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RESmart® Auto-CPAP
CLINICIAN’S MANUAL
RESmart® Auto-CPAP
CLINICIAN’S MANUAL
RESmart® Auto-CPAP
Indications for Use
®
CLINICIAN’S MANUAL
Indications for Use
®
The RESmart APAP system is a CPAP (Continuous
Positive
device
The RESmart
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is a CPAP
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designed for the treatment of adult Obstructive
Sleep
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only.
RESmart
has Sleep Apnea (OSA) only. R
designed for the treatment of adult Obstructive
three treatment modes: Auto, Titrate and fixed-pressure
CPAP.
three treatment
modes: Auto, Titrate and fixed-pressure CPAP.
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The RESmart® APAP is to be used only The
on the
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RESmart
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to your health care professional’s prescription.
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Indications for Use
three treatment modes: Auto, Titrate and fixed-pressure CPAP.
® the entire user manual before operating this system. If you have
IMPORTANT!The
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any questions concerning the use of this system, contact
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any
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professional.
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to your health care professional’s prescription.
Contraindications
Contraindications
Several accessories are
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The RESmart AutoCPAP
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3B Medical, Inc.
1142 N. Scenic Highway
Lake Wales, FL 33844 USA
Email: [email protected]
Tel: (863) 226-6285 Fax: (863) 226-6284
continuous therapy.
continuous therapy.
Positive airway pressure therapy may bePositive
contraindicated
in sometherapy
patientsmay
withbethe
airway pressure
contraindicated in some patie
IMPORTANT!
understand
the entire
user manual before operating this system. If you
following pre-existing
conditions: Read and
following
pre-existing
conditions:
• Bullous Lung any
Disease
• Bullous
Diseasecontact your home care provider or health care
questions concerning the
use ofLung
this system,
• Bypassed Upper Airway
•
Bypassed
Upper
Airway
professional.
• Pneumothorax
• Pneumothorax
• Pathologically Low Blood Pressure
• Pathologically Low Blood Pressure
• Pneumocephalus has been reported in a patient
using nasal Continuous
PositiveinAirway
• Pneumocephalus
has been reported
a patient using nasal Continuous Po
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Contraindications
RESmart® AutoCPAP Clinician’s Manual
RESmart® Auto-CPAP
CLINICIAN’S MANUAL
Indications for Use
The RESmart® APAP system is a CPAP (Continuous Positive Airway Pressure) device
designed for the treatment of adult Obstructive Sleep Apnea (OSA) only. RESmart® has
three treatment modes: Auto, Titrate and fixed-pressure CPAP.
The RESmart® APAP is to be used only on the instruction of a licensed health care
professional. Your home care provider will make the correct pressure settings according
to your health care professional’s prescription.
Several accessories are available to make your OSA treatment with the RESmart®
AutoCPAP system as convenient and comfortable as possible. To ensure that you receive
the safe, effective therapy prescribed for you, use only BMC accessories are recommended.
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.
Contraindications
The RESmart® APAP is not a life support device and may stop operating with power
failure or certain fault conditions. It should not be used by patients who are dependent on
continuous therapy.
Positive airway pressure therapy may be contraindicated in some patients with the
following pre-existing conditions:
• 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 be used 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.
Sensitivity
The speed of pressure adjustment can be modified to improve patient comfort.
A lower sensitivity setting corresponds to a more gradual pressure adjustment.
The higher the sensitivity setting the faster the speed of pressure adjustment.
For example, at a Sensitivity setting of 5, the higher the speed of pressure
adjustment (increasing or decreasing). When respirations increases rapidly and
suddenly, as during waking, the treatment pressure decreases rapidly for
patient comfort.
Definitions
Avg. Daily Compliance (H:M):
Average time of patient use of the device in nightly therapy
Average P95 (cmH20):
Auto pressure at or below the pressure 95-percent of that it is in use
Mean Pressure (cmH20):
The mean pressure level, in hPa, delivered within the selected range
AHI:
Apnea/Hypopnea Index (AHI), represents the average number of the apnea and
hypopnea per hour for the timeframe
SNI:
Snore Index (SNI), represents the mean snore count per hour
Adverse Effects
Patients should report unusual chest pain, severe headache or increased breathlessness
to their prescribing physician. An acute upper respiratory tract infection may require
temporary discontinuation of treatment.
