Fresenius 4008 HDF User manual

4008 HDF

Technical Manual

Fresenius Medical Care

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:	Manufacturer:
Fresenius Medical Care	Fresenius Medical Care
Deutschland GmbH	Deutschland GmbH
Borkenberg 14	Plant Schweinfurt
D-61440 Oberursel/Ts., Germany	Hafenstraße 9
Tel.: [phone]	D-97424 Schweinfurt, Germany
Telex: 410805 fres d	Tel.: [phone]
Fax: [phone]	Fax: [phone]
Local Service:

Part No. 674 398 1

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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.

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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.
Component marking	For example:				24 means ground for 24 V voltage.
	Example:		75
in circuit diagrams

1R5

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 Ω	µ 1:	0.1 µ	F
	1R5:	1.5 Ω	1µ 5:	1.5 µ	F
	1K5:	1.5 kΩ	1000µ :	1000 µ F
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.

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

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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

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1.1Description

1.1.1Components

The components of the 4008 HDF option are permanently connected to the hemodialysis machine. The 4008 HDF option comprises the following components:

–Substituate lift

–Scales (weighing range < 20 kg) with data interface and taring facility

–Substituate pump with bidirectional data interface

–UF2 pump

1.1.2Description

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 or

–Line 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.

1.1.3Component 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 pump

–The 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.

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Fig.: Block diagram

Scales

Serial communication

W

CPU 1

Operating system

Safety system

Serial communication	CPU 2

Serial communication

UF2 pump

Substituate

TMP

pump

1-4 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

Fig.: Flow diagram

XHDF2–4

Scales

Substituate bag

Substituate sensor

X348v/4–5

andtaringline

X634L/

A–C23

X634L/

A–C24

X634R/

C11

serialinterface

serialinterface

LP634

Output

board

X634R/

A24

X633L/

C14

X633L/

C23

LP633

Input

board

interface

extender

X633R/

C28–30

pressuredialy.Acknowledgem.,

pumpUFControl,

pumpUF2Control,

UF2Acknowledgement,pump

UFAcknowledgement,pump

pumpUF2Control,

pumpUFControl,

dialysateAcknowledgement,pressure

763LP

SSE

Serial

X633L/

B6

serial LP631

interface

X632/

A29

X632/

C27

Balancingchamber

CPU1

LP632

CPU2

X632/

B24

X632/

C7

X632/

A7

Substituate pump	Venousbubblecatcher	Airdetector	Venousline clamp	Patient	Arterial bloodpump
			Dialyzer

V24

V26

V24b

Dialysate

pressure

transducer

V126

Flow pump

UF pump

UF2 pump

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Fig.: Flow diagram

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Legend
2	Temperature sensor	77	Heat exchanger
3	Temperature sensor	78	Relief valve
5	Float switch	84	Disinfection valve
6	Level sensor	85	Disinfectant conncector
7	Conductivity measuring cell	86	Recirculation valve
8	Blood leak detector	87	Discharge valve
9	Pressure transducer	88	Multifunction block
10	Reed contact for concentrate	88a	Degassing chamber
12	Reed contact for bicarbonate	88b	Secondary air separator
20	UF2 pump	88c	Primary air separator
21	Flow pump	89	Degassing orifice
22	UF pump	90a	Rinse chamber concentrate
23	Concentrate pump	90b	Rinse chamber bicarbonate
24	Dialyzer valve 1	91	Rinse valve
24b	Dialyzer valve 2	92	Vent valve
25	Bicarbonate pump	94	Concentrate suction tube
26	Bypass valve	95	Bicarbonate suction tube
29	Degassing pump	97	Ventilation pump
30	Drain valve	99	Rinse valve
31	Balancing chamber valve 1	100	Rinse valve
32	Balancing chamber valve 2	102	Concentrate valve in central delivery system
33	Balancing chamber valve 3	104	Bicarbonate valve in central delivery system
34	Balancing chamber valve 4	109	Temperature sensor
35	Balancing chamber valve 5	111	Hydrophobic filter
36	Balancing chamber valve 6	112	Vent valve
37	Balancing chamber valve 7	114	Dialysate filter
38	Balancing chamber valve 8	115	Disinfection valve sensor
41	Water inlet valve	116	Sampleing valve
43	Fill valve	117	Check valve (concentrate)
54	Heater rod	118	Check valve (bicarbonate)
61	Pressure reducing valve	119	Filter (concentrate)
63	Filter/water inlet	120	Filter (bicarbonate)
65	Loading pressure valve	121	Concentrate connector in central delivery system
66	Heater block	122	Bicarbonate connector in central delivery system
66a	Water inflow chamber	123	Pressure switch for V 102
66b	Heater rod chamber	124	Pressure switch for V 104
66c	Float chamber	125	Adapter plate
68	Balancing chamber	126	4008 HDF vent valve
71	Filter/concentrate	148	Filter/rinse valve
72	Filter/bicarbonate	149	Filter/rinse valve
73	Filter/external dialysate	150	Filter
74	Filter/UF	151	Orifice
75	External flow indicator	152	4008 HDF hydrophobic filter
76	Filter/fill valve

