Ak 95 Monitor_Service Manual

AK 95 / AK 95 S Service 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 technician’s 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 Magistratsvägen 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

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 Operator’s 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:

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.

1. Practical experience of the AK 95 S monitor.

Disclaimer

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

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

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.

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 Magistratsvägen 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. HCEN9095, Rev. 10.2006

Denomination 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 HCEN9134 Rev. 10. 2005 HCEN9369 Rev. 10. 2005 HCEN9135 Rev. 10. 2005 HCEN9136 Rev. 10. 2005

Installation Guide Technical Description Technical Data, AK 95S Technical Data, AK 95 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 Guide AK 95 / AK 95 S January 2004

Installation Guide

1. Installation Guide Contents Installation Unpacking and inspection .......................... 1:2 Environment and ........................................ 1:2 Physical Data .............................................. 1:2 Operating Environment ........................ 1:2 Transport and Storage Environment .... 1:2 Physical Data ......................................... 1:2 Mains Voltage and Power ...................... 1:3 Consumption .......................................... 1:3 Service Outlets ....................................... 1:3 Line Fuses .............................................. 1:3 Mains Water Supply .............................. 1:3 Tools ............................................................. 1:3 Top Tray ....................................................... 1:3 Connection to the Water Supply ................ 1:4 Connection to the Power Supply ................ 1:4 Connection of the battery ........................... 1:4 How to remove the cover to connect the battery ..................................... 1:5 Installation of RP 95 S ................................ 1:6 Back-up battery ........................................... 1:8 Turn on the AK 95 S .................................... 1:9 Functional check - Fch............................... 1:9 Recommended start-up procedure .............. 1:9 Checklist ..................................................... 1:11 Note! This installation Guide provides the information needed to install both AK 95 and AK 95 S. The text from this point forward only states AK 95 S.

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

1:1

Installation Guide

Installation Unpacking and inspection

Environment and Physical Data

When unpacking, the equipment should be checked. If the equipment is in any way damaged, proper operation cannot be guaranteed. Please contact your Gambro Service representative.

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

The packages contain the units and components shown in Figure 1.

Operating Environment AK 95 S: Ambient temperature: Relative humidity: Air pressure:

+18 °C to + 35 °C 15 % - 85 % 70 - 106 kPa

AK 95: Ambient temperature: Relative humidity: Air pressure:

+10°C to + 35 °C 30% - 85 % 70 - 106 kPa

Transport and Storage Environment Units being transported or stored must be kept in their original packaging. Units must be handled en route in accordance with special instructions. Units can be transported or stored in the following environment for up to 15 weeks: Ambient temperature: Relative humidity: Air pressure:

-20 °C to +70 °C 10 % - 96 % 50 - 106 kPa

Note! Units to be transported and/or stored for more than 15 weeks may only be subjected to the conditions specified under Operating Environment. Figure 1. AK 95 S Units. Ensure that the specified equipment has been delivered. Do the packages contain the specified monitor and options? Are there any units/ components missing? Check the additional packing list (inside the additional package box). If in doubt, please contact your Gambro Service representative. Ensure that the voltage specified on the voltage tag matches the mains voltage. If in doubt, please contact your Gambro Service representative.

Physical Data AK 95 S:

Machine Stand

Width mm

Height mm

Weight kg

600 625

480 580

1270

78 (all options included)

Depth mm

Width mm

Height mm

Weight kg

420 680

350 625

1270

62

AK 95:

Machine Stand

1:2

Depth mm

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

Installation Guide

Mains Voltage and Power Consumption The AK 95 S must be plugged into a grounded power point not more than 3 metres distant.

Tools The tools listed below are needed during the installation procedure.

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 V 1575 W at 110 V 1275 W at 100 V

Top Tray

Service Outlets

Tube cutter, 113 500 084 Adjustable wrench, 113 003 009 Hexagon spanner set Screwdriver, 1,2 x 8,0 - 175mm, 113 002 006

To avoid leakage into the machine, the top tray must always be placed on the top of the machine, except during technical service.

One extra grounded power socket should be available close to the AK 95 S, for troubleshooting and maintenance purposes.

Line Fuses Never overload the line fuses and do not supply too many systems via a single line fuse.

Mains Water Supply Required quality: Level of purity according to ASAIO and AAMI recommended standards on feed water for dialysis monitors. Water for the dialysis unit has to be supplied from a Reverse Osmosis purification system. Pressure: 1.2 - 6 bar to the pressure regulator mounted in the MM 95. Note! The pressure should be measured with the flow from the water supply.

A

B Acetate

Lift points

Lift points

Temperature:+5 °C to +30 °C (treatment) Consumption in treatment: AK 95 S: 500 ml/min AK 95: 550 ml/min

Note! Local ordanances may require the use of special measures to protect against the possibility of back-siphonage from dialysis equipment into the water supply. When installing the AK 95 S, such ordanance should be observed. AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

EN1075

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

Figure 2. AK 95 S

1:3

Installation Guide

Connection to the Water Supply The water must fulfil all requirements set out under Environment and Physical Data.

Connection of the Battery The rechargeable 9V battery (100 224 006) is used to drive the buzzer alarm during main’s power failure. The battery is not connected at delivery.

Water in Drain NOTE! The battery must be connected during the installation according to the instruction on next page.

Connection to the Power Supply Fuses Main switch, ON/OFF

A discharged battery will be charged with maximum 10 mA and it must be charged for at least 50 hours to get completely charged. An allup charged battery will receive a maintaining current of approximately 1,5 mA. The AK 95 S charge the battery as long as the AC/DC converter is switched on, i.e. AK 95 S itself does not need to be switched on. The battery is tested during every functional check to ensure that the capacity is enough in the battery, otherwise an attention will be given: BATTERY FAILURE Change battery or press SELECT

Mains power, connected to a grounded power socket

1:4

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

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

Installation Guide

How to remove the cover to connect the battery. 1.

Loosen the three cover bolts, accessible underneath the fluid part.

A

2.

Move the cover upwards and then backwards.

3.

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

4.

Turn the cover backwards counter-clockwise to pass the circuit boards and the cover can be removed.

Cover A

A

B Acetate

A

5.

Connect the rechargeable battery to board connector P205 on the Protective Driver board.

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

1070

Front

1:5

Installation Guide

Installation of RP 95 S 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.

Step 1

4

3

1. Loosen the two screws (with black plastic knobs) under the service tray holder.

MB

2. Pull out the service tray holder to its end position.

2

RO

5

3. Loosen the two hexagonal socket screws. 4. Remove the service tray holder complete. 5. Fasten the hexagonal socket screws again.

GAMB RO

1 GAM

6

BRO

6. Attach the plug to the rear hole of the stand and fasten the screw (with black plastic knob).

Step 2 1. Put the RP 95 S unit into the front hole of the stand. Fasten it with the attached spacer and screw (∅ M4, 16mm)

GAM BRO

2. Fasten the screw (with black plastic knob).

1:6

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

Installation Guide

180° Step 3 1. Turn the RP 95 S 180° in counter clockwise direction.

90°

2. Rotate the RP 95 S 90° to be parallel with the AK 95 S front. GAM BRO

GAM BRO

Step 4 1. Fasten the cable on the right upper part of the stand with the enclosed cable holder and screw. 2. Fasten the cable even on the back part of machine with the enclosed cable holder - use an existing screw.

1

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

2

1:7

Installation Guide

Back-up Battery The optional back-up battery is pre-assembled under the monitor stand at delivery. Let the machine stay with the ACDC-unit in power on mode over night in order to charge the batteries. Replacement of the lead acid batteries must be done according to following electrical diagram. Both lead acid batteries must be changed at the same time and only batteries approved or supplied by Gambro Lundia AB may be used. Changed batteries must be recycled or disposed of properly.

