iSleep 20 - CPAP Australia
Contents
1. 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 004268 En Eu T 3 iSleep 20 users manual Navigate to the humidifier section by using the function button The 4 humidity setting range from Off 1 to 5 L 9 where 9 generates the maximum e humidity Always set the humidity control to the setting recommended by your doctor Adding Water to the Humidifier e Never add or pour out water from the humidifier when attached to the Sleep 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 24 Using the iSleep 20 iSleep 20 users manual Doc 004268 En Eu T 3 Fo2. 21 5 2 Switching the iSleep 20 On and Off eee eeeeceeeeeeeeeceeeeenaeeeeeeeneeeeteneeeeees 21 5 3 USA MS MEAT di hai Meds Na aed an auaetace eat auens 22 5 4 Using the integrated Humidifier oocccononononoccccnonnnnonanoncncncnnnnnnnannnnrncrnn 23 5 5 Using an External Battery si o 26 6 Preparing the iSleep 20 for US ooooooccononccccnococcccncnoncncnnnnannncnnnnnnnnnnnrnnnnnnnnannncrnranannnnnnnns 28 6 1 Installing the iSleep 20 iii ec leaevecced did iadisactes 28 6 2 Placing ING ISIS 20 eiin aeea ee a sated ed tad conde ia guce 29 6 3 Connecting the Sleep 20 to the Mains Supply cccceeeeeeeeeeeeeeeeeeeeesneeees 29 6 4 Connecting the Patient Circuit assi 30 7 Setting UP the iSleep 20 ains ias 31 7 1 Settings Applicable for Sleep 20 oooonnocccconncccccnonoccccnononnccnnnannncnnnnnnnnn nana nc 31 7 2 Setting the Parameters noia dani dai 31 7 3 Viewing Device Information ses 32 Internal Function Error Sn at iak 33 Cleaning the Sleep 20 and Replacing the Filters cceeceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneees 34 9 1 Cleaning the Sleep 20 caladas ie 34 9 2 Cleaning and Replacing the Patient Air Filter ooooooooccnnnnccccnnniccconnnaccccnanancnonos 36 TO JMAalMtenance cocida bs 37 10 1 Regular Maintenance Control cooooncccccnnoccccnnnoncccnononnncnnnnnnnncnnnnnnnnnnn nan nnnnnna nes 37 Table of Contents 1 Doc 004268 En Eu T 3 Sleep 20 users manual 10 2 Servico ANA REPAIM usina ii 38 10 3 o
3. device unexplainable or sudden pressure performance or sound changes during operation or if the delivered air from the iSleep 20 is abnormally hot or emits an odour The Sleep 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 iSleep 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 Sleep 20 users manual 7 2 2 Electrical Safety e Do not operate the iSleep 20 if it has a damaged power cord power supply or casing e The Sleep 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 Sleep 20 into any fluids e When handling the HA 01 humidifier disconnect the iSleep 20 from any power source e Do not connect cables to the iSleep 20 when there is water in the HA 01 humidifier 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 performan
4. Doc 004268 En Eu T 3 iSleep 20 users manual 13 Patient Settings Patient Settings Breas iSleep 20 PAIGE ad A ai aAa Ss ete aha tate E eet ee bales Cite ae bata CUES ESE ENS II O ee eae ee Nae Adie Sleep Seta number laica at GPAR Caria Humidifier Le Ramp Time votas Ramp Start Pressure vse 42 Patient Settings iSleep 20 users manual Doc 004268 En Eu T 3
5. On Off 2 Display window Mode and settings display 3 Function Menu navigation 4 Decrease Decrease setting 5 Increase Increase setting 6 Ramp start and stop Ramp function start and stop 16 Product Description iSleep 20 users manual Doc 004268 En Eu T 3 3 3 The iSleep 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 Patient air humidification optional 4 Air inlet Air path in replaceable filters 5 Data connection Data cable connection 6 DC inlet External DC power connection Doc 004268 En Eu T 3 Product Description 17 iSleep 20 users manual 18 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 3 Class II electrical equipment dual isolation Body floating IEC 60601 1 Type BF Isolated Applied Part gt Bio Read the User Manual thoroughly before con necting the iSleep 20 to the patient X A 0123 CE marking applies in accordance with the direc tive MDD 93 42 EEC x Product Description iSleep 20 users manual Read Disposal on page 38 for information about recycling and disposal Doc 004268 En Eu T 3 4 Functions and Parameters of the Sleep 20 This chapter includes descripti
6. Table of Contents 1 Intended Use of the iSleep 20 cciocioinicconsinatia teens biscends ceteaeestacareeheandnacsPeeteeseeeetbecnsle 3 1 1 What is A k ash oe ord aoas decree A pone eas 3 1 2 Indications for USE didas 4 1 3 ContraindicationS sssri enpe e 4 1 4 About this Manual aiii gies 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 OXY OOM ie a E E 13 3 Product Descripti Nk aa ra a adri 14 3 1 Main COMponents e a aso a oil as 14 3 2 The iSleep 20 s Front Panel rca le n 16 3 3 The iSleep 20 s Side Panels anni 17 3 4 Equipment Designation and Safety Label ceececcececeeeeeeeeeenteeeeeeeeeeeeeneaes 18 4 Functions and Parameters of the Sleep 20 oooooccncoccccnonoccccnononcncccconnnnnnnnnnancnnnnnnnnccnnnns 19 4 1 SDS TUN qlo AA O arena aa ne ducates teat a a eta tana 19 5 US MIU ds leon casal EEE eds EEEE 21 5 1 Checking the Sleep 20 before US8 oooooccccooccccnnoocccccoconccccononancnnnnnanccnnnnna nc
7. are eee en er er a Neer ere re Cee eee eee eee ee 38 10 4 ps A A E sta dansecae tetas tesa O heaeuateset ee encte 38 11 Technical Specific as aia 39 11 1 Data aia AAA ets 39 A A A AN 41 12 1 Breas Accessories List iia 41 13 Patent Osasuna DEL 42 2 Table of Contents Sleep 20 users manual Doc 004268 En Eu T 3 1 Intended Use of the Sleep 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 pres sure This can prevent the user s upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction The Sleep 20 has a press
