Fresenius 5008 Service manual

Service Manual

Hemodialysis System

5008

Edition: 1/08.04
Part number: M35 179 1

Fresenius

Medical

0123

Care

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

Page

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

Fresenius Medical Care 5008 SM 1/08.04 i

Kapitel :

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)

ii Fresenius Medical Care 5008 SM 1/08.04

1 Index

How to use the index: E.g., index entry 1-3 is to be interpreted as: Chapter 1, page 3

Chapter 1: Index

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

R

Reinfusion 5-2

T

Temperature 3-6

U

Ultrafiltration 5-3
User interface 5-5

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

Fresenius Medical Care 5008 SM 1/08.04 1-1

Kapitel 1: Index

1-2 Fresenius Medical Care 5008 SM 1/08.04

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

Chapter 2: Important Information

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.

Fresenius Medical Care 5008 SM 1/08.04 2-1

Chapter 2: Important Information

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

Precautions Before turning power on, repair any visible damage.

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

Monitor support arm If the 5008 hemodialysis system is to be placed in a horizontal position

To be observed after
working on the system

To be observed after
aborting a disinfection
program

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

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.

applicable ESC precautions (e.g. EN 100 015-1).

for servicing, the monitor support arm must be protected with the
transport protection to prevent it from flipping over.

A disinfection and a T1 test must be performed after working on the
system.

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

2-2 Fresenius Medical Care 5008 SM 1/08.04

Chapter 2: Important Information

Service
Central Europe

Service
International

Local Service

Fresenius Medical Care
Deutschland GmbH
Geschäftsbereich Zentraleuropa
Kundendienst / Servicecenter
Steinmühlstraße 24 I
61352 Bad Homburg
Germany
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

Fresenius Medical Care
Deutschland GmbH
Service Support International
Hafenstraße 9
97424 Schweinfurt
Germany
Phone: [phone] (hotline)
Fax: [phone]

Fresenius Medical Care 5008 SM 1/08.04 2-3

Chapter 2: Important Information

2-4 Fresenius Medical Care 5008 SM 1/08.04

3 Specifications

O Dimensions, 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

O Type label

Chapter 3: Specifications

1

2

3

4

1 Type identification, serial number
2 Power requirements
3 Protection against ingress of liquids: drip-proof
4 Caution, consult accompanying documents
5 Degree of protection against electric shock: Type B
6 CE mark

6

5

O Electrical safety (classification according to EN 60601-1, IEC 601-1)

Type of protection against

Safety class I

electric shock

Degree of protection

Type B, symbol:

against electric shock

Fresenius Medical Care 5008 SM 1/08.04 3-1

Chapter 3: Specifications

Applicable only to the BPM
blood pressure cuff:
Degree of protection
against electric shock

Degree of protection
against ingress of liquids

Leakage currents According to EN 60601-1

EMC specifications
according to EN 60601-1-2
(IEC 601-1-2)

O Electric supply

Line voltage 100 to 230 V AC, ±10 %, 47 to 63 Hz

Type CF, symbol:

Drip-proof, symbol: IPX1

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

(The decisive criterion is the line voltage and the operating current
specified on the type label of the system)

Connection to power
supply

Operating current
dialysis

Power supply
(internal)

Battery Lead-acid battery (maintenance-free)

O Fuses

Main power switch 2 x G 16 A (miniature circuit-breaker) rear of power supply unit

O Operating conditions

Water inlet pressure 1.5 to 6.0 bar

16 A at 230 V, regulation according to VDE 0100 part 0107

Approx. 6 A, (at 230 V)
at a water inlet temperature of 17 °C
Dialysate temperature 37 °C
Dialysate flow: 500 ml/min

+24 V ± 3 %, 20 A short-circuit proof
+18 V ± 3 %, 14 A short-circuit proof
480 W total power output

24 V, 7 Ah

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

3-2 Fresenius Medical Care 5008 SM 1/08.04

Chapter 3: Specifications

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; maximum suction height 1m

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

Atmospheric pressure 700700 hPa to 1060 hPa

Relative humidity 30 % to 75 %, temporarily 95 %

Stability 5°

IV pole load capacity Maximum: 5 kg

O External connection options

15 °C to 35 °C

Maximum load capacity of one hook: 5 kg

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.

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

Fresenius Medical Care 5008 SM 1/08.04 3-3

Chapter 3: Specifications

Service/diagnostics (Protected by cover!)

