Gambro AK-96 User manual

Important Information

Concerning this manual; Operator’s Manual, AK 96 Dialysis machine, Program version 3.xx,
Rev 12.2010

Dear operator,

The exterior of the machine that you are using might be different in appearance from the
exterior described in this manual. If there is a difference, this is because you are using a
previous version of the machine.

Whenever this asterix symbol appears in the manual, it indicates that it is the previous
version of the machine.
The differences are to be found in chapter 2 and 4.

Machine in this manual Previous version of the machine

AK 96®Dialysis Machine

Operator's Manual

For use with program version 3.xx

Manufacturer:

Gambro Lundia AB

Box 10101

Magistratsvägen 16

SE-220 10 LUND

Sweden

Phone [phone]

www.gambro.com

Questions or comments about this publication can be directed to your lo

Order number:

MHCEN12239–12/10

cal representative or to the manufacturer.

HCEN12239 Revision 12.2010
Program version 3.xx

Intellectual Property Rights

Copyright:

© 2007, 2008-2009 G ambro Lundia AB. All rights reserved.

Trademarks:

AK 96®is a trademark of Gambro Lundia AB filed in the United S tates and registered in the European Community,

Australia, Bulgaria, Belarus, Switzerland, Ukraine, China, Croatia, Japan, South Korea, Morocco, Norway, Russian

Federation, Singapore, Syria and Turkey

®

BiCart

is a trademark registered in Austria, Bosnia-Herzegovina, Bulgaria, Benelux, Belarus, Czech Rep

Algeria, Egypt, Spain, France, Croatia, Hungary, Italy, North Korea, Kazakstan, Liechtenstein, Morocco, Monaco, The

former Yugoslav Republic of Macedonia, Mongolia, Portugal, Romania, Russian Federation, Sudan, Slovenia, Slovak

Republic, San Marino, Tunisia, Ukraine, Uzbekistan, Vietnam, Serbia and Montenegr

Finland, Mexico, New Zealand, Sweden, Uruguay, Japan, Greece, Australia, Brazil, Chile, Colombia, Denmark, Great

Britain, South Korea, Peru, Taiwan and the United States in the name of Gambro Hospal (Schweiz) AG, Gambro AB

and Gambro Lundia AB

CleanCart

Poland, Portugal, Romania, Russian Federation, Sudan, Slovenia, Slovak Republic, Albania, Armenia, Austria, Azerbaijan,

Bosnia-Herzegovina, Bulgaria, Benelux, Belarus, China, Cuba

Croatia, Hungary, Italy, Kyrgyzstan, North Korea, Kazakstan, Liech ten s tein , Liberia, Latvia, Morocco, Monaco, San

Marino, Tajikistan, Ukraine, Uzbekistan, Vietnam, Serbia and Montenegro, Canada, Japan, Sweden and Australia in the

name of Gambro Hospal (Schweiz) AG, Gambro AB and Gambro Lun

Diascan

Czech Republic, Germany, Greece, Croatia, Italy, Norway, Poland, Portugal, Russian Federation, Slovenia, Turkey,

Ukraine, Hong Kong, Mexico, Taiwan, United Stat

name of Gambro Hospal (Switzerland) ltd

U9000

The following trade m arks mentioned in the Op

Dialox

®

is a trademark registered in Switzerland, Moldova, The former Yugoslav Republic of Macedonia, Mongolia,

, Czech Republic, Germany, Algeria, Egypt, Spain, France,

dia AB

®

is a trademark registered in France, A ustria, Australia, Benelux, Switzerland, China, Serbia and Montenegro,

es and Great Britain in the name of Gambro Lundia AB and in the

®

is a tradema rk of Gambro Lundia AB re gistered in the European Community

erator’s Manual are not owned by any company within Gambro:

o, Switzerland, Argentina, Canada,

ublic, Germany,

Patents:

The AK 96 dialysis machine is protec

US: 5173125, 5792367, 5567320, 7246530, 7435235

EP: 745213, 658352

CA: 1327022, 2138354

DE: 69528156T2, 69406253, 69406257

ES: 2109643

FR: 9403710

JP: 3183528, 3618352

KR: 94404

SE: 524229

The AK 96 dialysis machine is protected by one or more of the following designs:

WO: DM/070849

EU: 000747811–00

AL: 420833801

AU: 318776 – 318782

CA: 123590

IN: 213741, 213742

KR: 497613

01 – 000747811–0007

ted by one or more of the following patents:

