Fresenius 5008 Service manual

Service Manual

Hemodialysis System

5008

Edition: 1/08.04
Part number: M35 179 1	0123

Fresenius Medical Care

Page

Table of Contents

1Index

2Important 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

3Specifications

4Installation

	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
5	Setup
	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

6.2Test Report – Technical Safety Checks, Technical Measurements Checks and Maintenance Procedures6-3

6.3Explanations on Technical Safety Checks, Technical Measurement Checks and Maintenance Procedures6-11

6.4

TSC / TMC Report ....................................................................................................................

6-27

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i

Kapitel :

7Error Messages

8Tools (Service Equipment)

9Calibration / Adjustment

10Repair

11Functional 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)

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Chapter 1: Index

1 Index

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

	A	R
	Addresses 2-2	Reinfusion 5-2
	Alarm processing 5-4	T
	AutoFlow 3-6
	B	Temperature 3-6
		U
	Blood pump 5-1
	BPM 5-10	Ultrafiltration 5-3
	BTM 5-11
		User interface 5-5
	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

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Kapitel 1: Index

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Chapter 2: Important Information

2 Important Information

2.1Organization 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

2.2How 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.

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Chapter 2: Important Information

2.3Precautions 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	The activities described in this technical document require the
accessories	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	A disinfection and a T1 test must be performed after working on the
working on the system	system.
To be observed after	After a disinfection program has been aborted or if the system is to be
aborting a disinfection	preserved, the hemodialysis system must be disconnected from the
program	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

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Chapter 2: Important Information

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

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Chapter 2: Important Information

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Chapter 3: Specifications

3 Specifications

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
Type label

1

2

3 6

4	5

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

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

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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

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

Electric supply

Line voltage

Connection to power supply

Operating current dialysis

Power supply (internal)

Battery

Fuses

Main power switch

Operating conditions

Water inlet pressure

Water inlet temperature

Water inlet rate

Type CF, symbol:

Drip-proof, symbol: IPX1

According to EN 60601-1

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

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)

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

Lead-acid battery (maintenance-free) 24 V, 7 Ah

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

1.5 to 6.0 bar

5 °C to 30 °C

with "Integrated hot rinse": 85 °C to 95 °C

1.5 l/min; at an inlet pressure of 1.5 bar

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	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	0 to -100 mbar; maximum suction height 1 m
	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	15 °C to 35 °C
temperature
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
External connection options
	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

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Chapter 3: Specifications

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.
Override 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	Override time: after starting removal of air: approx. 4 seconds
detector
Operating 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	Minimum rinse volume 500 ml; automatic switching to rinsing, if level in
blood lines	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)

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Chapter 3: Specifications

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
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	=	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
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

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Chapter 3: Specifications

Balancing	Accuracy: ±0.1 % related to the total dialysate volume
Maximum balancing error	F	=	FUF + FBil
	F	=	Maximum balancing error
	FUF	=	Ultrafiltration error
	Fbil	=	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 = FUF + FBil = (±10 ml/h) + (±30 ml/h) = ±40 ml/h
Degassing	Method: Negative pressure
Dialysate concentration	Display range: 12.8 to 15.7 mS/cm
(conductivity)	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	Desired temperature: 37 °C
disinfection temperature	Resolution: 0.5 °C
	Measuring accuracy: ±0.2 °C
Rinse and chemical	Desired value: 600 ml/min
disinfection flow

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Chapter 3: Specifications

Hot rinse and heat	Desired temperature: 85 °C
disinfection temperature	Resolution: 0.5 °C
	Measuring accuracy: ±2.0 °C
Hot rinse and heat	Desired value: 600 ml/min
disinfection flow
Concentration of	Dilution: Disinfectant is diluted with purified water in the dialysis system
disinfectant	at a ratio of 1+24.
Flow alarm	Dependent on the programmed flow
Extracorporeal blood circuit and safety systems
Arterial pressure	Display range: –300 to +300 mmHg
measurement	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	Display range: –100 to +500 mmHg
measurement	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

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Chapter 3: Specifications

	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

DIASAFE®plus (option)

Filter life: maximum 12 weeks.

Monitored by the dialysis system and a warning (Filter change) is displayed.

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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.