Fuse: T15 A Running time: 30 minutes The charge indicator on the power supply is lit when the AK 95 S is equipped with the back-up battery. The machine must be connected to mains voltage and the mains switch must be on. In a mains failure situation following attention will be given. POWER FAILURE, BATTERY OPERATION Battery operated for x minutes Before the battery is empty following attention will be given. LOW BATTERY POWER Machine turnes off in one minute

1:8

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

Installation Guide

Turn on the AK 95 S The ON/OFF button on the Operators Panel is used to turn the machine on and off. The ON/OFF button must be pressed at least 3 sec. in order to switch the machine on and off. The main switch on the power supply should always be in ON position, even when the machine is not in use. This “Stand by” mode is indicated by a lit segment on the TIME display on the operators panel.

h.min

Recommended start-up procedure First check: • That the 9V battery is connected. • That the mains cable is connected to power. • That the main switch on the rear of the monitor is turned on. • That the machine is connected to the water supply.

Time

If a power failure occurs when AK 95 S is working, the same segment in the TIME display is flashing.

• That the drain tube is properly connected to the machine and placed with an air gap between the drain tube and the drain. • That the dialysis fluid tubes are connected to the safety couplings.

h.min Time

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

For further information about operating instructions, please see: AK 95 S Operator's Manual, HCEN 9794 or AK 95 Operator's Manual, HCEN 9542.

2. Perform a Heat disinfection procedure according to the Operator’s Manual. 3. Perform a complete functional check according to the Operator’s Manual.

Functional check - Fch Each time the AK 95 is started, the automatic functional check, Fch, is carried out. The functional check will be aborted if Rinse/ Drain or any of the disinfection modes are selected.

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

1:9

Installation Guide

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1:10

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

Installation Guide

Checklist -

Check if applicable

Yes Unpacking and inspection

Ensure that the voltage specified on the voltage tag matches the mains voltage.

Check that the additional package box contains the specified components.

Ensure that the machine is correctly connected to the Power Supply. Mains power must be connected to a grounded power socket.

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

Environment and Physical Data

Checklist - filed by the Sevice Engineer responsible for the installation.

Connection to the Power Supply

Ensure that the specified equipment has been delivered.

Connection of the Battery

Ensure that the Operating Environment is according to the specifications.

Ensure that the rechargeable 9V battery is correctly connected according to the instructions.

Interconnection

Connection of the dialysis fluid tubes

Ensure that the monitors are interconnected correctly.

Ensure that the dialysis fluid tubes are connected to the safety couplings.

Top Tray

Start-up procedure

Ensure that the top tray is placed at the top of the machine.

Ensure that the recommended start-up procedure is followed.

Connection to the Water Supply

Out of box report

Ensure that the machine is correctly connected to the Water Supply.

Fill out the Installation / Out of Box report and return it to:

Ensure that the water fulfils all requirements set out under Environment and Physical Data. Ensure that the machine is correctly connected to the drain.

Gambro Lundia AB Monitor Division Magistratsvägen 16 PO Box 10101 SE-220 10 Lund Sweden

Note! If you have any remarks during installation, please contact your Gambro Service representative.

This record is to be signed and filed by the Service Engineer responsible for the installation. Date............................Signature........................................................................ Serial number: ..................................

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

1:11

Installation Guide

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1:12

AK 95 / AK 95 S Service Manual HCEN 9133 Rev. 01. 2004

HCEN9133 © Gambro Lundia AB,1996. Revision January 2004

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

Technical Description

2. Technical Description Contents Introduction General ........................................................ 2:2 Protective system: .................................. 2:2 System and Treatment Parameters ........... 2:3

Fluid Part Flow Diagram .............................................. 2:4 Valves .......................................................... 2:4 Flow Diagram with Service Variables ........ 2:5 Flow Diagram with Service Variables ........ 2:6 Treatment .................................................... 2:7 Fluid part: .............................................. 2:8 MM 95: ................................................... 2:9 Fluid part, continue: ............................ 2:11 Disinfection and rinse ............................... 2:13 Heat disinfection .................................. 2:13 Component Description ............................ 2:14 Relayboard ........................................... 2:14 Pressure regulator ............................... 2:14 Conductivity measuring unit .............. 2:14 Degassing chamber .............................. 2:14 Deairating chamber ............................. 2:14 Flow pump unit .................................... 2:14 Dialyzer connections ............................ 2:14 Safety coupling unit ............................. 2:14 UF measuring unit .............................. 2:14 FM I/O board ........................................ 2:14 Heater unit ........................................... 2:14 Blood leak detector .............................. 2:15 Suction pump ....................................... 2:15 Distribution board ............................... 2:15 CPU board ............................................ 2:15 Battery ................................................. 2:15 Expansion board .................................. 2:15 Prom module board .............................. 2:15 Fan ........................................................ 2:15 Driver board ......................................... 2:15 Rear printed circuit boards ....................... 2:16

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Blood Part Blood Flow Diagram ................................. Treatment .................................................. Component Description ............................ Arterial pressure guard ....................... Blood pump unit .................................. Heparin pump ...................................... Venous pressure transducer ................ Arterial pressure transducer (option) . Air detector .......................................... Priming detector .................................. Operators panel ......................................... BPM ...........................................................

2:17 2:18 2:19 2:21 2:21 2:21 2:21 2:21 2:21 2:21 2:22 2:23

Power Supply Design ........................................................ 2:24 Block Diagram Description ....................... 2:25

2:1

Technical Description

Introduction General The AK 95 S is designed to be used as a single patient machine to perform conventional hemodialysis. The AK 95 S can be divided into three parts: • • •

Blood part Fluid part Operators panel

The blood part is used to control and monitor the extra corporeal blood flow through the dialyzer and, where applicable, to control the addition of heparin to the blood before dialysis. Both Single needle and Double needle treatment are carried out with one blood pump. Disposable blood lines are used for the blood flow. The blood part includes the following main functions: • • • • • • •

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 correct conductivity) from water and concentrate, and to transport the fluid through the dialyzer. The fluid part maintains the dialysis flow through the dialyzer with controlled ultrafiltration. If a fault occurs, the fluid part bypasses the dialyzer. AK 95 S fluid part includes the following main functions: • • • • • • • • •

2:2

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.

AK 95 S operates in either acetate- or bicarbonate mode. In bicarbonate mode the monitor mixes dialysis fluid from water and two concentrates: acid and bicarbonate. The mode is selected from the operator's panel. A disinfection must be performed after every treatment. Both heat disinfection and chemical disinfection are available. The power supply supplies the AK 95 S with the necessary supply voltages. The mains voltage is also used to supply the heater within the AK 95 S. The AK 95 S is operated from the operators panel located on the blood part. The panel has an overlay translated into different languages. For information about the use and function of the panel, see the document AK 95 Operators Manual, HCEN 9542 or AK 95 S Operators Manual, HCEN 9794.

Protective system AK 95 S is equiped with a protective system. The main task is to supervise the dialyzing process and if needed take correct action to prevent hazard to the patient. The protective system can take actions independently of the control system. It is a separate system, with its own sensors and electronics. Protective system is responsible for setting the AK 95 S in a patient safe state when any of the supervised parameters exceed their approved limits. The control system has to start up the AK 95 S in a controlled way when the hazardous situation is cleared. The kind of action that is to be taken depends of in which state the AK 95 S is, for example treatment or disinfection. Another task of protective system is to make a function check of AK 95 S sub systems. The protective system of AK 95 S is separated in two parts, the blood part and the fluid part.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

System and Treatment Parameters The system and treatment parameters can be set at five different levels (table 1). Level Type of parameters

Adjustable by...

4

Treatment parameters

Operator, nurse

3

Alarm limits and defaults

Clinics technician

2

Clinic or customer adaptions

Gambro technician or Gambro subsidiary

1

Market adaptions

Gambro Head office

0

Safety limits

Fixed

Table 1. System and Treatment parameters

For information about the use and functions of the parameters in level 2 and 3, see the chapter Technicians Guide.

A

B Acetate

1002

For information about the use and functions of the parameters in level 4, see AK 95 Operators Manual, HCEN 9542 or AK 95 S Operators Manual, HCEN 9794.

