ak 95 monitor_service manual

AK 95 / AK 95 SService Manual

A better way to better care

AK 95 / AK 95 S - Service manual

Contents:

Chapter 1 Installation guide

Chapter 2 Technical description

Chapter 3 Technical data

Chapter 4 Service technicians guide

Chapter 5 Maintenance manual

Chapter 6 Calibrations

Chapter 7 Spare parts list

Chapter 8 Cable survey

Chapter 9 Symbol description

Chapter 10 Replacements

Chapter 11 Electrical safety inspections

Preface

About this manual This service manual provides the information needed to install the AK 95 or AK 95 S monitor and how to carry out maintenance and calibrations. It is a guidance how to identify and repair faults that may occur. All information, texts and figures, are valid for AK 95 S. If the information is specific for AK 95 only, it is stated in the corresponding text.

Installation Installation of the machine should be done in accordance with the recommended procedures in the Installation Guide. When installing a new monitor kindly remember to fill out the Installation / Out of Box report and return it to: Gambro Lundia AB Monitor Division Magistratsvgen 16 PO Box 10101 SE-220 10 Lund Sweden This is an important information and it will assist us to improve the product for you. The Out of Box system is not valid for products, components or printed circuit boards that isn't in its original delivered condition.

Complaint If a complaint is raised it shall be communicated to the relevant Gambro Sales Company. In order for the Sales Company to be able to determine the relevance of a complaint, it is of vital importance that the deviation is communicated to them as comprehensive as the issue requires. Complaints are important information and it will assist Gambro to improve the product for you. The Complaint system is not valid for products, components or printed circuit boards that isn't in its original delivered condition. Disclaimer The manufacturer accepts responsibility for the safety, reliability, and performance of this equipment only if installation, operational procedures, maintenance, calibrations, and repairs are carried out by appropriately trained and suitable qualified people; if all

equipment modifications are authorized in writing by the manufacturer and carried out by appropriately trained and suitable qualified people; if the electrical installation of the relevant room complies with all applicable local electrical codes and, if applicable, IEC requirements; and if the equipment is used in accordance with the published Operators Manual.

Maintenance To ensure proper operation of the AK 95 / AK 95 S, a qualified service technician must perform a complete series of maintenance procedures at regular intervals. The maintenance and calibration information that you need to use is provided in this Service Manual. It is mandatory to perform at least a preventive maintenance every second year. A yearly maintenance is recommended. The rate of preventive maintenance might be different due to variations of the operating environment.

Competence of Service Engineers There is a certain minimum level of competence required for Service Engineers who are to maintain and repair Gambro products, summarized as follows. A Service Engineer is considered suitable qualified if he/she has: 1. Practical experience of the AK 95 S

monitor.

2. Attended AK 95 S technical service course and has been given a certificate stating that the technician has passed the course.

3. Access to the recommended test equipment and special tools detailed in this Service Manual.

4. Access to the recommended spare parts, see section Spare Parts List.

5. Access to and understanding of the AK 95 S Operator's Manual, HCEN9794 or AK 95 Operator's Manual, HCEN9542.

In general, this policy implies that training will be carried out by Gambro Lundia AB: Monitor Division, while local markets are responsible for their own service organization.

Repair Parts which are sent for repair shall be sent to the following address: Gambro Lundia AB Monitor Division Workshop Magistratsvgen 16 PO Box 10101 SE-220 10 Lund Sweden Technical support For technical support please contact your local Gambro Service representative.

Valid revision Publication no. Denomination HCEN9095, Rev. 10.2006 AK 95 / AK 95 S -

Service Manual The complete AK 95 / AK 95 S - Service Manual, HCEN9095, consists of the following separate chapters: HCEN9133 Rev. 01. 2004 Installation Guide HCEN9134 Rev. 10. 2005 Technical Description HCEN9369 Rev. 10. 2005 Technical Data, AK 95S HCEN9135 Rev. 10. 2005 Technical Data, AK 95 HCEN9136 Rev. 10. 2005 Service Technicians

Guide HCEN12189 Rev. 10. 2006 Maintenance Manual HCEN9138 Rev. 10. 2005 Calibrations HCEN9094 Rev. 10. 2005 Spare Parts List K16756 CO 25702 Cable Survey HCEN9160 Rev. 10. 2005 Symbol Description HCEN12078 Rev.10. 2005 Replacements HCEN12190 Rev. 05. 2006 Electrical safety

inspections All rights reserved. Copyright Gambro Lundia AB, Sweden, 1996 Gambro Lundia AB Monitor Division Box 10101 SE-220 10 Lund Sweden Tel: +46 46 16 90 00 Fax: +46 46 16 96 96 www.gambro.com

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Installation GuideAK 95 / AK 95 S

January 2004

AK 95 / AK 95 S Service ManualHCEN 9133 Rev. 01. 2004

Installation Guide

1:1

1. Installation GuideContentsInstallation

Unpacking and inspection .......................... 1:2Environment and ........................................ 1:2Physical Data .............................................. 1:2

Operating Environment ........................ 1:2Transport and Storage Environment .... 1:2Physical Data ......................................... 1:2Mains Voltage and Power ...................... 1:3Consumption .......................................... 1:3Service Outlets ....................................... 1:3Line Fuses .............................................. 1:3Mains Water Supply .............................. 1:3

Tools ............................................................. 1:3Top Tray....................................................... 1:3Connection to the Water Supply ................ 1:4Connection to the Power Supply ................ 1:4Connection of the battery ........................... 1:4How to remove the cover toconnect the battery ..................................... 1:5Installation of RP 95 S ................................ 1:6Back-up battery ........................................... 1:8Turn on the AK 95 S .................................... 1:9Functional check - Fch............................... 1:9Recommended start-up procedure .............. 1:9Checklist ..................................................... 1:11

Note!This installation Guide provides the information needed toinstall both AK 95 and AK 95 S.The text from this point forward only states AK 95 S.


1:2

Installation Guide

Figure 1. AK 95 S Units.

Ensure that the specified equipment has beendelivered. Do the packages contain the specifiedmonitor and options? Are there any units/components missing? Check the additionalpacking list (inside the additional package box).If in doubt, please contact your Gambro Serv-ice representative.

Ensure that the voltage specified on the voltagetag matches the mains voltage. If in doubt,please contact your Gambro Servicerepresentative.

The AK 95 S can be installed in most environ-ments if certain conditions as the temperature,relative humidity, mains voltage etc. are met.

Operating Environment

AK 95 S:Ambient temperature: +18 C to + 35 CRelative humidity: 15 % - 85 %Air pressure: 70 - 106 kPa

AK 95:Ambient temperature: +10C to + 35 CRelative humidity: 30% - 85 %Air pressure: 70 - 106 kPa

Transport and Storage EnvironmentUnits being transported or stored must be keptin their original packaging. Units must behandled en route in accordance with specialinstructions. Units can be transported or storedin the following environment for up to 15 weeks:

Ambient temperature: -20 C to +70 CRelative humidity: 10 % - 96 %Air pressure: 50 - 106 kPa

Note!Units to be transported and/or stored formore than 15 weeks may only be subjected tothe conditions specified under Operating Envi-ronment.

Environment andPhysical Data

Unpacking andinspectionWhen unpacking, the equipment should bechecked. If the equipment is in any way dam-aged, proper operation cannot be guaranteed.Please contact your Gambro Servicerepresentative.

The packages contain the units and componentsshown in Figure 1.

Installation

Physical Data

AK 95 S: Depth Width Height Weight mm mm mm kg

Machine 600 480 1270 78Stand 625 580 (all options

included)

AK 95: Depth Width Height Weight mm mm mm kg

Machine 420 350 1270 62Stand 680 625


Installation Guide

1:3

AB

AcetateEN

1075

Lift points Lift points

ToolsThe tools listed below are needed during theinstallation procedure.

Tube cutter, 113 500 084 Adjustable wrench, 113 003 009 Hexagon spanner set Screwdriver, 1,2 x 8,0 - 175mm,

113 002 006

Top TrayTo avoid leakage into the machine, the top traymust always be placed on the top of the ma-chine, except during technical service.

Mains Voltage and PowerConsumptionThe AK 95 S must be plugged into a groundedpower point not more than 3 metres distant.

