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Candela Corporation Proprietary GentleLASE Service Manual Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. Caution Federal (USA) law restricts this device to sale by or on the order of a physician.
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GentleLASE Service Manual Candela Corporation Proprietary TABLE OF CONTENTS SECTION ONE THEORY OF OPERATION Revision 8501-00-1762 Theory of Operation, GentleLASE................A SECTION TWO FIRMWARE DOCUMENT 1010-01-3020 Firmware Design Document, GentleLASE............B2 1010-06-3020 Firmware Requirement Specification ..............B2 SECTION THREE SERVICE PROCEDURES 8503-01-0060 Inspection and cleaning of Optics ...............02 8503-01-0821 Installation Procedure....................A...
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Candela Corporation Proprietary GentleLASE Service Manual SECTION FOUR ENGINEERING DRAWINGS.................Revision 8501-02-1741 DRAWING PACKAGE Schematics Revision 7111-80-2230 Touch Panel Interface PCB...................06 7111-80-2510 HP Bulkhead PCB ....................01 7111-80-2520 DCD Canister PCB....................03 7111-80-2610 AC Distribution PCB....................08 7111-80-2620 HV Bleeder PCB......................06 7111-80-2630 CPU / I/O PCB......................03 7111-80-2650 Energy Detector PCB .....................03...
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Candela Corporation Proprietary GentleLASE Service Manual SECTION FIVE REFERENCE 8501-00-1741, Revision A PROPRIETARY Page vii...
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GentleLASE Service Manual Candela Corporation Proprietary Page viii PROPRIETARY 8501-00-1741 Revision A...
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AK 200 S - Operator’s manual Program version 8.xx 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.
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Contents 1. Before you get started - general information How to use this manual ........Definitions of expressions used in this manual .
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Alarm function of the parameter buttons ..... . . 3:18 Override possibilities ......... 3:20 Stand-by group .
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Confirm treatment end ....... 4:25 If desired, start emptying BiCart or BiCart, SelectCart and SelectBag .
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Chapter 1 Before you get started - general information How to use this manual ........Definitions of expressions used in this manual .
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How to use this manual Below is a brief explanation of how the chapters in this manual are structured and are intended to be used. Chapter 1; Before you get started - general information This chapter contains information to be read before using the AK 200 S machine.
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Chapter 9; 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 15; 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.
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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 may result in malfunctioning or have other serious consequences for the safe operation of the equipment. WARNING CAUTION The AK 200 S may only be operated by persons trained in hemodialysis and who have studied the instructions in this manual.
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→ → → CAUTION Preventive inspection, maintenance and calibration of the AK 200 S shall be performed by a fully trained service technician according to the Maintenance Manual in the AK 200 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.
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Note • This operator’s manual provides instructions necessary for the proper operation of the AK 200 S. 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. •...
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Intended use The Gambro AK 200 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. The AK 200 S System comprises of two monitors;...
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Safety philosophy The AK 200 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.
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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.
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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.
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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.
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List of concentrates, accessories and disposables, for use with the AK 200 S This manual contains a number of references to concentrates, accessories and disposables for use with the AK 200 S. For ease of reference, set out below is a comprehensive listing of such concentrates, accessories and disposables as follows: Concentrates Liquid concentrates...
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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.
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Infusion fluid for low volume HDF Infusion solution Area of use Hemofiltrasol 2x serie Infusion fluid used for low volume hemodiafiltration. Blood pressure measurement accessories Gambro Cuff Area of use Standard No. 1 (7 cm) for 12 - 18 cm arm circumference. Standard No.
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List of symbols Note • All symbols in this list may not be represented on this product. Note 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 Handle with care This way up...
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Symbol Description Input /Output Year of manufacturing Heater power supply outlet Conforms to requirements in EC Council Directive 93/42/EEC concerning medical devices. 0086 identifies BSI, British Standards Institution, as Notified Body. CSA approved for Canada CSA approved for Canada and USA CSA-listed label manufacturer Prohibited behaviour Equipotentiality...
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CE-marking This product is CE-marked in accordance with the requirements in EC Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and is classified as IIb equipment. Notified body is: British Standards Institution (BSI) with the notified body number 0086. The CE-marking of this manual is only valid if the device which it describes is CE-marked.
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Chapter 2 Description - the machine and its components Blood monitor ..........BM 200 - Single Pump, BM 202 - Double Pump .
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Blood monitor BM 200 - Single Pump, BM 202 - Double Pump Figure 2:1 Blood monitor 1. Top tray To protect the machine against leakage the top tray must always be placed on top of the machine. 2. Air detector The air detector head is designed for a drip chamber with a diameter of 22 mm.
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7. Heparin pump The heparin pump can be programmed for different syringe sizes . Syringes shall comply with ISO 7886 - 2. Upon delivery the machine is programmed for a 30 ml Becton Dickinson syringe with a length of 81,0 mm . Syringes of other volumes and brands can be programmed.
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Fluid monitor FM 202 - Acetate and Bicarbonate Figure 2:2 Fluid monitor 1. Disinfection ports for concentrate pick-up tubes 2. B pick-up tube marked blue-white The B pick-up tube is used for intake of: - Bicarbonate concentrate - Acetate concentrate - Concentrated or diluted disinfectants 3.
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9. SelectBag holder ® The machine is designed for use with the Gambro SelectBag , a bag containing electrolytes (except sodium chloride). 10. SelectCart holder The machine is designed for use with the Gambro SelectCart ® cartridge containing dry sodium chloride. 11.
