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Fresenius Medical Care 4008 E User Manual

Fresenius Medical Care 4008 E
595 pages
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4008 E / 4008 B / 4008 H / 4008 S
Hemodialysis Machine
Technical Manual
CareFreseniusMedical

Table of Contents

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Fresenius Medical Care 4008 E Specifications

General IconGeneral
TypeHemodialysis machine
ManufacturerFresenius Medical Care
Model4008 E
Control SystemMicroprocessor-controlled
Heparin pump flow0.1 - 10 ml/h
Temperature range35 - 39 °C
Treatment ModesHemodialysis, Hemodiafiltration
Power Supply100-240 V AC
Blood Flow Rateup to 500 ml/min
Dialysate Flow Rateup to 800 ml/min
DisplayLCD
Venous pressure range+500 mmHg
WeightApprox. 85 kg (187 lbs) without options
Ultrafiltration Rate0.0 - 4.0 l/h

Summary

Important Information

Organization of the Technical Manual

Explains the interpretation of page numbering (Chapter X, page Y).

Page identification

Explains the interpretation of page numbering (Chapter X, page Y).

Editorial information

Details the update status of the manual and provides a table to verify current versions.

Modifications

States that manual changes are released as new editions or supplement sheets.

How to use the technical manual

Intended use

Specifies the manual is for service technicians for initial studies, maintenance, and repair.

Requirements

Lists necessary knowledge in mechanics, electrical, and medical engineering.

Specifications

Refers to current Operating Instructions for system specifications.

Circuit diagrams and component layouts

Explains how PCB identification helps verify circuit/component matches.

Explanation of the Note and Caution symbols used

Defines the meaning of 'Note' and 'Caution' symbols used in the manual.

Instructions to be Observed when Servicing the System

Authorized persons

States that assembly, adjustments, and repairs must be done by manufacturer or authorized personnel.

Test equipment and accessories

Highlights the need for necessary technical test equipment and accessories.

Precautions

Lists precautions for working on an open system, including fluid ingress and live parts.

ESD precautions

Advises observing ESD precautions when repairing or replacing parts.

Addresses

Manufacturer

Provides contact details for the manufacturer, Fresenius Medical Care AG.

Service Central Europe

Offers contact information for the Central Europe service center.

International Service

Provides contact details for international service support.

Local Service

No specific description provided for local service.

1 Description of machine functions and malfunctions

1.1 Description of the T1 test

Details the T1 test, including flow diagrams and serial program steps.

1.1.1 T1 test flow diagram, serial program steps

Presents the serial program steps for the T1 test flow diagram.

1.1.2 T1 test flow diagram, parallel program steps

Presents the parallel program steps for the T1 test flow diagram.

1.1.3 Description of the T1 test incl. error messages

Describes the T1 test, including associated error messages.

1.1.4 Description of machine errors during the cleaning programs

Details machine errors that may occur during cleaning programs.

1.1.5 Error messages after turning power on

Lists error messages that appear after the machine is powered on.

1.1.6 Error messages during dialysis

Lists error messages that may occur during the dialysis process.

1.2 Functional description of the modules

Provides functional descriptions of key modules like blood pump and heparin pump.

1.2.1 Blood pump (arterial)

Describes the functional aspects of the arterial blood pump.

1.2.2 Blood pump (single needle), optional

Describes the functional aspects of the optional single needle blood pump.

1.2.3 Heparin pump

Describes the functional aspects of the heparin pump.

1.2.4 Air detector

Describes the functional aspects of the air detector.

1.3 Functional description of the hydraulic unit

Explains the function of the hydraulic unit, including flow diagrams and theories of operation.

1.3.1 Description of the hydraulic unit

Provides a detailed description of the hydraulic unit's operation.

1.3.2 Theory of operation of the balancing chamber

Explains the theory behind the operation of the balancing chamber.

1.3.3 Central delivery system option

Describes the functionality of the central delivery system option.

1.3.4 Program runs during the cleaning programs

Details the sequence of program runs during cleaning procedures.

2 Technical safety checks / Technical measurement checks / Maintenance

2.1 Technical safety checks and maintenance for 4008 hemodialysis systems and options

Covers TSC and MA procedures for safety checks and maintenance.

2.1.1 Important notes

Provides important notes regarding technical safety checks and maintenance.

2.1.2 Description – Technical safety checks and maintenance

Details the procedures for technical safety checks and maintenance.

2.1.3 Checklist – Technical safety checks and maintenance

Provides a checklist for technical safety checks and maintenance.

