Fresenius Medical Care 5008 User manual

Edition: 1/08.04
Part number: M35 179 1
Service Manual
Hemodialysis System
5008
Fresenius Medical Care
0123

Page
Fresenius Medical Care 5008 SM 1/08.04 i
Table of Contents
1Index
2 Important Information
2.1 Organization of the Technical Document................................................................................ 2-1
2.2 How to Use the Technical Document ...................................................................................... 2-1
2.3 Precautions for Working on the System ................................................................................. 2-2
2.4 Addresses .................................................................................................................................. 2-2
3 Specifications
4 Installation
4.1 Preface........................................................................................................................................ 4-1
4.2 Important Information on Initial Start-Up ................................................................................ 4-1
4.3 Initial Start-Up Report ............................................................................................................... 4-2
4.4 Explanations on the Initial Start-Up Report ............................................................................ 4-9
5Setup
5.1 Operator Setup .......................................................................................................................... 5-1
5.2 Technician's SETUP ................................................................................................................ 5-13
5.3 Information Regarding the Setting of Concentrates in the Technician’s Setup................ 5-21
6 TSC / TMC / Maintenance
6.1 Important Information ............................................................................................................... 6-1
6.2 Test Report – Technical Safety Checks, Technical Measurements Checks and Maintenance
Procedures6-3
6.3 Explanations on Technical Safety Checks, Technical Measurement Checks and
Maintenance Procedures6-11
6.4 TSC / TMC Report .................................................................................................................... 6-27

Kapitel :
ii Fresenius Medical Care 5008 SM 1/08.04
7 Error Messages
8 Tools (Service Equipment)
9 Calibration / Adjustment
10 Repair
11 Functional Description
11.1 Overall System......................................................................................................................... 11-1
11.2 Overview of P.C.B.s................................................................................................................. 11-3
11.3 Monitor...................................................................................................................................... 11-4
11.4 EBM (Extracorporeal Blood Module) ..................................................................................... 11-6
11.5 Hydraulics Unit ........................................................................................................................ 11-8
11.6 Power Supply Unit................................................................................................................. 11-10
11.7 Pneumatic Unit....................................................................................................................... 11-12
11.8 Hydraulics Unit ...................................................................................................................... 11-14
12 Service Program (Option)

Chapter 1: Index
Fresenius Medical Care 5008 SM 1/08.04 1-1
1 Index
How to use the index: E.g., index entry 1-3 is to be interpreted as: Chapter 1, page 3
A
Addresses 2-2
Alarm processing 5-4
AutoFlow 3-6
B
Blood pump 5-1
BPM 5-10
BTM 5-11
C
Concentrates 3-6
D
DIASAFE®plus 3-8
E
EcoFlow 3-6
Emergency 5-8
External connections 3-3
F
Flow diagram 11-14
H
Heparin pump 3-8
O
OCM 3-9, 5-9
ONLINEplus™ 5-9
Operating programs 3-4
Operator Setup 5-1
Optical detector 3-7
Override conditions 3-4
P
Patient card 5-8
R
Reinfusion 5-2
T
Temperature 3-6
U
Ultrafiltration 5-3
User interface 5-5

Kapitel 1: Index
1-2 Fresenius Medical Care 5008 SM 1/08.04

Chapter 2: Important Information
Fresenius Medical Care 5008 SM 1/08.04 2-1
2 Important Information
2.1 Organization of the Technical Document
Page identification Page number 1-3 is to be interpreted as: Chapter 1, page 3.
Document changes Document changes will be released as new editions or supplements. In
general: this manual is subject to change without notice.
Editorial information The current edition of this technical document is:
1/08.04 = 1st edition, August 2004
2.2 How to Use the Technical Document
Intended use This technical document 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 study of this
document, however, does not replace the training courses offered by
the manufacturer.
Requirements Knowledge of the current Operating Instructions of the respective
system.
Background experience in mechanics, electrical and medical
engineering.
Note and Caution symbols
Explanation of the Note and Caution symbols used:
Note
Informs the operator that in case of a failure to follow the steps as
described, a specific function will be executed incorrectly or will not be
executed at all, or will not produce the desired effect.
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.