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Rear of the machine - without options Figure 2:3 Rear of the machine - without options 1. BPM (Blood Pressure Monitor) connection The line to the optional blood pressure cuff is connected to the nipple. 2. Potential equalization connection This connection is used for the potential equalization conductor. When a central venous catheter is used, the conductor must be connected to minimize the risk of electric shock.
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6. UF calibration unit connection, marked blue 7. Mains supply inlet 8. Main switch 9. Fuses 10. Power supply unit 11. Halt button When the button is pressed the power supply to the AK 200 S is interrupted. As soon as the button is released the power returns and the machine performs a recovery.
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Rear of the machine - options included Figure 2:4 Rear of the machine, options included 1. BPM (Blood Pressure Monitor) connection The line to the optional blood pressure cuff is connected to the nipple. 2. Potential equalization connection This connection is used for the potential equalization conductor. When a central venous catheter is used, the conductor must be connected to minimize the risk of electric shock.
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6. UF calibration unit connection, marked blue 7. Mains supply inlet 8. Main switch 9. Fuses 10. Power supply unit 11. Halt button When the button is pressed the power supply to the AK 200 S is interrupted. As soon as the button is released the power returns and the machine performs a recovery.
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Monitor stand MS 200: Adjustable height: five fixed positions Figure 2:5 Monitor stand, five fixed positions 1. Infusion pole The maximum allowed load is 10 kg. 2. Height adjustment for infusion pole 3. Rear handle 4. Bars, lifting positions Positions where the AK 200 S is safely lifted, both on the right and left hand side of the machine.
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5. Screws For locking the handle (service frame). 6. Screws (rear side) For height adjustment in five fixed positions. 7. Tray for concentrate containers 8. Lockable wheels The wheels must be locked during treatment. During internal transportation the AK 200 S must be in upright position. HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Description 2:11...
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MS 202: Electrically adjustable height Figure 2:6 Monitor stand, electrically adjustable 1. Infusion pole The maximum allowed load is 10 kg. 2. Height adjustment for infusion pole 3. Rear handle 4. Bars, lifting positions Positions where the AK 200 S is safely lifted, both on the right and left hand side of the machine.
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6. Control for height adjustment 7. Power supply cord For height adjustable stand only. 8. Tray for concentrate containers 9. Lockable wheels The wheels must be locked during treatment. During internal transportation the AK 200 S must be in upright position. HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Description 2:13...
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Chapter 3 Controlling the machine - general guidelines Operator’s panel ..........Hygiene group .
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Operator’s panel Both the blood monitor and the fluid monitor are controlled and supervised from the operator’s panel. The panel consists of a number of buttons, bargraph displays, flow paths, a time display, an information display, a blood flow knob and one set knob. The panel is divided into six logical groups: 1.
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Figure 3:1 Operator’s panel HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Controlling Program version 8.xx...
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Hygiene group The ON/OFF button is used to switch the machine on and off. (The main switch on the back of the machine should always be in the ON position even when the machine is not in use). It is only possible to turn the machine off when time is 0.00 and no blood is detected by the priming detector.
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Mode group The Isol UF button is used to select isolated ultrafiltration (sequential dialysis). The SN button is used to select single needle treatment. Single needle treatment can be performed with one blood pump or with two blood pumps (BM 202 only). Function not available.
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Concentrate stand-by mode When the machine has been switched on, has passed the function check with proper concentrates connected, and the bypass path on the flow diagram lights up green, it is possible for the machine to enter a stand-by mode where the consumption of concentrates will be stopped.
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Procedure for manual activation Press the lit Bicarbonate (or Acetate button) twice and this screen will be shown on the information display: Figure 3:2 Concentrate stand-by mode, activation Press the lit Arrow button to activate Concentrate stand-by mode. When the mode has been activated, the text will change and be replaced by CONCENTRATE STANDBY MODE ACTIVE.
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Therapy group The Priming button is used to activate priming mode. The Heparin button is used to select heparinization with the heparin pump. The Profiling button is used to select automatic variation of sodium, bicarbonate and ultrafiltration rate. The HDF button is used to select low volume hemodiafiltration mode and set infusion parameters.
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Treatment overview group Bargraph display The bargraph displays shows values from the control system in the machine. There are bargraphs attached to values for venous pressure, arterial pressure, blood flow, temperature, conductivity, TMP, UF volume and UF rate. For further information, see corresponding button below “Parameter buttons and their displays”...
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The flow diagram can be lit in different colours: 1-2 lights off during priming. 1-2 is red when the priming detector detects blood. 3-4-6-7 is green when dialysis fluid is correct and passes through the dialyzer. 3-5-7 is green when dialysis fluid is correct but the machine performs a self-calibration.
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Parameter buttons and their displays Bargraph Information Explanation display display Yellow bar Actual value VEN PRES Red bars Alarm limits LOW HIGH Double needle mode Set value Green bar Yellow bar Actual value BL FLOW Accumulated volume ACC VOL Blood pump segment diameter SEGMENT Single needle/single pump mode Green bar...
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Bargraph Information Explanation display display Green bar Set value Yellow bar Actual value TEMP Red bars Alarm limits LOW HIGH Acetate mode Green bar Calculated conductivity value Set value Yellow bar Actual value COND Red bars Alarm limits Flashing red bars Temporarily extended alarm limits Actual pH value (optional) (pH)
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Bargraph Information Explanation display display If pressed twice (not valid if the function is removed by preset) UF supervision measured SUPERV accumulated UF volume Lower level for UF supervision alarm Settable alarm limit for UF LIMIT supervision Upper level for UF supervision HIGH alarm Green bar...