24 V (Protected by cover!)

Alarm output For the connection of an external alarm indicator (nurse call). (Potential-

O Override conditions

Audible alarm suppression Mute alarm time: maximum 2 minutes

For inhouse computer diagnostics.
Port: DSUB 15-pin

24 V connection (2 A fuse)
Port: Flanged socket, 4-pin

free alarm output. Alternating contact maximum 24 V/24 W).
Port: 5-pin diode plug via a shielded line; shield grounded on either side.

When overriding a safety system the responsibility for the patient’s
safety rests with the operator of the machine.

(adjustable in the SETUP)

Alarm override After confirmation of the error message and start of the blood systems:

Blood leak override Override time: maximum 2 minutes

Override air-bubble
detector

O Operating programs

T1 test Automatic test for verification of the operating and safety systems.

Preparation Defined by the optical detector located below the venous bubble

Priming and rinsing the
blood lines

Arterial and venous pressure alarm for approx. 10 seconds (window
inactive)
Air detector alarm for approx. 2 seconds

Override time: after starting removal of air: approx. 4 seconds

The T1 test is mandatory,
– after power on (not following a power failure)
– after a cleaning program

catcher.
Preparation is terminated as soon as the optical detector senses
opaque fluid in 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)

3-4 Fresenius Medical Care 5008 SM 1/08.04

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.

Chapter 3: Specifications

Flush Rinsing of the water supply area

O Dialysate 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:

TMP = P

TMP = Transmembrane pressure
P

bo

P

di

P

do

Offset = Flow-dependent pressure fluctuations

– (Pdi + Pdo) / 2 + Offset

bo

= Blood pressure on the outlet side of the dialyzer
= Dialysate pressure on the inlet side of the dialyzer
= Dialysate pressure on the outlet side of the dialyzer

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 P

> –500 mbar)

di

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

Fresenius Medical Care 5008 SM 1/08.04 3-5

Chapter 3: Specifications

Balancing Accuracy: ±0.1 % related to the total dialysate volume

Maximum balancing error

F=

F=
F

UF

F

bil

F

+ F

UF

Bil

Maximum balancing error

=

Ultrafiltration error

=

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+FBil

=(±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

Desired value: 600 ml/min

disinfection flow

3-6 Fresenius Medical Care 5008 SM 1/08.04

Chapter 3: Specifications

Hot rinse and heat
disinfection temperature

Desired temperature: 85 °C
Resolution: 0.5 °C
Measuring accuracy: ±2.0 °C

Hot rinse and heat

Desired value: 600 ml/min

disinfection flow

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

O Extracorporeal 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

Fresenius Medical Care 5008 SM 1/08.04 3-7

Chapter 3: Specifications

Air bubble detector Method:

Distinguishes between
OD light (saline or air in the tubing system)
OD dark (blood in the tubing system).

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

Heparin pump Delivery rate: 0.5 to 10 ml/h

Audible alarm Setting range of the loudness of the audible alarm:

O DIASAFE

®

plus (option)

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.

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

Factory setting ≥ 65 db (adjustable)
Minimum setting: ≥ 65 db

Filter life: maximum 12 weeks.
Monitored by the dialysis system and a warning (Filter change) is
displayed.

3-8 Fresenius Medical Care 5008 SM 1/08.04

O OCM (option)

O ONLINEplus™ (option)

Chapter 3: Specifications

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.

Measuring accuracy of the clearance: ± 6 % standard deviation
Shortest measuring interval: 25 min
Time scale of the display: 10 s

Delivery rate: 25 to 600 ml/min (inside line diameter: 8.0 mm)
Resolution: 1 ml/min

O Single Needle (option)

Blood pump
stop alarm
Single Needle pump

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:
–UF rate
– Blood flow
– Hematocrit (HCT)
– Total protein (TP)
– Filter performance

During Single Needle operation 180 seconds.

Stroke volume 10 to 50 ml in increments of 5 ml

External compliance

50 ml or 60 ml stroke volume

chamber

Fresenius Medical Care 5008 SM 1/08.04 3-9

Chapter 3: Specifications

Auto SN
Delivery rate of the
Single Needle pump

O BPM (option)

Blood pressure Display Area

Pulse Display range: 20 to 245 1/min

O BTM (option)

Required blood flow for
accurate BTM function

+20 % (programmable in the Operator setup.)

