Service Manual - Hoffrichter GmbH
Contents
1. eee eee aaa aaa emen eene 11 ternal Ballet NA O EWA rende oko 11 Fani BOX aaa EU EM 11 MAMO A REM 11 BASE sD 11 Sensor Maniold s REPORT AD 11 FIOW SONSONS a eis RISE ERE EXER ERU FERREIS 11 NUDE CG OMMEGUOMN Ai aa af 12 ave Iulio M EET 12 Filter Cardo e TT 12 Power SUP DIY E 12 Handle Mechanism r 12 Tools Metering Devices 1 RUN 13 Opening the WINS T 19 Maintenance Hardware 14 Cleaning and Disinfection dA PO naeh hands nn 14 Fiter CATAJO W PEAK dA AAAA FA EIER 14 Check al TUDES sores sesame ESE SEE EEE bE tags 14 Check the Cable and ConnectiONnS sass 14 Check Attachment of Printed Circuit Boards 15 eere 15 Check the Display and emen enne 15 Button Functional Check sess 15 eleg LE 15 out Battery lest nn ETE 18 Closing the Machine 3 ice a era 18 Maintenance and Replacement Kits2. memes 19 1 c 20 Data 2191 Do 20 Standard Values the Factory Setting eee eau 20 9 1 9 2 9 3 9 4 10 10 1 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 10 11 10 12 10 13 11 12 12 1 12 2 12 3 12 4 13 13 1 13 2 13 3 Safety Related Check and Maintenance 22 MAIMIENA CO Naa Athos 22 Recommended Maintenance 22 Safety Related 23 Check the Electrical Safety of the External Power 23 Exploded VIEWS 24 Exploded View Inner Casing CARAT l i memes 24 Exploded View C Inner Casing CARAT ll mee 25 Exploded View C Inner Casing CARAT ll 26 Exploded View A Top Cover CARAT 1 ener 27 Exploded View A Top Cover CARAT II Hem eene 28 Exploded View E Sensor Manifold CARAT 1 emen 29 Exploded View E Sensor Manifold CARAT ll 30 Exploded View B Lower Cover CARAT rear 31 Exploded View B Lower Cover CARAT front view 32 Exploded View Assembling CARAT 33 Exploded Vi
3. 3 3 3 4 3 5 Leak Test For the CARAT connect the inspiration and expiration connections with the respiration tube and the metering tube with the pressure metering connection of the device For the CARAT connect the respiration tube with pressure metering tube to the inspiration connection and the metering tube with the pressure metering connection of the device Install a blanking cap in the open side of the respiration tube On the third screen select the menu item Leak Test enter the PIN code and confirm The machine now goes through the complete pressure range and identifies leaks autono mously These are shown on the display The maximum deviation must not exceed 5 l min at flow sensor 1 and must not exceed 1 l min at flow sensor 2 During the leak test the complete pressure range is tested up to the maximum value The switching threshold is between 55 hPa and 60 hPa If there are deviations adjustments can be made on the pressure switch 8 10 CARRY OUT BATTERY TEST During the test of the internal battery the machine remains connected to the mains is switched on at the main switch and must not be disconnected from the mains during the test No line circuit or other accessories must be used during the test procedure To start the test procedure press and hold the MFK until the service screen appears Select the menu item Battery Test and use the MFK to confirm After entering the PIN code the battery
4. Compressed air supply or stationary compressed air connection Soft brush and vacuum cleaner Soft underlay Disposable gloves Airflow Pressure Meter 0 100 hPa e g HOFFRICHTER Art no 00004832 Blanking caps with T piece and silicon tubes Art no 00004831 Flow meter 0 200 l min e g HOFFRICHTER Part No 00004832 Therapy tube with pressure metering tube Part No 00007116 CARAT power supply Art no 00004510 24 VDC 54A or a 230 V AC power supply connec tion PC Windows 95 XP Vista 128 MB RAM high colour capable graphic card PC cable RS232 Art no 00007110 HOFFRICHTER software CaratControl Spray disinfectant e g Mikrozid AF 110 06 Replacement or maintenance kit according to the maintenance cycle see chapters 8 12 and 8 12 Adapter and machine to check the electrical safety e g SECUTEST SIII Machine and maintenance documentation OPENING THE MACHINE Main switch OFF disconnect power supply Remove the filter cartridge and pull the Put the machine with the upper side on a soft underlay and use a long screwdriver special cross head PH1 x 200 and remove the two screws at the rear of the machine above the type label Use a screwdriver and remove the other two attachment screws at the front lower side of the machine top cover Turn the machine over and lift off the top cover place in a safe place and secure from falling and mechanical damage Discon
