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Service manual - Hoffrichter GmbH
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1. 3 SAFETY INFORMATION For hygiene reasons we recommend wearing disposable gloves whenever work ing on the device Before further work the device must be subjected to wipe disinfection with a standard disinfectant solution When doing so observe the manufacturer s safety instructions and instructions for use The documents delivered with the device must be checked when the device arrives at the Service department Devices contaminated with MRSA methicillin resistant Staphylococcus aureus must be subjected to hygienic preparation according to the validated KR1000 Keredusy preparation procedure All other devices must be prepared according to the point 2 hygiene concept Special hygiene measures are advisable when performing maintenance or repairs on devices contaminated with MRSA In this case protective clothing such as disposable gloves mask and disposable apron should be worn without fail Hygienic preparation according to the validated KR1000 Keredusy preparation procedure must be carried out before performing maintenance or repair 4 DEVICE DESCRIPTION 4 1 HOUSING DISPLAY AND CONTROL ELEMENTS Control panel and display Humidifier lock Therapy tube con nection eZ aquapoln Contact socket for humidifier Controls for humidifier Fig 1 Front view of the device Air inlet for barometric sensor tuse only with the provided power supply pdit2 AutoFLEX O A mere SN JAB122 24 V
2. Enter user140372 as the Password Select the view Times and Counters Click on the button ADU Test to open the ADU Test window Start measurement by clicking on the button Start in the top right The entire pressure range is now checked for pressure deviations The maximum deviation must not exceed 0 5 hPa If the maximum deviation is exceeded you should perform automatic zero point calibration of the pressure sensor To do so operate the device for min 2 hours in standby During this period the device continuously measures the ambient temperature and determines a correc tion factor that is used as a basis for the pressure sensor s zero point calibration system Perform zero point calibration at the same location as for performance of the ADU Test This will lead to better results Then perform the ADU Test once again If the measured pressure deviation still exceeds the maximum deviation limit contact the manufacturer 9 Close the ADU Test window ON Oo gi P amp M gt 6 3 rer O oa ron 6 5 6 6 CHECKING DISPLAY AND CONTRAST Press any key The display lights up with a brightness of 100 Check the display to see whether all characters are shown correctly and completely The background of the display is illuminated the display should be clearly legible in daylight After 15 seconds the display fades to the basic brightness level selected in the device menu 0 100 The display should
3. DC 12 1 A 0123 RS232 Rating plate interface Filter or connection port for the filtersystempoint 2 Fig 2 Rear view of the device Window element for display underneath ON OFF key HOFFRICHTER QO Q Selector keys Enter key Fig 3 Control panel 1 optional equipment variant for use with humidifier 4 2 EXPLODED VIEW DRAWING Membrane keyboard Top section of housing Display Controller cir cuit board Meander lid Fixing element Blower a bellows Retaining ring 2 Fixing element Flow resistance Damper Sealing gasket internal air outlet Room divider Acoustic protection plate Cover plate for DC and PC mi PC connection cover Air outlet Bottom section of housing Base rear Filter insert Control panel base Base front Adapter for Housing foot Cover for humidifier humidifier electronics guide Housing foot 4 3 CONTROLLER CIRCUIT BOARD 4 3 1 SOLDER SIDE Battery Battery contact contact 8 S RESTE SEEREN EET Alarm generator Plug connection for Plug connection for Display humidifier electronics membrane keyboard Fig 4 Controller board solder side 4 3 2 COMPONENT SIDE Serial interface 24 V DC input Microphone Motor control connection Motor voltage connection contact Battery a PF contact ae 1 T es Pressure pe sensor Bac