Figure 1. AK 95 S.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

2:3

Technical Description

Fluid Part Flow Diagram

MM 95

B

B, Ac

Mixing Chamber Feeding Pumps

A

Cond. Cell "A"

A

BiCart

Mixing Chamber Cond. Cell "B" FLVA T

T

Fluid connector detection

pH-SENSOR (Optional)

Safety by-pass Unit

P

RIVA

SAGS DRVA M

REVA INPS P Water Inlet

Drain

Pressure regulator PR 1

Flow Restrictor

INVA Flow switch AIVA

°C

Degassing pressure transducer P

T

Heater

PR 2

Expansion chamber

Draining Restrictor

Degassing Chamber

Flow Pump

Cond. Cell ”P”

Suction Pump

Heat exchanger

T

ZEVA

HPG Blood Leak Detector

Outlet Restrictor

EVVA

Level Detector Pressure Dialysis (PD)

P

P UF-measuring Cell

Draining Restrictor

2

1

Deairating Chamber

TAVA

BYVA

DIVA

Particle Filter

Flow diagram AK 95 S

Dialyzer

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

Valves INVA DRVA RIVA ZEVA DIVA

2:4

Inlet valve Degass restrictor valve Rinse valve Zero (UF) valve Direct valve

BYVA TAVA EVVA AIVA REVA FLVA

Bypass valve Taration (UF) valve Evacuation valve Air inlet valve Recirculation valve Flush (BCH) valve

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Drain

Water Inlet

PR 2

(Inlet open)

INVA SRL(17)

(Pressure within limits)

Heat exchanger

°C

INPS P

SRL(33) SRL(16)

Fluid connector detection

Treg

Heater

T

SAGS activated = TRUE

Pressure Dialysis (PD) SRP(4)

P

Particle Filter

Level Detector

Current: SRI(54) Duty cycle: SRI(55)

TMP SRP(1)

Outlet Restrictor

SRI(31)

(Optional)

pH-SENSOR

FLVA SRL(18)

with variable flow

SRI(18) Deairating 0 = High Chamber 1 = Mid 2 = Low

Blood Leak Detector

SRI(53)

Draining Restrictor

Expansion chamber

SRI(15)

TAVA SRL(30)

Dialyzer

Draining Restrictor

Flow Restrictor

SRI (59)* DRVA M

T

Cond. Cell "B"

MM 95

SRI(24)

Mixing Chamber

*only active for machines

T SRI(14)

SRL(31) EVVA

SRL(4) Energized = TRUE

SRI(13)

Cond. Cell "A" SRI(20)

Mixing Chamber

Rel. pump speed: SRI(22)

A

Feeding Pumps

B

Heater duty cycle: SRI(11) Flow switch SRL(3) Flow = TRUE AIVA SRL(34) Suction Pump

REVA

SAGS

P SRL(9)

(Both connectors NOT in the safety by-pass unit)

Flow diagram AK 95 S

Pressure regulator PR 1

SRL(35)

SRL(36)

(Both connectors in the safety by-pass unit)

Safety by-pass Unit

SRL(7) = TRUE SRL(8) = TRUE

A

B, Ac

Rel. pump speed, BiC:SRI(26), Rel. pump speed, Ac: SRI(27)

UF-rate SRR(0)

BYVA SRL(27)

SRR(2)

SRL(32) ZEVA

2

1

SRP(2)

SRL(24) DIVA

UF-measuring Cell Taration timer: SRI(39) SRR(1)

HPG SRI (17), Pressure P SRL(23), Alarm

T

Cond. Cell ”P” SRP(3)

Degassing Chamber

RIVA SRL(21)

Flow Pump Duty cycle: SRI(33) Current: SRI(32)

Degassing pressure transducer P SRI(34)

SRL(19) (TRUE = Open)

BiCart

Technical Description

2:5

2:6

Drain

Water Inlet

PR 2

(Inlet open)

INVA SRL(17)

(Pressure within limits)

Heat exchanger

°C

INPS P

SRL(33) SRL(16)

Fluid connector detection

Heater

Treg

T

SAGS activated = TRUE

Pressure Dialysis (PD) SRP(4)

P

Particle Filter

Level Detector

Current: SRI(54) Duty cycle: SRI(55)

TMP SRP(1)

Outlet Restrictor

SRI(31)

(Optional)

pH-SENSOR

FLVA SRL(18)

with variable flow

SRI(18) Deairating 0 = High Chamber 1 = Mid 2 = Low

UF-rate SRR(0)

Ultrafilter U 8000 S

BYVA SRL(27)

SRR(2)

SRL(32) ZEVA

2

1

SRL(24) DIVA

UF-measuring Cell Taration timer: SRI(39) SRR(1)

HPG SRI (17), Pressure P SRL(23), Alarm

T SRP(2)

Cond. Cell ”P” SRP(3)

Degassing Chamber

RIVA SRL(21)

SRL(19) (TRUE = Open)

BiCart

Flow Pump Duty cycle: SRI(33) Current: SRI(32)

Degassing pressure transducer P SRI(34)

FIVA SRL(56)

Blood Leak Detector

SRI(53)

Draining Restrictor

Expansion chamber

SRI(15)

TAVA SRL(30)

Dialyzer

Draining Restrictor

Flow Restrictor

M

SRI (59)* DRVA

T

Cond. Cell "B"

MM 95

SRI(24)

Mixing Chamber

*only active for machines

T SRI(14)

SRL(31) EVVA

SRL(4) Energized = TRUE

SRI(13)

Cond. Cell "A" SRI(20)

Mixing Chamber

Rel. pump speed: SRI(22)

A

Feeding Pumps

B

Heater duty cycle: SRI(11) Flow switch SRL(3) Flow = TRUE AIVA SRL(34) Suction Pump

REVA

SAGS

P SRL(9)

(Both connectors NOT in the safety by-pass unit)

Flow diagram AK 95 S, UFD

Pressure regulator PR 1

SRL(35)

SRL(36)

(Both connectors in the safety by-pass unit)

Safety by-pass Unit

SRL(7) = TRUE SRL(8) = TRUE

A

B, Ac

Rel. pump speed, BiC:SRI(26), Rel. pump speed, Ac: SRI(27)

Technical Description

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Treatment Fluid part: This technical description of the AK 95 S is based on the flow diagram on page 2:5. Water is taken in through a pressure regulator, PR 1, and a heat exchanger, before entering the AK 95 S fluid-unit. The pressure regulator is set to approximately 600 mmHg, measured after the heat exchanger. The inlet pressure switch, INPS, detects too low pressure. If the inlet pressure is too low (less than +99 mmHg), the inlet valve, INVA, is closed, the heater is switched off and the AK 95 S enters the fluid bypass mode. An attention will be given when the pressure is too low. The inlet pressure should be constant, but normally there are small fluctuations. The second pressure regulator, PR 2, is used to ensure a constant pressure, approximately +130 mmHg. Normaly during treatment INVA is open.

The TReg transducer is used in the fast temperature control loop. The set value for the loop is the set value entered by the user adjusted for the measured temperature drop to the conductivity cell B. The temperature drop is calculated when the temperature measured at cond.cell B is stable. The temperature considers to be stable when it has been in a window of ± 0.25 °C for one minute or more. The function of the flow switch is to sense if there is fluid flow or not through the heater. If the flow switch does not detect flow, the heater will be switched off in order to protect the heater from overheating. There is a temperature transducer in each conductivity cell, used for compensating the conductivity calculation.

