AK95S Operators Manual Ver 12xx

Contents 1. Before you get started - general information 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 95 S... List of symbols... CE-marking... Manufacturer...

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2. Description - the machine with its components Blood unit... Fluid unit... Mixing unit... Rear of the machine...

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3. Controlling the machine - general guidelines Operator’s panel... Hygiene group... Mode group... Concentrate stand-by mode... Treatment overview group... Bargraph display... Flow diagram... Time display... Mode buttons and Parameter buttons and their displays... Alarms... Alarm indicators... Air detector alarm... Attention alarm... Technical message... pH alarm (option)... Blood leak alarm... BPM alarm (option)... Alarm function of the parameter buttons... Venous pressure alarm... Centralizing alarm... Blood pump alarm... Single needle data alarm... Temperature alarm... Conductivity alarm... Arterial pressure alarm... Centralizing alarm... Transmembrane pressure alarm...

3:4 3:6 3:7 3:8 3:10 3:10 3:10 3:11 3:12 3:18 3:18 3:18 3:18 3:18 3:18 3:18 3:18 3:19 3:19 3:19 3:19 3:19 3:19 3:19 3:19 3:19 3:19 HCEN9794 Revision.06.2005 Program version 12.xx

Centralizing alarm... Clinic Automation alarm... UF volume alarm... UF rate alarm... Heparin pump alarm... Time attention alarm... Override possibilities... Stand-by group... Display and setting group... Information display... Viewing Angle Adjustment... Treatment overview... Dialysis fluid flow rate... The eight commandments... Setting of parameters... The following parameters can be set:... Chemical disinfection... Heat disinfection... Rinse/Drain... Acetate... Bicarbonate... Venous pressure... Blood flow... Single needle data... Temperature... Conductivity... Arterial pressure... TMP... UF volume... UF rate... Time... Heparin... BPM (option)... Profiling... Setting of the pressure alarm limits... The ultrafiltration control... Power failure... Returning the blood during a power failure... Recovery from power failure... Battery back-up... Halt button function during power failure (installed battery back-up)... Change of blood pump segments... Change of BiCart cartridge...

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4. Treatment operations Initial procedures... 4:2 First check... 4:2 Start the machine... 4:3 Attaching the dialyzer and the blood lines... 4:7 Dialyzer... 4:7 Arterial blood line... 4:8 Venous blood line... 4:12

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Dialysis fluid tubes... Priming and rinsing the extracorporeal circuit... Before priming... Priming and rinsing procedure... Initiating dialysis... Setting of treatment parameters... Connect the patient... Start of ultrafiltration... Set the alarm limits... BPM (option)... High arterial pressure alarm limit setting... Minimize the risk of generating “microbubbles”... Single needle treatment... Isolated UF... Discontinuing dialysis... Returning the blood... Emptying and disconnecting the dialyzer...

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5. Auto priming, Rinse-back Auto priming (Option)... General description... Filling... Pressure test (Option)... Priming... Flushing part one... Flushing part two... Venous drip chamber level adjustment (Option)... Filling of venous line (Option)... Dialysis fluid... Operation of the autopriming... Rinse-back... General description... Operation of the Rinse-back...

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6. Profiling General... 6:2 Profiling of Na+ and HCO3 - dialysis fluid concentration... 6:2 Profiling of ultrafiltration rate... 6:3 Profiling models... 6:6 Handling... 6:6 Profiling starting procedure... 6:7 Start profiling without preset model... 6:8 Start profiling with preset model... 6:12

7. BPM - Blood Pressure Monitor (option) General... The cuff... Patient factors which affect readings... Handling BPM... Menus... The first menu...

