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CARAT pro Service ENG_2015-02-03_04.indd

1. 8 1 1 Symbols used in this service MANUAL cccssecceeeeeceeeeceeeeceececsucecsuecceueeseueessueeeseeeeeseeesseeeseneesaes 8 1 2 rci sit Ire Rr MiTo NENNT Em 9 1 3 Maintenance repair hygienic reconditioning and safety related check 10 L J MURERE SI eis NS IIT E E T E E E emm 10 Toa R lae EE D m Nem 11 1 94 ml SE SEE 2 e aede T m m Umm 11 CHAPTER 2 bizme aR leldupeet i c ce 12 2 1 General device description ccccesceccseecceeeccaecccaueccaueeceueecaueeeeueeesaueesaeesaueesaueesaueesaueesseeessaees 12 2 2 Connections at the front of the CEVICE cccceecceseeeseeteeeteseceeeteeeteueceeeseeteeetegetsueetaeetsueeeneeees 12 2 9 Connections on the rear side of the device lseeeseeessessseesseeeeee nennen nennen nnne nnne nnns 13 20 1 es e aie aee ES E ce T mE 16 2 4 CEDO e m 17 2 5 Movable and removable housing parts sss cesevssannsnscdinmns avaiseuindatdedeumboabsevennentvaletnewdetelieiscdiatedensentiest 18 2 6 mdeicinriiiegEoliiu Sroe eiiiies gm T 19 2 7 Device configuration Mechanical sub assemblies ccecceseeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeaeeeeseeeenaees 21 2 51 quc mS ee i a NT OmU TEUER 2 2 ue Overview CARAT pro pneumatic block essee menm 21 Ala Overview CARAT II pro pneumatic DIOCK ssssstevsiesest ib Posteeid taxes iia OP sari vof aded t anon ibd rav Ru ER p vada dn 22
2. Page 54 of 82 3 6 CARRY OUT MAINTENANCE 2 D When 623 Replacement parts A Equipment Every 2 years For CARAT I pro Maintenance kit 2 a Art No 00004993 e 2x valve membranes e 2x O rings e 1x course filter e x fine filter e 1x tubing set CARAT pro e 1x ready made battery pack Li lon For CARAT II pro Maintenance kit 2b Art No 00004494 e 2x valve membranes e 2x O rings e 1x course filter e x fine filter e 1x tubing set CARAT II pro e 1x ready made battery pack Li lon Long screwdriver PH1x200 Needle nose pliers M14x1 socket wrench Softpad Pressure meter APM blind plug Therapy tube with pressure measuring tube Adapter bacterial filter CARAT II pro 3 6 1 WHAT NEEDS TO BE DONE DURING MAINTENANCE 2 Replace course and fine filter Page 52 oh Replace the battery pack 5 Visual inspection 5 1 Check tubes and tube connections 5 2 Check cables and plug connections 5 3 Check fit of all printed circuit boards 6 Calibrate the device 6 1 Calibrate the pressure sensor 6 2 Calibrate the flow sensor only CARAT II pro 6 3 Tightness check 6 4 Battery check 7 Perform safety related check see Page 69 8 Check the electrical safety of the external power supply see Page 67 Page 55 of 82 Replacing valve membranes and o rings for inspiration and expiration gt Page
3. Tightness Check by turning the MEK and press the MEK 3 The device now scans the entire pressure range Observe the flow value If the flow value should exceed 5 l min during the tight ness check there must be a leak in the tube Calibrate Oe Sensor system In that case check the entire system Calibrate Tube for leaks in tubes and at tube connections Calibrate Pressure Sensor Calibrate Flow Sensor As long as the flow remains under 5 l min tne Patery Check tightness check has been passed success Oe Valve Check fully Press the MFK to complete the test Tightness Check Change PIN Factory Settings p R n hPa Flow l min Finish test 4 Press the MFK to stop the tightness check Page 65 of 82 4 7 PERFORM THE BATTERY CHECK D When A Equipment e Maintenance 2 e Power supply unit e After replacing the battery pack The battery check checks that the lithium ion batteries in the battery pack still have sufficient capacity and whether the batteries are functioning properly Operate the CARAT pro on the mains network and turn on the AC main switch No accessories such as the tube circuit should be connected at the time Do not separate the device from the mains supply during the battery check To perform the battery check 1 Navigate to Battery Check by turning the Calibrate Pressure Sensor MFK Calibrate Flow Sensor Calibrate O Sensor Calibrate Tube Battery Check O2 Valve Check
4. eeeeeeeeeee 61 System configuration for CARAT Il pro flow sensor calibration ceeennnn 61 Os Valve check svstemiCont bl d OM ss eisepioaca bruit oss basia uat bios ate pee Am Rosi irae OR Ila tego ad ked 64 System configuration for CARAT pro tightness ChecK essuesrrerrresrrsrrrerrrerrnsrresrrerrrsrrrerrns 65 system configuration for CARAT Il pro tightness check sesennn 65 System configuration for measuring the device discharge current eeeeeene 67 Page 6 of 82 1 2 LIST OF TABLES Table 1 Service intervals overview ssssensesseereek ekte kt kk kk ERE EN ERNE ENE bep da dba ERE AG trn sa PER LU Pat eens 10 Table 2 Error messages during operation and at device start UP er sresrrrrerrerrrrrsrerrerrsrrsrnrrerrsrrsrrrrerrerr 70 Table 3 Default settings for ventilation parameter essssesseee mmm nmn nnne nnne nnne nnns 71 Table 4 Default factory settings for alarm parameter cceccceccceeceeeeeeeeeee seta eeeee seen mener nnns 72 Table 5 Default settings for device DSralTiete S ss asse ceret eb We vano itr br PER evo DRE ERE b ue a REE c E ER T2 tapie 6 Replacement DAS Slaen A EEE A arta AEE EA te ics cay gi ee ccend e T TTE f Page 7 of 82 CHAPTER 1 INTRODUCTION This service manual is directed towards providers and service technicians for performing maintenance and repair work on CARAT pro and CARAT II pro ventilato
5. has to be installed on the PC Connection of remote alarm nurse call An alarmbox optional accessory or a nurse call system may be connected here RS232 interface service interface Accessories connectionControl elements Page 13 of 82 a f Figure 3 Control elements 14 eS Alarm key The alarm button has several functions Function Condition Action Confirm all current alarms Active alarms Press briefly confirm no longer active alarms Stored alarms Press briefly Mute the audible alarm for 2 min audio alarm pause Active alarms Press briefly Cancel the audible alarm suppression Audio alarm paused Press briefly When multiple events occur at the same time only one event is confirmed each time the button is pressed and in the order they are listed above 15 Bll ON OFF key Function Action Start ventilation Press briefly Stop ventilation Press MFK briefly and confirm with Yes 16 Multifunction key MFK Function Action Select another parameter Turn Set parameters Turn Confirm parameter selection Press briefly Confirm modified parameter value Press briefly Open settings window for curves and loops Press briefly in the monitoring screen The MFK is backlit only when MFK brightness gt 0 96 The color of the light depends on the operating sta tus or the alarm priority of the currently displayed alarm The backlight intensity of the MFK can be adjusted in the sy
6. sensor connection Hecalibrate FiOosensor Replace FiO sensor Error Pressure Sensor Defective pressure sensor Device must be serviced Calibration File Damaged Calibration data for sensors is damaged Device must be serviced Eventlog File Damaged Event read data failed Device must be serviced Primary Alarm Not Working Primary alarm sound unit is defective Device must be serviced Secondary Alarm Not Working Secondary alarm sound unit is defective Device must be serviced No Alarm Available Primary and secondary alarm sound units are defective Device must be serviced Booting Error Boot failed Device must be serviced Fatal Error Fatal error occurred Device must be serviced Maintenance 5 necessary Maximum blower run times reached Device must be serviced Page 71 of 82 6 2 FACTORY SETTINGS 6 2 1 VENTILATION PARAMETERS Table 3 Default settings for ventilation parameter Mode PCV PSV P SIMV APOV PSV S VOV AVOV V SIMV CPAP Parameter Set 1 Set 2 Set 3 Pressure 4 hPa IPAP 20hPa 20hPa 20hPa 20hPa 20hPa PS 20 hPa 20 hPa Tidal Volume 0 05 0 05 0 05 PEEP 5 hPa 5 hPa 5 hPa 5 hPa 5 hPa 5 hPa 5 hPa 5 hPa Frequency 12bpm 12bpm 12bpm 12 bpm 12bpm 12bpm 12 bpm Time Inspiration 2S 2S 2S 2S 2S 2S 2S Flow Ramp
7. 1 1 1 Max Pressure 30hPa SOhPa 30hPa Min Pressure 10hPa 10hPa 10hPa Ti Max s 4s 4s 4s Ti Min 0 4s 0 4s 0 4s 0 4s Apnoea Time 10s Ramp 3 3 3 3 3 3 Inspiration Trigger 3 3 3 3 3 3 Expiration Trigger 30 96 30 30 96 30 96 Trigger Lock Off Off Off Off Off Off Minimum Volume Off Off Off Off oigh Function Off Off Off Off Off Off Off Off Page 72 of 82 6 2 2 ALARM PARAMETERS Table 4 Default factory settings for alarm parameter Mode ON PCV P SIMV APOV PSV S VCV AVCV V SIMV CPAP Parameter Set 1 Set 2 Set 3 Apnoea Alarm 10s 10s High Frequency 30bpm 30bpm 330bpm 30 bpm 30bpm 30bpm 30 bpm Low Frequency Off Off Off High Inspiration Volume 11 11 11 11 11 Off 1 Low Inspiration Volume 0 2 0 21 0 2 0 2 0 2 Off 0 2 High Minute Volume Off Off Off Off Off Off Off Off Off Low Minute Volume Off Off Off Off Off Off Off Off Off Leak Rate Off Off Off Off Off Off Off Off Off High FiO Off Off Off Off Off Off Off Off Off Low FiO Off Off Off Off Off Off Off Off Off Low SpO Off Off Off Off Off Off Off Off Off Pos Pressure Tolerance 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa Neg Pressure Tolerance 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 3 hPa 6 2 3 DEVICE PARAMETERS Table5 Default settings for device parameters