5. Display P anagement i UART Tube System Contoller Sensors with Expiration Valve Figure 4 Block Diagram Controller Board 4 5 BLOCK DIAGRAM POWER MANAGEMENT CIRCUIT BOARD Relay Contact Main Switch FT ul Isense DC 24V Relay Contact VO Transistor Switch Relay Contact Battery 28 8V 24V Battery A Relay Contact DC Battery 45V Communication Controller Li lonen Charger Relay Contact Relay Contact Battery B Li lonen Charger uc Figure 5 Block Diagram Power Management Circuit Board 5 ASSEMBLIES 5 1 CONTROL CIRCUIT BOARD The control circuit board facilitates the operation and control of the artificial respiratory machine The machine is divided into two main function groups the operating section and the control sec tion 5 1 1 OPERATING SECTION Functions 1 Selection of the respiratory mode and display by the Light Emitting Diode LED 2 Input of the respiratory parameters using the Multi Function Knob MFK and display in the Liq uid Crystal Display LCD 3 Start the respiratory mode 4 Saving the respiratory parameters set and the applicable alarms 5 Display of alarms in the display and by the LED 6 Real time clock 7 Communication through the external RS232 interface remote alarm 8 Communication by the controller through the serial interface to 1 The selection of the respiratory mode is made by
6. checked through the controller and in the case of an alarm the emis sion of an acoustic signal The volume of this signal is adjustable to 3 The communication with the operation controller is through a serial interface to 4 The communication with the power management controller is through a second serial interface 5 1 3 RS232 CIRCUIT BOARD The communication with the external peripherals Windows computer gt software CaratControl is through the RS232 circuit board In addition with the help of this circuit board a remote alarm box or a call nurse can be connected to the machine 5 2 POWER MANAGEMENT CIRCUIT BOARD Functions 1 Current measurement and allocation of the available current according to the priority Display of the operating condition Determining the capacitance and state of charge of the internal battery Charge the internal battery Transmission of the battery data to the processor to be shown on the display RI O 5 3 INTERNAL BATTERY The internal battery comprises of two Lithium lon batteries Pana CRG 18650 CF that are con nected to a 28 8 V 2 25 Ah manifold 5 4 FAN BOX The fan is installed in the fan box and the fan comprises of a Direct Current DC motor from the firm Maxon 50 with high uniform speed and a fan impeller D 49 mm 5 5 VALVE MANIFOLD The valve manifold comprises of the following components as described and serves as the control and transfer as the c
7. pressing the esc mode button The actual respi ratory mode is displayed by the applicable continuous lights of the LED the new selected mode blinks until confirmation is made by pressing the MFK to 2 After selection of the respiratory mode the applicable respiratory and alarm parameters are shown on the display The choice and setting of the parameters is made through the MFK selection of the parameters is by turning acceptance by pressing the knob Setting of the parameters by turn ing and acceptance by pressing the knob Inputs made but not yet confirmed can be cancelled by pressing the esc mode button to 3 Respiration is started by actuation of the ON OFF button To stop the respiration the ON OFF but ton must be actuated once for a period of 3s It is shown as additional information as a message on the display to 4 The parameter set as well as the arising alarms set during the respiration are saved in two serial EEPROMs size 2 x 128 kByte to 5 An actual active alarm is signaled by the alarm LED red top row left as well as by an acoustic sig nal The alarm signal can be muted for a maximum period of 2 minutes by actuation of the alarm button The optical alarm remains until the discontinuation of the cause of the alarm If an alarm occurs during respiration and the cause of the alarm disappears before the alarm can be switched to mute the optical alarm display remains until actuation by pressing t
8. silicon tube used in the machine for signs of mechanical damage ageing and for cor rect seating and if necessary replace e Oxygen connection tube in the bottom cover 9 Connecting tubes in the manifold between the valve base and tube connection e Pressure metering tubes on the pressure sensors 8 4 CHECK THE CABLE AND CONNECTIONS Check every connection and supply cable for signs of damage and correct seating and if neces sary to correct or replace e RS232 cable 9 DC cable e Battery cable e Resistance cable e Valve connecting cable e Flow sensor cable e O2 sensor cable e Motor cable e Display cable 85 CHECK ATTACHMENT OF PRINTED CIRCUIT BOARDS The controller circuit board is attached to the inner mounting Subsequently check the attachment of all PCBs e Controller circuit board 2 screws e RS232 circuit board 2 screws e Power management circuit board screws e Oometering cell circuit board 1 screw 8 6 CHECK AIR OUTLET Check the air outlet on the rear of the valve manifold for correct seating and attention must be paid to make sure that the synthetic hopper is inserted to the shoulder in the valve base if neces sary correct the seating After completion of the task position the inner mounting in the bottom cover and connect all of the electrical and pneumatic connections A DANGER During the following tasks there is a voltage supply to the open machine The task therefore must only be carri