2.1.4 Notes – Checking the electrical safety

Provides notes and procedures for checking the electrical safety of the system.

2.2.1 Important notes

Provides important notes regarding technical measurement checks and maintenance.

2.2.2 Description – Technical measurement checks and maintenance

Details the procedures for technical measurement checks and maintenance.

2.2.3 Checklist – Technical measurement checks and maintenance

Provides a checklist for technical measurement checks and maintenance.

2.3 TSC checklist

Provides a checklist for Technical Safety Checks.

3 Adjustment instructions

3.1 Overview of the DIP switches in the 4008

Details the function and configuration of DIP switches on the 4008.

3.1.1 P.C.B. LP 631 (CPU 1) DIP switch array 1

Describes the DIP switch array 1 on the LP 631 PCB for CPU 1.

3.1.2 P.C.B. LP 631 (CPU 1) DIP switch array 2

Describes the DIP switch array 2 on the LP 631 PCB for CPU 1.

3.1.3 P.C.B. LP 632 (CPU 2) DIP switch array 1

Describes the DIP switch array 1 on the LP 632 PCB for CPU 2.

3.1.3 P.C.B. LP 632 (CPU 2) DIP switch array 2

Describes the DIP switch array 2 on the LP 632 PCB for CPU 2.

3.2 Calibration mode

Explains the basic conditions and messages for calibration mode.

3.2.1 Basic conditions

Outlines the basic conditions required for calibration mode.

3.2.2 Messages on the displays on the UF monitor (4008 E/B) or on the screen (4008 H/S)

Describes messages displayed on UF monitor or screen during calibration.

3.3 Hydraulics

Covers hydraulic checks like pressure, flow, and pump volumes.

3.3.1 Reduced water inlet pressure

Details the procedure for checking and adjusting reduced water inlet pressure.

3.3.2 Degassing pump pressure

Explains how to check and adjust the degassing pump pressure.

3.3.3 Balancing chamber loading pressure

Details the procedure for checking and adjusting balancing chamber loading pressure.

3.3.4 Flow pump pressure

Describes how to check and adjust the flow pump pressure.

3.3.5 UF pump volume

Explains how to check and adjust the UF pump volume.

3.3.6 CDS pressure switch

Details the procedure for checking and adjusting CDS pressure switch.

3.4 Air detector

Explains the test and adjustment procedures for the air detector.

4 Calibration program

Part 1: Calibrate arterial pressure

Guides through the calibration process for arterial pressure.

Part 2: Calibrate the pressure in the arterial blood pump

Details the calibration procedure for arterial blood pump pressure.

Without display messages: adjusting the blood pump stop alarm (blood pump or HDF pump)

Explains how to adjust the blood pump stop alarm without display messages.

Part 3: Calibrate the venous pressure

Guides through the calibration process for venous pressure.

Part 4: Calibrate the venous pressure measurement in the air detector

Details calibration of venous pressure measurement within the air detector.

Part 5: Calibrate the blood pump rates

Provides procedures for calibrating arterial, single needle, and HDF blood pump rates.

Part 5.1: Calibrate arterial blood pump

Details the calibration process for the arterial blood pump rate.

Part 5.2: Calibrate single needle blood pump rate

Guides through the calibration of the single needle blood pump rate.

Part 5.3: Calibrate ONLINE-HDF pump

Details the calibration process for the ONLINE-HDF pump rate.

Part 6: Adjust UF pump volume

Explains how to adjust the UF pump volume.

Part 7: calibrate degassing pressure

Guides through the calibration of the degassing pump pressure.

Part 8: 300 ml/min flow

Details the calibration procedure for a 300 ml/min flow rate.

Part 9: Calibrate 500 ml/min flow

Guides through the calibration procedure for a 500 ml/min flow rate.

Part 10: 800 ml/min flow

Details the calibration procedure for an 800 ml/min flow rate.

Part 11: Calibrate dialysate temperature

Guides through the calibration process for dialysate temperature.

Part 12: Calibrate mixing system

Provides procedures for calibrating the mixing system components.

Part 12.1: Run-in of membrane pumps

Explains the run-in procedure for membrane pumps.

Part 12.2: Determine the balancing chamber volume

Details how to determine the balancing chamber volume.

Part 12.3: Calibrate the concentrate pump stroke

Guides through the calibration of the concentrate pump stroke.

Part 12.4: Determine the concentrate pump volume

Explains how to determine the concentrate pump volume.