The main function of the temperature transducers in the AK 95 S is to measure the dialysis fluid temperature and control the heat regulation. The regulating temperature transducer, TReg, is located after the heater.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

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Technical Description

Pressure regulator, PR2

Heater

Conductivity cell P

Heater/ Flow switch AIVA REVA

INVA

Flow pump

RIVA BYVA DIVA

FM I/O board

ZEVA TAVA

UF-measuring cell

EVVA

Suction pump Blood leak detector

Expansion chamber

Degassing chamber Deairating chamber Variable flow unit (Stepper motor) Line clamp unit

Clamp house Dialyzer connection

Figure 3. AK 95 S - Fluid part

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

MM 95: The concentrate connectors are connected to the water flow path by self-sealing valves. The heated water flows through the feeding pumps. The pumps are ceramic, and need a constant flow of water through the pump element; this acts as a lubricant. In Bicarbonate mode the acid concentrate is taken up through the red A-concentrate connector by the A-pump and added to the water flow. The acid/water mixture goes through a mixing chamber, to prevent air from causing unstable conductivity readings, before entering the Aconductivity cell. The measurement from the A-cell is compared with the required conductivity and any difference between the two will result in a change of the A-pump speed to correct the difference. There is a temperature transducer in the conductivity cell to compensate the conductivity calculation since it varies with temperature, approximately +1,8 % per °C. The bicarbonate concentrate is taken up through the B-concentrate connector by the B-pump and added to the acid/water solution. The acid/

B, Ac

bicarbonate/water mixture goes through the second mixing chamber, to prevent air from causing unstable conductivity readings, before entering the B- conductivity cell. The measurement from the B-cell is compared with the required conductivity and any difference between the two will result in a change of the B-pump speed to correct the difference. There is a temperature transducer in the B-conductivity cell to compensate the conductivity calculation since it varies with temperature, approximately +1,8 % per °C. When BiCart® is mounted, the flushing valve, FLVA, is used for priming of the BiCart cartridge. FLVA is also used during fill up of diluted chemical disinfection solution. Note that in acetate mode the A conductivity cell and A pump are not used. The acetate concentrate is taken up through the blue B-concentrate connector. The mixed fluid is then passing the (optional) pH-sensor before leaving the MM 95.

MM 95

B Mixing Chamber Feeding Pumps

A

A

Mixing Chamber Cond. Cell "A"

T

BiCart

Cond.Cell "B" FLVA T pH-SENSOR

Figure 4. MM 95 - Flow diagram

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Technical Description

A Feeding Pump

B

A Mixing Chambers B Heat Exchanger FLVA

A Conductivity Cell B

Figure 5. MM 95

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Fluid part, continued: The degassing chamber is used to separate air from the dialysis fluid. A negative pressure is created by means of the flow restrictor together with the flow pump. This degassing pressure is presettable between -400 mmHg and -700 mmHg, to adjust the degassing on high altitudes. The air expands in the expansion chamber. A draining restrictor is integrated in the botton of the expansion chamber. The degassing pressure transducer, which measures the negative pressure, is used to control the flow pump in order to ensure the correct degassing pressure. The air bubbles are separated in the degassing chamber. When the fluid level in the degassing chamber reaches the minimum level depending on increased air pressure, the float valve in the degassing chamber is opened and the air is led from the degassing chamber to the drain via the suction pump. When the fluid level in the degassing chamber reaches the maximum level, the float valve is closed. The dialysis fluid is taken out in the bottom of the degassing chamber. The rinsing valve, RIVA, is closed during treatment. During disinfection the rinsing valve is open, in order to fill the degassing chamber completely.

Figure 6. Flow pump and degassing chamber The flow restrictor is also used to control the main flow in the system. The main flow is variable between 300-700 ml/min in steps of 20 ml/ min. The degassing restrictor valve, DRVA, is regulated to achieve correct flow. During disinfection and rinse this valve is completely open. The third conductivity cell, Cond.Cell P, is only used for the protective system. There is a temperature transducer in the conductivity cell to compensate the conductivity calculation since it varies with temperature, approximately +1,8 % per °C.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

The treatment is carried out under controlled ultrafiltration, UF. The UF- volume is a measure of the ultrafiltrate. The differential flow is measured in the UF measuring cell. The required UF-rate is selected by setting the treatment time and the UF-volume. The actual UF-rate is compared with the required UF-rate and the suction pump is regulated so that the desired UF-rate is obtained. If the actual value is lower than the required value, the suction pump will run faster. When the operator adjusts the UF- volume or treatment time, the system automatically calculates the UF-rate. Every 30 minutes during treatment, the UF-cell is automatically self-calibrated. This is called a taration. This has to be done because waste products in the fluid returned from the dialyzer will be deposited in layers on the inside of the measuring channel 2. The taration can be divided into two phases: Phase 1: Offset (Zerosetting) phase. The UF measuring cell and the dialyzer are “disconnected”, i.e. there is no fluid passing through neither of the two channels in the UF cell. The offset of the two measurement channels can now be measured. During this phase the DIVA, BYVA and TAVA valves are closed and the ZEVA valve is open. The pressure in the flow path is controlled by the suctionpump. The HPG-pressure is used and the set value is the pressure measured just before start of the self-calibration. Phase 2: Coefficient (flow deviation) phase. The dialysis fluid is led past the dialyzer but through the UF unit, i.e. the same amount of fluid is passing through both channels of the UF cell. The DIVA, TAVA and ZEVA valves are closed and the BYVA valve is open. The calibration coefficient 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 is resumed. Before the UF measuring cell there is a pressure transducer, HPG (high pressure guard). INVA is closed if the pressure measured by the HPG transducer is above or equal to +550 mmHg (presetable).

2:11

Technical Description

For example, if there is a blockage somewhere in the tubes, the HPG generates an alarm and the AK 95 S enters the bypass mode. Treg after the heater is used together with the temperature transducer on conductivity cell B, to control the heater. The bypass unit includes two valves: The direct valve, DIVA, is normally open during treatment (if the temperature, pressure, conductivity etc. are within the predefined limits). The direct valve is closed and the bypass valve, BYVA, is opened when the dialysis fluid is bypassed from the dialyzer. The dialysis fluid is led past the dialyzer directly to the drain. The dialysis fluid is forwarded to the dialyzer via the output tube.

The dialysis fluid is led through channel 2 of the UF measuring cell to the blood leak detector. The blood leak detector detects any blood in the fluid. In the event of leak between the blood side and dialysis fluid side of the dialyzer, an alarm will be activated and the machine enters the bypass mode. Most of the dialysis fluid (90 to 95%) is taken out at the top of the blood leak detector. The rest is let out via a drain restrictor. The reason for this is that the blood leak detector has to be completely emptied during drain phase. Finally, the dialysis fluid is led to the drain, via the suction pump, the outlet restrictor and the drain-tube.

From the dialyzer the dialysis fluid (mixed with waste products) is returned to the fluid unit via the input tube. The input tube nipple is fitted with a filter. The Dialysis fluid pressure transducer, PD, after the dialyzer measures the dialysis fluid pressure. This pressure transducer is the most important pressure transducer in the system. PD is used for calculation of the transmembrane pressure, TMP. TMP is calculated by the system and presented on the operators panel. If the TMP is not within the predefined limits, an alarm is issued. The dialysis fluid is fed to a deairating chamber, which is used to separate air from the fluid. For example, a leakage may occur in the dialyzer connection. It is important that the air bubbles are separated from the dialysis fluid, otherwise the UF measuring could be affected. When the fluid level in the deairating chamber reaches the minimum level, i.e. when there is too much air in the deairating chamber, the evacuation valve, EVVA, is opened and the air is released. When the fluid level reaches over the minimum level, the evacuation valve is closed and so on. The “degassed” fluid is taken out in the bottom of the deairating chamber. The taration valve, TAVA, is normally open during treatment. During calibration of the UF measuring unit, the taration valve is closed. TAVA is also closed when the protective system demands a minimum of UF.

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Disinfection and rinse Chem disinfection When Disinfection is selected by pressing the CHEM DISINF key, the information display will show three alternatives of disinfection solutions. The disinfectant fluid will be taken up by the Btube and if the B tube is not taken out of the machine and/or if the A-tube is taken out, there will be an attention.

Heat disinfection is selected with the HEAT DISINF button. The remaining disinfection time shows on the time display as soon the disinfection starts. How many minutes a program lasts is seen below. Total time for Disinfection Programs are estimated and may vary. Disinfection programs

Time [min]

230 V 110 V

100 V

35

39

49

Heat Citric acid 20% 52

57

67

Heat CleanCart

49

54

64

33

37

47

Heat Citric acid 20% 50

55

65

Heat CleanCart

51

61

With UFD installed

When the filling phase is finished the AK 95 S will give an attention that requests you to place the B-tube back in the monitor. When this is done the disinfection solution is distributed in all of the fluid path and the dwell time starts. As soon as the dwell time is done, an automatic rinse will start. It is possible to end the Disinfection dwell program before it is finished by pressing RINSE/DRAIN key. It is not possible to go from chemical disinfection mode to treatment mode without a rinse. In case of a power failure the monitor will save recovery data and continue the disinfection when the power returns.