4. power supply Motor control A piezoelectric sensor differential pressure measuring procedure measuring range 0 3500 Pa continuously measures the actual output pressure The set point pressure value is output by the computer The difference between these two values is corrected by the PI controller and the motor control Switching controllers are used to minimize power losses Motor DC motor operating voltage 4 24 V electronically commutated point 2 processor ATmega2561 The ATmega 2561 processor is a microcontroller which is used in all point 2 devices The key tech nical data includes e 256kByte flash memory e 4AkByte EEPROM e 8kByte RAM e programmable interface e an integrated A D converter 10 bit e 54 programmable I O pins Clock The point has a real time clock The real time clock is supplied by an internal battery CR2032 which offers an operating time of 8 to 10 years This battery supplies the IC with power when the device is disconnected from the mains With mains operation the clock is supplied with power by the power supply unit Alarm generator Output of an acoustic alarm for wake up function as well as in the case of absent or excessive mask pressure 6 TOOLS AND MEASURING EQUIPMENT 6 1 PRELIMINARY STEPS 6 1 1 PROTECTIVE AGENTS AND DISINFECTANTS e Hand sanitizers e g Sterillium Bode e Disinfectant sprays e g Mikrozid AF Liquid e Surface disinfectants e g Mikrozid AF e In t
5. HOFFRICHTER Quality makes the Difference E E m m service manual Respiratory therapy device point 2 CONTENTS 1 Symbols in this manual geist daedrceveserscncnstedaecans sunainas un sidenaseanw ated onan Lee Er ERE 3 2 GEN SE RE EE NE EE fora ncaa 3 3 Safety informa EE NR Rd 3 4 Device descriptio EE EE ele 4 4 1 Housing display and control elements rrrrrrrrrrrrrvrrrrnrrrrarrnnsrrrrrnnnnrrrrrrnnnnrrrrrnnnnnerrrnnnnner 4 4 2 Exploded view GrAWINGhavsscesasdesessisacessedcctaeessaevncneeduig neasedudag klas A OE an bb R E bb AE DEHN er 5 4 3 Gontraller circuit board sern hbn el LE ne DE aa DELE aranes sae died tenes 6 5 Technical explanations ssseeeeeer eee rr EDEL EDEL LEE 8 6 Tools and measuring equiPmentu saunmanannsrnenmnven E eaduetewadearesteeenenne 10 6 1 Preliminary Steps sninen EA E A ET PEE EN E ETETE 10 6 2 DIE EEE EE EN 11 6 3 Checking display and Contrast 0 cece cecee cece renerne ere ere EET REELLE EEEE EEEE 12 6 4 Opening the device c srssestaz aevaedsedeanvsscsoecsnsusdensces anscavatudbacescoth Seg seadebaiedshawbavarcsaveusddonensmae 12 6 5 CISANING css saz lt aceenssinades toads v ancbassndeahdsavebectinsuadeimachaVanvcadaaeibaces oth Sta ENEDES DEERE RR deat sive ssdiaeen ie 12 6 6 Checking the heating Cable ccc cccccccccseeceeeceeeeeeeeecsaeeeeeeesaaeeeeeessseeeeeeesseeeeeeeeeeeeeeseneaees 12 6 7 Assembling the COVICE cc ccccecccee ccc neeeeeeceeneeeeeesaeeeeeeeeaeeeeeeeeeseee
6. eeeeeeneeeeseeeeeeeeesesaeneeeneas 13 6 8 CHECKING TNS KEYS asus ad ED Sak aeit 13 6 9 Excess pressure calibration rrrrrrrnnrrrvrnrnnrrvevnnnrrrvnnrnrerrennnnsrsrrenssnrrrrnnnnnererrsnnsnesssennnn 13 6 10 SEN SOP TOS uten bea 14 6 11 Resetting counters setting date and time ce ececcccceeeceneeeeee scene eeeeecaeeeeeeeseneeeeesenees 14 6 12 Restoring device SettingS 00 ccccccececccceceeeeeceeeeeeeeeeeeeaeeeeeeeaseeeeeecaaeeeeeessaeaeeeseseeeeeeeesaees 14 6 13 Checking electrical safety cccccccccecccseeeeeeceeaeeeeeceaeeeeeeesaeeeeeeeesaseeeeeessaeaeeeeesaseeeeeeeseees 14 7 Resetting the therapy hour counter and de activating the PIN code function directly at the device rea aa east dGesVauhesteavenced anket age dacncdbedvecwedediune 15 7 1 Resetting the therapy hour counter ccceccececcceeeeeceeeeeeeeeceaueeeeeecaaaeeeeessaaeeeeeesseeeeeseesaees 15 7 2 De activating the PIN code function eeeeseseesssrs kerne ERE ERE 15 8 FinalstepsL EEN a E E 15 9 Disposal seirena E E E E S 16 9 1 Device and Components asser spren n er r ene O balle 16 9 2 PACKAGIAG ESSEN REE SES PE SES E ES SE ET E R ETE EEE a AE D EEE RENSE i EEE ERD 16 9 3 See E E T E E E E A anonh sad 16 9 4 Accessories and wear patS essssssseeerrrttttttttttttttttt see eeeeeseeeeeeseeneeeeseeseeeeeeeeeaeneseeses 16 Other tests not part f device Servicing sirrin treisio seein tui N E a aae 17 Pressure stability measuremen
7. essure limiting value It needs to be performed whenever hardware components were added replaced or removed 1 2 CON OP amp Use the RS232 adapter cable to connect the device to the PC Connect the therapy tube to the device and plug the 5 mm flow resistor into the tube s open endpiece Start the TRENDset PC software and click on the device at Found devices Go to Settings gt Service gt Log in in the menu bar Enter service as the User Name Enter user140372 as the Password Select view Times and Counters Click on the Calibration button Follow the instructions on the PC screen If calibration fails despite being executed correctly check the device for loose or incorrectly attached connectors plugs tubes etc or any other installation errors If calibration fails per manently please contact the HOFFRICHTER service department 6 10 SENSOR TEST The sensor test needs to be performed whenever changes to the controller circuit board were made 1 Use the RS232 adapter cable to connect the device to the PC 2 Connect the therapy tube to the device and plug the 5 mm flow resistor into the tube s patient side endpiece Start the TRENDset PC software and click on the device at Found devices Go to Settings gt Service gt Log in in the menu bar Enter service as the User Name Enter user140372 as the Password Select view Times and Counters Click o