8. ce 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 004268 En Eu T 3 2 3 Environmental Conditions O Doc 004268 En Eu T 3 Do not use the Sleep 20 in any toxic environment Do not use the Sleep 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 Sleep 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 Sleep 20 Radio emitting devices are for example cellular or cordless telephones microwave ovens and high frequency surgery apparatus The Sleep 20 any accessories and all replaced parts must be disposed of in accordance with the local environmental regulation
9. contact your care provider e 30 High temperature Let the Sleep 20 cool down and restart The ambient temperature might be too high e 61 Check settings Check that the settings of the iSleep 20 are according to prescription Action The iSleep 20 will continue or stop the treatment 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 Internal Function Error iSleep 20 users manual 33 9 Cleaning the iSleep 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 iSleep 20 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 iSleep 20 To avoid electrical shock disconnect the mains supply to the iSleep 20 before cleaning Do not immerse the iSleep 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 iSleep 20 and dis connect the mains supply ME 2 Remove the patient circuit AND 34 Cleaning the iSleep 20 and Replacing
10. e placed lower than the patient in order to prevent the device from falling 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 y 2 Connect the power cord into the power supply lt 4 Preparing the iSleep 20 for Use 29 Doc 004268 En Eu T 3 iSleep 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 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 004268 En Eu T 3 7 Set
11. 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 pressing UUUU the Start Stop button on the front L MAS panel for 2 seconds A This operation switches the iSleep 20 between standby and operating mode The iSleep 20 is connected to a power supply when the LCD display is lit up Using the iSleep 20 21 Doc 004268 En Eu T 3 iSleep 20 users manual 5 3 Using the menu Read chapter The Sleep 20 s Front Panel on page 16 for exact position of the buttons Use the function button to toggle through the different functions of the iSleep 20 000 The plus and minus buttons are used to alter a value The ramp button is used to activate the ramp function during operation Overview The Sleep 20 menu has the following layout Standby only Operating only Main CPAP syi time l 4 Ramp time p Humidity view only view only Standby only Standby only Device tel Icons in the Display Window ICON EXPLANATION cH Pressure O Time 22 Using the Sleep 20 Sleep 20 users manual Doc 004268 En Eu T 3 ICON EXPLANATION M Ramp 900 Humidity o Information 1 9 Wake up alarm Gq Panel lock 5 4 Using the integrated Humidifier A Read the chapter Usage of the HA 01 Humidifier on page 12 carefully
12. he 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 iSleep 20 users manual 5 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 004268 En Eu T 3 2 Safety Information 2 1 General User Precautions Doc 004268 En Eu T 3 The iSleep 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 responsible care provider for an inspection in the event of suspected damage to the
13. hnical Specifications 11 1 Data i The iSleep 20 and it s packaging do not contain any natural rubber latex Doc 004268 En Eu T 3 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 O 90 1 min mode 13 3 cmH O 130 1 min 20 cmH 0 160 l min Breathing resist 0 8 cmH 0 at 30 1 min ance under single 2 8 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 SPECIFICATION TOLERANCE Pressure 0 to 20 cmH O Internal function Message shown in the display indication Technical Specifications 39 iSleep 20 users manual 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 1 A 24 W with Breas external battery Standby power 3 W ENVIRONMENTAL 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 Humidit
14. 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 004268 En Eu T 3 1 4 O Doc 004268 En Eu T 3 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 per forming maintenance on the iSleep 20 to ensure correct usage maxi mum performance and serviceability Breas Medical AB reserves the right to make changes to the contents of this manual without any prior notification Audience This manual is intended for patients and other lay users operating the iSleep 20 Care providers clinical personnel physicians and others who require a working knowledge of the 15leep 20 will find additional information on settings and func tions in the Clinicians Manual Icons In this manual icons are used to highlight specific information T
15. 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 Sleep 20 with a patient air inlet filter installed Only use fil ters 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 Safety Information iSleep 20 users manual Doc 004268 En Eu T 3 2 6 Cleaning and Maintenance e The Sleep 20 shall be cleaned and maintained in accordance with this user manual e Do not attempt to autoclave or sterilise the Sleep 20 e The Sleep 20 shall be subjected to maintenance service and control and any applicable upgrades in accordance with Breas service instructions e 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 e Do not under any circumstances attempt to service or repair the Sleep 20 yourself If you do so the manufacturer will no longer be re
