4000 E, B, H and S Technical Manual 5th Edition Sept March 2009

Important information on the Technical Manual How to use the Technical Manual Identification

The document can be identified by the following information on the title page and on the labels, if any: – Edition of the technical document – Part number of the technical document

Page identification

The page identification 1-3, for example, refers to: chapter 1, page 3.

Editorial information

The editorial information 1/01.05, for example, refers to the 1st edition, January 2005.

Changes

Changes to the Technical Manual will be released as new editions or supplements. In general: This manual is subject to change without notice.

Significance of the safety precautions

Explanation of the Caution and Note symbols used:

Caution Advises the operator against certain procedures or actions that could cause damage to the equipment or may have adverse effects on operators and patients.

☞

Note Informs the operator that if the steps are not followed as described, a specific function will be executed incorrectly or will not be executed at all, or will not produce the desired effect.

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Important information on the system Technician’s qualification Purpose

This Technical Manual is intended for service technicians and is to be used for first studies (to acquire a basic knowledge) and for reference purposes (for TSC, Maintenance and repair). The Technical Manual, however, does not replace the training courses offered by the manufacturer.

Requirements

Knowledge of the current Operating Instructions for the respective system. Background experience in mechanics, electrical and medical engineering.

Precautions for working on the system Authorized persons

Assembly, extensions, adjustments, modifications or repairs may only be carried out by the manufacturer or persons authorized by him.

Test equipment and accessories

The activities described in this technical document require the availability of the necessary technical test equipment and accessories.

Specifications

For the specifications of the respective system, refer to the current Operating Instructions. Observe the information on the specifications.

Precautions

Before turning power on, repair any visible damage. Prior to opening the system and when working on the open system, the following precautions have to be observed: – Protect the components against ingress of fluids. – Do not touch live parts (e.g. connectors of the power cable or heater). – Disconnect and connect all jacks, connectors and components only when the system is turned off.

ESD precautions

When repairing the system and replacing spare parts, observe the applicable ESD precautions.

Hygienic measures

The system and the consumables are generally considered to be contaminated and must therefore be sufficiently disinfected by the responsible organization as specified by the manufacturer.

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Table of contents Section

Page

1 1.1 1.2 1.3

Description of system functions and malfunctions ... Description of the T1 test ... Functional description of the modules ... Functional description of the hydraulic unit ...

11-3 1-78 1-83

2 2.1

2-

2.2

Technical Safety Checks / Maintenance ... Technical Safety Checks and Maintenance for 4008 hemodialysis systems and options ... TSC report ...

3 3.1 3.2 3.3 3.4

Adjustment instructions ... Overview of the DIP switches in the 4008 ... Calibration mode ... Hydraulics ... Air detector ...

33-9 3-13 3-15 3-31

4

Calibration program ...

4-

5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13

Diagnostics program... General notes ... Menu structure ... Reading the analog inputs of CPU I ... Reading the analog inputs of CPU II ... Reading the digital inputs of CPU I ... Reading the digital inputs of CPU II ... Writing the analog outputs of CPU I ... Writing the analog outputs of CPU II ... Writing the digital outputs of CPU I ... Writing the digital outputs of CPU II ... Writing/Reading the digital outputs of CPU I ... ONLINEplus™ module ... HPU ...

55-3 5-5 5-7 5-9 5-10 5-15 5-19 5-20 5-21 5-27 5-30 5-31 5-32

6 6.1 6.2 6.3 6.4

Setup menu ... Overview Setup menu settings ... Overview ... Main menu 4008 E/B ... Main menu 4008 H/S ...

66-3 6-7 6-9 6-37

7

Miscellaneous ...

