iSleep 20+ - CPAP Australia
Contents
1. 131 The HA 01 humidifier has been discon nected when the Sleep 20 was running Always turn of the Sleep 20 before disconnecting the HA 01 humidifier 34 Indications Sleep 20 users manual Doc 004270 En Eu T 3b ITEM DESCRIPTION The leakage has been too high during the night for an accumulated time longer than 30 minutes Check the mask fitting Error code 133 Low humidifier temperature Check humidifier Ok 133 Low humidifier temperature Check that the humidifier is connected correctly this error is shown after the treatment session If the error remains contact your care provider 134 High humidifier temperature Turn off the iSleep 20 Disconnect the humidifier and recon nect it If the error remains contact your cate pro vider Action The iSleep 20 will continue or stop the treat ment depending on the type and priority of the event Indication The indication is asserted audible with a tone and visible by a display message Reset If possible correct the error cause and disconnect and connect the mains power source If the error remains contact your care provider Indications 35 Doc 004270 En Eu T 3b Sleep 20 users manual 9 Cleaning the Sleep 20 and Replacing the Fil ters The patient connected parts and the filter must be cleaned and replaced regu larly to ensure correct function of the Sleep 202. i i Humidifi e Device settings umiainer function e Device information Humidity level L Always start with ramp e Memory card standby only 22 Using the iSleep 20 iSleep 20 users manual Doc 004270 En Eu T 3b Icons in the Display Window ICON EXPLANATION The Sleep 20 is operating Wake up alarm 1 31 A A Humidity 5 ail Ramp B El Panel lock Panel lock 5 4 Using the integrated Humidifier A Read the chapter Usage of the HA 01 Humidifier on page 12 carefully to make sure all conditions are fulfilled and considered The humidifier is intended to humidify the patient air The humidifier must be installed in order to access this setting since it is applicable for humidifier navi gation in both clinical and home mode A full humidifier will be able to humidify the air for about 11 hours with the fol lowing settings and conditions SETTING VALUE Humidifier setting 5 CPAP pressure 10 cmH O Ambient temperature 20 C 68 F Leakage 20 1 min Altitude Sea level Using the iSleep 20 23 Doc 004270 En Eu T 3b Sleep 20 users manual 24 At the main menu choose Humid ity to navigate to the humidifier sec tion The humidity setting range from Off 1 to 9 where 9 generates the maximum humidity Always set the humidity control to the setting recommended by your doctor Adding Water to the Humidifier Humidifier e
3. Ventilate the room adequately Do not smoke in a room where oxygen is being used Naked light bulbs and other sources of ignition must be kept a minimum of 2 metres away from the oxygen cylinder or any part of the patient circuit Do not use aerosols or solvents close to the oxygen supply even when the oxygen supply is shut off Safety Information iSleep 20 users manual 13 3 Product Description 3 1 Main Components The Sleep 20 system contains the following components WU Eni Pn Wy PTL TC 14 Product Description iSleep 20 users manual Doc 004270 En Eu T 3b No COMPONENT FUNCTION PART NO 1 Carrying bag Storage for transportation 003793 Ze Users manual Product and usage information 004270 3 Patient tube Tube for mask and iSleep 20 000245 4 iSleep power supply 003773 5 Mains power cord 003723 6 HA 01 Humidifier Patient air humidification 003530 T Rear lid Usage without HA 01 Humidi 003591 fier 8 Filter white disposa Inlet air filtration 003762 ble optional 9 Filter grey washable Inlet air filtration 003693 10 iSleep 20 main unit Included in the iSleep 20 basic package Product Description 15 Doc 004270 En Eu T 3b Sleep 20 users manual 3 2 The Sleep 20 s Front Panel Sleep 20 2 No USER BUTTONS AND DISPLAYS FUNCTION 1 Start Stop Main unit On Off 2 Display window Mode and setti
4. nents and ordered accessories have been delivered refer to the packing note or the invoice Y if available 2 Ensure that the equipment is in good condition 3 Check that the mandatory Y grey patient air filter is installed 28 Preparing the iSleep 20 for Use iSleep 20 users manual Doc 004270 En Eu T 3b 6 2 Placing the iSleep 20 Read the chapter Environmental Conditions on page 9 carefully to make sure all conditions are fulfilled and considered 1 Place the iSleep 20 on a solid flat surface The Sleep 20 should be placed lower than the patient in order to prevent the device from fall ing on the user 2 Make sure that nothing can block the patient air inlet at the side of the iSleep 20 Connecting the iSleep 20 to the Mains Supply Read the chapter Electrical Safety on page 8 carefully to make sure all conditions are fulfilled and considered Be To Connect the Sleep 20 to the Mains Supply 1 Plug the power supply into the power inlet of the Sleep 20 2 Connect the power cord into the power supply lt y Preparing the iSleep 20 for Use 29 Doc 004270 En Eu T 3b Sleep 20 users manual 3 Connect the power cord to the mains supply KE 6 4 Connecting the Patient Circuit WN Read the chapter Usage of Patient Circuit on page 10 carefully to make sure all conditions are fulfilled and considered