HCEN12239 Revision 12.2010

Program version 3.xx

AK 96®Dialysis Machine
Operator's Manual
Program version 3.xx

Part 1 Base Manual for General Use

1. Before you get started - General Information

2. Description - The Machine and its Components

3. Operating the Machine - Handling Guidelines

4. Hemodialysis - Double Needle Treatment

5. Hemodialysis - Single Needle Treatment (option)

6. Isolated Ultrafiltration

7. Profiling

8. Hygiene and Maintenance

9. Technical Data and Specifications

10. Major Changes in Operator's Manual

Part 2 Instructions for Measurement Functions

11. BPM – Bloo

d Pressure Monitor (option)

12. Diascan® (option)

Part 3 Alarm Handbook

13. Alarms

14. Attention Alarms

Note

• Please observe that this part of the Operator's manual f or the AK 96 dialysis

machine is one out of three. To assimilate these instructions the complete
manual must be available. For information see “How To Use this Manual”
on page 1:2 in part 1.

Note

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Program version 3.xx

This page is intentionally left blank

HCEN12239 Revision 12.2010

Program version 3.xx

Chapter 1

Before you get started - General
Information

Contents

HowToUsethisManual ..................................

How to findwhatyouarelookingfor ..................

ChapterDescriptions ...................................

Part1;BaseManualforGeneralUse ....................

Part2;InstructionsforMeasurementFunctions ............

Part3;AlarmHandbook ..............................

Definitions of Expressions used in this Manual . ..............

Warning ..........................................

Caution ...........................................

Note .............................................

OtherKeywordsusedinthisManual ....................

Figures .............................................

Symbols ............................................

SymbolswithinthisManual ...........................

SymbolswithintheUserInterface ......................

Symbols fixedontotheMachine .......................

GeneralPrecautionsbeforeuse ..............................

IntendedUse ...........................................

SafetyPhilosophy ........................................

The Preparation of Dialys

Inlet Water Requirement
Preparation of the Dia
UFD- Ultrafiltered Di

Ultrafilter - Frequ

List of Concentra

Concentrates

Lines ...............................................

Dialyzers
Blood Pre

Certific

ationmarks .......................................

tes,AccessoriesandDisposables ...............

.........................................

/Ultrafilter ....................................

ssureMeasurementAccessories ...................

isFluid ............................

s ...............................

lysisFluid ..........................

alysisFluid(option) ...................

encyofChange .......................

1:2
1:2
1:3
1:3
1:4
1:4
1:5
1:5
1:5
1:5
1:6
1:7
1:8
1:8
1:8

1:9
1:11
1:14
1:15
1:17
1:17
1:17
1:17
1:17
1:18
1:19
1:20
1:21
1:21
1:22

HCEN12239 Revision 12.2010
Program version 3.xx

AK 96®Operator's Manual - Before you get started

1:1

How To Use this Manual

This Operator's Manual for the AK 96 dialysis machine is divided up
into three parts according to their contents. The reason for this is ease
of access for the operator of the machine. It is important to observe
that the parts should be considered as one document in spite of the
fact that it is printed in three separate parts. This means that things like
references and index extend over the complete manual. Furthermore,
note that all alarms and attention alarms are described in the third part,
the “Alarm Handbook”.
The first part; “Base Manual for General Use” include instructions on
how to generally use and run the m achine.
The second part; “Instructions for Measurement Functions” include
instructions on how to use the optional BPM (Blood Pressure Monitor)
and Diascan function.
The third part; “Alarm Handbook” include all alarms and attention
alarms originating from all functions of the machine.

The first part is printed in A 4 format, the second and third in A 5.
The parts are put in a box which should be considered as cover of the
complete manual. Conseqently, when the manual needs to be chang
to a m ore recent version due to updating of the machine program
version, the complete m anual (all three parts) needs to be changed at
the same time.

ed

How to find what you are looking for

To be able to find what you are looking for in this manual, first read the
brief explanation of how the chapters are structured and intended to be
used further on in this section. Then use the table of contents either
at the beginning of the complete manual or at the beginning of each
chapter. There is also an index included last in each part extending
over all three parts of the m anual.

References to pages within the manual are shown with two figures,
divided by a colon. The first figure is the chapter number and the
second is the page number. For example; page 4:10 would be chapter
4, page 10. The first page in all three parts is the same, i.e. an overview
of which chapter numbers are included in which part.

A small reference number beside the figures within the manual has
been added to simplify manual production.

On the following pages is a brief explanation of how the parts and
chapters in this manual are structured and are intended to be used.

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AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Chapter Descriptions

Part 1; Base Manual for General Use

Chapter 1; Before you get started - General Information

This chapter contains information to be read before using the
AK 96 dialysis machine.