Hydraulic measurement points

AReduced water inlet pressure

BBalancing chamber loading pressure

CFlow pump pressure

DDegassing pump pressure

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1.2Description 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:

1.2.1Test 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:

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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 safeguard-
	ed 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.

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1.3Error messages during treatment and the HDF test

Message on the	Cause	Possible error elimination
display
F321 HDF-failure	The UF pump or UF2 pump	Check level sensor (6) (de-
	test will not be started as long	fect).
	as the level sensor (6) detects
	air. The level sensor (6) will
	detect air one minute after the
	4008 HDF test has been se-
	lected
F322 HDF-failure	The UF pump or UF2 pump	Check V126 (does not open,
	has carried out more than 50	venous bubble catcher col-
	strokes and still no air has	lapses), check V43 (whether
	been detected.	leaking or open).
		Check UF pump or UF2 pump,
		respectively (mech. defect).
F323 HDF-failure	The substituate pump runs at a	Check substituate tubing
	rate of 10 ml/min. to raise the	(clamped off, not connected to
	fluid level by a defined amount	the venous bubble catcher).
	in the secondary air separator
	(the fluid will just be detected).
	Air will still be detected after 2
	minutes.
F324 HDF-failure	Since fluid has been recog-	Check substituate tubing
	nized in the secondary air sep-	(clamped off).
	arator 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 dif-
	ference in weight established
	after one minute.
F325 HDF-failure	If the expected change in	Check bag (fluctuations in air
	weight (i.e. a jump in	draft)
	grammes) is higher or lower	Check scales (for drifting).
	than –1 g, the respective UF
	pump test will be repeated.
	The UF pump test was repeat-
	ed more than 5 times.

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Message on the	Cause	Possible error elimination
display
F326 UF-failure	The fluid level in the second-	Check substituate hose
	ary air separator is raised	(clamped off, not connected
	again by the substituate pump	with the venous bubble
	after 100 strokes of the UF	catcher).
	pump or UF2 pump, respec-
	tively, 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 (de-
	pending on the delivery rate of
	the substituate pump).
UF1 volume-Error	One UF pump did not pass the	Check UF pump or UF2 pump,
or	test. The filling volume for the	respectively (not calibrated,
UF2 volume-Error	secondary air separator is not	mechanical defect).
	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.
F327 UF-failure	Interval between two strokes	Check CPU 1 (defect).
	of the UF pump less than
	220 ms.
F328 UF-failure	Pulse time of a stroke of UF	Check LP 634 (regulating
	pump less than 180 ml.	monoflop defect).
F329 UF-failure	Pulse time of a stroke of UF	Check LP 634 (regulating
	pump more than 500 ms.	monoflop defect).
F330 UF-failure	Starting time for the UF pump	Check LP 634 (regulating end
	more than 10 seconds.	stage defect).
F331 UF-failure	Difference between desired or	Check CPU 1 / CPU 2
	actual delivery rate of the UF	(communication problems).
	pump greater than + 10%.
F332 UF-failure	UF pump stops longer than the	Check LP 634 (regulating end
	maximum period time.	stage defect).
		Check UF pump
		(interruption, control).
		Check CPU 1 / CPU 2
		(communication problems)
F333 UF-failure	Despite switched off ultrafiltra-	Check CPU 1 / CPU 2
	tion the change in delivery rate	(communication problems)
	of the UF pump is greater than
	10 ml.
F334 UF-failure	Interval between two strokes	Check CPU 1 (defect).
	of the UF2 pump less than
	220ms.