8. hat the heating cable is still intact and that the contact springs are not bent On assembly the heating cable must be protected from tension compression and clamping 6 7 ASSEMBLING THE DEVICE Only start assembly once all cleaning agents and disinfectants have dried completely 1 Position the motor cable in the space between the motor and the wall of the housing and run the heating cable between the box and the wall of the housing Position the pressure measuring tube above the controller circuit board and connect it to the pressure sensor Check whether the controller circuit board is properly seated in its correct position Check all plug connections on the controller circuit board for secure positioning and where necessary correct deficiencies Carefully fit the upper case of the housing making sure that no cables or tubes are com pressed or crushed Turn the device over and screw the upper and lower casing together Then reattach the hous ing feet If the point 2 was set up for the connection of a humidifier install the controls and the control electronics of the humidifier Insert the filter or fit the filtersystempoint 2 optional 6 8 CHECKING THE KEYS ale 2 Check that the turbine switches on and off properly when the ON OFF key is pressed Check whether the menu can be operated properly using the arrow keys 6 9 EXCESS PRESSURE CALIBRATION Excess pressure calibration is used for test measuring the pr
9. he case of medical devices exposed to hazardous contamination MRSA additional protective clothing such as disposable gloves a mask and a disposable apron and goggles should be worn NOTICE Where possible wipe disinfection is preferable to spray disinfection 6 1 2 TOOLS MEASURING EQUIPMENT AND AIDS The following equipment is required for servicing e Service manual user s manual and maintenance documents e Battery pack powerpackpoint 2 or point 2 power supply unit with mains cable e Phillips screwdriver PHO and PH1 e Slot screwdriver 06x3 5 e Soft brush and vacuum cleaner e Soft base e point auxiliary tool art no 00007939 e Therapy tube 1 80 m long with 22 mm therapy tube connection as per ISO 5356 1 e Flow resistor 4mm art no 00007303 e Flow resistor 5 mm art no 00007306 e RS232 adapter cable Sub D9 RJ45 art no 00005232 e Device for testing electrical safety e g SECUTEST SIII DIN EN 62353 2008 e PC with following system requirements MS Windows 98 2000 NT4 0 ME XP Server 2008 Vista or 7 AMD Athlon Pentium class x86 clock frequency 700 MHz min 192 MB system memory for MS Windows 98 NT4 0 ME min 400 MB system memory for MS Windows 2000 XP Server 2003 Vista min 150 MB free hard drive space or more depending on the required storage capac ity for patient files min 280 MB free hard drive space for the Microsoft NET Framework 2 0 Redistribut able
10. illation OFF appears on the display NOTICE Make sure to reactivate the oscillation after pressure stability measurement Otherwise obstructive apneas won t be detected during therapy Activating oscillation 1 Keep selector key Q and enter key both pressed down while connecting the power supply to the device s DC power connection N Oscillation ON Presse appears on the display Press the enter key 4 Oscillation ON appears on the display oo HOFFRICHTER GmbH Mettenheimer StraBe 12 14 19061 Schwerin Germany phone 49 385 39925 0 fax 49 385 39925 25 e mail info hoffrichter de web www hoffrichter de point 2 service eng 060612 03