9. test is then carried out It consists of three phases 1 Phase Battery being charged max 3 Hrs depending on the charge condition of the battery 2 Phase Battery now being discharged with constant charge 3 3 5 Hrs 3 Phase Battery being charged 3 5 Hrs After completion of the 3 Phase the capacitance of the battery is shown on the display instead of the battery icon If the capacitance is 80 96 the test was successful If the capacitance is less and an additional display Error shows on the display the battery must be replaced with a new one Always replace both of the Lithium lon batteries The test takes a maximum of 10 Hrs The internal battery must be replaced after every 500 charge and discharge cycles or every two years The test intervals are specified in the recommended maintenance schedule chapter 9 2 8 11 CLOSING THE MACHINE After the maintenance and calibration is completed the machine must again be closed 1 Remove all components used for the calibration blanking caps meters respiratory tube etc 2 Check to make sure that the inner mounting is in the correct position in relation to the bottom COVer 3 The closing position is attained when both of the front corners of the inner mounting are located in the corners of the bottom cover 4 Check to make sure that no cables or tubes impede or complicate the installation of the top cover and that none will be trapped or squeezed From the
10. 00004956 Spring Circlip Design A8 DIN7993 4 X Intake Adjustment Knob lower part CARAT A5 Push button A6 Protective Film Display CARAT Intake Adjustment Knob upper part CARAT A8 Protective Cap RS232 coated 42202446 A9 Label CARAT HOFFRICHTER 22000049 A10 Label CARAT Il HOFFRICHTER 22000050 B Bottom Cover CARAT B1 Cover Assembly Kit right 00004961 B2 Cover Assembly Kit left 00004962 B3 Housing with Aperture upper part drilled painted CARAT B4 Lower Housing Cover for Expiration Valve 42202460 B5 Assembly Kit Handle Lever left 00004958 B6 Assembly Kit Handle Lever right 00004957 B7 Screw for Handle 43000097 B8 Wool Felt 9 Assembly Kit Stop Plate for Handle Lever 00004954 B10 Impact Sleeve natural white M5 x 8 6 x 11 B11 Oxygen Manifold 42100447 B12 Handle incl Impact Sleeve and Screws 00004953 513 Main Switch assembled 00004201 B14 DC Cable assembled 00004102 B15 Type Label Artificial Respiratory Machine B16 O2 Coupling 41000086 B17 Protective Cap for Main Switch 32100027 B18 Foot small 42100426 B19 3 2 Way Valve with Screws Socket Board 00004273 520 Socket Boards 2 pin for 3 2 Way Valve 32200068 B21 Silicon Tube for Oxygen Manifold 45000019 B22 Foot large 42100425 C Inner Mounting CARAT C1 Air Outlet 42100441 C2 PCB Power Management 00004336 C3 Inner Mounting upper part C4 Inner Mounting lower part assembled C5 CARAT assembled 00004505 C6 Battery Pack assembled L
11. HOFFRICHTER Quality makes the Difference 8 gt gt Q gt m Service Manual Ventilator valid for devices of the types 9LV102 and 9LV202 TABLE OF CONTENTS 3 1 3 2 3 3 4 1 4 2 4 3 4 4 4 5 5 1 5 1 1 5 1 2 5 1 3 5 2 5 3 5 4 5 5 5 5 1 5 5 2 5 5 3 5 5 4 5 6 5 7 5 8 5 9 8 1 8 2 8 3 8 4 8 5 8 6 8 7 8 8 8 9 8 10 8 11 8 12 8 13 8 14 8 15 Symbols in this Service 4 Safety 181 891 15 116 111666 4 Preparing the Device when Changing Patient 5 Reprocessing Procedure ek nenn ES EDE SEE GDG 1944486964 A GA 884446 5 Reprocessing Procedure 2 REESE Eai 5 Reprocessing ProCedUte 3 nenne mans 6 Block Diagrams ana 6 Block Diagram Pneumatic CARAT Tann 6 Block Diagram Pneumatic CARAT Il 7 Block Diagram Complete Machine mme 7 Block Diagram Controller Board eee eee aaa aaa aaa aaa eene 8 Block Diagram Power Management Circuit Board 8 ASSEMDBIIES E 9 Kt 9 Operating Pre by ten Tee 9 BONO SECTION HE 10 RS232 GIreulE BOAR E 10 Power Management Circuit Board
