SleepOne Bilevel ST User manual

SleepOneBilevel ST
User Manual
04.07.2012
Rev.02

2
INDEX
INDEX..........................................................................Error! Bookmark not defined.
SYMBOL DEFINITIONS............................................................................................. 3
IMPORTANT SAFEGUARDS..................................................................................... 3
GENERAL INFORMATION......................................................................................... 4
PARTS AND ACCESSORIES.................................................................................... 5
SYSTEM CONTENT................................................................................................... 5
ACCESSORIES.......................................................................................................... 5
ASSEMBLY OF SLEEPONE DEVICE........................................................................ 6
INSTRUCTION FOR USE.......................................................................................... 7
MAINTENANCE AND CLEANING............................................................................ 12
POSSIBLE PROBLEMS........................................................................................... 13
SPECIFICATION...................................................................................................... 15

3
SYMBOL DEFINITIONS
Class II electrical protection–
double
Type BF equipment–applied
part insulated
Standby –turns the device on or
off
Next Item and adjust the
settings on LCD display
Setting
Previous Item and adjust the
settings on LCD display
Ramp –Starts the ramp function
Heat
IPX1 Drip-Proof
100 –240 Volts AC input 50/60
Hz

Locked

Unlocked
Read user guide before
operating
IMPORTANT SAFEGUARDS
When using electrical products basic safety precautions should always be followed. Read all
instructions that is mentioned to this guide before using this device. Important information is
highlighted by the following items.
Danger
Urgent safety information for hazards that will cause serious injury or death.
Warning
Important safety information for hazards that might cause serious injury.
Caution
Information for preventing damage to the product.
Note
Information to which you should pay special attention.
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING THIS DEVICE.
KEEP THESE INSTRUCTIONS
DANGER
Electrical shock hazard, do not use device while bathing.
Electrical shock hazard, do not immerse this device into water or any other liquid.
Electrical shock hazard, do not attempt to open or remove the case. There are no user
serviceable internal components.
SleepOne should be used only with masks recommended by Kare Medical.
SleepOne is not a life support device and may stop operating with certain device faults or with
a power failure.
To avoid electric shock, alwaysunplug power cord from outlet power source when performing
cleaning.

4
Use only accessories recommended by Kare Medical Ltd Co.
CAUTION–Never rinse or place the device in water. Never allow liquids to get into or
around any of the ports, switches or air filter; doing so will result in device damage. If this
occurs, discontinue use and remove the power cord from the power source. Allow the device
to completely dry before use.
CAUTION–Do not places the SleepOne device where it can be fallen downthe floor or where
the power cord may create a trip hazard.
CAUTION–Oxygen is a prescription gas and should only be administered under the
supervision of a doctor.
GENERAL INFORMATION
SleepOne Bilevel is a device which is intended for use in treating Obstructive Sleep Apnea
(OSA).
Obstructive sleep apnea (OSA) is the most common category of sleep-disordered breathing.
The muscle tone of the body ordinarily relaxes during sleep, and at the level of the throat the
human airway is composed of collapsible walls of soft tissue which can obstruct breathing
during sleep. It can be seen process of OSAon the following diagram.
Cycle of Obstractive Sleep Apnea
Individuals with low muscle tone and soft tissue around the airway (e.g., because of obesity)
and structural functions that give rise to a narrowed airway are at high risk for obstructive
sleep apnea. The elderly are more likely to have OSA than young people. Men are more
typical sleep apnea sufferers than women and children, although it is not uncommon in the
latter two.
Bilevel device is intended to provide noninvasive pressure support for patients with
respiratory insufficiency or obstructive sleep apnea.Device 'splints' the patient's airway open
during sleep by means of a flow of pressurized air into the throat, Device applies Inspiratory
Positive Airway Pressure(IPAP) during inhalation and Expiratory Positive Airway
Pressure(EPAP) during exhalation

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CONTRAINDICATION
Positive airway pressure may be contraindicated in some patients with the following
conditions:
• Pneumothorax or pneumomediastinum
• Pathologically low blood pressure, particularly if associated with intravascular volume
depletion
• Cerebrospinal fl uid leak, recent cranial surgery or trauma
• Severe bullous lung disease
• Dehydration.
SleepOne Bilevel Devices
SleepOne Bilevel device was initially used mainly by patients for the treatment of sleep apnea
at home. Obstructive sleep apneaoccurs when the upper airway becomes narrow as the
muscles relax naturally during sleep. This reduces oxygen in the blood and causes arousal
from sleep. SleepOne BILEVEL device stops this phenomenon by delivering a stream of
compressed air via a hose to a nasal pillow, nose mask or full-face mask, splinting the airway
(keeping it open under air pressure) so that unobstructed breathing becomes possible,
reducing and/or preventing apneas and hypopneas.
PARTS AND ACCESSORIES
SYSTEM CONTENTS
1. Sleep One Device
2. AC Cord
3. Carrying Case
4. Air Supply Tube
5. Standard filter pack(spare)
6. User Manual
ACCESSORIES
1.Heater-Humidifier
2.CPAP Masks

