®CPAP and Auto-CPAP User Manual
Assembling the Circuit (interface "Mask")
Tousethesystem,youwillneedthefollowing accessories in order to
assemble the recommended circuit.
(1) Mask with integrated exhalation port
(2) 6ft. (1.83 m} flexible Tubing (included}
(3) Headgear (for the mask)
WARNING!
Ifmultiplepersonsaregoingtousethe RESmart® CPAPandAuto-CPAP
(e.g., rental devices), a low-resistance, main flow bacteria filter
should beinstalledin-linebetweenthe RESmart® CPAPandAuto-
CPAP and the circuit tubing. Pressures must be verified by your
home healthcare provider when alternate or optional accessories
are in place.
a. Connect theflexible tubingtotheairoutlet onthefront ofthe
RESmart® CPAP andAuto-CPAP.
b. If you are using a mask with a built-in exhalation port, connect
the mask's connector to the flexible tubing.
If you are using a mask with a separate exhalation port, connect
the flexible tubing to the exhalation port. Position the exhalation
port so that the vented air is blowing away from your face.
Connect the mask's connector tothe exhalation port.
WARNING!
Do not block or otherwise try to seal the air openings (vent holes}
on the exhalation port.
Explanation of the warning:The RESmart®CPAP and Auto-CPAP is
intended to be used with masks and circuits that have an
exhalation portdesigned toexhaust C0
2
from the circuit.When the
RESmart® CPAP and Auto-CPAP is turned on and functioning
properly, new air from the RESmart® CPAPandAuto-CPAPflushesthe
exhaledairoutthroughthe exhalationport.Whenthe RESmart® CPAP
andAuto-CPAP is turnedoff, enough fresh air will not be provided
through the mask, and exhaled air may be rebreathed.
Rebreathing of exhaled air for longer than several minutes can,in
some circumstances, lead to suffocation. This warning applies to
mostCPAPdevices.