Фрезениус 5008s ошибка гидравлики

Edition: 1/08.04

Part number: M35 179 1

0123

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

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

6.1

Important Information …………………………………………………………………………………………………

6-1

6.4

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

6-27

Fresenius Medical Care 5008 SM 1/08.04

i

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

ii

Fresenius Medical Care 5008 SM 1/08.04

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

Fresenius Medical Care 5008 SM 1/08.04

1-1

1-2

Fresenius Medical Care 5008 SM 1/08.04

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

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

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.

2-2

Fresenius Medical Care 5008 SM 1/08.04

Service

Fresenius Medical Care

Central Europe

Deutschland GmbH

Geschäftsbereich Zentraleuropa

Kundendienst / Servicecenter

Steinmühlstraße 24 I

61352 Bad Homburg

Germany

Phone: +49 6172 609-7100

Fax: +49 6172 609-7102

E-mail: ServicecenterD@fmc-ag.com

Service

Fresenius Medical Care

International

Deutschland GmbH

Service Support International

Hafenstraße 9

97424 Schweinfurt

Germany

Phone: +49 9721 678-333 (hotline)

Fax: +49 9721 678-130

Local Service

Fresenius Medical Care 5008 SM 1/08.04

2-3

2-4

Fresenius Medical Care 5008 SM 1/08.04

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

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

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

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

Fresenius Medical Care 5008 SM 1/08.04

3-3

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)

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.

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

Fresenius Medical Care 5008 SM 1/08.04

3-5

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

3-6

Fresenius Medical Care 5008 SM 1/08.04

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

Fresenius Medical Care 5008 SM 1/08.04

3-7

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

3-8

Fresenius Medical Care 5008 SM 1/08.04

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

Fresenius Medical Care 5008 SM 1/08.04

3-9

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

3-10

Fresenius Medical Care 5008 SM 1/08.04

Fresenius Medical Care 5008 SM 1/08.04

3-11

3-12

Fresenius Medical Care 5008 SM 1/08.04

Fresenius Medical Care 5008 SM 1/08.04

4-1

5008

Initial Start-Up Report

Technician’s name:

Service report number:

Customer/Customer no.:

Inventory no.:

Device no.

Operating hours:

Device type including option(s):

4-2

Fresenius Medical Care 5008 SM 1/08.04

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

Fresenius Medical Care 5008 SM 1/08.04

4-3

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)

Fresenius Medical Care 5008 SM 1/08.04

4-5

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

Fresenius Medical Care 5008 SM 1/08.04

4-9

4-10

Fresenius Medical Care 5008 SM 1/08.04

Fresenius Medical Care 5008 SM 1/08.04

4-11

4-12

Fresenius Medical Care 5008 SM 1/08.04

Fresenius Medical Care 5008 SM 1/08.04

4-13

4-14

Fresenius Medical Care 5008 SM 1/08.04

M1

Differential current measurement

according to figure C.6

L

L(N)

N

N(L)

PE

or

L

Direct measurement according to figure

C.5

Fresenius Medical Care 5008 SM 1/08.04

4-15

4-16

Fresenius Medical Care 5008 SM 1/08.04

Fresenius Medical Care 5008 SM 1/08.04

4-17

4-18

Fresenius Medical Care 5008 SM 1/08.04

Submenu

Default value

Value range

Resolution

Selectable

options

Tubing system

AV Set 5008

–

–

–

Blood pump

Submenu

Default value

Value range

Resolution

Selectable

options

Pump segment

8.0 mm

–

–

(4.4 mm)

(6.4 mm)

8.0 mm

Delivery rates

Prime

100 ml/min

30–600 ml/min

10 ml/min

–

Precirculation

100 ml/min

30–600 ml/min

10 ml/min

–

Reinfusion

100 ml/min

30–300 ml/min

10 ml/min

–

Fresenius Medical Care 5008 SM 1/08.04

5-1

Submenu

Default value

Value range

Resolution

Selectable

options

Preparation (NaCl)

Rinse vol.

500 ml

500–5000 ml

100 ml

–

(UF rinse vol.)