Mains voltage:100 V(at 50 Hz or 60 Hz)110 V(at 50 Hz or 60 Hz)230 V(at 50 Hz or 60 Hz) (12%)

Power consumption:2025 W at 230 V1575 W at 110 V1275 W at 100 V

Service OutletsOne extra grounded power socket should beavailable close to the AK 95 S, for troubleshoot-ing and maintenance purposes.

Line FusesNever overload the line fuses and do not supplytoo many systems via a single line fuse.

Mains Water SupplyRequired quality:Level of purity according to ASAIO and AAMIrecommended standards on feed water fordialysis monitors.Water for the dialysis unit has to be suppliedfrom a Reverse Osmosis purification system.

Pressure:1.2 - 6 bar to the pressure regulator mounted inthe MM 95.

Note! The pressure should be measured withthe flow from the water supply.

Temperature:+5 C to +30 C (treatment)

Consumption in treatment:AK 95 S: 500 ml/minAK 95: 550 ml/min

Drain: Open type. Not more than 1.2 metresabove outlet from fluid monitor.

Note! Local ordanances may require the use ofspecial measures to protect against the possibil-ity of back-siphonage from dialysis equipmentinto the water supply. When installing theAK 95 S, such ordanance should be observed.

Figure 2. AK 95 S


1:4

Installation Guide

Connection to the WaterSupplyThe water must fulfil all requirements set outunder Environment and Physical Data.

Connection to the PowerSupply

Main switch,ON/OFF

Mains power,connected to agroundedpower socket

Water in

Drain

Fuses

Connection of the BatteryThe rechargeable 9V battery (100 224 006) isused to drive the buzzer alarm during mainspower failure. The battery is not connected atdelivery.

NOTE! The battery must be connected duringthe installation according to the instruction onnext page.

A discharged battery will be charged withmaximum 10 mA and it must be charged for atleast 50 hours to get completely charged. An all-up charged battery will receive a maintainingcurrent of approximately 1,5 mA. The AK 95 Scharge the battery as long as the AC/DC con-verter is switched on, i.e. AK 95 S itself does notneed to be switched on.

The battery is tested during every functionalcheck to ensure that the capacity is enough inthe battery, otherwise an attention will begiven:

BATTERY FAILUREChange battery or press SELECT

NOTE! Jumper J200 on the Protective Driverboard must be mounted for the rechargeablebattery.If use of an alkaline non-chargeable battery,jumper J200 must be removed, if not, thebattery will be damaged.


Installation Guide

1:5

AB

Acetate

1070

A A

How to remove the cover to connectthe battery.1. Loosen the three cover bolts, accessible

underneath the fluid part.

2. Move the cover upwards and then back-wards.

3. Pull the cover to the right just 10 mm (if youare positioned in front of the AK 95 S).

4. Turn the cover backwards counter-clockwiseto pass the circuit boards and the cover canbe removed.

5. Connect the rechargeable battery to boardconnector P205 on the Protective Driverboard.

A

Cover

Front


1:6

Installation Guide

GAMBRO

Step 2

1. Put the RP 95 S unit into the front holeof the stand. Fasten it with the attachedspacer and screw ( M4, 16mm)

2. Fasten the screw (with black plasticknob).

GAMBRO

1GAMBRO

2

3MBRO

4

5

6

NOTE! This instruction is for AK 95 S equipped with RP 95 S at delivery.RP 95 S can also be ordered and installed as a kit, K23054. Refer to rebuilding instruction K23055.

Installation of RP 95 S

Step 1

1. Loosen the two screws (withblack plastic knobs) under theservice tray holder.

2. Pull out the service tray holderto its end position.

3. Loosen the two hexagonalsocket screws.

4. Remove the service tray holdercomplete.

5. Fasten the hexagonal socketscrews again.

6. Attach the plug to the rear holeof the stand and fasten thescrew (with black plastic knob).


Installation Guide

1:7

GAMBRO

GAMBRO

180

90

Step 3

1. Turn the RP 95 S 180 in counterclockwise direction.

2. Rotate the RP 95 S 90 to beparallel with the AK 95 S front.

21

Step 4

1. Fasten the cable on the right upperpart of the stand with the enclosedcable holder and screw.

2. Fasten the cable even on the backpart of machine with the enclosedcable holder - use an existing screw.


1:8

Installation Guide

Back-up BatteryThe optional back-up battery is pre-assembledunder the monitor stand at delivery.

Let the machine stay with the ACDC-unit inpower on mode over night in order to chargethe batteries.

Replacement of the lead acid batteries must bedone according to following electrical diagram.

Both lead acid batteries must be changed at thesame time and only batteries approved orsupplied by Gambro Lundia AB may be used.

Changed batteries must be recycled or disposedof properly.

Fuse: T15 ARunning time: 30 minutes

The charge indicator on the power supply is litwhen the AK 95 S is equipped with the back-upbattery. The machine must be connected tomains voltage and the mains switch must be on.

In a mains failure situation following attentionwill be given.

POWER FAILURE, BATTERY OPERATIONBattery operated for x minutes

Before the battery is empty following attentionwill be given.

LOW BATTERY POWERMachine turnes off in one minute


Installation Guide

1:9

Turn on the AK 95 SThe ON/OFF button on the Operators Panel isused to turn the machine on and off.

The ON/OFF button must be pressed at least 3sec. in order to switch the machine on and off.

The main switch on the power supply shouldalways be in ON position, even when themachine is not in use. This Stand by mode isindicated by a lit segment on the TIME displayon the operators panel.

If a power failure occurs when AK 95 S is work-ing, the same segment in the TIME display isflashing.

For further information about operatinginstructions, please see:AK 95 S Operator's Manual, HCEN 9794orAK 95 Operator's Manual, HCEN 9542.

Functional check - FchEach time the AK 95 is started, the automaticfunctional check, Fch, is carried out.

The functional check will be aborted if Rinse/Drain or any of the disinfection modes areselected.

h.minTime

h.minTime

Recommended start-upprocedureFirst check:

That the 9V battery is connected.

That the mains cable is connected to power.

That the main switch on the rear of themonitor is turned on.

That the machine is connected to the watersupply.

That the drain tube is properly connected tothe machine and placed with an air gap betweenthe drain tube and the drain.

That the dialysis fluid tubes are connected tothe safety couplings.

Start the machine

1. Press the ON/OFF button for 3 seconds.

2. Perform a Heat disinfection procedure accord-ing to the Operators Manual.

3. Perform a complete functional check accord-ing to the Operators Manual.


1:10

Installation Guide



Installation Guide

1:11

Checklist - Check if applicable

Yes

Chec

klis

t - file

d by

the

Sevic

e En

gi-

neer

resp

onsib

le fo

r the

inst

alla

tion.

Unpacking and inspectionEnsure that the specified equipmenthas been delivered.

Check that the additional package boxcontains the specified components.

Check, by visual inspection that themachine shows no sign of damage.

Environment and Physical DataEnsure that the Operating Environmentis according to the specifications.

InterconnectionEnsure that the monitors are intercon-nected correctly.

Top TrayEnsure that the top tray is placed atthe top of the machine.

Connection to the Water SupplyEnsure that the machine is correctlyconnected to the Water Supply.

Ensure that the water fulfils all require-ments set out under Environment andPhysical Data.

Ensure that the machine is correctlyconnected to the drain.

Connection to the Power SupplyEnsure that the voltage specified on thevoltage tag matches the mainsvoltage.

Ensure that the machine is correctlyconnected to the Power Supply.Mains power must be connected to agrounded power socket.

Connection of the BatteryEnsure that the rechargeable 9V battery iscorrectly connected according to the instruc-tions.

Connection of the dialysis fluid tubesEnsure that the dialysis fluid tubes areconnected to the safety couplings.

Start-up procedure

Note! If you have any remarks during installa-tion, please contact your Gambro Servicerepresentative.

This record is to be signed and filed by the Service Engineer responsible for the installation.

Date............................Signature........................................................................

Serial number: ..................................

Ensure that the recommendedstart-up procedure is followed.

