iSleep 10 - CPAP Australia
Contents
1. En Eu T 3 11 Technical Specifications 11 1 Data i The iSleep 10 and it s packaging do not contain any natural rubber latex Doc 004266 En Eu T 3 SETTING VALUE RANGE SPECIFICATION RESOLUTION CPAP 4 to 20 cmH O 0 5 cmH O 15 of max value and 10 of set value Ramp time 5 to 60 min 5 min Ramp start pressure 4cmH O to CPAP 0 5 cmH O Maximum flow gt 125 l min Maximum limited 30 cmH O pressure during sin gle fault condition Max flowin CPAP 6 7 cmH O 77 l min mode 13 3 cmH O 113 l min 20 cmH O 138 l min Breathing resist 0 7 cmH 0 at 30 1 min ance under single 2 6 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 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 Technical Specifications 33 iSleep 10 users manual POWER SUPPLIES SPECIFICATION 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 3W ale 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 Altitude setting Low 1060 to 900 mb2. 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 10 Safety Information iSleep 10 users manual Doc 004266 En Eu T 3 2 8 Usage of Oxygen Doc 004266 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 10 the oxygen flow must be turned off when the Sleep 10 is not operating If the Sleep 10 is not in operation and the oxygen flow is left on oxygen delivered into the patient tubing may accumulate within the iSleep 10 enclosure Oxygen accumulated in the iSleep 10 enclosure will create a risk of fire 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 w
3. 0 The Sleep 10 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 1 2 Indications for Use The Sleep 10 is intended for non invasive use Intended Use of the iSleep 10 3 Doc 004266 En Eu T 3 Sleep 10 users manual 1 3 The iSleep 10 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 10 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 10 is intended to be operated by trained users and qualified person nel The iSleep 10 is not intended for life support or life sustaining applica tions or for transport of critical care patients Contraindications Therapy with the Sleep 10 should not be prescribed when the following spe cific diseases or conditions are present e Bullous lung disease e Pathologically low blood pressure e Severe cardiac arrhythmias e Coronary artery disease e Unstable angina pectoris e Decompensated cardiac failure or hypotension particularly if associated with intravascular volume depletion e R
4. 10 and Replacing the Filters oooooooocinnccccnnnnncccccnnncccnncnanancnnnanancnnn 28 9 1 Cleaning the iSleep 10 tual eae oad cence aed bus 28 9 2 Cleaning and Replacing the Patient Air Eiter 30 TO Maintenance 0 a 31 10 1 Regular Maintenance Control scort 31 10 2 Service and EE eege 32 10 3 ID ie EE 32 Ti Technical Specification it 33 Table of Contents 1 Doc 004266 En Eu T 3 Sleep 10 users manual 11 1 Data gt als 33 V2 ele EE 35 12 1 Breas Accessories List 35 13 Patient Settings ini iS 36 2 Table of Contents iSleep 10 users manual Doc 004266 En Eu T 3 1 Intended Use of the Sleep 10 WARNING iSleep 10 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 10 is operated and maintained before taking it into use to ensure correct usage maximum performance and serviceability WARNING Do not use the iSleep 10 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 1
5. Operating Time Total number of hours the iSleep 10 an has been operating e E LI 3 Software version 1 26 Setting up the iSleep 10 iSleep 10 users manual Doc 004266 En Eu T 3 8 Internal Function Error The indication function of the Sleep 10 consists of a message shown in the display window TEM DESCRIPTION Definition An internal function error will be given when the Sleep 10 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 30 High temperature Let the Sleep 10 cool down and restart The ambient temperature might be too high e 61 Check settings Check that the settings of the iSleep 10 are according to prescription Action The iSleep 10 will continue or stop the treatment depending on the type and priority of the event Indication The indication is asserted visible by a display mes sage 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 27 Doc 004266 En Eu T 3 Sleep 10 users manual 9 Cleaning the iSleep 10 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 10 All replaced parts must be dis posed of in accord
