贝朗血透机维修手册1.pdf

5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 1 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH CopyrightThis technical documentation contains confidential information of B Braun Medizintechnologie GmbH and may not be copied partly or whole nor made accessible to third parties without our written consent and remains with all rights the property of B Braun Medizintechnologie GmbH ServiceOnly competent individuals that are trained in the repair maintenance and software installation of the Dialog Dialog Advanced should attempt to service the machine The servicing of the Dialog Dialog Advanced in accordance with this service manual should never be carried out in the absence of proper tools calibration equipment and the most recent edition of this service manual which must be clearly and thoroughly understood Prevent Electrical Shock HazardSwitch off the Dialog Dialog Advanced and disconnect unit from mains before opening the machine Do not touch any exposed wiring or conductive surfaces while the Dialog Dialog Advanced is open The voltages present when electrical power is connected to the Dialog Dialog Advanced can cause serious injury or death If necessary open the machine for maintenance and repair ESD RecommendationsPay attention to ESD requirements because electronic components are sensitive to electrostatic discharges see appendix FusesIf fuses are replaced they must exactly match the type and rating specified by the manufacturer Where applicable Fuses must be approved by UL CSA CalibrationOnly perform a calibration after the Dialog Dialog Advanced has reached working temperature 5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 2 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH Seite 5 Technical Safety Inspection and Preventive Maintenance 5 3 5 1Inspection Protocol for Automatic Blood Pressure Measurement ABPM 5 7 5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 3 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH The technical safety inspection according to the specified check list must be performed and documented every 12 months with reference to the service manual and operating instructions which are subject to technical amendments The preventive maintenance with the exchange of wear and tear parts is recommended every 12 months and should be documented according to the specified check list with reference to the service manual and operating instructions which are subject to technical amendments Art No Machine No Year of Purchase User Operating Hours h Inventory No SW Version HW Version Manufacturer B Braun Medizintechnologie GmbH Check List Note Only calibrated measurement equipment must be used ESD recommendations must be applied Technical Safety Inspection Technical Safety Inspection with Preventive Maintenance S M S Technical Safety Inspection Points M Preventive Maintenance PointsNoYesOK M Disinfection decalcification was performed S1 Heat Exchanger option without leakages TSM LLC Manual Test 2 Visual Inspection with Maintenance Procedures S2 1Machine clean complete no damages moisture influences unit rollers are moveable machine record book present no special incidents type plates and inscriptions legible options present M 2 1 1Clean interior space and exterior surfaces S2 2Check mains supply power supply line and connectors M 2 3Suction tubing for disinfection and concentrate exchanged M 2 4O rings in suction rod exchanged M 2 5Tight seat of the tubing connectors clamps and couplings M 2 6Dialyser coupling membranes o rings and tubings exchanged M 2 7Tight seat of tubings clamps and couplings of inlet and outlet tubings M 2 8Tight seat of boards and connectors M 2 9Fan in power supply clean if necessary clean 2 9 1Exchange dust filter of fan rear door M 2 10PC motherboard 2 10 1 CPU fan exchanged depends on hardware status CPU fan not included in the maintenance kit if necessary order separately 2 10 2 Battery or rechargeable battery on PC motherboard exchanged after operating period of 4 years Battery or rechargeable battery are not included in the maintenance kit if necessary order separately M 2 11Monitor no restriction of motion of rotation and fan tight seat touch membrane keyboard membrane S2 11 1 Function of the keys display illumination and touch 2 11 2 Image display geometry 2 11 3 Alarm activation M 2 12No cracks in covers rear door cover front cover and mains suppression cover M 2 13Tight seat of ground