Chapter 2; Description - The Machine and its Components

This chapter contains component descriptions (terms and details) of the
blood part, the fluid part and the rear of the machine.

Chapter 3; Operating the Machine - Handling Guidelines

This chapter contains explanations of how the machine is to be
controlled. For example, how to use the buttons and the keypad of the
Operator's panel together with the menus on the Information Display.
Furthermore in this chapter, the alarm functions are described and how
parameters are to be set. How to use handling features of the machine
are also explained here. The overview screens displayed on the
Information Display are explained as well as the ultrafiltration control,
and information is provided on what to do if a power failure occurs.

Chapter 4; Hemodialysis - Double Needle Treatment

This chapter contains instructions on how to p

erform hemodialysis
with two needles, using the AK 96 dialysis machine. The chapter
begins with how to start the machine and continues with how to attach
the dialyzer and the blood lines, the prim

ing procedure, starting the
treatment and setting of parameters. It finishes with the discontinuing
procedure.

Chapter 5; Hemodialysis - Single Needle Treatment (option)

This chapter contains instructions on how to perform hemodialysis
with one needle. The chapter is based on chapter 4 "Hemodialysis ­Double Needle Treatment" starting on page 4:1 in part 1, with added
specific instructions for single needle treatment.

Chapter 6; Isolated Ultrafiltration

This chapter contains instructions on how to perform isolated
ultrafiltration.

Chapter 7; Profiling

This chapter contains instructions on how to use the profiling function
for ultrafiltration, as well as for the dialysis fluid concentration of
sodium and bicarbonate.

HCEN12239 Revision 12.2010
Program version 3.xx

Chapter 8; Hygiene and Maintenance

This chapter contains information and instructions concerning the
hygiene

and maintenance of the machine that should be carried out
by the operator of the machine. The chapter begins with a general
section where a schedule for hygiene and maintenance is included.
The H

ygiene sections contain general information and instructions
on how to perform the disinfection programs. The Maintenance
sections include instructions on the maintenance of the flow path and

e e xterior of the machine.

th

AK 96®Operator's Manual - Before you get started

1:3

Chapter 9; Technical Data and Specifications

This chapter contains technical specifications of the control and
supervisory systems of the machine. It also includes physical data,
materials which come into contact with water, concentrates and dialysis
fluid, environmental data and a list of standards which the machine
complies with.

Chapter 10; Major changes in operator's manual

This chapter includes brief information about major changes
between the current and previous program versions of the machine
that have been made in the manual. The changes mentioned are
mostly information concerning the operation of the machine and are
specifically addressed to the operator.

Part 2; Instructions for Measurement Functions

Chapter 11; BPM – Blood Pressure Monitor (option)

This chapter contains instructions on how to use the BPM (if installed),
which measures blood pressure and pulse rate. A particular bloo

d
pressure measurement cuff and a cuff hose are to be used. The
chapter includes explanations of how the BPM is handled using t he
BPM button and the BPM screens, and also describes the alarm
function. The BPM can be used manually if only one measurement
check is to be done, or at set intervals during treatment.

Chapter 12; Diascan®function (option)

This chapter contains instructions on how to use the Diascan function,
which m easures clearance (K) and dialysis dose (Kt or Kt/V). The
chapter is divided into two parts where the first section includes
general information about the Diascan function, explanation of the
Diascan screens and the alarm functions. The second section includes
step-by-step instructions for measuring clearance and Kt/V, single or
continuous measuring.

Part 3; Alarm Handbook

Chapter 13; Alarms

This chapter contains a list of alarms. The list includes additional
information concerning possible causes and suggestions about
measures to be taken f

Chapter 14; Attention Alarms

or each alarm.

This chapter contains a list of attention a larms. The list includes
additional information concerning possible causes and suggestions
about measures to be taken for each attention alarm. The attention
alarms in the list is shown in alphabetical order.

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AK 96

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Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Definitions of Expressions used in this Manual

Warning

WARNING

Is used to alert the user/operator not to take a certain action, which
if taken can cause a potential hazard and result in a serious adverse
reaction, injury or death. A warning may also be used to alert the
user/operator to take a certain action to avoid the potential hazard
as above.

Caution

CAUTION

Is used to alert the user/operator to take a certain action to protect
against a possible hazard which, if ignored, could have an adverse
effect on the patient or the equipment. A caution may also be us
to alert the user/operator not to take a certain action to avoid the
potential hazard as above.

