Technical Manual
184 Pages
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HF440 MT_ENG 2015.doc _ 05/02/2015
V.8.6.0
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Copyright Infomed. All rights reserved.
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HF440 MT_ENG 2015.doc _ 05/02/2015
Infomed SA - chemin de la Gravière 4 -1227 – Genève – Switzerland Questions or comments can be directed to your local representative or to the manufacturer
CONTENTS
INTRODUCTION TO PRODUCTS FAMILY 1.1 1.2 1.3 1.4 1.5 1.6 a) b) c)
II.
9
ABOUT THIS MANUAL PRODUCT PRESENTATION WARNING GENERAL INFORMATION INFOMED PARTS EXCHANGE AND SUPPORT POLICY IDENTIFYING MODELS Models Identification label Options
9 9 9 10 10 11 11 11 12
ASSEMBLING / DISASSEMBLING PARTS
13
2.1 INTRODUCTION 2.2 ELECTRONIC BOARDS 2.2.1 BC400 2.3 ASSEMBLING PROCEDURE 2.4 ASSEMBLING PROCEDURE 2.4.1 CU160 2.5 MP400 2.5.1 Assembling the MP400 board on the metallic plate: 2.5.2 Assembling the MP400 plate in the machine: 2.6 CHANGING PROCESSOR BOARDS 2.6.1 BC400 replacement 2.6.2 MP400 replacement 2.6.3 CM400 replacement 2.6.4 CU160 replacement 2.7 SUB-ASSEMBLIE 2.7.1 Air detector 2.7.1.1 Assembling procedure 2.8 BATTERY PACK 2.8.1 Battery replacement 2.9 BLOOD LEAK DETECTOR BLD 2.9.1 Assembling procedure 2.10 CLAMPS 2.10.1 Venous clamp 2.10.1.1 Assembling procedure 2.11 DOUBLE FILTRATION AND CPFA CLAMPS (OPTIONAL) 2.11.1 Assembling procedure 2.11.1.1 Rear door 2.11.1.2 Fluid heater 2.12 ASSEMBLING PROCEDURE ON HF440 2.12.1 Fixing the plate 2.12.2 Fixing the door 2.12.3 Fixing the switch 2.12.3.1 Hematocrit sensor (optional) 2.13 ASSEMBLING PROCEDURE 2.13.1 Main Switch 2.14 ASSEMBLING PROCEDURE 2.14.1 Power supply AL-127-00 2.15 ASSEMBLING THE POWER SUPPLY ON THE METALLIC PLATE: 2.16 ASSEMBLING THE POWER SUPPLY PLATE ON THE MACHINE:
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I.
2.16.1 Pressure connectors 2.17 PUMPS 2.17.1 Motor plate 2.17.1.1 Assembling procedure 2.17.1.2 Pump heads 2.17.1.3 Assembling procedure 2.18 HEPARIN PUMP 2.18.1 Scale sensors 2.18.2 Assembling procedure 2.18.3 Visual alarm 2.18.4 Syringe pump 2.18.4.1 Potentiometer adjustement
TECHNICAL WINDOWS
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3.1 INTRODUCTION 3.2 TECHNICAL WINDOW 3.3 PUMPS MANUAL COMMAND 3.4 SYRINGE PUMP COMMAND (OPTIONAL) 3.5 OPEN / CLOSE CLAMPS (OPTIONAL) 3.6 PRESSURES 3.7 VENOUS CLAMP POSITION (MIDDLE RIGHT) 3.8 SCALES MEASURED WEIGHT (MIDDLE RIGHT) 3.9 BLOOD DETECTORS VALUES CM400, MP400 (OPTIONAL) 3.10 AIR DETECTOR 3.11 TEMPERATURE DISPLAY 3.12 ALARM HEATER 3.13 BATTERY 3.13.1 Buttons 3.14 DIAGNOSIS WINDOW 3.14.1 Service sync 3.15 OPTIONS WINDOW 3.16 CALIBRATIONS WINDOW 3.17 TOUCH SCREEN CALIBRATION 3.18 UPDATE LICENSE AND UPDATE SOFTWARE
IV.