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Bargraph Information Explanation display display No display. When the function check of the blood monitor is completed, the button is flashing. The button has to be pressed to activate priming mode, the button lights up. The light will go off when the priming detector has detected blood.
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Bargraph Information Explanation display display The BPM measures blood pressure and pulse rate. See the BPM chapter for activation and settings. The BVS measures relative blood volume. See the BVS chapter for activation and settings. The Diascan measures clearance, Kt and Kt/V. See the Diascan chapter for activation and settings.
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Alarms Alarm indicators The alarm indicators will light up in certain alarm situations. The Mute button will flash and the buzzer will sound. By pressing a lit alarm indicator it is possible to obtain further information on the information display. Air detector alarm Steady light indicates that air is detected in the venous drip chamber.
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Alarm function of the parameter buttons Certain parameter buttons also serve as alarm indicators for the corresponding parameters. The parameter button/alarm indicator will light up in alarm situations. In addition, the Mute button blinks and the buzzer sounds. Venous pressure alarm Steady light The venous pressure is outside the set limits.
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Time attention alarm Flashing light The treatment time has expired. BPM attention alarm Flashing light. See attention message. Diascan attention alarm Flashing light. See attention message. HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Controlling 3:19 Program version 8.xx...
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Override possibilities It is possible to override (bypass) the alarm actions for low venous pressure, arterial pressure, air detector and blood leak alarms for a limited amount of time . The purpose of the override option is to facilitate the handling of the machine in alarm situations.
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Blood leak alarm override Press the lit Blood leak button for 3 seconds; the blood pump will now run with the set blood flow rate and the venous and arterial clamps will be open. The dialysis fluid will not be bypassed, the UF rate will be set to minimum UF rate.
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Stand-by group The Blood pump button is used to start and stop the blood pump at the selected flow rate. The button can show a constant light, a flashing light or no light at all. Constant light - the blood pump is activated. Flashing light - the blood pump is stopped and the selected blood flow rate is more than 0 ml/min.
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Display and setting group Information display The information display, as the name implies, is used to give the operator further information. In order to obtain information on the display, an appropriate button has to be pressed. The information is then shown for 15 seconds .
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Treatment overview screen When no other screen is displayed on the information display, the Treatment overview screen will be displayed at all times during treatment. On this screen, the operator can obtain an overall picture of parameter values, valid at that time, for the on-going treatment. All parameters are measured values except sodium and bicarbonate concentrations which are set values.
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Parameters shown on Treatment overview screen current blood flow rate current arterial pressure current venous pressure accumulated blood volume bacc current system pressure current ultrafiltration rate accumulated ultrafiltration volume (patient weight loss) accumulated ultrafiltration volume (patient weight loss) as percentage of the set value current transmembrane pressure accumulated infusion volume current infusion rate...
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Function check overview screen The Function check overview screen will be displayed on the information display during the function check of the machine. The screen gives the operator information about how long the function check has been in progress and also what is being tested at that moment. The ticks to the right of each test show that the test has been successfully performed.
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Tests shown on Function check overview screen Fch_BM function check of the blood monitor Fch_FM function check of the fluid monitor, this position is the main test, tests below are more detailed and included in this ↓mS/cm test of the conductivity cell test of the conductivity cell ↑mS/cm test of the temperature sensor...
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The eight commandments 1. When a blue button is lit, it indicates an activated function. 2. When a red button is lit, it indicates an alarm. 3. When a button flashes, it is a request to press it. 4. The information display only shows information on request. 5.
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Setting of parameters All treatment parameters are set in a similar way. To illustrate this, a detailed description follows showing how the values for the Temp (temperature) are changed. Press the Temp button. The information display and its buttons show: Figure 3:13 Temp button and the information display The set value for the temperature can be changed with the Set knob if the...
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Note • The bargraphs displays show the set value, the actual value and the alarm limits for the control system, while the information display shows the corresponding values of the protective system (see chapter 1). In order to verify that the control and protective systems are operating with the correct input values, the user is instructed to compare the readings of the current bargraph displays and the information display before connecting the patient.
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Conductivity in bicarbonate mode The set values for sodium and bicarbonate can be changed with the Set knob. When one or both set values are changed, the alarm limits will automatically follow, at 5% of the resulting set value of the conductivity. Arterial pressure The low and high alarm limits can be changed with the Set knob either together or separately.
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Downloading treatment parameters It is possible to download certain treatment parameters from an external computer system via a patient card or other external equipment. After the ON/OFF button has been pressed and the first part of the function check has been completed (“Fch” shown on the time display), it is possible to download a list of treatment parameters and their values.
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If the list of treatment parameters is rejected, the downloaded settings for concentrates will remain. An attention alarm will appear to remind the operator about this. CONC. SETTINGS NO LONGER DEFAULT Check settings, press LOW To continue, press the lit Arrow button to confirm the downloaded settings. Check if the downloaded concentrate settings are the desired ones, if not, select and connect new concentrates manually, as is the usual procedure.
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The ultrafiltration control During treatment the following equation is always applicable. Ultrafiltration volume UF rate Treatment time Treatment time and UF volume can be set within certain limits. The machine will automatically calculate and show the UF rate. When treatment time or UF volume is changed the UF rate will also change and new TMP alarm limits have to be set.
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Protective system for ultrafiltration Upon demands from the clinic the below described function in the machine can be removed. This preset (i.e. removal of function) is done by a qualified technician in the clinic. The operator is requested to read the corresponding information for the ultrafiltration system in section “Safety philosophy”...
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set by the operator according to the patients needs and tolerance and according to the routines of the clinic. The alarm limits HIGH and LOW will automatically be set by the machine equally around the estimated accumulated UF volume, i.e. if LIMIT is set to 0.4 the deviation between HIGH and LOW will be 0.8.