6
Keypad/LCD Display
Air Supply Port on Top
AC Connector
USB Port
Air Inlet Filter
Standby –turns the device on or off
Setting
Ramp –Starts the ramp function
Previous Item and Adjust the Settings on
LCD Display
Next Item and Adjust the Settings on
LCD Display
ASSEMBLY OF SLEEPONE DEVICE
1. Place the SleepOne on a stable surface. Ensure that the air inlet in the back of the device is
not blocked by anything.
NOTE–Never place the SleepOne device on a soft surface.
2. Insert the power cord into the back of the device. Make sure the power cord is fully inserted
into the connector. Plug the other end of the power cord into theAC outlet.
3. Attach the air supply tubing to the air supply interface on the top of the device.
4. Prepare the mask by referring to the mask’s instruction guide.
5. Connect the air supply tubing to the mask.
1
5
4
3
5
4
2
3 1
2

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INSTRUCTION FOR USE
To begin operation, verify that your SleepOne is connected to a ‘power source. When plugged
in, the LCD display should appear as noted.
Off
Put on your CPAP mask and press the ON/OFF button on the keypad to turn on airflow or put
on your CPAP mask and take a few breaths to turn on airflow automatically. If the device does
not automatically start after taking 2-3 breaths, Auto On function may have been disabled. If
Auto ON is disabled, you must manually press the ON/OFF button to start and stop the
device. The pressure in your mask will rise to the set pressure in a while.
The display shows the actual mask pressure while the device is in use. Because this is the
actual pressure, the device pressure reading may vary slightly as you breathe. Your display
should appear as noted.
Bilevel ST
P: 3.0 H: Off
If your SleepOne Bilevel systems include a humidifier, after heater has been enabled from the
menu, heater controls and status are displayed as noted in the image.
Bilevel ST
P: 3.0 H :1
Press the ON/OFF button to turn the device off. You may also simply remove your mask.
After a few seconds the device will display the message “Mask Off” If you do not put the
mask on again the device will automatically turn off after a while. If the device does not turn
off automatically, theAuto Off function may have been disabled. In this case you must
manually turn the device off.
LCD Display
Description
EX - >S bpm: 12
P:5.0 I/E 1:1.0
This is the first real time info screen. In this screen
breath state (EX for exhale, IN for inhale), breath for
minute(bpm), measured mask pressure and I:E ratio is
displayed .
EX - > S leak:30
EV: ** Vol:800
This is the second of the info screens. Upper left of the
screen is the exhalation and inhalation event. (EX is
exhalation, IN is inhalation). Mask leak is shown with
label leak and tidal volume is shown with Vol label. If a
sleep event is observed, it is shown at the down left of
the screen as EV label.

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EPAP
5.0 cmH2O
This is a pressure setting which controls the pressure
during exhale. This setting can not be adjusted by
patient. Only clinicians are authorized to adjust this
level.
IPAP
10.0 cmH2O
This is a pressure setting which controls the pressure
during inhale. This setting can not be adjusted by
patient. Only clinicians are authorized to adjust this
level.
EPAP Rounding
2
This is a setting which controls the comfort rounding
when switching IPAP to EPAP.If menu is unlocked,
press Settings button to activate it . Use the Up and
Down button to adjust the settings .
IPAP Rounding
2
This is a setting which controls the comfort rounding
when switching EPAP to IPAP. If menu is unlocked,
press Settings button to activate it . Use the Up and
Down button to adjust the settings .
Ins. Trigger
5
This is a setting which controls the patient flow during
exhalation to trigger inspiration. If menu is unlocked,
press Settings button to activate it . Use the Up and
Down button to adjust the settings .
Exp. Trigger
%70
This is a setting which controls the patient flow during
inhalation to trigger exhalation. If menu is unlocked,
press Settings button to activate it. Use the Up and
Down button to adjust the settings .
I:E Ratio
1:1.5
(Only ST/T modes) This is a setting which affects the
back up pressure cycle rate. This is the ratio of the
inhale to exhale time and is expressed as I:X. a new
exhale will be triggered by the Bilevel if the patient’s
breathing is slower than this setting, also linked to
Backup Rate.
Ins. Time
1.5 s (1:1.0)
(Only ST/T modes) This setting is used to adjust the
inspiration time, proportional to backup rate. I:E Ratio is
also shown.
Backup Rate
6
This is a setting which affects the backup pressure cycle
rate. A new breath will be triggered if the patient’s
breathing is slower than this setting.