(0 ml)

(0–5000 ml)

(100 ml)

(–)

Reinfusion (NaCl)

Reinfusion volume

250 ml

0–480 ml

10 ml

–

Anticoagulation

Submenu

Default value

Value range

Resolution

Selectable

options

Heparin

Heparinization

Yes

–

–

Yes

No

Heparin unit

ml

–

–

ml

I.U.

Heparin start

Automatic

–

–

Automatic

Manual

Hep. rate

1.2 ml/h

0.5–10.0 ml/h

0.1 ml/h

–

10 I.U./h

10–25 000 I.U./h

10 I.U./h

–

Stop time

0:30

0:00–2:00

0:01

–

Syringe

Fresenius 30 ml

–

–

Depending on

Technician’s

Setup

(define syringe

types)

Bolus

5.0 ml/h

1.0–20.0 ml/h

0.1 ml/h

–

1000 I.U./h

0–15 000 I.U./h

10 I.U./h

–

5-2

Fresenius Medical Care 5008 SM 1/08.04

Chapter 5: Setup

Dialysate

Submenu

Default value

Value range

Resolution

Selectable

options

Dialyzer

FX series

–

–

FX series

F series

others

Auto flow factor

1.2 (depending on

–

–

not adjustable

dialyzer)

Empty bibag

Automatic

–

–

Automatic

Manual

Ultrafiltration

Submenu

Default value

Value range

Resolution

Selectable

options

Maximum UF rate

3000 ml/h

500–4000 ml/h

10 ml/h

–

Maximum profile rate

3500 ml/h

3010–4000 ml/h

10 ml/h

–

Program. UF profile

Closed

–

–

Closed

Released

UF start

Automatic

–

–

Automatic

Manual

UF goal

0 ml

0–9990 ml

10 ml

–

UF time

0 hrs 0 min

0–24 hrs.

1 min

–

UF rate

0 ml/min

0–4000 ml/min

10 ml/min

–

Fresenius Medical Care 5008 SM 1/08.04

5-3

Submenu

Default value

Value range

Resolution

Selectable

options

Tone Mute time

120 seconds

60–120 seconds

10 seconds

–

Warning times

Flow off

10 min

–

–

10 min

20 min

30 min

UF off

5 min

5–15 min

1 min

–

Heparin off

1 min

1–5 min

1 min

–

Arterial/venous

pressure settings

Art. alarm limit

Centered

–

–

Centered

Asymmetric

Art. window width

100 mmHg

40–200 mmHg

10 mmHg

–

Ven. alarm limit

Asymmetric

–

–

Asymmetric

Centered

Ven. window width

100 mmHg

40–200 mmHg

10 mmHg

–

Ven. window position

Unlimited

–

–

Unlimited

≥ 20 mmHg

5-4

Fresenius Medical Care 5008 SM 1/08.04

Chapter 5: Setup

User interface

Submenu

Default value

Value range

Resolution

Selectable

options

Screen saver

Screen saver

Yes

–

–

Yes

No

Delay

5 min

1–60 min

1 min

–

Graphics

The diagram types listed under selectable options can be assigned to a group.

Each group can contain a maximum of 4 graphics. Each diagram type can be

contained in any group, but only once. Graphics can be assigned only if the

particular option is available.

Group 1

UF Na diagram

–

–

UF Na diagram

OCM diagram

Pressure graphs

Pressure graphs

BTM

BPM history

BPM

BPM (MAP)

BVM

OCM diagram

BPM history

Group 2

BPM

–

–

See group 1

BPM (MAP)

Group 3

–

–

See group 1

Group 4

–

–

See group 1

Defining options

A maximum of 4 option buttons may be added The option buttons which have been

added will appear on the lower right above the SYSTEM button.

(If the BPM option is available, a maximum of 3 options may be created.)

Options can be added only if the particular option is available.

Option

HEPARIN

–

–

HEPARIN

ONLINE

EMERGENCY

CIRCULATE

SINGLE NEEDLE

ONLINE

OCM

BPM

BVM

BTM

Defining controls

–

–

–

–

–

Fresenius Medical Care 5008 SM 1/08.04

5-5

Submenu

Default value

Value range

Resolution

Selectable

options

Mand. cleaning pgm.