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Power failure Returning the blood during a power failure If the AK 200 S is not equipped with a battery back-up function, it is possible to manually return the blood to the patient during a power failure. 1. Clamp the arterial blood line and disconnect it from the patient. 2.
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Recovery from a short power failure In case of a power failure, settings and accumulated values are stored by the AK 200 S. The machine will perform a recovery when the power returns; ”rec” is shown on the time display and the buzzer sounds. The operator must check the extracorporeal circuit for possible blood clots and has to confirm continued treatment by pressing the Time button.
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Recirculation during treatment When the blood circuit is recirculated it is the operator’s responsibility to decide for how long a period it can be safely done. The operator should also remember to note the time for the recirculation in order to add it to the non-diffusion time at the end of the treatment. 1.
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4. If required increase the minimum UF rate to the desired set value. 5. If required adjust the UF volume. 6. Press the flashing Start UF Stop button to restart ultrafiltration. Press the flashing Arterial pressure, Venous pressure and TMP buttons to set the alarm limits around current pressures.
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Change of blood pump segment AK 200 S can be used with 3 presettable diameters of blood pump segments. Change of blood pump segment should be done before the patient is connected. CAUTION Make sure a correct blood pump rotor is used. The blood pump rotor has to be properly adjusted in order to correctly occlude the blood pump segment being used.
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BiCart/SelectCart change during treatment If the BiCart and/or the SelectCart cartridge needs to be replaced by new ones during treatment, do as follows: 1. Remove the cartridge that is to be changed and close both the latches of the cartridge holder properly (vertical position) for at least 2 seconds.
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Chapter 4 Hemodialysis, double needle treatment Double needle treatment ........Check before starting the machine .
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Double needle treatment Check before starting the machine • That the mains cable is connected to a mains supply with protective earth. • That the main switch on the rear of the machine is turned on. • That the water supply is turned on. •...
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Function check When the machine starts up it always carries out checks on internal safety and calibrations; the function check. FCH/Fch is shown on the time display. These checks require that the dialysis fluid tubes are connected to the safety couplings during the entire function check. The dialysis fluid tubes can be moved from the safety couplings when the time appears on the time display instead of ”Fch”...
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Select concentrates 2. Check that the correct treatment mode has been selected; the corresponding button for Bicarbonate mode or Acetate mode will be lit. Press the lit button briefly in order to select/check that the proper concentrate has been selected on the information display and is in accordance with the prescribed concentrates that will be connected to the machine during treatment.
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Figure 4:2 Select SelectBag The picture above shows the information display when the lit Arrow button below SelectBag is pressed. SelectBag will flash and the concentrate below will be lit. Turn the Set knob until the desired SelectBag is shown. Press the Arrow button again to confirm the chosen concentrate, both BiCart and SelectBag will be flashing.
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Connect concentrates There are four different alternatives for concentrate combinations described below. Choose the alternative that is to be used. • SelectCart and SelectBag together with BiCart: Follow step 3 and 4 in corresponding instruction. • Acidic concentrate and BiCart: Follow step 3 and 4 in corresponding instruction.
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SelectCart and SelectBag together with BiCart Handling procedure: 3. SelectCart: Open the upper latch of the SelectCart holder, pull out the latch and lift upwards to its uppermost position. Open the lower latch. Place the bottom port of the SelectCart cartridge into the hole of the lower latch.
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4. BiCart: Open the upper latch of the BiCart holder, pull out the latch and lift upwards to its uppermost position. Open the lower latch. Place the bottom port of the BiCart cartridge into the hole of the lower latch. Bring down the upper latch and place the top port of the cartridge into the hole of the upper latch.
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Start the machine - continued 5. Check all set values and alarm limits. Adjust if necessary. Press the respective button and check/adjust the values on the information display by using the Arrow buttons and the Set knob. 6. Turn the BVS off if it is not to be used. Press the BVS button followed by the right Arrow button and turn the Set knob until BVS OFF shown on the information display.
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Attaching the dialyzer and the blood lines When the Priming button is flashing, the dialyzer and the blood lines may be attached, if this has not been done before power on. WARNING The operator must take proper precaution in order to prevent coagulation in the extracorporeal circuit.
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Arterial blood line Follow the instructions for the use of the arterial blood line. Specifically observe the following items. 1. Arterial line clamp - place the patient end of the arterial line in the line clamp colour-coded with the red dot. 2.
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Figure 4:4 Arterial blood line in HD, set-up 7. Heparinization - using the heparin pump. See the following pages for instructions on how to attach the syringe to the heparin pump, and setting the heparin values in the machine. WARNING The operator must take proper precaution in order to prevent coagulation in the extracorporeal circuit.
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Preparations if the heparin pump is to be used If heparinization is desired by using the heparin pump the preparations are made in the two following steps: 1. Attach the syringe to the heparin pump: Prepare a syringe with the desired amount of heparin solution (or other anticoagulantia).
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2. Set the heparin values in the machine: Press the Heparin button briefly. Select the heparin flow rate (ml/h). Check/adjust the STOP TIME in minutes i.e. at which time the heparinization should stop before treatment ends. As soon as the treatment starts (priming detector detects blood) the heparinization starts (the Heparin button: lights up).
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Venous blood line Follow the instructions for the use of the venous blood line. Specifically observe the following items. 1. Venous line clamp - place the patient end of the venous line in the line clamp colour-coded with the blue dot. CAUTION Check carefully that the venous blood line is correctly placed in the priming detector.