Chapter 2: Important Information
2-2 Fresenius Medical Care 5008 SM 1/08.04
2.3 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.
Measuring equipment and
accessories
The activities described in this technical document require the
availability of the necessary technical measuring equipment and
accessories.
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 taken:
– Protect the components against ingress of liquids.
– Do not touch live parts.
– All plugs, connections and components may only be disconnected or
connected if de-energized.
ESD precautions When repairing the system and replacing spare parts, observe
applicable ESC precautions (e.g. EN 100 015-1).
Monitor support arm If the 5008 hemodialysis system is to be placed in a horizontal position
for servicing, the monitor support arm must be protected with the
transport protection to prevent it from flipping over.
To be observed after
working on the system
A disinfection and a T1 test must be performed after working on the
system.
To be observed after
aborting a disinfection
program
After a disinfection program has been aborted or if the system is to be
preserved, the hemodialysis system must be disconnected from the
water supply after a maximum of 3 days. When the system is returned
to use, check that the pressure of the water supply meets the prescribed
minimum pressure.
2.4 Addresses
Please address any inquires to:
Fresenius Medical Care AG
61346 Bad Homburg
Germany
Phone: + 49 6172 609-0
www.fmc-ag.com

Chapter 2: Important Information
Fresenius Medical Care 5008 SM 1/08.04 2-3
Service
Central Europe
Fresenius Medical Care
Deutschland GmbH
Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstraße 24 I
61352 Bad Homburg
Germany
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Service
International
Fresenius Medical Care
Deutschland GmbH
Service Support International
Hafenstraße 9
97424 Schweinfurt
Germany
Phone: [phone] (hotline)
Fax: [phone]
Local Service

Chapter 2: Important Information
2-4 Fresenius Medical Care 5008 SM 1/08.04

Chapter 3: Specifications
Fresenius Medical Care 5008 SM 1/08.04 3-1
3 Specifications
ODimensions, weight and housing material
Dimensions Height: approx. 162 cm (approx. 210 cm incl. IV pole)
Width: approx. 48 cm (on base incl. brake)
Depth: approx. 72 cm (approx. 86 cm with extended concentrate rack)
Weight Approx. 135 kg (without options)
Housing material PU vacuum cast resin
OType label
1Type identification, serial number
2Power requirements
3Protection against ingress of liquids: drip-proof
4Caution, consult accompanying documents
5Degree of protection against electric shock: Type B
6CE mark
OElectrical safety (classification according to EN 60601-1, IEC 601-1)
Type of protection against
electric shock
Safety class I
Degree of protection
against electric shock
Type B, symbol:
1
6
2
3
45

Chapter 3: Specifications
3-2 Fresenius Medical Care 5008 SM 1/08.04
Applicable only to the BPM
blood pressure cuff:
Degree of protection
against electric shock
Type CF, symbol:
Degree of protection
against ingress of liquids
Drip-proof, symbol: IPX1
Leakage currents According to EN 60601-1
EMC specifications
according to EN 60601-1-2
(IEC 601-1-2)
RFI emissions:
Limit class A according to EN 55011, Group 1
Immunity:
– Electrostatic discharge, atmospheric discharge: 8 kV
– Electromagnetic fields: 27 MHz – 1000 MHz: 3 V/m
– Bursts: Power line (alternating current): 1 kV
– Surge voltages (alternating current): 2 kV
OElectric supply
Line voltage 100 to 230 V AC, ±10 %, 47 to 63 Hz
(The decisive criterion is the line voltage and the operating current
specified on the type label of the system)
Connection to power
supply
16 A at 230 V, regulation according to VDE 0100 part 0107
Operating current
dialysis
Approx. 6 A, (at 230 V)
at a water inlet temperature of 17 °C
Dialysate temperature 37 °C
Dialysate flow: 500 ml/min
Power supply
(internal)
+24 V ± 3 %, 20 A short-circuit proof
+18 V ± 3 %, 14 A short-circuit proof
480 W total power output
Battery Lead-acid battery (maintenance-free)
24 V, 7 Ah
OFuses
Main power switch 2 x G 16 A (miniature circuit-breaker) rear of power supply unit
OOperating conditions
Water inlet pressure 1.5 to 6.0 bar
Water inlet temperature 5 °C to 30 °C
with "Integrated hot rinse": 85 °C to 95 °C
Water inlet rate 1.5 l/min; at an inlet pressure of 1.5 bar

