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Sleep One Auto CPAP System User Manual

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1. 60 Snore Sensivity To activate the function press Settings button and then use the Up and Down button to Low adjust the settings Range Low High Exit Menu To exit to patient menu press Settings button The following chart shows each Display you will scroll through using the Up or Down 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 or press Settings button to return Patien Menu Sleep One CPAP 1 P 3 0 cmH20 l Language English Pressure Unit cmH20 14 Tubingh Length 1 8m Auto Lock Disabled Delay Lock Disabled l Compliance Hour 0 Hours Hour Meter 0 Hours Apnea 10 Apnea Duration 10 sec HypoAp 50 15 HypoAp Duration 10 sec Serial DA10 CA00000 LCD Light 20 Snore Sensivity Low Exit Menu 20 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
2. 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 them section for instructions 16 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 f this occurs do not use the device Contact your provider company for service 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 filler 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 a
3. 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 1 An error has occurred in the device and requires servicing 1 Contact your provider company for service 18 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 1 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 source 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 b
4. CE Sleep One Auto CPAP System User Manual EN ISO 9001 2008 OQ EN ISO 13485 2003 i Issue date 02 01 2010 rev00 INDEX INDEX SYMBOL DEFINITIONS IMPORTANT SAFEGUARDS GENERAL INFORMATION PARTS AND ACCESSORIES SYSTEM CONTENTS ACCESSORIES ASSEMBLY OF SLEEPONE DEVICE INSTRUCTION FOR USE MAINTENANCE AND CLEANING POSSIBLE PROBLEMS AND HOW TO SOLVE THEM SPECIFICATIONS o OO 0 Da W N N 00 O D SYMBOL DEFINITIONS Class Il electrical Type BF equipment protection double applied part insulated Next Item and adjust the settings on LCD display Standby turns the device on or off a 5 Previous Item and adjust the settings on Go Settings O LCD display g Ramp Starts the gt p A ramp function pea 100 240 Volts AC IPX1 ASEE C input 50 60 Hz 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 DANG
5. ER 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 always unplug 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 down the 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 is a CPAP 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 i
6. e mask To activate the Auto Off Disabled Menu press Settings button Use the Up and Down button to adjust the settings Firmware Shows version of installed firmware USB MODE To Activate the USB Mode press Settings button Use the Up and Down button to adjust Disabled the settings This option controls the Heater functions if the Heater heater To Activate the Heater Menu press Disabled Settings button Use the Up and Down button to adjust the settings The following chart shows each Display you will scroll through using the Up or Down 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 Sleep One CPAP P 3 0 cmH20 1 Upper Limit 15 0 cmH20 Lower Limit 5 0 cmH20 10 Delay Time 0 minutes Delay Pressure 3 0 cmH20 Auto On Disabled Auto Off Disabled Firmware 1 0 01 02 2010 USB MODE Enabled Heater Disabled 11 Clinical Menu Control To activate the Clinical Menu first press the Down Button While holding the Down button press Standby button Use the Up and Down button to adjust the settings Sleep One CPAP This is the default screen for SleepOne CPAP System The actual mask pressure and P 3 0 cmH20 Z heater setting are
7. eing drawn into the device is at room temperature If the problem persists contact your provider company Nasal sinus or ear pain possibly with runny nose 1 You may have a reaction to air flow pressure 1 Do not continue to use and contact your doctor 19 SPECIFICATIONS ZO e eras ns detecte n 18 1 x 15 5x 11 7 cm L EST o A RE SR lara iii 1 20kg Electrical Requirements 100 230 V AC Maximum Power Consumption errar 50W Pressure Range aaa ii 3 20 cm H20 Operating Temperature Range 5 C to 40 C Operating Humidity Range 0 to 95 RH Sound Level tested per ISO 17510 a lt 29dB Equipment classification protection from electric shock Class Il Degree of protection from electric shock Type BF Applied Part Degree of protection against ingress of liquids ii IPX1 Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Mode of operation Continuous Manufacturer KARE MEDICAL LTD CO Address Ziya Gokalp Cad 36 23 06420 Yenisehir Ankara Turkey Phone 90 312 435 08 18 Fax 90 312 435 83 08 e mail export kare ltd com www karemedical eu 20
8. elax naturally during sleep This reduces oxygen in the blood and causes arousal from sleep SleepOne CPAP 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 AC Cord Carrying Case Air Supply Tube User Manual MELO D ACCESSORIES 1 Heater Humidifier 2 CPAP Masks 1 Keypad LCD Display 2 Air Supply Port on Top 3 AC Connector 4 USB Port 5 Air Inlet Filter 3 4 1 Standby turns the device on or off 2 Settings 3 Ramp Starts the ramp function 4 Previous ltem and Adjust the Settings on LCD Display 5 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 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 ai