8. 2 1 4 FIOUSINO TOR FOr CF UO 23 EEDS FORS Fe O A A T O ea A EE 24 2 1 6 mic pee E m m 20 gula Igi MAESTRO TE meme 26 2 4 0 wmeweseqigeoll Mec 2r 219 Serer DIOC qe No T HT 28 24 10 Comolete device SssenDlysssassiceepra niert tet pas en dla mess att ti dran Ca dons e RUP ple ON aate ha ding d 29 2 111 QARMAITpro Tube connection dagraa senaren aneia eie totas edu cnp e DUE ne 30 21 12 CARAT Ipro tube connection disci AM orne READ EDEN AAEN 31 2 8 Device configuration Electronic components ccceecccececeeeceeeeceeecaeeceeeeaeeeseeeseeeseeeeseeesaeees 32 2 0 2 Operaing CIRCUIT DOAN RTI OPE OT c 34 CHAPTER 3 Ve gus i echec 36 3 1 PED TANO M 36 3 1 1 Proc ing andado eges ac TTE TOO OTT 36 o h2 TOOIS ANG measuring SaulplHielib s sesssesoisad bids uf dR cups Rica ra S rA E Pa pie ar a oot a cr n aaa ST 3 1 3 IITA IG ea Vl CS IS CWC NETT Omm 39 3 1 4 Bade sige Or mna aaa O HERRER NERE RER ERE een nee ene atu ano UNO em ee MU esr een ee ene teen eee 39 oS 8 dc e 100 39 3 2 Disassemble the device Tm cT 40 3 25 axle RS SEES ES EES ES EDER en ET ee ee ee ee 40 O72 Disconnect the top cover from the device esssssesseeeeenn mme nemen rne nnn nnns 42 3 2 9 Remove the multifunction key an
9. 26 Filter cassette The filter cassette contains the two air filters coarse and fine filter Page 18 of 82 2 6 EXPLANATION OF THE TOOLBAR ICONS Symbol IM 7 Meaning Clinic mode Active Home mode Active Alarm active A Red icon high priority alarm S Yellow icon gt medium priority alarm A Turquoise icon low priority alarm X Audio alarm paused The audible alarm has been paused for 2 min The audible alarm of even a new alarm event will also be paused for 2 min The audible alarm may be deactivated by pressing the alarm key before an alarm event occurs Pressing the key again reactivates the audible alarm in case an alarm event has occurred 1 45 Counter for audio alarm paused Indicates how much longer the audible alarm will be paused Keypad lock activated The functions of all controls are disabled except for the ON OFF and alarm key A FiO sensor is connected and FiO2 Monitoring setting has been set to Internal in the system screen The FiOs Monitoring setting has been set to External in the system screen Measurement of oxygen con centration is performed using an external FiOs Monitoring unit A FiO sensor is connected the FiOs Monitoring setting has been set to Internal in the system screen and oxygen is supplied The FiOs Monitoring setting has been set to External in the system screen Measurement of oxygen con centratio
10. 53 Replace silicon tubing in accordance with the tube connection diagram starting on Page 30 3 CARRY OUT MAINTENANCE 5 D When A Equipment ee Heplacement parts Every 15 000h For CARAT pro SS e Long screwdriver PH1x200 blower run time Maintenance kit 5 a A CD e Wire cutters or At NO 00094999 e Needle nose pliers every 5 years 2x valve membranes e M14x1 socket wrench e 2x O rings 1x course filter e softpad 1x fine filter e Pressure meter 1x tubing set e APM blind plug CARAT pro e Therapy tube with pressure e 1x blower box measuring tube e 4x cable ties 71 mm e Adapter bacterial filter CARAT II pro For CARAT II pro Maintenance kit 5b Art No 00004996 e 2x valve membranes e 2x O rings e 1x course filter e x fine filter e 1x tubing set CARAT II pro e 1x blower box e 4x cable ties 71 mm SE J S 3 7 1 WHAT NEEDS TO BE DONE DURING MAINTENANCE 5 Replacing valve membranes and o rings for inspiration and expiration gt Page 53 Replace course and fine filter Page 52 Replace silicon tubing in accordance with the tube connection diagram starting on Page 30 Replace blower box ppm I oI 5 Visual inspection 5 1 Check tubes and tube connections 5 2 Check cables and plug connections 5 9 Check fit of all printed circuit boards 6 Calibrate the device 6 1
11. Calibrate the pressure sensor 6 2 Calibrate the flow sensor only CARAT Il pro Page 56 of 82 6 3 lightness check 7 Perform safety related check see Page 69 8 Check the electrical safety of the external power supply see Page 67 3 8 BATTERY CARE 3 8 1 PERFORM THE BATTERY QUICK TEST The battery quick test verifies whether the device in case of a power failure can be operated on battery for at least one hour When the device is used the battery quick test must be performed out by the provider or user every 6 months However a monthly check Is recommended 1 Make sure that the batteries are fully charged 100 2 Disconnect the device from the mains and operate the device for 1 hour on battery power 3 The test is positive if after 1 hour the battery capacity is gt 1096 and the alarm Low Internal Battery has not sounded If the battery capacity has fallen below 10 96 and the alarm Low Internal Battery has sounded the batteries must be replaced by an authorized service technician 4 Charge the batteries up to 100 96 by operating the devices via mains 3 8 2 CHARGING THE BATTERIES During storage charge the batteries every 6 months up to 100 96 capacity by operating the devices via mains supply Page 57 of 82 CHAPTER 4 CALIBRATIONS AND TESTS A CAUTION After each maintenance and repair session is completed all calibrations have to be performed Page 58 of 82 4 1 THE SERVICE SCREEN IN THE CARAT pro
12. Check Tightness Check Change PIN 4 Press the MFK Calibrate Pressure Sensor Check whether a flow is showing on the Saran sae 39 device The flow with which the oxygen is fed Tre HOW Sensor ERE ees wt in should match the flow in the device If it Calibrate O2 Sensor does not check the oxygen connecting tube Calibrate Tube Finish test and the oxygen connection point for leaks Battery Check If the values still don t match after that do juli colas a pressure sensor calibration Oz Valve Check Tightness Check Change PIN 5 Press the MFK to stop the O valve check Page 64 of 82 4 6 PERFORMA TIGHTNESS CHECK D When A Equipment e After each repair and maintenance e Single line patient circuit CARAT pro if a tube circuit is present e Double line patient circuit CARAT II pro e End cap The tightness check serves to check the tube circuit for leaks and or damage To perform the tightness check 1 Connect the therapy tube with CARAT pro according to Figure 31 or Figure 32 Mim A End cap supplied with delivery scope B Expiration valve C Control tube D Ventilation tube E Pressure measuring tube Figure 31 System configuration for CARAT pro tightness check rz S sand ES i SAN Hn FRICHTER A End cap supplied with delivery scope B Pressure measuring tube C Expiration section D Inspiration section Figure 32 System configuration for CARAT II pro tightness check 2 Navigate to
13. Parameter Factory setting Setting range oetting steps FiOs Monitoring Internal internal external Alarm Volume 3 qe 1 Brightness Display 100 96 5 100 96 5 96 Brightness LEDs 100 96 5 100 96 5 96 Brightness MFK 100 96 5 100 96 5 96 Language English German English i and others Pressure Unit hPa hPa mbar cmH20 Display Time Insp S s LE Number Ventilation Sets 3 1 3 1 Page 73 of 82 6 3 REPLACEMENT PARTS LIST Table 6 Replacement parts list Name Figure Article number Controller circuit board 00004146 Encoder 21000017 gl Name Figure Article number Operating Circuit Board 00004147 Lithium cell CR2032 3 V for clock function 16000004 60 mbar over pressure trigger 00014156 an LP SD card module 20200122 Piezo signal head with 2 expansion rivets Heady made battery pack Li lon 00004129 CARAT pro top cover without operating circuit board without display frame without display 00004169 00004339 Battery holder 42101307 3 CARAT Il pro top cover mM without operating circuit board without display frame without display 00004170 7 display 15200021 Multifunction key consisting of rotary knob cover input rotary knob circlip o ring 75 00004150 CARAT pro foil set 22000228 CARAT Il pro foil set 22000227 Display frame 42101311 Right trim handle 3 scre
14. The following calibrations and tests may be performed in the Service Screen environment changing the PIN code and reset the device to the factory settings Menu item Explanation Calibrate Pressure Sensor Calibration of the pressure sensor Calibrating Flow Sensor Calibration of the flow sensor only on CARAT II pro Calibrate Os sensor Calibrating the FiO2 sensor Calibrate Tube Calibration of the connected tube circuit only for tube circuits without pressure measuring tube Battery Check You can carry out the battery check here O Valve Check You can check the oxygen valve by performing the O valve test here Tightness Check You can check the tube circuit by performing the tightness check here Change PIN To change the PIN code Factory Settings To reset all settings to the factory defaults see Page 72 This will take you to the service screen 1 Navigate to Service in the home screen L 2 Press the MFK 3 Enter the PIN code 1302 Enter PIN 2 5 8 O Press to Cancel 4 Navigate to the desired menu item by turning E E E N the multifunctional key MFK Calibrate Flow Sensor Calibrate O2 Sensor Calibrate Tube Battery Check O2 Valve Check Tightness Check Change PIN Factory Settings NOTE The device will switch back to the home screen 2 minutes after the last performed operation Page 59 of 82 4 2 CALIBRATE THE PRESSURE SENSOR D When A Equipment