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The second menu... 7:6 The third menu... 7:6 Alarms... 7:7 Modes... 7:8 Manual - single measuring... 7:9 Automatic - interval measuring... 7:10 Continuous - five minutes measuring... 7:12 BPM Off... 7:14

8. Hygiene and maintenance General hygiene and maintenance... 8:2 Glossary of disinfection terms... 8:3 Disinfection history... 8:3 Schedule for hygiene and maintenance... 8:4 When the machine is planned not to be in use... 8:5 Characteristics of different disinfection, decalcification and cleaning agents... 8:6 Hygiene - Heat disinfection... 8:7 General - Heat disinfection... 8:7 Performing Heat disinfection program... 8:9 Performing Heat disinfection program with CleanCart... 8:10 Performing Heat disinfection program with liquid citric acid... 8:11 Automatic start of Heat disinfection program... 8:13 Automatic switch off after Heat disinfection program... 8:15 Integrated Heat disinfection... 8:15 Hygiene - Chemical disinfection... 8:16 General - Chemical disinfection... 8:16 Chemical disinfectants... 8:17 Performing Chemical disinfection program... 8:19 Filling the machine with chemical disinfectant... 8:20 Residual test after Chemical disinfection... 8:22 Central Chemical disinfection... 8:23 Performing central Chemical disinfection... 8:23 Hygiene - Rinse/Drain... 8:25 Performing Rinse/Drain program... 8:25 Automatic start of Rinse/Drain program... 8:26 Automatic switch off after Rinse/Drain program... 8:27 Maintenance - the flow path... 8:28 The flow path... 8:28 Ultrafilter; how to change... 8:29 Maintenance - the exterior of the machine... 8:30 The outside... 8:30 Top tray... 8:30 Pick-up tubes... 8:30 Blood pump... 8:30 Blood leak detector... 8:30 BPM cuff... 8:31

9. Technical data and specifications Performance and specification - Control system... Blood flow control... Heparin administration...

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Blood pressure control... Blood Pressure Monitor (BPM)... Dialysis fluid preparation... Ultrafiltration control... Profiling... Disinfection and cleaning... Water supply... Power supply... Connection of external equipment... Battery back-up... Performance and specification - Supervisory system... Blood pressure supervision... Extracorporeal blood loss to the environment... Air detection... Extracorporeal blood loss due to coagulation... Dialysis fluid preparation... Ultrafiltration supervision... Blood leakage detection... pH-meter... Physical data... Dimensions and weight... Infusion stand... References... Materials in contact with dialysate, concentrates and water... Environmental data... Operation... Transportation and storage... Standards...

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10. Alarm lists Alarm list... 10:2 Attention alarm list... 10:10 Technical alarm list... 10:45

11. Major changes in operator’s manual Major changes in operator’s manual between program versions 11.xx and 12.xx... Chapter 3... Chapter 6... Chapter 8...

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12. Index

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Figures 2. Description - the machine with its components Figure 2:1 Figure 2:2 Figure 2:3 Figure 2:4

Blood unit... Fluid unit... Mixing unit... Rear of the machine...

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3. Controlling the machine - general guidelines Figure 3:1 Figure 3:2

Operator’s panel... 3:4 Flow diagram... 3:10

4. Treatment operations Figure 4:2 Figure 4:3 Figure 4:4 Figure 4:5 Figure 4:7

Arterial blood line, set-up... Change position of the heparin pump holder... Syringe attached to the heparin pump... Venous blood line, set-up... Venous blood line with expansion chamber...

4:9 4:10 4:10 4:13 4:24

6. Profiling Figure 6:1 Figure 6:2 Figure 6:3 Figure 6:4 Figure 6:5 Figure 6:6

Linear graphs for sodium and bicarbonate profiling... Decreasing linear graph for UF rate profiling... Decreasing graph in steps for UF rate profiling... Graph in intervals for UF rate profiling... Change of UF rate linear graph when UF volume has been changed... Change of UF rate linear graph when time has been changed...

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7. BPM - Blood Pressure Monitor (option) Figure 7:1 Figure 7:2 Figure 7:3 Figure 7:4 Figure 7:5 Figure 7:6 Figure 7:7 Figure 7:8

Information display, BPM, the first menu with measured values... 7:5 Information display, BPM, the first menu with previously measured values... 7:5 Information display, BPM, second menu... 7:6 Information display, BPM, third menu... 7:6 Information display, BPM, alarm limits set for systolic blood pressure... 7:7 Information display, BPM, performing single measurement check... 7:9 Information display, BPM, adjusting time intervals between measurement checks... 7:10 Information display, BPM, continuous measuring... 7:12

8. Hygiene and maintenance

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Figure 8:1

BPM cuff, removal procedure of rubber bladder from cloth bag 1. Small hole 2. Large hole... 8:31

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Chapter 1 Before you get started - general information 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 95 S... List of symbols... CE-marking... Manufacturer...