terminals in frame front door rear door and sub racks if necessary order separately for sub racks M 2 14Check set pressure reducer DMV to 1 3 bar 2 14 1 Check pressure non return valves RVDA DDE RVFPE RVFPA M 2 15Conductivity Sensors 2 15 1 ENDLF sensor Visual inspection 2 15 2 BICLF sensor Visual inspection 5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 4 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH S M S Technical Safety Inspection Points M Preventive Maintenance PointsNoYesOK M 2 16Piston Pumps 2 16 1 BIC piston pump 2 16 1 1 Visual inspection 2 16 1 2 Check tight seat of driving elbow on motor axis if necessary tighten screw M 2 16 2 KP piston pump 2 16 2 1 Visual inspection 2 16 2 2 Check tight seat of driving elbow on motor axis if necessary tighten screw M 2 16 3 UF piston pump TSM LLC Manual Calibration 2 8 Flow UF Pump 2 16 3 1 Visual inspection 2 16 3 2 Check tight seat of driving elbow on motor axis if necessary tighten screw 2 16 3 3 Check one way bearing if present M 2 17Check temperature sensors TSBIC TSD TSD S TSM LLC Manual Test difference 0 5 oC M 2 18No visible leakages of balance chamber 2 18 1 Valves VEBK1 2 VDEBK1 2 VABK1 2 VDABK1 2 VDE VBP VLA Pressure test passed M 2 19Disinfection valvel VD if necessary exchange parts and calibrate Parts not included in the maintenance kit if necessary order separately M 2 20Blood leak detector BLD test passed 2 20 1 Blood leak detector calibrated M 2 21Pressure sensors water side PE PDA Pressure test passed TSM LLC Manual Test 2 21 1 PE permissable tolerance 50 mmHg Comparison measurement at 400 mmHg 100 mmHg 2 21 2 PDA permissable tolerance 50 mmHg Comparison measurement at 400 mmHg 0 mmHg M 2 22Heparin Pump 2 22 1 Heparin Pump Comfort Syringe recognition passed TSM LLC Manual Test 1 4 Heparin Pump with 20 ml and 50 ml template 2 22 2 Heparin Pump Compact Check display position 80 mm 15 mm mm Drive fast forward to end position with 30 ml syringe Check display position in mm M 2 23Filter FVD FB FK FBK1 2 FBIC exchanged M 2 24O rings in BIC cartridge holder option exchanged M 2 25Summer Winter Time Setting TSM Treatment Support System Configuration M 2 26HDF Online Filter HFB exchanged Filter not included in maintenance kit if necessary order separately S2 27SAKV Curentless Closed Option 2 27 1 O ring for magnetic plate exchanged O ring not included in maintenance kit if necessary order separately 2 27 2 Gap for magnetic plate 1 6 0 05 mm 3 Function Inspection Document Measurement Values S3 1Blood Pump Check function moveability drive belt noise rating 3 1 1Check roller if necessary lubricate bearings 3 1 2Alarm cover switch 3 1 3One way bearing 5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 5 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH S M T Technical Safety Inspection Points P Preventive Maintenance PointsNoYesOK S3 2Single Needle Pump Option Check function moveability drive belt noise rating 3 2 1Check roller if necessary lubricate bearings 3 2 2Alarm cover switch 3 2 3One way bearing S3 3Venous Tubing Clamp Function and moveability 3 3 1Gap 1 4 0 1 mm S3 4Arterial Tubing Clamp Option Function and moveability 3 4 1Gap 1 4 0 1 mm S 3 5Arterial Pressure PA Comparison measurement at 400 mmHg permissable tolerance 12 mmHg 0 mmHg S 3 6Inlet Pressure PBE Comparison measurement at 0 mmHg permissable tolerance 12 mmHg 400 mmHg S 3 7Inlet Pressure PBS Option Comparison measurement at 0 mmHg permissable tolerance 12 mmHg 400 mmHg S 3 8Venous Pressure PV Comparison measurement at 0 mmHg permissable tolerance 12 mmHg 400 mmHg S3 9Mains Failure Interruption Check function and alarm tone S3 10Staff Call Option Function or contact continuity passed S3 11BIC Cartridge Holder Option Check reed sensors BKUS and if present BKOS TSM LLC Manual Test S3 12Automatic Blood Pressure Measurement ABPM Option Check ABPM option see 5 1 S3 13Balance System HDF Bag Option Switch to therapy document applied reference weight and controller value from service overview 3 13 1 Load cell comparison measurement with reference weight at g g permissable tolerance 50 g Difference between Reference Actual Value g 3 13 2 Load cell comparison measurement without reference weight at 0 g g permissable tolerance 50 g Difference between Set Actual Value g M 3 14DF Filter Pyrogen Filter Option Visual inspection passed 4 Electrical Safety Check According to EN 60601 1 IEC 601 1 S4 1Measure mains voltage V S4 2Protective earth conductor