9. ion The absolute values below which the respirotory flow must fall to be considered as Apnea an apnea To activate the function press 10 Settings button and then use the Up and Down button to adjust the settings Range 0 20 increments of 5 Apnea Duration 10 sec The number of seconds the respiratory flow must remain below the apnea percent to be detected as an apnea To activate the function press Settings button and then use the Up and Down button to adjust the settings Range 6 150 sec increments of 2 HypoAp 50 The percent which the respiratory flow must fall from its normal value to be considered as a hypopnea To activate the function press Settings button and then use the Up and Down button to adjust the settings Range 30 70 increments of 5 HypoAp Duration 10 sec The number of seconds the respiratory flow must remain below the hypopnea percent to be detected as an hypopnea To activate the function press Settings button and then use the Up and Down button to adjust the settings Range 6 150 sec increments of 2 13 Serial Shows the serial number of the device DA10 CA00000 This setting changes the duration of LCD LCD Light display light To activate the function press Settings button and then use the Up and 20 Down button to adjust the settings 20 40
10. l This is the default screen for SleepOne CPAP System The actual mask pressure and heater setting are shown To reach menu items press to Settings button once Sleep One Auto P 3 0 cmH20 W This is a setting which limits the maximum pressure at which the Sleep One will operate if in Auto mode To activate the Upper Limit Upper Limit Menu first press the Ramp button While 15 0 cmH20 holding the Ramp button press Settings button Use the Up and Down button to adjust the settings This is a setting which limits the minimum pressure at which the Sleep One will operate if in Auto mode To activate the Lower Limit Lower Limit Menu first press the Ramp button While 5 0 cmH20 holding the Ramp button press Settings button Use the Up and Down button to adjust the settings 1 Selectable delay time setting To activate the Delay Time Delay Time Menu press Settings button Use 0 minutes the Up and Down button to adjust the settings This option controls the Auto ON function which automatically starts the flow of air after Auto On breathing once or twice into the mask To Disabled activate the Auto On Menu press Settings button 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 1 0 01 02 2010 Auto Off taking off th
11. nd 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 17 POSSIBLE PROBLEMS AND HOW TO SOLVE THEM 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 port plug is missing or not firmly fitted 5 The humidifier chamber is not fully engaged into the cradle or is missing 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 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
12. r supply tubing to the mask 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 Sleep One Auto P 3 0 cmH20 If your SleepOne CPAP system includes a humidifier its heater controls and status are displayed as noted in the image Sleep One Auto 1 P 3 0 cmH20 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 the Auto Off function may have been disabled In this case you must manually turn the device off Patient Menu Contro
13. s 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 sleep Onset Disrupted Snoring 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 The most common treatment for sleep apnea is the use of a continuous positive airway pressure CPAP device which splints the patient s airway open during sleep by means of a flow of pressurized air into the throat 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 e Dehydration SleepOne CPAP Device SleepOne continuous positive airway pressure CPAP device was initially used mainly by patients for the treatment of sleep apnea at home Obstructive sleep apnea occurs when the upper airway becomes narrow as the muscles r
14. shown To reach menu items press to Settings button once This function is used for selecting preferred Language language To activate the function press English Settings button and then use the Up and Down button to select preferred language Pressure Unit cmH20 This function is used for selecting preferred pressure unit To activate the function press Settings button and then use the Up and Down button to select preferred pressured unit cmH20 mbar hPa Tubingh Length 18m By this function you can adjust air supply tubing length of Sleep One device The standard tubing length supplied with the device is 1 8 meters To activate the function press Settings button and then use the Up and Down button to select preferred air supply tubing length 1 8 m 3 m This function is used for locking the Auto Off Auto Lock and Auto On feature To activate the function Disabled press Settings button and then use the Up and Down button to adjust the settings This function is used for lock the Delay Delay Lock feature To activate the function press Disabled Settings button and then use the Up and Down button to adjust the settings 12 Compliance Hour The total number of hours that the Sleep One has been providing therapy 0 Hours Hour Meter The total number of hours that the Sleep One 0 Hours has been in operat

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