CHECKS AND CALIBRATIONS
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4.1 INTRODUCTION 4.2 POWER SUPPLY 4.2.1 Check procedure 4.3 TROUBLESHOOTING 4.3.1 Controlling voltages on MP400 power cable connector 4.3.2 Controlling voltages on CM400 board 4.4 AIR DETECTOR 4.4.1 Check procedure 4.4.2 Trouble shooting 4.5 PRESSURE SENSORS 4.5.1 Check procedure 4.6 TROUBLESHOOTING 4.6.1 Problem 1: The maximum pressure cannot be reached 4.6.2 Problem 2: At maximum pressure the difference with reference is greater than 50 mmHg 4.6.3 Problem 3: At maximum pressure the pressure drop is greater than 10 mmHg in 10 s. 4.6.4 Problem 4: More than 1 pressure sensor reacts at a time 4.6.5 Problem 5: The wrong pressure sensor reacts 4.7 VENOUS CLAMP 4.7.1 Check procedure 4.7.2 Troubleshooting Page 4/ 184
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III.
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4.7.2.1 Problem 1: The clamp doesn’t move by hand 4.7.2.2 Problem 2: The clamp doesn’t close 4.7.2.3 Problem 3: The clamp is not occluding (pressure drop > 10 mmHg in 10 s) 4.7.2.4 Problem 4: Sensor position is less than 800 when clamp is closed without tube 4.7.2.5 Problem 5: The position of the sensor remains the same after 1 mm 4.8 PLASMA / WASTE CLAMPS 4.8.1 Check procedure 4.8.2 Troubleshooting 4.8.2.1 Problem 1: The clamp doesn’t open 4.8.2.2 Problem 2: The wrong clamp opens 4.8.2.3 Problem 3: It is difficult to pass the tube inside the clamp or to remove it 4.8.2.4 Problem 4: The clamp is not occluding (pressure drop > 10 mmHg in 10 s) 4.9 PUMPS 4.9.1 Procedure 4.9.2 Troubleshooting 4.9.2.1 Problem 1: No pump is rotating 4.9.2.2 Problem 2: Some pumps but not all are rotating 4.9.2.3 Problem 3: Torque too high on some pump when operating the machine 4.10 BLOOD LEAK DETECTOR(S) 4.10.1 Procedure 4.10.2 Troubleshooting: 4.10.2.1 Problem 1: The “No chamber” or “Dark” or “ON” or “OFF” value is not within range 4.10.2.2 Problem 2: The value doesn’t remain stable within range 4.11 SCALES 4.11.1 Check procedure 4.11.2 Troubleshooting 4.11.2.1 Problem 1: When loading some scale, there is no reaction of corresponding A/D 4.11.2.2 Problem 2 : Scale value doesn’t stabilize 4.11.2.3 Problem 3: Any scale value is out of rang 4.12 HEATER 4.12.1 Procedure 4.12.1.1 Calibration procedure 4.12.1.2 Troubleshooting 4.12.1.3 Problem 1: The temperature is equal to or below 37 degrees 4.12.1.4 Problem 2: The temperature is above 39 degrees 4.12.1.5 Problem 3: The heater switch generates unnecessary alarms when the door is closed 4.13 BATTERY 4.13.1 Check 4.13.1.1 Troubleshooting: 4.13.1.2 Problem 1: Battery voltage is below 1V 4.13.1.3 Problem 2: The battery voltage is slightly too low (max 1.5 V below requested value) 4.13.1.4 Problem 3: The battery status is not "CONNECTED" 4.13.1.5 Adjusting the battery charger voltage 4.14 SYRINGE PUMP 4.14.1 Check procedure 4.14.1.1 Calibration procedure 4.14.1.2 Troubleshooting for syringe pump 4.14.1.3 Problem 1: The pump motor doesn’t rotate 4.14.1.4 Problem 2: The value of the sensor displayed in the technical window doesn’t change 4.14.1.5 Problem 3: The syringe pump pusher doesn’t move on the whole distance 4.14.1.6 Problem 4: The sensor value isn’t stable 4.14.1.7 Problem 5 (PS-450-01 only): Syringe detection is wrong (alarm #222) 4.15 HEMATOCRIT VARIATION SENSOR (OPTIONAL) 4.15.1 Check procedure 4.16 MAIN ALARMS CHECK 4.16.1 Air in venous line 4.16.2 Blood leak detection 4.16.3 Arterial pressure beyond limits 4.16.4 Venous pressure beyond limits
4.16.5 Substitution bag empty 4.16.6 Waste container full 4.16.7 Imprecise fluid balance 4.16.8 Heater temperature too high
V.