Heat disinfection During the heat disinfection program the inlet water is heated and rinsed through the fluid unit. The machine is then drained. It is also possible to run the heat disinfection in combination with Citric Acid 20% or with a CleanCart installed. For heat disinfection a heat exchanger is a requirement. For 230V version the exchanger must have an efficiency of minimum 60%. 110V and 100 V requires 76% efficiency. To get a proper heat disinfection, the fluid must exceed 80°C. The exchanger is not only necessarily to achieve proper temperature but it is also important for stabilization of the heater control system.

Heat

Without UFD Heat

46

Four minutes before completion of the heatdisinfection, the program enters the drain phase and the heat disinfection lamp is turned off. The heat disinfection completes when the RINSE/ DRAIN key is flashing. When pressing the flashing RINSE/DRAIN key after a completed disinfection, the machine will perform a functional check (Fch).

Rinse/Drain Rinse mode will be started automatically after a disinfection as described above or manually by pressing the RINSE/DRAIN key. The display shows the rinse time and allows you to change it if you wish. The rinse program will run for the set time. Both A- and B- pick-up tubes must be placed in the monitor, otherwise there will be an attention. During the final drain phase the air intake valve, AIVA, is open. When rinse is completed the RINSE/DRAIN key will be flashing. 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 the chemical disinfection mode by enter the service mode. For more information, see chapter 4, Technicians guide.

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Technical Description

Component Description Heater relay board

Dialyzer connections

The heater relay board comprises the following: • Opto relay • Heater safety relay • Heater sensor (“energized”)

The input tube nipple is fitted with a particle filter.

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

Conductivity measuring unit The unit includes the following components: • Measuring cell. • Conductivity board, which is mounted directly on the measuring cell. The conductivity board interfaces to the CPU board, via a board connector and a flat cable. • Temperature transducer.

Degassing chamber The AK 95 S contains one degassing chamber used to separate air from the dialysis fluid. The degassing chamber comprises a mechanical float valve.

Mixing chambers The AK 95 S contains two mixing chambers used to mix the concentrate with the water and separate air from the dialysis fluid before entering the conductivity cell.

Deairating chamber The deairating chamber comprises a level detector and the dialysis fluid pressure transducer. The level detector interfaces to the FM I/ O board, via a cable. The pressure transducer is connected to a pressure transducer board, via a twisted cable. The pressure transducer board interfaces directly to the FM I/O board.

Flow pump unit The flow pump unit consists of the following: • Gearwheel pump driven by a DCmotor. • Pressure transducer with board. The pressure transducer is connected to the transducer board, via a twisted cable. The transducer board interfaces directly to the FM I/O board, via a board connector. 2:14

Safety coupling unit The safety coupling unit comprises two tube connections, which are used when the machine is to be disinfected, and a pressostate SAGS, which detects when the tubes are disconnected from the safety coupling. The AK 95 S is also equipped with a pair of mechanical switches that sense if the dia connectors are attached to the bypass block.

UF measuring unit The UF measuring unit consists of the following components: • Measuring cell. • UF amplifier board. • UF driver board. The boards are mounted on each side of the measuring cell. The UF measuring unit interfaces to the Control Driver, via the UF amplifier board, a board connector and a flat cable.

FM I/O board The FM I/O board contains of 6 connectors to pressure transducers and temp. transducers. It also contains the running time meter.

Heater unit The heater is connected to the relay board, via a cable. It comprises a temperaturetransducer TReg. The transducer is connected to a transducer board, via a twisted cable. The transducer board interfaces directly to the FM I/O board, via a board connector. NOTE! If the heater cartridge has been overheated, this must be exchanged and the leakage current to earth measured before restart.

Flow Switch A mechanical flow switch is mounted before the heater. The flow switch will turn off the heater in a no-flow situation.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Blood leak detector

CPU board

The blood leak detector includes the following components: • Housing with cover. • Transmitter and Receiverboard • Blood leak detector board.

AK 95 S is equipped with one Control CPU board and one Protective CPU board. The CPU boards comprises among other things the microcomputers. The spare parts list gives the board connectors which reside on the CPU boards.

The transmitter and receiver boards are connected to the blood leak detector board, via twisted cables. The blood leak detector board interfaces directly to the FM I/O board, via a board connector.

Suction pump The suction pump consists of a gearwheel pump driven by a DC-motor.

Battery The battery is a rechargeable 9V battery. The battery is used to drive the buzzer alarm during mains power failure. The battery is not connected at delivery. NOTE! The battery must be connected during the installation according to the instruction in the Installations Guide.

MM I/O board The MM I/O board is mounted in the mixing module. It transfers control and data information received from the CPU boards to the various electronic and electromechanical parts in the mixing module. It also transmits sensor information from the mixing module up to the CPU boards in the AK 95 S.

Fan The drive motor (DC-motor) and the fan form a single unit. The fan is connected to the driver board, via a cable.

Driver board AK 95 S is equiped with one Control Driver board and one Protective Driver board, according to the figure 8.

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Technical Description

Rear printed circuit boards

Protective Driv board

Protective board

CPU

er

Contr ol board Driver

Cont ro boar l CPU d

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

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Blood Part Blood Flow Diagram Arterial pressure P transducer (optional) Arterial line clamp Arterial pressure guard Arterial blood pump

Arterial blood line

Heparin pump

Patient Venous blood line

Dialyzer

Venous drip chamber Priming detector

Air detector

Venous line clamp P Venous pressure transducer

Figure 9. AK 95 S - Blood Flow Diagram.

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Technical Description

Treatment Arterial blood is taken in via the arterial line clamp. During treatment the line clamp is open.

If the venous pressure is too low, the cause may be:

The arterial pressure guard is used to give an alarm if the pressure becomes too low. For example, if the needle or the arterial blood line is blocked, an alarm will be given ( the blood pump is stopped). The alarm is activated if there is an increased negative pressure between the patient 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 maintain the extra corporeal blood flow. Blood is removed from the patient, forwarded to the dialyzer and then returned to the patient. The blood pump can not be run when the pump cover is open. If necessary, the blood can be returned to the patient manually. The purpose of the heparin pump is to add heparin to the blood. An alarm is issued when the syringe is empty or if the heparin line is kinked. The heparin parameters can be adjusted by pressing the heparin button. The venous pressure transducer measures the venous bloodpressure. The lamp in the Venous pressure button is lit and the buzzer sounds if the alarms are activated and the venous bloodpressure is outside the alarm limits. If the event of an alarm, the blood flow is stopped. If the venous pressure is too high, the cause may be: • •

2:18

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 chamber is too low, an alarm is given and the blood flow is stopped (the blood pump and heparin pump are stopped and the venous line clamp is closed). The venous drip chamber acts as an expansion chamber to even out pressure pulsations. When the air detection alarm is generated, the lamp in the Air detect button is lit and the buzzer sounds. The lamp begins flashing when the air detector does not detect air any longer. The operator must reset the air detection alarm by pressing the Air detect button. After pressing the Air detect button for 3 seconds, the air detector alarm is bypassed for x seconds (presettable 0-120 sec.). Default it is disabled (0 seconds) and no override is possible.

The priming detector detects if there is blood in 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 via the venous line clamp. The clamp is normally open. But in the event of an alarm from the air detector or the venous pressure transducer, the line clamp clamps the blood line and stops the blood flow (not during high pressure alarm).

An obstruction after the venous drip chamber. A change in the patients position.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Component Description

1

3 7

4 5

2

1076

6

Figure 10. AK 95 S Blood part - Outside components

1. Operators panel 2. Air detector 3. Venous pressure transducer 4. Arterial pressure transducer 5. Blood pump unit 6. Heparin pump unit 7. Expansion chamber holder

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

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Technical Description

Figure 11 . AK 95 S Blood part - Inside components

1. Operators panel 2. Air detector 3. Venous pressure transducer 4. Arterial pressure transducer 5. Blood pump unit 6. Heparin pump unit 7. Expansion chamber holder 8. BM I/O Board 9. Level regulation

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Line clamps

Venous pressure transducer (C+P)

The blood unit includes two line clamps: Arterial line clamp and venous line clamp. The arterial line clamp is located to the right and the venous line clamp is located to the left when viewed from the front. The clamp covers also have different colour markings: The arterial clamp cover is marked with a red dot and the venous clamp cover is marked with a blue dot. The line clamp unit consists of the following:

The blood unit is equipped with two pressure transducers connected to one port, which are used to measure the venous blood pressure. The pressure transducers are mounted on a pressure transducer board, which interfaces directly to the BM I/O board, via a board connector. The pressure transducers are connected to the venous pressure transducer nipple (located on the front), via a small tube.