6. Table of Contents 1 Intended Use of the iSleep 10 ENEE innata paria 3 1 1 What is A oe eda ade cri phn eae aus 3 1 2 Indications for USE orders 3 1 3 ele Tee 4 1 4 About this Manual geegent aa gaa e een 5 2 Satelite 6 2 1 General User Precautions wsncaiosnontccairca tic ena deter iaa 6 2 2 Electrical Safety xcs aaa setae eee Sea ela at Mince hn toutes tas 7 2 3 Environmental Conditions 8 2 4 Usage of Patient Circuit 1er ii 9 2 5 Usage of ed io iodo 9 2 6 Cleaning and Maintenance An 10 2 7 Adverse E E len 10 2 8 Usage OF e E WEE 11 3 Product Descrip vs iii 12 3 1 El Bue El EE 12 3 2 The iSleep 10 s Front Panel Circa Ce 14 3 3 The iSleep 10 s Side Panels e 15 3 4 Equipment Designation and Safety Label ceeeeeeeceeeeeeeeeeeeeeeeeeeeeeeeeneaes 16 4 Functions and Parameters of the Sleep 10 17 4 1 SENJ CEET 17 5 Using the Sleep 1 0 EE EE 18 5 1 Checking the iSleep 10 before Use AEN 18 5 2 Switching the iSleep 10 On and On AEN 18 5 3 Using the MER ri bi 19 5 4 Using an External Ba aa ER 20 6 Preparing the iSleep 10 for USES miccional ed 22 6 1 Installing the iSleep E Li atra 22 6 2 Placing the iSleep 10 EE 23 6 3 Connecting the iSleep 10 to the Mains Supply cccceeesseeeeeeeeeeeeeeeeeneeees 23 6 4 Connecting the Patient Circuit cti ias 24 7 Setting up the iSleep WO ic a ata 25 7 1 Setting the Parameters ciao la ia 25 7 2 Viewing Device Information ai da 26 Internal Function dee 27 Cleaning the Sleep
7. ance with local environmental regulations regarding the disposal of used equipment and waste 9 1 Cleaning the iSleep 10 To avoid electrical shock disconnect the mains supply to the iSleep 10 before cleaning Do not immerse the iSleep 10 into any fluids A 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 10 Main Unit 1 Switch off the iSleep 10 and dis connect the mains supply 2 Remove the patient circuit 28 Cleaning the iSleep 10 and Replacing the Filters iSleep 10 users manual Doc 004266 En Eu T 3 3 Disconnect all cables 4 Clean the outside of the iSleep 10 using a lint free cloth and a mild detergent solution 5 Reconnect cables and the patient circuit Make sure all parts ate dry before the iSleep 10 is put into operation Patient Circuit 8 The patient circuit should be cleaned in accordance with the care provider s instruc tions 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 1 Place the dismantled parts in hot water containing washing up liquid 2 Remove fouling with a brush 3 Rinse parts thoroughly under running hot water 4 Shake water out of all parts 5 Dry the parts completely 6 Store in dust free location The patient circuit shall be replaced in intervals according to the ca
8. ar ambient pressure equal to approximately lt 500 m over sea level Medium 900 to 800 mbar approx 500 m to 1500 m High 800 to 700 mbar approx 1500 m to 2600 m 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 Weight 1 3 kg Air outlet 22 mm male conical standard connector 34 Technical Specifications Sleep 10 users manual Doc 004266 En Eu T 3 12 12 1 Doc 004266 En Eu T 3 Accessories Breas Accessories List 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 10 The following Breas accessories are currently available for the Sleep 10 DESCRIPTION PART No Carrying bag 003793 Users manual 004266 Patient tube 000245 Filter grey washable 004154 5 pcs Filter white disposable optional 004153 5 pes iMask 100 003971 iMask 200 003972 Breas one size headgear 003434 iSleep power supply 003772 EB 2 external battery pack 24 V DC including 004147 cable charger and bag External DC cable EB 2 003679 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 004138 Accessories 35 iSlee
9. e iSleep 10 yourself If you do so the manufacturer will no longer be responsible for the performance and safety of the iSleep 10 DEVIATION FROM THESE SERVICE INSTRUCTIONS MAY LEAD TO RISK OF PERSONAL INJURY 10 1 Regular Maintenance Control The iSleep 10 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 31 Doc 004266 En Eu T 3 Sleep 10 users manual 10 2 Service and Repair The service and repair of the iSleep 10 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 UL Authorized service workshops can order the Sleep 10 Service Manual that con tains all technical documentation required for the maintenance and service of the Sleep 10 10 3 Disposal The iSleep 10 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 32 Maintenance Sleep 10 users manual Doc 004266
10. ecent thoracic surgery Pneumothorax e Pneumomediastinum e Massive epistaxis or previous history of massive epistaxis risk of recurrence 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 4 Intended Use of the iSleep 10 iSleep 10 users manual Doc 004266 En Eu T 3 1 4 D Doc 004266 En Eu T 3 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 10 or per forming maintenance on the iSleep 10 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 Sleep 10 Care providers clinical personnel physicians and others who require a working knowledge of the 15leep 10 will find additional information on settings and func tions in the Clinicians Manual Icons In this manual icons are used to highlight specific information The meaning of each icon i
