Table of Contents
Contents
1. eeessssssessseseeeeenee nennen nennen nnne Product returned PS UNUM AE E A Pr TECR HRS General See instruction ref Check OK Open new service record and identify CPAP device 2 2 1 p 6 Note number of total operating hours 22 1 Check all markings 2 2 2 di Check information from user 2 223 Check validity of documentation 2 2 A eee External Checks Inspect for external damage and wear 23 4 p 7 2 2 4252 Check the HA01 humidifier if used iSleep 20 only 2 3 2 Check power connection 2 3 3 Inspect patient circuit 2 3 A anes Inspect the CPAP device accessories 2 3 5 Change wash the patient filters 23 6 4 52 Perform minimum function check 23 04 0 nee Internal Checks when required Clean inside of the CPAP device 24 1 p 8 Check cabling 24 2 2e Check fastening of components 243 Check the power supply 24 4 eee Reassemble the casing 245 s Complete Function Check Check the pressure 251 ux Check the snooze function iSleep 20 only D ca Adjust settings for patient 253 Notes 36 Appendices Breas iSleep 10 20 Service Manual Doc 004284 En X 1 9 4 Returning Products to Breas You may need to return the CPAP device components or accessories to Breas Medical AB for serv ice warranty upgrade or repair In this case follow the instructions below to ensure that the correct action is taken to avoid unnecessary del2. Parts Location Breas iSleep 10 20 Service Manual 15 16 Functional Diagrams LCD Display controller Buttons Control logic LED iSleep 20 only Blower amplifier Pressure transducer iSleep 20 only Power control ea 5 Electrical connection Pneumatic connection Functional Diagrams Breas iSleep 10 20 Service Manual analog out Com port This chapter contains a diagram of the pneumatic system of the CPAP device and a block diagram of the iSleep 10 20 s functions The functional block diagram below shows how the electronics and pneumatics are designed and how they ate connected to the other components Doc 004284 En X 1 The table below describes the components of the pneumatic diagram No DESCRIPTION Air inlet filter Blower Silencer box iSleep 10 20 casing Pressure sensor iSleep 20 only Humidifier optional iSleep 20 only Patient tube Leak holes Oo CO NL C HY BY WY N Mask 4 1 Filtering Smoothing Techniques FUNCTION TECHNIQUE DESCRIPTION Pressure Low pass average time constant 16 ms 4 2 iSleep 10 20 Measuring and Display Devices DEVICE PURPOSE TYPE RANGE RESOLUTION ACCURACY SENSING POSITION Pressure Regulate Differential 1
3. 2 1 Reading the Error Codes When an internal function failure occurs a four digit error code will be stored in the iSleep 10 20 ertor log The function failure will also generate a message shown on the display You need the tSlep Vivo Service Software fo access the error log 8 2 2 Error Code Tables Error Codes Shown on the Display The table below lists the error codes and the corresponding text that can be shown on the LCD dis play The problem is explained together with the action that is necessary to correct the problem see also Internal Error Codes Not Shown on the Display iSleep 20 only on page 29 If more than one action is listed the actions should be performed in the order in which they are listed For example if action no 1 does not solve the problem you should continue with action no 2 and so on See Opening the iSleep 10 20 and Replacing the Main Components on page 18 for information about how to replace the circuit board ESO TEXT ON LCD DISPLAY PROBLEM ACTION CODE 20 Er20 Internal function failure 1 Restart the iSleep 10 20 by dis connecting and reconnecting the power supply 2 Perform an internal inspection 3 Replace the circuit board or send the iSleep 10 20 for service 21 Er21 Power supply voltage out Check the power supply of range 28 E128 Humidifier not heating 1 Replace the HA 01 humidifier iSleep 20 only 2 Perform an internal inspection 3 Replace the circuit boatd or send the iSleep 10 20 fo
4. 4 Recommended separation distances between portable and mobile RF communi cations equipment and the iSleep 10 20 The iSleep 10 20 are intended for use in an electromagnetic environment in which radiated RF dis turbances are controlled The customer or the user of the iSleep 10 20 can help prevent electro magnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the iSleep 10 20 as recommended below according to the maximum output power of the communications equipment RATED MAXIMUM OUTPUT SEPARATION DISTANCE ACCORDING TO THE POWER OF TRANSMITTER W FREQUENCY OF TRANSMITTER M 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz d 0 27 4P m d 0 27 4P m d 0 54 P m 0 01 0 03 0 03 0 05 0 1 0 08 0 08 0 17 1 027 0 27 0 54 10 0 85 0 85 1 7 100 2 7 PA 5 4 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer 9 1 5 Notes At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 34 Appendices Br