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SOFTWARE UPDATE PROCEDURE
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5.1 FOREWORD: MANDATORY CONTROLS FOLLOWING SOFTWARE UPDATES 5.2 INTRODUCTION 5.2.1 System overview 5.2.2 Description 5.3 UPDATE MACHINE'S MAIN SOFTWARE (BC400 APPLICATION) 5.3.1 Downloading the BC400 main program 5.4 COMPLETING APPLICATION INSTALL 5.4.1 CM400 Supervisor software install 5.4.2 License install 5.4.3 Install instructions 5.4.4 Options and calibrations 5.4.5 Check machine options configuration 5.5 CALIBRATIONS 5.5.1 User setups (language, time) 5.6 CONCLUSION 5.7 MORE TROUBLE SHOOTING 5.8 UPDATE PROCEDURE FOR ELECTRONIC BOARDS 5.8.1 MP400 Board 5.8.2 MPLAB software install 5.8.3 MP400 jumpers position 5.8.4 Connection of the “MPLAB ICD2” to the MP 5.8.5 PIC Programming 5.8.6 CU160 board 5.8.7 CU160 programming jumper 5.8.8 Connection to the CU160 5.8.9 Software upgrade procedure 5.8.10 CM400 board 5.8.11 Connection for CM400 Supervisor programming 5.8.11.1 Programming of Motor or Supervisor from technical window 5.8.11.2 Procedure to modify BC400 Linux operating system
VI.
MAINTENANCE
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6.1 PUTTING DEVICE INTO SERVICE 6.2 MAINTENANCE 6.2.1 Maintenance procedure 6.2.2 Finalising the maintenance procedure 6.3 NECESSARY TOOLS FOR MACHINE CONTROLS
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WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT
7.1 PARTS FALLING UNDER WEEE RULES 7.2 METALLIC PARTS 7.2.1 Stainless steel parts 7.2.2 Aluminium parts 7.2.3 Others
VIII. 8.1 8.2 8.3 8.4
IX. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31.