15. e After each repair and maintenance e Pressure meter e APM blind plug To perform the pressure sensor calibration 1 Connect the pressure meter and the CARAT pro according to Figure 27 HOFFRICHTER 4 a H FFRICHTER D Figure 27 System configuration of pressure sensor calibration system configuration for CARAT I pro and CARAT II pro is identical 2 Navigate to Calibrate Pressure Sensor by Calibrate Pressure Sensor turning the MFK Calibrate Flow Sensor Calibrate O2 Sensor Calibrate Tube Battery Check O2 Valve Check Tightness Check 3 Press the MFK 4 Press the MFK again to start measuring at O allspene Wessuie Gansor O hPa 0 hPa Turn the MFK until the pressure meter Beas Ep displays the pressure value of 5 hPa The osi a d s value at the pressure meter must be set with Calibrate O2 Sensor 10 hPa an accuracy of 0 05 hPa Calibrate Tube 20 hPa Battery Check ALO ale Press the MFK uu An PEE O Valve Check Tightness Check 5 Repeat the calibration for 10 hPa 20 hPa and 40 hPa Press the escape key to cancel the pressure sensor calibration fs 6 Finish calibration will appear after the cali Calibrate Pressure Sensor O hPa O Ok bration has been completed Press the MFK forenkler Calibrate Flow Sensor 5 hPa 1 Ok Calibrate O2 Sensor 10 hPa 2 Ok In case of an error message repeat the cali RTE 20 hPa Ok bration If the calibration should
16. min press the escape key J Calibrate Tube 40 l min Battery Check 60 l min O Valve Check 80 l min Tightness Check 100 l min Change PIN 120 l min Factory Settings 160 l min Press the MEK o Calibrate Pressure Sensor Ol mn O Ok The second value 10 l min is selected CU IE mE mum WE Turn the MFK as long as the calibration value mis dup citi AM Onde a LU is reached The value must be set to an accu Calibrate O2 Sensor 20 l min racy of 1 5 96 Afterwards press the MFK Calibrate Tube 40 l min The message OK appears when the calibra e Banas tion has been done successtully O Valve Check 80 l min Repeat these steps also for 20 40 60 80 Tightness Check 100 l min 100 120 and 160 l min Change PIN 120 l min Factory Settings 160 l min Press the MFK to complete the flow sensor Palllayeia Bresse Senor mm ool calibration Calibrate Flow Sensor 10 l min 5 Ok Calibrate O Sensor 20 l min 18 Ok Calibrate Tube 40 l min 1 Ok Battery Check 60 l min 126 Ok O Valve Check 80 l min 205 Ok Tightness Check OO Dm ede Ok Change PIN 120l min 350 Ok Factory Settings 160l min 362 Ok Finish calibration Page 62 of 82 4 4 CALIBRATE THE FiO SENSOR D When e After each repair and maintenance A Equipment e FiO sensor Use the FiO sensor calibration to check the electrical connection between the FiO sensor and the device To perform the FiO sensor calibration 1 Navigate to Calibrate FiO Sensor by turning
17. recondition after contamination e g MRSA the device should be treated according to the CARAT pro hygiene concept Page 11 of 82 CHAPTER 2 DEVICE DESCRIPTION 2 1 GENERAL DEVICE DESCRIPTION CARAT pro is used for continuous or intermittent respiratory support and for the ventilation of patients The device is suitable for adults and children with a tidal volume of 50 ml and higher and is designed home or clinical applications CARAT pro has pressure and volume controlled ventilation modes The ventilation can be invasive e g using a tracheostoma or non invasive using a mask CARAT pro has the technical prerequisites allowing it to run with a single line patient circuit with exhalation valve CARAT pro and CARAT II pro or with a double line patient circuit CARAT II pro as required The device can be connected to a low pressure source of oxygen for ventilation with increased oxygen concen tration There is also the option of combining CARAT pro with an external humidifier 2 2 CONNECTIONS AT THE FRONT OF THE DEVICE f o H FFRICHTER Figure 1 Connections at the front of the device l 3 Connection of tube circuit inspiration The single line patient circuit or the inspiration section of a double line patient circuit are connected here 2 Connection of FiO sensor cable Connect the FiO2 sensor cable here for measuring the oxygen concentration 3 Connection of pressure measuring tube The pres
18. sleeve 65 Flow sensor 66 Sensor block without 65 67 68 69 72 77 67 O Ring 30x1 2 ben X m 68 j 3 ue ia ds Jj 68 Valve membrane 69 Valve cover 70 4x1 O ring 71 3 8x1 25 O ring 72 M3 tie rod 73 Non return valve 74 17x1 O ring 75 ST2 2x9 5 countersunk screw 76 Proportional valve with seal and bushing strip 77 Valve base 78 4 6x1 85 O ring 79 5x1 8 O ring 80 FiO coupling Page 28 of 82 81 Oxygen adapter internal 82 Oxygen valve 3 2 way valve with seal and bushing strip 83 M3x8 countersunk screw 84 ST2 2x19 fillister head screw 85 Baffle FiOs adapter 86 Oxygen block 90 Air outlet 96 3 0x20 self tapping screw 97 ST2 2x9 5 filister head screw 2 10 COMPLETE DEVICE ASSEMBLY Figure 16 Complete device assembly 41 M3x8 pan head screw 91 M3x8 Allen screw C Housing base 87 DC connection point front nut A CARAT II pro sensor block D Complete internal frame 88 Filter cassette complete with flow sensor 89 Filter cassette cover B CARAT Il top cover Page 29 of 82 2 11 CARAT pro TUBE CONNECTION DIAGRAM Figure 18 Tube connection diagram for CARAT pro part 2 Page 30 of 82 2 12 CARAT II pro TUBE CONNECTION DIAGRAM Figure 20 Tube connection diagram for CARAT Il pro part 2 Page 31 of 82 2 8 DEVICE CONFIGURATION 2 8 1 CONTROL CIRCUIT BOARD 7 arite e a ere l ok d E4 zn z Figure 21 Control circuit board top 1 NTC 2 Cable con
19. the MFK Calibrate Pressure Sensor Calibrate Flow Sensor Calibrate O Sensor Calibrate Tube Battery Check Oo2 Valve Check Tightness Check Change PIN 2 Press the MFK The FiO calibration begins If the calibration was successful the word OK will appear after a few seconds If the calibration should not have been successful the word Error will display In case of an error message repeat the calibration Should the result be unsuccessful replace the FiO sensor 21 Ok Finish calibration Calibrate Pressure Sensor Calibrate Flow Sensor Calibrate O Sensor Calibrate Tube Battery Check Oo2 Valve Check Tightness Check Change PIN 3 Press the MFK to end the FiO sensor calibration Page 63 of 82 4 5 OSVALVE CHECK D When e Equipment e Annually after each maintenance e Oxygen source e Straight FiOs connection adapter The O valve check checks if the oxygen valve is working properly To run the Os valve check 1 Connect the oxygen source with the CARAT II pro according to Figure 30 A Oxygen connection B Oxygen connection adapter straight C Tube from the oxygen source Figure 30 Os valve check system configuration 2 Turn on the oxygen source Check if the fed in oxygen is being expelled from the oxygen outlet O5 3 Navigate to O Valve Check by turning the CETT MFK i Calibrate Flow Sensor Calibrate O Sensor Calibrate Tube Battery Check O Valve
20. Disconnect the expiration tube from the device and close up the expiration tube at the device connection side 4 After 3 breaths the alarm Check Expiration Outlet must appear To simulate a Check Measuring Tube alarm a tube circuit with a meas uring tube is required CARAT I pro und CARAT II pro 1 Start ventilation setting the PCV mode 2 Disconnect the pressure measuring tube from the device 3 The Check Measuring Tube alarm must appear after about 3 s Page 70 of 82 CHAPTER 6 APPENDIX 6 1 ERRORLIST Table 2 Error messages during operation and at device start up Error message Error SpO sensor Cause Communication with SpO measuring module not possible A Correction Device must be serviced SpOs sensor defective Replace SpO sensor SD card is full No storage space available on the SD card Insert blank SD card Flash Not Working No access to the flash Device must be serviced An older parameter set is on the device Current parameter set Is incorrect The device uses the old parameter set and can continue to be utilized Default parameters are on the device No valid parameter set available or they are faulty The device uses the efault param eter set and can continue to be uti lized The flow sensor shows an error Flow sensor is defective Device must be serviced The FiO sensor shows an error FiO sensor is defective Check FiO