5. REMEDIAL ACTION SEE REF The iSleep 10 20 The power cord is not Connect the power cord 6 3 in does not start properly connected iSleep 10 20 Clinician s manual The DC fuse on the circuit Replace the circuit board and 5 3 p 20 boatd has blown check the power supply The power supply is not Check the power transformer 24V DC External battery discharged Charge external battery The external battery cable is 1 Connect the cable not connected properly oris 2 Measure the voltage RU 3 Replace the cable if faulty Battery polarity faulty Check polatity May be the case if fuse blows immediately after connecting to external battery cable TheiSleep 10 20 External leaks from patient Check the tubes connectors 2 3 P7 does not give the circuit or nasal mask and mask for leaks adequate pres Internal leaks from tubes Check the tubes air channels 2 4 p 8 S humidifier or air channels and the humidifier Air inlet is blocked Check filter and air channels Pressureindicator The internal supply tube is Check the tubes 2 4 p 8 shows no pressure blocked or loose reading a En The circuit boatd is faulty Replace the circuit board 5 3 p 20 The clock resets The clock battery discharged Replace the clock battery 5 4 p 21 when having dis connected the power supply iSleep 20 only Doc 004284 En X 1 Fault Tracing 27 Breas iSleep 10 20 Service Manual 28 8 2 Function Failure Error Codes 8
6. meaning of each icon is explained in the table below 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 importance tips Reference Reference to other manuals with additional information on a specific topic GG Ow 4 Introduction Breas iSleep 10 20 Service Manual Doc 004284 En X 1 2 Service Instructions The iSleep 10 20 is designed to give users many years of trouble free breathing assistance The iSleep 10 20 requires no periodic maintenance This chapter describes all the checks and additional service instructions for the iSleep 10 20 WARNING This product must be repaired and or modified in accordance with Breas service man uals technical bulletins and any special service instructions by service technicians that have been authorised after the Breas iSleep 10 20 service training or have an equivalent technical knowledge on medical respiratory devices Deviation from these service instructions may lead to risk of personal injury The patient and care provider should follow the checks that are described in the iSleep 10 20 User and Clinician s Manual 2 4 Introduction Before you start a service read the safety precautions and make sure you have a new service record and all the necessary equipment t
7. strength in the location in which the iSleep 10 20 is used exceeds the applicable RF compliance level above the iSleep 10 20 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the iSleep 10 20 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 32 Appendices Breas iSleep 10 20 Service Manual Doc 004284 En X 1 9 1 3 Guidance and Manufacturer s Declaration Electromagnetic Emission Doc 004284 En X 1 The iSleep 10 20 are intended for use in the electromagnetic environment specified below The cus tomer ot the user of the iSleep 10 20 should assure that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions Group 1 The iSleep 10 20 use RF energy only for its internal func CISPR 11 tion Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equip ment RF emissions Class B TheiSleep 10 20 ate suitable for use in all establishments CISPR 11 including domestic establishments and those directly con mI Class A nected to the public low voltage power supply network akion that supplies buildings used for domestic purposes TEC 61000 3 2 Voltage Complies fluctuations flicker emission TEC 61000 3 3 Appendices 33 Breas iSleep 10 20 Service Manual 9 1
8. the Patient Filters 1 Change the white air filter if used 2 Change or wash the grey filter if necessary Minimum Function Check 1 Connect the power cord 2 Connect the patient circuit 3 Start the CPAP device and make sure it operates normally Service Instructions 7 Breas iSleep 10 20 Service Manual ag 2 4 2 2 4 3 2 4 4 2 4 5 Internal Inspection Perform an internal inspection if having opened the iSleep 10 20 Make sure to disconnect the power supply before opening the casing of the CPAP device Cleaning the Inside of the CPAP device 1 Open the casing See Opening the iSleep 10 20 and Replacing the Main Components on page 18 for instructions 2 Remove any dirt or dust that has collected in the CPAP device casing 3 Open the dark grey air channel top by pulling it straight up and remove any dirt or dust Press the air channel back in place and Q make sure it fits propetly 4 Checking the Cables Inspect all the cables and their connectors Check the front and rear panels to make sure that the cables and the wires are not pinched or kinked Checking the Fastening of Components Make sure that all the components such as the circuit board the connectors and the tubings iSleep 20 only are securely fastened Checking the Power Supply Make sure that the power connector is undamaged and that it is securely in place Reassembling the Casing See Opening the iSleep 10 20 and Replacing the