9
Tubing Length
1.8 m
The standard tubing length is 1.8 meters however
customer can adjust tubing length of 3.0 meters. If menu
is unlocked, press Settings button to activate it. Use the
Up and Down button to adjust the settings.
Delay Time
0 minutes
Selectable delay time setting. If menu is unlocked, press
Settings button to activate it. Use the Up and Down
button to adjust the settings.
Delay Pressure
3.0 cmH2o
This is a pressure setting which controls the operating
EPAP during the delay time. If menu is unlocked, press
Settings button to activate it. Use the Up and Down
button to adjust the settings.
Auto On
Disabled
This option controls the Auto-ON function, which
automatically starts the flow of air after breathing once
or twice into the mask. If menu is unlocked, press
Settings button to activate it. Use the Up and Down
button to adjust the settings.
Auto Off
Disabled
This option controls the Auto-OFF function, which
automatically stops the flow of air after taking off the
mask. If menu is unlocked, press Settings button to
activate it. Use the Up and Down button to adjust the
settings.
Firmware
5.0.0
Shows version of installed firmware.
Heater
Disabled
This option controls the Heater functions if the heater.
To Activate the Heater Menu, press Settings button. Use
the Up and Down button to adjust the settings.
Serial
DB10-0000
Shows the serial number of the device
Set Pressure
3.0 cmH2O
This is a pressure setting which controls the operating
pressure in CPAP mode.
The following chart shows each Display you will scroll through using the Up or Down

10
buttons after pressing the Settings button on the keypad. Once the final Display is reached,
pressing the Next button will return you to the first Display.
Locks are setted by clinicians before patients start therapy. If the menu is unlocked , patient
can edit some settings according to their comfort.
Menu Display
Adjusting Display
Bilevel ST
P: 3.0 cmH2O H:OFF
EX - >S bpm: 12
P:5.0 I/E 1:1.0
EX - > S leak:30
EV: ** Vol:800
EPAP
5.0 cmH2O
EPAP Rounding
Bilevel S,
ST and T
Mode
EPAP Rounding
2
2 
IPAP Rounding
Bilevel S,
ST and T
Modes
IPAP Rounding
2
2 
Ins. Trigger
Bilevel
Mode
Ins. Trigger
5
5 
Exp. Trigger
Bilevel ST
and T Modes
Exp. Trigger
%80
%80 
IPAP
10 cmH2O

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I:E Ratio
1:1.5
Ins Time
1.5s (1:1.0)
Bilevel ST and T Modes
Backup Rate
6
Tubing Length
Tubing Length
1.8 m
1.8 m 
Delay Time
Delay Time
0 minutes
0 minutes 
Delay Pressure
Delay Pressure
3.0 cmH2O
3.0 cmH2O 
Auto On
Auto On
Disabled
Disabled/Enabled 
Auto Off
Auto Off
Disabled
Disabled/Enabled 
Firmware
1.0 07/07/2011
Heater
Heater
Disabled
Disabled/Enabled 
Serial
DB10-0000

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Set Pressure
Set Pressure
3.0 cmH2O
3.0 cmH2O 
PATIENT MESSAGES
Delay Running
5 Minutes Left
While Ramp Mode is active, this message is
display every 5 minutes to let you know how
much time is left in the delay.
Mask Off
This message appears whenever a high
airflow condition occurs. High airflow is
normally due to a poor mask fit or a removed
mask. If the high airflow condition persists
for about 30 seconds, the device will
automatically turn off (if AutoOFF function
is enabled).
Error
E00
If a device error message is displayed, refer
to POSSIBLE PROBLEMS AND HOW TO
SOLVE THEM for instructions.
Check Mask Fit
The leak of your mask is calculated
simultaneously and if the amount of leak
exceeds 200 liters/minute for more than 3
times , this notification is displayed on the
screen unless the mask is properly fitted to
your face.
MAINTENANCE AND CLEANING
DANGER
Electric shock hazard –Do not attempt to open or remove the case; there are no user-
serviceable components inside. If service is required, contact your provider.
WARNING
If the operation of the device appears to get out of normal operation or begins to be heard
unusual sounds, do not continue to use device and contact your provider company.
If the device has been fallen down, verify functionality of the device. If the device does not
function or the case is damaged, do not continue to use device and contact your provider
company.
If the device does not appear to be functioning properly refer to the possible problems and
how to solve themsection for instructions.
Standard Air-Inlet Filter–Check the filter every 10 days and clean it if necessary. Replace the
filter every 6 months or sooner if it is damaged.
CAUTION–Never rinse or place the device in water. Never allow liquids to get into or
around any of the ports, switches or air filter. If this occurs, do not use the device. Contact
your provider company for service.