5. 1 Connect the patient tube to the air outlet 2 Connect the other end of the patient tube to the mask and the ventilation valve if applicable Mask Leakage The leakage from the mask should be at least 12 1 min at 4 cmH 0O to prevent re breathing of exhaled air The recommended mask leakage is 20 40 1 min at 10 cmH O pressure This leakage may be achieved by e small holes in the mask e an adjoining ventilation valve i In order to receive a suitable leakage the Breas iMask Nasal CPAP Mask is recommended 30 Preparing the iSleep 20 for Use iSleep 20 users manual Doc 004270 En Eu T 3b 7 Setting up the Sleep 20 The configuration of the iSleep 20 therapy settings must always be pre scribed by a licensed physician and carried out by an authorized health care professional For more information about the Breas Sleep 20 3 settings please contact your care provider 7 1 Settings Applicable for iSleep 20 SETTING RANGE RESOLUTION Ramp time 5 to 60 min 5 min Humidifier Off 1 to 9 1 R The operation modes and setting parameters are described in detail in the chapter Functions and Parameters of the iSleep 20 on page 19 7 2 Setting the Parameters For more information about how to use the menu please read the chapter Using L the Menu on page 22 Study the overview picture in Using the Menu on page 22 if a page or section can not be found The Ramp function Setting range
6. All replaced parts must be dis posed of in accordance with local environmental regulations regarding the disposal of used equipment and waste 9 1 Cleaning the Sleep 20 IN To avoid electrical shock disconnect the mains supply to the iSleep 20 before cleaning Do not immerse the Sleep 20 into any fluids o e Always be careful when cleaning to ensure that you do not damage any equipment Fluid must not be allowed to enter into the Sleep 20 Main Unit 1 Switch off the Sleep 20 and dis connect the mains supply ME 2 Remove the patient circuit AND 36 Cleaning the iSleep 20 and Replacing the Filters iSleep 20 users manual Doc 004270 En Eu T 3b 3 Detach the tear lid or the humidi fier 4 Disconnect the cable 5 Clean the outside of the iSleep 20 using a lint free cloth and a mild detergent solution 6 Reconnect the cable and the patient circuit Make sure all parts are dry before the iSleep 20 is put into opera tion HA 01 Humidifier The HA 01 humidifier must be cleaned regularly Information on cleaning the HA 01 humidifier can be found in the Breas HA 01 humidifier User Manual The HA 01 humidifier shall be replaced in intervals according to the care pro vider s instructions Also check the HA 01 humidifier for damage regularly In case Of damage replace the HA 01 humidifier Patient Circuit g The patient circuit should be cleaned in accordance with the care prov
7. 40 10 3 A en a er a NO Pee ere tere Ceres Perr ere rete ee 40 10 4 PSO Seale sca tt Se A E cea dant ecas tetas tase O hesenaeeset ean cs 40 11 Technical Specific as aia 41 11 1 Data aaa AA is 41 A A AN 43 12 1 Breas Accessories List concisa SREE 43 13 Patent Settings st o has 44 2 Table of Contents Sleep 20 users manual Doc 004270 En Eu T 3b 1 Intended Use of the iSleep 20 WARNING iSleep 20 must only be used For the intended treatment in accordance with this manual and with the instructions given by the responsible clinical personnel e In accordance with the operating conditions specified in this manual e In original and unmodified shape and only with accessories spec ified or approved by Breas Medical AB Every other use may lead to risk of personal injury CAUTION Read this manual thoroughly so that you completely understand how the iSleep 20 is operated and maintained before taking it into use to ensure correct usage maximum performance and serviceability WARNING Do not use the iSleep 20 for any kind of life support treatment h Breas Medical AB reserves the right to make changes to this product without any prior notification 1 1 What is the Sleep 20 The Sleep 20 is a CPAP system that provides a continuous positive airway pressure This can prevent the user s upper airways from collapsing and there fore avoid breathing problems associated with airway collapse a
8. the display will lighten up and Set Up Others Humidity Ramp the iSleep 20 delivers a low flow In order to start the treatment again start to breath in the mask or press the Start Stop button shortly The iSleep 20 will then increase the pressure to the set level during up to 10 seconds The iSleep 20 will turn off automatically after 10 minutes of inactivity once the snooze function has been activated Once the snooze is activated and the mask has not been taken off within 10 seconds the pressure will rise to the pressure set before the snooze function was activated Humidifier optional The humidifier function is adjustable to provide additional humidity to the patient air Automatic Restart After Power Fail The Sleep 20 will restart after a power failure with a duration shorter than 5 seconds Wake Up optional The wake up function will initiate an alarm at a set time when activated Press the Start Stop button to turn off the alarm 20 Functions and Parameters of the iSleep 20 iSleep 20 users manual Doc 004270 En Eu T 3b 5 Using the Sleep 20 5 1 Checking the Sleep 20 before Use Always make the following checks before using the Sleep 20 1 Connect a cleaned or a new patient circuit to the Sleep 20 2 Connect the Sleep 20 to the mains supply 3 Check patient settings 4 Switch on the iSleep 20 by pressing the Start Stop button on the front panel Ensure that the Sleep 20 is runn