Yes

–

–

Yes

after treatment

No

5-6

Fresenius Medical Care 5008 SM 1/08.04

Chapter 5: Setup

Auto On

Submenu

Default value

Value range

Resolution

Selectable

options

Weekly programs

The program and the power-up time may be preselected.

Then turn programming on or off via Status.

If various programming actions have been performed, it is possible to turn them all

on or off via the Auto On Programs I/O button.

Program

No program

–

–

Rinse

Heat disinfection

T1 Test

No program

Power-up time

00:00

00:00–24:00

1 min

–

Single programs

The program and the power-up time may be preselected.

Then turn programming on or off via Status.

If various programming actions have been performed, it is possible to turn them all

on or off via the Auto On Programs I/O button.

Program

No program

–

–

Rinse

Heat disinfection

T1 Test

No program

Power-up time

00:00

00:00–24:00

1 min

–

Fresenius Medical Care 5008 SM 1/08.04

5-7

Submenu

Default value

Value range

Resolution

Selectable

options

UF off

Yes

–

–

Yes

No

Blood flow reduction

Yes

–

–

Yes

No

Blood pressure

No

–

–

Yes

measurement

No

Online bolus

Yes

–

–

Yes

No

Bolus

90 ml

90–240 ml

30 ml

–

Bolus rate

200 ml/min

50–250 ml/min

10 ml/min

–

Patient card

Submenu

Default value

Value range

Resolution

Selectable

options

Patient card

Writing to the patient card:

– Patient card button In the Operator setup touched.

– Remove the operator card.

– Insert the patient card.

– Message: Patient card for … date of birth… – OK.

– Touch the OK button.

– Insert the desired patient data.

(After touching the desired field, the patient data may be entered via the

keypad.)

– Touch the OK button to confirm the entered patient data.

Visually check the confirmed patient data.

– Touch the Create patient card button.

– Message: Saving data to card. Leave card inserted!

– Remove the patient card after the message disappeared.

First name

–

–

–

–

Surname

–

–

–

–

Finesse ID

–

–

–

–

Date of birth

–

–

–

–

5-8

Fresenius Medical Care 5008 SM 1/08.04

Submenu

Default value

Value range

Resolution

Selectable

options

Treatment mode

Treatment mode

HDF postdilution

–

–

HD

HDF predilution

HDF postdilution

HF predilution

HF postdilution

Bolus

Bolus

150 ml

90–240 ml

30 ml

–

Bolus rate

200 ml/min

100–250 ml/min

10 ml/min

–

Preparation (Online)

Onl. rinse vol.

800 ml

500–5000 ml

100 ml

–

Onl. UF rinse vol.

500 ml

0–5000 ml

100 ml

–

Reinfusion (online)

Reinfusion volume

360 ml

60–480 ml

60 ml

–

Substitution

Auto-sub

Yes

–

–

Yes

No

Submenu

Default value

Value range

Resolution

Selectable

options

OCM start

Automatic

–

–

Automatic

Manual

Kt/V warning

Yes

–

–

Yes

(see OCM description)

No

Fresenius Medical Care 5008 SM 1/08.04

5-9

Submenu

Default value

Value range

Resolution

Selectable

options

Maximum stroke vol.

50 ml

–

–

–

Stroke volume

35 ml

10-50 ml

5 ml

–

Rate ratio

+20 %

–60 % to +60 %

5 %

–

(ratio blood pump

speed to SN pump

speed)

Miscellaneous

Submenu

Default value

Value range

Resolution

Selectable

options

Installation place

Installation place of the 5008 hemodialysis system may be entered here (e.g. name

of the clinic).

Submenu

Default value

Value range

Resolution

Selectable

options

SYS max

165 mmHg

100–280 mmHg

1 mmHg

–

DIA max

100 mmHg

100–240 mmHg

1 mmHg

–

MAP max

120 mmHg

80–255 mmHg

1 mmHg

–

PULSE max

150 1/min

50–245 1/min

1 1/min

–

SYS min

90 mmHg

30–140 mmHg

1 mmHg

–

DIA min