7-

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Section

Page

8 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 8.16 8.17 8.18 8.19 8.20 8.21 8.22 8.23 8.24 8.25 8.26 8.27

Circuit diagrams and circuit descriptions ... Block diagram 4008 ... Block diagram of voltage supply ... Block diagram of screen 4008 H/S ... Connection layout diagram ... P.C.B. LP 450-2 Level detector control (LD) ... P.C.B. LP 493 Blood leak detector ... P.C.B. LP 624 Control board (BP) ... P.C.B. LP 630 Motherboard ... P.C.B. LP 631 CPU 1 ... P.C.B. LP 632 CPU 2 ... P.C.B. LP 633 Input board ... P.C.B. LP 634 Output board ... P.C.B. LP 635 Display board ... P.C.B. LP 636 External connectors ... P.C.B. LP 950 Control board (HEP) ... P.C.B. LP 644-4 Display board (HEP) ... P.C.B. LP 645 Position sensor membrane pump ... P.C.B. LP 649-2 Display board (4008 B/S) ... P.C.B. LP 742 Interference filter ... P.C.B. LP 748 Display board (BP) ... P.C.B. LP 763 Multi interface board (COMMCO III) ... P.C.B. LP 922 Display board (4008 S) ... P.C.B. LP 923 Traffic light (4008 H/S) ... P.C.B. LP 924 Display board (4008 H) ... P.C.B. LP 941 Hydraulics processor ... Heater board (power supply unit 4008) ... Power board (power supply unit 4008) ...

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88-3 8-4 8-5 8-6 8-9 8-11 8-12 8-13 8-14 8-16 8-18 8-20 8-22 8-24 8-25 8-26 8-27 8-28 8-30 8-31 8-32 8-33 8-34 8-35 8-36 8-37 8-38

Table of contents 1 Description of system functions and malfunctions Section

Page

1.1 1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.6

Description of the T1 test ... T1 test flow diagram, serial program steps ... T1 test flow diagram, parallel program steps ... Description of the T1 test incl. error messages ... Description of system errors during the cleaning programs ... Error messages after turning power on ... Error messages during dialysis ...

1-3 1-3 1-5 1-7 1-53 1-70 1-71

1.2 1.2.1 1.2.2 1.2.3 1.2.4

Functional description of the modules ... Blood pump (arterial) ... Blood pump (Single-Needle), optional ... Heparin pump ... Air detector ...

1-78 1-78 1-79 1-80 1-82

1.3

Functional description of the hydraulic unit ... Fig.: Flow diagram ... Description of the hydraulic unit ... Theory of operation of the balancing chamber ... Central delivery system option ... Program sequences during the cleaning programs ... Fig.: Flow chart of cleaning programs – overview ...

1-83 1-83 1-85 1-87 1-91 1-92 1-92

1.3.1 1.3.2 1.3.3 1.3.4

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1.1

Description of the T1 test

1.1.1

T1 test flow diagram, serial program steps TEST ACCUMULATOR

MODULE T1

START T1 TEST TEST OK ?

no

STORAGE ERROR NUMBER

no

STORAGE ERROR NUMBER

no

STORAGE ERROR NUMBER

no

STORAGE ERROR NUMBER

no

STORAGE ERROR NUMBER

no

STORAGE ERROR NUMBER

no

STORAGE ERROR NUMBER

yes

TEST BYPASS

TEST OK ?

TEST BLOOD LEAK DETECTOR

no

STORAGE ERROR NUMBER

TEST OK ? yes

yes

TEST TEMPERATURE

TEST OPT. DETECTOR

TEST OK ?

no

STORAGE ERROR NUMBER

TEST OK ? yes

yes

NEG. PRESSURE HOLDING TEST

TEST BLOOD SYSTEM

TEST OK ?

no

STORAGE ERROR NUMBER

TEST OK ? yes

yes

POS. PRESSURE HOLDING TEST

TEST VENOUS PRESSURE

TEST OK ?

no

STORAGE ERROR NUMBER

TEST OK ? yes

yes

TEST UF-FUNCTION

TEST AIR DETECTOR

TEST OK ?

no

STORAGE ERROR NUMBER

TEST OK ? yes

yes

TEST CONDUCTIVITY

TEST DISPLAY

TEST OK ?

no

STORAGE ERROR NUMBER

TEST OK ? yes

yes

TEST ARTERIAL PRESSURE

TEST OK ? yes

no

Basic hydraulics

Advanced hydraulics

TEST DIASAFE/HDF FILTER

TEST DIASAFE PLUS / ONLINE PLUS / HPU TEST

STORAGE ERROR NUMBER TEST OK ?