•

Arterial pressure transducer

• • •

Housing with covers (mounted on the front plate). 2 solenoids (as one unit). Line clamp driver board. 2 clamp detectors.

The line clamp driver board interfaces to the protective CPU board, via a board connector and a flat cable.

Blood pump unit The 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.

AK 95 S can be equipped with a second pressure transducer, named Arterial Pressure Transducer. This pressure will be displayed on the arterial bargraph. The transducer is used for true arterial pressure measurement or any other pressure. The pressure transducer is mounted on a pressure transducer board, which interfaces directly to the BM I/O board, via a board connector.

Air detector The air detector consists of an ultrasonic transmitter and receiver mounted in a head. The air detector head is adjustable to accomodate most drip chambers of 18-30 mm diameter. The air detector interfaces to the BM I/O board and the driver board via 2 cables.

Priming detector The blood pump unit, except the tube pump, is mounted on the back of the front plate. The motor, cover detector and position board interface to the BM I/O board, via connectors and cables.

Heparin pump The heparin pump unit consists of the following components: • • • • •

The priming detector is intergrated in the Line Clamp Unit. It has a detector board (on the back of the front). The detector board contains a LED and a phototransistor. The current through the LED is indicating how much current that is needed to get a certain light transmission through the light guides to the receiver. The lower the value is, the better.

Syringe pump. The diameter of the syringe 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 position board and heparin pump potentiometer interface to the BM I/O board, via cables.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

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Technical Description

Operators panel The operators panel is a flat surface panel. It comprises: • • • • •

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 driverboard, via 3 board connectors and 3 flat cables.

Figure 12. Operators panel

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

BPM The BPM (Blood pressure monitor) is physically placed in the MM95. The BPM monitor is a passive measuring device that can issue attentions and alarms but the alarms will not interfere with the AK 95 S treatment. The intended use for the BPM is to measure the patient’s blood pressure and to activate an alarm if the patient’s blood pressure goes under an alarm limit set by the operator. This will give the nurses the possibility to take measures before the patient suffers the ill effects of hypotension (low blood pressure). The BPM module includes the following components; air pump, bleed valve, dump valve, pressure transducers (control and protective) and microprocessor board. The module includes control and protective systems. The control system measures the pressure and pulse wave to calculate the systolic, diastolic, mean blood pressure and pulse rate. The air pump, dump and bleed valves are controlled by this system as well as external communication.

The relationship between the changes of cuff pressure and its oscillation is used to determine the blood pressure. When the BPM deflates the cuff and the blood starts to pass the restriction, the oscillation incline rapidly and the systolic (high) pressure is measured. When the oscillation has peaked and is declining rapidly the diastolic (low) pressure is measured. The mean pressure is measured when the oscillation is peaking. The heart rate is determined by using the pressure oscillations measured by the pressure transducer. When to measure the diastolic pressure is determined by extensive experiments to establish an algorithm, which is included in the BPM software. In the field it is possible to perform a check of the device to determine if it works or not. The device has to be sent to Gambro for repair incase of malfunction.

The protective system supervises the maximum pressure and inflating time. Maximum pressure is 320 ± 10 mmHg and maximum inflating time is 180 seconds. When these values exceed specified limits, dump and bleed valves are opened and air pump is stopped by the protective system. A self-calibration/auto zero function is included in the module, which means that the offset for the pressure transducers is calibrated/adjusted each time the module is turned on. The BPM measures and calculates the non-invasive blood pressure by using the oscillometric method. This method uses the pulsation that occurs in the artery in the arm when it is restricted by the inflated cuff. The noise or oscillation originates from the fact that when the cuff restricts the vessel, the flow in the vessel becomes turbulent, instead of laminar. The pulsation causes the pressure in the cuff to oscillate which the pressure transducer in the BPM module measures.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

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Technical Description

Power Supply Design Power supply to heater relay board

External Fuses: 12 AH

Power supply to Control CPU board

T12AH 250AC

HALT

BACH

BACO

Contact Fan Intake Mains Switch

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

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Technical Description

Block Diagram Description External fuses 12AH

MAINS to heater rod

Filter

12AH

Internal fuses

AC Filter DC

+5VDC +5VDC ±12VDC +24VDC

AC +12VDC DC MAIN SWITCH MAINS INPUT

Figure 14. Block diagram, power supply

The mains voltage is fed to an AC/DC converter which generates different DC supplies to the monitor. •Two +5 volt supplies, one for the control system and 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 the ON/OFF logic.

AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Battery 24 V

The mains voltage also supplies the voltage to the heating element. In a mains power failure situation, the AK 95 S gives an intermittent buzzer alarm and performs a recovery, when the power returns. All the settings and accumulated values are stored in the machine. The treatment will be continued from where it was interrupted. AK 95 S will perform a recovery when the monitor is in treatment or disinfection. In service and preset mode the monitor will start with a Fch.

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Technical Description

This page is left intentionally blank.

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AK 95 / AK 95 S Service Manual HCEN 9134 Rev. 10.2005

Chapter 3 Technical data and specifications Performance and specification - Control system . . . . . . . . . . . . . . . . . Blood flow control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Heparin administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood pressure control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Pressure Monitor (BPM) . . . . . . . . . . . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ultrafiltration control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Profiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Disinfection and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Connection of external equipment . . . . . . . . . . . . . . . . . . . . . . . . . Battery back-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Performance and specification - Supervisory system . . . . . . . . . . . . . Blood pressure supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Extracorporeal blood loss to the environment . . . . . . . . . . . . . . . . Air detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Extracorporeal blood loss due to coagulation . . . . . . . . . . . . . . . . . Dialysis fluid preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ultrafiltration supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood leakage detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . pH-meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Physical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Infusion stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Materials in contact with dialysate, concentrates and water . . . . . . . . Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HCEN9369 Revision.10.2005 Program version 12.xx

AK 95 S Service manual - Technical data and specifications

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3:1

Performance and specification - Control system Blood flow control Values for the blood pump(s) are based on a pressure of -150 mmHg before the arterial blood pump with a pump segment of 7.9 mm. For pediatric blood tubes with pump segment of 4.0 mm it is also possible to set blood flow to 5, 10 or 15 ml/min. Double needle Flow rate: Flow accuracy: Accumulated blood volume: Volume accuracy:

0 and 20 - 500 ml/min (-150 mmHg prepump pressure, pump segment diameter 7.9 mm) ±10 ml/min or ±15%, whichever is largest 0 - 327 litres ±0.6 l

treatment time (h) or ±15%

Single needle Flow rate: Flow accuracy: Time control:

Pressure control: Accumulated blood volume: Volume accuracy:

0 and 20 - 500 ml/min (-150 mmHg prepump pressure, pump segment diameter 7.9 mm) ±10 ml/min or ±18%, whichever is largest 2 - 20 seconds (±1 sec.), arterial and venous time. The actual clamp opening time is depending on blood flow rate, size of expansion chamber and pressure limits. 10 - 500 mmHg (±50 mmHg), venous pressure control 0 to 327 litres ±0.6 l

treatment time (h) or ±18%

Heparin administration Heparinization: Syringe size:

Stop time: Counter pressure: Accumulated heparin volume:

3:2

0 to 10 ml/h (±1 ml/5 h or ±5%) The accuracy is based on tests with 20 ml and 30 ml syringes Syringes shall comply with ISO 7886-2. Upon delivery, the machine is set for a 20 ml Terumo syringe. Syringes of other volumes and brands can be set. Heparinization stops before end of treatment 0.00 to 9.59 h Maximum 400 mmHg 0 to 999.9 ml

AK 95 S Service manual - Technical data and specifications

HCEN9369 Revision.10.2005 Program version 12.xx

Blood pressure control Venous pressure: Operating range Alarm limits: Accuracy:

-700 to 750 mmHg 10 to 500 mmHg in treatment mode, -100 to 500 mmHg in priming mode -700 to -500 mmHg, ±10% -500 to 500 mmHg, ±5 mmHg or ±3%, whichever is largest 500 to 750 mmHg, ±10%

Blood Pressure Monitor (BPM) Systolic pressure range1 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default)

60 - 250 mmHg 60 - 250 mmHg (100 mmHg)

Diastolic pressure range1 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default)

40 - 200 mmHg 40 - 200 mmHg (60 mmHg)

Mean pressure range1 Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default)

45 - 235 mmHg 45 - 235 mmHg (75 mmHg)

Pulse rate range Low alarm limit, can be preset (Default) High alarm limit, can be preset (Default)

40 - 200 bpm (±2 bpm or ±2% of reading) 40 - 200 bpm (40 bpm)

60 - 250 mmHg (150 mmHg)

40 - 200 mmHg (100 mmHg)

45 - 235 mmHg (115 mmHg)

40 - 200 bpm (150 bpm)

1

Meets ANSI/AAMI SP-10 (1992). Mean error ±5 mmHg. Standard deviation 8 mmHg

H CEN9369 Revision.10.2005 Program version 12.xx

AK 95 S Service manual - Technical data and specifications

3:3

Dialysis fluid preparation Pressure regulators:

After pressure regulator PR 1 and the heat exchangers: 80 kPa (0.8 ±0.1 bar) After pressure regulator PR 2: 130 ±10 mmHg

Temperature: Alarm limits: Accuracy: Heater capacity: Overheat protection:

Flow rate: Accuracy:

300-700 ml/min in steps of 20 ml/min ±10% or 50 ml/min whichever is largest

Degassing:

Accuracy:

By use of negative pressure, -610 mmHg. Adjustable degassing pressure between -300 and -700 mmHg (-650 mmHg with 700 ml/min flow rate). ±40 mmHg

Dialysis fluid pressure: Accuracy:

-400 to +300 mmHg. ±10 mmHg or ±5%

Proportioning of concentrates:

The proportioning of concentrate is done through conductivity control. The concentrates are pumped into the system with one/two volume trically supervised pumps. No minimum feeding pressure is necessary, the fluid is sucked in. Maximum feeding pressure, 150 kPa. Na+ , 130 to 160 mmol/l, (±3 mmol/l) Na+ , 130 to 160 mmol/l, (±6 mmol/l)HCO3- , 20 to 40 mmol/l, (±6 mmol/l) 13 to 16 mS/cm ±5% of the calculated conductivity set value

Acetate: Bicarbonate: Measuring range: Alarm limits:

3:4

Adjustable 33 to 40 °C. Accuracy is valid only if dialysis fluid temperature is greater or equal to ambient temperature. Adjustable 33 to 40 °C +0.5/-1.5 °C (+1,0/-2.5 °C with UFD-kit) at the dialysis fluid outlet from the machine. 1000 W (+10% / -5%) at 100 V 1300 W (+10% / -5%) at 110 V 1750 W (+10% / -5%) at 230 V Reg-temp 80 °C or Cond A-temp 70 °C in treatment, software Reg-temp 99 °C in disinfection, software. The heater can only be on if there is a flow through the heater. The flow is detected by a flow switch.

AK 95 S Service manual - Technical data and specifications

HCEN9369 Revision.10.2005 Program version 12.xx

Ultrafiltration control Volume control: UF volume: Accuracy of measured volume: UF coefficient: UF rate: Time:

Direct electromagnetic measurement of dialysis fluid flow, before and after the dialyzer. Adjustable 0 to 10.00 l ±50 ml/h or ±1% whichever is largest Maximum 85 ml/h/mmHg 0.0 to 4 l/h, given by the set values of UF volume and treatment time. Remaining treatment time control. 0.05 to 9.59 hour. minute (±1 minute)

Profiling UF-rate Na+, Acetate mode Na+, Bicarbonate mode HCO3-, Bicarbonate mode

0.0 to 4 l/h 130 to 160 mmol/l 130 to 160 mmol/l 20 to 40 mmol/l

Disinfection and cleaning Chemical disinfection Peracetic Acid Program (presetable) Concentration of disinfectant Concentration in machine Volume Contact time between treatments Contact time overnight or when not in use (recommended with UFD-kit) Total time

3.5% peracetic acid 0.1%, i.e. diluted 1 + 34 (1:35) approx. 85 ml (with UFD-kit approx. 92 ml) 10 minutes Minimum 3h dwell time 30 minutes (with UFD-kit 59 minutes) including 10 min. contact time

Hypochlorite Program (presetable) Concentration of disinfectant Concentration in machine Volume Contact time between treatments Contact time overnight or when not in use Total time

H CEN9369 Revision.10.2005 Program version 12.xx

10% available chlorine 0.5%, i.e. diluted 1 + 19 (1:20) Approx. 145 ml (with UFD-kit approx. 153 ml) 10 minutes Maximum 20 min, not intended for overnight disinfection! 30 minutes (with UFD-kit 48 minutes) including 10 min. contact time

AK 95 S Service manual - Technical data and specifications

3:5

Formaldehyde Program (presetable) Concentration of disinfection Concentration in machine Volume Contact time between treatments Contact time overnight or when not in use (recommended with UFD-kit) Total time

37 % formaldehyde 3.7%, i.e. diluted 1 + 9 (1:10) Approx. 275 ml (with UFD-kit approx. 290 ml) 20 min Minimum 6h dwell 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. The second alternative is presetable for a combined heating program and the third is a CleanCart / heating alternative. The default settings are as follows. AK 95 S

With UFD installed

Without UFD

3:6

Disinfection programs

Total Time [min] 230 V

110 V

100 V

Heat

35

39

49

Heat Citric acid 20 %

52

57

67

Heat CleanCart

49

54

64

Heat

33

37

47

Heat Citric acid 20 %

50

55

65

Heat CleanCart

46

51

61

AK 95 S Service manual - Technical data and specifications

HCEN9369 Revision.10.2005 Program version 12.xx

Auto Heat disinfection Auto Heat can be used with or without CleanCart. If the Auto Heat shall be performed with CleanCart must the cartridge be installed before the Auto Heat starts. AK 95 S

With UFD installed

Without UFD

Disinfection programs

Total Time [min] 230 V

110 V

100 V

Heat

31

35

45

Heat CleanCart

43

49

58

Heat

31

35

45

Heat CleanCart

43

48

58

Temperature:

+93 °C (measured after heating rod) ≥80 °C (measured in the outlet before the heat exchanger)

Note: The temperatures are verified at nominal values for the mains voltage and at 20 °C ambient temperature. Rinse/Drain: Rinse/Drain Drain

10 minutes 4 minutes

Exterior cleaning:

All outside parts of the machine can be cleaned with ethanol (70%) or isopropanol (60%).

Note: Total Time for Disinfection Programs are estimated and may vary.

Water supply Flow rate:

Minimum inlet pressure: Maximum inlet pressure: Inlet temperature: Connector in/outlet: Quality:

H CEN9369 Revision.10.2005 Program version 12.xx

During treatment: maximum 770 ml/minDuring disinfection and rinse/drain: a maximum flow rate of 800 ml/min is required. 0.12 MPa (1.2 bar) 0.6 MPa (6 bar) Treatment: +5 to +30 ºC Disinfection: +5 to +90 ºC Diameter 8 mm Inlet water quality must comply with local regulations and if no such regulation is available follow ISO 13959. Level for conductivity shall not exceed 0.1 mS/cm. It is possible to use water with higher conductivity if it consists mainly of sodium salts. This may however affect the accuracy of the fluid composition.