16. leep 20 delivers a low flow In order to start the treat ment again start to breath in the mask The iSleep 20 will then increase the pressure to the set level during up to 10 seconds The Sleep 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 iSleep 20 will restart after a power failure with a duration shorter than 5 sec onds 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 004268 En Eu T 3 5 Using the Sleep 20 5 1 Checking the Sleep 20 before Use Always make the following checks before using the iSleep 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 Sleep 20 by pressing the Start Stop button on the front panel Ensure that the Sleep 20 is running 5 Put on the mask and adjust its fit 6 Ensure that the settings are adjusted as prescribed The iSleep 20 is ready
17. llow 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 004268 En Eu T 3 iSleep 20 users manual 26 5 5 Using an External Battery The iSleep 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 correctly 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 oth erwise 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 setti
18. nd 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 004268 En Eu T 3 2 9 Usage of Oxygen Doc 004268 En Eu T 3 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 iSleep 20 the oxygen flow must be turned off when the iSleep 20 is not operating If the iSleep 20 is not in operation 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 Ventilate
19. ng 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 004268 En Eu T 3 BATTERY TYPE HUMIDIFIER OPERATION TIME EB 2 24 V 7 2 Ah 5 Not recommended Car battery 12 V 60 Ah Off 90h Car battery 12 V 60 Ah 5 25h When using a 12 V external power the iSleep DC converter 12 24 V needs to be used Using the iSleep 20 27 Doc 004268 En Eu T 3 iSleep 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 nents and ordered accessories gt 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 Sleep 20 for Use Sleep 20 users manual Doc 004268 En Eu T 3 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 b
20. ons of the settings used for controlling the func tions of the iSleep 20 4 1 Settings All the parameters that are used for controlling the breathing by the iSleep 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 Time Ramp start Set ramp time Mask Off Detection The Sleep 20 automatically detects if the mask is taken off during operation and reduces the air flow If the patient removes the mask the iSleep 20 will minimise the pressure to approximately 1 cmH O the pressure level depends on the mask type When the patient has put on the mask again and taken a few breaths the iSleep 20 will go back to the pressure delivered before the patient removed the mask The iSleep 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 Functions and Parameters of the iSleep 20 19 Doc 004268 En Eu T 3 Sleep 20 users manual The snooze function allows the patient to pause the treatment This is done by shortly pressing the Start Stop button When the snooze is started the display will lighten up and the iS
21. s regarding the disposal of used equipment and waste The performance of the Sleep 20 and treatment of the patient may detert orate if the operation conditions in Technical Specifications on page 39 are not fulfilled Do not use the iSleep 20 immediately after storage or transport outside the recommended operating conditions Safety Information iSleep 20 users manual 9 10 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 Sleep 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 iSleep 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 citcumstances
22. sing the menu on page 22 for information about how to navigate to the device info screen Navigate to the Device info section in standby only User the but ton to cycle through the screens ce Con Ol The Device info section contains three information screens ee J0 1 Patient Operating Time E A I Total number of hours a patient has 1 h been using the iSleep 20 for CPAP treatment ramp and mask off not LT A included i pE 2 Total Operating Time Total number of hours the iSleep 20 mum has been operating 3 Software version fale 32 Setting up the iSleep 20 iSleep 20 users manual Doc 004268 En Eu T 3 8 Doc 004268 En Eu T 3 Internal Function Error The indication function of the iSleep 20 consists of a message shown in the display window ITEM Definition DESCRIPTION An internal function error will be given when the iSleep 20 has an internal function failure The fol lowing error codes exist e 20 Function error Contact your care provider e 21 Low power Check the power cables and the mains connection e 28 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 e 29 High humidifier temperature Turn off the iSleep 20 Disconnect the humidifier and reconnect it If the error remains