21. For device types 9LV103 and 9LV203 CARAT I pro CARAT Il pro Ventilator Service manual for providers and service technicians 2014 HOFFRICHTER GmbH All rights reserved The content published in this service manual is the sole property of the HOFFRICHTER GmbH All forms of repro duction editing distribution and any kind of exploitation even in part require the prior written consent of the HOF FRICHTER GmbH The HOFFRICHTER GmbH reserves the right to amend or replace this service manual without prior notice Please ensure that you are always working with the most current version of this service manual Should you have any questions please contact the ventilation device provider or check our information at www hoffrichter de The respiratory device may only be operated and maintained by trained personnel The following documents are available for CARAT II pro in addition to this service manual User s manual CARAT I II pro for physicians and medical professionals User s manual for CARAT I II pro for patients Brief instructions for CARAT MII pro Hygiene concept Maintenance plan Mettenheimer Stra e 12 14 19061 Schwerin Germany Telephone 49 385 39925 0 Fax 49385 39925 25 Email info hoffrichter de Article No 50000650 www hoffrichter de CARAT pro Service ENG 2015 02 03 04 i HOFFRICHTER GmbH TABLE OF CONTENTS CHAPTER 1 IA RODU PIO N Pe
22. Press the MFK to Continue pa ee a pan esd tt 0 3 6 9 12 8 21 24 i5 i 27 Show battery state Page 16 of 82 2 4 LED DISPLAYS A o H FFRICHTER Figure 4 LED Displays 21 Alarm LED The alarm LED lits flashes in the event of an alarm It also provides information on the alarm priority Color Status light Priority Red Flashes HIGH Yellow Flashes MEDIUM Turquoise Glows steadily LOW 22 Q Power LED The power LED gives information about the status of the power supply Color Status light Status Green Glows steadily Mains operation Yellow Glows steadily Unacknowledged power failure White Flashes Device shuts down None Off Confirmed AC power failure or no mains voltage battery power 23 Battery LED The battery LED provides information about the state of the internal battery charge Color Status light Battery charge state Green Glows steadily gt 60 96 Yellow Glows steadily 220 96 vce 6096 Hed Glows steadily 2099 20 96 White Flashes Device shuts down Page 17 of 82 2 9 MOVABLE AND REMOVABLE HOUSING PARTS E Figure5 Left device side Figure 6 Right side of the device with filter cassette 24 Handle pull out The handle may be pulled out for device transport 25 Bottom flap Valve membrane expiration is located under the bottom flap which must be replaced before every change of patient or maintenance work
23. Tightness Check Change PIN 2 Press the MEK Calibrate Pressure Sensor During the first phase of the battery check the batteries are being recharged Calibrate Flow Sensor Actual Capacity Calibrate O2 Sensor IT Use the escape key 99 to cancel the battery Calibrate Tube CAROK Battery Check O Valve Check Tightness Check Change PIN Charging 3 In phase two the batteries are discharged ata Galibrate Pressure Sensor constant load This takes about 3 to 4 hours Rs Actual Capacity depending on the battery capacity Soca ees pauses Calibrate O2 Sensor ndi Calibrate Tube Battery Check O2 Valve Check Tightness Check Change PIN Discharging 4 Atthe end of the battery check the battery atari Eyes Sansa Capacity actual capacity will be displayed The test has been passed when the capac ity is gt 80 If the capacity is lower plus an Calibrate O2 Sensor e Error message appears the battery pack Calibrate Tube has to be replaced with a new one O Calibrate Flow Sensor Actual Capacity 93 Battery Check Oo2 Valve Check Tightness Check Change PIN Finished ok Page 66 of 82 4 8 TEST THE POWER SUPPLY FOR ELECTRICAL SAFETY 4 8 4 TESTS The tests are done with a device safety related check e g SECUTEST SIII which works according to the DIN EN 62353 2008 standard Discharge currents always have to be calculated via direct measuring The ventilator system is t
24. ake rotary control knob Page 23 of 82 2 5 HOUSING TOP FOR CARAT II pro Figure 11 Housing top for CARAT II pro 1 Rotary control cover 2 Rotary control knob 3 Round wire circlip 4 M4 hex nut 5 7 3 rotary control knob washer 6 Intake rotary control knob 7 39x1 O ring 8 Membrane keyboard 10 Threaded bush 11 lop cover 13 LED cover arch 14 Display Page 24 of 82 fe M o O 15 Display bezel 16 Operating circuit board 17 ST2 9x13 screw 18 Double line patient circuit foil 98 Display seal 2 1 6 HOUSING BASE Figure 12 Housing base 19 M5x8 Torx pan head screw 20 Right trim handle 21 Felt strips 22 Lever handle 23 Speaker 24 M4x8 countersunk screw 25 Fillister head screws ST2 2x4 5 26 Spacer bush 27 26 4 washer 28 M4 hex nut 29 Stop bracket 30 Filter cassette cover 31 M4x10 shoulder screw 32 S12 9x13 countersunk screw 33 Foot 34 AC main switch Page 25 of 82 35 Housing base 36 Interface plate 37 Sub D9 bushing 38 Handle 39 Bottom flap 40 Left trim handle 41 M3x8 pan head screw 2 f INTERNAL FRAME Figure 13 Internal frame 42 Internal frame for top 43 Blower box 44 Battery pack Li lon 45 Seal for air outlet CARAT box 46 Battery holder 47 Internal frame for Base 48 Control tube valve for CARAT Il pro 49 M3x16 pan head screw 50 Fire protection cover 51 LP spacer MSCBT M3 6 52 LP SD card module 53 LP spacer 22 5x6 4 Page 26 o
25. box 00004505 Seal for air outlet CARAT box 42100424 30x1 2 O ring 44000068 Valve membrane 42100423 Valve cover 00004530 FiO sensor bushing replacement kit 00004988 CARAT pro air outlet 42100454 CARAT pro tubing set 00004167 CARAT II pro tubing set 00004168 CARAT pro maintenance kit 1a 00004991 CARAT Il pro maintenance kit 1b p 00004992 Cy CARAT pro maintenance kit 2 a 00004993 CARAT II pro maintenance kit 2b 00004994 Page 76 of 82 Table 6 Replacement parts list Name Figure Name Figure Article number Article number CARAT pro CARAT II pro maintenance kit 5 a 2 Cc maintenance kit 5b Cy O 00004995 C 00004996 Reconditioning Kit 1 for CARAT I pro Reconditioning Kit 2 for CARAT II pro 00004997 00004998 Membrane replacement kit wr 00004990 CYC Page 77 of 82 6 4 ACCESSORY LIST Table 7 Accessory list Name Figure Article number Disposable single line patient circuit for adults with expira tory valve and pressure meas urement and control tube _ 180 cm 2 22 mm 00014967 Disposable single line patient circuit for adults with ex piratory valve and pressure measurement and control tube plus water trap L2 180 cm 2 22 mm 00014995 Disposable single line patient circuit for children with ex pi
26. calibrations and checks have been performed the device must be checked for damage and proper func tionality The following describes the measures to be taken Implementation of the safety related checks are to be logged in the medical product book Test Handle intact and functional Execution Do a visual inspection for signs of physical damage scratches etc Pull the handle upwards There must not be any noise to be heard Check that the handle holds its position in the fully extended position Hardware test at device start up Power on the device using the AC main switch and check if the device starts without error messages Operational controls are functioning properly Check all operating elements for damage and proper function Check the touch pad function Connections intact and functional Check display Check the touch feature Check all pneumatic and electrical connection points for damage and proper function Make sure the display is operating properly If necessary change the brightness Serial numbers type plate and device are iden tical Check that the serial number on the type plate and the serial number on the device match Device switches off Shut down the ventilation if necessary and turn off the device via the AC main switch Make sure the device has been properly shut down and the standby screen is showing Then unplug the power cord from the unit and check that the device i
27. ccsecececeseeeceeceecesaeesaeecaeeesaeeseeseeseseeesaeeseesaseeseeeseeesegeeseeesaeess 74 6 4 Yee sg Mir RTT 78 6 5 BEBOS MEE m ene es eer eee eee en en eee ee eee 81 657 BER eee ere SEERE ts ae A 81 6 5 2 Ee E e TNTE A E GE eee E ee ee eee ee ee eee 81 6 5 9 mmi EET E E E E O E E E E E E 81 6 54 OS I T m 81 Page 4 of 82 6 6 6 6 1 6 6 5 SID DING INSIUCHONS sereine nn REDEE EKE FOE EEO SEn ENSE RE SEE EESE Shipping instructions for contaminated medical technology essessenm Shipping devices after maintenance or repairs seseeseseem emnes Page 5 of 82 1 1 LIST OF ILLUSTRATIONS Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23 Figure 24 Figure 25 Figure 26 Figure 27 Figure 28 Figure 29 Figure 30 Figure 31 Figure 32 Figure 33 Connections at ithe ront or the device recidere esa Sacer int ueteri wma ben anb ante aad E lus kneben bad 12 Connections on the rear side of the device sesssssssesseene nnne 13 eue c NONE D o uo mmm 14 LEE BEDER s e 17 Eneas OE E E E arn E E Se coe 18 Right side of the device wi