Out of box reportFill out the Installation / Out ofBox report and return it to:

Gambro Lundia ABMonitor DivisionMagistratsvgen 16PO Box 10101SE-220 10 LundSweden


1:12

Installation Guide


Gambro Lundia AB, Monitor DivisionBox 10101SE-220 10 LundSweden

Tel: +46 46 16 90 00Fax: +46 46 16 96 96www.gambro.com

HC

EN

9133

G

ambr

o Lu

ndia

AB

,199

6. R

evis

ion

Janu

ary

2004

AK 95 / AK 95 S Service ManualHCEN 9134 Rev. 10.2005

Technical Description

2:1

2. Technical Description

ContentsIntroduction

General ........................................................ 2:2Protective system: .................................. 2:2

System and Treatment Parameters ........... 2:3

Fluid PartFlow Diagram.............................................. 2:4Valves .......................................................... 2:4Flow Diagram with Service Variables ........ 2:5Flow Diagram with Service Variables ........ 2:6Treatment .................................................... 2:7

Fluid part: .............................................. 2:8MM 95: ................................................... 2:9Fluid part, continue: ............................ 2:11

Disinfection and rinse ............................... 2:13Heat disinfection .................................. 2:13

Component Description ............................ 2:14Relayboard ........................................... 2:14Pressure regulator ............................... 2:14Conductivity measuring unit .............. 2:14Degassing chamber .............................. 2:14Deairating chamber ............................. 2:14Flow pump unit .................................... 2:14Dialyzer connections ............................ 2:14Safety coupling unit ............................. 2:14UF measuring unit .............................. 2:14FM I/O board ........................................ 2:14Heater unit ........................................... 2:14Blood leak detector .............................. 2:15Suction pump ....................................... 2:15Distribution board ............................... 2:15CPU board ............................................ 2:15Battery ................................................. 2:15Expansion board .................................. 2:15Prom module board .............................. 2:15Fan........................................................ 2:15Driver board ......................................... 2:15

Rear printed circuit boards ....................... 2:16

Blood PartBlood Flow Diagram ................................. 2:17Treatment .................................................. 2:18Component Description ............................ 2:19

Arterial pressure guard ....................... 2:21Blood pump unit .................................. 2:21Heparin pump ...................................... 2:21Venous pressure transducer ................ 2:21Arterial pressure transducer (option) . 2:21Air detector .......................................... 2:21Priming detector .................................. 2:21

Operators panel ......................................... 2:22BPM ........................................................... 2:23

Power SupplyDesign ........................................................ 2:24Block Diagram Description ....................... 2:25



2:2

GeneralThe AK 95 S is designed to be used as a singlepatient machine to perform conventional hemo-dialysis. The AK 95 S can be divided into threeparts:

Blood part Fluid part Operators panel

The blood part is used to control and monitorthe extra corporeal blood flow through thedialyzer and, where applicable, to control theaddition of heparin to the blood before dialysis.Both Single needle and Double needle treatmentare carried out with one blood pump.Disposable blood lines are used for the bloodflow. The blood part includes the following mainfunctions:

Blood flow regulation Venous blood pressure monitoring Arterial pressure monitoring Heparin flow regulation Air detection Priming detector Arterial and venous line clamps control

The fluid part is used to produce dialysis fluid(with the correct temperature and correctconductivity) from water and concentrate, and totransport the fluid through the dialyzer.

The fluid part maintains the dialysis flowthrough the dialyzer with controlled ultrafilt-ration.If a fault occurs, the fluid part bypasses thedialyzer.

AK 95 S fluid part includes the following mainfunctions:

Inlet pressure monitoring. Temperature monitoring and regulation. Conductivity monitoring and regulation. Degassing pressure and flow regulation. UF measuring and regulation. High pressure monitoring. TMP monitoring. Blood leak detection. pH meassurement of the fluid, optional.

Introduction

AK 95 S operates in either acetate- orbicarbonate mode. In bicarbonate mode themonitor mixes dialysis fluid from water and twoconcentrates: acid and bicarbonate. The mode isselected from the operator's panel.

A disinfection must be performed after everytreatment. Both heat disinfection and chemicaldisinfection are available.

The power supply supplies the AK 95 S with thenecessary supply voltages. The mains voltage isalso used to supply the heater within the AK 95S.

The AK 95 S is operated from the operatorspanel located on the blood part. The panel hasan overlay translated into different languages.

For information about the use and function ofthe panel, see the document AK 95 OperatorsManual, HCEN 9542 or AK 95 S OperatorsManual, HCEN 9794.

Protective systemAK 95 S is equiped with a protective system.The main task is to supervise the dialyzingprocess and if needed take correct action toprevent hazard to the patient. The protectivesystem can take actions independently of thecontrol system. It is a separate system, with itsown sensors and electronics.

Protective system is responsible for setting theAK 95 S in a patient safe state when any of thesupervised parameters exceed their approvedlimits.

The control system has to start up the AK 95 Sin a controlled way when the hazardous situa-tion is cleared.

The kind of action that is to be taken depends ofin which state the AK 95 S is, for exampletreatment or disinfection.

Another task of protective system is to make afunction check of AK 95 S sub systems.

The protective system of AK 95 S is separated intwo parts, the blood part and the fluid part.



2:3

Level Type of parameters Adjustable by...

4 Treatment parameters Operator, nurse

3 Alarm limits and Clinics techniciandefaults

2 Clinic or customer Gambro technician oradaptions Gambro subsidiary

1 Market adaptions Gambro Head office

0 Safety limits Fixed

System and TreatmentParametersThe system and treatment parameters can beset at five different levels (table 1).

Table 1. System and Treatment parameters

For information about the use and functions ofthe parameters in level 2 and 3, see the chapterTechnicians Guide.

For information about the use and functions ofthe parameters in level 4, seeAK 95 Operators Manual, HCEN 9542 orAK 95 S Operators Manual, HCEN 9794.

Figure 1. AK 95 S.

AB

Acetate

1002



2:4

Flow DiagramFluid Part

Figure 2. AK 95 S Flow Diagram, Bicarbonate/BiCart

ValvesINVA Inlet valveDRVA Degass restrictor valveRIVA Rinse valveZEVA Zero (UF) valveDIVA Direct valve

BYVA Bypass valveTAVA Taration (UF) valveEVVA Evacuation valveAIVA Air inlet valveREVA Recirculation valveFLVA Flush (BCH) valve

B, Ac

A

B

DIVABYVA

ZEVA

PBlood LeakDetector

PINPS Heater

T VA

ParticleFilter

P

EVVA

OutletRestrictor

Safety by-passUnit

SAGSP

T

Cond.Cell "A"

HPG

DRVA

P

Degassingpressure

transducer

SuctionPump

DeairatingChamber

DrainingRestrictor

FlowRestrictor

Mixing ChamberMixing Chamber

UF-measuringCell

FeedingPumps

MM 95

WaterInlet

Drain

A

Flow diagramAK 95 S

FlowPump

DegassingChamber

LevelDetector

Dialyzer

T

Bi- Cart

FLVA

RIVA

PressureregulatorPR 1

REVA

AIVAC

PR 2

12

PressureDialysis(PD)

pH-SENSOR(Optional)

T

Cond.Cell "B"

T

Cond.Cell P

Heatexchanger

Flowswitch

INVA

Fluid connectordetection

Expansionchamber

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M

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2:7

TreatmentFluid part:This technical description of the AK 95 S isbased on the flow diagram on page 2:5.

Water is taken in through a pressure regulator,PR 1, and a heat exchanger, before enteringthe AK 95 S fluid-unit. The pressure regulator isset to approximately 600 mmHg, measured afterthe heat exchanger.

The inlet pressure switch, INPS, detects toolow pressure. If the inlet pressure is too low (lessthan +99 mmHg), the inlet valve, INVA, isclosed, the heater is switched off and theAK 95 S enters the fluid bypass mode. An atten-tion will be given when the pressure is too low.

The inlet pressure should be constant, butnormally there are small fluctuations. Thesecond pressure regulator, PR 2, is used toensure a constant pressure, approximately+130 mmHg. Normaly during treatment INVAis open.

The main function of the temperature transduc-ers in the AK 95 S is to measure the dialysisfluid temperature and control the heat regula-tion. The regulating temperature transducer,TReg, is located after the heater.

The TReg transducer is used in the fast tempera-ture control loop. The set value for the loop is theset value entered by the user adjusted for themeasured temperature drop to the conductivitycell B.The temperature drop is calculated when thetemperature measured at cond.cell B is stable.The temperature considers to be stable when ithas been in a window of 0.25 C for one minuteor more.

The function of the flow switch is to sense ifthere is fluid flow or not through the heater.If the flow switch does not detect flow, theheater will be switched off in order to protect theheater from overheating.

There is a temperature transducer in eachconductivity cell, used for compensating theconductivity calculation.