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Priming Priming and rinsing the extracorporeal circuit Before priming • Connect the arterial line to the priming fluid. • Check that the venous line is correctly positioned in the priming detector. • Check all connections. • Check that the priming UF rate is correct by pressing the UF rate button, check PRIMING.
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6. When the level in the air detector is correct, the Air detect button will start flashing and an attention regarding the inactivated air detector will appear. The buzzer can be muted but the attention will remain until the air detector is activated (manually when desired/automatically if the PRIMING VOLUME ACHIEVED attention alarm appears or when blood has been detected).
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Initiating Set the treatment parameters CAUTION To avoid hazardous side effects during the treatment, parameters set should be suitable for the patient’s needs and tolerance. The correct setting of the UF rate is important to avoid backfiltration. Set a minimum UF rate according to the instruction for the specific dialyzer.
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Connect the patient Note • A flashing Bicarbonate or Acetate button indicates that Concentrate stand-by mode is active. Resume dialysis fluid preparation (deactivate concentrate stand-by mode) by pressing the flashing button once. The dialysis fluid will be ready within approximately 3 minutes.
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When blood has been detected for 20 seconds the blood path will remain lit until treatment has been discontinued. This is valid even if the venous blood line is removed from the priming detector. Start the treatment CAUTION Make sure that the blood path of the flow diagram lights up, if it does not light up, check that the venous blood line is correctly placed in the priming detector.
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Pressure alarm limits setting The machine is equipped with a centralizing function to simplify the correct setting of the pressure alarm limits. If there is a choice not to use the centralizing function as a preset or wide alarm limits range are preset, it is the operator’s responsibility to check that the alarm limits are set around current pressure.
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Low venous pressure alarm limit setting below +10 mmHg During certain conditions a very low venous pressure can occur e.g. when a central venous catheter is being used. In order to perform a dialysis treatment under this condition it can be necessary to set the low alarm limit below the normal limit of +10 mmHg.
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Discontinuing In order to maintain a high level of performance of the AK 200 S machine, it is recommended that the machine carries out a disinfection program after each treatment. When the treatment is finished certain conditions must have been fulfilled for the machine to be able to start a disinfection program;...
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Discontinuing procedure Note • If the treatment is to be discontinued before the set treatment time is achieved, the remaining time should be changed to 0:00 (press Time button, change by using the Set knob). Note Confirm treatment end When the remaining treatment time shown on the Time display equals 0:00 an attention alarm appears: TREATMENT TIME EXPIRED Press TIME key to confirm...
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6. Start the blood pump, the rinse-back flow rate (blood flow rate) is set to 100 ml/min, adjust if required. CAUTION After having started the blood pump again, the operator is responsible for the monitoring of the venous pressure. CAUTION Note •...
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14. If used, remove the empty BiCart and SelectCart cartridge(s) after draining and close both the latches of the cartridge holder(s) properly (vertical position). (To close the lower latch; pull out and close.) If used, also remove the SelectBag when it is empty (or earlier if desired) by lifting the latch upwards.
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Chapter 5 Hemodialysis, single needle treatment Single needle treatment ........General .
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Single needle treatment General The blood monitor offers a single needle facility using either one or two blood pumps (two blood pumps only possible with BM 202). Single needle treatment with two blood pumps is controlled by the stroke volume which gives an optimized accumulated blood volume for the treatment.
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Glossary of single needle parameters and key terms Single needle, double pump The Arterial phase is when the arterial blood pump is running. The arterial blood pump runs until the system pressure high alarm limit has been reached. The Venous phase is when the venous blood pump is running. The venous blood pump runs until the stroke volume has been achieved.
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Single needle treatment with two blood pumps - BM 202 only Preparations Follow the instructions in chapter 4 "Double needle treatment" beginning with "Check before starting the machine". Continue up to "Arterial blood line" in "Attaching the dialyzer and the blood lines". Arterial blood line Continue to follow the instructions in chapter 4 in "Arterial blood line".
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Venous blood line Continue to follow the instructions in chapter 4 in "Venous blood line". Add the following items below, which refer to single needle/double pump treatments. 1. Venous blood pump - leave the venous blood pump segment outside the pump housing as priming with one blood pump is recommended. See “Priming and rinsing procedure”...
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Priming Priming and rinsing the extracorporeal circuit Before priming • Connect the arterial line to the priming fluid. • Check that the venous line is correctly positioned in the priming detector. • Check all connections. • Check that the priming UF rate is correct by pressing the UF rate button, check PRIMING.
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WARNING Do not use the level adjustment buttons in combination with blood lines incorporating the ”balloon” type transducer protector, as the venous pressure reading might be adversely affected. WARNING 5. Press the flashing Blood pump button. The blood flow rate will automatically start at 100 ml/min.
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11.a. Manually: Turn the blood pump manually to thread the pump segment through it. When the pump segment is in place, close the blood pump cover. 11.b. Automatically: Place the pump segment over the blood pump rotor and close the blood pump cover, the blood pump segment will be threaded as soon as the flashing Blood pump button has been pressed.
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Priming and rinsing procedure in single needle/double pump mode 1. Tilt the double chamber holder backwards until it clicks into position. By doing so the expansion chambers will be filled to a suitable level during priming. 2. Open the cover of the venous blood pump and place the venous pump segment inside the pump housing as in the figure below.
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9. Attach the dialysis fluid tubes to the dialyzer when the time appears on the time display instead of Fch and the bypass path lights up on the flow diagram. Press the flashing Fluid bypass button and the dialysis fluid will enter the dialyzer when the bypass path lights up green on the flow diagram.