9. 0 to 0 1 cmH20 0 1 FSS Air outlet sensing pressure to ambient 60 cmH5O of iSleep Pressure Indicate patient LCD 0 to 20 cmH5O 0 1 cmH20 0 5cmH 0 Air outlet display pressure of iSleep Doc 004284 En X 1 Functional Diagrams Breas iSleep 10 20 Service Manual 17 5 Opening the iSleep 10 20 and Replacing the Main Components P Make sure to disconnect the power supply before removing the casing of the CPAP device 5 1 Opening the iSleep 10 20 o Before closing the iSleep 10 20 perform an internal inspection see Internal Inspection on page 8 e Always perform a complete function test after reassembling the iSleep 10 20 see Complete Function Test on page 9 Always perform an electrical safety test after reassembling the iSleep 10 20 see Electrical Safety Precautions on page 11 Make sure that the iSleep 10 20 is placed on a non scratching surface Make sure that the tubes are not pinched or kinked when closing the iSleep 20 1 Remove the rear lid ot the HA01 humidi fiet if used iSleep 20 only 2 Remove the six screws for the casing 18 Opening the iSleep 10 20 and Replacing the Main Components Breas iSleep 10 20 Service Manual Doc 004284 En X 1 3 Lift the back casing straight up and tilt it backwatds onto the table 4 Reassemble in reverse order Make sure that the inlet and outlet tubes are properly fitted The outlet tube should be pointing slightly upwards when fitted to the ba
10. 1053 Failed to write parameters to flash Er20 1054 Failed to erase a block in flash Er20 1055 Failed to erase a block in flash Er20 1056 Failed to write log data to flash Er20 1057 Flash memory contains no data Er20 1058 Flash memory is full Er20 1059 Flash data is corrupt Er20 1100 1199 LCD error Er20 1200 1299 Initiate error Er20 1300 Selftest error Er20 1301 Humidifier temperature is not rising Er28 1350 Critical selftest error Er20 1351 A D channel error Er20 1352 RAM error Er20 Doc 004284 En X 1 Fault Tracing Breas iSleep 10 20 Service Manual 29 ERROR Sono PROBLEM ERROR CODE ON DISPLAY 1353 FLASH error Er20 1354 Timer error Er20 1355 Motor voltage out of range at start up Er20 1356 Motor current out of range at start up Er20 1357 Motor phase E120 1358 Motor phase Er20 1359 Motor phase Er20 1360 Pressure to high Er20 1361 Motor current too high when operating Er20 1362 VCC too high Er21 1363 VCC too low Er21 1364 Motor sense too high in stand by mode Er20 1365 CPU voltage too high Er20 1366 CPU voltage too low Er20 1367 Adapter sense too low E120 1368 VCC Adapter voltage is out of range E120 1369 Internal temperature too high Er30 1370 Internal temperature too low Er20 1371 Adapter ground potential too low Er20 1372 Adapter ground potential too high Er20 1373 Adapter out voltage too high in stand by mode Er20 1374 Pressure
11. 5 8 Fa lt Tracing ec EE 27 8 1 Fault Tracing Table o teresa se uty eines eiecit punto ge Reano ins 27 8 2 Function Failure Error Codes ccccccecccecceecececececeeeeceeeeeeceeeeeeeeeeeeeeeeeeeteess 28 8 2 1 Reading the Error COGOGS ui ores tutus Leste Oboe Dro o eno eden 28 8 2 2 Error Code Tables ou cccccccccscccscccecccecceecceceececceeceeceeeceeseeeeeeeeseness 28 9 Appendices 21 2 d rto dote eee eher aed ee Roe n D Eee e er teer t Prot dp HE dts 32 9 1 Emission and Immunity Declaration ssseee 32 9 1 1 Guidance and Manufacturer s Declaration Electromagnetic Dni T 32 9 1 2 Notes 3t omittere artt Ete acetates 32 9 1 3 Guidance and Manufacturer s Declaration Electromagnetic EMISSION c issccies nist e Eee Ies eg eU e Een ME a te deb e eds 33 9 1 4 Recommended separation distances between portable and mobile RF communications equipment and the iSleep 10 20 34 9 1 5 NOTOS ciere di Fein en RH ERR YR AREE RAQYTE An RE trent OMEN SER ATH ORV EvDH ERO EERS 34 9 2 CPAP Pressure Volume Data sise isiiaseiaot nran netos piana S 35 9 2 1 Sleep WO re a E a A E E aE 35 9 2 2 Sleep 2D er 35 9 3 Service Record iSleep 10 20 sssssssssssssssseseeeee nee 36 9 4 Returning Products to Breas 23d hpc nee Pate boue deridet ed cep rasta 37 9 5 Product Return Form Breas iSleep 10 20 CPAP device 38 2 Table of Contents Breas iSleep 10 20 Servic
12. Main Components on page 18 for instructions 8 Service Instructions Breas iSleep 10 20 Service Manual Doc 004284 En X 1 Complete Function Test You can also perform the complete function test using the SSleebl Vivo Service Sofimare ig 2 5 To perform a complete function test all tasks in this section needs to be completed in the written order 2 5 4 Checking the Pressure 1 Connect a 4mm restrictor and a pressure manometer to the iSleep 10 20 Leakage 4mm hole Pressure manometer SETTING VALUE 2 Adjust the settings as follows CPAP 4 cmH O 3 Start the iSleep 10 20 and let it run for 30 minutes before the test 4 Measure and check that the measured value for pressure is correct iSleep 10 tolerance 5 of the maximum value and 10 of the set value iSleep 20 tolerance 1 cmH5O 5 Change the CPAP pressure to 10 cmH O and repeat the measuring 6 Change the CPAP pressure to 15 cmH O and repeat the measuring 7 Change the CPAP pressure to 20 cmH5O and repeat the measuring If the measured pressure values ate not within tolerance perform a pressute calibration adjustment of the CPAP device see Upgrade and Calibration on page 23 Service Instructions 9 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual 2 5 2 Checking the Snooze Function iSleep 20 only 1 Start the iSleep 20 Shortly press the on off button Check that the iSleep 20 reduces pressure and that the fan symbol d starts