2:8

Figure 3. AK 95 S - Fluid part

Heater/Flow switch

Heater

FM I/O board

UF-measuring cell

Suction pump

Blood leak detector

Dialyzer connectionClamp house

Line clamp unit

Deairating chamber

Expansion chamber

Degassing chamber

Pressure regulator, PR2

INVARIVA

BYVA

DIVAZEVATAVAEVVA

Variable flow unit(Stepper motor)

AIVAREVA

Conductivity cell P

Flow pump



2:9

MM 95:The concentrate connectors are connected to thewater flow path by self-sealing valves.The heated water flows through the feedingpumps. The pumps are ceramic, and need aconstant flow of water through the pump ele-ment; this acts as a lubricant.

In Bicarbonate mode the acid concentrate istaken up through the red A-concentrate connec-tor by the A-pump and added to the water flow.The acid/water mixture goes through a mixingchamber, to prevent air from causing unstableconductivity readings, before entering the A-conductivity cell. The measurement from theA-cell is compared with the required conductiv-ity and any difference between the two willresult in a change of the A-pump speed to correctthe difference. There is a temperature trans-ducer in the conductivity cell to compensate theconductivity calculation since it varies withtemperature, approximately +1,8 % per C.

The bicarbonate concentrate is taken up throughthe B-concentrate connector by the B-pump andadded to the acid/water solution. The acid/

bicarbonate/water mixture goes through thesecond mixing chamber, to prevent air fromcausing unstable conductivity readings, beforeentering the B- conductivity cell. The meas-urement from the B-cell is compared with therequired conductivity and any difference be-tween the two will result in a change of theB-pump speed to correct the difference. There isa temperature transducer in the B-conductivitycell to compensate the conductivity calculationsince it varies with temperature, approximately+1,8 % per C.

When BiCart is mounted, the flushing valve,FLVA, is used for priming of the BiCart car-tridge. FLVA is also used during fill up of di-luted chemical disinfection solution.

Note that in acetate mode the A conductivity celland A pump are not used. The acetate concen-trate is taken up through the blue B-concentrateconnector.

The mixed fluid is then passing the (optional)pH-sensor before leaving the MM 95.

B, Ac

A

B

T

Cond.Cell "A"

T

Mixing ChamberMixing ChamberFeedingPumps

MM 95

ACond.Cell "B"

Bi- Cart

FLVA

pH-SENSOR

Figure 4. MM 95 - Flow diagram



2:10

HeatExchanger

FLVA

A

B

MixingChambers B

A

B

AFeedingPump

ConductivityCell

Figure 5. MM 95



2:11

The treatment is carried out under controlledultrafiltration, UF. The UF- volume is a meas-ure of the ultrafiltrate. The differential flow ismeasured in the UF measuring cell. Therequired UF-rate is selected by setting thetreatment time and the UF-volume. The actualUF-rate is compared with the required UF-rateand the suction pump is regulated so that thedesired UF-rate is obtained. If the actual valueis lower than the required value, the suctionpump will run faster. When the operator adjuststhe UF- volume or treatment time, the systemautomatically calculates the UF-rate.

Every 30 minutes during treatment, the UF-cellis automatically self-calibrated. This is called ataration. This has to be done because wasteproducts in the fluid returned from the dialyzerwill be deposited in layers on the inside of themeasuring channel 2. The taration can bedivided into two phases:

Phase 1: Offset (Zerosetting) phase. The UFmeasuring cell and the dialyzer are discon-nected, i.e. there is no fluid passing throughneither of the two channels in the UF cell. Theoffset of the two measurement channels can nowbe measured.

During this phase the DIVA, BYVA and TAVAvalves are closed and the ZEVA valve is open.The pressure in the flow path is controlled bythe suctionpump. The HPG-pressure is used andthe set value is the pressure measured justbefore start of the self-calibration.

Phase 2: Coefficient (flow deviation) phase. Thedialysis fluid is led past the dialyzer but throughthe UF unit, i.e. the same amount of fluid ispassing through both channels of the UF cell.The DIVA, TAVA and ZEVA valves are closedand the BYVA valve is open. The calibrationcoefficient of channel 2 can now be calculated,channel 1 is reference.

The taration takes totally about 60 seconds.When the taration is completed, the treatment isresumed.

Before the UF measuring cell there is a pres-sure transducer, HPG (high pressure guard).INVA is closed if the pressure measured by theHPG transducer is above or equal to +550 mmHg(presetable).

Fluid part, continued:The degassing chamber is used to separate airfrom the dialysis fluid. A negative pressure iscreated by means of the flow restrictor to-gether with the flow pump. This degassingpressure is presettable between -400 mmHg and-700 mmHg, to adjust the degassing on highaltitudes.

The air expands in the expansion chamber. Adraining restrictor is integrated in the bottonof the expansion chamber.

The degassing pressure transducer, whichmeasures the negative pressure, is used tocontrol the flow pump in order to ensure thecorrect degassing pressure. The air bubbles areseparated in the degassing chamber. When thefluid level in the degassing chamber reaches theminimum level depending on increased airpressure, the float valve in the degassing cham-ber is opened and the air is led from thedegassing chamber to the drain via the suctionpump. When the fluid level in the degassingchamber reaches the maximum level, the floatvalve is closed. The dialysis fluid is taken out inthe bottom of the degassing chamber. Therinsing valve, RIVA, is closed during treatment.During disinfection the rinsing valve is open, inorder to fill the degassing chamber completely.

The flow restrictor is also used to control themain flow in the system. The main flow is vari-able between 300-700 ml/min in steps of 20 ml/min. The degassing restrictor valve, DRVA, isregulated to achieve correct flow. During disin-fection and rinse this valve is completely open.

The third conductivity cell, Cond.Cell P, is onlyused for the protective system.There is a temperature transducer in the con-ductivity cell to compensate the conductivitycalculation since it varies with temperature,approximately +1,8 % per C.

Figure 6. Flow pump and degassing chamber



2:12

For example, if there is a blockage somewhere inthe tubes, the HPG generates an alarm and theAK 95 S enters the bypass mode.

Treg after the heater is used together with thetemperature transducer on conductivity cell B,to control the heater.

The bypass unit includes two valves:The direct valve, DIVA, is normally open duringtreatment (if the temperature, pressure, conduc-tivity etc. are within the predefined limits).The direct valve is closed and the bypass valve,BYVA, is opened when the dialysis fluid isbypassed from the dialyzer. The dialysis fluid isled past the dialyzer directly to the drain.

The dialysis fluid is forwarded to the dialyzervia the output tube.

From the dialyzer the dialysis fluid (mixed withwaste products) is returned to the fluid unit viathe input tube. The input tube nipple is fittedwith a filter.

The Dialysis fluid pressure transducer, PD,after the dialyzer measures the dialysis fluidpressure. This pressure transducer is the mostimportant pressure transducer in the system.PD is used for calculation of the transmembranepressure, TMP.

TMP is calculated by the system and presentedon the operators panel. If the TMP is not withinthe predefined limits, an alarm is issued.

The dialysis fluid is fed to a deairating cham-ber, which is used to separate air from the fluid.For example, a leakage may occur in the dialyzerconnection. It is important that the air bubblesare separated from the dialysis fluid, otherwisethe UF measuring could be affected. When thefluid level in the deairating chamber reaches theminimum level, i.e. when there is too much airin the deairating chamber, the evacuation valve,EVVA, is opened and the air is released. Whenthe fluid level reaches over the minimum level,the evacuation valve is closed and so on. Thedegassed fluid is taken out in the bottom of thedeairating chamber.The taration valve, TAVA, is normally openduring treatment. During calibration of the UFmeasuring unit, the taration valve is closed.TAVA is also closed when the protective systemdemands a minimum of UF.

The dialysis fluid is led through channel 2 of theUF measuring cell to the blood leak detector.The blood leak detector detects any blood in thefluid. In the event of leak between the blood sideand dialysis fluid side of the dialyzer, an alarmwill be activated and the machine enters thebypass mode.

Most of the dialysis fluid (90 to 95%) is taken outat the top of the blood leak detector. The rest islet out via a drain restrictor. The reason forthis is that the blood leak detector has to becompletely emptied during drain phase.

Finally, the dialysis fluid is led to the drain, viathe suction pump, the outlet restrictor andthe drain-tube.