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Initiating Set the treatment parameters CAUTION To avoid hazardous side effects during the treatment, parameters set should be suitable for the patient’s needs and tolerance. The correct setting of the UF rate is important to avoid backfiltration. Set a minimum UF rate according to the instruction for the specific dialyzer.
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Connect the patient Note • A flashing Bicarbonate or Acetate button indicates that Concentrate stand-by mode is active. Resume dialysis fluid preparation (deactivate concentrate stand-by mode) by pressing the flashing button once. The dialysis fluid will be ready within approximately 3 minutes.
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When the priming detector detects blood in the venous line, the blood path in the flow diagram will light up red. The Start UF Stop button, the Venous pressure button (if the Venous pressure is below +10 mmHg) and the TMP button starts to flash. If no heparin value has been set, the Heparin button will also flash.
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Note • It is possible to optimize the current mean blood flow rate by adjusting the blood flow rate for the venous pump or the arterial pump separately. This results in more cycles during treatment i.e. increased accumulated blood volume. Note that the arterial pump never runs faster than twice the speed, or more slowly than half the speed, of the venous pump and vice versa.
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Pressure alarm limits setting The machine is equipped with a centralizing function to simplify the correct setting of the TMP alarm limits. If there is a choice not to use the centralizing function as a preset or wide alarm limits range are preset, it is the operator’s responsibility to check that the alarm limits are set around current pressure.
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Low venous pressure alarm limit setting below +10 mmHg During certain conditions a very low venous pressure can occur e.g. when a central venous catheter is being used. In order to perform a dialysis treatment under this condition it can be necessary to set the low alarm limit below the normal limit of +10 mmHg.
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Discontinuing The discontinuing procedure can be performed either in double needle mode or in single needle/double pump mode. (The recommended procedure is in double needle mode as it is easier and less time-consuming.) Discontinuing in double needle mode after single needle/double pump treatment Follow the instructions in chapter 4 "Discontinuing"...
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Single needle treatment with one blood pump Preparations Follow the instructions in chapter 4 "Double needle treatment" beginning with "Check before starting the machine". Add the following below. Attach an expansion chamber, connecting it between the dialyzer and the venous blood line. This is in order to reduce the amount of recirculation in the system (i.e.
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Prime and de-air the blood lines and the dialyzer as described in chapter 4. The venous expansion chamber should be filled to be level with the groove of the chamber. Close the clamp at the top of the expansion chamber. Single needle / single pump settings The arterial and venous phases during a cycle can either be controlled by pressure or time settings.
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Note • Always follow the manufacturer’s recommendations for the minimum rinsing volume (for the blood lines and the dialyzer). Note 6. Press the SN button briefly and select SINGLE PUMP by using the corresponding Arrow button; SINGLE PUMP will be flashing. Activate the function by pressing the SN button for 3 seconds (lights up).
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Start the treatment CAUTION Make sure that the blood path of the flow diagram lights up, if it does not light up, check that the venous blood line is correctly placed in the priming detector. If the blood path does not light up, the machine considers the patient not connected and as a consequence the UF system is not controlling the patient ultrafiltration.
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8. Press the SN data button. Check that the current stroke volume (STROKE) shows a proper value. See "Glossary of single needle parameters and key terms" previously in this chapter for further information. Note • The achieved stroke volume is determined by the size and position of the venous pressure alarm window.
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6. Press the Arterial pressure button to manually set the alarm limits around the current pressure. As the arterial pressure fluctuates during the cycle the alarm window has to be set accordingly. Change the limits on the information display by using the Arrow buttons and the Set knob. 7.
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Double needle to single needle treatment - change during treatment Attach an expansion chamber, connecting it between the dialyzer and the venous blood line. This is in order to reduce the amount of recirculation in the system (i.e. to achieve a greater stroke volume). Follow the instructions below.
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Depending on whether pressure- or time-controlled phases are to be used, continue by following the instructions starting with position 9 for each variant. Only for pressure-controlled phases 9. Press the SN data button briefly and maximize the preset times for the arterial and venous phases to 20 seconds .
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Note • The achieved stroke volume is determined by the size and position of the venous pressure alarm window. The wider the window, the greater the stroke volume. The higher the position of the window, the higher the venous flow. Set the venous pressure alarm limits in such a way that a proper stroke volume is being achieved.
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Continue by following "Pressure alarm limits setting" instructions under "Single needle treatment with two blood pumps", in this chapter, as they are the same for single needle double pump and single needle single pump treatments. Discontinuing Follow the instructions in "Single needle treatment with one blood pump", "Discontinuing"...
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Chapter 6 Isolated UF HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Isolated UF Program version 8.xx...
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Follow the instructions in "Hemodialysis, double needle treatment" up to "Connect the patient" chapter 4, after that see below. Note • Isolated UF can only be run in hemodialysis mode. • Isolated UF can be performed before, in the middle of, or after the "normal"...
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When the time for the ultrafiltration phase is 0.00, an attention alarm appears and the Time button starts to flash. 1. Press the Isol UF button for 3 seconds (the light goes out). 2. Press the Time button and set the time for the diffusion phase. 3.
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Chapter 7 Profiling Profiling of Na and HCO dialysis fluid concentration ... . . Profiling of ultrafiltration rate ........Operation .
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Profiling of Na and HCO dialysis fluid concentration In order to optimize the dialysis treatment, the dialysis fluid concentrations of sodium and bicarbonate can automatically follow a predetermined, continuous curve changing the concentrations in a linear, degressive or progressive graph. A linear graph gives a constant change of concentration.