12. No maintenance is necessary to the PC software 8 15 STANDARD VALUES THE FACTORY SETTING Parameter values in accordance with the factory setting through a PC or direct on the device General Parameters Mode POV Display Display Pressure Units hPa Display Screen STD Safety Lock Manual Safety Lock Machine OFF Volume 50 Pressure Deviation 3 0 hPa Max Inspiration time 4s Leakage OFF Max Oxygen OFF Min Oxygen OFF PIN code 1302 Device Language ENG Parameter PCV IPAP 20 0 hPa BEER 5 0 hPa Frequency 12 bpm 1 83148 Chute 3 Inspiration trigger OFF Min Volume OFF Additional pressure 5 0 hPa not active Min volume is set to OFF Max Volume 1 00 Min Volume 0 20 Max Frequency bom 20 Parameter PSV PS BEER Frequency Apnoea limit Chute Inspiration trigger Expiration trigger Min Volume Additional pressure Max Volume Min Volume Max Frequency Parameter SIMV IPAP PS SIMV Frequency Inspiration time Chute Inspiration trigger Expiration trigger Max Volume Min Volume Max Frequency Parameter VCV Volume BEER Frequency Chute Inspiration trigger Max Pressure Min Pressure Max Frequency Patients data Patients ID Patients surname Patients christian name Patients birthday Patients gender 20 0 hPa 5 0 hPa 12 bpm AUTO 3 3 30 96 OFF 5 0 hPa not active Min volume is set to OFF 1 00 0 20 30 bpm 20 0 hPa 20 0 h
13. Pa 5 0 hPa 12 bpm 2 05 3 3 30 96 1 001 0 20 30 bpm 0 501 12 3 8 0148 4 OFF 30 0 hPa 10 0 hPa 30 bpm deleted deleted deleted deleted 2 undefined 21 9 SAFETY RELATED CHECK AND MAINTENANCE 9 1 MAINTENANCE The respiratory machine must be serviced by an authorised specialist every 12 months 9 2 RECOMMENDED MAINTENANCE SCHEDULE Operating Hours Required Maintenance Before and during storage every 6 months Weekly Before return to ser vice Monthly or earlier by heavy contamination Every 6 months with out bacteria filter or by change of patient By change of patient Every 12 months with bacteria filter Every 6 months with out bacteria filter Every 12 months Every 2 years Every 15000 h or every 5 years or graphical display in CARAT Control Disinfect Carry out battery test see chapter 8 10 Clean the air filters coarse filter Alarm test leakage power failure Carry out battery test after 3 month storage see chapter 8 10 Replace of the air filters coarse and fine filter Replace the valve diaphragms expiration diaphragm replacement kit Hygienic overhaul with KR1000 in accordance with the report V 1 2 of the disinfection of the home care respiratory machine CARAT Replace the valve diaphragms Inspiration Safety Regulation Check SRC diaphragm replacement kit Maintenance Maintenance Kit 1 Replace the internal batter
14. ap takes place at the dealer s or in the service departments Power cable ventilation equipment users manual and other accessories with minimal risk of infec tion 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 13 3 SHIPPING The delivery note must be on the outside of the equipment packaging Notice on delivery note CAUTION CONTAMINATED EQUIPMENT or CAUTION MRSA CON TAMINATED EQUIPMENT Shipping takes place by appropriate logistics companies 40 HOFFRICHTER GmbH Mettenheimer StraBe 12 14 19061 Schwerin Germany Phone 49 385 39925 0 Fax 49 385 39925 25 E Mail info hoffrichter de www hoffrichter de CARAT FL service eng 07091 1 06
15. ase may be between inspiration and expiration The valve manifold is directly connected by a seal with the fan box The oxygen feed is through the valve manifold into the inspi ration sector 5 5 1 VALVE BASE The valve base comprises of several control ducts that are shut with special seals a non return valve in the inspiration sector and a proportion valve The valve base is bolted to the sensor manifold The sealing is by O rings There is a connection for the oxygen tube on the valve base 5 5 2 SENSOR MANIFOLD The pneumatic control for the inspiration and the expiration is done through the sensor manifold This function is done by two diaphragms one each in the inspiration and expiration sector The diaphragms are inserted in the manifold and subsequently the valve cap installed and closed by turning the bayonet connection The sealing is by an O ring 5 5 3 FLOW SENSORS For the measurement of the flow airflow sensors AWM720P1 from the firm Honeywell are used The sensors are directly in the inspiration and expiration sector with seals between the manifold and tube connection IMPORTANT There is only one sensor installed inspiration sector in the CARAT machine 5 5 4 TUBE CONNECTION The tube connection completes the manifold It comprises of the connection for the inspiration tube 22M the connection for the expiration tube 22 the connection for the pressure tube 0 3 5 mm and the connection for the cont
16. ction Port Mechan Valve in the port G valve Air Inlet Blower Valvemembrane 1 Flow Sensor 1 Pressure Sensor 1 Pressure Y Sensor 2 Air Proportionalvalve Figure 1 Block Diagram Pneumatic CARAT Mechan Valve in the port Tube Connector for Inspiration Connector Measuring Tube Connector Control Tube 4 2 BLOCK DIAGRAM PNEUMATIC CARAT II Oxygen Connection Port Air Inlet Air Outlet Mechan Valve in the port Blower Proportional Valve Oxygen Outlet Valve Valve Membran 1 Valve Membran 2 Figure 2 Block Diagram Pneumatic CARAT II Flow Sensor 1 Pressure Sensor 1 Pressure Sensor 2 Flow Sensor 2 4 3 BLOCK DIAGRAM COMPLETE MACHINE SEED Power Supply P 100 250 V AC 20 10 Ventilator Y Internal Power Management Battery ry Controller Control and Operating iw Unit Display Switched Mode 85232 Remote Alarm v Double Line Patient Circuit Single Line Patient Circuit with Exhalation Valve Parameter PC Nurse Call Figure 3 Block Diagram Complete Machine Mechan Valve in the port Tube Connector Inspiration Connector Measuring Tube Connector Control Tube Tube Connector Expiration 4 4 BLOCK DIAGRAM CONTROLLER BOARD PC Remote Control Manuel Input