2:13

Disinfection and rinseChem disinfectionWhen Disinfection is selected by pressing theCHEM DISINF key, the information displaywill show three alternatives of disinfectionsolutions.

The disinfectant fluid will be taken up by the B-tube and if the B tube is not taken out of themachine and/or if the A-tube is taken out, therewill be an attention.

When the filling phase is finished the AK 95 Swill give an attention that requests you to placethe B-tube back in the monitor. When this isdone the disinfection solution is distributed in allof the fluid path and the dwell time starts. Assoon as the dwell time is done, an automaticrinse will start.

It is possible to end the Disinfection dwellprogram before it is finished by pressingRINSE/DRAIN key.

It is not possible to go from chemical disinfectionmode to treatment mode without a rinse. In caseof a power failure the monitor will save recoverydata and continue the disinfection when thepower returns.

Heat disinfectionDuring the heat disinfection program the inletwater is heated and rinsed through the fluidunit. The machine is then drained.It is also possible to run the heat disinfection incombination with Citric Acid 20% or with aCleanCart installed.

For heat disinfection a heat exchanger is arequirement. For 230V version the exchangermust have an efficiency of minimum 60%. 110Vand 100 V requires 76% efficiency.To get a proper heat disinfection, the fluid mustexceed 80C. The exchanger is not only necessar-ily to achieve proper temperature but it is alsoimportant for stabilization of the heater controlsystem.

Heat disinfection is selected with the HEATDISINF button. The remaining disinfectiontime shows on the time display as soon thedisinfection starts. How many minutes a pro-gram lasts is seen below. Total time for Disinfec-tion Programs are estimated and may vary.

Disinfection programs Time [min]

230 V 110 V 100 V

With UFD installed

Heat 35 39 49

Heat Citric acid 20% 52 57 67

Heat CleanCart 49 54 64

Without UFD

Heat 33 37 47

Heat Citric acid 20% 50 55 65


Four minutes before completion of the heat-disinfection, the program enters the drain phaseand the heat disinfection lamp is turned off. Theheat disinfection completes when the RINSE/DRAIN key is flashing.

When pressing the flashing RINSE/DRAIN keyafter a completed disinfection, the machine willperform a functional check (Fch).

Rinse/DrainRinse mode will be started automatically after adisinfection as described above or manually bypressing the RINSE/DRAIN key. The displayshows the rinse time and allows you to change itif you wish. The rinse program will run for theset time. Both A- and B- pick-up tubes must beplaced in the monitor, otherwise there will be anattention. During the final drain phase the airintake valve, AIVA, is open. When rinse iscompleted the RINSE/DRAIN key will be flash-ing.The machine will perform a functional check(Fch), when pressing the flashing RINSE/DRAIN key after a completed disinfection.

There is a possibility to reset and preset thechemical disinfection mode by enter the servicemode. For more information, see chapter 4,Technicians guide.



2:14

Component DescriptionHeater relay boardThe heater relay board comprises the following: Opto relay Heater safety relay Heater sensor (energized)

Pressure regulator, PR 2The pressure regulator is adjusted to give cor-rect pressure (approx.. +130 mmHg).

Conductivity measuring unitThe unit includes the following components: Measuring cell. Conductivity board, which is mounted

directly on the measuring cell. The con-ductivity board interfaces to the CPUboard, via a board connector and a flatcable.

Temperature transducer.

Degassing chamberThe AK 95 S contains one degassing chamberused to separate air from the dialysis fluid.The degassing chamber comprises a mechanicalfloat valve.

Mixing chambersThe AK 95 S contains two mixing chambers usedto mix the concentrate with the water andseparate air from the dialysis fluid before enter-ing the conductivity cell.

Deairating chamberThe deairating chamber comprises a leveldetector and the dialysis fluid pressure trans-ducer. The level detector interfaces to the FM I/O board, via a cable. The pressure transducer isconnected to a pressure transducer board, via atwisted cable. The pressure transducer boardinterfaces directly to the FM I/O board.

Flow pump unitThe flow pump unit consists of the following: Gearwheel pump driven by a DC-

motor. Pressure transducer with board. The

pressure transducer is connected to thetransducer board, via a twisted cable. Thetransducer board interfaces directly to theFM I/O board, via a board connector.

Dialyzer connectionsThe input tube nipple is fitted with a particlefilter.

Safety coupling unitThe safety coupling unit comprises two tubeconnections, which are used when the machineis to be disinfected, and a pressostate SAGS,which detects when the tubes are disconnectedfrom the safety coupling.The AK 95 S is also equipped with a pair ofmechanical switches that sense if the dia connec-tors are attached to the bypass block.

UF measuring unitThe UF measuring unit consists of the followingcomponents: Measuring cell. UF amplifier board. UF driver board.

The boards are mounted on each side of themeasuring cell. The UF measuring unit inter-faces to the Control Driver, via the UF amplifierboard, a board connector and a flat cable.

FM I/O boardThe FM I/O board contains of 6 connectors topressure transducers and temp. transducers. Italso contains the running time meter.

Heater unitThe heater is connected to the relay board, via acable. It comprises a temperaturetransducerTReg. The transducer is connected to a transducerboard, via a twisted cable. The transducer boardinterfaces directly to theFM I/O board, via a board connector.

NOTE! If the heater cartridge has been over-heated, this must be exchanged and the leakagecurrent to earth measured before restart.

Flow SwitchA mechanical flow switch is mounted before theheater. The flow switch will turn off the heaterin a no-flow situation.



2:15

Blood leak detectorThe blood leak detector includes the followingcomponents: Housing with cover. Transmitter and Receiverboard Blood leak detector board.

The transmitter and receiver boards are con-nected to the blood leak detector board, viatwisted cables. The blood leak detector boardinterfaces directly to the FM I/O board, via aboard connector.

Suction pumpThe suction pump consists of a gearwheel pumpdriven by a DC-motor.

MM I/O boardThe MM I/O board is mounted in the mixingmodule. It transfers control and data informa-tion received from the CPU boards to the variouselectronic and electromechanical parts in themixing module. It also transmits sensor informa-tion from the mixing module up to the CPUboards in the AK 95 S.

CPU boardAK 95 S is equipped with one Control CPU boardand one Protective CPU board.The CPU boards comprises among other thingsthe microcomputers. The spare parts list givesthe board connectors which reside on the CPUboards.

BatteryThe battery is a rechargeable 9V battery. Thebattery is used to drive the buzzer alarm duringmains power failure. The battery is not con-nected at delivery.

NOTE! The battery must be connected duringthe installation according to the instruction inthe Installations Guide.

FanThe drive motor (DC-motor) and the fan form asingle unit. The fan is connected to the driverboard, via a cable.

Driver boardAK 95 S is equiped with one Control Driverboard and one Protective Driver board, accordingto the figure 8.



2:16

Rear printed circuit boards

Protective CPU

boardControl CPUboard

Control Driverboard

Protective Driver

board

Figure 8 . AK 95 S CPU-boards and Driver boards.



2:17

Blood PartBlood Flow Diagram

Figure 9. AK 95 S - Blood Flow Diagram.

DialyzerHeparin pump

Arterial bloodpump

Arterialpressure guard

Arterial pressuretransducer (optional)P

P

Venous dripchamber

Air detectorPrimingdetector

Patient

Venous lineclamp

Arterial lineclamp

Arterial bloodline

Venous bloodline

Venous pressuretransducer



2:18

TreatmentArterial blood is taken in via the arterial lineclamp. During treatment the line clamp is open.

The arterial pressure guard is used to give analarm if the pressure becomes too low. Forexample, if the needle or the arterial blood lineis blocked, an alarm will be given ( the bloodpump is stopped). The alarm is activated if thereis an increased negative pressure between thepatient and the blood pump,e.g:

A drop in blood pressure. Altered positions of the arterial needle. A kink in the arterial line between the

patient and the blood pump.

The function of the blood pump is to maintainthe extra corporeal blood flow. Blood is removedfrom the patient, forwarded to the dialyzer andthen returned to the patient.The blood pump can not be run when the pumpcover is open.

If necessary, the blood can be returned to thepatient manually.

The purpose of the heparin pump is to addheparin to the blood.An alarm is issued when the syringe is empty orif the heparin line is kinked.The heparin parameters can be adjusted bypressing the heparin button.