13. Table of Contents 1 Doc 004284 En X 1 Introduction x ai 3 1 1 About the iSleep 10 20 CPAP device ssssssss HH 3 1 1 1 gigi ect 3 1 1 2 Intended US 5 ioo meto pee do etate ra OUR DU Rua RN Feed 3 1 1 3 Big 3 1 1 4 Service Personnel s Training Requirements sssse 3 1 2 PADOUT this Manual ac ait nonton code deb cote enema tinet ire vane Ee Rte anahi E das nane 4 1 2 1 SCOPES ERE 4 1 2 2 Intended AUdIGFrCB txt Foto erp reete tech teni Re bienes 4 1 2 3 ICONS i essent e ee nm RE ah MN t SD a Ms 4 Serice NSU ONOS 552s ee cance hawt NC DNE LR 5 2 1 Introduction EN 5 2 1 1 Safety Precaution S aiaee painitan taaa acne Dese tony thantess ans 5 2 1 2 Service Record uci e t P REO eM UD ete ern ab uta latens 5 2 1 3 Inspection Equipment and Tools cccccscccccccecceceeeeeeeeeeeeeeeeeees 5 2 1 4 Replacement Parts sss 6 2 2 Preparing for Inspection serdara a aa a a a aaa 6 2 2 1 initial Recording ie oi E rat o he Pac e iae de ee aek ak 6 2 2 2 Inspecting the Markings 22 Sect qer c HDi tein esaet dy oic 6 2 2 3 Information from the Patient User ssseeeeeeeeeee 6 2 2 4 Validity of the Documentation eese 7 2 3 External Inspection serrie eee 7 2 3 1 Visual Inspection for External Damage and Wear 7 2 3 2 Checking the HA01 Humidifier if used iSleep 20 on
14. ays 1 Pack the product in its original packing If this is not available pack the product in packaging suitable for the transportation to Breas Medical AB 2 Take a photocopy of the delivery report on the next page 3 Fill out the delivery report and pack it together with the product to be returned Product damage caused by poor packaging or during transportation is not covered by the factory warranty Appendices 37 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual 9 5 Product Return Form Breas iSleep 10 20 CPAP device Customer information Product information Model Serial no Total operating hours 38 Appendices Breas iSleep 10 20 Service Manual Doc 004284 En X 1
15. blinking Shortly press the on off button Check that the iSleep 20 delivers the set pressure Shortly press the on off button so that the snooze function activates Create a spontaneous breath ON Oo PR W N Check that the iSleep 10 20 delivers the set pressure Read more about the Snooze function in the iSleep 20 Clinicians manual 2 5 3 Adjusting the Settings for the Patient Adjust the settings as prescribed for the patient 10 Service Instructions Breas iSleep 10 20 Service Manual Doc 004284 En X 1 2 6 Doc 004284 En X 1 Electrical Safety Precautions Electrical safety measurements must be made in accordance with IEC 601 Use an automatic electrical safety tester to make the measurements All tests must be performed in accordance with class II type BE Supply Voltage Note the power voltage reading The voltage must be noted at each service check as the currents measured are directly in relation to the supply voltage This allows all measurements made on the same CPAP device to be compared with measurements made on different occasions Insulation The insulation resistance is measured using a 500 V DC power supply The most suitable method is to connect the plus lead to the two CPAP device power socket pins and the minus lead to the casing or the patient air connector The measurements made during the delivery inspection can be used as reference values for measurements made during future services If no referenc
16. ck casing SF MS 5 2 Replacing the Complete Blower Assembly 1 Open the iSleep 10 20 as in section 5 1 2 Disconnect the cabling for the BLDC motor control Opening the iSleep 10 20 and Replacing the Main Components 19 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual 3 Disconnect the pressure sensing tube iSleep 20 only f La T ME 4 Lift the blower assembly straight up Remove the old pressure sensing tube from the circuit board and connect the one that is attached to the blower assembly iSleep 20 only 5 Reassemble in reverse order 5 3 Replace the Circuit Board The iSleep 10 20 serial number needs to be programmed into the new circuit board after replacement 8 You need the iSleep Vivo Service Software to program the circuit board with the correct serial number 1 Open the iSleep 10 20 as in section 5 1 2 Disconnect the cabling for the humidifier Sleep 20 only 20 Opening the iSleep 10 20 and Replacing the Main Components Breas iSleep 10 20 Service Manual Doc 004284 En X 1 3 Remove the five sctews for the circuit boatd 4 Lift the circuit board by it s edges straight up 5 Reassemble in reverse order Remove the pressure sensing tube from the old circuit board and attach it to the new one iSleep 20 only 5 4 Replace the Clock Battery iSleep 20 only 1 Open the iSleep 20 as in section 5 1 and move the blower assembly from the circuit board so y
17. d on the set tings and pressure iSleep 20 also monitors the reference ambient pressure so that the device auto matically will compensate for altitude changes 1 1 4 Service Personnel s Training Requirements Service personnel working with the iSleep 10 20 should have medical technical training and a good knowledge of the construction and function of respiratory devices Always contact your Breas representative if you have any questions or if any training is required Introduction 3 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual 1 2 About this Manual 1 2 1 Scope This manual desctibes all the checks and the additional setvice actions for the iSleep 10 20 The manual contains all the documentation that is required for the service of the CPAP device Breas Medical AB reserves the right to make changes to the products and or the contents of this manual without any prior notice 1 2 2 Intended Audience This service manual is intended for service technicians who have medical technical training and who have a good knowledge of the construction and function of respiratory devices Always contact your Breas representative if you have any questions or if any training is required The service manual is not intended for clinical personnel or patients who will find all the information UN they need in the iSleep 10 20 Clinician s and User Manual 1 2 3 Icons In this manual icons are used to highlight specific information The