WARNING

ed

CAUTION

Note

Note

• A reminder to the user/operator on normal treatment activity

and on what is a suitable action in a particular situation.

Note

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AK 96®Operator's Manual - Before you get started

1:5

Other Keywords used in this Manual

User

A User in this manual, designates a person who has the comprehensive
responsibility for how the AK 96 dialysis machine is being used. The
user decides which clinic routines are applicable for the AK 96 dialysis
machine.

Operator

An Operator in this manual, designates a person who has knowledge of
and has been trained in hemodialysis and is in charge of the machine
i.e. makes the machine settings which have to be done before, during
and after the hemodialysis treatment. The operator is sometimes
referred to as ”You”.

Authorized technician

The Authorized technician is a technician who has been through
Gambro training on the AK 96 dialysis machine and has received a
Gambro certificate or has gained equivalent knowledge in some other
way.

Machine

Whenever the word Machine is used within this manual, machine
always refers to the AK 96 dialysis machine if no other is written.

Manual

Whenever the word Manual is used within this m anual, manual always
refers to this Operator's Manual for the AK 96 dialysis machine if no
other is written.

Option

Sometimes functions and machine compone

nts are marked Option,
meaning that the machine may not be equipped with the described
function/component. Sometimes the option is a function/component
of which the machine has been manufactu

redwithandsometimesthe
option can be implemented by an authorized technician afterwards
upon request.

1:6

AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Figures

There are different type of figures included in this manual. Screens and
menus shown on the Information Display are one type of figure. These
figures are a direct "shot" of the Information Display of the machine
and have not been revised afterwards in order for the operator to
recognize current machine displays for the ongoing procedure. Some
figures illustrate handling or point out components of the machine.
To highlight certain items or illustrate movements arrows have been
included in these figures.

This "straight arrow" in figures points out details described in the
corresponding text. The arrow can also show a direction, i.e. if
somethingistobemovedinacertaindirection.

This "curved arrow" i n figures shows a direction of a rotation. This can
be the direction of something that is to be connected or opened/closed.

This "pressure arrow" appears in figures when something is to be
pressed in or pulled out. The point where the arrow points to is the
pressure/pulling point.

In addition, to highlight certain items, the details that the describing
text in the instructions aims at, are highlighted in gray in the
corresponding figure.

The buttons on the operator's panel light up in different situations to
guide the operator or to inform of current status. If the button is lit or
not is not normally illustrated in the handling instructions; the button
figures are the same for lit, flashing and not lit buttons. This is valid
for all instructions except for the alarm list (see "Alarm List" on page
13:9 in part 3) where the button figures also show status in order for
the operator to apprehend the instructions fully.

This is an example of a lit button.

This is an example of a flashing button.

HCEN12239 Revision 12.2010
Program version 3.xx

A small reference number beside the figure has sometimes been added
to simplify manu

al production.

AK 96®Operator's Manual - Before you get started

1:7

Symbols

Symbols within this Manual

When this symbol appears in the manual text, it indicates that it is
possible to preset the value of a parameter. The preset can be done to
adapt the settings of the m achine to correspond with the routines of the
user/clinic. It has to be done by an authorized technician.
All values mentioned in this manual are default values set in the
machine when it was manufactured. It is important to check with the
authorized technician if values have been changed, and if so, which
ones.
For instance, it is possible to preset the machine for which mode to
start up in, some alarm limits, some functions and options.

This symbol appears at the right hand side of a page when there is more
important information to be read on the following page (there is not
enough room for all assembled information on the same page). Please
continue your reading to obtain the complete information.

In lists, different icons in front of the items show how the lists are
to be used.

1. A numbered list is to be followed from the beginning to the end.

This kind of list mostly appears in handling

instructions.

• In a bullet list not all items may be valid and the items in the list

are not presented in a particular order.

A checkbox list is used when a number of items should be checked
before a procedure is perform

ed.

- In a dashed list all items are valid but are not presented in a

particular order.

Symbols within the User Interface

See chapter 3, "Buttons" starting on page 3:8 in part 1.

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AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

SymbolsfixedontotheMachine

All symbols in the list below may not be represented on this product.
The symbols can be attached to the machine or attached to the original
packaging.

Symbol Description

Alternating c urrent

Protective earth (ground)

Warning, consult accompanying
documents

Off (power, disconnection from the
mains)

On (power, connection to the mains)

Type B, applied part

NIBP type BF applied part, defibrillator
proof

HCEN12239 Revision 12.2010
Program version 3.xx

Do not stack

Fragile – Handle with care

AK 96®Operator's Manual - Before you get started

1:9

Symbol Description

This way up

Keep dry

Year of manufacturing

Equipotentiality

Separate collection for electrical and
electronic equipment

The AK 96 dialysis machine is protected
against dripping water

Warning, Dangerous voltage. Contact
may cause electric shock or burn.