11. ep 10 is abnormally hot or emits an odour e The iSleep 10 therapy settings must always be based on medical advice and must be carried out by authorized clinical personnel only e Always perform the procedure Checking the Sleep 10 before Use on page 18 before use e Inadequate use of device or accessories may cause loss of treatment or decreased performance A e Clinical personnel and the patient must read the manual thoroughly and understand the usage of the iSleep 10 before setting up and using the iSleep 10 e Handle the iSleep 10 with care e Do not use the Sleep 10 while in bag 6 Safety Information iSleep 10 users manual Doc 004266 En Eu T 3 2 2 Electrical Safety Doc 004266 En Eu T 3 Do not operate the Sleep 10 if it has a damaged power cord power supply or casing The Sleep 10 may not work properly if any part has been dropped dam aged or submerged in water To avoid electrical shock disconnect the electrical supply to the iSleep 10 before cleaning Do not immerse the Sleep 10 into any fluids If an external battery is used it must be disconnected when the iSleep 10 is switched off Otherwise the battery will discharge The performance of the iSleep 10 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 Safety Information iSleep 10 users manual 7 2 3 Env
12. h 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 10 especially when changing patient Failure to replace or clean a dirty filter may cause the iSleep 10 to operate at higher temperatures than intended e When operating the iSleep 10 make sure that the air inlet and the filter is not obstructed or occluded Safety Information Doc 004266 En Eu T 3 Sleep 10 users manual 9 2 6 Cleaning and Maintenance The Sleep 10 shall be cleaned and maintained in accordance with this user manual Do not attempt to autoclave or sterilise the Sleep 10 The iSleep 10 shall be subjected to maintenance service and control and any applicable upgrades in accordance with Breas service instructions The iSleep 10 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 Sleep 10 yourself If you do so the manufacturer will no longer be responsible for the performance and safety of the Sleep 10 2 7 Adverse Patient Symptoms A If the patient experiences any of the following symptoms while using the iSleep 10 a physician or responsible clinician shall be contacted immediately Bloated feeling from excessive
13. hen the oxygen supply is shut off Safety Information iSleep 10 users manual 11 3 Product Description 3 1 Main Components The iSleep 10 system contains the following components OMI gi Creme S TCI 12 Product Description iSleep 10 users manual Doc 004266 En Eu T 3 No COMPONENT FUNCTION PART NO 1 Carrying bag Storage for transportation 003793 Ze Users manual Product and usage information 004266 3 Patient tube Tube for mask and iSleep 10 000245 4 iSleep power supply 003772 5 Filter white disposa Inlet air filtration 003762 ble optional 6 Filter grey washable Inlet air filtration 003693 7 iSleep 10 main unit Included in the iSleep 10 basic package Product Description 13 Doc 004266 En Eu T 3 Sleep 10 users manual 14 3 2 The Sleep 10 s Front Panel iSleep 10 4 5 6 No USER BUTTONS AND DISPLAYS FUNCTION 1 Start Stop Main unit On Off 2 Display window Mode and settings display 3 Function Menu navigation 4 Decrease Decrease setting 5 Increase Increase setting 6 Altitude Ramp start and stop Altitude setting Ramp func tion start and stop Product Description iSleep 10 users manual Doc 004266 En Eu T 3 3 3 The Sleep 10 s Side Panels No ITEM FUNCTION 1 Air outlet Air path out to the patient S Air inlet Air path in replaceable filters 3 Data connection Data cable connection only for service
14. ide the recommended operating conditions 8 Safety Information iSleep 10 users manual Doc 004266 En Eu T 3 2 4 Usage of Patient Circuit e Only use the Sleep 10 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 10 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 10 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 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 10 wit