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Device Case Cleaning
1. Unplug the SleepOne from the power source. Use a clean dry cloth and mild detergents for
cleaning the unit.
2. Allow the device to dry completely before plugging it into a power source.
Filter Cleaning
Air-Inlet Filter (Standard)
1. The air-inlet filter should be checked every 10 days and cleaned as necessary. The filter is
located in the rear of the device.
CAUTION–Proper filter function is important for the operation of the device and to protect
the device from damage.
2. To clean, remove filter from the frame.
3. Wash the filter in a solution of warm water and mild detergent, and rinse with water. Allow
the filter to dry completely. If the filter is damaged, contact your provider company for a
replacement.
4. Ensure the filter is completely dry before installation and use.
Tubing
The air supply tubing should be cleaned daily. Remove the tubing from the device and mask.
Use a mild detergent and water to clean the inside of the tubing. Rinse the tubing and allow to
air dry.
POSSIBLE PROBLEMSAND HOW TO SOLVE THEM
If you are having problem with the operation of your SleepOne , please refer to the table
below for a list of problems with possible reasons and solutions. If you are unable to resolve
the problem by following, contact your provider.
Possible Problem
Reason
Solution
Display shows
nothing.
1. Device is not
plugged in or the
power cord is not
firmly fitted to
outlet power.
2. There is no outlet
power.
1. Ensure that power cord is firmly fitted to the
SleepOne and the power outlet.
2. Ensure outlet power is live
SleepOne does not
start when breathing
into the mask.
1. The Auto-ON
function has been
disabled.
2. There is no
power to the device.
3. Breath is not
deep enough for the
Auto-ON function
to detect.
4. The air supply
1. Use the ON/OFF button to start and stop the
device.
2. Ensure that power cord is firmly fitted to the
SleepOne and the power outlet.
3. Breathe deeper to start the SleepOne.
4. Make sure the air supply port plug is firmly
fitted into the unit.

14
port plug is missing
or not firmly fitted.
5. The humidifier
chamber is not fully
engaged into the
cradle or is missing.
5. Slide the humidifier chamber fully into the
slot.
The airflow has
stopped suddenly
during use.
1. The Auto-OFF
function has
detected large
airflow because of
wrong placed mask.
2. During use you
may breathe by
mouth.
1. Ensure you have a good mask fit; adjust the
mask and headgear as needed.
2. Contact your provider company for a chin
strap or different mask which will help prevent
mouth breathing.
If problem is not resolved with above
solutions, disable Auto-OFF function.
The display shows
an error.
An error has
occurred in the
device and requires
servicing.
Contact your provider company for service.
Symptoms of OSA
have recurred.
1. Air filter may be
obstructed.
2. Sleep apnea
condition has
changed.
1. Clean or replace the air filter and change the
location of device against drapes and other
dusty surfaces.
2. Contact your doctor.
Dryness of throat or
nose.
Inadequate
humidity.
1. Add Heated Humidifier.
2. Increase the heater setting on the humidifier.
Condensation of
water is collecting
in the hose causing
a gurgling noise.
1.Your
humidification
setting is too high.
2.The room
temperature
fluctuates from
higher to lower
levels through the
night.
Reduce the humidifier heater setting and/or
increase the temperature of the room.
Air from flow
generator seems to
be too warm.
1. The air filter(s)
is/are dirty.
2. The air inlet port
is blocked.
3. The room
temperature is too
high.
4. The SleepOne is
located near a heat
1. Refer to the filter cleaning section for
instructions on filter maintenance.
2. Unblock the air inlet.
3. Decrease the room temperature.
4. Locate the device away from the heat source
so the air being drawn into the device is at
room temperature.
If the problem persists contact your provider
company.

15
source.
Nasal, sinus or ear
pain, possibly with
runny nose.
You may have a
reaction to air flow
pressure.
Do not continue to use and contact your doctor.
SPECIFICATIONS
Size............................................................................................. 18.1 x 15.5 x 11.7 cm
Weight................................................................................................................. 1.25kg
Electrical Requirements.......................................................................... 100-230 V AC
Maximum Power Consumption..............................................................................50W
Pressure Range........................................................................................3-35 cm H2O
Operating Temperature Range..................................................................5°C to 40°C
Operating Humidity Range.....................................................................0% to 95% RH
Sound Level (tested per ISO 17510)..................................................................<30dB
Manufacturer: KARE MEDICAL LTD. CO.
Adress: Ziya Gokalp Cad. 36/23 Yenisehir
Ankara/TURKEY
Ph: [phone]
Fax: [phone]
e-mail: [email protected]
web: www.karemedical.eu
1984