no

STORAGE ERROR NUMBER

yes

1

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1

T1 TEST UNSUCCESSFUL no

yes

DIALYSIS START KEY

INCORRECT TEST STEP

RETURN

TEST OK ?

no

ERROR DISPLAY

yes

NEXT INCORRECT TEST STEP

yes

FURTHER INCORRECT TEST STEPS no RETURN

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1.1.2

T1 test flow diagram, parallel program steps

MODULE T1

START T1 TEST

TEST OPT. DETECTOR

TEST BLOOD SYSTEM

yes

TEST OK ?

STORAGE ERROR NUMBER

yes

TEST OK ?

1

no

TEST BYPASS

TEST OK ?

no

STORAGE ERROR NUMBER

TEST VENOUS PRESSURE

TEST TEMPERATURE

yes

TEST OK ?

TEST OK ?

no

STORAGE ERROR NUMBER

TEST AIR DETECTOR

NEG. PRESSURE HOLDING TEST

yes

TEST OK ? no

TEST OK ?

no

Conductivity?

yes

STORAGE ERROR NUMBER

1

no STORAGE ERROR NUMBER

yes

TEST BLOOD LEAK DETECTOR

yes

yes

TEST OK ? no

1

STORAGE ERROR NUMBER

yes

TEST CONDUCTIVITY

yes

no STORAGE ERROR NUMBER

TEST CONDUCTIVITY

POS. PRESSURE HOLDING TEST

TEST UF-FUNCTION

yes

no

TEST OK ? no

STORAGE ERROR NUMBER

STORAGE ERROR NUMBER

TEST DIASAFE/HDF FILTER

yes

TEST OK ?

yes

no STORAGE ERROR NUMBER

TEST UF-FUNCTION

Basic hydraulics

Advanced hydraulics

TEST DIASAFE/HDF FILTER

TEST DIASAFE PLUS / ONLINE PLUS / HPU-TEST

yes TEST OK ?

yes

TEST OK ?

yes

1 no

STORAGE ERROR NUMBER

yes

TEST OK ?

1

no

TEST OK ?

STORAGE ERROR NUMBER

no

TEST ARTERIAL PRESSURE

yes

TEST OK ?

1

STORAGE ERROR NUMBER

STORAGE ERROR NUMBER

no

TEST OK ?

yes

TEST OK ? no

no

1

STORAGE ERROR NUMBER

TEST OK ?

TEST ACCUMULATOR

no

STORAGE ERROR NUMBER

TEST OK ?

yes

no

STORAGE ERROR NUMBER

POS. PRESSURE HOLDING TEST

TEST DISPLAY

STORAGE ERROR NUMBER

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no

1

STORAGE ERROR NUMBER

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1

T1 TEST UNSUCCESSFUL no

yes

DIALYSIS START KEY

INCORRECT TEST STEP

RETURN

TEST OK ?

no

ERROR DISPLAY

no

NEXT INCORRECT TEST STEP

yes

FURTHER INCORRECT TEST STEPS yes RETURN

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1.1.3

Description of the T1 test incl. error messages ● Prerequisites for starting and running the test

Error message

Description

Power failure

Power failure while the test is in progress

Dialines not conn

The dialysate lines are not in the interlock shunt.

Shunt Cover open

The interlock shunt is open.

Connect Conc.Line Wrong conc. supply

The concentrate connector is in the rinse chamber, or concentrate is not connected at all. The error message depends on the central delivery system preselected in the setup menu.

Blood Sensed by OD

The optical detector senses blood in the system.

Flow alarm

Line to or from the dialyzer kinked, malfunctions in the hydraulics.

Water alarm

Water supply interrupted.

XXX not calibrated

A valid calibration value is missing in the NOVRAM.