15. inus buttons are used to alter a value e Standby mode The altitude button is used to set the altitude e Active mode The ramp button is used to activate the ramp function during opera tion Overview The iSleep 10 menu has the following layout Standby only Standby only CPAP view only L Ramp time _ _ Device E info Icons in the Display Window ICON EXPLANATION cH Pressure a Ramp Using the iSleep 10 19 iSleep 10 users manual 20 ICON EXPLANATION o Information D Panel lock 5 4 Using an External Battery The Sleep 10 can be powered from e 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 10 Make sure it is fitted correctly 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 10 from an external battery source e The battery must be disconnected when the Sleep 10 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 10 pressure setting The operation time is based on the following settings SETTING VALUE CPAP p
16. ironmental Conditions e Do not use the iSleep 10 in any toxic environment e Do not use the Sleep 10 in environments where there are explosive gases or other flammable anesthetic agents present A e The performance of the Sleep 10 may deteriorate at ambient temperatures below 5 C 41 F and above 40 C 104 F ambient relative humidity below 10 RH relative humidity and above 95 RH atmosphere pressure below 700 mbar and above 1060 mbat e Do not use the iSleep 10 while positioned in a warm place such as direct sunlight e 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 char 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 10 Radio emitting devices are for example cellular or cordless telephones microwave ovens and high frequency surgery apparatus e The iSleep 10 any accessories and all replaced parts must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste e The performance of the iSleep 10 and treatment of the patient may deteri orate if the operation conditions in Technical Specifications on page 33 are not fulfilled Do not use the iSleep 10 immediately after storage or transport outs
17. ized health care professional For more information about the Breas 15 leep 105 settings please contact your care S provider The CPAP setting can be set to 4 to 20 cmH O Setting the Parameters For more information about how to use the menu please read the chapter Using the menu on page 19 Study the overview picture in Using the menu on page 19 if a page or section can not be found The Ramp function Setting range 5 to 60 min Resolution 5 min Navigate to the Ramp section The ramp function can only be activated during operation Altitude Setting range low LO medium ME and high where HI is used for the highest altitude Press the altitude setting button and adjust setting with the and buttons r gt Setting up the iSleep 10 25 Sleep 10 users manual 7 2 Viewing Device Information Check the chapter Using the menu on page 19 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 Log Cot Ol The Device info section contains three information screens m A SE AL 1 Patient Operating Time S 11 Total number of hours a patient has e i been using the iSleep 10 for CPAP treatment ramp and mask off not UE ei included td 2 Total
18. k the patient air inlet at the side of the iSleep 10 Connecting the iSleep 10 to the Mains Supply Read the chapter Electrical Safety on page 7 carefully to make sure all conditions are fulfilled and considered Be To Connect the Sleep 10 to the Mains Supply 1 Plug the power supply into the power inlet of the Sleep 10 2 Connect the power supply to the mains supply Preparing the Sleep 10 for Use 23 Doc 004266 En Eu T 3 Sleep 10 users manual 6 4 Connecting the Patient Circuit A Read the chapter Usage of Patient Circuit on page 9 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 D In order to receive a suitable leakage the Breas iMask Nasal CPAP Mask is recommended 24 Preparing the iSleep 10 for Use iSleep 10 users manual Doc 004266 En Eu T 3 7 Setting up the Sleep 10 D 7 1 Doc 004266 En Eu T 3 The configuration of the iSleep 10 therapy settings must always be pre scribed by a licensed physician and carried out by an author
19. p 10 users manual 13 Patient Settings Patient Settings Breas iSleep 10 PAIGE tnd alata atin Dac A Alar tte dtm tans ete aha tate E eet ee bales Cite ae bata CUES EEES ENS DEED tt ae eae E Ate Sleep 10 Sera number laca ca ati CPAP ds Ramp Time ermitas Ramp Start Pressure ween 36 Patient Settings iSleep 10 users manual Doc 004266 En Eu T 3
20. purpose 4 DC inlet External DC power connection Doc 004266 En Eu T 3 Product Description 15 iSleep 10 users manual 16 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 10 to the patient X A 0123 CE marking applies in accordance with the direc tive MDD 93 42 EEC x Product Description iSleep 10 users manual Read Disposal on page 32 for information about recycling and disposal Doc 004266 En Eu T 3 4 Functions and Parameters of the Sleep 10 This chapter includes descriptions of the settings used for controlling the func tions of the iSleep 10 4 1 Settings All the parameters that are used for controlling the breathing by the iSleep 10 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 Altitude setting In order to achieve the correct pressure the altitude has to be selected The alti tude settings are divided in three different settings low medium and high Low 1060 to 900 mbar ambient p