HCEN9794 Revision.06.2005 Program version 12.xx

AK 95 S Operator’s manual - Before you get started

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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.

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.

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

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General precautions before use WARNING Unauthorized modifications, alterations or repair and lack of maintenance or calibration of the AK 95 S may result in malfunctioning or have other serious consequences for the safe operation of the equipment.

CAUTION 1. The AK 95 S 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” in chapter 1. Verify that the first digit of the program version of both the machine and the manual is the same. If the AK 95 S does not perform as described in this manual, it should not be used until the condition is rectified. 2. When unpacking, check the equipment for any signs of damage. If the equipment is in any way damaged, proper operation can not be assured. 3. Patients connected to the AK 95 S should be monitored by competent personnel since life threatening situations can arise without any AK 95 S alarm activation. 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. 4. During installation all calibration checks must be completed before the machine is used for dialysis treatment. 5. The AK 95 S needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the "Technical data and specifications" chapter in this manual. 6. The use of mobile telephones or communication equipment in the vicinity of the AK 95 S could adversely influence the performance of the machine. For further information, see the "Technical data and specifications" chapter in this manual. 7. The AK 95 S 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 95 S 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.

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CAUTION 8. Preventive inspection, maintenance and calibration of the AK 95 S shall be performed by a fully trained service technician according to the Maintenance Manual in the AK 95 S 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. 9. The AK 95 S dialysis machine is in compliance with certain requirements concerning patient leakage current from the dialysis fluid in accordance with international standards and regulations. During specific treatments a central venous catheter is used and the tip of the catheter is close to the heart. In order to minimize the risk of electric shock a potential equalization conductor must be connected between the dialysis machine and the potential equalization bus bar in the electrical installation. 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. 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.

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AK 95 S Operator’s manual - Before you get started

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NOTE 1. This operator’s manual provides instructions necessary for the proper operation of the AK 95 S. It is not a guide for the administration of hemodialysis. 2. Machines are not disinfected before delivery. Always perform a chemical disinfection after installation, before initial use. 3. When accuracy ranges are written as e.g. ”(±1 ml/min or ±1%)” the widest range is valid. 4. 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. 5. For the qualified technician the AK 95 S Service Manual is available. The Service Manual provides all of the necessary information for installation and safe and required maintenance of the machine. 6. It is important that the protective earth in the installation is of high quality. 7. For the purpose of protecting the environment the AK 95 S 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.

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Intended use The Gambro AK 95 S System 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. AK 95 S comprises of three units; one blood unit, one fluid unit and one mixing unit. The blood unit is designed to control and supervise the extracorporeal blood circuit. Single needle treatment can be performed with one pump (double clamp function). To prevent coagulation, anticoagulantia may be administered by means of a heparin pump. The fluid unit is designed to administer the dialysis fluid and to control the ultrafiltration. The mixing unit is designed to proportion concentrate(s) with reverse osmosis water. Both acetate and bicarbonate treatments can be performed. CAUTION 1. 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. 2. When AK 95 S is used to produce bicarbonate containing dialysis fluid originating from non-liquid concentrates, the AK 95 S is designed and validated for use with the Gambro BiCart® system. Gambro does not accept responsibility for use of other non-liquid concentrate containers.

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AK 95 S Operator’s manual - Before you get started

HCEN9794 Revision.06.2005 Program version 12.xx

Safety philosophy The AK 95 S 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 95 S 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 of the current bargraph display and the information display, before connecting the patient. The bargraph displays show the set value, the actual value and the alarm limits for the control system. The information display shows the corresponding values from the protective system. If the comparisons are not satisfactory, call your service technician. The protective system will, when a parameter (measured by the protective system) is outside the alarm limits, put the AK 95 S 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. 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. To protect the patient against a hazardous blood loss to the environment AK 95 S 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.