18. e Manual Doc 004284 En X 1 1 Introduction This chapter gives an overview of the iSleep 10 20 CPAP device and this service manual WARNING This product must be repaired and or modified in accordance with Breas service man uals technical bulletins and any special service instructions by service technicians that have been authorised after the Breas iSleep 10 20 service training or have an equivalent technical knowledge on medical respiratory devices Deviation from these service instructions may lead to risk of personal injury 1 4 About the iSleep 10 20 CPAP device 1 1 1 Function The iSleep 10 20 is a CPAP system that provides a continuous positive airway pressure This can prevent the user s upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction The iSleep 20 has a pressure sensor that continuously monitors output pressure to the patient and reference ambient pressure so that the device automatically will compensate for altitude changes The internal memory of the iSleep 20 can be downloaded to a PC where you can view the patient compliance data in the Breas iSleep PC Software 1 1 2 Intended Use For a detailed description on intended use refer to the iSleep 10 20 Clinician s or User Manuals 1 1 3 Design The iSleep 10 20 is constructed around a blower assembly A microprocessor controls the speed of the blower motor by means of calculations base
19. e values are available the value for the insulation resistance should be gt 20 MQ Leakage Currents The leakage currents are measured at different parts of the CPAP device using an RC circuit to earth Make the measurements partly at normal case NC and at the single fault condition SFC Reverse the polarity of the power supply and note the highest value Leakage currents to earth must not exceed the stated limit values Leakage Currents from the Casing The leakage current of the casing is measured at an unpainted point for example the head of a screw Limit values NC lt 0 1 mA SFC lt 0 5 mA Break neutral for SFC Patient Leakage Currents The patient leakage current is measured between the patient connector and earth Limit values NC lt 0 1 mA SFC lt 0 5 mA Break neutral for SFC Leakage Currents with Mains Power Supply at the Patient connected Part This test must be done using an automatic electrical safety tester with this function See the safety instructions for the tester Limit value SFC lt 5 mA Service Instructions Breas iSleep 10 20 Service Manual 3 Parts Location This chapter contains part number lists and drawings of the parts for the iSleep 10 20 3 14 Parts Drawing 1 Main Components Accessory Humidifier HAO01 iSleep 20 only iSleep 10 iSleep20 ELL CON For definitions of the part numbers refer to the parts list in section 3 5 Parts List for the
20. eas iSleep 10 20 Service Manual Doc 004284 En X 1 9 2 CPAP Pressure Volume Data The values have been produced during a test whete the iSleep 10 20 have been attached to a 0 5 litre test lung simulating a sinusoidal breathing pattern with 20 breaths minute 9 2 1 iSleep 10 Average Value and Variation of Air Pressure at the Patient Air Outlet VOLUME PRESSURE BREATHING RATE AVERAGE VALUE VARIATION L P CMH20 F MIN cMH20 CMH20 0 5 1 Pmax 65 20 7 2 52 0 5 pudo 20 142 7 3 0 5 Pinay 720 0 20 21 8 9 2 9 2 2 iSleep 20 Average Value and Variation of Air Pressure at the Patient Air Outlet VOLUME PRESSURE BREATHING RATE AVERAGE VALUE VARIATION L P CMH20 F MIN CMH20 CMH20 0 5 V Pmax 6 5 20 6 99 2 48 0 5 abra 13 20 13 35 1 14 0 5 Pinay 720 0 20 20 26 1 42 Doc 004284 En X 1 Appendices 35 Breas iSleep 10 20 Service Manual 9 3 Service Record iSleep 10 20 Use a photocopy of this service record for the inspections described in Service Instructions on page 5 Use the next page for comments and notes Service record no MOG TATUS NIUNIT Serial no Inventory HO eiiis eeex rd imadax ii au eco ces AGCOSSOMES oes ELS Delivery date Total operating NOUMS ccscccecccecceecceecceeccaeeeeeeeeeeeeeeeeeeess Service started gc Service completed Signature
21. g 3 Tube connections iSleep 20 only 13 3 4 Parts Drawing 4 Front Casing Circuit Board sssesesssss 14 3 5 Parts List for the iSleep 10 and iSleep 20 ssssssmmMBBR 14 F n tional DIAG cu Ht 16 4 1 Filtering Smoothing Techniques eeeeeeeeeeceneneeneeeee eene tendens 17 4 2 iSleep 10 20 Measuring and Display Devices sseeeeeesess 17 Table of Contents Breas iSleep 10 20 Service Manual 1 5 Opening the iSleep 10 20 and Replacing the Main Components 18 5 1 Opening the iSleep 10 20 sss eene 18 5 2 Replacing the Complete Blower Assembly sseeseeeee 19 5 3 Replace the Circuit Board ssssssssss HH 20 5 4 Replace the Clock Battery iSleep 20 only seeeeees 21 5 5 Replacing the Keypad cscs iiss ertet er nne a ose dicis quse Maan 22 6 Upgrade and Calibration x ierat tet ett ode tto p tone ha perti ater bleue erede 23 6 1 Firmware Upgrade ere dices cre ter ERR ERI ER IR SE RC RO eR mr HD manned 23 6 2 Pressure Calibration te tne mee pe e de oe La Re eut 23 7 Electronics iioii e od n ERR devs DRM TNR INR MORIR RERO RM Re ERROR RR ERR RHLR TOP YLE EORR ERHA 24 7 1 Main Cabling DI amp agralTi oed oe Etro Sed cued Ue Denon tre tans tension didt bcc 24 7 2 Circuit Board Description sess eee 2