– 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

Resolution: 1/min

≥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

3-10 Fresenius Medical Care 5008 SM 1/08.04

O Network (option)

Chapter 3: Specifications

Caution

The responsible organization of the network is responsible for
protecting the machine from excessive network load (e.g. by
accumulation of broadcast messages or port scans). If necessary, the
connection to the network must be established via a router or a firewall,
for example.

The system configurator is responsible for the further secure data
processing, e.g. in PC software applications.

The responsible organization of the network is responsible for the
protection of the not encrypted, transferred data.

The data transfer of alarm states via the network must not be used as
an external alarm alert (nurse call).

Fresenius Medical Care 5008 SM 1/08.04 3-11

Chapter 3: Specifications

3-12 Fresenius Medical Care 5008 SM 1/08.04

4Installation

4.1 Preface

Instructions for all technicians who are authorized to commission
our hemodialysis systems.

We, as manufacturers, permanently aim at delivering systems of
highest quality.

To reach this aim, we need your support.

Please commission our hemodialysis systems by uniformly using the
enclosed "initial start-up report" and enter the values determined in the
columns provided.

The following is applicable:
Corrections are necessary only if the measured values are outside
of the tolerances specified!

Chapter 4: Installation

We will then evaluate the initial start-up reports, which will enable us to
monitor the quality of our systems on their delivery.

After initial start-up, please asap send – by mail or by fax – the
completed form (Initial Start-Up Report) back to the following address:

Fresenius Medical Care
Deutschland GmbH
Werk Schweinfurt
Herrn Alfred Laus, Abt. BM
Hafenstraße 9
97424 Schweinfurt
Fax: [phone]

Thank you very much for your help!

4.2 Important Information on Initial Start-Up

This technical document is intended for initial start-up only. It is not
intended for restarting hemodialysis systems that have been shut down
or have been put out of service temporarily.

The initial start-up must be performed by the Technical Service of
Fresenius Medical Care or a person authorized by them!

Any information on initial start-up and the specifications in the Operating
Instructions must be observed.

When bringing the hemodialysis system from a cooler to a warmer
room, allow approx. 2 hours for the system to adjust to the ambient
temperature before turning the unit on.

Fresenius Medical Care 5008 SM 1/08.04 4-1

Chapter 4: Installation

4.3 Initial Start-Up Report

5008 Initial Start-Up Report

Fresenius

Technician's name: Service report number:

Customer/Customer no.:

Inventory no.: Device no. Operating hours:

Device type including option(s):

Med ical

Care

4-2 Fresenius Medical Care 5008 SM 1/08.04

Chapter 4: Installation

No. Description Measure-



ment
value

1 Preparation

1.1 Hemodialysis system without visible shipping damage. T

1.2 Remove the transport protection for the monitor support arm. T

Install the IV pole. T

1.3 Connect the water supply tubing. T

Connect the drain and the flush tubings. T

Protect the tubings from slipping out. T

Standard: Length 3 m, internal diameter 6 mm

T

Tubing dimensions, adjusted: Length _____ m, internal diameter_____ mm

1.4 Connect the CDS tubings and protect them from slipping out.

Apply a shrink tube marking for the CDS tubings. T

CDS 1 T

CDS 2 T

BIC T

1.5 Remove the shipping plugs from the overflows. T

1.6 When turning the hemodialysis system on, perform an audible check of the watchdog alarm. T

1.7 Rinse out the anti-freeze. T

1.8 Select the Filter change program.
Connect the filter. DIASAFE

®

plus/ONLINEplus™

T

In the service mode, delete mandatory disinfection.
Then completely run the rinse program.

2 SETUP settings (Technician's SETUP/Operator SETUP)

2.1 Check the SETUP on the hemodialysis system. T

3 Check – water inlet flow / adjustment – degassing

3.1 Check MaxWaterFlow.
Desired value: 1300 ml/min to 1550 ml/min

________ Corr.:

T Yes
T No

3.2 Perform the degassing adjustment. T

4 Check – dialysate flow

4.1 Check flow at 800 ml/min.

________ T

Desired value: 770 ml/min to 830 ml/min

Fresenius Medical Care 5008 SM 1/08.04 4-3

Chapter 4: Installation

No. Description Measure-

ment
value

5 Check – temperature

5.1 Check PT07 (temperature) at 37 °C. (flow 500 ml/min)
Desired value: 36.8 °C to 37.2 °C (display on hemodialysis system)

Measure the reference temperature with an external measuring instrument.
Difference = Reference temperature minus PT07
Desired value – difference: –0.5 °C to +0.2 °C