28. d operating circuit board sseeeee nn 43 3 2 4 Remove the display frame and the CISDIAY ccccccssccseccneceeeeneeeeeessesseeeeseeeesseseeeeeeeraeeeeeeentaeetanas 45 Ou mco uu seA Bic MT TOO TET 46 Page 3 of 82 5 20 Uninstall the tube connection seals and the support frame ssssssrsssseerrssrrrsrrerrerrrrerrrsrrrerrrsereni 48 3 2 Sae E EES KETAS E E E OO OS 49 3 2 8 Caiac EE eae e E T E NTE A E E AE A A ET EE N TOE TT 50 3 2 9 Bee AE HOS E T E oo Omm 21 3 3 Hardware maintenance scsursdocivetraevcaintsasemnssipeaastndintesssesiotsiatien ip pw vato ER ndn dub I RR EU RS 52 3 9 1 yai N m 02 S Replace course and fine filter 0 cee cecc cece eeeceeceeeceeeeeeseeee eee nennen nnn nennen nnn nnns 52 3 4 Replace expiration valve membrane eeeeesseessseesseeee nennen nennen nnne nnns nnne anne nis 99 3 9 Garry out malnten Me NE at es a act ok ec ed teed EEEa evi UTR 54 3 6 Say out mamntenant NOR tm 55 3 7 Carny eiae Misa ie NEN o6 3 8 mici RETI ENTER Ec 57 Chol FE HEE HEARTS FEE m UTE OT S02 AO MNO Te BA ER SEE EE A ETE Of CHAPTER 4 TNI escFusEg lIpte C 58 4 1 The service screen in the CARAT pro cccssccccseeeceeeecenceceueeceueesauseesueeesaeeesausesaueesaneeseneessneesags 59 4 2 Calibrate the pressure sensor uoces nesiseveecwscccoeleivissicuevevusiondsccesaeencebieseseecie
29. e bottom flap E AE N 2 Page 53 of 82 3 5 CARRY OUT MAINTENANCE 1 D When 623 Replacement parts A Equipment Annually For CARAT pro e Long screwdriver PH1x200 Maintenance kit 1a Art No 00004991 e 2x valve membranes Needle nose pliers M14x1 socket wrench e Softpad L e 2x O rings i e 1x course filter 3 Aa a e 1x fine filter poe APM blind plug e 1x tubing set e Therapy tube with pressure CARAT pro measuring tube e Adapter bacterial filter CARAT II pro For CARAT Il pro Maintenance kit 1b Art No 00004992 e 2x valve membranes e 2x O rings e 1x course filter ce L e x fine filter e 1x tubing set CARAT II pro s 3 5 1 WHAT NEEDS TO BE DONE DURING MAINTENANCE 1 Replace valve membranes and o rings for inspiration and expiration Page 53 Replace course and fine filter Page 52 Replace Silicon tubing in accordance with the tube connection diagram starting on Page 30 4 Visual inspection 4 1 Check tubes and tube connections 4 2 Check cables and plug connections 4 3 Check fit of all printed circuit boards 5 Calibrate the device 5 1 Calibrate the pressure sensor 5 2 Calibrate the flow sensor only CARAT Il pro 5 3 lightness check 6 Perform safety related check see Page 69 7 Check the electrical safety of the external power supply see Page 67 a qw us
30. etroreceaeensuersuessonds 60 4 3 Calibrate the flow sens of 2 os En ENEE E REE 61 4 4 Calibrate the FiO sensor mmm 63 4 5 BEAVIS ere RESET nee ae er E Oe ee DIN I RD ee ere 64 4 6 Perform a tightness check MR Tee 65 4 7 Perform the battery check vcs diccccactevisscsnevieaccutetssaesteveuaisuesesebiseacuueed saacdvuwssescenewesiaessaveeneaaersicnteade 66 4 8 Test the power supply for electrical safety cccccsecccseeceeeceeeceeeeceeeseeeseeeeceeesaeeseeeseeeseeesaeees 67 4 8 1 67 4 8 2 Device diseharge CUOI ees ert eee ne tet meme EA AS n nner rena enna Penance eee ee I HMM E 67 4 9 Send Pa amela wcuunsncautisanatmastenotisamonasseuasndentaenainaatsunenoaes eR n e n aaee Eeee EEEn hiire e UD 68 4 9 1 Resetting the device to factory settings ssrssrssrrrrrsrrsrrsrrsrrrsrrrrrsrrsrrrsrrrrrrrrrrnrrerrsrrsrrsrrrerrni 68 4 9 2 Send the patient device S NGE issnin anaa aai aai 68 CHAPTER 5 PERFORM THE FINAL INSPEC TION sannanannannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnannnnnnnnnannnnnnnnnnn nnn 69 CHAPTER 6 APR PENDIA oorsee EE AEE EEEE EEE EEEE AAEE E EE E EEEE 71 6 1 midce a cT T 71 6 2 E266 agi gs Se nn nn eee ee ee A EET 72 6 2 1 Ven AE EET esinin EE E a nr O ERN 72 6 2 2 AE DEERE FE a TET ent ae ee heen E TETTE res 6 2 9 FS e Sezi usc TT Tm 179 6 3 Replacement parts list cccccccsse
31. f 82 54 Control circuit board 91 Allen screw 92 M2 5x9 0 spacer bolts 93 22 7 steel washer 94 M2 5x6 pan head screw 95 22 7 plastic washer 2 8 SENSOR BLOCK FOR CARAT pro Figure 14 Sensor block for CARAT pro 55 Seal for tube connections 56 Support frame for tube connection seal 57 O sensor bushing 59 CARAT pro tube connector 60 23 2 washer 61 M3 hex nut 62 Flow sensor seal 63 Long spacer sleeve 64 Short spacer sleeve 65 Flow sensor 66 Sensor block without 65 67 68 69 72 77 67 30x1 2 O ring 68 Valve membrane 69 Valve cover 70 4x1 O ring 71 3 8x1 25 O ring 72 M3 tie rod 73 Non return valve 74 17x1 O ring 75 ST2 2x9 5 countersunk screw 76 Proportional valve with seal and bushing strip 77 Valve base 78 4 6x1 85 O ring 79 5x1 8 O ring 80 FiO coupling Page 27 of 82 L AS Sx 60 81 Oxygen adapter internal 82 Oxygen valve 3 2 way valve with seal and bushing strip 83 M3x8 countersunk screw 84 ST2 2x19 fillister head screw 85 Baffle Os adapter 86 Oxygen block 90 Air outlet 96 3 0x20 self tapping screw 97 ST2 2x9 5 fillister head screw 2 9 SENSOR BLOCK FOR CARAT II pro Figure 15 Sensor block for CARAT II pro 55 Seal for tube connections 56 Support frame for tube connection seal 57 Os sensor bushing 58 CARAT Il pro tube connector 60 23 2 washer 61 M3 hex nut 62 Flow sensor seal 63 Long spacer sleeve 64 Short spacer
32. fail again contact the HOFFRICHTER service depart Ene y CE E i Ok ment O Valve Check Finish calibration Tightness Check Press the MFK to stop the pressure sensor calibration Page 60 of 82 4 3 CALIBRATE THE FLOW SENSOR D When A Equipment e After each repair and maintenance e Pressure Flow meter with flow sensor e herapy tube with pressure measuring tube e Adapter bacterial filter CARAT Il pro With the flow sensor calibration you calibrate the flow sensor CARAT pro or the two flow sensors CARAT Il pro To perform the flow sensor calibration 1 Setup the system according to Figure 29 or Figure 29 Mim Figure 28 System configuration for CARAT I pro flow sensor calibration E Vi Hils mor 00 hPa a r d A Pressure Flow meter B Therapy tube C Pressure measuring tube D Adapter bacterial filter E Flow sensor P Filio Figure 29 System configuration for CARAT Il pro flow sensor calibration 2 Navigate to Calibrate Flow Sensor by turn ing the MFK Calibrate Pressure Sensor Calibrate Flow Sensor Calibrate O Sensor Calibrate Tube Battery Check Oo2 Valve Check Tightness Check Change PIN Factory Settings Page 61 of 82 3 Press the MFK a Calibrate Pressure Sensor O l min OF Rune The first value O l min is selected l Calibrate Flow Sensor 10 l min If you want cancel the flow sensor calibration Calibrate O2 Sensor 20 l
33. fications e Pressure Flow measuring range O 100 hPa 0 2 96 from the pressure measuring range O 200 l min 0 2 96 from the flow measuring range e Display accuracy Pressure 0 01 hPa Flow 0 1 l min e Units hPa mbar cmH5O l min e g APM by HOFFRICHTER 00004040 Scope of delivery APM including APM incl flow sensor 00004832 APM blind plug 00004831 Therapy tube with pressure measuring tube 00007116 Adapter bacterial filter 00004933 Name Article number Test lung with the following specifications e Compliance hardness of the lungs 25 ml mbar e Vt 500 ml PEEP 0 mbar e Resistance airway resistance 20 mbar l s e idal volume max 1000 ml 00004960 Figure Phillips head screwdriver PH1 x 200 Needle nose pliers Wiecutles Mea cutters SW10 socket wrench Canned air or fixed compressed air connection DRUCKLUFT E Allen wrench SW 2 5 Switched mode power supply 00014206 M14x1 socket wrench 00004130 saat SoS a brush and vacuum cleaner Power cable 31100023 a ms N A Ls C Page 37 of 82 Name Figure Name Figure Article number Article number PC with the following minimum USB cable PC cable system requirements 00005291 e MS Windows 98 2000 NT4 0 ME XP Server 2008 Vista 7 or 8 e Microsoft NET Framework 2 0 Redistributable x86 e one free COM interface per dev
34. he device tube circuit FiO sensor etc If necessary remove the HOFFRICHTER warranty seal Pull the filter cassette from the device OF OF ee Ge qo Use the socket wrench to loosen the front nut of the DC connection 7 Place the back of the device on a softpad 8 Use the screwdriver to loosen the four housing retaining screws 9 Replace the device back on its housing base Page 40 of 82 10 Lift the handle and pull off the top cover towards the front Page 41 of 82 3 2 2 DISCONNECT THE TOP COVER FROM THE DEVICE Required tools auxiliary material none 1 Detach the Operating circuit board ribbon cable from the device s operating circuit board Page 42 of 82 3 2 3 REMOVE THE MULTIFUNCTION KEY AND OPERATING CIRCUIT BOARD Required tools auxiliary material SW10 socket wrench Phillips head screwdriver PH1 1 Pull firmly at the MFK to pull if off 3 Turn over the top cover Page 43 of 82 4 Detach the Membrane keyboard ribbon cable from the operating circuit board Page 44 of 82 3 2 4 REMOVE THE DISPLAY FRAME AND THE DISPLAY Required tools auxiliary material Wire cutters Phillios screwdriver PH1 1 Disconnect the cable tie with the wire cutters Page 45 of 82 3 2 5 REMOVE INTERNAL FRAME Required tools auxiliary material none 1 Detach the speaker cable from the control circuit boa