21. re provider s instructions Check the patient circuit for damage regularly In case of damage replace the circuit Cleaning the iSleep 10 and Replacing the Filters 29 Doc 004266 En Eu T 3 Sleep 10 users manual 9 2 Cleaning and Replacing the Patient Air Filter The patient air filter is located on the side of the iSleep 10 There ate two types of filters g Y g 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 A Do not wash or reuse the disposable filter 30 Cleaning the iSleep 10 and Replacing the Filters iSleep 10 users manual Doc 004266 En Eu T 3 10 Maintenance WARNING Sleep 10 should be subjected to maintenance service and control and any applicable upgrades in accordance with Breas service instructions iSleep 10 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 Sleep 10 service training Do not under any circumstances attempt to service or repair th
22. ressure equal to approximately lt 500 m over sea level Medium 900 to 800 mbar 500 m to 1500 m High 800 to 700 mbar 1500 m to 2600 m Functions and Parameters of the iSleep 10 17 Doc 004266 En Eu T 3 Sleep 10 users manual 5 Using the iSleep 10 5 1 Checking the Sleep 10 before Use Always make the following checks before using the iSleep 10 1 Connect a cleaned or a new patient circuit to the Sleep 10 2 Connect the Sleep 10 to the mains supply 3 Check patient settings 4 Switch on the Sleep 10 by pressing the Start Stop button on the front panel Ensure that the Sleep 10 is running 5 Put on the mask and adjust its fit 6 Ensure that the settings are adjusted as prescribed The iSleep 10 is ready for use 5 2 Switching the iSleep 10 On and Off 1 Make sure the power supply Y is connected 2 Turn on the Sleep 10 by pressing UUUU the Start Stop button on the front L MAS panel for 2 seconds BT This operation switches the iSleep 10 between standby and operating mode The Sleep 10 is connected to a power supply when the text OFF is shown in the display 18 Using the Sleep 10 Sleep 10 users manual Doc 004266 En Eu T 3 5 3 a Doc 004266 En Eu T 3 Using the menu Read chapter The Sleep 10 s Front Panel on page 14 for exact position of the buttons Use the function button to toggle through the different functions of the iSleep 10 The plus and m
23. ressure 10 cmH O Ambient temperature 20 C 68 F Altitude Sea level Using the iSleep 10 iSleep 10 users manual Doc 004266 En Eu T 3 SETTING VALUE Battery status New battery fully charged BATTERY TYPE OPERATION TIME EB 2 24 V 7 2 Ah 13h Car battery 12 V 60 Ah 90 h When using a 12 V external power the iSleep DC converter 12 24 V needs to be used Using the iSleep 10 21 Doc 004266 En Eu T 3 iSleep 10 users manual 6 Preparing the iSleep 10 for Use A Read the chapter Safety Information on page 6 before setting up and using the iSleep 10 6 1 Installing the iSleep 10 When using the iSleep 10 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 22 Preparing the Sleep 10 for Use Sleep 10 users manual Doc 004266 En Eu T 3 6 2 Placing the iSleep 10 WN Read the chapter Environmental Conditions on page 8 carefully to make sure all conditions are fulfilled and considered 1 Place the iSleep 10 on a solid flat surface The iSleep 10 should be placed lower than the patient in order to prevent the device from falling on the user 2 Make sure that nothing can bloc
24. s explained in the table below ICON EXPLANATION Warning Risk of death and serious personal injury Caution Risk of minor or moderate injury Risk of equipment damage loss of data extra work or unexpected results Note Information that may be valuable but is not of critical impor tance tips ka OB Reference Reference to other manuals with additional information on a specific topic G Intended Use of the iSleep 10 iSleep 10 users manual 5 2 Safety Information 2 1 General User Precautions e The Sleep 10 should not be used for any kind of life support treatment e The Sleep 10 shall only be used by patients with spontaneous breathing e Ifyou 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 e The Sleep 10 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 e Do not use the Sleep 10 and contact your responsible 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 iSle
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