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The venous pressure measuring system is the protection against blood loss to the environment. This measuring system is checked automatically at 0 mmHg before each treatment. A failure will make it impossible to start the treatment. Furthermore, the user is instructed to make a leakage test of the dialyzer at a certain pressure. 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. 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. 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. For a more detailed information, please refer to the AK 95 S Service Manual.

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AK 95 S Operator’s manual - Before you get started

HCEN9794 Revision.06.2005 Program version 12.xx

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 chapter “Technical data and specifications/Water supply” in this manual for more details.

Preparation of the dialysis fluid The AK 95 S 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 “List of concentrates” in this chapter.

UFD - Ultrafiltered Dialysis Fluid (option) The AK 95 S 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.

Ultrafilters; frequency of change The ultrafilter used in Ultrafiltered Dialysis Fluid kit 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”, in chapter 8.

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List of concentrates, accessories and disposables, for use with the AK 95 S This manual contains a number of references to concentrates, accessories and disposables for use with the AK 95 S. For ease of reference, set out below is a comprehensive listing of such concentrates, accessories and disposables as follows: Concentrates Liquid concentrates

Area of use

001-099 series 6xx series

Liquid acetate concentrates for preparation of acetate dialysis fluid.

2xx series 7xx series 8xx series

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

3xx series

Liquid A and B concentrates for preparation of bicarbonate dialysis fluid.

Non-liquid concentrates

Area of use

BiCart®

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

CAUTION Incorrect choice of dialysis fluid concentrate may cause incorrect composition of the dialysis fluid.

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AK 95 S Operator’s manual - Before you get started

HCEN9794 Revision.06.2005 Program version 12.xx

Lines Line number

Area of use

Gambro Medical Line (PVC+DOP/ EtO sterilized) BL 10 series

Arterial and venous blood line set.

BL 100 series

Arterial and venous blood line set.

AV 100 series

Arterial and venous blood line set.

A 5000 series

Arterial blood lines.

V 5000 series

Venous blood lines.

Gambro Blood Tubing System (PVC+DOA/Beta sterilized) BL 200 series

Arterial and venous blood line set.

Gambro Accessories C series

Hemodialysis accessories.

C 705

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

Dialyzers/Ultrafilter

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Dialyzer/Ultrafilter

Area of use

U 8000 S

Ultrafilter used in Ultra Filtered Dialysis Fluid kit.

Dialyzers

Most types of dialyzers, except plate dialyzers, can be used. However, it is essential to verify that the specifications and instructions for use of the dialyzers are not in discrepancy with those given for AK 95 S, with regards to e.g. the maximum UF coefficient and the recommended priming procedure. The connectors and the ports of the dialyzer must comply with ISO 8637 and EN 1283.

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Blood pressure measurement accessories Gambro Cuff

Area of use

No. 1 (7 cm) No. 2 (9 cm) No. 3 (12 cm) No. 4 (14 cm)

for 12 - 18 cm arm circumference. for 17 - 23 cm arm circumference. for 23 - 33 cm arm circumference. for 31 - 40 cm arm circumference.

Gambro Cuff hose 3,5 m

Cuff hose used for measuring blood pressure together with the AK 95 S.

CAUTION 1. The AK 95 S has been tested and validated for use with the concentrates, accessories and disposables specified above. 2. Gambro does not accept any responsibility or liability for use of concentrates, accessories or disposables other than those specified above. Depending on the circumstances, use of concentrates, accessories or disposables other than those specified above may also reduce Gambro’s warranties for the AK 95 S.

NOTE 1. The user should make sure to have a current listing of concentrates, accessories and disposables available. 2. The user should follow the facility procedures for proper disposal of used blood lines, dialyzers and other disposables per local regulations.

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AK 95 S Operator’s manual - Before you get started

HCEN9794 Revision.06.2005 Program version 12.xx