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ANNEX - UNPACKING THE MACHINE
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STEP 1 : UNPACKING THE MACHINE STEP 2 : ASSEMBLING THE STAND STEP 3 & 4 : MOUTING THE MACHINE STEP 5 : ASSEMBLING HANDLE
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ANNEX - TECHNICAL DRAWINGS
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AT-106-01 : LUER-LOCK ON ITS SUPPORT BC-400-30 : BC400 ASSEMBLY LINUX VERSION BL-299-01 : FIXING PART FOR BAGS SUPPORTS BL-300-01 : COMPLETE 4 BAGS ROD (WITH TURNING HOOKS) BL-706-00 : SINGLE 6KG WEIGHT SYSTEM WITH HANGER BL-740-00 : COMPLETE 40 KG SENSOR ASSEMBLY CH-201-18 : COMPLETE FOOT FOR HF440 CM-410-01 : CM400-MP400 ASSEMBLY CP-110-00 : AIR DETECTOR ASSEMBLY CP-210-00: HEMATOCRITE SENSOR ASSEMBLY CP-515-00 : BLD CHAMBER HOLDER ASSEMBLY CP-720-01 : INCREMENTAL SENSOR COMPLETE ASSEMBLY GM-520-11 : MOTOR ASSEMBLY WITH PLUG ON RIGHT GM-550-21 : MOTOR ASSEMBLY WITH OVERRUNNING CLUTCH AND PLUGS ON LEFT GM-550-31 : MOTOR ASSEMBLY WITH PLUGS ON LEFT GM-610-00 : COUPLING SHAFT ASSEMBLY FOR PUMP WITH OVERRUNNING CLUTCH GM-610-10 : COUPLING SHAFT ASSEMBLY FOR PUMP HC-454-00 : CPFA CLAMP MODULE FOR HF440 HC-455-00 : DF AND CPFA CLAMP MODULE FOR HF440 HC-456-01 : DF CLAMP MODULE HC-510-00 : EXTERNAL PART ASSEMBLY OF VENOUS CLAMP HC-550-00 : EXTERNAL CASCADE CLAMP ASSEMBLY HF-412-09 : HF FRONT FACE ASSEMBLY HF-445-00 : COMPLETE UPPER REAR DOOR PF-402-00 : FILTER HOLDER WITH SCREWS PS-450-01 : HEPARIN PUMP HF 440 RE-100-11 : COMPLETE HEATING PLATE 220VA RE-120-01 : HF440 HEATING PLATE MODULE WITHOUT DOOR 220VA RE-130-11: HF440 COMPLETE DOOR FOR PLATE HEATER RE-140-10 GUTTER ASSEMBLY FOR HF HEATER IR-400-10 : COMPLETE MAIN SWITCH
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VII.
ANNEX – WIRING DRAWINGS 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16.
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BC400 MOTOR MAIN SWITCH HF-443-00 : HF COMMON PART HF-401-01 : DEVICE OPTION – HEPARINE PUMP HF-401-05 : HF OPTION – INTEGRATED PLATE FLUID HEATER 220V HF-401-08 : INTEGRATED PLATE FLUID HEATER 110V HF-401-10 : DEVICE OPTION – PP HF-401-11: DEVICE OPTION – DF OR DF&PP HF-401-12: DEVICE OPTION – CPFA OR CPFA&PP HF-401-13 : DEVICE OPTION – CPFA&DF OR CPFA&DF&PP HF-401-14: DEVICE OPTION – 5TH PUMP, 3RD WEIGHT SYSTEM HF-401-16 : DEVICE OPTION – EXTENDED PRESSURE RANGE HF-401-25 : DEVICE OPTION – BLD WITH MOVABLE HOOD HF-401-26 : DEVICE OPTION – BLD WITH PLASTIC HOLDER HF-402-14 : DEVICE OPTION – NO 5TH PUMP, NO 3RD WEIGHT SYSTEM
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X.
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I.
Introduction to products family
1.1
About this manual
This manual is targeted at Infomed customers' technical team. Its aim is providing required technical information to maintain, check and repair machines from the reception until the disposal. Chapter 1, 2 and 3 are describing the machine: identification of options, assemblies and wiring. Chapter 4, 5, 6 and 7 are explaining how to maintain and check the machine: software Technical Window, checks and calibrations, maintenance, software upgrade.
1.2
Product presentation
To get an introduction to this product please refer to the HF440 users manual describing, among other things, intended use and options. HF440 was introduced on the European market in 2004. The present manual is written for machines produced from 2009 and running Linux operating system on BC400. For machines produced until end of 2008 please refer to original technical manuals. The elements that may differ between different models are scales mechanic, enclosure-foot, as well as fluid heater. Moreover some HF440 are equipped with a new option, the 5th pump and third scale. The present manual covers technical aspects for all uses and options which can be present or not on the machine to check and maintain.