● Overview of the individual test steps Bypass test ... Optical detector test ... Blood system test ... Venous pressure system test ... Air detector test ... Display test ... Arterial pressure system test ... Battery test ... Blood leak test ... Temperature test ... Negative pressure holding test ... Positive pressure holding test ... UF function test ... Conductivity test ... Diasafe/HDF filter test ... Online plus / Diasafe plus filter / HPU test ...

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● Bypass test Test description: Check of the following functions: – Heater relay – Bypass (electric) – Check of the temperature range changeover

Illustration: X632/A26

HOT_RINSE

LP 639 (4008E/H) X639/

Power Logic

A20

X632/A10

H_REL_W

X639/A12

X632/A9

EM_H_OFF

X639/A17

X632/C25

V24_EN

X632/C26

V24B_EN

X632/B22

CI

X632/A6

V26

X632/A6

V26

X632/A5

V24B

X634R/

X634R/

X632/A4

V24

A18

C22

LP 647 (4008S/B)

LP 632 CPU 2

X632/B28

LP 634 X634R/

Input board

X631/A21

LP 631 LP 630

CPU 1

Output board

X634L/A25

X631/A20

A23

X634L/C25

LP 633

X634L/C12

X632/B27

DATA BUS

(4008 B)

Display board LP 924 (4008 H)

LP 922 (4008 S) Testgenerierung/Generation of Test

Rueckmeldung/Acknowledgement

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V26

LP 649

(4008 E)

V24B

LP 635

V24

Mother board

V24

V24B

V26

X634R/ C24

Error description:

Error message

Description

F 01 Bypass

The heater relay is switched off. – Acknowledgement (H_REL_W, X639/A12) → X632/A10, 0 V are missing.

F 02 Bypass

The heater relay cannot be switched off by CPU2. – Acknowledgement (H_REL_W, X639/Y12) → X632/A10, 12 V are missing. – Control line (EM_H_OFF, X632/A9) → X639/A17, 12 V are missing.

F 03 Bypass

The temperature measurement range is set to hot rinse. – Control line (HOTRINSE, X634R/C24) → X639/A20, 0 V are missing. – Acknowledgement (HOTRINSE, X634R/C24) → X632/A26, 0 V are missing.

F 04 Bypass

The extended bypass cannot be correctly switched by CPU2 (V24 = off, V26 = on, V24B = off). – Acknowledgement (V24, X637/C1) → X632/A4, 24 V are missing. – Acknowledgement (V26, X637/C2) → X632/A6, 0 V are missing. – Acknowledgement (V24B, X637/C23) → X632/A5, 24 V are missing.

F 05 Bypass

The extended bypass cannot be correctly switched off by CPU2 (V24 = on, V26 = off, V24B = on). – Acknowledgement (V24, X637/C1) → X632/A4, 0 V are missing. – Acknowledgement (V26, X637/C2) → X632/A6, 24 V are missing. – Acknowledgement (V24B, X637/C23) → X632/A5, 0 V are missing.

F06 Bypass

CPU1 fails to set the temperature control to hot rinse. – Control line (HOTRINSE, X634R/C24) → X639/A20, 12 V are missing. – Acknowledgement (HOTRINSE, X634R/C24) → X632/A26, 12 V are missing.

F 07 Bypass

The extended bypass cannot be correctly switched by CPU1 (V24 = off, V26 = on, V24B = off). – Acknowledgement (V24, X637/C1) → X632/A4, 24 V are missing. – Acknowledgement (V26, X637/C2) → X632/A6, 0 V are missing. – Acknowledgement (V24B, X637/C23) → X632/A5, 24 V are missing.

F08 Bypass

CPU1 fails to reset the temperature control to dialysis. – Control line (HOTRINSE, X634R/C24) → X639/A20, 0 V are missing. – Acknowledgement (HOTRINSE, X634R/C24) → X632/A26, 0 V are missing.

F09 Bypass

The extended bypass cannot be correctly switched off by CPU1 (V24 = on, V26 = off, V24B = on). – Acknowledgement (V24, X637/C1) → X632/A4, 0 V are missing. – Acknowledgement (V26, X637/C2) → X632/A6, 24 V are missing. – Acknowledgement (V24B, X637/C23) → X632/A5, 0 V are missing.