22. iSleep 10 and iSleep 20 on page 14 12 Parts Location Breas iSleep 10 20 Service Manual Doc 004284 En X 1 3 2 Parts Drawing 2 Back Casing Blower Unit 9 2 iSleep 10 12 iSleep 10 10 2 iSleep 20 13 iSleep 20 5 iSleep 10 only 2 11 2 2x iSleep 20 only 11 1 iSleep 20 only 1 iSleep 10 1 iSleep 20 For definitions of the part numbers refer to the parts list in section 3 5 Parts List for the iSleep 10 and iSleep 20 on page 14 3 3 Parts Drawing 3 Tube connections iSleep 20 only 10 3 104 106 105 7 EA Z2 For definitions of the part numbers refer to the parts list in section 3 5 Parts List for the iSleep 10 and iSleep 20 on page 14 G Parts Location 13 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual 3 4 Parts Drawing 4 Front Casing Circuit Board 7 5 iSleep 10 7 6 iSleep 10 7 2 iSleep 10 7 3 iSleep 10 14 iSleep 10 8 5 iSleep 20 8 6 iSleep 20 8 2 iSleep 20 8 3 iSleep 20 15 iSleep 20 iSleep 10 7 4 iSleep 10 D 3 iSleep 20 8 4 iSleep 20 7 1 iSleep 20 only 8 1 6 1 11 For definitions of the part numbers refer to the parts list in section 3 5 Parts List for the iSleep 10 and iSleep 20 on page 14 3 5 Parts List for the iSleep 10 and iSleep 20 The parts and service kits of the iSleep 10 and iSleep 20 are listed in the table below BREAS Kir N
23. ly 7 2 3 3 Checking the Power Connection 020 ecesecccceeeeeeeeeseeeeceeeeeeeesenenes 7 2 3 4 Inspecting the Patient Circuit eene 7 2 3 5 Inspecting the CPAP Device Accessories sseseeeeese 7 2 3 6 Changing Washing the Patient Filters eeeeesseessseesss 7 2 3 7 Minimum Function Check asas itin I ntoa tot be i tatit diane daietr ans 7 24 Internal Inspection ssssesssse Hee 8 2 4 1 Cleaning the Inside of the CPAP device eeen 8 2 4 2 Checking the Cables entente rne dentata pa adn 8 2 4 3 Checking the Fastening of Components eeesseeess 8 2 4 4 Checking the Power Supply 2 cccccseseeseccceeeeeeeeeeseeeeseeeeeeeneesees 8 2 4 5 Reassembling the Casing trece eee eee sgbeucaededbeetedudnens ad 8 2 5 Complete Function Test cccscessecceeeceeeeceeeeeeeaaeeaaeeaaeeaaecaeeaaeeeaeeeaeeeaeeeeeeeas 9 2 5 1 Checking the Pressure secas e oco aiaa ue Mtr edu 9 2 5 2 Checking the Snooze Function iSleep 20 only 10 2 5 3 Adjusting the Settings for the Patient eeen 10 2 6 Electrical Safety Precautions eese enn rnnneete nnn 11 Prats QO AUOM RT T Y 12 3 1 Parts Drawing 1 Main Components ssssseeeem 12 3 2 Parts Drawing 2 Back Casing Blower Unit ssesseeeessss 13 3 3 Parts Drawin
24. n the recommended separation distance calcu lated from the equation applicable to the frequency of the transmitter IMMUNITY IEC 60601 COMPLIANCE TEST TEST LEVEL LEVEL RECOMMENDED SEPARATION DISTANCE Conducted RF 3 Vms 10V d 0 27 4P m IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3V m 10 V m d 0 27 VP m at 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to d 0 54 4P m at 800 MHz to 2 5 GHz 2 5 GHz Equation description P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recom mended separation distance in metres m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey should be less than the compliance level in each frequency range tex Interference may occur in the vicinity of A equipment marked with this symbol 9 1 2 Notes e Ac80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless tele phones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast can not be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field
25. ntact Breas technical support for more information 2 1 4 Replacement Parts The following replacement parts should be available when servicing the CPAP device DESCRIPTION PART No Patient air filter grey washable 004154 5 pcs Patient air filter white disposable 004153 5 pes If required Clock battery CR 2032 iSleep 20 only 002129 2 2 Preparing for Inspection 2 2 1 Initial Recording Copy a new service record see Service Record iSleep 10 20 on page 36 Identify the iSleep 10 or iSleep 20 Note the model and serial number and any inventory number on the service record Check any comments recorded on the previous service records Document the current patient settings aoa h WN Note the number of Total operating hours on the service record The operating hours are found at the Device information screen Access the Device information LN using the menu as described in tbe iSleep 10 20 Clinicians Manual 2 2 2 Inspecting the Markings Make sure that all markings on the CPAP device s information labels can be read e Model description serial number Warning texts e Any inventory marking Any other texts 2 2 3 Information from the Patient User Check the following with the patient e Has the CPAP device functioned without any problems If not what were they How does the patient care providet check the function of the CPAP device How often How often is the filter replaced e Ho