Chapter 3: Specifications
Fresenius Medical Care 5008 SM 1/08.04 3-3
Water drain 0 to 100 cm above the floor, minimum 5 cm free fall. The water drain
must be located at a lower level than the dialyzer position.
Concentrate supply 0to-100mbar;maximumsuctionheight1m
with Central Delivery System (option): 0.05 to 2.0 bar
Heat dissipation Dialysis:
approx. 400 Watt (at an ambient temperature of 20 °C)
Range of operating
temperature
15 °C to 35 °C
Atmospheric pressure 700700 hPa to 1060 hPa
Relative humidity 30 % to 75 %, temporarily 95 %
Stability 5°
IV pole load capacity Maximum: 5 kg
Maximum load capacity of one hook: 5 kg
OExternal connection options
LAN Interface for the exchange of data.
Electrically isolated by transformer.
Port: RJ 45
RS232 Interface for the exchange of data.
Electrically isolated by optocoupler.
Port: DSUB 9-pin
Caution
Any additional equipment connected to the analog and digital interfaces
of the machine must comply with the applicable EN specifications (e.g.
EN 60950 for data processing equipment and EN 60601 (IEC 601) for
electro-medical equipment).
Apart from this requirement, all configurations must comply with the
system standard EN 60601-1-1 (IEC 601-1-1), or their applicability with
regard to safety has to be proven by a certificate issued by a testing
agency authorized to test the ready-for-use machine.
The connection of additional equipment to the signal input or output
component affects the system configuration and anyone connecting
additional equipment is therefore responsible for compliance with the
system standard EN 60601-1-1 (IEC 601-1-1).
Caution
The external alarm indicators do not relieve the operator of the
obligation to observe the local alarms of the system.

Chapter 3: Specifications
3-4 Fresenius Medical Care 5008 SM 1/08.04
Service/diagnostics (Protected by cover!)
For inhouse computer diagnostics.
Port: DSUB 15-pin
24 V (Protected by cover!)
24 V connection (2 A fuse)
Port: Flanged socket, 4-pin
Alarm output For the connection of an external alarm indicator (nurse call). (Potential-
free alarm output. Alternating contact maximum 24 V/24 W).
Port: 5-pin diode plug via a shielded line; shield grounded on either side.
OOverride conditions
When overriding a safety system the responsibility for the patient’s
safety rests with the operator of the machine.
Audible alarm suppression Mute alarm time: maximum 2 minutes
(adjustable in the SETUP)
Alarm override After confirmation of the error message and start of the blood systems:
Arterial and venous pressure alarm for approx. 10 seconds (window
inactive)
Air detector alarm for approx. 2 seconds
Blood leak override Override time: maximum 2 minutes
Override air-bubble
detector
Override time: after starting removal of air: approx. 4 seconds
OOperating programs
T1 test Automatic test for verification of the operating and safety systems.
The T1 test is mandatory,
– after power on (not following a power failure)
– after a cleaning program
Preparation Defined by the optical detector located below the venous bubble
catcher.
Preparation is terminated as soon as the optical detector senses
opaque fluid in the blood lines.
Priming and rinsing the
blood lines
Minimum rinse volume 500 ml; automatic switching to rinsing, if level in
bubble catcher detected. Automatic raising of the fluid level during the
rinse phase.
Reinfusion Reinfusion volume adjustable in the SETUP.
Return to dialysis still possible.
Dialysis Bicarbonate dialysis
ISO-UF Ultrafiltration without dialysate flow (Bergström method)

Chapter 3: Specifications
Fresenius Medical Care 5008 SM 1/08.04 3-5
Cleaning programs Rinse clear/rinse/mandatory rinse:
Time adjustable in the TECHNICIAN's SETUP,
Temperature: approx. 37 °C,
Flow: 600, 800 ml/min (adjustable in the SETUP)
Cold disinfection/degreasing, cold disinfection:
Time adjustable in the TECHNICIAN's SETUP,
Temperature: approx. 37 °C,
Flow: max. 900 ml/min
Heat disinfection:
Time adjustable in the TECHNICIAN's SETUP,
Flow: max. 900 ml/min
In all programs:
Blood pump stops, arterial and venous line occlusion clamp closed.
Progress of the program (time-counting) is interrupted in the event of a
flow alarm.
The cleaning programs can be aborted.
The chemical disinfection program is followed by a mandatory rinse.
Flush Rinsing of the water supply area
ODialysate circuit and safety systems
Blood leak detector Threshold of response ≤0.5 ml blood loss per minute into the dialysate
at a hematocrit of 0.25.
(flow rate 100 ml/min to 1000 ml/min)
Transmembrane pressure Display range: –100 to 400 mmHg
Resolution: 5 mmHg
Definition:
Ultrafiltration Selectable UF rate: 0 ml/h to 4000 ml/h (in 10 ml increments)
Maximum rate internally adjustable to 1, 2, 3, or 4 l/h.
Pump volume accuracy: ±1 % (at Pdi > –500 mbar)
The UF rate/effective blood flow ratio is being monitored during the
treatment. If an incongruity occurs a warning will be displayed after
approx. 10 seconds.
Pressure holding test Event-controlled
TMP = Pbo – (Pdi + Pdo) / 2 + Offset
TMP = Transmembrane pressure
Pbo = Blood pressure on the outlet side of the dialyzer
Pdi = Dialysate pressure on the inlet side of the dialyzer
Pdo = Dialysate pressure on the outlet side of the dialyzer
Offset = Flow-dependent pressure fluctuations

Chapter 3: Specifications
3-6 Fresenius Medical Care 5008 SM 1/08.04
Balancing Accuracy: ±0.1 % related to the total dialysate volume
Maximum balancing error
Example:
Ultrafiltration error: with 1000 ml in 1 hour: ±1 % = ±10 ml/h
Balancing error: with 30 l fluid flow in 1 hour at a dialysate flow of
500 ml/min: ±0.1 %= ± 30 ml/h
Maximum balancing error:
F=F
UF +F Bil =(±10ml/h)+(±30ml/h)=±40ml/h
Degassing Method: Negative pressure
Dialysate concentration
(conductivity)
Display range: 12.8 to 15.7 mS/cm
Resolution: 0.1 mS/cm
Accuracy: 0.1 mS/cm
Method:
Temperature-compensated electronic conductivity meter with
adjustable alarm limits.
Concentrates Entering concentration types
Adjustment range: 125 to 151 mmol/l, depending on the concentrate
used ±10 % of the base value.
Bicarbonate readjustment range: corresponds to ±8 mmol/l
bibag®Bicarbonate concentrate preparation from the bibag®
Temperature range: 15 to 35 °C
Dialysate temperature Adjustment range: (prescribed temperature) 34.0 °C to 39.0 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.2 °C
Dialysate flow Display range: 100 to 1000 ml/min
Resolution: 100 ml/min
Desired values: 100 to 1000 ml/min
Measurement by means of time pulse monitoring and balancing
chamber volume
Auto flow: dialysate flow controlled in relation to the blood flow,
determined by the dialyzer.
EcoFlow: dialysate flow automatically reduced to 100 ml/min in
Preparation
Rinse and chemical
disinfection temperature
Desired temperature: 37 °C
Resolution: 0.5 °C
Measuring accuracy: ±0.2 °C
Rinse and chemical
disinfection flow
Desired value: 600 ml/min
F=
FUF + FBil
F=
Maximum balancing error
FUF =Ultrafiltration error
Fbil =Balancing error

Chapter 3: Specifications
Fresenius Medical Care 5008 SM 1/08.04 3-7
Hot rinse and heat
disinfection temperature
Desired temperature: 85 °C
Resolution: 0.5 °C
Measuring accuracy: ±2.0 °C
Hot rinse and heat
disinfection flow
Desired value: 600 ml/min
Concentration of
disinfectant
Dilution: Disinfectant is diluted with purified water in the dialysis system
at a ratio of 1+24.
Flow alarm Dependent on the programmed flow
OExtracorporeal blood circuit and safety systems
Arterial pressure
measurement
Display range: –300 to +300 mmHg
Resolution: 5 mmHg
Accuracy: 7 mmHg (typical)
OD senses non-opaque presence:
Alarm window width: –300 to +300 mmHg
OD senses opaque presence:
Alarm window width: +40 to +200 mmHg
Default value adjustable in the SETUP, factory setting 120 mmHg
Blood pump Delivery rate: 30 to 600 ml/min
Resolution: 10 ml/min (with a line diameter of 8 mm)
Accuracy: < 5 % (without lines)
Line diameter: 4.4 mm, 6.4 mm, 8.0 mm
Blood pump stop alarm: 60 seconds
Spring-loaded rollers, fully occluding, pressure-limited to 2 bar with 8 x
2.1 pump line segment (when using the prescribed tubing systems).
(The blood pump design allows manual operation, hand crank in the
rotor, in clockwise direction only.)
Venous pressure
measurement
Display range: –100 to +500 mmHg
Resolution: 5 mmHg
Accuracy: 7 mmHg (typical)
OD senses non-opaque presence:
Alarm window width: –100 to +500 mmHg
OD senses opaque presence:
Alarm window width: 40 to 200 mmHg
Default value adjustable in the SETUP,
Factory setting 120 mmHg
adjustable over a range of 20 to 500 mmHg
(adjustable from -100 to 500 mmHg via SETUP.)
Fill level detector Method:
Capacitive measurement
Switching point 13 mm, ±4 mm from upper edge
Optical detector Method:
Infrared transmission

Chapter 3: Specifications
3-8 Fresenius Medical Care 5008 SM 1/08.04
Distinguishes between
OD light (saline or air in the tubing system)
OD dark (blood in the tubing system).
Air bubble detector Method:
Ultrasonic transmission measurement on the line
Sensitivity:
– Air bubbles:
Bubble volume ≥20 µl
– Blood foam (air-blood mixture)
Air alarm:
– BP rate < 100 ml/min:
Air bubble: Volume ≥20 µl
Blood foam
– BP rate ≥100 ml/min:
10 air bubbles with an air bubble volume of < 50 µl each
or 1 air bubble with an air bubble volume of ≥50 µl,
Blood foam
The specified data refer to the most unfavorable case with a BP rate of
0 to 600 ml/min when using the blood lines specified in chapter
Consumables.
Heparin pump Delivery rate: 0.5 to 10 ml/h
Resolution: 0.1 ml/h
Accuracy: ±5 % for delivery rates of 0.5 to 10 ml/h and a measuring time
of 2 hours up to 1.2 bar counter-pressure
(calibrated for 30 ml Fresenius heparin syringes)
With delivery rates of <1.0 ml/h the tolerance may exceed the specified
±5 %.
Stop time: 0 minutes up to 2 hours.
Resolution: 1 minute
Bolus injection: 1.0 up to 20.0 ml
Resolution: 0.1 ml
30 ml Fresenius heparin syringe
Audible alarm Setting range of the loudness of the audible alarm:
Factory setting ≥65 db (adjustable)
Minimum setting: ≥65 db
ODIASAFE®plus (option)
Filter life: maximum 12 weeks.
Monitored by the dialysis system and a warning (Filter change) is
displayed.

Chapter 3: Specifications
Fresenius Medical Care 5008 SM 1/08.04 3-9
When using ONLINEplus™ (option):
Filter life: maximum 100 treatments.
Monitored by the dialysis system and a warning (Filter change) is
displayed. If the warning is ignored, ONLINEplus™ will be disabled after
the respective number has been exceeded.
After 90 treatments the number of the remaining treatments will be
displayed in the cleaning programs.
OOCM (option)
Measuring accuracy of the clearance: ± 6 % standard deviation
Shortest measuring interval: 25 min
Time scale of the display: 10 s
OONLINEplus™ (option)
Delivery rate: 25 to 600 ml/min (inside line diameter: 8.0 mm)
Resolution: 1 ml/min
Exchange volume: substituate goal 500 l adjustable in relation to
treatment parameters
Accuracy: < 5 % (without lines)
(This specification only applies to the range from 30 to 350 ml/min. With
delivery rates of < 30 ml/min the deviation may be greater.)
Volume counter display: 0.1 to 210 liters
Resolution: 0.1 liter
Spring-loaded rollers, fully occluding, pressure-limited to < 1.3 bar.
(The blood pump design allows manual operation, hand crank in the
rotor, in clockwise direction only.)
Auto sub: The sub rate is determined as a function of:
–UFrate
– Blood flow
– Hematocrit (HCT)
– Total protein (TP)
– Filter performance
OSingle Needle (option)
Blood pump
stop alarm
Single Needle pump
During Single Needle operation 180 seconds.
Stroke volume 10 to 50 ml in increments of 5 ml
External compliance
chamber
50 ml or 60 ml stroke volume

Chapter 3: Specifications
3-10 Fresenius Medical Care 5008 SM 1/08.04
Auto SN
Delivery rate of the
Single Needle pump
+20 % (programmable in the Operator setup.)
OBPM (option)
Blood pressure Display Area
– Systole: 30 mmHg to 280 mmHg
– Diastole: 10 mmHg to 240 mmHg
– MAP: 20 mmHg to 255 mmHg
Resolution: 1 mmHg
Accuracy of measured value ±3 mmHg
Pulse Display range: 20 to 245 1/min
Resolution: 1/min
OBTM (option)
Required blood flow for
accurate BTM function
≥120 ml/min
(The measuring and control functions of the BTM are deactivated if the
blood flow is < 100 ml/min.)
Temperature
measurement
Accuracy of the fistula temperatures (if correct ambient temperature is
indicated): ± 0.5 °C
Error in fistula temperatures per °C error of the set ambient temperature
0.08 °C (at a blood flow of 100 ml/min)
0.03 °C (at a blood flow of 300 ml/min)
Body temperature change accuracy: ± 0.2 °C
Recirculation
measurement
Accuracy of recirculation measurement
(for 2.5 °C venous bolus amplitude): ± 2 %
Maximum bolus amplitude: – 3 °C or + 3 °C
Maximum duration of the bolus: up to 10 min
Maximum dialysate temperature range used by the BTM:
33.5 °C to 39.5 °C
Body temperature control Allowed range of desired values for body temperature change rate:
– 0.5 °C/h to + 0.5 °C/h
Maximum dialysate temperature range used by the BTM:
33.5 °C to 39.5 °C