35. ice Straight FiOs connection PC software EASYset adapter DV 41000104 Softpad Device for checking electrical safety e g SECUTEST SIII DIN EN 62353 2008 User s manual for CARAT pro for physicians and medical User s manual for CARAT II pro for physicians and medical professionals professionals 5000061 1 50000625 Service manual g Hygiene Concept 50000650 50000652 MA CAUTION All tools measuring equipment and aids possibly exposed to contamination must be cleaned after they have been used and treated with disinfectant Page 38 of 82 3 1 3 UNPACKING AND DISINFECTING A CAUTION To protect against germs the surface of the device and where present the humidifier must be treated with a disinfectant immediately after unpacking 3 1 4 CHECKING FOR EXTERNAL DAMAGE Before starting the service works check the device for external damage 3 1 5 DATA BACKUP We recommend that a backup is carried out before starting maintenance work Connect the device to a PC and use the PC software EASYset not yet available to read out and save the device data Page 39 of 82 3 2 DISASSEMBLE THE DEVICE 3 2 1 REMOVE TOP COVER Required tools auxiliary material Phillios head screwdriver PH1 x 200 socket wrench M14x1 softpad 1 Switch off the device at the main switch Disconnect the device from the power supply Disconnect the attached accessories from t
36. n is performed using an external FiOe Monitoring unit and oxygen is supplied Spontaneous breathing detected The device has detected spontaneous breathing by the patient This triggered the inspiration trigger The icon will remain visible during inspiration and will shut off with the beginning of the expiration Trigger lock On Trigger lock momentarily active SD card is inserted into the device No SD card inserted into the device ZEZEBHHERREEER NJ LII SpOs sensor connected Page 19 of 82 Meaning PC is connected via the USB port Error detected Selecting this symbol results in a list of all current errors see 6 1 Error list on page 71 Internal battery fully charged Internal battery being charged 1 bar amp 20 charged Page 20 of 82 2 DEVICE CONFIGURATION MECHANICAL SUB ASSEMBLIES 2 1 OVERVIEW COMPLETE UNIT The CARAT pro and CARAT Il pro ventilators consist of the following components Motherboard Power management Control and operating unit Communication Blower Sensors Internal battery Programming board display and membrane keyboard Figure 7 Block diagram for the device 2 2 OVERVIEW CARAT pro PNEUMATIC BLOCK The pneumatic block is the connector unit for the single line patient circuit and consists of the following components Oxygen connection Pressure sensor ORDER Oxygen valve Connection point a ET E P
37. nection point for operating circuit board 3 Cable connection point for motor 4 Cable connection point for speaker 5 Almega 1281 steering controller 6 Cable connection point for display backlight 7 Inspiration pressure sensor measurement without pressure measuring tube 8 Cable connection point for LVDS Display 9 Cable connection point for FiO measuring cell 10 Pressure sensor for pressure measuring tube mask pressure 11 STM32 F407IGT6 operating controller 12 SpO module 13 Cable connection point for SpO sensor 14 Cable connection point for proportional valve 15 Cable connection point for FiO valve 16 LP SD card module Page 32 of 82 ELECTRONIC COMPONENTS m i Lj aL r 17 CR2032 3V clock battery 18 Internal battery pack input fuse T4A 19 Input fuse 12 V DC F8A 20 DC connector bushing 21 Cable connection point for battery pack 22 Input fuse 24 V DC F8A 23 Cable connection point for AC main switch mier ngu H r ee IE ENE E ED ie HTYRTFYT ehiititii nae TIT Yi op oan L to E rz TITETTUTFEFTTTIEFTTTTRETTTT Figyi EEELLIT OQ Figure 22 Control circuit board bottom 1 NIC 6 Cable connection point for 8 Cable connection point for 2 DC connector bushing CARAT II pro control tube valve expiration flow sensor 3 RS232 Interface 2 2 way valve 9 60 mbar maximum pressure 4 Connector bushing for remote 7 Cable connection point for governo
38. o be checked according to protection category II with the application part Type BF The associated power sup ply of Protection category Il is checked in the system Defects at the power supply will be detected while checking the entire system according to Protection category Il 4 8 2 DEVICE DISCHARGE CURRENT The device discharge current is measured with a probe of the device safety related check equipment e g SECUT EST SIII at the FiOo sensor connection The test is considered passed when the limit values of the device discharge currents are within the standards of DIN EN 62353 2008 table 2 4 a H FFRICHTER Figure 33 System configuration for measuring the device discharge current Page 67 of 82 4 9 SEND PARAMETERS 4 9 1 RESETTING THE DEVICE TO FACTORY SETTINGS To reset the device to factory settings 1 Turn on the main switch 2 Navigate to Factory Settings by turning the MFK Calibrate Pressure Sensor Calibrate Flowsensor Calibrate O Sensor Calibrate Tube Battery Check Oo2 Valve Check Tightness Check Change PIN Factory Settings 3 Press the MFK 4 Navigate to Yes by turning the MFK Factory Setting Restore Factory Settings Yes NO 5 Press the MFK 4 9 2 SEND THE PATIENT DEVICE SETTINGS Send the device settings for data backup to the device using the EASYset software not yet available Page 68 of 82 CHAPTER 5 PERFORM THE FINAL INSPECTION After all
39. on Dieses Ger t wurde nur oberfl chendesinfiziert Es erfolgte keine hygienische Aufbereitung For your information This device was disinfected only at the surface There was no hygienic treatment Shipping takes place by appropriate logistics companies Page 82 of 82
40. ources and prevents harmful substances being released into the environment 6 5 1 DEVICE AND COMPONENTS The device or components must not be disposed of with the household waste They must be disposed of at a communal collection point or public waste disposal authority 6 5 2 PACKAGING The packaging can be disposed with the normal household waste 6 5 3 BATTERIES Batteries must not be disposed of with the household waste They must be disposed of at a local retailer or at a communal collection point 6 5 4 FiO SENSOR The FiO sensor must not be disposed of with the household waste It should be disposed of correctly by incine ration in a hazardous waste incineration plant Local official regulations should be observed 6 6 SHIPPING INSTRUCTIONS 6 6 1 SHIPPING INSTRUCTIONS FOR CONTAMINATED MEDICAL TECHNOLOGY The following shipping instructions apply to contaminated medical technology which is delivered to HOFFRICH TER GmbH for processing 6 6 2 PICK UP The dealer medical technician or authorised personnel picks up the contaminated medical technology from the patient A local surface disinfection of the equipment and accessories with microcide liquid spray MRSA active takes place followed by carefully placing the objects in bags with the use of disposable gloves mask and dispo sable apron The proper disposal of disposable materials is respected 6 6 3 PACKAGING FOR SHIPPING The packaging of equipment accessories in ste
41. place the coarse filter User Visually check of the fine filter User Monthly or before if heavily Replace fine filter User contaminated Every 6 months Battery quick test User Provider Every 6 months during in storage Charge battery to 100 User Provider Every 6 months without Replace the valve membrane Provider Service bacterial filter expiration Every 12 months Maintenance 1 Provider Service Safety related check Provider Service Every 2 years Maintenance 2 Provider Service After 15 000 h blower run time or Maintenance 5 Provider Service every 5 years Complimentary activities E What E By whom If patient has changed reconditioning Hygienic reconditioning manually or with Provider Service recondition contaminated devices the KR1000 Keredusy procedure MRSA contaminated devices Hygienic reconditioning using the KR1000 Provider Service Keredusy process Page 10 of 82 1 3 3 REPAIR WORK Repairs to the device may only be carried out by an authorized service agency The following should be carried out in the case of a repair Wipe disinfect the device surface e g schulke wipes or local equivalent Check the error description and error analysis Performing the repairs Final inspection Packing the device according to packaging instructions Shipping according to the shipping instructions see Page 81 oe eS i uet 1 3 4 HYGIENIC RECONDITIONING During recondition recondition on changing patients as well as
42. r alarm nurse call inspiration flow sensor 5 USB interface Page 33 of 82 2 8 2 OPERATING CIRCUIT BOARD 37891 28 13 171551 Figure 23 Operating circuit board top 1 Cable connection point for 3 Cable connection point for membrane keyboard control circuit board 2 Cable connection point for 4 Piezo signal transmitter touch display Page 34 of 82 bl o i 0 L i bl HIE HERE 111111113 ASTRA LIO pe212111 13 J i24 4 ALITER ae FELLULTT 1 13 bol LI a n TELERI aii 11044593 m Eg Figure 24 Operating circuit board bottom 1 Alarm LED 3 Battery LED 5 Encoder 2 Power LED 4 MFK background LED Page 35 of 82 CHAPTER 3 MAINTENANCE WORK A CAUTION Make sure that all ventilation and alarm parameters have been restored in the device after all maintenance work has been completed 3 1 PREPARATION 3 1 1 PROTECTING AND DISINFECTING AGENTS e Hand disinfectant e g Sterillium Bode or local equivalent e Surface disinfectant e g schulke wipes or local equivalent e n case of dangerously contaminated medical products MRSA additional personal protective gear must be used like disposable gloves masks and aprons Page 36 of 82 3 1 2 TOOLS AND MEASURING EQUIPMENT The following tools and measuring equipment are needed for the maintenance work Name Figure Article number Pressure Flow meter with the following speci
43. ratory valve pressure measurement and control tube L 180 cm 15 mm 00014923 Name Article number Disposable double line patient circuit for adults with pressure measuring tube _ 180 cm 2 22 mm 00007969 Disposable double line patient circuit for adults with pressure measuring tube and water traps _ 180 cm 2 22 mm 00007996 measuring tube _ 180 cm 2 15 mm 00004928 Disposable double line patient circuit for children with pressure Figure cu SS Ay Bacterial filters 00004932 Bacterial filter adapter 00004933 FIO measurement set con sisting of FiO sensor T adapter FiO sensor adapter connec tion cable FiO sensor with screw connection 00004944 FiO sensor OOM103 1 23000018 T adapter 23000019 Housing gas line FiO sensor connector piece 23000020 FiO sensor connecting cable with screw terminal 00014116 FIO connection adapter angled 41000087 Page 78 of 82 Table 7 Accessory list Name Figure Article number FiO connection adapter strai 3 4 1 O00 04 9j Name Figure Article number Aperture for expiration tube connection 42100449 Filter cassette complete open 00002145 Filter cassette open with filters 00002038 Filter cassette complete closed 00002146 Filter cassette closed with filters 00002058 E D Filter cas
44. rd 2 Slightly lift the internal frame at the front and pull it out about 5 cm 3 Pullthe battery holder from the internal frame Page 46 of 82 Remove the batteries from the battery holder Temporarily place the batteries on the internal frame Detach the Battery pack and AC main switch cables from the control circuit board Pull the interface plate up and out the top DUO p Or om Page 47 of 82 3 2 6 UNINSTALL THE TUBE CONNECTION SEALS AND THE SUPPORT FRAME Required tools auxiliary material none 1 Remove the support frame and the tube connection seals from the sensor block Page 48 of 82 3 2 7 UNINSTALL THE CONTROL CIRCUIT BOARD Required tools auxiliary material Phillips head screwdriver PH1 needle nose pliers 1 Detach all cables and tubing from the control circuit board 2 Loosen the 4 control circuit board screws 3 Depress the center of the plastic dome using needle nosed pliers and remove the control circuit board from the internal frame Page 49 of 82 3 2 8 UNINSTALL THE SENSOR BLOCK Required tools auxiliary material Allen wrench 2 5 1 Disconnect all tubes from the sensor block and from the control tube membrane only on CARAT II pro 2 Use the Allen wrench to loosen the 3 screws from the sensor block and remove the sensor block from the internal frame Page 50 of 82 3 2 9 REMOVE THE BLOWER BOX Required tool
45. re is a risk for fire and explosion For hygienic reasons it is recommended to wear disposable gloves when you carry out a task on the device Before the next tasks please wipe the device with a commercial disinfec ting solution e g Mikrozid Liquid The documents delivered with the device must be checked when the device arrives at the Service department Should anything point to contamination of the device e g MRSA this device should be treated separately according to the CARAT pro hygiene concept transport storage processing Special hygienic measures are necessary when a maintenance or repair task is carried out on a machine contaminated by MRSA Methicillin Resistant Staphylococcus Aureus In all circumstances protective clothing must be worn such as gloves lab coat and face mask Please refer to the CARAT pro hygiene concept for further information on the handling of MRSA contaminated devices Page 9 of 82 1 3 MAINTENANCE REPAIR HYGIENIC RECONDITIONING AND SAFETY RELATED CHECK NOTICE All procedures performed are to be documented 1 3 1 MAINTENANCE The ventilator is to be serviced only by authorized service companies Servicing intervals as outlined in the main tenance schedule must be observed 1 3 2 MAINTENANCE SCHEDULE Table 1 Service intervals overview When A What 8 By whom Before commissioning Safety related check Provider Service Weekly Clean re
46. ressure measuring Ep tube 3 5 mm Pressure switch Flow sensor P Tube circuit connection Inspiration M22 Air inlet gt Blower gt Connection point Control tube o 4 5 mm Proportional valve Ambient air Air outlet Figure 8 Pneumatic block diagram for the CARAT I pro Page 21 of 82 2 3 OVERVIEW CARAT II pro PNEUMATIC BLOCK The pneumatic block is the connector unit for the double or single line patient circuit and consists of the follow ing components Oxygen connection Pressure sensor ee a Connection point Oxygen E Pressure measuring output tube o 2 3 5 mm Pressure switch Flow sensor gt Tube circuit connection Inspiration M22 Air inlet Blower gt Connection point Control tube o 4 5 mm gt Ambient air Air outlet A Tube circuit Flow sensor 4 connection Expiration FM22 Figure 9 Pneumatic block diagram for the CARAT II pro Page 22 of 82 2 4 HOUSING TOP FOR CARAT pro A 9 i n 13 ub Figure 10 Housing top for CARAT pro 1 Rotary control cover 7 39x1 O ring 13 LED cover arch 2 Rotary control knob 8 Membrane keyboard 14 Display 3 Round wire circlip 9 Single line patient circuit foil 15 Display bezel 4 M4 hex nut 10 Threaded bush 16 Operating circuit board 5 7 3 rotary control knob washer 11 Top cover 17 ST2 9x13 screw 12 Blanking plug for single line 98 Display seal 6 Int
47. rile welding foil followed by shrink wrap or packing in PVC or PE bags tear resistant and sealed by tape or tie wrap takes place at the dealer s or in the service departments Power cable ventilation equipment user s manual and other accessories with minimal risk of infection must be properly disposed of Hint CAUTION CONTAMINATED EQUIPMENT or CAUTION MRSA CONTAMINATED EQUIPMENT must be visibly placed on the packaging The packaging must be proper and robust and must not be contaminated The box is conscientiously sealed with packing tape 6 6 4 SHIPPING The delivery note must be on the outside of the equipment packaging Notice on delivery note CAUTION CONTAMINATED EQUIPMENT or CAUTION MRSA CONTAMINATED EQUIPMENT Shipping takes place by appropriate logistics companies 6 6 5 SHIPPING DEVICES AFTER MAINTENANCE OR REPAIRS The shipping instructions apply to medical technology which is sent back to the customer or dealer by the Service department after maintenance or repairs Page 81 of 82 6 6 6 PACKAGING FOR SHIPPING The device is packaged in PVC or PE bags tear proof The bag must be sealed securely e g tape or cable ties The packaging must be proper and robust and must not be contaminated The box should be sealed carefully with packing tape 6 6 7 SHIPPING The accompanying documents must contain the following information which must be visible to the recipient Zu Ihrer Informati
48. rs 1 1 SYMBOLS USED IN THIS SERVICE MANUAL Important information is denoted by symbols in this service manual Be sure to follow these instructions 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 Ad 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 light or severe injuries NOTICE This symbol denotes information tips and instructions for the efficient correct use of the device Page 8 of 82 1 2 SAFETY INFORMATION Before you start with the maintenance fully read and understand the contents of this Service Manual There is a danger of short circuiting of the capacitors and battery even when no electrical power is applied to the device If the main switch is switched off and the power supply is connected the internal battery is charged electrical power is still applied to the device Repair and maintenance tasks may only be carried out by suitably qualified authorized and competent personal FiO sensors contain a caustic liquid Avoid skin or eye contact if there is a sensor leak For FiO sensors no adjustment or repair work is required Components carrying oxygen must not come into contact with oils or fats The