AK 95 S Service manual - Technical data and specifications

3:7

Drain:

Length of drain tube: High pressure guard transducer: Inlet pressure switch (INPS): Safety guard switch (SAGS):

The drain tube outlet must be placed between floor level and maximum 1.2 m above the outlet connection from the fluid monitor. An air gap to atmospheric pressure must always be arranged at the tube outlet. 30 minutes T 15 A

AK 95 S Service manual - Technical data and specifications

HCEN9369 Revision.10.2005 Program version 12.xx

Performance and specification - Supervisory system Blood pressure supervision Venous pressure: Operating range Alarm limits: Accuracy:

-700 to 750 mmHg 10 to 500 mmHg in treatment mode, -100 to 500 mmHg in priming mode -700 to -500 mmHg, ±10% -500 to 500 mmHg, ±5 mmHg or ±3%, whichever is largest 500 to 750 mmHg, ±10%

Arterial pressure: Operating range Alarm limits: Accuracy:

-700 to 750 mmHg -700 to 750 mmHg -700 to -500 mmHg, ±10% -500 to 500 mmHg, ±5 mmHg or ±3%, whichever is largest 500 to 750 mmHg, ±10%

Extracorporeal blood loss to the environment Detection method:

Venous pressure supervision

Air detection Detection method:

Drip chamber size: Sensitivity:

Ultrasonic detector placed at the venous drip chamber. The detector has a two channel structure and the function of the detector is tested at the function test made by the microcomputers. Diameter 22 mm Bubbles larger than 1 µl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector.

Extracorporeal blood loss due to coagulation Detection method: Alarm:

H CEN9369 Revision.10.2005 Program version 12.xx

Supervision of the stop time of the blood pump The attention “BLOOD PUMP STOP TIME EXPIRED, Start Blood pump”.

AK 95 S Service manual - Technical data and specifications

3:11

Dialysis fluid preparation Temperature: Temperature alarm (fixed) Overheat protection:

40 °C (±0.5 °C) The heater can only be on if there is a flow through the heater. The flow is detected by a flow switch.

Conductivity: Alarm limits:

±5 % of the calculated conductivity set value

Ultrafiltration supervision TMP:

Alarm limits: Accuracy:

TMP is defined as the difference, Pb out P d out, where Pb out is the venous pressure and P d out is the pressure measured in the dialysis fluid, where it enters the machine after the dialyzer. -100 to 500 mmHg ±500 ( ±10 mmHg or ±5 %, whichever is largest )

Blood leakage detection Detection method: Sensitivity:

Infrared light detector. Alarm will be given for ≥0.3 ml blood, haematocrit 32%, per minute at 700 ml/min dialysis fluid flow. Time delay for alarm, maximum 5 seconds (diffusion mode).

pH-meter Measuring range: Accuracy: Alarm limits:

3:12

1 - 9.9 pH, measured in the dialysis fluid before dialyzer. ±0.2 pH 5.0 to 9.0 pH

AK 95 S Service manual - Technical data and specificat

ions

HCEN9369 Revision.10.2005 Program version 12.xx

Physical data Dimensions and weight Width: Depth: Height: Weight:

Approx. Machine 480 mm, stand 580 mm. Approx. Machine 600 mm, stand 625 mm. Approx. 1270 mm (without infusion stand). Approx. 62-78 kg (depending on options).

Infusion stand Maximum total load:

2 kg

References Assembly Drawing K23000

H CEN9369 Revision.10.2005 Program version 12.xx

AK 95 S Service manual - Technical data and specifications

3:13

Materials in contact with dialysate, concentrates and water Polymers Silicon rubber Santroprene PVC (Polyvinylchloride) PEEK (Polyetherketone) PEX (Polyethylene) PP (Polypropylene) PSU (Polysulphone) PVDF (Polyvinylidene fluoride) PTFE (Polytetrafluoro ethylene) Metals Stainless steel SS2343 Stainless steel SS2353 Stainless steel SS2562 Titanium Platinum Others Carbon Ceramic, Steatite 221 Ceramic, Aluminium oxide (Al2O3) Glass

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AK 95 S Service manual - Technical data and specifications

HCEN9369 Revision.10.2005 Program version 12.xx

Environmental data Operation If condensation occur when moving the equipment between locations with different temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside of the equipment shall be allowed to dry before switching on the equipment. Ambient Temperature range +18 to +35 °C 15 to 85% RH Relative Humidity range Air Pressure range ( atm. 700 to 1060 hPa Pressure )

Transportation and storage During transportation and storage the equipment has to be kept in its original packing. If transportation or storage time is more than 15 weeks, the environmental data relating to the operation has to be followed. The maximum ambient temperature for transportation and storage in 96% Relative humidity is +40 °C. Ambient Temperature range -20 to +70 °C 10 to 96% RH Relative Humidity range Air Pressure range ( atm. 500 to 1060 hPa Pressure )

H CEN9369 Revision.10.2005 Program version 12.xx

AK 95 S Service manual - Technical data and specifications

3:15

Standards The 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 automatic cycling indirect blood pressure monitoring equipment EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements EN 1060-3 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electromechanical blood pressure measuring systems

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AK 95 S Service manual - Technical data and specifications

HCEN9369 Revision.10.2005 Program version 12.xx

Technical Data

Chapter 3 Technical data and specifications for AK 95

AK 95 HCEN9135 Rev. 10.2005

3:1

Technical Data

Machine specification AK 95, K18022 Blood flow control Double needle Flow rate: Flow accuracy: Accumulated blood volume: Volume accuracy: Single needle Flow rate: Flow accuracy: Time control: Pressure control: Accumulated blood volume: Volume accuracy:

0 and 20 - 500 ml/min (-150 mmHg prepump pressure, pump segment diameter 7.9 mm) ±10 ml/min or ±10 %, whichever is largest 0 - 999 litres ±10 %

0 and 20 - 500 ml/min (-150 mmHg prepump pressure, pump segment diameter 7.9 mm) ±10 ml/min or ±10 %, whichever is largest 2 - 20 seconds, arterial and venous time. 10 - 500 mmHg ( ±5 mmHg or ±3 %, whichever is largest), venous pressure control 0 to 999 litres ±10 %

Blood pressure supervision Venous pressure: Operating range Alarm limits: Accuracy:

Arterial pressure: Operating range Alarm limits: Accuracy:

3:2

-700 to 750 mmHg 10 to 500 mmHg in treatment mode, -100 to 500 mmHg in priming mode -700 to -500 mmHg, ±10 % -500 to 500 mmHg, ±5 mmHg or ±3 %, whichever is largest 500 to 750 mmHg, ±10 %

-700 to 750 mmHg -700 to 750 mmHg -700 to -500 mmHg, ±10 % -500 to 500 mmHg, ±5 mmHg or ±3 %, whichever is largest 500 to 750 mmHg, ±10 %

AK 95 HCEN9135 Rev. 10.2005

Technical Data

Air detection Detection method:

Drip chamber size: Sensitivity:

Ultrasonic detector placed at the venous drip chamber. The detector has a two channel structure and the function of the detector is tested at the function test made by the microcomputers. Diameter 22 mm Bubbles larger than 1 µl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector.

Heparin administration Heparinization: Syringe size:

Stop time: Counter pressure: Accumulated heparin volume:

0 to 10 ml/h (±1 ml/5h or ±5%) The accuracy is based on tests with 20 ml and 30 ml syringes Syringes shall comply with ISO 7886-2. Upon delivery, the machine is set for a 20 ml Terumo syringe. Syringes of other volumes and brands can be set. Heparinization stops before end of treatment 0.00 to 9.59 h Maximum 400 mmHg 0 to 999.9 ml

Water supply Flow rate:

Minimum inlet pressure: Maximum inlet pressure: Inlet temperature: Connector in/outlet: Quality:

Drain:

Length of drain tube: High pressure guard transducer: Inlet pressure switch (INPS):

AK 95 HCEN9135 Rev. 10.2005

During treatment: maximum 770 ml/min During disinfection and rinse/drain: a maximum flow rate of 800 ml/min is required. 0.12 MPa (1.2 bar) 0.6 MPa (6 bar) +5 to +30 ºC Diameter 8 mm Inlet water quality must comply with local regulations and if no such regulation is available follow ISO 13959. Level for conductivity shall not exceed 0.1 mS/cm. It is possible to use water with higher conductivity if it consists mainly of sodium salts. This may however affect the accuracy of the fluid composition. The drain tube outlet must be placed between floor level and maximum 1.2 m above the outlet connection from the fluid monitor. An air gap to atmospheric pressure must always be arranged at the tube outlet.