17. e equipment security tester e g SECUTEST SIII at the RS232 housing GND pin 5 at the alarm box connection at the connection piece for pressure measurement and at the connection of the oxygen sensor The test is passed if the limits of the leakage current are maintained acc to DIN EN 62353 2008 table 2 23 10 EXPLODED VIEWS 10 1 EXPLODED VIEW C INNER CASING CARAT I 10 2 EXPLODED VIEW C INNER CASING CARAT II OO UO SAS 06 25 10 3 EXPLODED VIEW C INNER CASING CARAT II 26 10 4 EXPLODED VIEW A COVER CARAT I Q0 Q9 10 5 EXPLODED VIEW A TOP COVER II 10 6 EXPLODED VIEW E SENSOR MANIFOLD CARAT I 10 7 EXPLODED VIEW E SENSOR MANIFOLD CARAT II 30 10 8 EXPLODED VIEW B LOWER COVER REAR VIEW Qn 8 m m w me m 2 w u s ee 10 9 EXPLODED VIEW B LOWER COVER FRONT VIEW MI IL 4 200000000000 10 10 EXPLODED VIEW ASSEMBLING CARAT 10 11 EXPLODED VIEW ASSEMBLING 10 12 EXPLODED VIEW ASSEMBLING 10 13 EXPLODED VIEW ASSEMBLING II 11 SPARE PARTS LIST Pos Nomenclature OrderNo A Top Cover CARAT A Cover CARAT plus 00004645 Cover CARAT plus 00004646 A1 Cover Adjustment Knob CARAT A2 with Cover
18. ed out by authorized qualified and competent personal If the service task is done in the home the patient must be advised of the dangers The following checks are carried out with the machine switched on 8 7 CHECK THE DISPLAY AND CONTRAST Do a check to make sure that all of the characters are completely and correctly displayed The contrast can be adjusted with the assistance of the potentiometer on the right adjacent to the display 8 8 BUTTON FUNCTIONAL CHECK Operate the alarm ON OFF esc mode buttons and the MFK to make sure that they function cor rectly 8 9 CALIBRATION A calibration must be carried out in the scope of the annual maintenance or after a repair of rele vant assemblies 1 Pressure Sensor Calibration 1 1 Install blanking caps on the inspiration connection Connect the metering tube of one leg of the T piece with the pressure metering connection of the CARAT and the second with the pressure inlet of the APM 1 2 Press the MFK for an extended period to get to the Service screen 1 3 There make the selection menu item Pressure Sensor Calibration enter the appropriate PIN code and confirm 1 4 The calibration is carried out at O 5 10 20 and 40 hPa 1 5 1 6 1 7 1 8 The value shown on the meter is set to the calibration value by turning the MFK and accepted by pressing the esc mode button The value must be set to an accuracy of 0 05 hPa Abortion is by pressing the MFK
19. ew Assembling CARAT em eene 34 Exploded View Assembling CARAT He 35 Exploded View Assembling CARAT Hee 36 Spare Parts List PPM MERO IT 37 Disposal m 39 DEVICE Se Os ILL ML LM 39 Secs SE EE Ha conn 39 Batteries eoe S I REL e 39 Oxygen SENSON kienean a qr tea Kremer ne uno 39 Shipping Instructions for Contaminated Medical Technology 40 mic euo 40 Packaging Tor SIMO PING se erga iu et Ud 40 SIMON 689 PT 40 1 SYMBOLS IN THIS SERVICE MANUAL In this Service Manual the most important notes for users are indicated by symbols Please make sure to follow these hints in order to avoid personal injury or property damage Furthermore all local accident prevention and general safety rules applicable to the intended use should be followed A This symbol marks a general safety precaution Please follow these hints in order to avoid acci dents and personal injury or property damage 4 DANGER This symbol denotes hazardous situations that lead to serious injuries or death AWARNING This symbol denotes hazardous situations that may lead to serious injuries or death IMPORTANT This symbol denotes information tips and