F95 Bypass

System error

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● Optical detector test Test description: Attenuation of the optical detector. Check of the acknowledgement of the optical detector.

Illustration: LP 632

CPU 2

X632/C16

LDSA

X632/C15

ODSA

X632/A30

OD_OUT X633L/C7

32/B27

X632/B28

LP 633

LP 634

Input board

Output board

31/A20

OD_IN

X633L/C8

X631/A21

LP 631 LP 630

CPU 1

DATA BUS

Mother board

X351/5

LP 635

LP 649

(4008 E)

(4008 B)

X351/10

Display board LP 924

LP 922

(4008 H)

(4008 S)

Testgenerierung/Generation of Test

Rueckmeldung/Acknowledgement

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Fresenius Medical Care 4008

X351/7

Pven

5/03.09 (TM)

Error description:

Error message

Description

F01 opt. Detector

CPU1 interprets the optical detector in a different way than does CPU2. – Acknowledgement (OD_OUT, X633L/C7) → X632/A30 and the digital input of P.C.B. LP 633 measure different levels.

F02 opt. Detector

CPU2 fails to recognize blood in the system. – Acknowledgement (OD_OUT, X633L/C7) → X632/A30, 0 V are missing. – Detuning (ODSA, X632/C15) → X351/7 not 12V.

F03 opt. Detector

CPU1 fails to recognize blood in the system. – Acknowledgement (OD_OUT, X633L/C7) → digital input on P.C.B. LP 633. – Detuning (ODSA, X632/C15) → X351/7 not 12V.

F04 opt. Detector

CPU2 recognizes that the optical detector senses opaque fluid (required because of the test in the cleaning program). – Acknowledgement X632/A30 not 12V. – AD28 defective.

F96 opt. Detector

System error.

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● Blood system test Test description: Check of the following functions: – Blood alarm acknowledgement – Blood pump switch-off

Illustration:

LP 632

X632/C10

CLP_CTL

X632/C14

LDA2

X632/C21

BL_AL

X632/B11

BPSB_VEN

X632/A11

BPSB_ART

X632/A15

SN_ART

CPU 2

X632/B28

X632/B27

X634L/ C15

Input board

Output board

A13 X633L/

LP 647 (4008S/B) X634L/ B15

X634L/

B14

C14

X631/A21

LP 631

BPSST_A

DATA BUS

LP 635

LP 649

(4008 E)

(4008 B)

LP 922

(4008 H)

(4008 S) Testgenerierung/Generation of Test

Rückmeldung/Acknowledgement

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X351/6

X348/V3

X348/V6

X348a/1

X348a/3

Pven

Display board LP 924

X348a/6

X348a/2

BPSST_V

Mother board

X351/8

LP 630

CPU 1

X348/V1

X631/A20

(4008E/H)

A15

BPST_ART

X633L/ C13

LP 634

X634L/ A14

LP 633

Error description:

Error message

Description

F09 Bloodsystem

Acknowledgement that CPU2 recognizes that the arterial blood pump is inactive (BP not running). – Acknowledgement (BPSB_ART, X348a/6) → X632/A11, 12 V missing. – Control line (BPSST_ART, X634L/B14) → X348a/1, 12 V missing or (BPST_ART, X634L/A14) → X348a/3, 12 V are missing.

F10 Bloodsystem

Acknowledgement that CPU1 recognizes that the arterial blood pump is inactive (BP not running). – Acknowledgement (BPSB_ART, X348a/6) → X633L/A11, 12 V are missing. – Control line (BPSTT_ART, X634L/B14) → X348a/1, 12 V missing or (BPST_ART, X634L/A14) → X348a/3, 12 V missing. – Level is raised during the T1 test.

F11 Bloodsystem

The arterial blood pump cannot be stopped by CPU1. CPU2 recognizes that the arterial blood pump remains active. – Control line (BPSST_ART, X634L/B14) → X348a/1, 0 V missing, as well as (BPST_ART, X634L/A14) → X348a/3, 0 V missing. – Acknowledgement (BPSB_ART, X348a/6) → X632/A11, 0 V are missing. – The level is raised during the T1 test, or the up/down key on the air detector is blocked and the level is constantly raised.