6 Check – conductivity

6.1 Check CD7 (conductivity).
Desired value: approx. 13.5 mS/cm to approx. 14.5 mS/cm

Measure the reference conductivity with an external measuring instrument.
Difference = Reference conductivity minus CD7
Desired value – difference: ±0.2 mS/cm

7 Check – blood leak detector

7.1 Check the blood leak:
Desired value: 4.8 V to 5.2 V

7.2 Check the dimness:
Desired value: 4.8 V to 5.2 V

________ Corr.:

________

________ Corr.:

________

________ Corr.:

________



T Yes
T No

T Yes
T No

T Yes
T No

4-4 Fresenius Medical Care 5008 SM 1/08.04

Chapter 4: Installation

No. Description Measure-

ment
value

8 Check – dialysate pressure

8.1 Zero point S03/S07 Corr.:

Reference measuring instrument: 0 mbar ________

Check S03.
Desired value: +16 mbar to +76 mbar

Check S07.
Desired value: +16 mbar to +76 mbar

8.2 Slope S03/S07 (+)

Reference measuring instrument: +533 mbar (± 26 mbar) ________

Check S03.
Desired value: S03 = Display of reference measuring instrument + (+16 mbar
to +76 mbar)

Check S07.
Desired value: S07 = Display of reference measuring instrument + (+16 mbar
to +76 mbar)

________

________

________

________



T Yes
T No

8.3 Slope S03/S07 (–)

Reference measuring instrument: –533 mbar (± 26 mbar) ________

Check S03.
Desired value: S03 = Display of reference measuring instrument + (+16 mbar
to +76 mbar)

Check S07.
Desired value: S07 = Display of reference measuring instrument + (+16 mbar
to +76 mbar)

________

________

Fresenius Medical Care 5008 SM 1/08.04 4-5

Chapter 4: Installation

No. Description Measure-

ment
value

9 Check – electrical safety

In Germany according to DIN VDE 0751-1, edition 10/2001.
In other countries, observe the local regulations!

9.1 Visual inspection performed. T

9.2 Protective earth resistance maximum 0.3 ohms (with power cord) ______ Ω T

9.3 Leakage current measurement (device leakage current)

T Differential current measurement according to figure C.6

or

T Direct measurement according to figure C.5

Nominal voltage of power supply: __________ V

Device leakage current mains polarity 1 __________ µA

with line voltage __________ V

scaled to nominal voltage (maximum 500 µA, see Additional requirements) _____ µA

Device leakage current mains polarity 2 __________ µA

with line voltage __________ V



T

scaled to nominal voltage (maximum 500 µA, see Additional requirements) _____ µA

Test equipment used: ________________________

10 Check – zero point arterial/venous pressure display and venous clamp

10.1 Zero point arterial pressure display Corr.:

Check the arterial pressure display (standby operation).
Desired value: –5 mmHg to +5 mmHg

10.2 Zero point venous pressure display Corr.:

Check the venous pressure display (standby operation).
Desired value: –5 mmHg to +5 mmHg

10.3 Check – venous clamp:

A pressure change within 3 minutes must not exceed the following values:

Arterial pressure display
Maximum pressure change: ±5mmHg

Reference measuring instrument for pressure display
Maximum pressure drop: –0.1 bar

________

________

T Yes
T No

T Yes
T No

T

4-6 Fresenius Medical Care 5008 SM 1/08.04

Chapter 4: Installation

No. Description Measure-

ment
value

11 Final check

11.1 Check the error memory. T

11.2 Save calibration data and SETUP settings on a data disk. T

11.3 Perform the T1 test. T

11.4 Run the disinfection program
(with Puristeril 340 or Puristeril plus or Diasteril or Citrosteril).

11.5 Check the alarm function during the disinfection program.
Open the shunt interlock.
Audible alarm and traffic light

11.6 Check absence of disinfectant by means of test strips (not with Citrosteril). T

11.7 Record entries in the medical device register and on the machine card. T

11.8 Operating Instructions and accessories package complete and appropriate for the system. T



T

T

Fresenius Medical Care 5008 SM 1/08.04 4-7

Chapter 4: Installation

Date: Signature: Stamp:

The system has been released for the intended use. T Yes T No

Test equipment used:

Temperature, conductivity, pressure
(type, serial number):
Protective earth resistance, leakage current
(type, serial number):

Comments:

________________________
________________________
________________________
________________________

Date: Signature: Stamp:

4-8 Fresenius Medical Care 5008 SM 1/08.04