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 |
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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 +46 46 169000
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
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 – 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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Program version 3.xx
Chapter 1
Before you get started - General Information
Contents |
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How To Use this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:2 |
How to find what you are looking for . . . . . . . . . . . . . . . . . . |
1:2 |
Chapter Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:3 |
Part 1; Base Manual for General Use . . . . . . . . . . . . . . . . . . . . |
1:3 |
Part 2; Instructions for Measurement Functions . . . . . . . . . . . . |
1:4 |
Part 3; Alarm Handbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:4 |
Definitions of Expressions used in this Manual . . . . . . . . . . . . . . . |
1:5 |
Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:5 |
Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:5 |
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:5 |
Other Keywords used in this Manual . . . . . . . . . . . . . . . . . . . . |
1:6 |
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:7 |
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:8 |
Symbols within this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:8 |
Symbols within the User Interface . . . . . . . . . . . . . . . . . . . . . . |
1:8 |
Symbols fixed on to the Machine . . . . . . . . . . . . . . . . . . . . . . . |
1:9 |
General Precautions before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:11 |
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:14 |
Safety Philosophy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:15 |
The Preparation of Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:17 |
Inlet Water Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:17 |
Preparation of the Dialysis Fluid . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:17 |
UFDUltrafiltered Dialysis Fluid (option) . . . . . . . . . . . . . . . . . . . |
1:17 |
Ultrafilter - Frequency of Change . . . . . . . . . . . . . . . . . . . . . . . |
1:17 |
List of Concentrates, Accessories and Disposables . . . . . . . . . . . . . . . |
1:18 |
Concentrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:19 |
Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:20 |
Dialyzers/Ultrafilter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:21 |
Blood Pressure Measurement Accessories . . . . . . . . . . . . . . . . . . . |
1:21 |
Certification marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
1:22 |
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AK 96® Operator's Manual - Before you get started |
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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 manufactured with and sometimes the 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 something is to be moved in a certain direction.
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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Symbols fixed on to the Machine
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 |
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This way up |
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Keep dry |
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Year of manufacturing |
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Equipotentiality |
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Separate collection for electrical and |
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electronic equipment |
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The AK 96 dialysis machine is protected |
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against dripping water |
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Warning, Dangerous voltage. Contact |
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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 is of 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
The Gambro AK 96 dialysis machine is designed to be used as a 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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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 microprocessors. 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 protective 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.
There is a risk that the blood of the patient may be contaminated with bacteria and endotoxins due to transport 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 concentrates 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 TMPAlarm limit x UFcoefficient. Example: If the alarm window is set to ±50 mmHg and the UF-coefficient is 10 ml/mmHg x h the maximum weight deviations
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.
Venous pressure
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,
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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 able 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. Instructions for infusions can be read in "Infusions during Treatment" on page 3:36 in part 1.
Chemical disinfectant intake
The AK 96 dialysis 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 automatically 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.
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The Preparation of Dialysis Fluid
Inlet Water Requirements
The chemical and microbiological quality of the water used to prepare fluids for dialysis is an important factor for achieving and maintaining the proper quality of the dialysis 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 from 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 bicarbonate (B) concentrate or from an acetate concentrate. See "Concentrates" on page 1:19 in part 1.
UFDUltrafiltered 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 preparing Ultra Filtered Dialysis Fluid is to be changed regularly depending on the primary fluid quality and the desired final fluid quality. The results from microbiological controls have to determine the frequency of change. A frequency between once a month and once every three months can be expected.
For instructions on how to change the ultrafilter, see “Ultrafilter - How to change" on page 8:39 in part 1.
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List of Concentrates, Accessories and
Disposables
This manual contains a number of references to concentrates, accessories and disposables for use with the AK 96 dialysis machine. For ease of reference, set out below is 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
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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.
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CAUTION |
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Liquid concentrates |
Area of use |
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001-099 series |
Liquid acetate concentrates for |
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preparation of acetate dialysis fluid. |
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2xx series |
Liquid A-concentrate for preparation of |
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7xx series |
bicarbonate dialysis fluid together with |
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8xx series |
BiCart cartridge or with bicarbonate |
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hemodialysis concentrate D 200 (Sodium |
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bicarbonate 8,4%). |
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3xx series |
Liquid A and B concentrates for |
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preparation of bicarbonate dialysis fluid. |
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Non-liquid concentrates |
Area of use |
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BiCart® cartridge |
Dry bicarbonate concentrate for |
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preparation of bicarbonate dialysis |
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fluid together with proper liquid |
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A-concentrate. |
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Lines
Line number |
Area of use |
Gambro Medical Line (PVC+DOP/ EtO sterilized) |
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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 |
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Note especially the Warning text below |
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concerning pediatric blood line set |
V 5000 series |
Venous blood lines |
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Note especially the Warning text below |
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concerning pediatric blood line set |
Gambro Blood Tubing System (PVC+DOA/Beta sterilized)
BL 200 series |
Arterial and venous blood line set |
Gambro Accessories |
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C series |
Hemodialysis accessories |
C 705 |
A connection line with an expansion |
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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
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Dialyzers/Ultrafilter
Dialyzer/Ultrafilter |
Area of use |
U9000® |
Ultrafilter used when preparing Ultra |
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Filtered Dialysis Fluid. |
Dialyzers |
Most types of dialyzers, except plate |
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dialyzers, can be used. However, it is |
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essential to verify that the specifications |
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and instructions for use of the dialyzers |
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are not in discrepancy with those given |
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for AK 96 dialysis machine, with regards |
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to e.g. the maximum UF coefficient and |
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the recommended priming procedure. |
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The connectors and the ports of the |
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dialyzer must comply with ISO 8637 and |
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EN 1283. |
Blood Pressure Measurement Accessories
Gambro Cuff |
Size |
Adult |
23 - 33 cm |
Large Adult |
31 - 40 cm |
Small Adult |
1725 cm |
Child |
12 - 19 cm |
Gambro Cuff |
Size |
(single hand) |
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Adult |
28 - 37 cm |
Large Adult |
36 - 46 cm |
Small Adult |
21 - 29 cm |
Gambro Cuff hose) |
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3.0 m |
Cuff hose used for measuring blood |
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pressure together with the AK 96 dialysis |
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machine. |
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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 Certification and Accreditation Administration of People’s Republic of China (CNCA). The “S” adjacent to the CCC mark indicates that safety requirements are met.
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Chapter 2
Description - The Machine and its Components
Contents |
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The Blood Part of the Machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:2 |
Blood Part Component Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:3 |
Blood Part Component Details . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:5 |
The Fluid Part of the Machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:16 |
Fluid Part Component Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:17 |
Fluid Part Component Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:19 |
The Rear of the Machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:28 |
Rear Component Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
2:29 |
Rear Component Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
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The Blood Part of the Machine
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AK 96® Operator's Manual - Machine Description |
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