11. kup battery for internal clock CPU ATMEGA 2561 Px display contrast Fig 5 Controller component side ATTENTION The settings on the potentiometers P246 and P257 must not be changed as this would necessitate recalibration at the factory 5 TECHNICAL EXPLANATIONS Bae Humdifier 4 i i ti m mask optional ES x ies ad v box gt Load Management BONE v t Pressure PI controller Sensor Motor A A D A converter Sd Motor lt controller CPU Display lt lt Flash external tM RAM EEPROM EEPROM ADC Control panel RS232 DC power supply unit 4 AC mains RCI Battery Fig 6 Block diagram Heating when optional humidifier is connected The humidifier heating consists of a heating element in the bottom of the humidifier The heating power can be set to 5 different heating levels using the controls The maximum temperature of the heating plate is limited to 60 C In addition there is a thermal fuse in the electronic unit of the humidifier which trips at a temperature of 90 C in the event of a fault Power supply The device is operated via an external switched mode power supply with a wide input range of 100 240 V AC and a frequency of 50 60 Hz No maintenance or repairs should be performed on the switched mode
12. n the Sensor test button 9 Follow the instructions on the PC screen ON D gi amp If the microphone and or barometer test fails despite the sensor test being executed correctly check whether all tubes are properly connected and not squeezed or kinked If the test fails perma nently please contact the HOFFRICHTER service department 6 11 RESETTING COUNTERS SETTING DATE AND TIME Use the RS232 adapter cable to connect the device to the PC Start the TRENDset PC software and open the connected device at Found devices Select the view Times and Counters Reset the filter counter if the filter was changed Reset the blower runtime if the blower box was changed Reset the date and time if necessary Click on Send pO o ae NS 6 12 RESTORING DEVICE SETTINGS Select the view Patient Data If necessary enter the patient data using the data backup printout Click on Send to store the settings in the device Select the view Device Settings If necessary enter the patient data using the data backup printout oa fron Click on Send to store the settings in the device 6 13 CHECKING ELECTRICAL SAFETY The point basic device is equipped with protective insulation and does not have any exposed electrically conductive parts at the housing As such electrical safety testing of the device is unpro vided for Electrical safety testing is only possible on the power supply unit and is perf
13. ormed by a device safety tester e g SECUTEST SIII which complies with the DIN EN 62353 2008 standard The ref erence point is the ground conductor on the secondary side of the power supply unit external con tact 7 RESETTING THE THERAPY HOUR COUNTER AND DE ACTIVATING THE PIN CODE FUNCTION DIRECTLY AT THE DEVICE 7 1 RESETTING THE THERAPY HOUR COUNTER 1 Keep the selector keys Q and V both pressed down while connecting the power supply to the device s DC power connection 2 Therapy Counter Reset Press lt appears on the display 3 Press the enter key 4 Theraps Courter deleted appears on the display 7 2 DE ACTIVATING THE PIN CODE FUNCTION Deactivating the PIN code function 1 Keep selector key and enter key both pressed down while connecting the power supply to the device s DC power connection 2 PIN Code OFF Presse appears on the display 3 Press the enter key 4 FIN Code OFF appears on the display NOTICE Make sure to reactivate the PIN code function before the device is passed on e g to patients Activating the PIN code function 1 Keep selector key and enter key both pressed down while connecting the power supply to the device s DC power connection 2 PIN Code ON Presse appears on the display 3 Press the enter key 4 FIN Code ON appears on the display 8 FINAL STEPS After finishing servicing draw up a final report and affix a test seal showing the date and
14. still be clearly legible If required the display contrast can be re adjusted via Px with the device open see bage 7 OPENING THE DEVICE Unplug the mains plug Remove the filter or the filter system filtersystempoint 2 optional Remove the humidifier where present Remove the two batteries powerpackpoint 2 where present Place the device top down on the soft base Open the device as follows a Remove the feet of the housing b Ifthe point 2 is set up for the connection of a humidifier remove the control electronics of the humidifier and disconnect the plug connection c Release the four screws at the housing d Take off the upper casing of the housing Disconnect the plug connections and the pressure measuring connection Carefully remove the heating cable using aids if necessary NOTICE Avoid any tension on the microphone tubing CLEANING Clean the inside of the device carefully using the brush and the vacuum cleaner Use compressed air to clean areas which are not readily accessible Then remove loose parti cles with the vacuum cleaner Remove stubborn dirt inside and outside the upper casing of the housing and in the opened device not circuit boards using a damp cloth and a solution of soapy water in a standard con centration Optional If a humidifier is present wash out the water container with water and apply a 5 solution of vinegar to stubborn limescale CHECKING THE HEATING CABLE Check t