9. 5 to 60 min Resolution 5 min amp Time 18 Min Navigate to the Ramp section The Ramp Function an Always start with ramp OFF ramp function can only be activated during operation Setting up the iSleep 20 31 Doc 004270 En Eu T 3b iSleep 20 users manual Humidifier optional Setting range 1 to 9 Off where 9 is the maximum humidity Humidifier ON Navigate to the Humidity section If the HA 01 humidifier is not attached to the iSleep 20 the F Humidity section will not be availa ble in the menu The HA 01 humidifier can only be activated during operation 7 3 Viewing Device Information Check the chapter Using the Menu on page 22 for information about how to navigate to the device info screen At the main menu choose Others and navigate to the Device Informa Wakeup Alarm Time Date Device settings tion page Pee levice Information Memorycard E Select The Device Information page con tains the following information Total Op Time 20 H Patient Op Time 13 H 1 Total Operating Time Software Version 1 08 Total number of hours the Sleep 20 has been operating ia 2 Patient Operating Time Total number of hours a patient has been using the iSleep 20 for CPAP treatment ramp and mask off not included 3 Software Version 32 Setting up the Sleep 20 Sleep 20 users manual D
10. IFICATION TOLERANCE Pressure 0 to 20 cmH O Doc 004270 En Eu T 3b Power fail indica tion Message shown in the display Technical Specifications 41 Sleep 20 users manual 42 INDICATIONS SPECIFICATION TOLERANCE Internal function Message shown in the display indication POWER SUPPLIES SPECIFICATION Mains supply 100 to 240 V AC tolerance 15 10 50 to 60 Hz max 140 VA DC output 24 V External DC supply 24 V DC tolerance 15 25 20 4 to 30 V Max 2 5 A 60 W with Breas external battery Standby power 3W NVIRONMENTAL SPECIFICATION CONDITIONS Operating temperature 5 to 40 C 41 to 104 F range Storage and transport tem 20 to 60 C 4 to 140 F perature Ambient pressure range 700 to 1060 mbar Humidity 10 to 95 non condensing OPERATING CONDITIONS SPECIFICATIONS Recommended leakage 20 to 40 l min at 10 cmH O Minimum leakage 12 l min at 4 cmH O DIMENSIONS SPECIFICATIONS WxHxD 173 x 172 x 209 mm with rear lid 173 x 172 x 201 mm with HA 01 humidifier Weight 1 9 kg with rear lid 2 0 kg with HA 01 humidifier Air outlet 22 mm male conical standard connector Technical Specifications iSleep 20 users manual Doc 004270 En Eu T 3b 12 Accessories 12 1 Breas Accessories List IN Only use accessories recommended by Breas Medical AB Breas Medical AB cannot guarantee the performance and safety for the use of other accessories with t
11. Never add or pour out water from the humidifier when attached to the iSleep 20 main unit e Prevent water from entering the iSleep 20 e Always turn off the iSleep 20 and disconnect the mains supply before removing the humidifier e Do notuse the humidifier if the internal pipe in the water container is miss ing e Do not overfill the humidifier e If water on outside of the humidifier after filling dry the humidifier using a lint free cloth before reconnecting it to the iSleep 20 Using the iSleep 20 iSleep 20 users manual Doc 004270 En Eu T 3b Follow the instruction in the illustration below Use the same procedure when emptying water from the humidifier Q 2 G o op mee Add distilled water or boiled chilled tap water to the humidifier until it reaches the marking Max on the humidifier A full humidifier contains approximately 400 ml Do not overfill the humidifier Cleaning the Humidifier e Clean with hot water and a mild detergent or in a dishwasher without dish washer detergent at max 70 C Rinse carefully and allow to dry Using the iSleep 20 25 Doc 004270 En Eu T 3b Sleep 20 users manual 26 5 5 Using an External Battery The Sleep 20 can be powered from The Breas external EB 2 Battery Pack e A12V external power source The Sleep DC converter 12 24 V needs to be used 1 Connect the external DC cable to the Sleep 20 Make sure it is fitted co
12. Table of Contents 1 Intended Use of the iSleep 20 s cciocioinicnncinia in ciencia paid 3 1 1 What is the iSleep 20 an 3 1 2 Indications for USE dieron 4 1 3 ContraindicationS ssnstinin ee 4 1 4 About this Manual aiii aa gaa a a T aiia Ge 5 2 Satelite 7 2 1 General User Precautions wnvecosmosntacarcc tir vatedeneviond teensassconedae 7 2 2 Electrical Safety ut AN 8 2 3 Environmental Conditions ooooocononicccccnnoccccnnnonannnnnnnnnccnnnnnnncnn non cnn nnnnnn rn nannnno 9 2 4 Usage of PatientCircuit ii dcir 10 2 5 USADO ONES red io tii 10 2 6 Cleaning and Maintenance ccoooncccccnonocccnnononcccnnnanoncnnnnnnnn cnn ron nn nan nnnncrn nana nen 11 2 7 Adverse Patient SYMPlOM Swssetcete tsk aahe ice eekddel ettleis oli 11 2 8 Usage of the HA 01 Humidifier ecc sia 12 2 9 Usage of OXYGEN i 13 3 Product Descripti Nk ira eo aa dr 14 3 1 Main COMponents css ao ol ela as 14 3 2 The iSleep 20 s Front Panel viu le n 16 3 3 The iSleep 20 s Side Panels ari ai 17 3 4 Equipment Designation and Safety Label cececcceeceeeeeeeeeeeeeeeeseeeeeeensaes 18 4 Functions and Parameters of the Sleep BO t oooooccncoccccnonoccccnnonocnccccnnnancnnnnnnccnnanancncnnnns 19 4 1 1 yl A ele cen as ene Ge NAN andor a ca geen emote a anata 19 5 Use elias 21 5 1 Checking the Sleep 20 before Use ooooccoocccconoocccconconcccccnonancnnnnannccn nana nnnnns 21 5 2 Switching the iSleep 20 On and Off ioooocccconcccccnnooccccconancncncnonancnonnnnnccn
