SleepOneBilevel ST User Manual
Contents
1. 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 ZN 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 1s 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 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 1s intended for use in treating Obstructive Sleep A2. temperature is too high 4 The SleepOne is located near a heat Condensation of water is collecting in the hose causing a gurgling noise Air from flow generator seems to be too warm 5 Slide the humidifier chamber fully into the slot 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 Contact your provider company for service 1 Clean or replace the air filter and change the location of device against drapes and other dusty surfaces 2 Contact your doctor 1 Add Heated Humidifier 2 Increase the heater setting on the humidifier Reduce the humidifier heater setting and or increase the temperature of the room 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 14 SOUTCE Nasal sinus or ear You may have a Do not continue to use and contact your doctor pain possibly with reaction to air flow runny nose pressure SPECIFICATIONS PP e e io UB A 18 1 x 15 5 x 11 7 cm OO O AA 1 25kg Electrical R QUIF ME NIS 22 ae en er 100
3. 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 the AC 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 INSTRUCTION FOR USE To begin operation verify that your SleepOne 1s 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 Afte
4. 230 V AC Maximum Power Consumption sise 50W o o o censteetncan vere seen 3 35 cm H20 Operating Temperature Range 5 to 40 C Operating Humidity Range Rs 0 to 95 RH Sound Level tested per ISO 17510 lt 30dB Manufacturer KARE MEDICAL LTD CO Adress Ziya Gokalp Cad 36 23 Yenisehir Ankara TURKEY 1984 Ph 90 312 435 08 18 Fax 90 312 435 83 08 e mail export kare ltd com web www karemedical eu 15
5. SleepOneBilevel ST Bilevel ST TIVIVE AIR BILEVEL POSTI WAY PRESSURE DEVICE 2 Q User Manual 04 07 2012 Rev 02 INDIE rn Error Bookmark not defined SMS DEANTMNON Sandia dad 3 IMPORTANT SAFEGUARDS ene nn NN ee 3 GENERALINFORMATIONS 22 nn nn ils mienne 4 PARTS AND ACCESSORIES ER RL dida datada dde 5 So TEN CONTENT ER nd a ne a Da a ai 5 ASE a a ee nt 5 ASSEMBLY OF SLEEPONE DEVICE usara aa 6 INSTRUCTION FOR USE scort iia 7 MAINTENANCE AND CLEANING osieiiciiieciaiaiieniciiedadiiadialdadeiadieidi 12 ROSS LEPROBPENM anre Osa 13 SPECIFIC ATIONS En 15 SYMBOL DEFINITIONS Class IT electrical protection double Standby turns the device on or Type BF equipment applied part insulated Next Item and adjust the sa O off settings on LCD display Settin Previous Item and adjust the E AA settings on LCD display gt Ramp Starts the ramp function Heat IPX1 Drip Proof o a 240 Volts AC input 50 60 Locked Unlocked Read user guide before operating gt e 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
6. Up and Down button to adjust the settings 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 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 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 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 Only ST T modes This setting is used to adjust the inspiration time proportional to backup rate I E Ratio is also shown 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 Tubing Length 1 8m Delay Time 0 minutes Delay Pressure 3 0 cmH20 Auto On Disabled Auto Off Disabled Firmware 5 0 0 Heater Disabled Serial DB10 0000 Set Pressure 3 0 cmH20 The standard tubing length 1s 1 8 meters how
7. ever customer can adjust tubing length of 3 0 meters If menu 1s unlocked press Settings button to activate 1t Use the Up and Down button to adjust the settings Selectable delay time setting If menu 1s unlocked press Settings button to activate 1t Use the Up and Down button to adjust the settings This 1s a pressure setting which controls the operating EPAP during the delay time If menu is unlocked press Settings button to activate 1t Use the Up and Down button to adjust the settings 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 1t Use the Up and Down button to adjust the settings 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 1t Use the Up and Down button to adjust the settings Shows version of installed firmware This option controls the Heater functions 1f the heater To Activate the Heater Menu press Settings button Use the Up and Down button to adjust the settings Shows the serial number of the device This 1s 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 9 buttons after pressing the Settings button on the keypad Once the final Display 1