20. for a period of more than 3 seconds After the calibration press the MFK momentarily to return to the standard screen Figure 6 Measurement setup pressure sensor calibration CARAT and CARAT II 2 2 2 3 2 4 2 5 2 6 2f 2 8 Flow Sensor Calibration For the CARAT I attach the respiration tube with pressure metering tube to the inspiration connection and connect the pressure metering tube The measurement of the flow is taken at the open side of the tube For the CARAT II attach the flow meter to the inspiration connection or expiration connection The open connection of the flow meter must be connected to the open section of the CARAT II by the respiration tube with pressure metering tube Thereby the metering tube must be con nected with the pressure metering connection of the device In the Service display make the selection menu item Flow Sensor Calibration enter the appropriate PIN and confirm The calibration is carried out at O 10 20 40 60 80 100 120 and 160 l min The measured value shown on the flow meter is to be set to the calibration value by turning the MFK and accepted by pressing the esc mode button The value must be set to an accuracy of 1 5 96 To abort the calibration press the for a period of more than seconds After the calibration press the MFK momentarily to return to the standard screen Figure 8 Measurement setup flow sensor calibration CARAT II 3 2
21. front guide the top cover over the tube connections and into the installation position Attach the top and bottom covers together at the front and rear Insert the filter cartridge with new coarse and fine filter in the filter tray Attach the MFK 8 12 MAINTENANCE AND REPLACEMENT KITS Use the following kits for the various replacement and maintenance cycles chapter 9 2 Diaphragm Replacement Kit Art no 00004983 Quantity 1 Valve diaphragm 1 O Ring 1 Cable tie Maintenance Kit 1 Art no 00004984 Anzahl Length 2 Valve diaphragm 2 O Ring 1 Coarse filter 1 Fine filter 1 Cable tie 0 5m Silicon tube 4 x 2 mm 0 35 m Silicon tube 2 x 1 5 mm Maintenance Kit 3 Art no 00004987 Anzahl Length 2 Valve diaphragm 2 O Ring 1 Coarse filter 1 Fine filter 2 Cable tie 0 5m Silicon tube 4x2 mm 0 35 m Silicon tube 2x 1 5 2 Lithium Ion battery Pana CRG 18650 Maintenance Kit 5 Art No 00004986 Anzahl Length 2 Valve diaphragm 2 O Ring 1 Coarse filter 1 Fine filter 6 Cable tie 0 5m Silicon tube 4 x 2 mm 0 35 m Silicon tube 2 x 1 5 mm 1 Fan box complete 8 13 CHECK THE ALARMS You must adhere to the procedure given in chapter Functional Check of the User s Manual 8 14 DATA BACKUP If it is proposed to change the set parameters during SRC or maintenance the contents of the device memory must be read and saved If necessary the data is to be analyzed
22. he control but ton 10 6 The real time clock is foremost to indicate the time for an occurrence of an alarm Furthermore the operator date and time is shown on the display to 7 The communication with the external peripherals e g Windows computer is through an isolated 85232 interface The programming software update of the controller can also be done through this interface to 8 The communication with the controller is through another serial interface 5 1 2 CONTROL SECTION Functions 1 Control the turbine and the valves to implement the set respiration modes with the appertain ing parameters 2 Detection of alarm situations Communication with the operation controller through a serial interface 4 Communication with the power management controller through a serial interface to 1 The calculation for the nominal values for the motor control is made from the respiratory mode set and the appertaining parameters The nominal value output is through a DAC on the motor control The nominal values analog measured values pressure or flow are read and evaluated from the controller Furthermore the switching on off of the turbine is through the controller as well as the control of the electromagnetic proportion valve This valve controls the pneumatic expiration valve in the line circuit expiration valve closed gt inspiration expiration valve open gt expiration to 2 The condition of the alarm is
23. i lon 16000015 C7 Battery Retainer 00004124 C8 Pressure Switch C9 POBRS232 00004329 C10 Cover RS232 C11 PCB Controller 00004328 C12 RS232 and Controller Cable assembled 00004103 C13 Display 00004318 37 Pos Nomenclature Order D Filter Housing CARAT D Filter Housing CARAT complete Sensor Manifold CARAT Bil Tube Connection E2 Connection CARAT ES Oxygen 00004323 E4 Cover for O2 Metering Cell E5 Coupling Control Connection 41000089 EG Einsatz Tube Connection chem nickel plated E7 Valve Diaphragm 42100423 Valve Cover sensor manifold 42100463 E9 Valve Base E10 Proportion Valve Socket Board 00004272 E11 Support O2 Metering Cell E12 Seal Flow Sensor E13 Spacer long nickel plated E14 Flow Sensor 23000023 Flow Sensor Cable CARAT assembled 000044 21 Flow Sensor Cable CARAT Il assembled 00004101 E15 Spacer short nickel plated E16 Tie Rod M3 nickel plated E17 Sensor Manifold for Replacement of Diaphragm E18 Seal Air Outlet Fan Box 42100424 E19 O Ring 32x 1 sensor manifold 44000030 E20 O Ring 30 6 x1 sensor manifold from SN 0510351 44000039 E21 Silicon Tube 2x 1 5x 350 mm 45000002 Diaphragm Replacement Kit 00004983 Maintenance Kit 1 00004984 Maintenance Kit 3 00004987 Maintenance Kit 5 00004986 12 DISPOSAL Proper disposal saves natural resources and prevents harmful substances being released into the environment 12 1 DEVIGE The