The label is yellow with a black frame
and icon. This symbol is a warning label
not to tilt the machine through an angle
of more than 5°.

WARNING

If a remote operator's panel has been installed, fluid bags must
be removed from the in
transporting (moving) the machine.

fusion pole or placed on the top tray when

WARNING

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AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

General Precautions before use

WARNING

Unauthorized modifications, alterations or repair and lack of
maintenance or calibration of the AK 96 dialysis machine may result
in malfunctioning or have other serious consequences for the safe
operation of the equipment.

CAUTION

The AK 96 dialysis machine may only be operated by persons
trained in hemodialysis and who have studied the instructions in this
manual. The user/operator should draw special attention towards
the text valid for the safety philosophy of the machine. See section
"Safety Philosophy" on page 1:15 in part 1. Verify that the first digit
of the program version of both the machine and the manual is the
same. If the AK 96 dialysis machine does not perform as described
in this manual, it should not be used until the condition is rectified.

When unpacking, check the equipment for any signs of damage.
If the equipment is in any way damaged, proper operation cannot
be assured.

WARNING

Patients connected to the AK 96 dialysis machine should be
monitored by competent personnel since life thr
can arise that may not activate alarms. The operator should pay
attention to all appropriate alarms and follow the instructions,
warnings, cautions, and notes given in this
that the machine has passed the function check before connecting
to a patient.

During installation all calibration checks must be completed before
the machine is used for dialysis treatment.

The AK 96 dialysis machine needs special precautions regarding
EMC and needs to be installed and put into service according to
the EMC information provided
Data and Specifications".

The use of mobile teleph
vicinity of the AK 96 dialysis machine could adversely influence the
performance of the machine. For further information, see part 1 and
chapter 9, "Technica

The AK 96 dialysis machine will perform as designed only if it is
used and maintai
Any warranties made by Gambro with respect to the AK 96 dialysis
machine are void if the equipment is not used in accordance with
the instructi
any damage or injury resulting from improper use or maintenance
or unauthorized repair.

ons provided. Gambro will not accept responsibility for

l Data and Specifications".

ned in accordance with Gambro’s instructions.

in part 1and chapter 9, "Technical

ones or communication equipment in the

eatening situations

manual. It is imperative

CAUTION →

→→

HCEN12239 Revision 12.2010
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AK 96®Operator's Manual - Before you get started

1:11

→→→CAUTION

Preventive inspection, maintenance and calibration of the
AK 96 dialysis machine shall be performed by a fully trained
authorized service technician according to the Maintenance Manual
in the AK 96 Service Manual which can be ordered from your
Gambro representative. It is mandatory for preventive maintenance
to be performed at least every other year. Yearly maintenance
is recommended. The interval between preventive maintenance
procedures might differ due to operating environment variations.

The AK 96 dialysis machine is in compliance with certain
requirements concerning patient leakage current from the dialysis
fluid in accordance with international standards and regulations.
When a central venous catheter is used, and the tip of the
catheter is close to the heart, it is however necessary to take
extra precautions to minimize the risk of arrythmia due to leakage
currents. For these treatments it is necessary to connect the
potential equalization conductor between the AK 96 dialysis
machine and the potential equalization bus bar in the electrical
installation. Potential equalisation also has to be used when legal
requirements of the installation place requires it.
To minimize the leakage currents from other electrical equipment it
is recommended to place such equipment outside the patient area.
Any equipment within the patient area shall fulfil the IEC 60601-1
and IEC 60601-1-1 standards and be a part of the potential
equalization. One way to minimize the leakage currents from
equipment within the patient area is to electrically isolate it. Make
sure leakage current values are below respective limit required by
CF type applied parts. Check with authorized technician.
If your clinic/hospital uses a central venous catheter during
treatments please make sure your machine is equipped with a
potential equalization connection. If not please contact your local
Gambro Service Technician for further assistance.

The AK 96 dialysis machine is not suitable for use in the presence
of a flammable anesthetic mixture with air or with oxygen or nitrous
oxide.

CAUTION

1:12

AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Note

• This Operator’s Manual provides instructions necessary for the

proper operation of the AK 96 dialysis machine. It is not a
guide for the administration of hemodialysis.

• Machines are not disinfected before delivery. Always perform

a chemical disinfection after installation, before initial use.