8. for about 30 seconds the device will automatically turn off Gf AutoOFF function is enabled If a device error message is displayed refer to POSSIBLE PROBLEMS AND HOW TO SOLVE THEM for instructions The leak of your mask is calculated simultaneously and if the amount of leak exceeds 200 liters minute for more than 3 ones Masi rt times this notification is displayed on the screen unless the mask is properly fitted to your face MAINTENANCE AND CLEANING Error EO 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 d
9. o not use the device Contact your provider company for service 12 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 PROBLEMS AND 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 1 Device is not 1 Ensure that power cord is firmly fitted t
10. o the plugged in or the SleepOne and the power outlet power cord is not firmly fitted to 2 Ensure outlet power is live outlet power 2 There is no outlet power 1 The Auto ON 1 Use the ON OFF button to start and stop the function has been device disabled 2 Ensure that power cord is firmly fitted to the 2 There is no SleepOne and the power outlet power to the device 3 Breathe deeper to start the SleepOne 3 Breath is not 4 Make sure the air supply port plug is firmly deep enough for the fitted into the unit Auto ON function to detect 4 The air supply Display shows nothing SleepOne does not start when breathing into the mask 13 port plug is missing or not firmly fitted 5 The humidifier chamber 1s not fully engaged into the cradle or is missing 1 The Auto OFF function has detected large airflow because of wrong placed mask 2 During use you may breathe by mouth The airflow has stopped suddenly during use An error has occurred in the device and requires servicing 1 Air filter may be obstructed 2 Sleep apnea condition has changed The display shows an error Symptoms of OSA have recurred Dryness of throat or Inadequate nose humidity 1 Your humidification setting is too high 2 The room temperature fluctuates from higher to lower levels through the night 1 The air filter s is are dirty 2 The air inlet port is blocked 3 The room
11. pnea 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 OSA on the following diagram Sleep SIeer Disrupted Popes nf Breating Airway Stops Collapses 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 CONTRAINDICATION Positive airway pressure may be contraindicated in some patients with the following conditions e Pneumothorax or pneumomediastinum e Pathologically low blood pressure particularly if associated with intravascular
12. r 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 the Auto Off function may have been disabled In this case you must manually turn the device off This 1s the first real time info screen In this screen bpm 12 breath state EX for exhale IN for inhale breath for VE 1 10 minute bpm measured mask pressure and I E ratio is displayed This 1s the second of the info screens Upper left of the screen 1s 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 EPAP 5 0 cmH20 IPAP 10 0 cmH20 EPAP Rounding 2 IPAP Rounding 2 Ins Trigger 5 Exp Trigger Yo 70 l E Ratio 1 1 5 1 5 s 1 1 0 Backup Rate 6 This 1s 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 This 1s 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 This 1s a setting which controls the comfort rounding when switching IPAP to EPAP If menu is unlocked press Settings button to activate it Use the
13. s 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 cmH20 H OFF EX gt S bpm 12 P 5 0 VE 1 1 0 EX gt S leak 30 EV Vol 800 EPAP 5 0 cmH20 IPAP 10 cmH20 Bilevel S EPAP Rounding STandT EPAP Rounding Mode 2 2 Bilevel S IPAP Rounding STandT IPAP Rounding Modes 2 2 Bilevel Ins Trigger Meda Ins Trigger 5 5 Bilevel ST Exp Trigger TAMOS Exp Trigger 080 080 10 lE Ratio 1 1 5 Ins Time 1 5s 1 1 0 Bilevel ST and T Modes Backup Rate Tubing Length 1 8m Delay Time O minutes Delay Pressure 3 0 cmH20 Auto On Disabled Auto Off Disabled Firmware 1 0 07 07 2011 Heater Disabled Serial DB10 0000 Tubing Length 1 8m Delay Time 0 minutes Delay Pressure 3 0 cmH20 Disabled Enabled Auto Off Disabled Enabled Heater Disabled Enabled 11 Set Pressure Set Pressure 3 0 cmH20 3 0 cmH20 PATIENT MESSAGES Delay Running While Ramp Mode is active this message is display every 5 minutes to let you know how 9 Minutes Left much time is left in the delay This message appears whenever a high airflow condition occurs High airflow is Mask Off normally due to a poor mask fit or a removed mask If the high airflow condition persists
14. volume depletion e Cerebrospinal fl uid leak recent cranial surgery or trauma e Severe bullous lung disease e 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 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 ltem 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
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