15. t cece ceccececeeeeeeeceeeeeeeeecaaeeeeeeeaueaeeeeeeseneeeeeseeeeeeeeseeeneseesaeneeeeeas 17 1 SYMBOLS IN THIS MANUAL Important information is denoted by symbols in this service manual Be sure to follow these instruc tions in order to avoid accidents personal injury and material damage In addition the local accident prevention regulations and general safety regulations in force in the area of use must be observed This symbol denotes general safety instructions Follow these instructions to avoid accidents personal injury or material damage CAUTION This symbol denotes hazardous situations that may lead to moderately severe injuries ATTENTION This symbol denotes situations that may lead to material damage or damage to the device NOTICE This symbol denotes information tips and instructions for efficient error free use of the device 2 GENERAL e Before starting maintenance read this service manual through carefully Observe the user s manual as well as the warning and safety instructions it contains Repair and maintenance may only be carried out by qualified authorized and competent specialist personnel This manual refers solely to the point 2 respiratory therapy device It does not deal with accessories such as therapy tubes and masks If an accessory is sus pected of being defective it should be visually inspected by the service techni cian and the result recorded in the servicing report
16. tester s ini tials to a suitable position on the device 9 DISPOSAL Proper disposal saves natural resources and prevents the release of harmful substances into the environment 9 1 DEVICE AND COMPONENTS The device and its electronic components must not be disposed of with household waste They must be disposed of at a communal collection point or public waste disposal authority 9 2 PACKAGING The packaging can be recycled or be disposed of with household waste 9 3 BATTERIES Batteries must not be disposed of with household waste They must be returned to the distributor or disposed of at a communal collection point 9 4 ACCESSORIES AND WEAR PARTS Disposal of accessories such as tubing masks filter cassettes and wear parts e g sealing gaskets and other replaced components must be carried out according to the statutory provisions in force at the area of use This also applies to contaminated accessories OTHER TESTS NOT PART OF DEVICE SERVICING PRESSURE STABILITY MEASUREMENT To check the device s pressure stability according to EN ISO 17510 1 2009 clause 6 8 2 aa appen dix BB 2 14 4 3 2007 MDS Hi the device has to be put in basic CPAP mode by deactivating oscillation Deactivating oscillation 1 Keep selector key Q and enter key both pressed down while connecting the power supply to the device s DC power connection 2 Oscillation OFF Presse appears on the display 3 Press the enter key 4 Osc
17. x86 2 MB graphics card min High Color 16 bit Mouse 1 free COM interface per device 1 free SD interface only when using DATA box e HOFFRICHTER TRENDset PC software e Cleaning agent for cleaning surfaces e g solution of soapy water in a standard concentration CAUTION All tools measuring equipment and aids possibly exposed to contamination must be cleaned after they have been used and treated with disinfectant 6 1 3 UNPACKING AND DISINFECTING ACAUTION To protect against germs the surface of the device and where present the humidifier must be treated with a disinfectant immediately after unpacking 6 1 4 CHECKING FOR EXTERNAL DAMAGE Before starting the service check the device and where present the humidifier for external dam age 6 1 5 DATA BACKUP Before starting the service perform a data backup 1 Connect the device to the mains power using mains cable and power supply unit Use the PC cable to connect the device to the PC Start the TRENDset PC software For security reasons make sure you save the device settings File gt Save as a S ee Print out the device settings File gt Print and keep the printout for data recovery S DO ADU TEST Insert the flow resistor 4 mm into the air outlet opening Disable the soft start function and the mask test on the device Go to Settings gt Service gt Log in in the menu bar Enter service as the User Name
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