The venous pressure transducer measuresthe venous bloodpressure. The lamp in theVenous pressure button is lit and the buzzersounds if the alarms are activated and thevenous bloodpressure is outside the alarmlimits. If the event of an alarm, the blood flow isstopped.If the venous pressure is too high, the cause maybe:

An obstruction after the venous dripchamber.

A change in the patients position.

If the venous pressure is too low, the cause maybe:

A line separation. A drop in blood pressure. A change in the patients position.

The air detector has the following function:If the blood level in the venous drip chamberis too low, an alarm is given and the blood flow isstopped (the blood pump and heparin pump arestopped and the venous line clamp is closed). Thevenous drip chamber acts as an expansion cham-ber to even out pressure pulsations.When the air detection alarm is generated, thelamp in the Air detect button is lit and thebuzzer sounds. The lamp begins flashing whenthe air detector does not detect air any longer.The operator must reset the air detection alarmby pressing the Air detect button. After press-ing the Air detect button for 3 seconds, the airdetector alarm is bypassed for x seconds (preset-table 0-120 sec.). Default it is disabled (0 sec-onds) and no override is possible.

The priming detector detects if there is bloodin the venous blood line. If no blood is detected,it is not possible to start the treatment.

The blood is transported back to the patient viathe venous line clamp. The clamp is normallyopen. But in the event of an alarm from the airdetector or the venous pressure transducer, theline clamp clamps the blood line and stops theblood flow (not during high pressure alarm).



2:19

1076

Component Description

3 45

6

7

1. Operators panel2. Air detector3. Venous pressure transducer4. Arterial pressure transducer5. Blood pump unit6. Heparin pump unit7. Expansion chamber holder

Figure 10. AK 95 S Blood part - Outside components

1

2



2:20

1. Operators panel2. Air detector3. Venous pressure transducer4. Arterial pressure transducer5. Blood pump unit6. Heparin pump unit7. Expansion chamber holder8. BM I/O Board9. Level regulation

Figure 11 . AK 95 S Blood part - Inside components



2:21

Line clampsThe blood unit includes two line clamps: Arterialline clamp and venous line clamp. The arterialline clamp is located to the right and the venousline clamp is located to the left when viewedfrom the front. The clamp covers also havedifferent colour markings: The arterial clampcover is marked with a red dot and the venousclamp cover is marked with a blue dot.The line clamp unit consists of the following:

Housing with covers (mounted on the frontplate).

2 solenoids (as one unit). Line clamp driver board. 2 clamp detectors.

The line clamp driver board interfaces to theprotective CPU board, via a board connector anda flat cable.

Blood pump unitThe blood pump unit consists of the following:

Tube pump (self-threading). 24 V bruchless DC motor with an encoder

for velocity monitoring. Gear box (1:50). Cover detector.

The blood pump unit, except the tube pump, ismounted on the back of the front plate. Themotor, cover detector and position board inter-face to the BM I/O board, via connectors andcables.

Heparin pumpThe heparin pump unit consists of the followingcomponents:

Syringe pump. The diameter of the syr-inge can range between 10 to 30 mm

Stepping motor. Gear box (1:120). Heparin pump position board. Heparin pump feedback potentiometer.

The stepping motor, heparin pump positionboard and heparin pump potentiometer interfaceto the BM I/O board, via cables.

Venous pressure transducer (C+P)The blood unit is equipped with two pressuretransducers connected to one port, which areused to measure the venous blood pressure. Thepressure transducers are mounted on a pressuretransducer board, which interfaces directly tothe BM I/O board, via a board connector. Thepressure transducers are connected to thevenous pressure transducer nipple (located onthe front), via a small tube.

Arterial pressure transducerAK 95 S can be equipped with a second pressuretransducer, named Arterial Pressure Trans-ducer. This pressure will be displayed on thearterial bargraph. The transducer is used fortrue arterial pressure measurement or any otherpressure. The pressure transducer is mountedon a pressure transducer board, which interfacesdirectly to the BM I/O board, via a board connec-tor.

Air detectorThe air detector consists of an ultrasonic trans-mitter and receiver mounted in a head. The airdetector head is adjustable to accomodate mostdrip chambers of 18-30 mm diameter. The airdetector interfaces to the BM I/O board and thedriver board via 2 cables.

Priming detectorThe priming detector is intergrated in the LineClamp Unit. It has a detector board (on the backof the front). The detector board contains a LEDand a phototransistor. The current through theLED is indicating how much current that isneeded to get a certain light transmissionthrough the light guides to the receiver. Thelower the value is, the better.



2:22

Operators panelThe operators panel is a flat surface panel. Itcomprises:

40 buttons visible and 3 hidden.(LED luminated)

8 bar graph displays. (LED luminated) 1 alphanumerical display (LCD). 1 numerical display (LED). 2 knobs.

The panel interfaces to the protective driver-board, via 3 board connectors and 3 flat cables.

Figure 12. Operators panel



2:23

BPMThe BPM (Blood pressure monitor) is physicallyplaced in the MM95.The BPM monitor is a passive measuring devicethat can issue attentions and alarms but thealarms will not interfere with theAK 95 S treatment.

The intended use for the BPM is to measure thepatients blood pressure and to activate an alarmif the patients blood pressure goes under analarm limit set by the operator. This will givethe nurses the possibility to take measures be-fore the patient suffers the ill effects of hypoten-sion (low blood pressure).

The BPM module includes the following compo-nents; air pump, bleed valve, dump valve, pres-sure transducers (control and protective) andmicroprocessor board. The module includes con-trol and protective systems.

The control system measures the pressure andpulse wave to calculate the systolic, diastolic,mean blood pressure and pulse rate. The airpump, dump and bleed valves are controlled bythis system as well as external communication.

The protective system supervises the maximumpressure and inflating time. Maximum pressureis 320 10 mmHg and maximum inflating timeis 180 seconds. When these values exceed speci-fied limits, dump and bleed valves are openedand air pump is stopped by the protective sys-tem.

A self-calibration/auto zero function is includedin the module, which means that the offset forthe pressure transducers is calibrated/adjustedeach time the module is turned on.

The BPM measures and calculates the non-inva-sive blood pressure by using the oscillometricmethod. This method uses the pulsation thatoccurs in the artery in the arm when it is re-stricted by the inflated cuff. The noise or oscilla-tion originates from the fact that when the cuffrestricts the vessel, the flow in the vessel be-comes turbulent, instead of laminar. The pulsa-tion causes the pressure in the cuff to oscillatewhich the pressure transducer in the BPM mod-ule measures.

The relationship between the changes of cuffpressure and its oscillation is used to determinethe blood pressure. When the BPM deflates thecuff and the blood starts to pass the restriction,the oscillation incline rapidly and the systolic(high) pressure is measured. When the oscilla-tion has peaked and is declining rapidly the dias-tolic (low) pressure is measured. The mean pres-sure is measured when the oscillation is peaking.The heart rate is determined by using the pres-sure oscillations measured by the pressure trans-ducer.

When to measure the diastolic pressure is deter-mined by extensive experiments to establish analgorithm, which is included in the BPM soft-ware.

In the field it is possible to perform a check ofthe device to determine if it works or not.The device has to be sent to Gambro for repairincase of malfunction.



2:24

T12AH250AC

BACH BACO

HALT

Power SupplyDesign

Power supply toheater relay board

Mains Switch

ContactFan Intake

Power supply toControl CPU board

Figure 13. AK 95 S, AC/DC-unit

ExternalFuses: 12 AH



2:25

Figure 14. Block diagram, power supply

Block Diagram Description

The mains voltage is fed to an AC/DC converterwhich generates different DC supplies to themonitor.

Two +5 volt supplies, one for the control systemand the other for protective digital electronics.

12 volt is used for analog electronics.

+24 volt is used for lamps, displays, bloodpump, heparin pump, clamps, pumpmotor(flow pump, suction pump), valves, fan and the heating relay. The lower +12 V is a standby voltage for theON/OFF logic.

The mains voltage also supplies the voltage tothe heating element.

In a mains power failure situation, the AK 95 Sgives an intermittent buzzer alarm and performsa recovery, when the power returns. All thesettings and accumulated values are stored inthe machine. The treatment will be continuedfrom where it was interrupted.

AK 95 S will perform a recovery when themonitor is in treatment or disinfection.In service and preset mode the monitor will startwith a Fch.