Part 12.5: Calibrate bicarbonate pump stroke

Guides through the calibration of the bicarbonate pump stroke.

Part 12.6: Determine the bicarbonate pump volume

Explains how to determine the bicarbonate pump volume.

Part 12.7: Check the concentrate and/or bicarbonate volume

Details how to check concentrate and bicarbonate pump volumes.

Part 13: Calibrate conductivity

Guides through the calibration of conductivity.

Part 14: Calibrate the dialysate pressure (stainless steel pressure transducer)

Details dialysate pressure calibration for stainless steel transducer.

Part 14.1: Dialysate pressure

Guides through the dialysate pressure calibration process.

Part 14.2: TMP check

Details the TMP check procedure during calibration.

Part 14.3: PDIAL2 pressure check

Explains the PDIAL2 pressure check procedure.

Part 15: Blood leak voltage

Guides through the calibration of blood leak voltage.

Part 16: Calibrate BIBAG values (optional)

Provides calibration steps for optional BIBAG values.

Part 17: Reset the failure record

Details the procedure for resetting the failure record.

Part 18: Initialize NOVRAM, reset mandatory rinse, reset V84 malfunction

Covers initialization of NOVRAM, reset of mandatory rinse, and V84 malfunction.

5 Diagnostics program

5.1 General notes

Provides general information about the diagnostics program and its menus.

5.2 Menu structure

Illustrates the hierarchical structure of the diagnostics program menus.

5.3 Reading the analog inputs of CPU I

Explains how to read analog inputs from CPU I, detailing specific signals and values.

5.4 Reading the analog inputs of CPU II

Explains how to read analog inputs from CPU II, detailing specific signals and values.

5.5 Reading the digital inputs of CPU I

Details how to read digital inputs from CPU I, referencing specific LEDs and signals.

5.6 Reading the digital inputs of CPU II

Details how to read digital inputs from CPU II, referencing specific signals and conditions.

5.7 Writing the analog outputs of CPU I

Explains how to write analog outputs for CPU I, detailing specific DAC values and settings.

5.8 Writing the analog outputs of CPU II

Explains how to write analog outputs for CPU II, detailing specific detuning values.

5.9 Writing the digital outputs of CPU I

Details how to write digital outputs for CPU I, referencing specific valves and ICs.

5.10 Writing the digital outputs of CPU II

Details how to write digital outputs for CPU II, referencing specific valves and ICs.

5.11 Writing/Reading the digital outputs of CPU I

Explains how to write and read digital outputs for CPU I, referencing specific signals.

5.12 ONLINEplus™ module

Describes the settings and functions related to the ONLINEplus™ module.

6 Setup menu

6.1 Overview Setup menu settings

Lists default and adjustable values for various setup menu items.

6.2 Overview

Provides a general overview of the menu structure.

6.3 Main menu 4008 E/B Rev. 5.2

Details the main menu structure for 4008 E/B models, Rev. 5.2.

6.4 Main menu 4008 H/S Rev. 4.3

Details the main menu structure for 4008 H/S models, Rev. 4.3.

7 Miscellaneous

7.1 bibag®

Details aspects related to the bibag® system, including connectors and O-rings.

7.2 DIASAFE

Covers maintenance and replacement of DIASAFE filters and O-rings.

7.3 DIASAFE®plus

Covers maintenance and replacement of DIASAFE®plus filters and O-rings.

7.4 4008 HDF

Details checks for the 2nd UF pump delivery rate in 4008 HDF systems.

7.5 ON-LINE-HDF (and DIASAFE)

Covers filter life, hydrophobic filter replacement, and O-rings for ON-LINE-HDF/DIASAFE.

7.6 ONLINEplus™ (and DIASAFE®plus)

Details filter life, hydrophobic filter replacement, and O-rings for ONLINEplus™/DIASAFE®plus.

7.7 OCM

No further technical safety checks and maintenance procedures are to be performed.

7.8 BPM 4008

Specifies performing technical measurement checks and maintenance every 2 years.

7.9 BTM 4008

No further technical safety checks and maintenance procedures are to be performed.

7.10 BVM 4008

No further technical safety checks and maintenance procedures are to be performed.

8 Checking the electrical safety

8.1 Visual inspections performed according to item 1

Refers to visual inspection procedures as per item 1.

8.2 Protective earth resistance

Specifies the maximum protective earth resistance value (max. 0.3 ohms).

8.3 Measurement of the leakage current

Describes differential and direct measurement methods for leakage current.

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