1.3
Warning
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The HF440 device must be maintained and repaired only by persons who are formally authorized to do so by Infomed. This is the case when the technical staff has completed the courses provided by Infomed and received a certificate validating the acquired knowledge. All technicians must carefully read the present manual and Users Manual, and follow all indications. Infomed will not be responsible for any work done by non agreed persons or by persons not following procedures described in this manual. All defects can be submitted to the distributor or manufacturer using the technical report form placed in annex of this document. In the cases that have, might have, caused a major injury or death to at least one patient, the distributor or the manufacturer shall be informed without delay.
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1.4
General information
Ground connection
Required
Operating conditions
Temperature from 15°C to 30°C Air pressure from 87 kPa to 106 kPa Relative humidity from 30% to 75% non-condensing
Shipping and storage conditions
Temperature from -20°C to 70°C Air pressure from 70 kPa to 106 kPa Relative humidity from 10% to 96% non-condensing
Technical characteristics
Defined on the respective user manual.
1.5
Infomed parts exchange and support policy
In case of technical problems, Infomed may require to receive the technical report form completed, before further analysis. To help identifying problems, Infomed may request machines logfiles before proceeding further. Any parts returned to Infomed shall be sent with the technical report form completed. Packing shall be done in such a way not to damage further parts. Parts that are under warranty can be sent back to Infomed for repair. Parts that are not covered by warranty can either be send to Infomed for further diagnostic or thrown away according to local regulations. The following parts must be returned to Infomed for repair, Infomed will not provide part for local repair of these assemblies: BC400, CM400, MP400, CU160, Pump heads, Scales assembly, Plate heater.
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In case repair is possible, Infomed will charge the time spent and the new parts to be changed. All other machine parts will be replaced by new ones.
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1.6
Identifying models
a) Models: The standard HF440 is delivered with the following features: 4 pumps Heater Syringe driver And performs the following treatments (if licensed): CVVH CVVHDF TPE HP
Machines have a main label identifying the serial number, date of manufacturing, and manufacturer, plus some extra indications and symbols described in the Users Manual.
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b) Identification label
c) Options Machine are customized through options, which require a software license to be activated. Options' license either come along with a treatment license, specific hardware or as a specific license. Most options can be identified checking the presence of these components as in Table 0.1 Double filtration
CPFA
and CPFA and DFPP
and Additional pump and central scale
Extended pressure range blood access
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Identifying options through hardware
II.
Assembling / disassembling parts 2.1
Introduction
The HF440 machines are made of the electromechanical modules described in this chapter, and drawings located in annex. References provided in here are those of the HF440 model produced from year 2009. For previous machines, please refer to the original technical manual. To simplify the update of present manual, text contains references to detailed drawings.
2.2
Electronic boards 2.2.1
BC400
The BC400 is to be considered as a closed box. In case of problem field technicians shall return it to Infomed for diagnostic and repair.
2.3
Make sure that the seal is present, properly glued and without hole Make sure that the 4 spacers are glued around the 4 screws Place the BC400 inside the machine Place the 2 grounding cables and the related spacers Screw the BC400 nuts
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1. 2. 3. 4. 5.
Assembling procedure
2.4
Assembling procedure
Assembling the CM400 board on the metallic plate: 1. If it is not present, place and fix the air detector board on the CM400. 2. Place the CM400 on 8 Spacers, the power supply connector being on the lower part where the battery is. 3. Fix the board with 8 screws. Assembling the CM400 plate in the machine: 1. 2. 3. 4.
Place the whole metallic plate in position Place the grounding cables Fix the plate on the left of the machine with screws 4 nuts Connect the CM400 board
See chapter 2 for connectors definition
board main components Internal reference : CM-400-03
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Micro
Supply voltage
Fuse value
5V
250V 5A
12V
250V 5A
24V
250V 1A
30V
250V 5A
CM-400-03 connections
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CM-400-03 fuse characteristic
2.4.1
CU160
The CU160 is mounted on the 6 spacers placed as a mezzanine on the CM400.
main connection Internal reference : CU-160-12, optional
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On HF440 CU160 is used only for the 5th motor and third scale and is thus not present if this option is not licensed to the machine.