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Setting individualized non-linear (exponential) profiles requires one figure more: half-time (set in hours and minutes). Half-time determines the time interval to reach halfway between start and stop concentration. The individual curves can easily be drawn into a diagram. To show a degressive graph, draw the start concentration value at time zero and stop concentration value at end of treatment.
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Profiling of ultrafiltration rate The UF rate can follow a predetermined decreasing or increasing linear graph. The UF profile is determined by the total UF volume, time and start UF rate. Figure 7:4 Linear graph for UF rate profiling When UF profiling is used TMP is also acting as protective system. The operator has to readjust the TMP alarm limits during treatment in accordance with the UF rate and the dialyzer UF coefficient.
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Operation Follow the instructions in "Hemodialysis, double needle treatment" up to "Pressure alarm limits setting" chapter 4 and add the following. Curve Setting/Change/Cancellation: The setting is guided by menu technique, stepping back with the Hold button. 1. Press the Profiling button briefly. 2.
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8.c. Press the arrow below the START value and one flashing dot on the bargraph display for conductivity will indicate the start conductivity, if sodium and bicarbonate profiles are to be verified. One flashing dot on the bargraph display for UF-rate will indicate the start value for UF-rate, if UF-profile is to be verified.
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Activation of profiling with already preset models 1. Press the Profiling button briefly. 2. Select the MODEL: 1, 2 or 3. 3. Activate the profiling mode by pressing the Profiling button for 3 seconds. As soon as blood is detected in the venous line the profiling mode starts.
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5. Readjust the TMP alarm limits during treatment in accordance with the UF rate and the dialyzer’s UF coefficient. CAUTION The operator has to make sure that the profile chosen is suitable for the treated patient. The parameters have to be verified prior to the treatment.
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Chapter 8 Hemodiafiltration, low volume General ........... Protective system for low volume HDF .
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General The BM 202 offers the possibility to perform infusion of substitution fluid from external infusion bags using the venous/infusion pump. A special infusion line for low volume HDF is required in addition to normal arterial and venous blood lines. See “List of concentrates, accessories and disposables, for use with the AK 200 S, Gambro Accessories”...
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The following conditions have to be met in order to fulfil the accuracy of the measuring system 1. The correct infusion line has to be used. 2. The placement of the infusion bags has to be correct throughout the treatment. The lowest part of the bags should be placed 0.5-1 meter above the venous infusion pump before priming procedure starts.
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Start up Follow the instructions in chapter 4 “Hemodialysis, double needle” from the beginning to “Priming and rinsing the extracorporeal circuit”. Continue as follows: 1. Place the infusion bags on the infusion pole 0.5-1 meter above the venous/infusion pump. 2. Expansion chamber - place the expansion chamber in the expansion chamber holder.
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Figure 8:1 Infusion line in HDF low volume, set-up HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - HDF, low volume Program version 8.xx...
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Priming and rinsing Follow the instructions in chapter 4 “Priming and rinsing the extracorporeal circuit” Add the following: 1. Activate HDF by pressing the HDF button for 3 seconds (the button will light up). 2. Set the priming volume for the infusion line (PRIMING) to at least 200 ml.
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Initiating and starting Continue to follow the instructions in chapter 4, “ Initiating dialysis” and “Start the treatment” and add the following: 1. Briefly press the HDF button and set the total infusion volume (SET). AK 200 S will now automatically calculate the “total” ultrafiltration volume, i.e.
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Bolus infusion possibility The machine is equipped with a ”bolus infusion” function to simplify extra infusion, e.g. in case of a hypotension episode during treatment. 1. Press the HDF button briefly. 2. Select the extra infusion volume (BOLUS). As soon as the value is selected, the bolus infusion will start and automatically run with a rate of 50 ml/min until the set infusion volume is given.
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Chapter 9 BVS - Blood Volume Sensor General ........... ∆BV text information .
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General CAUTION Medical decisions must not be based only on information from BVS, as there are many other factors that should be taken into account. There is no direct, independent supervision of the BVS. CAUTION The BVS measures changes in the blood volume of the patient continuously during the treatment.
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The BVS is handled through the information display. Press the BVS button and the information display will light up. Data and parameters are entered using the Set knob. The information display is capable to show the following graphs: • relative blood volume (∆BV) from the start of the measurement •...
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Alarm An alarm is issued when the relative blood volume is outside the set alarm limit. The alarm limit is adjustable at any time (default level presettable). The alarm function can be turned on or off (presettable). Figure 9:2 BVS, relative blood volume graph To set an alarm limit, press the left Arrow button and turn the Set knob.
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Graphs It is possible to choose which combination of graphs to be shown on the information display. In addition to the ∆BV graph, which is always shown, the graphs that can be selected are: • UF rate • conductivity in dialysis fluid •...
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BVS ON/OFF Pressing the right Arrow button, allows two options. These are BVS ON and BVS OFF. This can be performed any time during the treatment. By turning the Set knob it is possible to select the functions: • • Note •...
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BVS On The BVS is turned on by turning the Set knob to ON. The effect will depend on in which context this is done and on the previous history during treatment. If the BVS is turned on before the reference value has been acquired, the information display will change from the OFF display above to the following example.
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Note • If the BVS is turned on after the reference value would have been acquired in a normal treatment, the reference value will not be related to the treatment start. Note If the BVS is turned on again in a treatment during which the reference value has been acquired before, the BVS display may look like this: Figure 9:7 BVS, interrupted relative blood volume graph...
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Chapter 10 BPM - Blood Pressure Monitor (option) General ........... 10:2 Patient factors which affect readings .