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RESmart® AutoCPAP Clinician’s Manual
When treatment
pressure
approaches 10hPa(cmH2O) during rising, not only rising speed
CHANGING
DEVICE
SETTINGS
will decrease greatly but also snore or flow limitation must be detected for increasing
Topressure.
enter theThis
clinician’s
mode an
forinappropriate
the device, remove
thetopower
from the RESmart unit.
is to prevent
response
centralcord
apneas.
Press and hold both the start and ramp buttons simultaneously, while reconnecting the power
Snore
cord. The RESmart unit may now be programmed with therapy options.
When a patient snores, sound is generated and the inspiratory flow/time curve is distorted
®
by may
the step
frequency
theof the
sound.
RESmart
calculates
snore To
level
You
through of
each
options
using thedetects
+ and - and
buttons
on the device.
change
a breath-by-breath.
setting, press the When
ramp button.
your setting
by pressing
ramp than
a second
time.
snore Confirm
sound intensity
exceeds
50% higher
background
noise, then one snoring event is scored. Treatment pressure increases after continuing 3
Setting
options
include:
snores.
The rising
speed is inverse proportion to current pressure, namely the higher
current pressure the lower rising speed.
Mode:
CPAP, Titrate, or Auto
Snore
(SNI),
the mean snore count per hour.
Treat
P:Index set
therepresents
treament pressure
Snore
Level set
is index
for degreetreatment
of patient pressure
snoring. It is the percentage of all breathes with
Max
APAP:
the maximum
Ramp:
Set For
rampexample,
time from20%
starting
pressure
to treatment
in minutes.
snoring event.
means
20 breathe
along pressure,
with snoring
in all 100
breathes. Default time is 10 minutes
Init P:
set the starting ramp pressure. Default setting is 4.5 cmH20
Flow Limitation
Unit:
cmH20 or hPa
Flow
Limitation
is thehours
partialofairway
closure without snore. As the upper airway begins to
Use
time:
Useage
the device
collapse,
Mask
test: the shape of the inspiratory flow/time curve changes and the central section
flattens. RESmart® analyzes the curve shape of each breath and calculates the distortion.
Important:
to save
settings
you must
advance
through all setting
options
untilLimitation
you
Flow Limitation
usually
precedes
snoring
and obstruction.
Detection
of Flow
encounter
the
“Save?”
prompt.
Hit
ramp
to
confirm
settings.
enables the device to increase the pressure before obstruction occurs, making treatment
pre-emptive. This is also the important criterion for obstruction and central apnea.
Hypopnea
A hypopnea is defined as a 60-80% decrease in ventilation. After scores 6 hypopneas
within 3 minutes, treatment pressure will rise.
RESmart® AutoCPAP Clinician’s Manual
The following side effects may arise during the course of therapy with the RESmart®
device:
• Drying of the nose, mouth or throat
• Nosebleed
• Bloating
• Ear or sinus discomfort
• Eye irritation
• Skin rashes
• Chest discomfort.
Auto Mode
The treatment pressure required by the patient may vary through the night, and from night
to night, due to changes in sleep states, body position, and airway resistance. RESmart®
provides only sufficient pressure to maintain upper airway patency.
You can set the initial and maximum allowable treatment pressures. RESmart® analyzes
the state of the patient’s upper airway on a breath-by-breath basis and delivers pressure
within the allowed range according to the degree of obstruction.
Auto Mode improves patient compliance through enhanced algorithm of Auto Mode.
AutoSet algorithm auto-adjusts to maintain optimal therapy pressure. The pressure can
vary from treat pressure (Treat P) to maximum treat pressure (Max APAP), which is
shown as below:
Titrate Mode
For the previous Auto Mode of APAP, after Ramp time, the pressure will increase from
"Init P" to "Treat P". Once respiratory events appear, the treatment pressure increases; if
there is no occurrence of respiratory events, the treatment pressure drops. The pressure
range: the minimum is “Init P” and the maximum is “Max APAP”.
Pressure Adjustment of the Titrate Mode is shown as below:
Pressure change in Titrate Mode
When treatment pressure is rising, if current pressure is lower than Treat P, the rising
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RESmart® Auto Pressure adjusts treatment pressure as a function of four parameters:
Apnea, Snore, Flow Limitation, and Hypopnea.
Apnea
An apnea is defined as a greater than 80% decrease in ventilation. After scores 2 apneas
within 3 minutes, treatment pressure will rise. The rising speed is inverse proportion to
current pressure, namely the higher current pressure the lower rising speed. Treatment
pressure stops rising when normal ventilation and no snore. If ventilation keeps normal for
several minutes, treatment pressure will decrease. The descending speed is direct
proportion to current pressure, namely the higher current pressure the higher descending
speed.
3
RESmart® AutoCPAP Clinician’s Manual
RESmart® AutoCPAP Clinician’s Manual
When treatment pressure approaches 10hPa(cmH2O) during rising, not only rising speed
will decrease greatly but also snore or flow limitation must be detected for increasing
pressure. This is to prevent an inappropriate response to central apneas.
Snore
When a patient snores, sound is generated and the inspiratory flow/time curve is distorted
by the frequency of the sound. RESmart® detects and calculates snore level
breath-by-breath. When snore sound intensity exceeds 50% higher than background
noise, then one snoring event is scored. Treatment pressure increases after continuing 3
snores. The rising speed is inverse proportion to current pressure, namely the higher
current pressure the lower rising speed.
Snore Index (SNI), represents the mean snore count per hour.
Snore Level is index for degree of patient snoring. It is the percentage of all breathes with
snoring event. For example, 20% means 20 breathe along with snoring in all 100
breathes.
Flow Limitation
Flow Limitation is the partial airway closure without snore. As the upper airway begins to
collapse, the shape of the inspiratory flow/time curve changes and the central section
flattens. RESmart® analyzes the curve shape of each breath and calculates the distortion.
Flow Limitation usually precedes snoring and obstruction. Detection of Flow Limitation
enables the device to increase the pressure before obstruction occurs, making treatment
pre-emptive. This is also the important criterion for obstruction and central apnea.
Hypopnea
A hypopnea is defined as a 60-80% decrease in ventilation. After scores 6 hypopneas
within 3 minutes, treatment pressure will rise.
speed is doubled. If current pressure is higher than Treat P, the rising speed is normal (as
Auto mode). Contrarily, when treatment pressure is decreasing, if current pressure is
lower than Treat P, the decreasing speed is normal. If current pressure is higher than
Treat P, the decreasing speed is doubled.
Titrate Mode
For the previous Auto Mode of APAP, after Ramp time, the pressure will increase from
"Init P" to "Treat P". Once respiratory events appear, the treatment pressure increases; if
there is no occurrence of respiratory events, the treatment pressure drops. The pressure
range: the minimum is “Init P” and the maximum is “Max APAP”.
Pressure Adjustment of the Titrate Mode is shown as below:
Pressure change in Titrate Mode
When treatment pressure is rising, if current pressure is lower than Treat P, the rising
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Significance of Auto and Titrate Mode
The Titrate Mode is based on manual titration and its algorithm is sensitive to respiratory
events. Advantages: it can decrease AHI effectively and compute the P95 pressure
accurately. Disadvantages: it has large pressure range, the pressure changing is easy to
cause the patient discomfort.
The APAP combines the Titrate Mode with new Auto Mode to effectively adjust the
pressure for maximum comfort, with the premise of effective treatment. To get a accurate
P95 pressure, Titrate Mode is applicable for the first 1-2 weeks during the use. Based on
the P95 pressure, MAX APAP is determined. It is suggested to set the MAX APAP little
higher(1or 2 cm H2O) than P95 pressure. And based on the Pmean pressure, Treat P is
determined. It is suggested to set the Treat P little lower(1or 2 cm H2O) than Pmean
pressure. It can improve patient’s compliance with more accurate and humane pressure
range.
RESlex®
In Auto mode, you can select expiratory pressure relief (RESlex®). RESlex® is designed to
maintain optimal treatment pressure for the patient during inhalation and reduce the
delivered mask pressure during exhalation. The desired result of RESlex is to decrease
the pressure the patient must breathe out against, making the overall therapy more
comfortable.
The features of RESlex® are:
• RESlex® is disabled automatically in the event of an apnoea.
• RESlex® resumes automatically when the apnoea event has passed.
• You can select a RESlex® pressure drop of 0, 1, 2 or 3 (maximum drop is 3 cm H2O).
• Pressure drop is limited, to avoid sub-optimal treatment.
• When RESlex® is enabled, the delivered pressure will not drop below a minimum
pressure of 4 cm H2O.
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