• When accuracy ranges are written as e.g. ”(±1 ml/min or

±1%)” the widest range is valid.

• 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.

• For the authorized technician the Service Manual for the

AK 96 dialysis machine is available. The Service Manual
provides all of the necessary information for installation and
safe and required maintenance of the machine.

• It is important that the protective earth in the installation i

high quality.

• For the purpose of protecting the environment the

AK 96 dialysis machine must not be disposed of with
general domestic waste, but shall be separately collected
for dismantling and recovery. Where applicable

, national
regulations shall be applied. Consult your local Gambro
distributor for information.

• The AK 96 dialysis machine is intended for continuous

operation.

sof

Note

HCEN12239 Revision 12.2010
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AK 96®Operator's Manual - Before you get started

1:13

Intended Use

TheGambroAK96dialysismachineisdesignedtobeusedasa
single patient machine to perform hemodialysis treatments upon
prescription by a physician. Patient counselling and teaching of
treatment techniques are directly under the supervision and discretion
of the physician.

CAUTION

Patient education, counselling, home care follow-up and medical
maintenance must be performed under the direction and supervision
of the physician prescribing the treatment. Gambro specifically
denies any responsibility for patient education, counselling or home
care and medical maintenance.

When the AK 96 dialysis machine is used to produce bicarbonate
containing dialysis fluid originating from non-liquid concentrates, the
AK 96 dialysis machine is designed and validated for use with the
Gambro BiCart cartridge. Gambro does not accept responsibility for
use of other non-liquid concentrate containers.

CAUTION

1:14

AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Safety Philosophy

The AK 96 dialysis machine is designed according to the current
standards for hemodialysis equipment, IEC 60601-2-16. This means
that safety under so-called Single Fault Conditions is granted. In
practice this means that controllable treatment parameters (i.e.
conductivity, temperature and ultrafiltration) are controlled by one
system, the control system, and monitored by another completely
separate protective system, utilizing its own sensors, electrical circuits
and m icroprocessors. The functionality of the protective system is
checked by the AK 96 dialysis machine before each treatment. A fault
detection during the pre-treatment tests will make it impossible to
start the treatment.

In order to verify that the corresponding control and protective systems
are operating with the correct input values, the user is instructed to
compare the readings from these systems before connecting to the
patient. Check that the calculated conductivity values (C/P) displayed
in the conductivity menu are in agreement. If this comparison is not
satisfactory, call an authorized technician.

The protective system will, when a parameter (measured by the
protective system) is outside the alarm limits, put the AK 96 dialysis
machine into a patient-safe condition. This means that the
system can stop the blood pump, close the venous clamp, prevent the
dialysis fluid from reaching the dialyzer and alert the operator with
sound and light.

protective

There is a risk that the b lood of the patient may be contaminated
with bacteria and endotoxins due to transpor

t of undesired substances
from the dialysis fluid compartment to the blood compartment of the
dialyzer. This risk is reduced by using intact dialyzers, high inlet
water quality, high quality of conce

ntrates and by using the optional

ultrafilter for dialysis fluid.

Ultrafiltration

For the ultrafiltration control system, the transmembrane pressure
(TMP) is used as the protective system. Alarm limits for TMP related
to the dialyzer UF coefficient and the expected UF rate, are to be set
around the actual TMP value when starting treatment. The TMP alarm
limit correspond to a UF-deviation limit described by TMP
UF

coefficient

. Example: If the alarm window is set to ±50 mmHg and

Alarm limit

x

the UF-coefficientis10ml/mmHgxhthemaximumweightdeviations
without any alarm is ±500 g/h. Default the alarm window is set to
±100 mmHg. It is essential to ensure that the alarm window is set as
close as possible to the working TMP. As an additional precaution it is
recommended that the blood pressure is checked regularly.

HCEN12239 Revision 12.2010
Program version 3.xx

Venous pre

ssure

To protect the patient against a hazardous blood loss to the environment
AK 96 dialysis machine incorporates a venous pressure monitoring
system

. This system will react on a change in the venous pressure,

AK 96®Operator's Manual - Before you get started

1:15

i.e. when the pressure falls below the low alarm limit. It must be
observed that under certain pressure/ flow conditions a blood loss to
the environment may not be able to cause the venous pressure to fall
below the low alarm limit. To avoid blood loss to the environment
it is essential to ensure that all connections in the extracorporeal
blood circuit are tight and secured, that the fistula needle is correctly
positioned and secured and that the low alarm limit is set as close as
possible to the working venous pressure.