23. sponsible for the performance and safety of the Sleep 20 2 7 Adverse Patient Symptoms O Doc 004268 En Eu T 3 If the patient experiences any of the following symptoms while using the Sleep 20 a physician or responsible clinician shall be contacted immediately e Bloated feeling from excessive swallowing of air while awake e Air continually leaking from the mouth while sleeping e Dryness of air passages or nose e Ear pain runny nose or sinus discomfort e Day time sleepiness e Disorientation or memory lapse e Mood change or irritability e Skin sensitivity e Morning headache Safety Information 11 Sleep 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 spillage e When using the HA 01 humidifier the Sleep 20 should be located below the patient to prevent personal injury from accidental spillage e If a room humidifier is used place it at least 2 metres 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 Sleep 20 The fre quency at which these checks must be performed will depend on the patient s own condition a
24. the Filters iSleep 20 users manual Doc 004268 En Eu T 3 Doc 004268 En Eu T 3 3 Detach the tear lid or the humidi fier 4 Disconnect all cables 5 Clean the outside of the iSleep 20 using a lint free cloth and a mild detergent solution 6 Reconnect cables and the patient circuit Make sure all parts are dry before the Sleep 20 is put into operation 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 The patient circuit should be cleaned in accordance with the care provider s instruc tions Cleaning the iSleep 20 and Replacing the Filters 35 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 instr
25. the iSleep 20 DEVIATION FROM THESE SERVICE INSTRUCTIONS MAY LEAD TO RISK OF PERSONAL INJURY 10 1 Regular Maintenance Control The iSleep 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 37 Doc 004268 En Eu T 3 iSleep 20 users manual 10 2 Service and Repair The service and repair of the iSleep 20 must only be carried out by authorized service personnel in accordance with Breas service instructions Service inspec tions must always be carried out after any repair of the device q 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 Sleep 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 38 Maintenance Sleep 20 users manual Doc 004268 En Eu T 3 11 Tec
26. 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 lt lt E ie An O Q Y AY TTM S o 14 Product Description Sleep 20 users manual Doc 004268 En Eu T 3 No COMPONENT FUNCTION PART NO 1 Carrying bag Storage for transportation 003793 Ze Users manual Product and usage information 004268 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 optional fa 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 004268 En Eu T 3 iSleep 20 users manual 3 2 The iSleep 20 s Front Panel Sleep 20 2 No USER BUTTONS AND DISPLAYS FUNCTION 1 Start Stop Main unit
27. ting up the Sleep 20 The configuration of the Sleep 20 therapy settings must always be pre scribed by a licensed physician and carried out by an authorized health care professional i For more information about the Breas 15 leep 205 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 The operation modes and setting parameters are described in detail in the chapter Functions and Parameters of the Sleep 20 on page 19 7 2 Setting the Parameters For more information about how to use the menu please read the chapter Using da 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 5 to 60 min Resolution 5 min Q Navigate to the Ramp section The L ramp function can only be activated za min during operation Setting up the iSleep 20 31 Doc 004268 En Eu T 3 iSleep 20 users manual Humidifier optional Setting range 1 to 9 Off where 9 is the maximum humidity Navigate to the Humidity section aa If the HA 01 humidifier is not T attached to the iSleep20 the 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 U
28. uctions Check the patient circuit for damage regularly In case of damage replace the circuit 9 2 Cleaning and Replacing the Patient Air Filter A f Y ii The patient air filter is located on the side of the iSleep 20 There are two types of filters Y Washable Filter mandatory grey colour 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 or reuse the disposable filter 36 Cleaning the iSleep 20 and Replacing the Filters iSleep 20 users manual Doc 004268 En Eu T 3 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 serv ice instructions by service technicians that have been authorized after Breas iSleep 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
29. ure sensor that continuously monitors output pressure to the patient and reference ambient pressure so that the device automatically will compensate for altitude changes Intended Use of the iSleep 20 3 Doc 004268 En Eu T 3 iSleep 20 users manual The Sleep 20 has a memory that stores the usage and can be downloaded by yout care 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 ke 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 cardiac failure or hypotension particularly if associated with
30. y 10 to 95 non condensing OPERATING CONDITIONS SPECIFICATIONS Recommended leakage 20 to 40 1 min at 10 cmH O Minimum leakage 12 l min at 4 cmH 0 DIMENSIONS SPECIFICATIONS WxHxD 173 x 172 x 209 mm with rear lid 173 x 172 x 201 mm with HA 01 humidifier Weight 1 3 kg with rear lid 1 4 kg with HA 01 humidifier Air outlet 22 mm male conical standard connector 40 Technical Specifications iSleep 20 users manual Doc 004268 En Eu T 3 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 the iSleep 20 The following Breas accessories are currently available for the Sleep 20 DESCRIPTION PART No Carrying bag 003793 Users manual 004268 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 41
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