Fresenius 4008 HDF User manual

4008 HDF
Technical Manual
CareFresenius Medical
4008 HDF
Technical Manual

4008 HDF Technical Manual

The Technical Manual contains all information necessary for performing maintenance and repair work. The 4008 HDF option reflects the latest state of technology and complies with the requirements of
EN 60601-1 Assembly, extension, adjustment, modification or repair may only be carried out by the manufacturer or
persons authorized by him. Any inquiries should be addressed to:
Head office:
Fresenius Medical Care Deutschland GmbH Borkenberg 14 D-61440 Oberursel/Ts., Germany Tel.: 06171-60-0 Telex: 410805 fres d Fax: 06171-251-58
Local Service:
Manufacturer:
Fresenius Medical Care Deutschland GmbH Plant Schweinfurt Hafenstraße 9 D-97424 Schweinfurt, Germany Tel.: 09721-678-0 Fax: 09721-678-200
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 0-1Part No. 674 398 1
0-2 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

How to use the Technical Manual

Search and find What? Where?
Tables Contents Pages 0-5 and at the beginning of each chapter
Purpose This manual is intended for:
– first studies (to acquire basic knowledge) – reference purposes (for start-up, maintenance and repair)
Organization The manual is divided into 6 chapters:
0 General Notes 1 Description of machine functions 2 Technical safety checks 3 Calibration instructions 4 Circuit descriptions and circuit diagrams 5 Spare parts
Numbering system Page number 1-3 is to be interpreted as: Chapter 1, Page 3 Qualification This manual is intended for service technicians
– who are familiar with the current Operating Instructions (Operating Instruc-
tionseratining to this Technical Manual are available under part no. 674 406 1)
– who have the necessary background experience in mechanics, electrical and
medical engineering
– who have been authorized by the manufacturer to perform maintenance and
repair work
– who have access to the necessary auxiliary and measuring equipment
Restrictions The study of this manual does not represent an alternative to the training courses
offered by the manufacturer.
Manual changes Manual changes will be released as new editions, supplement sheets or product
information. Note:
Modifications relating to circuit diagrams and component layouts (SP/BP) do not necessarily involve a change of the footer (edition). Refer to the index field of the respective circuit diagram or component layout for the respective state of these diagrams. The identification on the P.C.B. permits the user/technician to verify if the circuit diagram / component layout matches the P.C.B. actually installed.
In general, this manual is subject to modification.
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 0-3
Representation New circuit symbols are used in the circuit diagrams. Potential data given in the
circuit diagrams and setting instructions refer to the respective earth. For example: 24 means ground for 24 V voltage.
Component marking Example: in circuit diagrams
This refers to a resistor with a position number 75 with a resistance of 1.5 Ohm. The decimal point is replaced by a unit symbol (to reduce the possibility of errors). Resistors: Capacitors:
R1: 0.1 Ωµ 1: 0.1 µF 1R5: 1.5 5: 1.5 µF 1K5: 1.5 k 1000µ: 1000 µF
Note: When repairing or exchanging replacement parts make sure to take the applica-
ble ESD precautions (e.g. EN 100 015-1). During repair/troubleshooting in the hydraulic unit, protect the components from dialysate.
Technical data: The technical data for the 4008 HDF option is to be found in Chapter 1 of the
Operating Instructions.
75
1R5
0-4 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

Table of contents

Section Page
1 Description of machine functions............................................................................... 1-
1.1 Description ...................................................................................................................... 1-3
1.2 Description of extended T1 test ...................................................................................... 1-8
1.3 Error messages............................................................................................................... 1-10
2 Technical safety checks............................................................................................... 2-
3 Calibration instructions ............................................................................................... 3-
3.0 General information on the calibration instructions ....................................................... 3-3
3.1 Calibrating the UF2 pump ............................................................................................... 3-5
3.2 VDE inspections.............................................................................................................. 3-7
3.3 Calibrating the 4008 HDF scale ...................................................................................... 3-8
3.4 Calibrating the substituate sensor .................................................................................. 3-13
3.5 Calibrating the HDF blood pump .................................................................................... 3-15
3.6 Repair instructions .......................................................................................................... 3-17
4 Circuit descriptions and circuit diagrams.................................................................. 4-
4.1 LP 625 display board ...................................................................................................... 4-3
4.2 LP 754 control board HDF .............................................................................................. 4-9
4.3 LP 760 HDF motor control .............................................................................................. 4-19
4.4 LP 761 HDF drive keyboard ........................................................................................... 4-27
4.5 LP 762 scale comm ........................................................................................................ 4-33
4.6 LP 763 SSE serial interface extender............................................................................. 4-39
5 Spare parts .................................................................................................................... 5-
5.0 How to use the spare parts catalog ................................................................................ 5-3
5.1 P.C.B.s............................................................................................................................ 5-4
5.2 Scales ............................................................................................................................. 5-6
5.3 Substituate lift ................................................................................................................. 5-8
5.4 UF2 pump / blood pump (HDF) / valve V 126................................................................. 5-10
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 0-5
0-6 Fresenius Medical Care 4008 HDF 3/11.97 (TM)
Table of contents 1 Description of machine functions
Section Page
1.1 Description .................................................................................................................... 1-3
1.1.1 Components.................................................................................................................... 1-3
1.1.2 Description ...................................................................................................................... 1-3
1.1.3 Component tests............................................................................................................. 1-3
Fig.: Block diagram ......................................................................................................... 1-4
Fig.: Flow diagram .......................................................................................................... 1-5
Fig.: Flow diagram .......................................................................................................... 1-6
1.2 Description of extended T1 test / error messages in T1 test................................... 1-8
1.2.1 Test UF-Function ............................................................................................................ 1-8
1.3 Error messages during treatment and the HDF test ................................................ 1-10
1.4 Error messages, substituate pump............................................................................. 1-13
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 1-1
1-2 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

1.1 Description

1.1.1 Components
The components of the 4008 HDF option are permanently connected to the hemodialysis machine. The 4008 HDF option comprises the following components:
Substituate liftScales (weighing range < 20 kg) with data interface and taring facilitySubstituate pump with bidirectional data interfaceUF2 pump
1.1.2 Description
The scales determine the actual weight of the substituate reserve and signals this to the hemodialysis machine. This calculates the substituate rate depending on the set treatment time.
A substituate sensor mounted on the substituate lift recognises whether:
Line set is fitted without substituate orLine set is fitted with substituate.
The substituate pump delivers the substituate solution to the venous bubble catcher. The filtrate from the dialysis fluid circuit is removed by the UF2 pump.
1.1.3 Component tests
The scales are checked by the operator by means of a plausibility test before treatment. The substituate sensor is tested while the 4008 HDF is filling. The 4008 HDF test tests:
The substituate pumpThe UF2 pump (electrically and hydraulically)
(If the 4008 HDF test is not carried out then the connections are to be tested but once). The UF2 pump is tested cyclically during treatment. The electric control system of the UF2 pump is checked continuously.
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 1-3
Fig.: Block diagram
Scales
Serial communication
Operating system Safety system
CPU 1
UF2 pump
W
Serial communication
Serial communication
Substituate
pump
CPU 2
TMP
1-4 Fresenius Medical Care 4008 HDF 3/11.97 (TM)
UF2
pump
UF
pump
Flow
pump
Dialysate
pressure
transducer
V126
V26
V24
V24b
Dialyzer
Air detector
Venous bubble catcher
Arterial
blood pump
Venous line
clamp
Substituate
pump
Substituate
sensor
Scales
Substituate
bag
Patient
Balancing chamber
LP 632
CPU 2
LP 631
CPU 1
LP 763
SSE
Serial
interface
extender
LP 633
Input
board
LP 634
Output
board
serial
interface
X632/
B24
X632/
C27
X634 R/
C11
X634 R/
A24
serial interface
serial interface and taring line
X632/
A7
X632/
C7
X632/
A29
X634 L/
A–C24
X634 L/
A–C23
X633 L/
C14
X633 L/
C23
X633 L/
B6
Control, UF2 pump
Control, UF pump
Acknowledgement, dialysate pressure
Control, UF pump
Control, UF2 pump
Acknowledgement, UF pump
Acknowledgement, UF2 pump
Acknowledgem., dialy. pressure
XHDF 2–4
X348v/4–5
X633 R/
C28–30
Fig.: Flow diagram
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 1-5
Fig.: Flow diagram
1-6 Fresenius Medical Care 4008 HDF 3/11.97 (TM)
Legend
2 Temperature sensor 3 Temperature sensor 5 Float switch 6 Level sensor 7 Conductivity measuring cell 8 Blood leak detector 9 Pressure transducer 10 Reed contact for concentrate 12 Reed contact for bicarbonate 20 UF2 pump 21 Flow pump 22 UF pump 23 Concentrate pump 24 Dialyzer valve 1 24b Dialyzer valve 2 25 Bicarbonate pump 26 Bypass valve 29 Degassing pump 30 Drain valve 31 Balancing chamber valve 1 32 Balancing chamber valve 2 33 Balancing chamber valve 3 34 Balancing chamber valve 4 35 Balancing chamber valve 5 36 Balancing chamber valve 6 37 Balancing chamber valve 7 38 Balancing chamber valve 8 41 Water inlet valve 43 Fill valve 54 Heater rod 61 Pressure reducing valve 63 Filter/water inlet 65 Loading pressure valve 66 Heater block 66a Water inflow chamber 66b Heater rod chamber 66c Float chamber 68 Balancing chamber 71 Filter/concentrate 72 Filter/bicarbonate 73 Filter/external dialysate 74 Filter/UF 75 External flow indicator 76 Filter/fill valve
77 Heat exchanger 78 Relief valve 84 Disinfection valve 85 Disinfectant conncector 86 Recirculation valve 87 Discharge valve 88 Multifunction block 88a Degassing chamber 88b Secondary air separator 88c Primary air separator 89 Degassing orifice 90a Rinse chamber concentrate 90b Rinse chamber bicarbonate 91 Rinse valve 92 Vent valve 94 Concentrate suction tube 95 Bicarbonate suction tube 97 Ventilation pump 99 Rinse valve 100 Rinse valve 102 Concentrate valve in central delivery system 104 Bicarbonate valve in central delivery system 109 Temperature sensor 111 Hydrophobic filter 112 Vent valve 114 Dialysate filter 115 Disinfection valve sensor 116 Sampleing valve 117 Check valve (concentrate) 118 Check valve (bicarbonate) 119 Filter (concentrate) 120 Filter (bicarbonate) 121 Concentrate connector in central delivery system 122 Bicarbonate connector in central delivery system 123 Pressure switch for V 102 124 Pressure switch for V 104 125 Adapter plate 126 4008 HDF vent valve 148 Filter/rinse valve 149 Filter/rinse valve 150 Filter 151 Orifice 152 4008 HDF hydrophobic filter
Hydraulic measurement points
A Reduced water inlet pressure B Balancing chamber loading pressure C Flow pump pressure D Degassing pump pressure
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 1-7

1.2 Description of extended T1 test / error messages in the T1 test

Possible error messages displayed in the T1 test are listed in the Technical Manual for the hemodialysis machine. If the HDF option is installed and activated the following error codes can also appear:
1.2.1 Test UF-Function
Test description:
CPU 1 starts up the UF2 pump at a defined rate. CPU 2 controls the hydraulic and electrical function of the UF2 pump. CPU 2 blocks the control line of the UF2 pump and checks for standstill. UF2 counter check.
Figure:
1-8 Fresenius Medical Care 4008 HDF 3/11.97 (TM)
Error description:
Error message Description
F11 UF-Function The interval between the strokes of the UF2 pump was less than
220 ms. Correct delivery of the required volume is not safeguard­ed because the stroke return travel is too short. – A pump rate which was too high was signalled by the CPU 1.
F12 UF-Function The pulse time for the UF2 pump is less than 180 ms. Correct
delivery of the required volume is not safeguarded because the discharge time is too short. – Monoflop on LP 634 defect (IC 42/R65/C45).
F 13 UF-Function The pulse for the UF2 pump is longer than 500 ms. A maximum
rate of 5000 ml/h is not possible. – Monoflop on LP 634 defect (IC 42/R65/C45).
F14 UF-Function UF2 pump not active during the test (4 s).
– Acknowledgement (UF_P2, X637/B26) → X632/C7 no LOW
pulse
– Control line (UF_P2, X634L/A–C24) → X637/B26 no LOW
pulse
F15 UF-Function The UF2 pump cannot be stopped by the CPU2.
Control line (UF_P_EN, X632/C28) X634R/A22 no 5 V.Reset input to IC 42/pin 13 on LP 634 defect.
F16 UF-Function The UF pump acknowledgement from CPU1 is faulty.
– Acknowledgement (UF_P2, X637/B26) → X633/C23 no LOW
pulse
F17 UF-Function The change in pressure after a UF2 pump stroke less than
20 mmHg.
UF2 pump mechanically defect.Control line (UF_P2_CRTL, X632/B24) X634R/C11 no
HIGH pulse.
F20 UF-Function Difference in pressure between UF pump stroke and UF2 pump
stroke more than 20 %. – Stroke rate for UF pump or UF2 pump not set correctly.
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 1-9

1.3 Error messages during treatment and the HDF test

Message on the display
F321 HDF-failure
F322 HDF-failure
F323 HDF-failure
Cause
The UF pump or UF2 pump test will not be started as long as the level sensor (6) detects air. The level sensor (6) will detect air one minute after the 4008 HDF test has been se­lected
The UF pump or UF2 pump has carried out more than 50 strokes and still no air has been detected.
The substituate pump runs at a rate of 10 ml/min. to raise the fluid level by a defined amount in the secondary air separator (the fluid will just be detected). Air will still be detected after 2 minutes.
Possible error elimination
Check level sensor (6) (de­fect).
Check V126 (does not open, venous bubble catcher col­lapses), check V43 (whether leaking or open). Check UF pump or UF2 pump, respectively (mech. defect).
Check substituate tubing (clamped off, not connected to the venous bubble catcher).
F324 HDF-failure
F325 HDF-failure
Since fluid has been recog­nized in the secondary air sep­arator the substituate pump starts at a rate of 10 ml/min. until a change in weight follows on the scales (i.e. a jump in grammes). There was no dif­ference in weight established after one minute.
If the expected change in weight (i.e. a jump in grammes) is higher or lower than –1 g, the respective UF pump test will be repeated. The UF pump test was repeat­ed more than 5 times.
Check substituate tubing (clamped off).
Check bag (fluctuations in air draft) Check scales (for drifting).
1-10 Fresenius Medical Care 4008 HDF 3/11.97 (TM)
Message on the display
Cause
Possible error elimination
F326 UF-failure
UF1 volume-Error
or
UF2 volume-Error
F327 UF-failure
The fluid level in the second­ary air separator is raised again by the substituate pump after 100 strokes of the UF pump or UF2 pump, respec­tively, until fluid is detected. Plus run-on time at a rate of 10 ml/min. for the gramme jump. Air will still be detected after a specific period of time (de­pending on the delivery rate of the substituate pump).
One UF pump did not pass the test. The filling volume for the secondary air separator is not within the given tolerance of 100 ml; ± 5 ml. Should the test give a reading of over 105 ml the cause could also be air taken in the flow from a badly vented dialysator.
Interval between two strokes of the UF pump less than 220 ms.
Check substituate hose (clamped off, not connected with the venous bubble catcher).
Check UF pump or UF2 pump, respectively (not calibrated, mechanical defect).
Check CPU 1 (defect).
F328 UF-failure
F329 UF-failure
F330 UF-failure
F331 UF-failure
F332 UF-failure
F333 UF-failure
Pulse time of a stroke of UF pump less than 180 ml.
Pulse time of a stroke of UF pump more than 500 ms.
Starting time for the UF pump more than 10 seconds.
Difference between desired or actual delivery rate of the UF pump greater than + 10%.
UF pump stops longer than the maximum period time.
Despite switched off ultrafiltra­tion the change in delivery rate of the UF pump is greater than 10 ml.
Check LP 634 (regulating monoflop defect).
Check LP 634 (regulating monoflop defect).
Check LP 634 (regulating end stage defect).
Check CPU 1 / CPU 2 (communication problems).
Check LP 634 (regulating end stage defect). Check UF pump (interruption, control). Check CPU 1 / CPU 2 (communication problems)
Check CPU 1 / CPU 2 (communication problems)
F334 UF-failure
Interval between two strokes of the UF2 pump less than 220ms.
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 1-11
Check CPU 1 (defect).
display
Cause
Possible error eliminationMessage on the
F335 UF-failure
F336 UF-failure
F337 UF-failure
F338 UF-failure
F339 UF-failure
F340 UF-failure
F341 UF-failure
Pulse time of a stroke of the UF2 pump less than 180 ms.
Pulse time of a stroke of the UF2 pump more than 500 ms.
Reaction time of the UF2 pump more than 10 seconds.
Difference in desired or actual delivery rate of UF2 pump greater than ± 10 %.
UF2 pump stops longer than the maximum period time.
Despite switched off 4008HDF change in delivery rate of the UF2 pump greater than 10 ml.
Failure of UF pump.
Check LP 634 (regulating monoflop defect).
Check LP 634 (regulating monoflop defect).
Check LP 634 (regulating end stage defect).
Check CPU 1 / CPU 2 (communication problems).
Check LP 634 (regulating end stage defect). Check UF pump (interruption, control). Check CPU 1 / CPU 2 (communication problems).
Check CPU 1 / CPU 2 (communication problems).
Check UF pump (spring, screen)
F342 UF-failure
F343 UF-failure
F344 HDF-failure
F345 HDF-failure
F346 HDF-failure
F348 HDF-failure
F349 HDF-failure
Failure of UF2 pump.
Volume difference between UF pump and UF2 pump.
Balance failure recognized by CPU2 greater than ± 500 ml.
Bolus exceeded by more than + 20 ml, detected by CPU2.
CPU2 failed to perform the cy­clic UF pump test within 5 min­utes.
Weight change on the scales during the weighing test great­er than 2g.
The delivery rate correction factor could still not be deter­mined after 20 minutes treat­ment time.
Check UF2 pump (spring, screen)
Check UF pump and UF2 pump (delivery volume)
Check monitor / scales (communication problems).
Check monitor / scales (communication problems).
Check V24B and V43 feed­back lines. Check sense of rotation of as­piration pump. Check hydraulics unit for leaks.
Check scales Check substituate bag
Check substituate bag (weight fluctuations) Check HDF control system (greater fluctuations)
1-12 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

1.4 Error messages, substituate pump

Code Description of failure
E.01 Line diameter outside the permitted range E.02 Non-defined hexaswitch position E.03 Venous pressure transducer not balanced E.04 Failure, running time monitoring system, SN operation E.05 SN stroke volume outside the permitted range E.06 The SN pressure thresholds outside the value range of the AD converter E.07 Not defined E.08 Failure in the AD conversion E.09 Not defined E.10 Not defined E.11 Not defined E.12 Failure, speed monitoring (hall sensor) E.13 Failure, monitoring system, current sensing resistors E.14 Failure, monitoring system, current sensing resistors E.15 Failure, speed monitoring system
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 1-13
1-14 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

2 T echnical safety checks

General Notes

This chapter includes all necessary technical safety checks (TSC). These inspections must be carried out every 12 months. The technical safety inspections stipulated for the hemodialysis machine must be carried out in addition to
these technical saftey checks. The technical safety checks are to be recorded in the equipment log. A technical safety checks report is to be found at the page 2-3.
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 2-1
2-2 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

Technical safety checks report Seite 1/1

Manufacturer: ............................. Date: .............................
Machine: ............................. Technician: .............................
Operating hours: .............................
Extent of checks and time limits for technical safety checks.
TIME LIMIT: every 12 months
The following checks and inspections have to be carried out on the machine at least every 12 months by persons who are capable of carrying out such technical safety checks efficiently as a result of their training, knowledge and experience gained in practice and are not subject to instructions as to their checking activity. (See also BMA Bulletin dated 02.04.1987)
TSC WA No. OKDescription Desired value/function
1 UF2 pump
TSC 1.1 Delivery volume (1 ml/stroke) 60 strokes = 60 ml ± 1%
2 VDE inspections (values according to EN 60601-1) TSC 2.1 Protective ground resistance max. 0.3 TSC 2.2 Summarized leakage current Must fulfill both conditions:
1. No more than 1.5 times the “summari- zed value first measured (Summarized value first measured: Refer to the machine card enclosed with the machine.)
2. No more than 1 mA
The technical safety checks are to be recorded in the equipment log and the results of the checks documented.
If the machines are not safe in function and/or operation they are to be repaired or the operator is to be informed as to the dangers involved when using the machine in its given state.
The correct completion of the listed work and the correctness of statements made are hereby certified.
Signature, technician: Signature, customer:
..........................., date ............................. ................................ , date .............................
.................................................................... .........................................................................
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 2-3
2-4 Fresenius Medical Care 4008 HDF 3/11.97 (TM)
Table of contents 3 Calibration instructions
Section Page
3.0 General information on the calibration instructions ................................................ 3-3
3.1 Calibrating the UF2 pump ............................................................................................ 3-5
3.2 VDE inspections............................................................................................................ 3-7
3.3 Calibrating the 4008 HDF scales ................................................................................. 3-8
3.4 Calibrating the substituate sensor.............................................................................. 3-13
3.5 Calibrating the HDF blood pump................................................................................. 3-15
3.5.1 Pressure transducer ....................................................................................................... 3-15
3.5.2 Checking SN switchover points ...................................................................................... 3-16
3.6 Repair instructions ....................................................................................................... 3-17
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 3-1
3-2 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

3.0 General information on the calibration instructions

Measuring instruments: The same measuring instruments as used for the hemodialysis machines are to be employed. Required in addition is a calibration weight PT6 – 5000 g.
Fig.: P.C.B. overview 4008 HDF
LP 762
LP 763 LP 761
LP 625
LP 760
Fresenius Medical Care
Fresenius Medical Care
I/O
Spülen
Heißreinigen
Desinfektion
Single Needle
Test
Vorbereiten
Dialyse Start
Alarm Ton Aus
Rate: ml/min
(Ø: mm)
Rate: ml/min
(Ø: mm)
HDFReset
Vol : l
4008
Arterieller
Venöser
Druck
mmHgkPa mmHgkPa mmHgkPa
280 200 100
0
100200300
Bolus
Rate
Druck
500
60
60
400
50
50
40
40
300
30
30
200
20
20
100
10
10
0
0
0
Rate: ml/h (Bolus: ml)
( :h.min)
Start Stop
TMP Leitfähigkeit
Luftdetektor
30
Blutleck
20
10
0
10
20
Überbrücken
30
40
Start Stop
Start Stop
500 400 300 200 100
0
Ultrafiltration
UF Menge
ml
Reset
UF Rate ml/h
UF Ziel ml
UF Restzeith:min
UF Variation
Prog.I/O Prog.I/O
Auswahl
Best.
Fluß
ml/min
900 700
mS/cm (25°C)
500 300
15.5 15
14.5
SetI/O
14
13.5
Temperatur
13
°C
39
Bic.Konz.
37 35
Set
P
ven.
LP 754
Fresenius Medical Care 4008 HDF 3/11.97 (TM) 3-3
Fig.: DIP switch 4008 HDF
ON
1 2 3 4 5 6 7 8
OFF
LP 632 CPU 2
SW1
SW 1, DIP switch 8: ON: 4008 HDF test selectable (required/not required) OFF: 4008 HDF test carried out automatically
3-4 Fresenius Medical Care 4008 HDF 3/11.97 (TM)
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