AK96 Operators Manual v 4.xx Dec 2012

Copyright: © 2007, 2008-2012 Gambro Lundia AB. All rights reserved. Trademarks: Gambro, AK 96, BiCart, CleanCart, Diascan, SoftPac, and U 9000 are trademarks belonging to the Gambro Group. Dialox is a trademark owned by Schülke & Mayr. Manufacturer: Gambro Lundia AB Box 10101 Magistratsvägen 16 SE-220 10 LUND Sweden Phone +46 46 169000 www.gambro.com Sales representative contact information, (if applicable):

Questions or comments about this publication can be directed to your local representative or to the manufacturer. Local regulatory registration (if applicable):

한국 시장에 관련된 정보 수입품목허가번호 수입업자

수허 09-204 호 한국갬브로(주), 서울시 강남구 삼성동 145-9 대한해운빌딩 4층

HCEN12239 Revision 12.2012 Program version 4.xx

AK 96® Dialysis Machine Operator's Manual Program version 4.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 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. Attentions 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

How To Use this Manual... How to find what you are looking for... Chapter Descriptions... Part 1; Base Manual for General Use... Part 2; Instructions for Measurement Functions... Part 3; Alarm Handbook... Definitions of Expressions used in this Manual... Warning... Caution... Note... Other Keywords used in this Manual... Figures... Symbols... Symbols within this Manual... Symbols within the User Interface... Symbols fixed on to the Machine... 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)... Ultrafilter - Frequency of Change... List of Concentrates, Chemical Disinfectants, Accessories, and Disposables... Concentrates... Chemical disinfectants... Lines... Dialyzers/Ultrafilter... Blood Pressure Measurement Accessories... Certification marks...

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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 attentions 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 Blood Pressure Monitor (option) and Diascan (option) function. The third part; “Alarm Handbook” include all alarms and attentions originating from all functions of the machine. The first part is printed in A4 format, the second and third in A5. The parts are put in a box which should be considered as cover of the complete manual. Consequently, 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

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. HCEN12239 Revision 12.2012 Program version 4.xx

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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; Attentions

This chapter contains a list of attentions. The list includes additional information concerning possible causes and suggestions about measures to be taken for each attention. The attentions in the list are 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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HCEN12239 Revision 12.2012 Program version 4.xx

Figures There are different type of figures included in this manual. Screens and menus shown on the Information Display are one type of figure. These figures are a direct "shot" of the Information Display of the machine and have not been revised afterwards in order for the operator to recognize current machine displays for the ongoing procedure. Some figures illustrate handling or point out components of the machine. To highlight certain items or illustrate movements arrows have been included in these figures. This "straight arrow" in figures points out details described in the corresponding text. The arrow can also show a direction, i.e. if 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 13:13 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)

Off (power, disconnection from the mains) On (power, connection to the mains)

Equipotentiality

The AK 96 dialysis machine is protected against dripping water

Type B, applied part

NIBP type BF applied part, defibrillator proof

Product does not contain latex.

Product does not contain pvc.

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Symbol

Description The maximum stacking load permitted on the transport package

Do not stack

Fragile – Handle with care

This way up

Keep dry

Catalogue number

Serial number

Humidity limitation. Upper and lower limit is expressed with numeric values in %.

Atmospheric pressure limitation. Upper and lower limit is expressed with numeric values in kPa.

Temperature limitation. Upper and lower limit is expressed with numeric values in degree Celsius or Fahrenheit.

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Symbol

Description Year of manufacturing Manufacturer. The date of manufacturing may be included below the symbol expressed as YYYY-MM (year-month).

Recycling symbol – Corrugated Cardboard. According to GB 18455–2001. This symbol indicates that the AK 96 dialysis machine contains toxic or hazardous substances or elements according to SJ/T 11363–2006. The figure 25 indicates the corresponding environmental protection use period of the AK 96 dialysis machine. Separate collection for electrical and electronic equipment

Warning, Dangerous voltage. Contact may cause electric shock or burn. The label is yellow with a black frame and icon. Warning. Do not lean the AK 96 dialysis machine more than 5° from the floor.The label is yellow with a black frame and icon.

Caution, consult accompanying documents Read instructions before use. The label is blue with a white icon. WARNING If a remote operator's panel has been installed, fluid bags shall 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. A trained and competent observer shall be present during treatment in home environment in case the patient may need assistance to resolve the situation and/or terminate the treatment in a safe way. Selfcare treatment, for example in home environment, shall only be allowed if the patient and the observer have received proper training to enable them to prepare the machine, perform and end the treatment in a safe way, and disinfect and clean the machine between treatments. The physician is responsible to ensure that the competence of the patient and/or the observer is checked on regular basis. Records of the training and/or competence checks shall be archived by responsible physician. WARNING

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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 1:17 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 anaesthetic mixture with air or with oxygen or nitrous oxide. Make sure that any used chemical disinfectants are stored according to manufacturer’s recommendations. The physician is responsible to ensure that the patient and the observer have access to the AK 96 Operator’s Manual when performing hemodialysis in a selfcare environment. 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. • 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 intended for use as a single patient machine to perform hemodialysis treatments of patients with renal failure or fluid overload upon prescription by a physician. Patient counselling and teaching of treatment techniques are directly under the supervision and discretion of the physician. The AK 96 dialysis machine is intended for the In-Center environment and for selfcare, for example in home environment, on the condition that the hemodialysis is performed by a qualified and competent person, as prescribed by a physician. WARNING Selfcare treatment, for example in home environment, shall only be allowed if the patient and the observer have received proper training to enable them to prepare the machine, perform and end the treatment in a safe way, and disinfect and clean the machine between treatments. The physician is responsible to ensure that the competence of the patient and/or the observer is checked on regular basis. Records of the training and/or competence checks shall be archived by responsible physician. WARNING 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 BiCart cartridge. Gambro does not accept responsibility for use of other non-liquid concentrate containers. The physician is responsible to ensure that the patient and the observer have access to the AK 96 Operator’s Manual when performing hemodialysis in a selfcare environment. CAUTION

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