24. instructions for the efficient error free use of the device 2 SAFETY INSTRUCTIONS 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 machine 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 machine Repair and maintenance tasks may only be carried out by suitably qualified authorized and competent personal Oxygen sensors contain a caustic liquid Avoid skin or eye contact if there is a sensor leak For oxygen sensors no adjustment or repair work is required For hygienic reasons it is recommended to wear disposable gloves when you carry out a task on the machine Before the next tasks please wipe the machine with a commercial disinfecting solution Special hygienic measures are necessary when a maintenance or repair task is carried out on a machine contaminated by MRSA Methicillin Resistant Staphylo coccus Aureus In all circumstances protective clothing must be worn such as gloves lab coat face mask 3 PREPARING THE DEVICE WHEN CHANGING PATIENT AWARNING Before using the ventilator on a different patient clean and disinfect it to such an extent that it is free from any human pathogens Please ensure that all tools used such as measuring inst
25. nect the multipole connector for the main switch top four plug contacts and DC con nection lower four plug contacts from the power management circuit board tag if necessary Remove the tube for the initiation of oxygen from the sensor manifold Lift up the inner mounting and pull lightly forward so that the multipole connector of the oxygen valve can be disconnected from the power management circuit board Lift the inner mounting from the bottom cover 8 MAINTENANCE HARDWARE 8 1 CLEANING AND DISINFECTION Use a brush and vacuum cleaner and carefully clean the bottom cover and inner mounting 2 Use compressed air to clean inaccessible areas and subsequently use a vacuum cleaner to gather loose particles 3 Use a cloth moist with normal concentrated soap solution to remove stubborn contamination on the inside and outside of the top and bottom covers 4 Use surface disinfection and spray for components that duct the air For this purpose coat the following components with 2 3 squirts Air inlet and filter insert inside of the bottom cover Intake port rear of the inner mounting Air outlet rear of the valve manifold connections the respiration tubes inside 8 2 FILTER CARTRIDGE Replace the filter pads coarse filter black and fine filter white IMPORTANT Remove the control circuit board to do points which described in the chapters 8 3 and 8 4 8 3 CHECK ALL TUBES Check every
26. re it safe from contamination with human pathogens 3 2 REPROCESSING PROCEDURE 2 The following measures may only be carried out by companies with a QM system and appropriately qualified authorized and experienced specialist personnel The hygienic reprocessing of the devices during a patient change can be carried out in accordance with the validated 1000 procedure The type and scale of the reprocessing are described in detail in the Instructions for validated ventilation technology The number of reprocessing cycles for the device is limited to 10 After reprocessing carry out a safety related test according to the User s Manual 3 3 REPROCESSING PROCEDURE 3 Procedure 3 can only be applied if the device was used with a bacteria filter both at the inspiration port and at the expiration port and the bacteria filter was changed daily or according to the manu facturer s instructions This is the only way to ensure that the device is free of human pathogens To reprocess the device carry out the following steps 9 Change the bacteria filter e Disinfect all the parts of the housing and the connections with a suitable agent e g Mikrozid Liquid e Change the coarse filter and the fine filter and disinfect the surface of the filter cassette You can also replace the entire filter cassette with a new one 4 BLOCK DIAGRAMS 4 1 BLOCK DIAGRAM PNEUMATIC CARAT Oxygen Outlet Conne
27. rol tube subminiature coupling with bayonet connection for one line circuit The Printed Circuit Board PCB for the electrical connector of the oxygen measurement cell is also mounted on the tube connection 5 6 OXYGEN MANIFOLD The oxygen manifold comprises of a 3 2 way valve and a synthetic manifold This manifold makes sure that oxygen only goes into the inspiration sector during inspiration If there is a feed of oxygen when respiration is switched off this is vented to atmosphere through an exhaust port for safety reasons According to the flow this emission is accompanied by an emission noise This is not a malfunction but a safety device The initiation of oxygen into the machine is through a quick release coupling 5 7 FILTER CARTRIDGE The filter cartridge accommodates both of the filter pads coarse filter black and fine filter white 5 8 POWER SUPPLY A switching power supply with a wide range power input of 100 250 V AC 20 10 96 50 Hz 60 Hz and an output voltage of 24 V 5 is used 5 9 HANDLE MECHANISM The handle mechanism comprises of an anodized aluminium handle that serves as a means of car rying Furthermore the handle mechanism has 2 handle levers right and left 2 covers right and left as well as 2 catches 6 TOOLS METERING DEVICES To carry out maintenance the tools and equipment are required as follows Screwdrivers of various sizes special cross head PH1 200