OCM (option)

Measuring accuracy of the clearance: ± 6 % standard deviation

Shortest measuring interval: 25 min

Time scale of the display: 10 s

ONLINEplus™ (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:
	–	UF rate
	–	Blood flow
	–	Hematocrit (HCT)
	–	Total protein (TP)
	–	Filter performance
Single Needle (option)
Blood pump	During Single Needle operation 180 seconds.
stop alarm
Single Needle pump
Stroke volume	10 to 50 ml in increments of 5 ml
External compliance	50 ml or 60 ml stroke volume
chamber

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Chapter 3: Specifications

Auto SN	+20 % (programmable in the Operator setup.)
Delivery rate of the
Single Needle pump
BPM (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
BTM (option)
Required blood flow for	≥ 120 ml/min
accurate BTM function	(The measuring and control functions of the BTM are deactivated if the
	blood flow is < 100 ml/min.)
Temperature	Accuracy of the fistula temperatures (if correct ambient temperature is
measurement	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	Accuracy of recirculation measurement
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

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Chapter 3: Specifications

Network (option)

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).

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Chapter 3: Specifications

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Chapter 4: Installation

4 Installation

4.1Preface

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!

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!

4.2Important 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.

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Chapter 4: Installation

4.3Initial Start-Up Report

5008	Initial Start-Up Report

Fresenius Medical Care

Technician's name:		Service report number:
Customer/Customer no.:
Inventory no.:	Device no.	Operating hours:
Device type including option(s):

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Chapter 4: Installation

No.	Description	Measure-
		ment
		value
1	Preparation
1.1	Hemodialysis system without visible shipping damage.
1.2	Remove the transport protection for the monitor support arm.
	Install the IV pole.
1.3	Connect the water supply tubing.
	Connect the drain and the flush tubings.
	Protect the tubings from slipping out.
	Standard: Length 3 m, internal diameter 6 mm
	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.
	CDS 1
	CDS 2
	BIC
1.5	Remove the shipping plugs from the overflows.
1.6	When turning the hemodialysis system on, perform an audible check of the watchdog alarm.
1.7	Rinse out the anti-freeze.
1.8	Select the Filter change program.
	Connect the filter. DIASAFE®plus/ONLINEplus™
	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.
3	Check – water inlet flow / adjustment – degassing
3.1	Check MaxWaterFlow.	________	Corr.:
	Desired value: 1300 ml/min to 1550 ml/min		Yes
			No
3.2	Perform the degassing adjustment.
4	Check – dialysate flow
4.1	Check flow at 800 ml/min.	________
	Desired value: 770 ml/min to 830 ml/min

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Chapter 4: Installation

	No.	Description	Measure-
			ment
			value
	5	Check – temperature
	5.1	Check PT07 (temperature) at 37 °C. (flow 500 ml/min)	________	Corr.:
		Desired value: 36.8 °C to 37.2 °C (display on hemodialysis system)		Yes
		Measure the reference temperature with an external measuring instrument.	________	No
		Difference = Reference temperature minus PT07
		Desired value – difference: –0.5 °C to +0.2 °C
	6	Check – conductivity
	6.1	Check CD7 (conductivity).	________	Corr.:
		Desired value: approx. 13.5 mS/cm to approx. 14.5 mS/cm		Yes
		Measure the reference conductivity with an external measuring instrument.	________	No
		Difference = Reference conductivity minus CD7
		Desired value – difference: ±0.2 mS/cm
	7	Check – blood leak detector
	7.1	Check the blood leak:	________	Corr.:
		Desired value: 4.8 V to 5.2 V		Yes
				No
	7.2	Check the dimness:	________
		Desired value: 4.8 V to 5.2 V

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.:
				Yes
	Reference measuring instrument: 0 mbar	________
				No
	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)
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)

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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.
9.2	Protective earth resistance maximum 0.3 ohms (with power cord)		______ Ω
9.3	Leakage current measurement (device leakage current)
	Differential current measurement according to figure C.6
	or
	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
	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).		________	Yes
				No
	Desired value: –5 mmHg to +5 mmHg
10.2	Zero point venous pressure display			Corr.:
	Check the venous pressure display (standby operation).		________	Yes
				No
	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: ±5 mmHg
	Reference measuring instrument for pressure display
	Maximum pressure drop: –0.1 bar

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.
11.2	Save calibration data and SETUP settings on a data disk.
11.3	Perform the T1 test.
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).
11.7	Record entries in the medical device register and on the machine card.
11.8	Operating Instructions and accessories package complete and appropriate for the system.

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.			Yes	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