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Message on the		Cause	Possible error elimination
display
F335	UF-failure	Pulse time of a stroke of the	Check LP 634 (regulating
		UF2 pump less than 180 ms.	monoflop defect).
F336	UF-failure	Pulse time of a stroke of the	Check LP 634 (regulating
		UF2 pump more than 500 ms.	monoflop defect).
F337	UF-failure	Reaction time of the UF2	Check LP 634 (regulating end
		pump more than 10 seconds.	stage defect).
F338	UF-failure	Difference in desired or actual	Check CPU 1 / CPU 2
		delivery rate of UF2 pump	(communication problems).
		greater than ± 10 %.
F339	UF-failure	UF2 pump stops longer than	Check LP 634 (regulating end
		the maximum period time.	stage defect).
			Check UF pump (interruption,
			control).
			Check CPU 1 / CPU 2
			(communication problems).
F340	UF-failure	Despite switched off 4008HDF	Check CPU 1 / CPU 2
		change in delivery rate of the	(communication problems).
		UF2 pump greater than 10 ml.
F341	UF-failure	Failure of UF pump.	Check UF pump
			(spring, screen)
F342	UF-failure	Failure of UF2 pump.	Check UF2 pump
			(spring, screen)
F343	UF-failure	Volume difference between UF	Check UF pump and UF2
		pump and UF2 pump.	pump (delivery volume)
F344	HDF-failure	Balance failure recognized by	Check monitor / scales
		CPU2 greater than ± 500 ml.	(communication problems).
F345	HDF-failure	Bolus exceeded by more than	Check monitor / scales
		+ 20 ml, detected by CPU2.	(communication problems).
F346	HDF-failure	CPU2 failed to perform the cy-	Check V24B and V43 feed-
		clic UF pump test within 5 min-	back lines.
		utes.	Check sense of rotation of as-
			piration pump.
			Check hydraulics unit for
			leaks.
F348	HDF-failure	Weight change on the scales	Check scales
		during the weighing test great-	Check substituate bag
		er than 2g.
F349	HDF-failure	The delivery rate correction	Check substituate bag
		factor could still not be deter-	(weight fluctuations)
		mined after 20 minutes treat-	Check HDF control system
		ment time.	(greater fluctuations)

1-12 Fresenius Medical Care 4008 HDF 3/11.97 (TM)

1.4Error 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

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2 Technical 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.

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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.	Description	Desired value/function	OK
		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 Ω
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 .............................
....................................................................	.........................................................................

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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

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3.0General 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

Fresenius Medical Care

Fresenius Medical Care 4008

								Best.	Auswahl
I/O		Arterieller		Venöser
Luftdetektor						TMP	Ultrafiltration		Leitfähigkeit			Fluß
		Druck		Druck
							UF Menge	ml				ml/min
Spülen								Reset				900
										mS/cm		700
	kPa	mmHg	kPa	mmHg	kPa	mmHg				(25° C)		500
Heiß reinigen		280		500		500				15.5		300
Blutleck	30	200	60		60		UF Rate	ml/h
				400		400				15
Desinfektion	20	100	50		50
	10		40	300	40	300				14.5	I/O	Set
	0	0
Single			30	200	30	200				14
	–10	–100
Needle			20	100	20	100	UF Ziel	ml		13.5
Ü berbrücken	–20	–200	10		10
Test	–30		0	0	0	0				13	Temperatur
	–40	–300										° C
Vorbereiten							UF Restzeit h:min		Konz.	Bic.		39
												37
Dialyse Start												35
							UF		Variation
Alarm							I/O	Prog.	I/O	Prog.		Set
Ton Aus
									Pven.
			Bolus
Start			Rate
Stop

Start

Stop

LP 625

Start

Stop

LP 760

LP 754

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Fig.: DIP switch 4008 HDF

SW1

ON

1 2 3 4 5 6 7 8

OFF

LP 632 CPU 2

SW 1, DIP switch 8:

ON: 4008 HDF test selectable (required/not required) OFF: 4008 HDF test carried out automatically

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