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 local representative or to the manufacturer.
Order number:
MHCEN12239–12/10
HCEN12239 Revision 12.2010
Program version 3.xx

Intellectual Property Rights
Copyright:
© 2007, 2008-2009 Gambro Lundia AB. All rights reserved.
Trademarks:
AK 96®is a trademark of Gambro Lundia AB filed in the United States 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 Republic, Germany,
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 Montenegro, Switzerland, Argentina, Canada,
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®is a trademark registered in Switzerland, Moldova, The former Yugoslav Republic of Macedonia, Mongolia,
Poland, Portugal, Romania, Russian Federation, Sudan, Slovenia, Slovak Republic, Albania, Armenia, Austria, Azerbaijan,
Bosnia-Herzegovina, Bulgaria, Benelux, Belarus, China, Cuba, Czech Republic, Germany, Algeria, Egypt, Spain, France,
Croatia, Hungary, Italy, Kyrgyzstan, North Korea, Kazakstan, Liechtenstein, 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 Lundia AB
Diascan®is a trademark registered in France, Austria, Australia, Benelux, Switzerland, China, Serbia and Montenegro,
Czech Republic, Germany, Greece, Croatia, Italy, Norway, Poland, Portugal, Russian Federation, Slovenia, Turkey,
Ukraine, Hong Kong, Mexico, Taiwan, United States and Great Britain in the name of Gambro Lundia AB and in the
name of Gambro Hospal (Switzerland) ltd
U9000®is a trademark of Gambro Lundia AB registered in the European Community
The following trademarks mentioned in the Operator’s Manual are not owned by any company within Gambro:
Dialox
Patents:
The AK 96 dialysis machine is protected by one or more of the following patents:
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: 000747811–0001 – 000747811–0007
AL: 420833801
AU: 318776 – 318782
CA: 123590
IN: 213741, 213742
KR: 497613
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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 – Blood 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 for 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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Chapter 1
Before you get started - General
Information
Contents
HowToUsethisManual .................................. 1:2
How to findwhatyouarelookingfor .................. 1:2
ChapterDescriptions ................................... 1:3
Part1;BaseManualforGeneralUse .................... 1:3
Part2;InstructionsforMeasurementFunctions ............ 1:4
Part3;AlarmHandbook .............................. 1:4
Definitions of Expressions used in this Manual . .............. 1:5
Warning .......................................... 1:5
Caution ........................................... 1:5
Note ............................................. 1:5
OtherKeywordsusedinthisManual .................... 1:6
Figures ............................................. 1:7
Symbols ............................................ 1:8
SymbolswithinthisManual ........................... 1:8
SymbolswithintheUserInterface ...................... 1:8
Symbols fixedontotheMachine ....................... 1:9
GeneralPrecautionsbeforeuse .............................. 1:11
IntendedUse ........................................... 1:14
SafetyPhilosophy ........................................ 1:15
The Preparation of DialysisFluid ............................ 1:17
Inlet Water Requirements ............................... 1:17
Preparation of the DialysisFluid .......................... 1:17
UFD- Ultrafiltered DialysisFluid(option) ................... 1:17
Ultrafilter - FrequencyofChange ....................... 1:17
List of Concentrates,AccessoriesandDisposables ............... 1:18
Concentrates ......................................... 1:19
Lines ............................................... 1:20
Dialyzers/Ultrafilter .................................... 1:21
Blood PressureMeasurementAccessories ................... 1:21
Certificationmarks ....................................... 1:22
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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 machine.
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 changed
to a more recent version due to updating of the machine program
version, the complete manual (all three parts) needs to be changed at
the same time.
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 manual.
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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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 perform 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 priming 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.
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 Hygiene 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
the exterior of the machine.
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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 blood
pressure measurement cuff and a cuff hose are to be used. The
chapter includes explanations of how the BPM is handled using the
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 measures 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 for each alarm.
Chapter 14; Attention Alarms
This chapter contains a list of attention alarms. 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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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.
WARNING
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 used
to alert the user/operator not to take a certain action to avoid the
potential hazard as above.
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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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 manual, manual always
refers to this Operator's Manual for the AK 96 dialysis machine if no
other is written.
Option
Sometimes functions and machine components 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 manufacturedwithandsometimesthe
option can be implemented by an authorized technician afterwards
upon request.
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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" in 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.
A small reference number beside the figure has sometimes been added
to simplify manual production.
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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 machine 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 performed.
- 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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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 current
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
Do not stack
Fragile – Handle with care
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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 infusion pole or placed on the top tray when
transporting (moving) the machine.
WARNING
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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.
WARNING
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.
Patients connected to the AK 96 dialysis machine should be
monitored by competent personnel since life threatening situations
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 manual. It is imperative
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 in part 1and chapter 9, "Technical
Data and Specifications".
The use of mobile telephones or communication equipment in the
vicinity of the AK 96 dialysis machine could adversely influence the
performance of the machine. For further information, see part 1 and
chapter 9, "Technical Data and Specifications".
The AK 96 dialysis machine will perform as designed only if it is
used and maintained in accordance with Gambro’s instructions.
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 instructions provided. Gambro will not accept responsibility for
any damage or injury resulting from improper use or maintenance
or unauthorized repair.
CAUTION → →→
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→→→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
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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 isof
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.
Note
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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
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