resistance 0 2 Potential equalization bolt Machine incl power supply line Screw connection heater body Rinsing bridge dialyser inlet and outlet Staff Call Option Rear door socket Substitution HDF Option Bag holder S4 3Earth leakage current 0 5 mA During heat up phase mA S4 4Patient leakage current 0 1 mA Under normal conditions mA Conductivity at 14 mS cm 5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 6 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH S M T Technical Safety Inspection Points P Preventive Maintenance PointsNoYesOK 5 Setting into Service According to Operating Instructions S5 1Switch on Machine Self test passed S5 2Temperature Comparison measurement at 37 oC 1 5 0 5 oC S5 3Conductivity Comparison measurement at dialyser coupling e g 14 3 mS cm 0 2 mS cm S5 4Saferty Air Detector SAD Test alarm function passed S5 5Ultrafiltration Comparison measurement at UF rate 500 15 ml h M 5 6A disinfection was performed by User Service technician CHECK RESULTS Defects were detected which could endanger patients users or third parties Applied Accessories Disposables Must actions be taken with reference to maintenance Note next appointment The technical safety inspection or technical safety inspection with preventive maintenance was performed correctly Name of Service Technician Name of Company Date Signature User Date Signature Maintenance Kit Dialog A maintenance kit can be ordered for the Dialog technical safety inspection with preventive maintenance All parts are included which are recommended for exchange during preventive maintenance Art No Description 3451 893AMaintenance kit Dialog 5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 7 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH 5 1Inspection Protocol for Automatic Blood Pressure Measurement ABPM Measurement Inspection The measurement inspection is recommended every 12 months12 months12 months12 months and should be documented The measuring methods are described in the execution procedures Dialysis Machine Dialog Dialog AdvancedSerial No Art No Automatic Blood Pressure Measurement ABPMSerial No ManufacturerB Braun Medizintechnologie GmbH UserAnschrift Environmental ConditionsThe environmental conditions must be from 15 C to 25 C the relative humidity must be between 20 and 85 normal room condition 1 Visual Inspection tight seat of all connectors no damages which could affect the function or the safety incl tubing and cuff OK OK 2 Limits of Error of the Pressure Indication Admit a static pressure to the unit The permissable tolerance is 5 mmHg for each measurement Pressure mmHg Measurement Value DialogReference Deviation mmHg 300300300300 250250250250 200200200200 150150150150 100100100100 50505050 0 0 0 0 3 Air Leakage including tubing and cuff The pressure drop must not exceed 18 mmHg Initial Pressure mmHg Final Pressure mmHg Air Leakage mmHg min 4 Rapid Exhaust Time for pressure reduction from 260 mmHg to 15 mmHg max 10 s s 5 Function Inspection The results of a measurement on a test person are plausible OK 6 Result of Inspection The blood pressure measurement module has passed the measurement inspection no yes Comments The measurement inspection was performed correctly Name of Service Technician Date Signature 5 Technical Safety Inspection and Preventive Maintenance4 2 0 0 25 8 MT MD DE08C M KAY DialogAd sm Chapter 5 4 2002 doc pdf ddmmyy D i a l o g D i a l o g A d v a n c e d B Braun Medizintechnologie GmbH Execution Procedure for Measurement Inspection Reference pressure instrument accuracy 0 8 mmHg Measurement chamber with 500 ml volume rigid metal vessel e g art no 770 3090 Syringe 50 ml for pressure build up Stopcock system e g art no 770 2035 Luer lock connector e g art no 3477 0739 Connection tubing To Point 2 Limits of Error of the Pressure IndicationMeasurement according to DIN EN 1060 1 1995 and DIN EN 1060 3 1997 500 ml 50 ml Reference Instrument Referenzme ger t Measurement Chamber Me kammer 50 ml Syringe 50 ml Spritze Pressure Tube Druckschlauch 1234 Dialog ABPM Stopcock System Mehrwegehahnsystem Fig Inspection Set up for Compliance of Error Limits of the Measurement Display 1 Connect all components acc to figure stopcock system acc fig 2 Switch on Dialog in TSM service program 3 Select in TSM Manual Test and Calibration TTL Manual Test and Calibration and then ABPM Maintenance 4 Press P Test button Wait until a pressure build up of approx 170 mmHg start of pressure retention pha