13. ance of the Sleep 20 may deteriorate at AC supply voltage below 15 and above 10 of declared nominal value DC supply voltage below 15 and above 25 of declared nominal value 8 Safety Information iSleep 20 users manual Doc 004270 En Eu T 3b 2 3 Environmental Conditions O Doc 004270 En Eu T 3b Do not use the Sleep 20 in any toxic environment Do not use the iSleep 20 in environments where there are explosive gases or other flammable anesthetic agents present The performance of the iSleep 20 may deteriorate at ambient temperatures below 5 C 41 F and above 40 C 104 P ambient relative humidity below 10 RH relative humidity and above 95 RH atmosphere pressure below 700 mbar and above 1060 mbat Do not use the iSleep 20 while positioned in a warm place such as direct sunlight The device complies with the EMC requirements of standards Measures should include but not be limited to normal precautions with regard to relative humidity and conductive chat acteristics of clothing in order to minimize the build up of electrostatic charges avoiding use of radio emitting devices closer than 1 m to the iSleep 20 Radio emitting devices are for example cellular or cordless telephones microwave ovens and high frequency surgery apparatus The iSleep 20 any accessories and all replaced parts must be disposed of in accordance with the local environmental re
14. gulations regarding the dis posal of used equipment and waste The performance of the iSleep 20 and treatment of the patient may dete riorate if the operation conditions in Technical Specifications on page 41 are not fulfilled Do not use the Sleep 20 immediately after storage or transport outside the recommended operating conditions Safety Information Sleep 20 users manual 9 2 4 Usage of Patient Circuit e Only use the Sleep 20 with a mask patient tube and ventilation valve if applicable recommended by Breas Medical AB and your health care pro fessional e Do not breathe in the connected patient circuit unless the iSleep 20 is turned on and operating properly e Do not use patient hoses or tubes made of electrically conductive or static material e Patient connected parts and filter must be replaced regularly to ensure cor rect function of the Sleep 20 All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and patts e Ifthe patient is using a full face mask covering mouth and nose the mask must be equipped with a safety entrainment valve e Make sure that the ventilation holes in the mask or the adjoining ventilation valve ate never blocked or obstructed These devices are used for ventilat ing the mask in order to prevent re breathing of exhaled air Re breathing of exhaled gases for longer than a few minutes can in some citcu
15. he Sleep 20 The following Breas accessories are currently available for the Sleep 20 DESCRIPTION PART No Carrying bag 003793 Users manual 004270 Patient tube 000245 Humidifier 003530 Rear lid 003591 Filter grey washable 004154 5 pcs Filter white disposable optional 004153 5 pcs iMask 100 003971 iMask 200 003972 Breas one size headgear 003434 iSleep power supply 003773 Mains power cord 003723 EB 2 external battery pack 24 V DC including 004150 cable charger and bag External DC cable EB 2 004136 Trafobox EB 2 external battery 001153 Charger EB 2 external battery 001159 Carrying bag EB 2 external battery 000269 EB 2 power cord 000539 Sleep DC converter 12 24 V 004139 Accessories 43 Doc 004270 En Eu T 3b iSleep 20 users manual 13 Patient Settings Patient Settings Breas Sleep 20 PAIGE ink alata an Dac dein O tte dtm tans ete aha tate E eet ee bales Cite ae bata CUES ESE ENS SE ii Sleep 20i senal TUDES a at GPAR Caria Humidifier Le Ramp Time votas Ramp Start Pressure vse 44 Patient Settings iSleep 20 users manual Doc 004270 En Eu T 3b
16. iac failure or hypotension particularly if associated with intravascular volume depletion Recent thoracic surgery Pneumothorax Pneumomediastinum Massive epistaxis or previous history of massive epistaxis risk of recurrence 4 Intended Use of the iSleep 20 iSleep 20 users manual Doc 004270 En Eu T 3b e Pneumoencephalus recent trauma or surgery that may have produced cranio nasopharyngeal fistula e Cerebral spinal fluid CSF leaks e Acute or unstable respiratory failure or insufficiency Caution should be used when prescribing CPAP therapy for susceptible patients such as patients with abnormalities of the cribriform plate or prior his tory of head trauma The use of CPAP therapy may be temporarily contraindicated if the patient exhibits signs of a sinus or middle ear infection About this Manual Always read this manual before setting up and using the iSleep 20 or performing maintenance on the iSleep 20 to ensure correct usage maximum performance and serviceability Breas Medical AB reserves the right to make changes to the contents of this manual without any prior notification E gt Audience This manual is intended for patients and other lay users operating the Sleep 20 Care providers clinical personnel physicians and others who require a working knowledge of the iS leep 20 will find additional information on settings and func tions in the Clinicians Manual Icons In this manual icon
17. ider s instruc tions Cleaning the iSleep 20 and Replacing the Filters 37 Doc 004270 En Eu T 3b iSleep 20 users manual Always clean the parts or use a new set when used by a new patient All parts that come into contact with the respiration gas must be cleaned as fol lows Place the dismantled parts in hot water containing washing up liquid Remove fouling with a brush Rinse parts thoroughly under running hot water Shake water out of all parts Dry the parts completely oOo oo A WO N Store in dust free location The patient circuit shall be replaced in intervals according to the care provider s instructions Check the patient circuit for damage regularly In case of damage replace the circuit 9 2 Cleaning and Replacing the Patient Air Filter A fo B by ii The patient air filter is located on the side of the Sleep 20 There are two types of filters Y Washable Filter grey colour mandatory Replace the washable filter at least once a year Wash the filter at least once a week 1 Wash the filter using warm water and a mild detergent 2 Rinse thoroughly 3 Dry the filter by squeezing it out in a towel Do not wring the filter Disposable Filter white colour optional Replace the filter at least every 4th week or more often when used in high pol lution or pollen rich environments 4 Do not wash ot reuse the disposable filter 38 Cleaning the Sleep 20 and Replacing the F
18. ilters Sleep 20 users manual Doc 004270 En Eu T 3b 10 Maintenance WARNING e Sleep 20 should be subjected to maintenance service and con trol and any applicable upgrades in accordance with Breas serv ice instructions iSleep 20 should only be repaired or modified in accordance with Breas service manuals technical bulletins and any special service instructions by service technicians that have been authorized after Breas Sleep 20 service training Do not under any circumstances attempt to service or repair the iSleep 20 yourself If you do so the manufacturer will no longer be responsible for the performance and safety of the iSleep 20 DEVIATION FROM THESE SERVICE INSTRUCTIONS MAY LEAD TO RISK OF PERSONAL INJURY 10 1 Regular Maintenance Control The Sleep 20 should not require any regular maintenance inspections if it is used and maintained in accordance with the instructions in this manual Do not use the device and contact your responsible care provider for an inspection of the device in the event of e Unexpected patient symptoms during treatment e Unexplainable or sudden pressure performance or sound changes during operation e Suspected damage to the device or power supply Maintenance 39 Doc 004270 En Eu T 3b Sleep 20 users manual 10 2 Service and Repair The service and repair of the Sleep 20 must only be carried out by authorized service personnel in accordance with Breas se
19. ing 5 Put on the mask and adjust its fit 6 Ensure that the settings are adjusted as prescribed The Sleep 20 is ready for use 5 2 Switching the iSleep 20 On and Off 1 Make sure the power supply Y is connected 2 Turn on the Sleep 20 by press UUUU ing the Start Stop button on the L ME front panel for 2 seconds A This operation switches the iSleep 20 between standby and operating mode The Sleep 20 is connected to a power supply when the LCD display is lit up Using the Sleep 20 21 Doc 004270 En Eu T 3b Sleep 20 users manual 5 3 Using the Menu UL Read chapter The Sleep 20 s Front Panel on page 16 for exact position of the buttons Humidifier OFF Humidifier OFF Humidity Level 3 umidity Level 0000 0000 0000 Use the 4 buttons under the display to navigate in the menu Depending on the location in the menu the buttons have different function The following icons are used ICON EXPLANATION Increase the selected value or turn a function On Decrease the selected value or turn a function Off Move up one step in the menu system a Enter the menu or select the value below Overview The iSleep 20 menu has the following layout Setup Others Humidity Ramp T 1 1 if used active i e 2 1 cp lam o _ Ramp time Time Date view only Ramp
20. mstances lead to suffocation e At low CPAP pressures the air flow through the ventilation holes in the mask or the adjoining ventilation valve may be inadequate to clear all exhaled gases from the mask Some re breathing may occur 2 5 Usage of Filters e Always use the iSleep 20 with a patient air inlet filter installed Only use filters that are specified in this manual e Replace or clean the filters regularly to ensure correct function of the iSleep 20 especially when changing patient Failure to replace or clean a dirty filter may cause the iSleep 20 to operate at higher temperatures than intended e When operating the iSleep 20 make sure that the air inlet and the filter is not obstructed or occluded 10 Safety Information iSleep 20 users manual Doc 004270 En Eu T 3b 2 6 Cleaning and Maintenance The Sleep 20 shall be cleaned and maintained in accordance with this user manual Do not attempt to autoclave or sterilise the Sleep 20 The Sleep 20 shall be subjected to maintenance service and control and any applicable upgrades in accordance with Breas service instructions The Sleep 20 should only be repaired or modified in accordance with Breas service manuals technical bulletins and any special service instruc tions by service technicians authorized by Breas Medical AB Do not under any circumstances attempt to service or repair the iSleep 20 yourself If you do so the manufacturer will no l
21. n and the device used This should be assessed on an individual basis in accordance with the patient s needs e If the condensation in the patient circuit is excessive the use of a heated humidifier may require the installation of a water trap in the circuit The water trap prevents any condensated water in the patient circuit from run ning into the patient airways and causing personal injury o e The HA 01 humidifier shall be disconnected from the Sleep 20 during transportation e The iSleep 20 shall not be placed in the bag with the HA 01 humidifier attached 12 Safety Information iSleep 20 users manual Doc 004270 En Eu T 3b 2 9 Usage of Oxygen Doc 004270 En Eu T 3b The presence of oxygen can speed up combustion of inflammable materi als If oxygen has been prescribed connect the oxygen supply tube to the appropriate oxygen port of the nasal mask or breathing system connector At a fixed flow rate of supplemental oxygen flow the inhaled oxygen con centration will vary depending on the pressure delivered patient s breath ing pattern mask selection and leak rate When oxygen is used with the Sleep 20 the oxygen flow must be turned off when the iSleep 20 is not operating If the iSleep 20 is not in opera tion and the oxygen flow is left on oxygen delivered into the patient tubing may accumulate within the iSleep 20 enclosure Oxygen accumulated in the iSleep 20 enclosure will create a risk of fire
22. nd obstruction The Sleep 20 has a pressure sensor that continuously monitors output pres sure to the patient and reference ambient pressure so that the device automati cally will compensate for altitude changes Intended Use of the iSleep 20 3 Doc 004270 En Eu T 3b Sleep 20 users manual The Sleep 20 has a memory that stores the usage and can be downloaded by your cate provider to a PC 1 2 Indications for Use The Sleep 20 is intended for non invasive use The Sleep 20 shall only be used by patients with spontaneous breathing The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea in adults who weigh more than 30 kg The Sleep 20 can be used in clinical settings e g hospitals sleep laboratories sub acute care institutions and home environments It must always be pre scribed by a licensed physician The Sleep 20 is intended to be operated by trained users and qualified person nel A The iSleep 20 is not intended for life support or life sustaining applica tions or for transport of critical care patients 1 3 Contraindications Therapy with the Sleep 20 should not be prescribed when the following spe cific diseases or conditions are present Bullous lung disease Pathologically low blood pressure Severe cardiac arrhythmias Coronary artery disease Unstable angina pectoris Decompensated card
23. ngs display 3 Navigation Navigation in menu system 16 Product Description iSleep 20 users manual Doc 004270 En Eu T 3b 3 3 The Sleep 20 s Side Panels No ITEM FUNCTION 1 Air outlet Air path out to the patient 2 Locking mechanism Release and lock HA 01 humidifier or rear lid 3 HA 01 Humidifier optional Patient air humidification Air inlet Air path in replaceable filters Data connection Data cable connection Memory card slot Read and write memory card NI DW Oy A DC inlet Doc 004270 En Eu T 3b External DC power connection Product Description 17 iSleep 20 users manual 3 4 Equipment Designation and Safety Label 1 2 3 4 5 6 7 No SYMBOL EXPLANATION 1 Model designation 2 Serial number the last seven alphanumeric char acters Class II electrical equipment dual isolation Body floating IEC 60601 1 Type BF Isolated Applied Part gt Bn Read the User Manual thoroughly before con necting the Sleep 20 to the patient DN oN 0123 CE marking applies in accordance with the direc tive MDD 93 42 EEC 4 18 Product Description Sleep 20 users manual Read Disposal on page 40 for information about recycling and disposal Doc 004270 En Eu T 3b 4 Functions and Parameters of the iSleep 20 4 1 Settings All the parameters that are used for controlling the breathing b
24. nnana nc 21 5 3 VNo MS MEAT a ea AAS E Ea eid S AAAS Rca garna ASi 22 5 4 Using the integrated Humidifier oooccoonononanoccnonannnnonanoncncncnnnnnnnnnnnnrncrnn 23 5 5 Using an External Battery si A o 26 6 Preparing the iSleep 20 for USO oooocoooocccccnococcccncnoncccnnnannncnnnannnnconcnnnnnnnnan nero rannnnnnnnns 28 6 1 Installing the iSleep 20 kcal id iedigaetes 28 6 2 Placing ING ISIGED 20E acusado ata dui 29 6 3 Connecting the Sleep 20 to the Mains Supply ooccoccncccccccconoccninanancnnnananoninos 29 6 4 Connecting the Patient Circuit a tio dile Mesias 30 7 Setting up the iSleep 20 srl sedis oteeetjuctas theud dota derauaeecetatepetoemssadee 31 7 1 Settings Applicable for Sleep 20 connnccccccnnnoccccnoconcccnonanccncnnnnnncnnnnnencnnnanancnnos 31 7 2 Setting the Parameters nic dai 31 7 3 Viewing Device Information fcsdeccssceecaierssostesaieisaduuedeetedaphaieetanyerseacnreraenategs 32 WIGIG AN ONS a aaa E SA AURE A ANE AA A ARE ROERE Naty 33 Cleaning the Sleep 20 and Replacing the Filters oooooconoccccnonicccccnnoccccncnccrncnnnanancnon 36 9 1 Cleaning the iSleep 20 idas a ai 36 9 2 Cleaning and Replacing the Patient Air Filter oooooooconnnncccc nnoccconncnccccnnnannnnno 38 TO JMAalMtenance soc 39 10 1 Regular Maintenance Control coooooccccccnnoccccnnnoccccnnnonnccnnnnnnnncnnnnnnnnnnnnnnnnnnnnnn ner 39 Table of Contents 1 Doc 004270 En Eu T 3b Sleep 20 users manual 10 2 Servico ANA Rel usina iio
25. oc 004270 En Eu T 3b 8 indications This chapter describes the Sleep 20 s indication functions messages shown in the display window Power Fail Indication TEM DESCRIPTION Definition A power fail indication will be given when the Sleep 20 is disconnected from the mains power source more than 5 seconds Action The Sleep 20 will terminate treatment Indication The indication is asserted with an audible tone Reset In order to reset the indication press the Start Stop button Internal Function Error ITEM DESCRIPTION Definition An internal function error will be given when the iSleep 20 has an internal function failure The following error codes exist Error code 35 High temperature Cool the device and restart 35 High temperature Let the iSleep 20 cool down and restart The ambient temperature might be too high Error code 45 Indications 33 Doc 004270 En Eu T 3b Sleep 20 users manual ITEM DESCRIPTION 45 Internal function failure Contact your care provider Error code 64 Check power supplies 64 Low power Check the power cables and the mains connection Error code 138 Stored settings corrupt Returned to default settings i 130 Settings corrupt Check that the settings of the Sleep 20 are according to prescription Error code 131 Humidifier disconnected 0
26. onger be responsible for the performance and safety of the iSleep 20 2 7 Adverse Patient Symptoms O Doc 004270 En Eu T 3b If the patient experiences any of the following symptoms while using the Sleep 20 a physician or responsible clinician shall be contacted immedi ately Bloated feeling from excessive swallowing of air while awake Air continually leaking from the mouth while sleeping Dryness of air passages or nose Ear pain runny nose or sinus discomfort Day time sleepiness Disorientation or memory lapse Mood change or irritability Skin sensitivity Morning headache Safety Information 11 iSleep 20 users manual 2 8 Usage of the HA 01 Humidifier e The HA 01 humidifier and the Sleep 20 are intended for non invasive use e When using an external humidifier it should be located below the Sleep 20 and the patient to prevent personal injury from accidental spill age e When using the HA 01 humidifier the Sleep 20 should be located below the patient to prevent personal injury from accidental spillage e Ifa room humidifier is used place it at least 2 meters away from the iSleep 20 e Periodically check for moisture in the patient circuit When present remove the moisture Before attempting to dry the circuit disconnect it from the iSleep 20 to ensure no water back flow into the iSleep 20 The frequency at which these checks must be performed will depend on the patient s own conditio
27. onsible care provider for an inspection in the event of suspected damage to the device unexplainable or sudden pressure performance or sound changes during operation or if the delivered air from the Sleep 20 is abnormally hot or emits an odour The iSleep 20 therapy settings must always be based on medical advice and must be carried out by authorized clinical personnel only Always perform the procedure Checking the Sleep 20 before Use on page 21 before use Inadequate use of device or accessories may cause loss of treatment or decreased performance Clinical personnel and the patient must read the manual thoroughly and understand the usage of the iSleep 20 before setting up and using the iSleep 20 Handle the iSleep 20 with cate Do not use the Sleep 20 while in bag Safety Information iSleep 20 users manual 7 2 2 Electrical Safety e Do not operate the Sleep 20 if it has a damaged power cord power sup ply or casing e The iSleep 20 may not work properly if any part has been dropped dam aged or submerged in water e To avoid electrical shock disconnect the electrical supply to the Sleep 20 before cleaning Do not immerse the iSleep 20 into any fluids e When handling the HA 01 humidifier disconnect the Sleep 20 from any power source o e Ifan external battery is used it must be disconnected when the Sleep 20 is switched off Otherwise the battery will discharge e The perform
28. rrectly 5 2 Connect the other end of the cable to the battery source e Always make a function check to test the battery condition before operat ing the Sleep 20 from an external battery source e The battery must be disconnected when the Sleep 20 is switched off otherwise the battery will be discharged Battery Operation Time The operation time is dependent on the battery condition its capacity the ambi ent air temperature and the iSleep 20 pressure setting The operation time is based on the following settings SETTING VALUE Humidifier setting 5 or Off CPAP pressure 10 cmH O Ambient temperature 20 C 68 F Altitude Sea level Battery status New battery fully charged BATTERY TYPE HUMIDIFIER OPERATION TIME EB 2 24 V 7 2 Ah Off 13h Using the iSleep 20 iSleep 20 users manual Doc 004270 En Eu T 3b BATTERY TYPE HUMIDIFIER OPERATION TIME EB 2 24 V 7 2 Ah 5 Not recommended Car battery 12 V 60 Ah Off 90 h Car battery 12 V 60 Ah 5 25h When using a 12 V external power the Sleep DC converter 12 24 V needs to be used Using the iSleep 20 27 Doc 004270 En Eu T 3b Sleep 20 users manual 6 Preparing the iSleep 20 for Use A Read the chapter Safety Information on page 7 before setting up and using the iSleep 20 6 1 Installing the iSleep 20 When using the iSleep 20 for the first time follow the instructions below 1 Check that all main compo A
29. rvice instructions Service inspec tions must always be carried out after any repair of the device g Authorized service workshops can order the Sleep 20 Service Manual that con tains all technical documentation required for the maintenance and service of the Sleep 20 10 3 Storage Empty clean and dry the humidifier if applicable before storage of the iSleep 20 10 4 Disposal The iSleep 20 any accessories and all replaced parts must be disposed of and recycled in accordance with the local environmental regulations regarding the disposal of used equipment and waste 40 Maintenance iSleep 20 users manual Doc 004270 En Eu T 3b 11 Technical Specifications 11 1 Data i The Sleep 20 and it s packaging do not contain any natural rubber latex SETTING VALUE RANGE SPECIFICATION RESOLUTION CPAP 4 to 20 cmH O 0 5 cmH O Ramp time 5 to 60 min 5 min Ramp start pressure 4cmH O to CPAP 0 5 cmH O Humidifier 1 to 9 10 to 30 mgH O I 1 lt 100 RH Heat up time from 23 C 1 hour Max gas temperature at patient port 41 C Maximum flow gt 125 l min Maximum limited 30 cmH O pressure during sin gle fault condition Max flowin CPAP 6 7 cmH 0O 108 l min mode 13 3 emH O 132 1 min 20 cmH 0O 132 1 min Breathing resist 0 9 cmH 0 at 30 l min ance under single 3 2 cmH O at 60 1 min fault Digital output 0to5V Sound level at 10 Less than 30 dB A Measured cmH O at 1 m INDICATIONS SPEC
30. s are used to highlight specific information The meaning of each icon is explained in the table below ICON EXPLANATION W Warning Risk of death and serious personal injury o Caution Risk of minor or moderate injury Risk of equipment damage loss of data extra work or unexpected results Intended Use of the iSleep 20 5 Doc 004270 En Eu T 3b iSleep 20 users manual ICON EXPLANATION Information that may be valuable but is not of critical impor tance tips 8 Reference Reference to other manuals with additional information on a specific topic 6 Intended Use of the iSleep 20 iSleep 20 users manual Doc 004270 En Eu T 3b 2 Safety Information 2 1 General User Precautions Doc 004270 En Eu T 3b The Sleep 20 should not be used for any kind of life support treatment The Sleep 20 shall only be used by patients with spontaneous breathing If you are admitted to a hospital or are prescribed any other form of medi cal treatment always inform the medical staff that you are on CPAP treat ment The iSleep 20 must only be used for the intended treatment in accordance with this user manual and with the instructions given by the responsible clinical personnel in accordance with the operating conditions specified in this manual in original and unmodified shape and only with accessories specified or approved by Breas Medical AB Do not use the iSleep 20 and contact your resp
31. y the Sleep 20 ate listed below The Ramp function The ramp function provides a pressure increase from the ramp start pressure to the set CPAP pressure during a set time Pressure Set ramp time Time Ramp start The ramp function will not be available if your care provider has chosen to deac tivate it Mask Off Detection The iSleep 20 automatically detects if the mask is taken off during opera tion and reduces the air flow j y Mask Off Set Up Others Humidity Ramp If the patient removes the mask the iSleep 20 will minimise the pressure to approximately 1 cmH 0O the pressure level depends on the mask type When the patient has put on the mask again and taken a few breaths the Sleep 20 will go back to the pressure delivered before the patient removed the mask Functions and Parameters of the Sleep 20 19 Doc 004270 En Eu T 3b Sleep 20 users manual The Sleep 20 will exclude any mask off time and ramp time when registering the patient operating time If the mask is not fitted properly to the patient the iSleep 20 may incor 0 rectly detect that the mask is taken off and may change the delivered pressure to the reduced mask off level In this case check the mask fit ting and adjust it if necessary Snooze The snooze function allows the patient to pause the treatment This is done by shortly pressing the Start Stop button When the snooze is Sn 00Z started
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