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General The Blood Pressure Monitor measures blood pressure and pulse rate. It is possible to use the BPM as soon as the machine is started. All measurements which are taken 30 minutes before the priming detector detects blood will be displayed as previously measured values on the information display.
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Patient factors which affect readings Excess patient movement can interfere with readings. Ensure that the patient is not moving during readings, just as one would with manual readings. Avoid applying external pressure to the cuff during readings. Some arrhythmias may cause pressure fluctuations that make obtaining readings more difficult.
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Handling The BPM is handled using the BPM button, the Arrow buttons and the Set knob, see “Operator’s panel” in the “Controlling the machine - general guidelines” chapter. When the BPM button is pressed, once or twice, the BPM screens will be shown on the information display.
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The BPM screens BPM button pressed once When the BPM button is pressed once, the latest measured values for systolic, diastolic, mean blood pressure and pulse rate will be shown as numerical values at the top of the information display. The clock symbol indicates the time for when the measurement check was performed.
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The vertical axis to the left will show mmHg for the blood pressure. The grading will be set to 25 - 250 mmHg, with a marker on every 25 mmHg. The vertical axis to the right will show beats/min for the pulse rate and is marked with this symbol .
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Alarm The BPM alarm function can be set to on or off by pressing the lit Arrow button below ALARM. Choose ON or OFF by using the Set knob. When the alarm function has been set to ON, attention alarms are generated when a value is outside the set alarm limit.
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Mode When the lit Arrow button below MODE is pressed it is possible to choose BPM mode. Set the desired mode by using the Set knob. The possibilities are manual (MANUAL ), automatic (AUTO), continuous (CONT) or off (OFF ). •...
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Start/Stop Press the BPM button once in order to light up the information display. Start To start a measurement check manually press the lit Arrow button below START. When a measurement check is in progress the current pressure in the cuff will be displayed in the bottom left corner of the information display.
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Chapter 11 Diascan General ........... 11:2 Application .
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General Application The Diascan can be used for: • Clearance measurement (K) in order to read off the current dialysis efficiency for the on going treatment. • Dialysis dose measurement (Kt or Kt/V) in order to check that the prescribed dialysis dose is being maintained, which provides quality assurance for the treatments.
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Glossary of Diascan parameters and key terms Parameters: K is clearance. Clearance tells the operator how much blood, in ml/min, is cleaned of urea after it has passed the dialyzer. This value can be compared with the current blood flow rate at that time. Kt is clearance multiplied by elapsed treatment time.
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Precautions before use CAUTION Medical decisions must not be based only on information from the Diascan, as there are many other factors that should be taken into account. CAUTION The Diascan function can be used in HD mode, double needle treatment. It can be used when performing single needle treatment but the accuracy of the machine measurement may be compromised.
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Handling The Diascan is handled using the Kt/V button, the Arrow buttons and the Set knob, see “Operator’s panel” in the “Controlling the machine - general guidelines” chapter. When the Kt/V button is pressed the Diascan screens will be shown on the information display.
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The first screen The Diascan measurement mode is to be set on this screen and, if desired, an alarm limit for clearance. Measurement result values for K, Kt (or Kt/V), Na , Qb and elapsed treatment time are displayed when measurement checks have been performed.
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Measurement result values Figure 11:4 First Diascan screen with measurement result values When a measurement check has been performed, measurement result values are shown as numerical values as well as graphs. • Red graph on the base line of the diagram shows elapsed treatment time (t) in hours.
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The second screen On this screen the distribution volume is to be set if Kt/V measurement is desired. It is also possible to set a target value and an alarm limit for Kt/V. Forecast and measurement result values for accumulated Kt (or Kt/V if distribution volume has been set) will be displayed when measurement checks have been performed.
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Distribution volume calculation using the Watson formula It is possible for the machine to carry out a distribution volume calculation, displayed in litres, using the Watson formula. In order for the machine to provide a value, gender, weight, height and age (if male) of the particular patient must be entered into the machine.
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Forecast The numerical value below FORECAST is a calculation of the Kt or Kt/V value that is estimated to be obtained when the treatment is complete. If a distribution volume (VOLUME) has been set, this Kt/V forecast value will be calculated by the machine and automatically be shown as soon as the first measurement check has been performed.
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Measurement result values when distribution volume has not been set Figure 11:8 Second Diascan screen with measurement result values, distribution volume not set • Red graph on the base line of the diagram shows elapsed treatment time (t) in hours. •...
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Measurement result values when distribution volume has been Figure 11:9 Second Diascan screen with measurement result values, set distribution volume • Red graph on the base line of the diagram shows elapsed treatment time (t) in hours. • White graph in the diagram shows the accumulated Kt/V value that has been achieved since treatment start.
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The third screen The third screen summarises measured and calculated parameters during treatment, shown as numerical values as soon as measurement checks have been performed. It is also possible to set or adjust the distribution volume and consequently the target value and the alarm limit for Kt/V, if this has not been done in the second screen.
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Time to target When a target value for Kt/V (TARGET) has been set in the second screen (or in this screen), the machine will show an estimate of the treatment time needed in order to reach the desired Kt/V target value. Time to target will be calculated by the machine and automatically shown as soon as the first measurement check has been performed indicated by this symbol...
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Alarms Clearance alarm limit The alarm limit for clearance is the lowest acceptable clearance value measured during treatment. When the lit Arrow button below K LIMIT (first screen) is pressed the text will flash. Set a proper alarm limit by using the Set knob. Once the Set knob is turned the starting point value is 50% of the current blood flow rate.
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Step-by-step instructions for measuring clearance and Kt/V Single clearance measurement check Procedure 1. