AK200S Operators Manual 10.xx April 2010

Intellectual Property Rights Copyright: Copyright © 2001-2003, 2005, 2007, 2009, 2010 Gambro Lundia AB.

Trademarks: AK 200™ S is a trademark of Gambro Lundia AB. BiCart® is a trademark of Gambro Lundia AB registered in: Australia, Brazil, Chile, Colombia, Denmark, Great Britain, Japan, South Korea, Taiwan and United States. BiCart® is a trademark of Gambro AB registered in: Argentina, Canada, Finland, Greece, Japan, Mexico, New Zealand, Peru, Sweden and Uruguay. BiCart® is a trademark of Gambro Hospal (Switzerland) Ltd. registered in: Algeria, Austria, Belarus, Benelux, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Italy, Kazakhstan, Liechtenstein, Macedonia, Monaco, Mongolia, Morocco, North Korea, Portugal, Romania, Russian Federation, San Marino, Serbia, Slovak Republic, Slovenia, Spain, Sudan, Switzerland, Tunisia, Ukraine, Uzbekistan and Vietnam. BiCart Select® is a trademark of Gambro Lundia AB registered in: Japan. BiCart Select® is a trademark of Gambro AB registered in: Australia, Canada, Great Britain and Sweden. BiCart Select® is a trademark of Gambro Hospal (Switzerland) Ltd. registered in: Albania, Algeria, Armenia, Austria, Azerbaijan, Belarus, Benelux, Bosnia-Herzegovina, Bulgaria, China, Croatia, Cuba, Czech Republic, Egypt, France, Germany, Hungary, Italy, Kazakhstan, Kyrgyzstan, Latvia, Liberia, Liechtenstein, Macedonia, Moldova, Monaco, Mongolia, Morocco, North Korea, Poland, Portugal, Romania, Russian Federation, San Marino, Serbia, Slovak Republic, Slovenia, Spain, Sudan, Switzerland, Tajikistan, Ukraine, Uzbekistan and Vietnam. CleanCart® is a trademark of Gambro Lundia AB registered in: Australia. CleanCart® is a trademark of Gambro AB registered in: Canada, Japan and Sweden. CleanCart® is a trademark of Gambro Hospal (Switzerland) Ltd registered. in: Albania, Algeria, Armenia, Austria, Azerbaijan, Belarus, Benelux, Bosnia-Herzegovina, Bulgaria, China, Croatia, Cuba, Czech Republic, Egypt, France, Germany, Hungary, Italy, Kazakhstan, Kyrgyzstan, Latvia, Liberia, Liechtenstein, Macedonia, Moldova, Monaco, Mongolia, Morocco, North Korea, Poland, Portugal, Romania, Russian Federation, San Marino, Serbia, Slovak Republic, Slovenia, Spain, Sudan, Switzerland, Tajikistan, Ukraine, Uzbekistan and Vietnam. Diascan® is a trademark of Gambro Lundia AB registered in: Hong Kong, Mexico, Taiwan and United States. Diascan® is a trademark of Gambro Hospal (Switzerland) Ltd registered in: Australia, Austria, Benelux, China, Croatia, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Italy, Norway, Poland, Portugal, Russian Federation, Serbia-Montenegro, Slovenia, Switzerland, Turkey and Ukraine. Exalis® is a trademark of Gambro Lundia AB registered in: Australia, Austria, Benelux, Canada, China P.R., Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Italy, Japan, Monaco, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovak Republic, Sweden, Switzerland, Turkey and United States. SelectBag® is a trademark of Gambro AB registered in: Australia, Canada, Great Britain, Japan and Sweden. SelectBag® is a trademark of Gambro Hospal (Switzerland) Ltd. registered in: Albania, Algeria, Armenia, Austria, Azerbaijan, Belarus, Benelux, Bosnia-Herzegovina, Bulgaria, China, Croatia, Cuba, Czech Republic, Egypt, France, Germany, Hungary, Italy, Kazakhstan, Kyrgyzstan, Latvia, Liberia, Liechtenstein, Macedonia, Moldova, Monaco, Mongolia, Morocco, North Korea, Poland, Portugal, Romania, Russian Federation, San Marino, Serbia, Slovak Republic, Slovenia, Spain, Sudan, Switzerland, Tajikistan, Ukraine, Uzbekistan and Vietnam. SelectCart® is a trademark of Gambro AB registered in: Australia, Canada, Great Britain, Japan and Sweden. SelectCart® is a trademark of Gambro Hospal (Switzerland) Ltd. registered in: Albania, Algeria, Armenia, Austria, Azerbaijan, Belarus, Benelux, Bosnia-Herzegovina, Bulgaria, China, Croatia, Cuba, Czech Republic, Egypt, France, Germany, Hungary, Italy, Kazakhstan, Kyrgyzstan, Latvia, Liberia, Liechtenstein, Macedonia, Moldova, Monaco, Mongolia, Morocco, North Korea, Poland, Portugal, Romania, Russian Federation, San Marino, Serbia, Slovak Republic, Slovenia, Spain, Sudan, Switzerland, Tajikistan, Ukraine, Uzbekistan and Vietnam. PEEK® is a registered trademark of Victrex Limited. SWINNEX® is a registered trademark of Millipore Corporation. SANTOPRENE® is a registered trademark of Advanced Elastomer Systems, L.P. Dialox® is a registered trademark of L'air Liquid, Société Anonyme. Dialox®HP is a registered trademark of L'air Liquid, Société Anonyme.

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Patents: The AK 200 S dialysis machine is protected by one or more of the following patents: AU: 715971, 743889 BR: PI9708633-9 CA: 2250985, 1327022, 2138354 CN: ZL97193761.3 DE: M9710482.5 EP: 745213, 909187, 1039940, 1088210, 1276522, 401130, 467804, 467805, 658352 FR: 9403710 IT: 1240489, 1240404, 1304996 JP: 3183528, 3618352, 3783783, 2831099, 4106403, 4221156, 4299989 KR: 94404 SE: 509424, 62953, 520638, 510511, 513838, 522400, 524229 US:5173125, 5792367, 6086753, D412578, 6428706, 6755976, 6440311, 6530262, 6601432, 6640611, 7044002, 5460446, 5727877, 5567320, 7246530

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AK 200 S Dialysis machine - Operator's manual Program version 10.xx Part 1 Base Manual for General Use 1. Before you get started - general information 2. Description - the machine and its components 3. Controlling the machine - general guidelines 4. Hemodialysis, double needle treatment 5. Hemodialysis, single needle treatment 6. Isolated UF 7. Profiling 8. Hygiene and maintenance 9. Hemodiafiltration, low volume 10. Technical data and specifications 11. Major changes in operator's manual Part 2 Instructions for Measurement Functions 12. BVS - Blood Volume Sensor 13. BPM - Blood Pressure Monitor (option) 14. Diascan Part 3 Alarms 15. Alarm list, Attention alarm list and Technical alarm list Note

• Please observe that this part of the Operator's manual for the AK 200 S 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

How to use this manual... Definitions of expressions used in this manual... General precautions before use... Intended use... Safety philosophy... The preparation of dialysis fluid... Inlet water requirements... Preparation of the dialysis fluid... UFD- Ultrafiltered Dialysis Fluid (option)... Ultrafilters; frequency of change... List of concentrates, accessories and disposables, for use with the AK 200 S... Concentrates... Lines... Dialyzers/Ultrafilter... Blood pressure measurement accessories... List of symbols... Certification marks...

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How to use this manual This paper version of the Operator's manual for the AK 200 S dialysis machine is divided up into three parts according to their contents. The reason for this is the accessibility. 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. 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 15:10 would be page 10 in chapter 15. The first page in all three parts is the same, i.e. an overview of which chapter numbers are included in which part. All parts finishes with an index including the complete manual. A small reference number beside the figures within the manual has been added to simplify manual production. Below is a brief explanation of how the chapters in this manual are structured and are intended to be used. 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 200 S dialysis machine. Chapter 2. Description - the machine and its components

This chapter contains component descriptions of the blood monitor, the fluid monitor, the rear of the machine and the monitor stands. Chapter 3. Controlling the machine - general guidelines

This chapter contains explanations of how the machine is to be controlled. This is, for example, how to use the buttons of the Operator's panel, their alarms functions, how parameters are to be set and how to use the concentrate stand-by mode. The Treatmentand Function check overview screens 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 200 S 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, setting of parameters, and finishes with the discontinuing procedure. Chapter 5. Hemodialysis, single needle treatment

This chapter contains instructions on how to perform hemodialysis with one needle, either using the double pump (if BM 202) or single pump function. The chapter is based on chapter 4, "Hemodialysis, 1:2

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double needle treatment" in part 1 with added specific instructions for single needle treatment.

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Chapter 6. Isolated UF

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 AK 200 S dialysis 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. Chapter 9. Hemodiafiltration, low volume

This chapter contains instructions on how to perform low volume hemodiafiltration using the AK 200 S dialysis machine. The chapter is based on chapter 4 with added specific instructions for low volume HDF treatment. There is a general section describing the protective system for low volume HDF, instructions for the bolus infusion possibility is also included. Chapter 10. 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 11. 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 12. BVS - Blood Volume Sensor

This chapter contains instructions on how to use the BVS, which measures changes in the blood volume of the patient continuously during treatment. The chapter begins with a general section where handling, alarm function and graphs are explained, and finishes with On and Off instructions.

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Chapter 13. BPM - Blood Pressure Monitor

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 14. Diascan

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, handling using the Kt/V button, explanation of the Diascan screens, and alarm functions. The second section includes step-by-step instructions for measuring clearance and Kt/V, single or continuous measuring. Part 3. Alarms Chapter 15. Alarm list, Attention alarm list and Technical alarm list

This chapter contains lists of alarms, attention alarms and technical alarms. The alarm list includes additional information and possible causes of parameter button alarms. The attention- and technical alarm lists include additional information concerning the alarms, describing the alarm text more in detail and giving suggestions about measures to take. The attention- and technical alarm lists are shown in alphabetical order.

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Definitions of expressions used in this manual 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 Is used to alert the user/operator to take a certain action to protect against a potential hazard which, if ignored, could have an adverse effect on the patient or the device. 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

• A reminder to the user/operator on normal treatment activity and on what is a suitable action in a particular situation. Note

This symbol indicates that it is possible to preset the value of a parameter. This can be done to adapt the settings of the machine to correspond with the routines of the user/clinic. It has to be done in service mode by an authorized service 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 service 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.

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General precautions before use WARNING Unauthorized modifications, alterations or repair and lack of maintenance or calibration of the AK 200 S dialysis machine may result in malfunctioning or have other serious consequences for the safe operation of the equipment. WARNING CAUTION The AK 200 S 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 1:11 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 200 S 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 can not be assured. Patients connected to the AK 200 S dialysis machine should be monitored by competent medical personnel, learned intermediaries or the like, since life threatening circumstances sometime 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 a patient. During installation all calibration checks must be completed before the machine is used to dialyze a patient. The AK 200 S dialysis machine needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in chapter 10, "Technical data and specifications" in part 1. The use of mobile telephones or communication equipment in the vicinity of the AK 200 S dialysis machine could adversely influence the performance of the machine. For further information, see chapter 10, "Technical data and specifications" in part 1. The AK 200 S 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 200 S 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 200 S dialysis machine shall be performed by a fully trained service technician according to the Maintenance Manual in the Service Manual for the AK 200 S dialysis machine 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 200 S 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 for arrythmia due to leakage currents. For these treatments it is necessary to connect the potential equalization conductor between the AK 200 S dialysis machine and the potential equalization bus bar in the electrical installation. 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 service technician. If your clinic/hospital use 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 200 S dialysis machine is not suitable for use in the presence of a flammable ansethetic 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 200 S 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 qualified technician the Service Manual for the AK 200 S 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 200 S dialysis machine must not be disposed 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 200 S dialysis machine is intended for continuous operation. Note

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Intended use The Gambro AK 200 S 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. The AK 200 S dialysis machine comprises of two monitors; one blood monitor (BM 200 or BM 202) and one fluid monitor (FM 202). The monitors are placed on a mobile stand (MS 200 or MS 202). The blood monitor is designed to control and supervise the extracorporeal blood circuit. Single needle treatment can be performed with one pump (double clamp function) or with two pumps (BM 202 only). To prevent coagulation, anticoagulantia may be administered by means of a heparin pump. The fluid monitor is designed to produce the dialysis fluid at a desired temperature, conductivity and pressure within given specifications, and to supervise the dialysis fluid. Both acetate and bicarbonate treatments can be performed. CAUTION Patient education, counselling, home care follow-up and medical maintenance must be performed under the direction of and supervision by the physician prescribing the treatment. Gambro specifically denies any responsibility for patient education, counselling or home care and medical maintenance. When the AK 200 S dialysis machine is used to produce bicarbonate containing dialysis fluid originating from non-liquid concentrates, the AK 200 S dialysis machine is designed and validated for use with the Gambro BiCart cartridge. When the AK 200 S dialysis machine is used to produce sodium chloride containing dialysis fluid originating from non-liquid concentrates, the AK 200 S dialysis machine is designed and validated for use with the Gambro BiCart Select concentrate system, i.e. the BiCart and SelectCart cartridges, and the SelectBag container. Gambro does not accept responsibility for use of other non-liquid concentrate containers. CAUTION

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Safety philosophy The AK 200 S 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 200 S 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 operator is instructed to compare the readings of the current time display/bargraph displays and the information display, before connecting to the patient. Check that the set time on the information display correspond with the set value on the time display. Check that the calculated conductivity value on the information display correspond with the set value on the bargraph display. Check that the set uf volume on the information display correspond with the set value on the bargraph display. If these comparisons are not satisfactory, call an authorized service technician. Note especially, that if the protective system for ultrafiltration using the FRN system has been disabled and the TMP is used for supervision, the TMP alarm limits has to be set. See further on in this section for details. The protective system will, when a parameter (measured by the protective system) is outside the alarm limits, put the AK 200 S 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. The ultrafiltration control system, the UF-cell, control the ultrafiltration volume with an accuracy corresponding to ±50 ml x passed treatment time (h) or ±2.5%. If the accumulated UF volume, measured by the UF-cell, differs more than 200 ml from the expected volume the machine issues an attention. In addition to this system there are independent ultrafiltration measuring systems, protective systems, as described below. In AK 200 S dialysis machine an independent ultrafiltration measuring system based on restrictor flow measurement (FRN) is used as protective system for the UF-volume. For further description, see chapter 3. It is automatically checked before each treatment and a failure will make it impossible to start the treatment. The default alarm limit is set to 800 ml. The accuracy of the system is ±120 ml/h. This means that for a four hour treatment the maximum weight deviation without any alarm issued is less than 1280 g (800 + 4 x 120). As an additional precaution it is recommended that competent personnel supervise the patient and that the blood pressure is checked regularly.

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This protective system can be disabled via a preset. If this is done the remaining supervision is based on the transmembrane pressure, see further below for description of this system.

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As an extra precaution there is also a system for supervision of the UF-rate. This system is available on condition that the FRN system is not disabled. The UF rate supervision is using the FRN system and the measured UF rate is supervised against a limit. This limit constitutes the maximum allowed deviation between the UF rate measured by FRN and the UF rate measured by the UF cell over a period of 2 minutes. The default limit is set to 5 ml/min. The accuracy of the system is ± 2 ml/min. If this limit, i.e. 5 ml/min, is violated the system initiates a taration of the UF measuring system. If the limit is violated more than four times during 30 minutes, the machine terminates the treatment and a technical error is issued. In addition, an independent ultrafiltration measuring system based on the transmembrane pressure is used as 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 competent personnel supervise the patient and that the blood pressure is checked regularly. The composition of the dialysis fluid is supervised by the protective system using an independent conductivity measuring system. The dialysis fluid conductivity and temperature systems are automatically checked before each treatment. A failure will make it impossible to start the treatment. To protect the patient against a hazardous blood loss to the environment the AK 200 S dialysis machine incorporates a venous pressure monitoring system. This system will react upon a change in the venous pressure, 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. A visual monitoring by the user/operator is recommended. The venous, arterial and system pressure measuring system is checked automatically at positive, atmospheric and negative pressure before each treatment. A failure will make it impossible to start the treatment. 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.

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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). If the system cannot detect these states, it is impossible to start the treatment. Furthermore, the system is checked every 5 minutes to ensure that it is able to detect non-transparency. If not, the system will act as if a blood leak alarm has occurred and enter a patient safe condition. The air detector utilizes an ultrasonic sensing system in which the transmitter is handled by one microprocessor and the receiver by another. The system is continuously tested for being able to detect an air leakage condition. If this test is not successful the system will act as if an air detection has occurred and the machine will enter a patient safe condition. Any infusion/transfusion/medication given to the patient via the extracorporeal blood circuit of the AK 200 S dialysis machine during treatment, must pass the venous drip chamber and the activated air detector. If the AK 200 S dialysis machine is used to perform Hemodiafiltration, low volume, an independent substitution flow supervision system is used as protective system. It is based on restrictor measuring as well as pump speed measuring. For the restrictor measuring it is essential that a correct infusion line is used to obtain specified level of safety.

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