49. s auxiliary material Wire cutters 1 Use wire cutters to cut through all 4 cable ties holding the top and bottom of the internal frame together 2 Remove the top cover 3 Lift out the blower box Page 51 of 82 3 3 HARDWARE MAINTENANCE 3 3 1 AIR FILTER A Filter frame cover B Filter cassette C Fine filter white D Course filter black Figure 25 Filter cassette design 3 3 2 REPLACE COURSE AND FINE FILTER D When 623 Replacement parts A Equipment e Once per year at each e Maintenance kit 1 e None maintenance visit How to replace the course filter and the fine filter Pull the filter cassette from the device Remove the course filter black and the fine filter white Insert the new filter back into the cassette Slide the filter cassette into the device pe Ie Page 52 of 82 3 4 REPLACE EXPIRATION VALVE MEMBRANE D When 623 Replacement parts e Equipment e Every 6 months if the device e Membrane replacement kit e Softpad has been operated without bacterial filter og A Bottom flap B Valve cover C Valve membrane Figure 26 Replace valve membrane expiration To replace the valve membrane Turn the device over and place it on a softpad Remove the bottom flap Turn the valve cover to the left and lift it off Replace the valve membrane with a new one Make sure it is placed into the correct position Reinstall the valve cover and th
50. s properly shut down Operation with internal battery With the device turned on unplug the power cord The message On battery should be showing in the window Nurse call remote alarm with alarm box If a remote alarm is available Connect an alarm box to the Remote alarm connection point Then create an alarm event and check if the alarm is forwarded to the alarm box Device language has been selected Check that the customer specific device language has been selected If not change the language on the system screen Safety related check Physical damage to the device exterior Damage to the accessories Check Expiration Outlet and Stenosis alarm Check if the device shows signs of damage If applicable check the accessories for damage CARAT pro 1 Start ventilation setting the PCV mode 2 Select the screen Alarm Log 3 Close up the tube at the patient connection side 4 After 3 breaths the alarms Stenosis and then Check Expiration Outlet must appear CARAT II pro Stenosis 1 Start ventilation setting the PCV mode 2 Select the screen Alarm Log 3 Disconnect the inspiration tube from the device and close up the inspiration port of the device 4 After 3 breaths the alarm Stenosis must appear Page 69 of 82 Test Check Measuring Tube alarm Execution Check Expiration Outlet 1 Start ventilation setting the PCV mode 2 Select the screen Alarm Log 3
51. sette cover 42101302 Coarse filter 1 pack 2 ea 00014950 Fine filter 1 pack 5 ea 00014951 CM Se USB cable PC cable 00005291 SD card Power cord 31100023 11200010 owitched mode power supply 00014206 _ eZ Carrying case 00004875 SpO gt finger clip sensor cable length 2 m GS 00005292 EY LY Functional bag 00004879 opO adhesive sensor for adults and children finger and toe cable length 2 m 00005294 Page 79 of 82 Table 7 Accessory list Name Article number Extension cable for SpO sensor cable length 1 m 00005293 Figure Name Article number Figure Brief instructions for CARAT pro 50000613 Brief instructions for CARAT II pro 50000645 User s manual for CARAT I pro for physicians and medical professionals 50000611 User s manual for CARAT I pro for patients 50000612 User s manual for CARAT II pro for physicians and medical professionals 50000625 User s manual for CARAT Il oro for patients 50000626 Service manual 50000650 Alarm box including cable and batteries 00014122 Hygiene concept 50000652 Alarm box 00004834 Cable for alarm box 00014115 APM airflow pressure meter incl accessories 00004040 PC software EASYset Page 80 of 82 6 5 DISPOSAL Proper disposal saves natural res
52. stem screen Page 14 of 82 17 Home key Function Action Return to the home screen Press briefly 18 Escape key Function Action Exit the current screen Press briefly Leave selected parameter Press briefly Cancel Press briefly 19 Safe key Function Action Activate key lock Press briefly and confirm with MFK Deactivate key lock Press briefly and confirm with MFK 20 Main switch Switch the device on and off with the main switch Page 15 of 82 2 3 1 TOUCH SCREEN OPERATION The following operations can be initiated with the touch screen m an Monitoring Parameter Statistics EN 1 45 Low Frequency Screen selection Alarm Log L Service Measurements Flow l min Freeze real time Select tab curve on the monitoring screen Flow l min Open settings window Enter PIN Press to Cancel Enter the PIN Set 2 Set 3 Mode PCV IPAP 20 0 hPa REER 5 0 hPa Frequency 12 bpm Time Inspirat 20s 37 Off Off 1 00 Ramp Dependencies Minimum Volume Sigh Funtion High Inspiration Volume Parameter selection 24 p Error FiO2 Sensor Primary Alarm Not Working Flow l min Continue real time curve w Show errors on the monitoring screen if present Battery State Flow l min charging
53. sure measuring tube is connected here Only when using a tube circuit with pressure measuring tube 4 Connection of tube circuit expiration The expiration section of a double line patient circuit is connected here 5 ES Connection of control tube Page 12 of 82 2 3 CONNECTIONS ON THE REAR SIDE OF THE DEVICE O 10 11 12 13 Figure 2 Connections on the rear side of the device DC connection The power supply plug is connected here Connection of SpO sensor A SpO sensor can be connected here SD card slot An SD card here can be inserted here FiO connection Low pressure connection lt 1000 hPa x 5 l min During oxygen input the oxygen source is connected here Use the supplied oxygen connection adapter for that purpose FiO output Oxygen monitoring This is the exit for excess oxygen from the oxygen valve of the unit when ventilation has been turned off Pressure monitoring Excess oxygen pressure is exhausted to the outside from this exit during oxygen therapy This is the case when the pressure is higher than 1 hPa above the pre set ventilation pressure setting In the volume controlled mode the valve also opens when the measured breathing volume is more than 10 96 higher than the pre set value USB interface Connection of PC A PC may be connected here with a USB cable optional accessory In order to be able to communicate with the device the PC software EASYset
54. th filter cassette nssrssrnsrrsrrrsrerrrsrrsrrrsrrsrrnrrsrrrarrsrrsrrerrsrrrsrene 18 Block 6s elegans alg Seem T REM 21 Pneumatic block diagram for the CARAT pro ssessseeseeenmm eene 21 Pneumatic block diagram for the CARAT ll pro essssseeseen mene 22 ROUSING Ton for CA M K m 23 S IKE ro TOR G BAM goo c P 24 gec Re E SE EET T T Tn 295 EA Mifc TTE TET mm 26 Sensor block for CARAT ION TRU TT 2f Sensor block for G BA eom TN UU TT 28 Complete device assembly cousins siepe kk Eb ER ERE rrr rrt rr errr ERNE ERE tU AGED hup nale ERE REE ERE Rs 29 Tube connection diagram for CARAT I pro part 1 oo ceccceccceceeeseeseeeseseee een 30 Tube connection diagram for CARAT I pro part 2 sssssse mene 30 Tube connection diagram for CARAT Il pro part 1 31 Tube connection diagram for CARAT Il pro part 2 ssesseenm em 31 Elegie Een lt a ia 918 Clio CER RET 32 OR FO here hr Bare Neue M Nm LT 33 Ge EU glas Cer8 DONO All TEN TOO To Oe 34 e rcugeRel ebiM Bie ie ge mele HORN PR m T OU ipl ESS e HS Oo 5 6 G T T Tm 92 Replace valve membrane expiration ccceccceeeceeeceeeeeeeeeeeeeeeeeeeeeaeeeaeeeeeeeeaeeeseeeaeeetaeetanetaneetees Od System configuration of pressure sensor calibration system configuration for CARAT pro and CPD MSO SER NS AN MERO mmn 60 System configuration for CARAT I pro flow sensor calibration
55. ws without speaker 00004131 Left trim handle 3 screws 00004132 Speaker screws 00004134 a Replacement handle screws 000041 74 Page 74 of 82 Table 6 Replacement parts list Name Figure Name Figure Article number Article number Bottom flap aie Mounted main switch 42101304 00004156 Ready made interface plate with SpO2 bushing and cable 00004165 Rubber feet 4 pieces 000041 75 Front nut for DC connection 430001 14 M14x1 socket wrench 00004130 3 2 way valve with fasteners seal and bushing strip 00004273 12 V proportional valve with Screws seal and bushing strip 23000039 Control tube valve Oxygen block CARAT II pro 2 2 way valve with 42100447 screws and bushing strip 000041 78 Oxygen adapter internal E FiOs coupling 42101310 4 41000086 FiOo adapter baffle Flow sensor waterproof 42101314 go with cable fae 23000041 4 pt 13 7 j e Exsp Exsp Flow sensor cable Flow sensor seal pum 00004135 cM 42100440 E AN CARAT pro sensor block CARAT I pro tube connector without flow sensors 00004159 00004180 Page 75 of 82 Table 6 Replacement parts list Name Article number CARAT II pro tube connector 00004160 Figure Name Article number Figure Support frame for tube connection seal 42101317 Tube connection seals 42101312 Blower

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