2.5
MP400 2.5.1
Assembling the MP400 board on the metallic plate:
1. Place the MP400 on 4 Spacers, the scale sensors connectors being on the lower part. 2. Fix the board with 4 screws.
2.5.2
Assembling the MP400 plate in the machine:
1. Place the whole metallic plate in position 2. Place the grounding cables (if any) 3. Fix the plate in the machine with screws (HF440) or nuts (HF440) ¨
Machine main supply
Fuse value
115V
10A
230V
5A
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MP-400-03 fuse characteristics
MP-400-03 connections Internal reference : MP-400-03
Changing processor boards
When changing boards containing a processor, the software must be compatible with those of other boards. Following procedures must be followed in order to ensure this compatibility. Software update procedure is dealt with in chapter 6.
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2.6
2.6.1
BC400 replacement
1. Disconnect the cables of the BC400 2. Unscrew the 4 nuts and remove the BC400 3. Place the new BC400 4. Connect the cables to the new BC400 5. Power on the machine 6. Update the BC400 following the chapter 6 of this manual 7. Insert machine license file from USB stick, will reboot application automatically. 8. Go to the technical window 9. Press the maintenance button to see the actual configuration 10. Modify the configuration so that it corresponds to the machine
2.6.2 1. 2. 3. 4. 5. 6. 7. 8.
MP400 replacement
Make sure to have the same MP400 hardware version If so, remove all connectors. Remove the board and replace it with the new one. If the MP400 program is different from the existing one, or in case of doubt, update the board following chapter 6 of the present manual Connect all connectors Power on the machine and go to the Technical window Go to the maintenance window Control, adjust and calibrate the scales, the heater and if used the haematocrit sensor, BLD and pressure sensors
2.6.3
CM400 replacement
1. 2. 3. 4. 5.
Make sure to have the same CM400 hardware version for replacement If so, remove all connectors. Remove the board and replace it with the new one. Connect all cables again Power on the machine and download the CM400 software following the chapter 6 of the present manual 6. Power off and on the machine and go to the Technical window 7. Control, adjust and calibrate the pressure sensors, venous clamp and heparin pump 8. Control and adjust the BLD and battery loader
CU160 replacement
1. Remove all connectors. 2. Remove the board and replace it with the new one. 3. If the CU160 program is different from the existing one, or in case of doubt, program the CU160 following the procedure described in the chapter 6 of the present manual. 4. Connect all connectors 5. Power on the machine and go to the Technical window 6. Go to the maintenance window 7. Control, adjust and calibrate the scales Page 19/ 184
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2.6.4
2.7
Sub-assemblie 2.7.1
Air detector
2.7.1.1 Assembling procedure 1. 2.
From the front face, push cables of the detector into its support and through the aluminium plate. Screw the detector with the 2 screws and washers.
2.8
Battery pack 2.8.1
1. 2. 3. 4.
Battery replacement
Disconnect the battery from the CM400 Remove the 2 nuts and the holder Replace the battery, holder and nuts Connect the battery to the CM400
2.9
Blood leak detector BLD
The lower blood leak detector is connected to the CM400 The 2 blood leak detectors are exactly identical but wire lengths. MP400 (CPFA) blood detector has longer wires. To install each BLD proceed as follows:
2.9.1 1. 2. 3. 4.
Assembling procedure
Screw the main part on the front or side face Place the interface on the blood detector circuit Mount this on the blood detector electronic using 2 screws Connect the interface to its electronic board
2.10
Clamps 2.10.1
Venous clamp
1. 2. 3. 4.
Insert the clamp finger in the clamp’s enclosure. Screw the clamp’s enclosure with 4 screws. Assemble, if not in place, the 4 Spacers on their screws. Place the electromagnet on the 4 Spacers with 4 nuts.
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2.10.1.1 Assembling procedure