The venous pressure measuring system is the protection against blood
loss to the environment. This measuring system is automatically
checked before each treatment. A failure will make it impossible to
start the treatment.

Blood pump

The supervision of the stop time of the blood pump is the protection
system against patient blood loss due to coagulation during treatment.
The operator will be notified via an attention alarm that the blood pump
stop time has been exceeded.

Blood leak detector

The blood leak detector system, which utilizes an optical sensor, is
automatically tested before each treatment for

being a ble to detect
transparency (no blood) and non-transparency (blood) before each
treatment. If the system cannot detect these states, it is impossible to
start the treatment.

Air detector

The air detector utilizes an ultrasonic sound sensing system in which
the transmitter is handled by one microprocessor and the receiver is
handled by both microprocessors in the protective system. The system
is tested pre-treatment for parameter deviation in terms of sensitivity
change.

Any infusion/transfusion/medication given to the patient via the
extracorporeal blood circuit of the AK 96 dialysis machine during
treatment, must pass the venous drip chamber and the activated air
detector. I nstructions for infusions can be read in "Infusions during
Treatment" on page 3:36 in part 1.

1:16

Chemical disinfectant intake

The AK 96 dial

ysis machine is designed to take in chemical
disinfectants via a permanent connection. For this reason, the machine
is equipped with an extra valve within the protective system. The
machine au

tomatically checks before each treatment if a chemical
disinfection program has previously been performed and if so, the
chemical intake valves are automatically checked during function
check. A

failure will make it impossible to start the treatment.

®

AK 96

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

The Preparation of Dialysis Fluid

Inlet Water Requirements

The chemical and microbiological quality of the water used to prepare
fluids for dialysis is a n important factor for achieving and maintaining
the proper quality of the d ialysis fluid.

The quality of the water depends on the technical equipment for water
treatment. Further, proper maintenance of the water treatment system
and of the water distribution loop is essential.

The inlet water must comply with valid standards for water for dialysis;
see "Water supply" on page 9:11 in part 1 for more details.

Preparation of the Dialysis Fluid

The AK 96 dialysis machine prepares dialysis fluid f rom inlet water
and concentrates.

The dialysis fluid should be made from an acidic (A) concentrate and a
dry bicarbonate concentrate (such as the BiCart cartridge). It can also
be made from an acidic (A) concentrate and a liquid
concentrate or from an acetate concentrate. See "Concentrates" on
page 1:19 in part 1.

bicarbonate (B)

UFD- Ultrafiltered Dialysis Fluid (option)

The AK 96 dialysis machine can be equipped with a holder in which
an ultrafilter can be mounted. The ultrafilter purifies the dialysis fluid
from possible contamination by bacteria and endotoxins.

Ultrafilter - Frequency of Change

The ultrafilter used when
be changed regularly depending on the primary fluid quality and the
desired final fluid quality. The results from microbiological controls
have to determine the
a month and once every three months can be expected.

For instructions

on how to change the ultrafilter, see “Ultrafilter - How

tochange"onpage8:39inpart1.

preparing Ultra Filtered Dialysis Fluid is to

frequency of change. A frequency between once

HCEN12239 Revision 12.2010
Program version 3.xx

AK 96®Operator's Manual - Before you get started

1:17

List of Concentrates, Accessories and
Disposables

This manual contains a number of r eferences to concentrates,
accessories and disposables for use with the AK 96 dialysis machine.
For ease of reference, set out below i s a comprehensive listing of such
concentrates, accessories and disposables as follows.

CAUTION

The AK 96 dialysis machine has been tested and validated for
use with the concentrates, accessories and disposables specified
as follows.

Gambro does not accept any responsibility or liability for use of
concentrates, accessories or disposables other than those specified
as follows. Depending on the circumstances, use of concentrates,
accessories or disposables other than those specified may also
reduce Gambro’s warranties for the AK 96 dialysis machine.

Observe the manufacturer's instructions for use regarding single
use of blood lines and dialyzers.

CAUTION

Note

• The user should make sure to have a current listing of

concentrates, accessories and disposables available.

• The user should follow the facility procedures for proper

disposal of used blood lines, dialyzers and other disposables
per local regulations.

Note

1:18

AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Concentrates

CAUTION

Incorrect choice of dialysis fluid concentrate may cause incorrect
composition of the dialysis fluid. Incorrect composition may lead to
electrolytic imbalance in the patient's blood.

Liquid concentrates Area of use

001-099 series Liquid acetate concentrates for

preparation of acetate dialysis fluid.