28. ruments and test lung are free from human pathogens If MRSA contamination is suspected the device must be packaged with the appropriate label ing and disinfected accordingly IMPORTANT If the accessories e g tube system mask fi Iter humidifier etc are intended for repeated use the manufacturer s provisions must be followed The reprocessing of the device acc to procedure 1 and 2 must be documented 3 1 REPROCESSING PROCEDURE 1 The following measures may only be carried out by companies with a QM system and appropriately qualified authorized and experienced specialist personnel To reprocess the device carry out the following steps e Properly dispose of the carrying case and if necessary the functional bag as well as all acces Sory components that carry respiratory gas e Dismantle the devices sensor block The sensor block s plastic parts are autoclaved The sen sors must not come into contact with cleaning fluids A spray disinfection e g using Mikrozid Liquid is possible The sensors must be completely dry before replacing them in the sensor block e Use the maintenance kit 1 e Disinfect all the parts of the housing and the connections with a suitable agent e g Mikrozid Liquid e Dispose of the filter cassette and replace it with a new one e Heassemble the device e After reprocessing carry out a safety related test according to the User s Manual e Until the device is used again sto
29. ventilator must not be disposed of with the household waste Please contact the manufacturer to find out how to dispose of the device properly 12 2 PACKAGING The packaging is taken back by the distributor but it can alternatively be disposed of separately in the normal household waste 12 3 BATTERIES Exchanged batteries must be recycled in accordance with battery regulations Please contact the manufacturer to find out how to dispose of the batteries properly 12 4 OXYGEN SENSOR The oxygen sensor must not be disposed of with the household waste Please contact the manu facturer to find out how to dispose of the oxygen sensor properly 39 13 SHIPPING INSTRUCTIONS FOR CONTAMINATED MEDICAL TECHNOLOGY The following shipping instructions apply to contaminated medical technology which is delivered to HOFFRICHTER GmbH for processing 13 1 PICK UP The dealer medical technician or authorised personnel picks up the contaminated medical technol ogy 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 disposable apron The proper disposal of disposable materials is respected 13 2 PACKAGING FOR SHIPPING The packaging of equipment accessories in sterile welding foil followed by shrink wrap or packing in PVC or PE bags tear resistant and sealed by tape or tie wr
30. y of the machine Maintenance Kit 3 Carry out battery test see chapter 8 10 Replace the fan box Maintenance Kit 5 Carry out battery test see chapter 8 10 The disinfection after a change of patient and by a MRSA pol luted machine is carried out by the manufacturer in accordance with report V 1 2 of the disinfection of the home care respiratory machine CARAT The maintenance carried out must be documented 22 9 3 SAFETY RELATED CHECK The safety related check must be carried out at intervals of no more than 6 months This consists of e A visual inspection of the machine for external damage e A functional check acc to User s Manual e A visual inspection of the accessories in accordance with the manufacturer s instructions respi ratory tubes oxygen sensor etc The safety related check carried out must be documented 9 4 CHECK THE ELECTRICAL SAFETY OF THE EXTERNAL POWER SUPPLY Tests The tests carried out by an equipment safety tester e g SECUTEST SIII which operates according to DIN EN 62353 2008 The leakage currents are always to calculate per direct measurement The ventilation system should be test acc to protection class Il type BF applied part The associated power supply with protection class will be tested within the system Defects in the power supply are detected by testing the entire system acc to protection class Il Leakage current The leakage current is measured with a probe from th
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