26. o DESCRIPTION B AMOUNT 1 Air outlet patient assembly 004116 1 2 Suspension noise box 004202 1 3 Battery CR2032 3V iSleep 20 only 002129 1 4 Friction pad 003692 1 5 Plug RJ45 8 iSleep 10 only 003733 1 6 Screw kit iSleep 004296 6 1 Screw STS T30x8 FZB 11 7 Case front kit iSleep 10 004295 7 1 Case front 1 7 2 Window iSleep 10 1 7 3 Keypad 1 14 Parts Location Breas iSleep 10 20 Service Manual Doc 004284 En X 1 BREAS Kir No DESCRIPTION p AMOUNT 7 4 Ait channel 1 7 5 Logotype iSleep 1 7 6 Insulation air channel 1 8 Case front kit iSleep 20 004287 8 1 Case front 1 8 2 Window iSleep 20 1 8 3 Keypad 1 8 4 Air channel 1 8 5 Logotype iSleep 1 8 6 Insulation air channel 1 9 Tube kit iSleep 10 004368 9 1 Tube outlet 1 9 2 Tube inlet 1 10 Tube kit iSleep 20 004288 10 1 Tube outlet 1 10 2 Tube inlet 1 10 3 Silicone tube Yellow short 1 10 4 Silicone tube Yellow long 1 10 5 Silicone tube Pink 1 10 6 Barbed tube connection 1 11 Lock device kit iSleep 20 004289 11 1 Lock device 1 11 2 Spring conical 2 12 Blower assembly iSleep 10 004225 1 13 Blower assembly iSleep 20 004226 1 10 3 Silicone tube Yellow short 1 10 4 Silicone tube Yellow long 1 10 5 Silicone tube Pink 1 10 6 Barbed tube connection 1 14 CPU board iSleep 10 003771 1 15 CPU board iSleep 20 003767 1 Doc 004284 En X 1
27. offset compensation out of range E120 1376 Humidifier temperature too high E129 1377 Inverse copy of parameters is corrupt Er20 1378 Inverse copy of time is corrupt Er20 1379 Inverse copy of date is corrupt E120 1380 Error buffer has been overrunned Er20 1400 1499 Log error Er20 1651 Set pressure out of range Er61 1652 Tried to set pressure above 20 cmH O Er61 1653 Set pressure out of range Er61 1654 Start ramp pressure out of range Er61 1655 Set humidifier out of range Er61 30 Fault Tracing Breas iSleep 10 20 Service Manual Doc 004284 En X 1 ERROR Sono PROBLEM ERROR CODE ON DISPLAY 1666 An old set of parameters is restored Er61 1667 Parameters has been set to default Er61 1700 1799 MMI error Er20 1850 Motor fault Er20 1851 High RPM might generate too high pressure Er20 2000 2099 Errors codes used for testing only E120 Doc 004284 En X 1 Fault Tracing Breas iSleep 10 20 Service Manual 31 9 A Appendices 9 1 Emission and Immunity Declaration According to TEC 60601 1 2 2001 A1 2004 9 1 1 Guidance and Manufacturer s Declaration Electromagnetic Immunity The iSleep 10 20 are intended for use in the electromagnetic environment specified below The cus tomer or the user of the iSleep 10 20 should assure that it is used in such an environment Portable and mobile RF radio frequency communications equipment should not be used no closer to any part of the iSleep 10 20 including cables tha
28. ools and replacement parts at hand It is important that any peripheral equipment is checked at the same time as the services are carried out 2 1 4 Safety Precautions Follow the safety precautions below when working with the iSleep 10 20 Do not work on the CPAP device with the casing removed and the power supply connected unless the instructions in this manual clearly says so e Always use caution when working with the CPAP device connected to the mains and the casing removed Donotuse explosive gases and or fluids near the CPAP device e Make sure that all precautions to prevent electrostatic discharge ESD have been taken Follow all regulations regarding ESD The iSleep 10 20 User and Clinician s Manuals contains extended lists of safety precautions 2 1 2 Service Record The iSleep 10 20 service record is found in Service Record iSleep 10 20 on page 36 Copy the service record and use it for noting the service checks while performing the service 2 1 3 Inspection Equipment and Tools Before starting the service of the iSleep 10 20 make sure you have the following equipment at hand e Pressure manometer Thommen HM 28 digital manometer Breas part no 001937 or equivalent Service Instructions 5 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual e Torx key TX 10 iSleep to PC communication cable Breas part no 003588 iSleep Vivo Service Software available for download from Breas Extranet Co
29. ou can access the clock battery 2 Remove the clock battery by pulling it straight up Press a new clock battery into place 1 o Make sure that the new battery is not handled with bare hands 3 Reassemble in reverse order Opening the iSleep 10 20 and Replacing the Main Components 21 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual 5 5 Replacing the Keypad 1 Remove the circuit board as in section 5 3 2 Remove and replace the keypad 3 Reassemble in reverse order 22 Opening the iSleep 10 20 and Replacing the Main Components Breas iSleep 10 20 Service Manual Doc 004284 En X 1 6 Upgrade and Calibration 6 1 Firmware Upgrade 8 To upgrade the iSleep 10 20 firmware you need the Firmware Upgrade Tool iSlep Vivo available for download from Breas Extranet Contact Breas technical support for more information 6 2 Pressure Calibration iSleep 20 only A To calibrate the iSleep 20 you need the iSleep Vivo Service Software available for download from Breas Extranet Contact Breas technical support for more information Upgrade and Calibration 23 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual 7 Electronics Always perform a complete function test see section 2 5 on page 9 if you have opened the iSleep 10 20 The electronics optics mechanics and pneumatics of the iSleep 10 20 are integrated To under stand fully the electronics of the iSleep 10 20 you must know h