AC

DC

Battery24 V

External fuses

Internal fuses

MAIN SWITCHMAINS INPUT

MAINS to heater rod12AH

12AH

+5VDC+5VDC12VDC+24VDC

+12VDCAC

DC

Filter

Filter



2:26

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Chapter 3

Technical data and specificationsPerformance and s pecifi cation - Control system . . . . . . . . . . . . . . . . . 3:2Blood fl ow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2Heparin administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:2Blood pressure control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:3Dialysis fl uid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:4Ultrafi ltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5Pro fi ling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5Disinfection and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:5Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:7Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:8Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . . 3:9Battery back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:10

Performance and s pecifi cation - Supervisory system . . . . . . . . . . . . . 3:11Blood pressure supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11Extracorporeal blood loss to the environment . . . . . . . . . . . . . . . . 3:11Air detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:11Extracorporeal blood loss due to coagulation . . . . . . . . . . . . . . . . . 3:11Dialysis fl uid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12Ultrafi ltration supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12Blood leakage detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12pH-meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:12

Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13Infusion stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:13

Materials in contact with dialysate, concentrates and water . . . . . . . . 3:14Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:15

Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:16

H CEN9369 Revision.10.2005Program version 12.xx AK 95 S Service m anual - Technical data and spec ifi cations 3:1

Performance and specification - ControlsystemBlood flow controlValues for the blood pump(s) are based on a pressure of -150 mmHgbefore the arterial blood pump with a pump segment of 7.9 mm. Forpediatric blood tubes with pump segment of 4.0 mm it is also possibleto set blood flow to 5, 10 or 15 ml/min.

Double needle

Flow rate: 0 and 20 - 500 ml/min (-150 mmHgprepump pressure, pump segmentdiameter 7.9 mm)

Flow accuracy: 10 ml/min or 15%, whichever is largestAccumulated blood vol-ume:

0 - 327 litres

Volume accuracy: 0.6 l treatment time (h) or 15%

Single needle

Flow rate: 0 and 20 - 500 ml/min (-150 mmHgprepump pressure, pump segmentdiameter 7.9 mm)

Flow accuracy: 10 ml/min or 18%, whichever is largestTime control: 2 - 20 seconds (1 sec.), arterial and

venous time. The actual clamp openingtime is depending on blood flow rate,size of expansion chamber and pressurelimits.

Pressure control: 10 - 500 mmHg (50 mmHg), venouspressure control

Accumulated blood vol-ume:

0 to 327 litres

Volume accuracy: 0.6 l treatment time (h) or 18%

Heparin administration

Heparinization: 0 to 10 ml/h (1 ml/5 h or 5%) Theaccuracy is based on tests with 20 ml and30 ml syringes

Syringe size: Syringes shall comply with ISO 7886-2.Upon delivery, the machine is set for a20 ml Terumo syringe. Syringes of othervolumes and brands can be set.

Stop time: Heparinization stops before end oftreatment 0.00 to 9.59 h

Counter pressure: Maximum 400 mmHgAccumulated heparinvolume:

0 to 999.9 ml

HCEN9369 Revision.10.2005Program version 12.xxAK 95 S Service m anual - Technical data and spec ifi cations3:2

Blood pressure controlVenous pressure:

Operating range -700 to 750 mmHgAlarm limits: 10 to 500 mmHg in treatment mode, -100

to 500 mmHg in priming modeAccuracy: -700 to -500 mmHg, 10% -500 to 500

mmHg, 5 mmHg or 3%, whichever islargest 500 to 750 mmHg, 10%

Blood Pressure Monitor (BPM)

Systolic pressure range1 60 - 250 mmHgLow alarm limit, can bepreset (Default)

60 - 250 mmHg (100 mmHg)

High alarm limit, can bepreset (Default)

60 - 250 mmHg (150 mmHg)

Diastolic pressure range1 40 - 200 mmHgLow alarm limit, can bepreset (Default)

40 - 200 mmHg (60 mmHg)


40 - 200 mmHg (100 mmHg)

Mean pressure range1 45 - 235 mmHgLow alarm limit, can bepreset (Default)

45 - 235 mmHg (75 mmHg)


45 - 235 mmHg (115 mmHg)

Pulse rate range 40 - 200 bpm (2 bpm or 2% of reading)Low alarm limit, can bepreset (Default)

40 - 200 bpm (40 bpm)


40 - 200 bpm (150 bpm)

1 Meets ANSI/AAMI SP-10 (1992). Mean error 5 mmHg. Standarddeviation 8 mmHg


Dialysis fluid preparation

Pressure regulators: After pressure regulator PR 1 and theheat exchangers:80 kPa (0.8 0.1 bar)After pressure regulator PR 2:130 10 mmHg

Temperature: Adjustable 33 to 40 C. Accuracy isvalid only if dialysis fluid temperature isgreater or equal to ambient temperature.

Alarm limits: Adjustable 33 to 40 CAccuracy: +0.5/-1.5 C (+1,0/-2.5 C with UFD-kit)

at the dialysis fluid outlet from themachine.

Heater capacity: 1000 W (+10% / -5%) at 100 V 1300 W(+10% / -5%) at 110 V 1750 W (+10% /-5%) at 230 V

Overheat protection: Reg-temp 80 C or Cond A-temp 70 Cin treatment, software Reg-temp 99 Cin disinfection, software. The heater canonly be on if there is a flow through theheater. The flow is detected by a flowswitch.

Flow rate: 300-700 ml/min in steps of 20 ml/minAccuracy: 10% or 50 ml/min whichever is largestDegassing: By use of negative pressure, -610 mmHg.

Adjustable degassing pressure between-300 and -700 mmHg (-650 mmHg with700 ml/min flow rate).

Accuracy: 40 mmHgDialysis fluid pressure: -400 to +300 mmHg.Accuracy: 10 mmHg or 5%Proportioning of concen-trates:

The proportioning of concentrate isdone through conductivity control. Theconcentrates are pumped into the systemwith one/two volume trically supervisedpumps. No minimum feeding pressureis necessary, the fluid is sucked in.Maximum feeding pressure, 150 kPa.

Acetate: Na+ , 130 to 160 mmol/l, (3 mmol/l)Bicarbonate: Na+ , 130 to 160 mmol/l, (6

mmol/l)HCO3- , 20 to 40 mmol/l,(6 mmol/l)

Measuring range: 13 to 16 mS/cmAlarm limits: 5% of the calculated conductivity set

value


Ultrafiltration control

Volume control: Direct electromagnetic measurement ofdialysis fluid flow, before and after thedialyzer.

UF volume: Adjustable 0 to 10.00 lAccuracy of measuredvolume:

50 ml/h or 1% whichever is largest

UF coefficient: Maximum 85 ml/h/mmHgUF rate: 0.0 to 4 l/h, given by the set values of UF

volume and treatment time.Time: Remaining treatment time control. 0.05

to 9.59 hour. minute (1 minute)

Profiling

UF-rate 0.0 to 4 l/hNa+, Acetate mode 130 to 160 mmol/lNa+, Bicarbonate mode 130 to 160 mmol/lHCO3-, Bicarbonate mode 20 to 40 mmol/l

Disinfection and cleaning

Chemical disinfection

Peracetic Acid Program (presetable)

Concentration of disinfec-tant

3.5% peracetic acid

Concentration in machine 0.1%, i.e. diluted 1 + 34 (1:35)Volume approx. 85 ml (with UFD-kit approx. 92

ml)Contact time betweentreatments

10 minutes

Contact time overnight orwhen not in use (recom-mended with UFD-kit)

Minimum 3h dwell time

Total time 30 minutes (with UFD-kit 59 minutes)including 10 min. contact time

Hypochlorite Program (presetable)

Concentration of disinfec-tant

10% available chlorine

Concentration in machine 0.5%, i.e. diluted 1 + 19 (1:20)Volume Approx. 145 ml (with UFD-kit approx.

153 ml)Contact time betweentreatments

10 minutes

Contact time overnight orwhen not in use

Maximum 20 min, not intended forovernight disinfection!

Total time 30 minutes (with UFD-kit 48 minutes)including 10 min. contact time


Formaldehyde Program (presetable)

Concentration of disinfec-tion

37 % formaldehyde

Concentration in machine 3.7%, i.e. diluted 1 + 9 (1:10)Volume Approx. 275 ml (with UFD-kit approx.

290 ml)Contact time betweentreatments

20 min

Contact time overnight orwhen not in use (recom-mended with UFD-kit)

Minimum 6h dwell time

Total time 119 minutes (with UFD-kit 150 minutes)including 20 min contact time

Heat disinfection

One of three alternatives for heat disinfection can be selected. Thesecond alternative is presetable for a combined heating program andthe third is a CleanCart / heating alternative. The default settings areas follows.

AK 95 S Disinfectionprograms

Total Time [min]

230 V 110 V 100 V

With UFDinstalled

Heat 35 39 49

Heat Citric acid 20 % 52 57 67

H eat C leanCart 49 54 64

Without UFD Heat 33 37 47

Heat Citric acid 20 % 50 55 65

H eat C leanCart 46 51 61


Auto Heat disinfection

Auto Heat can be used with or without CleanCart. If the Auto Heatshall be performed with CleanCart must the cartridge be installedbefore the Auto Heat starts.

AK 95 S Disinfection programs Total Time [min]

230 V 110 V 100 V

With UFDinstalled

Heat 31 35 45


WithoutUFD

Heat 31 35 45


Temperature: +93 C (measured after heating rod) 80C (measured in the outlet before the heatexchanger)

Note: The temperatures are verified at nominal values for the mainsvoltage and at 20 C ambient temperature.

Rinse/Drain:

Rinse/Drain 10 minutesDrain 4 minutesExterior cleaning: All outside parts of the machine can

be cleaned with ethanol (70%) orisopropanol (60%).

Note: Total Time for Disinfection Programs are estimated and mayvary.

Water supply

Flow rate: During treatment: maximum 770ml/minDuring disinfection andrinse/drain: a maximum flow rate of 800ml/min is required.

Minimum inlet pressure: 0.12 MPa (1.2 bar)Maximum inlet pressure: 0.6 MPa (6 bar)Inlet temperature: Treatment: +5 to +30 C Disinfection:

+5 to +90 CConnector in/outlet: Diameter 8 mmQuality: Inlet water quality must comply with

local regulations and if no such regulationis available follow ISO 13959. Levelfor conductivity shall not exceed 0.1mS/cm. It is possible to use water withhigher conductivity if it consists mainlyof sodium salts. This may however affectthe accuracy of the fluid composition.


Drain: The drain tube outlet must be placedbetween floor level and maximum 1.2m above the outlet connection from thefluid monitor. An air gap to atmosphericpressure must always be arranged at thetube outlet.

Length of drain tube:

Connection of external equipment

External connector: 25 pin D-Sub with RS-232C orRS-422/Current loop. Opto insulatedfulfilling IEC 60601-1-1.

External equipment: External equipment intended forconnection to signal input, signal outputor other connectors, shall comply withrelevant IEC standard (e.g. IEC 60950for IT equipment and the IEC 60601series for medical electrical equipment).In addition, all such combinations -systems - shall comply with the standardIEC 60601-1-1, Safety requirements formedical electrical systems. Equipmentnot complying to IEC 60601 shall bekept outside the patient environment, asdefined in the standard. 1)Any personwho connects external equipment tosignal input, signal output or otherconnectors has formed a system and istherefore responsible for the system tocomply with the requirements of IEC60601-1-1. If in doubt, contact qualifiedtechnician or your local representative.1)The normal distance can be mentionedi.e. at least 1.5 m from the patient or thepatient support.

Extern alarm:

Max voltage: 24 VAC or DC

Max current: 100 mAAC or DC

RS-232C:

Max input voltage: 15 VDC

High level min outputvoltage:

5.0 VDC

Low level max outputvoltage:

-5.0 VDC

Max output current: 5 mADC

RS-422/Current loop:

Typ current: 20 mADC

Max current: 50 mADC


Battery back-up

Battery back-up of powersupply

24 volt, 6,5 Ah

Running time >30 minutesFuse T 15 A


Performance and specification - SupervisorysystemBlood pressure supervision

Venous pressure:

Operating range -700 to 750 mmHgAlarm limits: 10 to 500 mmHg in treatment mode, -100

to 500 mmHg in priming modeAccuracy: -700 to -500 mmHg, 10% -500 to 500


Arterial pressure:

Operating range -700 to 750 mmHgAlarm limits: -700 to 750 mmHgAccuracy: -700 to -500 mmHg, 10% -500 to 500


Extracorporeal blood loss to the environment

Detection method: Venous pressure supervision

Air detection

Detection method: Ultrasonic detector placed at the venousdrip chamber. The detector has a twochannel structure and the function of thedetector is tested at the function test madeby the microcomputers.

Drip chamber size: Diameter 22 mmSensitivity: Bubbles larger than 1 l will be trapped

by the drip chamber. An alarm will beissued if the blood level falls below themiddle of the air detector.

Extracorporeal blood loss due to coagulation

Detection method: Supervision of the stop time of the bloodpump

Alarm: The attention BLOOD PUMP STOPTIME EXPIRED, Start Blood pump.


Dialysis fluid preparation

Temperature:

Temperature alarm (fixed) 40 C (0.5 C)Overheat protection: The heater can only be on if there is a

flow through the heater. The flow isdetected by a flow switch.

Conductivity:

Alarm limits: 5 % of the calculated conductivity setvalue

Ultrafiltration supervision

TMP: TMP is defined as the difference, Pb out -P d out, where Pb out is the venous pressureand P d out is the pressure measured in thedialysis fluid, where it enters the machineafter the dialyzer.

Alarm limits: -100 to 500 mmHgAccuracy: 500 ( 10 mmHg or 5 %, whichever is

largest )

Blood leakage detection

Detection method: Infrared light detector.Sensitivity: Alarm will be given for 0.3 ml blood,

haematocrit 32%, per minute at 700ml/min dialysis fluid flow. Time delayfor alarm, maximum 5 seconds (diffusionmode).

pH-meter

Measuring range: 1 - 9.9 pH, measured in the dialysis fluidbefore dialyzer.

Accuracy: 0.2 pHAlarm limits: 5.0 to 9.0 pH

HCEN9369 Revision.10.2005Program version 12.xxAK 95 S Service m anual - Technical data and specificat ions3:12

Physical dataDimensions and weight

Width: Approx. Machine 480 mm, stand 580mm.

Depth: Approx. Machine 600 mm, stand 625mm.

Height: Approx. 1270 mm (without infusionstand).

Weight: Approx. 62-78 kg (depending onoptions).

Infusion stand

Maximum total load: 2 kg

ReferencesAssembly Drawing K23000


Materials in contact with dialysate,concentrates and waterPolymers

Silicon rubberSantroprenePVC (Polyvinylchloride)PEEK (Polyetherketone)PEX (Polyethylene)PP (Polypropylene)PSU (Polysulphone)PVDF (Polyvinylidenefluoride)PTFE (Polytetrafluoroethylene)

Metals

Stainless steel SS2343Stainless steel SS2353Stainless steel SS2562TitaniumPlatinum

Others

CarbonCeramic, Steatite 221Ceramic, Aluminium oxide(Al2O3)Glass


Environmental dataOperationIf condensation occur when moving the equipment between locationswith different temperatures and high relative humidity (e.g. outdoorand indoor locations), the inside of the equipment shall be allowed todry before switching on the equipment.

Ambient Temperature range +18 to +35 CRelative Humidity range 15 to 85% RHAir Pressure range ( atm.Pressure )

700 to 1060 hPa

Transportation and storageDuring transportation and storage the equipment has to be kept inits original packing. If transportation or storage time is more than15 weeks, the environmental data relating to the operation has to befollowed. The maximum ambient temperature for transportation andstorage in 96% Relative humidity is +40 C.

Ambient Temperature range -20 to +70 CRelative Humidity range 10 to 96% RHAir Pressure range ( atm.Pressure )

500 to 1060 hPa


StandardsThe machine complies with the following standards:

IEC 60601-1 General requirements for safety, Class I, type B

IEC 60601-2-16 Particular requirements for safety of haemodialysis,haemodiafiltration and haemofiltration equipment

IEC 60601-1-1 Safety requirements for medical electrical systems

IEC 60601-1-2 Electromagnetic compatibility

IEC 60601-2-30 Particular requirements for the safety of automaticcycling indirect blood pressure monitoring equipment

EN 1060-1 Non-invasive sphygmomanometers Part 1: Generalrequirements

EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementaryrequirements for electromechanical blood pressure measuring systems

HCEN9369 Re

ak 95 monitor_service manual

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