F12 Bloodsystem

The arterial blood pump cannot be stopped by CPU1. CPU1 recognizes that the arterial blood pump remains active. – Control line (BPSST_A, X634L/B14) → X348a/1, 0 V missing, as well as (BPST_ART, X634L/A14) → X348a/3, 0 V missing. – Acknowledgement (BPSB_ART, X348a/6) → X633L/A11, 0 V are missing.

F13 Bloodsystem

Applicable for SW 4.91/2.91 and higher if SN, ONLINE-HDF or 4008 HDF pump is connected (= ADKS active) Acknowledgement that CPU2 detects that the pump is inactive (pump is not running). – Acknowledgement (BPSB_VEN, X348V/6) → X632/ B11, 12V missing – Control line (BPSST_VEN, X634L/B15) → X348V/1, 12V missing or (BPST_VEN, X634L/A15) → X348V/3, 12V missing – Transistor T9 on P.C.B. LP 754 defective – IC5 on P.C.B. LP 632 defective – In 4008 HDF an HDF treatment was performed, followed by a cleaning program with the substituate pump running, then the T1 test has been re-started. The substituate pump must be switched off because otherwise the test step will fail to be passed (problem was corrected with SW 3.20 in 4008 H/S systems: the substituate pump will be switched off automatically on starting a cleaning program).

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F14 Bloodsystem

Applicable for SW 4.91/2.91 and higher if SN, ONLINE-HDF or 4008 HDF pump is connected (= ADKS active) Acknowledgement that CPU1 detects that the pump is inactive (pump is not running). – Acknowledgement (BPSB_VEN,X348V/6) → X633L/A13, 12V missing – Control line (BPSST_VEN, X634L/B15) → X348V/1 not 12V or (BPST_VEN, X634L/A15) → X348V/3 not 12V – IC16 on P.C.B. LP 633 defective – P.C.B. LP 633 recognizes Single-Needle pump although it is not connected.

F15 Bloodsystem

Applicable for SW 4.91/2.91 and higher if SN, ONLINE-HDF or 4008 HDF pump is connected (= ADKS active) CPU1 fails to stop the corresponding blood pump. CPU2 detects that the pump remains active. – Control line (BPSST_VEN, X634L/B15) → X348V/1, 0V missing as well as (BPST_VEN, X634L/A15) → X348V/3 not 0V – Acknowledgement (BPSB_VEN, X348V/6) → X632/B11, 0V missing – Transistor T9 on P.C.B. LP 754 defective – IC5 on P.C.B. LP 632 defective – During the test the lines are inserted on the corresponding pump using the Start/Stop key. – P.C.B. LP 633 recognizes Single-Needle pump although it is not connected.

F16 Bloodsystem

Applicable for SW 4.91/2.91 and higher if SN, ONLINE-HDF or 4008 HDF pump is connected (= ADKS active) CPU1 fails to stop the corresponding blood pump. CPU1 detects that the pump remains active. – Control line (BPSST_VEN, X634L/B15) → X348V/1 not 0V as well as (BPST_VEN, X634L/A15) → X348V/3 not 0V – Acknowledgement (BPSB_VEN, X348V/6) → X633L/A13 not 0V – IC16 on P.C.B. LP 633 defective – P.C.B. LP 633 recognizes Single-Needle pump although it is not connected.

F17 Bloodsystem

Applicable for SW 4.91/2.91 and higher if SN, ONLINE-HDF or 4008 HDF pump is connected (= ADKS active) Although the recognition of the venous blood pump (ADKS) is not acknowledged, the 24-V supply voltage of the pump can be switched off. – Acknowledgement line (ADKS, X348V/7) → X633L/A10 not 12V – Acknowledgement (BPSB_VEN, X348V/6) → X633L/A13 not 12V – Acknowledgement (BPSB_VEN, X348V/6) → X632/B11 not 12V – Online-HDF has already been switched on during the T1 test. – IC16 on P.C.B. LP 633 defective.

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