Resvent iBreeze 20C User manual

CPAP Clinical Guide
iBreeze 20C / 20C Pro
iBreeze 20A / 20A Pro

Contents
1 Welcome..................................................................................................................................................................1
2 Intended use..........................................................................................................................................................1
3 Contraindications..................................................................................................................................................1
4 Symbol Key.............................................................................................................................................................2
5 System Overview.................................................................................................................................................4
6 Operation.................................................................................................................................................................5
7 Therapy Information......................................................................................................................................... 14
8 Device Alert......................................................................................................................................................... 20
9 Troubleshooting................................................................................................................................................. 22
10 Cleaning and Maintaining............................................................................................................................ 23
11 Maintenance..................................................................................................................................................... 24
12 Storage and disposal.................................................................................................................................... 24
13 Specification..................................................................................................................................................... 25

iBreeze CPAP Clinical Guide
1
1 Welcome
The iBreeze™ CPAP System are Resvent's premium bilevel positive airway pressure devices.
The iBreeze™ CPAP System include the following models:
iBreeze 20C, iBreeze 20C Pro, iBreeze 20A, iBreeze 20A Pro.
IMPORTANT
Read this entire guide before using the device. Please keep the manual after reading, so that at
any time you can read it when needed.
The device is to be used only on the instruction of a licensed physician. The home care provider
will make the correct pressure settings and device configurations including accessories,
according to the health care professional’s prescription.
Refer to the User Manual for more information on using the Resvent therapy devices.
Responsibility on the Manufacturer Party
Resvent is responsible for the effects on safety, reliability and performance of this product, only
if:
All installation operations, expansions, changes, modifications and repairs of this product are
conducted by Resvent authorized personnel.
All spare parts for repair, accessories, consumable are conducted by Resvent or the
authorized personnel.
The electrical installation of the relevant room complies with the applicable national standard
and the manual requirements.
The product is used in accordance with the instruction for use.
2 Intended use
The iBreeze CPAP system delivery positive airway pressure therapy for the treatment of
Obstructive Sleep Apnea（OSA）in spontaneously breathing patients weighting over
30kg(66lbs). It is for use in the home or hospital/institutional environment
3 Contraindications
When assessing the relative risks and benefits of using this equipment, the clinician should
understand that this device can deliver pressures up to 20 cmH2O. In the event of certain fault
conditions, maximum pressure 40 cmH2O is possible. Studies have shown that the following pre-
existing conditions may contraindicate the use of CPAP therapy for some patients:
Severe coronary artery disease
Bullous Lung Disease
Pathologically Low Blood Pressure
Bypassed Upper Airway
Pneumothorax
Caution should be used when prescribing CPAP for susceptible patients such as those with:
Cerebral Spinal Fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head
trauma, and/or Pneumothorax
The use of positive airway pressure therapy may be temporarily contraindicated if you exhibit
signs of a sinus or middle ear.
Note: In either case above, it can only be determined by a competent physician whether to use
CPAP device.

iBreeze CPAP Clinical Guide
2
4 Symbol Key
The following symbols may appear on the device, power supply and accessories.
Symbol
Definition
Manufacturer
Date of Manufacture
Serial number
DC Power
Temperature limitations at transport and storage
Humidity limitations at transport and storage
Atmospheric pressure at transport and storage
Follow instruction for use. This label on the device points the user to the
operator’s manual for complete information. In the operator’s manual, this
symbol cross-references the label.
The product bears CE mark indicating its conformity with the provisions of the
Council Directive 93/42/EEC concerning medical devices and fulfils the
essential requirements of Annex I of this directive
European Authorized Representative
Dispose according to Council Directive 2012/19/EU or WEEE (Waste Electrical
and Electronic Equipment)
Indicates the degree of protection against electric shock according to IEC
60601-1. Class II devices have double or reinforced insulation, as they have no
provision for protective grounding.
Indicates the degree of protection provided by enclosure according to IEC
60601-1
Type BF Applied part (classification of medical electrical equipment, type B, as
specified by IEC 60601-1)
The device is not suitable for use in MRI environment.
Respiratory air humidifier is heated. Do not touch the element

iBreeze CPAP Clinical Guide
3
Therapy On/Off Button(Starts and stops the airflow for therapy)
This way up at transport and storage
Fragile, handle with care
Keep dry at transport and storage
Stacking limitations
Recyclable materials
About the control panel
Symbol
Definition
Press to start/stop therapy.
Turn to navigate the menu and press to select an option.
Turn to adjust a selected option and press to save your change.
Press ramp to set ramp time quickly on standby interface.

iBreeze CPAP Clinical Guide
4
5 System Overview
#
Device Feature
Description
1
Therapy On/Off Key
Starts and stops the airflow for therapy.
2
Ramp Key
Activate the ramp feature during therapy.
3
LCD Display screen
This is the User interface for the therapy device.
4
Control Dial
Turn the dial to scroll between options on the screen. Press the dial to
choose the option.
5
Water Tank Lock
Press the water tank lock to remove the water tank.
6
Water Tank
This one piece removable water tank holds the water for
humidification.
7
Air Outlet Port
Connect the tubing here.
8
Power Inlet
Connect the power cord here.
9
SD card Access Door
This door lifts open for access to SD card.
10
Air Inlet Port
Inlet for room air.
11
Filter Cotton Cover
Open the filter cotton cover to place or change the filter cotton.
Navigating the Device Screens
The User Interface (UI) on this device allows you to adjust the device settings and view
information about your therapy. The UI is comprised of the display screen and the control dial.
Rotate the control dial in either direction to scroll through the menu options on the display screen.
Note: The screen does not support touch operations. You must use the control dial to navigate
the device menu.
To adjust a setting:
1. Rotate the control dial to your desired menu option.
2. Press the control dial to select that setting.
3. Rotate the control dial to change the setting.
4. Press the control dial again to save the change.
Note: The screens shown throughout this manual are examples for reference only. Actual
screens may vary based upon device model and provider settings.

iBreeze CPAP Clinical Guide
5
6 Operation
This chapter describes basic operation and precautions associated with this device.
6.1 Accessing Clinical Mode
You can access, view and set parameters relating to a patient's therapy and device configuration
in the Clinical Mode.
To access the Clinical Mode:
Press and hold both the control dial and the Ramp button on the device for three seconds.
The Home screen is displayed with an icon in the top right corner of the screen. You are
now in the Clinical Mode.
To exit the Clinical Mode:
Press and hold the dial and the Ramp button for three seconds.
6.2 Clinical Standby Interface
After accessing the clinical mode, the clinical standby interface is displayed as below:
Clinical standby interface

iBreeze CPAP Clinical Guide
6
#
Feature
Description
1
Therapy Mode
Displays the current mode and you can click here to set the
Therapy Mode.
Please refer Chapter7 “Therapy Information” for more details.
2
Patient Sleep
Quality Report
Displays the patient sleep quality report and the options for
period of the report are: daily (recent 6 days) / 7 days / 14 days /
1 month / 3 months / 6 months / 1 year.
3
Humidity
Humidity level setting, Enhance patient comfort of respiration.
Option: Auto / OFF / 1 to 8
Default: 3
When auto humidity is enabled, the control algorithm adjusts the
humidifier output to maintain a constant humidity level of 85%
relative humidity while protecting against rainout.
Note: The humidity only can be set when the water is higher than
the limit level in the humidifier.
4
Mask fit
Mask fit test:
In the selection of a new mask, need to test the face mask to
wear whether the occurrence of leakage
In standby or therapy mode, click on the mask fit test icon,
display mask fit test in process with the animation interface
5
Comfort
Press Comfort key, enter Clinical comfort setting interface
6
Setting
Press Setting key, enter Clinical System Setting interface
7
Parameters
Settings
Set the parameters of the current therapy mode
Please refer Chapter7 “Therapy Information” for more details.
8
Alarm Message
Display the alarm messages.
6.3 Clinical Therapy Interface
When the therapy starts, the screen will switch to the Patient Therapy Interface, which displays
the therapy parameters monitoring during therapy. The displayed parameters depend on the
current therapy mode.
Clinical Therapy clean interface

iBreeze CPAP Clinical Guide
7
#
Description
1
The background breathing dynamic diagram.
2
The current therapy mode.
Please refer Chapter7 “Therapy Information” for more details.
3
Display the alarm messages.
Please refer Chapter7 “Therapy Information” for more details.
4
Humidity adjustment shortcut key and Humidity level.
Note：Only the humidity function is turned on for humidity level display
5
Comfort key, enter Clinical comfort setting interface.
6
The current therapy pressure.
7
The settings parameters of the corresponding mode.
Please refer Chapter7 “Therapy Information” for more details.
8
If blood oxygen saturation is present and connected, the monitored blood oxygen
saturation and pulse rate values are displayed in this area.
9
Ramp time dynamic diagram.
Note：Only Ramp function is turned on for Ramp time dynamic diagram.
10
Work status icon bar.
6.4 Clinical Comfort Settings
Press key in the clinical standby interface to enter clinical comfort settings interface.
Clinical Comfort Settings Interface

iBreeze CPAP Clinical Guide
8
Ramp
Ramp is designed to deliver the pressure in a gentle increasing manner at the beginning of
therapy, affording enough time for the patient to adapt to the treatment pressure. The ramp
process brings more comfortable and easier to get to sleep for the user, especially in cases when
treatment pressure is high. Ramp is available for all therapy modes.
In Uni-Level mode, when ramp is enabled, the pressure delivered increases slowly from the initial
ramp pressure to the target treatment pressure in the specified ramp time.
Auto Ramp
When auto ramp is enabled, the minimum treatment pressure (3cmH2O) is delivered before
sleep onset of the patient. If sleep onset is detected, the pressure increases gradually from the
minimum treatment pressure to the target treatment pressure in the specified ramp time.
The minimum ramp time in auto ramp is 5 minutes. However, if sleep onset is not detected within
60 minutes, the device will start to increase the pressure in the same manner still. Auto ramp is
available for all therapy modes.
iPR
Intelligent pressure release is designed to make the therapy more comfortable by reducing the
treatment pressure in the cycle process and expiration. By applying iPR, the average treatment
pressure is lower than its counterpart in normal operation.
The treatment pressure will not drop below 3cmH2O regardless of the iPR setting. iPR is
available for all modes.
In Uni-Level modes, when iPR is enabled, the device senses the respirations of the patient and
boosts pressure in inspiration. After the airflow reaches its peak and starts to decay, the pressure
is released correspondingly. At the end of expiration, treatment pressure is kept below its
prescribed value.

iBreeze CPAP Clinical Guide
9
Icon
Text
Description
Preheat
Turn Preheat function on or off. When the Preheat is on, the
humidifier starts preheating in the standby mode and the
maximum preheating time is 30 minutes. In the therapy mode,
the preheating stops.
Option: ON / OFF Default: OFF
Note:
1. If the humidifier water level below the limit, Preheat function
will be turned off automatically.
2. If humidifier function is turned off, Preheat function will be
disable.
3.Preheat function is not available in the iBreeze 20C.
Auto Ramp
Turn Auto Ramp function on or off.
When Auto Ramp is on, Sleep state can be identified
automatically, sleep begins to start Ramp function, awake do
not start ramp function.
Option: On / OFF Default: OFF
Ramp Time
Set the increase time from Ramp pressure to the setting
therapy pressure.
Option: 0-60 mins, 5 mins increments
Default: 15 mins
Note: if Ramp Time sets to 0 min, Ramp function will be off.
P Ramp
Set the starting pressure of Ramp.
Setting Range: 3 cmH2O-Setting pressure, 0.5 cmH2O
increments.
Default: 4 cmH2O
Auto Start
Turn Auto Start function on or off.
When the Auto Start function is on, the system will start
therapy automatically if a breath with mask is detected. During
therapy, if the mask is removed more than 5 seconds, the
therapy mode will stop.
Option: ON / OFF Default: ON
IPR
Set IPR (Intelligence Pressure Release) level.
Option: OFF / 1-3 Default: 2
Tube Type
Set the Tube type.
Option: 15 mm / 19 mm Default: 15 mm

iBreeze CPAP Clinical Guide
10
Icon
Text
Description
P Mask Test
Setting the mask fit testing pressure
Setting Range: 6cmH2O-18, 2cmH2O increment
Default: 10 cmH2O
6.5 Clinical System Settings
Select key in the clinical standby interface to enter the clinical system settings interface.
Clinical Settings Interface
Icon
Text
Description
Pressure
Unit
Set the pressure unit.
Option: hPa / cmH2O Default: cmH2O
Screen
Brightness
Adjust the Screen Brightness.
Option: Auto / 1-3 Default: 2
Language
Set the system interface language.
Default: English / Chinese Default: English.
Energy
Saving
Set the Energy Saving function on or off.
When Energy Saving is on, the screen will be turned off
automatically if there is no operation within 3 minutes in standby
mode, or 30 seconds in therapy mode. If Energy Saving is off, the
screen is always on.
Option: ON / OFF Default: ON
Date
Set the system date.
Note:
1. Date setting can’t be earlier than the latest time of the report in
the device.
2. The system date is required to reset on the first time start up
when the device is restored the factory default settings.
Date Format
Set the system date format.
Option: YYYY-MM-DD / MM-DD-YYYY / DD-MM-YYYY Default:
YYYY-MM-DD

iBreeze CPAP Clinical Guide
11
Icon
Text
Description
Time
Set the system time.
Note: time setting can’t be earlier than the latest time of the report
in the device.
Key Tone
Set the switch key tone volume on or off.
Option: ON / OFF Default: OFF
WiFi
Set the WiFi function on or off.
Option: ON / OFF Default: OFF
GPRS
Set the GPRS function on or off.
Option: ON / OFF Default: OFF
Reminder
Set the Reminder type and time. You can turn on or off the different
type of reminders, including: Mask, Filter, Water tank, Tube, Clinic,
Maintenance interval.
Option: ON / OFF Default: OFF
Note:
1. Set the date of reminder, will pop-up reminder box first time to
enter standby mode in the day of setting reminder day.
2. Click OK to change the relevant accessories, and then no longer
remind.
3. Click Ignore, the next day and next starting time will pop-up
reminder box.
Mask Type
Set the Mask type.
Option: Full Face / Nasal / Pillow Default: Nasal
Info Menu
When you set the info menu on, the Clinical Information Interface is
displayed in patient mode.
Option: On / OFF Default: OFF
Factory
Reset
Restores the settings to the factory defaults.
Erase Data
Erase the therapy data on the device.
Service
Display the factory maintain function.
About
Display the device informaiton including system version, serial
number, blower running time etc..

iBreeze CPAP Clinical Guide
12
6.6 Clinical Alert Settings
Select Alert menu in the system settings screen to enter the alert settings menu.
Clinical Alert Settings Interface
#
Feature
Description
1
Leakage high
Alert level: Alert1
Setting leakage high alert
Option: OFF / 15S / 30S / 45S / 60S Default: OFF
Alert limit: Total velocity-base velocity>100L/min, trigger time is
the set time.
2
Mask vent holds
blocked
Alert level: Alert1
Setting Mask vent holds blocked alert
Option: ON / OFF Default: OFF
Alert limit: the actual leak flow is less than 10lpm or 30% of the
expected leak flow at present mask pressure and lasts longer
than 60s.
6.7 Clinical Information Interface
Press information key in clinical standby interface to enter clinical information interface. The
Information Screen provides a summary of the therapy session.
Clinical Information Interface

iBreeze CPAP Clinical Guide
13
#
Parameter
Description
1
Time and date
selection
Users can choose the date of the last 6 days to review the
corresponding date of the device use, also can choose 7 days, 14
days, 1 month, 3 months, 6 months, 1 year to review.
2
AHI
Apnea-Hypopnea Index—average AHI during the selected period.
3
OAI
Obstructive AI—average OAI during the selected period.
4
CAI
Central Apnea Index—average CAI during the selected period
5
AI
Apnea Index—average total AI during the selected period.
6
HI
Hypopnea Index—average HI the selected period.
7
P95
Average inspiratory pressure during the selected period (95th
percentile for each day;
average of 95th percentile values for periods >1 day) pressure
95%
The 95th percentile says that 95% of the time, the variable (eg,
pressure) is at or below this amount. Just the same, during the
remaining 5% of the time, the variable is above that amount.
8
Avg. leak
Avg. Leakage
Average of the 95th percentile values of leak during the selected
period
9
RERA
Respiratory Effort Related Arousals
One day: the average number of RERA events occurred in an
hour of the day used
>= One day: the average of RERA every day
10
SNI
Snore Index
One day: the average number of Snore events occurred in an
hour of the day used
>= One day: the average of SNI every day
11
Total Usage
Total therapy time
12
Days Used
Number of days the device has been used during the selected
period
13
Days>=4hrs
Number of days the device has been used for more than 4 hours
during the selected period
14
Avg.Usage
Average number of hours per day the device has been used
during the selected period.

iBreeze CPAP Clinical Guide
14
7 Therapy Information
To set the therapy mode, click the Therapy Mode button on the clinical standby interface to enter
the therapy mode menu.
Therapy Mode Setting Interface
Uni-Level therapy mode
In Uni-Level therapy mode, the treatment pressures in inspiration and expiration are equal. The
following modes are Uni-level therapy mode: CPAP, CPAP-V, APAP and APAPW.
7.1 CPAP Mode
In CPAP mode, a constant pressure is delivered to the patient throughout the whole therapy.
When E-COMP is enabled, the treatment pressure delivered at the first day is reduced to the
maximum value of 50% of the prescribed pressure and 4 cmH2O, then treatment pressure
increases 1 cmH2O per day, until the prescribed pressure is reached.
CPAP Mode Parameters Setting
#
Parameter
Description
1
Pressure
Set the prescribed pressure throughout the therapy. You can adjust
this setting from 4 to 20 cmH2O. The increment is 0.1/0.5 cmH2O.
2
E-COMP
This feature reduces the therapy pressure setting for the first few days
of operation and gradually increases this setting until the prescription
therapy pressure is reached.
OFF: E-COMP is deactivated.
ON: E-COMP is activated. The initial treatment pressure delivered at
the first day is reduced to the maximum value of 50% of the
prescription pressure, but no lower than 4 cmH2O. After each day of
successful use, the therapy pressure will increase by 1 cmH2O until
the prescription pressure is reached. From that point forward, the
therapy device would operate in normal CPAP mode.

iBreeze CPAP Clinical Guide
15
7.2 CPAP-V Mode
The CPAP-V mode is a combination of CPAP mode and APAP mode with limited trial days,
which is used to titrate the patient. The device operates in APAP mode with R-Care off in the
preset titration time, during which a P95 pressure is generated, when the titration time expires,
the device operates in CPAP mode, with P95 as suggested prescribed pressure.
CPAP-V Mode Parameters Setting
#
Parameter
Description
1
Pmax
This feature sets upper limit of the treatment pressure in titration session.
The device operates in APAP mode during the titration session, thus
treatment pressure is adapted automatically according to the patient’s
conditions. The initial default setting is 12 cmH2O. You can adjust the
setting from the P min setting to 20 cmH2O. The increment is
0.1/0.5cmH2O.
2
Pmin
This feature sets lower limit of the treatment pressure in titration session.
The device operates in APAP mode during the titration session, thus
treatment pressure is adapted automatically according to the patient’s
conditions. The initial default setting is 6 cmH2O. You can adjust the
setting from 4 cmH2O to the P max setting. The increment is
0.1/0.5cmH2O.
3
Titra time
Set the days that the device operates in APAP mode. When the titra time
expires, the device operates in CPAP mode and P95 is applied as the
prescribed pressure. This screen allows you to adjust the duration of the
Auto-Trial feature in number of days. You can set this from 7 to 28 days.
The default is 7 days.
Note: The CPAP-V mode can’t be used more than 28 days.

iBreeze CPAP Clinical Guide
16
7.3 APAP Mode
In APAP mode, the pressures delivered to the patient in both inspiration and expiration are equal.
The treatment pressure is adapted automatically according to the patient’s status, to maintain an
average lower pressure while keeping the upper airway open. A fuzzy adaptive algorithm is
applied to regulate the pressure by detecting four types of sleep disorders, obstructive Apnea,
Hypopnea, Snore and Flow Limitation (refer to chapter 7.5 Events). Within the upper and lower
limitations specified by Pmax and Pmin, the pressure increases and decreases accordingly with
the occurrence and cessation of those events. Refer to Automatically pressure regulation rules
for more information.
If R-Care is enabled, the initial treatment pressure is the P95 pressure of the last 7 days (if the
actual used days are less than seven, P95 of the actual available days are used), otherwise,
Pmin is used as the initial treatment pressure.
APAP Mode Parameters Setting
#
Parameter
Description
1
Pmax
This feature sets upper limit of the treatment pressure. The treatment
pressure is adapted automatically according to the patient’s conditions.
The initial default setting is 12 cmH2O. You can adjust the setting from
the P min setting to 20 cmH2O. The increment is 0.1/0.5cmH2O.
2
Pmin
This feature sets lower limit of the treatment pressure. The treatment
pressure is adapted automatically according to the patient’s conditions.
The initial default setting is 6 cmH2O. You can adjust the setting from 4
cmH2O to the P max setting. The increment is 0.1/0.5cmH2O.
3
R-care
ON: R-Care is activated, the initial treatment pressure is the P95 pressure
of the last 7 days (if the actual used days are less than seven, P95 of the
actual available days are used).
OFF: R-Care is deactivated. The initial treatment pressure is P Min.

iBreeze CPAP Clinical Guide
17
7.4 APAPW Mode
The APAPW (APAP Women) mode is an APAP mode specified for female patients, with
increased sensitivity on sleep disorders detection and moderate pressure regulations compared
with the APAP mode.
The APAPW mode treats apnea and hypopnea up to 15 cmH2O and continues to respond to
snore and flow limitation up to 20 cmH2O.
APAPW Mode Parameters Setting
#
Parameter
Description
1
Pmax
This feature sets upper limit of the treatment pressure. The treatment
pressure is adapted automatically according to the patient’s conditions.
The initial default setting is 12 cmH2O. You can adjust the setting from
the P min setting to 20 cmH2O. The increment is 0.1/0.5cmH2O.
2
Pmin
This feature sets lower limit of the treatment pressure. The treatment
pressure is adapted automatically according to the patient’s conditions.
The initial default setting is 6 cmH2O. You can adjust the setting from 4
cmH2O to the P max setting. The increment is 0.1/0.5cmH2O.
3
R-care
ON: R-Care is activated, the initial treatment pressure is the P95 pressure
of the last 7 days (if the actual used days are less than seven, P95 of the
actual available days are used).
OFF: R-Care is deactivated. The initial treatment pressure is P Min.

iBreeze CPAP Clinical Guide
18
7.5 Events
Automatically pressure regulation rules
The treatment pressure required for the patient to keep the upper airway clear may vary with
body position and sleep state of the patient throughout the night. To avoid uncomfortable feelings
resulting from high-level mask pressure, the adequate treatment pressure is expected to be the
lowest pressure that is enough to keep patency of the upper airway. The device adjusts the
treatment pressure according to the detection of the following several types of sleep events,
apnea, hypopnea, snoring, flow limitation, RERA and periodic breathing. A fuzzy adaptive
algorithm is applied to detect the events mentioned above. Treatment pressure is adjusted based
on the detecting results, as obstructive apnea, hypopnea, snoring and flow limitation lead to
pressure increasing, but the increasing amplitudes get more and more moderate sequentially. No
therapy adjustments are made in response to the other events. Once in normal breathing again,
the treatment pressure reduces gradually.
By the automatic pressure adjustment method mentioned above, the average treatment pressure
resides in a relative lower level, which offers a better therapy compliance. This function is
enabled in APAP, APAPW Mode.
Apnea
Apnea is defined as amplitude of the patient flow reduces to 10% of its corresponding value
when in normal breathing and lasts for over 10 seconds.
Once the device senses a latent apnea, the device delivers a test pulse to identity patency of the
upper airway. If the apnea is confirmed and the airway is clear, then central apnea is reported
and no action is taken. If the airway is obstructed, obstructive apnea is reported and treatment
pressure increases in an adaptive way as soon as breathing efforts detected. The treatment
pressure reduces gradually when in continuous normal breathing.
Hypopnea
Hypopnea is defined as amplitude of the patient flow reduces to 50% of its corresponding value
when in normal breathing and lasts for over 10 seconds.