30. ow to use the CPAP device study the pneumatic diagram and acquaint yourself with the mechanical construction 7 1 Main Cabling Diagram The diagram below illustrates the main cabling of the iSleep 10 20 24 Electronics Humidifier iSleep 20 only AT Brown 1 Blower Yellow X8 assembly Purple DC inlet X9 CPU LCD Breas iSleep 10 20 Service Manual Doc 004284 En X 1 7 2 Circuit Board Description The diagram below is an ovetview of the circuit board RJ45 DC inlet connector control interface Display Clock battery LEDs iSleep 20 only iSleep 20 only Buzzer z iSleep 20 only Real time BLDC Pressure sensor Humidifier amplifier iSleep 20 only interface iSleep 20 only Motor Humidifier connector connector iSleep 20 only Powet Control There is one power input 24 V DC The CPU board contains a voltage regulator for 5V and iSleep 20 also has a 8V regulator Battery iSleep 20 only A battery is used to keep the real time clock alive when the iSleep 20 is not powered CPU Central Processing Unit The processing core of the main unit is a M30281FAHP microcontroller The main processor has a supply voltage of 5V and is not operating when the iSleep 10 20 is not powered apart from the clock function on iSleep 20 which is powered by the clock battery Display The display used is a segment type and have a visible area of app
31. r service 29 Er29 Humidifier temperature Replace the HA 01 humidifier too high Sleep 20 only 30 Er30 Internal temperature too 1 Disconnect the iSleep 10 20 high from the power supply let the device cool off and restart 2 Check the ambient temperature 3 Replace the circuit boatd or send the iSleep 10 20 for service Fault Tracing Breas iSleep 10 20 Service Manual Doc 004284 En X 1 ERROR TEXT ON LCD DISPLAY PROBLEM ACTION CODE 61 Er61 Invalid settings 1 Restart the iSleep 10 20 by dis Settings set to default connecting and reconnecting the values power supply 2 Replace the circuit boatd or send the iSleep 10 20 for service Internal Error Codes Not Shown on the Display iSleep 20 only Ifa function failure listed in the table below occurs the four digit error code is stored in the iSleep 20 error log and one of the messages listed above is shown on the display You need the tSleep Vivo Service Software to access the error log FRROR PROBLEM ERROR CODE ON DISPLAY CODE 1000 Flash memory error Er20 1001 Checksum error when data was read back Er20 1002 Error when tried to write checksum to flash Er20 1003 Checksum error when tried to read parameters Er20 1004 Failed to wtite data to flash Er20 1050 Critical flash error Er20 1051 Flash has failed to be initiated Er20 1052 Flash has failed to erase memory to write parameters Er20
32. roximately 60x 20mm Buzzet iSleep 20 only The buzzer is triggered by software or hardware Electronics 25 Doc 004284 En X 1 Breas iSleep 10 20 Service Manual Pressure Sensor iSleep 20 only The iSleep 20 is equipped with a pressure sensor The processor supervise the actual pressure and have the availability to regulate the speed of the motor to attain a correct pressure Humidifier Interface iSleep 20 only The iSleep 20 can be equipped with an integrated humidifier HA01 The HA01 humidifier consumes 40W when attached to the iSleep 20 The power to the HA01 humidifier is controlled from the main CPU via a transistor The other two signals in the interface beside power and ground are an analogue temperature signal from the HA01 humidifier and a control signal to the HA01 humidifier Serial Interface To communicate with a PC the iSleep 10 20 uses a RS232 interface 26 Electronics Breas iSleep 10 20 Service Manual Doc 004284 En X 1 8 Fault Tracing iSleep 10 20 A Always perform a complete function test see section 2 5 on page 9 if you have opened the This chapter contains a fault tracing table and a table of error codes to use when troubleshooting the iSleep 10 20 8 1 Fault Tracing Table If the iSleep 10 20 does not work properly try to identify the problem in the table below Check the possible causes and carry out the suggested remedial actions SYMPTOM POSSIBLE CAUSE
33. w many filters will be required before the next service Other observations 6 Service Instructions Breas iSleep 10 20 Service Manual Doc 004284 En X 1 2 2 4 2 3 2 3 1 2 3 2 2 3 3 2 3 4 2 3 5 2 3 6 2 3 7 Doc 004284 En X 1 Validity of the Documentation 1 Check the validity of the User or Clinician s Manual enclosed with the CPAP device 2 Check if any modification or upgrading of the CPAP device needs to be done at the same time as the service External Inspection Visual Inspection for External Damage and Wear 1 Clean the outside of the CPAP device using a mild soap solution 2 Check for any visible damage to the casing and the other components 3 Check that nothing has become loose 4 Check that the rear lid is connected properly to the CPAP device Checking the HA01 Humidifier if used iSleep 20 only 1 Remove and open the HA0I 2 Check that there is no visible damage 3 Check that the water container is clean 4 Check that the humidifier is connected properly to the CPAP device Checking the Power Connection 1 Check the plugs on the power cord the cord itself and the CPAP device s power socket 2 Check the power supply 3 Inspect the external battery cable if used Inspecting the Patient Circuit Inspect the patient circuit and replace it if necessary Inspecting the CPAP Device Accessories Check any other accessories that are used with the CPAP device Changing Washing
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