CAUTION

2xx series
7xx series
8xx series

Liquid A-concentrate for preparation of
bicarbonate dialysis fluid together with
BiCart cartridge or with bicarbonate
hemodialysis concentrate D 200 (Sodium
bicarbonate 8,4%).

3xx series Liquid A and B concentrates for

preparation of bicarbonate dialysis fluid.

Non-liquid concentrates Area of use

®

BiCart

cartridge Dry bicarbonate concentrate for

preparation of bicarbonate dialysis
fluid together with proper liquid
A-concentrate.

HCEN12239 Revision 12.2010
Program version 3.xx

AK 96®Operator's Manual - Before you get started

1:19

Lines

Line number Area of use

Gambro Medical Line (PVC+DOP/ EtO sterilized)

BL 10 series Arterial and venous blood line set

BL 100 series Arterial and venous blood line set

AV 100 series Arterial and venous blood line set

A 5000 series Arterial blood lines

Note especially the Warning text below
concerning pediatric blood line set

V 5000 series Venous blood lines

Note especially the Warning text below
concerning pediatric blood line set

Gambro Blood Tubing System (PVC+DOA/Beta sterilized)

BL 200 series Arterial and venous blood line set

Gambro Accessories

C series Hemodialysis accessories

C 705

A connection line with an expansion
chamber. Used in single needle mode.

WARNING

Do not use the pediatric blood lines; A-5.128-B4 or V-5.127-X. The
blood line clamps of the AK 96 dialysis machine cannot clamp these
thin blood lines.

WARNING

1:20

AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Dialyzers/Ultrafilter

Dialyzer/Ultrafilter Area of use

U9000

®

Ultrafilter used when preparing Ultra
Filtered Dialysis Fluid.

Dialyzers Most types of dialyzers, except plate

dialyzers, can be used. However, it is
essential to verify that the specifications
and instructions for use of the dialyzers
are not in discrepancy with those given
for AK 96 dialysis machine, with regards
to e.g. the maximum UF coefficient and
the recommended priming procedure.
The connectors and the ports of the
dialyzer must comply with ISO 8637 and
EN 1283.

Blood Pressure Measurement Accessories

Gambro Cuff Size

Adult
Large Adult
Small Adult
Child

Gambro Cuff
(single hand)

Adult
Large Adult
Small Adult

Gambro Cuff hose)

3.0 m

23 - 33 cm
31 - 40 cm
17- 25 cm
12 - 19 cm

Size

28 - 37 cm
36 - 46 cm
21 - 29 cm

Cuff hose used for measuring blood
pressure together with the AK 96 dialysis
machine.

HCEN12239 Revision 12.2010
Program version 3.xx

AK 96®Operator's Manual - Before you get started

1:21

Certification marks

CE-marking

The CE-conformity mark indicates that the AK 96 dialysis machine
conforms to the requirements in the EC Council Directive 93/42/EEC
of 14 June, 1993 concerning medical devices. It also indicates that
the notified body British Standards Institution (BSI, No. 0086) has
approved the Quality Management System. The CE conformity mark
is only valid for the AK 96 dialysis machine. Disposables and any
accessories specified for use with the AK 96 dialysis machine are
marked with CE conformity marks in their own right.

CSA-marking

The CSA mark indicates that the AK 96 dialysis machine

conforms to
the requirements related to safety of medical devices for Canada and
that the AK 96 dialysis machine has been evaluated to the applicable
CSA standards for use in Canada.

CCC-marking

The CCC mark indicates that the AK 96 dialysis machine conforms to
the safety requirements for China Compulsory Certification (CCC) as
described by the competent authority Certi fication and Accreditation
Administration of People’s Republic of China (CNCA). The “S”
adjacent to the CCC mark indicates that safety requirements are met.

1:22

AK 96

®

Operator's Manual - Before you get started

HCEN12239 Revision 12.2010

Program version 3.xx

Chapter 2

Description - The Machine and its
Components

Contents

TheBloodPartoftheMachine ..............................

BloodPartComponentTerms ............................

BloodPartComponentDetails ...........................

TheFluidPartoftheMachine ..............................

FluidPartComponentTerms .............................

FluidPartComponentDetails ............................

TheRearoftheMachine ..................................

RearComponentTerms .................................

RearComponentDetails ................................

2:2
2:3

2:5
2:16
2:17
2:19
2:28
2:29
2:31

HCEN12239 Revision 12.2010
Program version 3.xx

AK 96®Operator's Manual - Machine Description

2:1

The Blood Part of the Machine

2:2

AK 96

®

Operator's Manual - Machine Description

HCEN12239 Revision 12.2010

Program version 3.xx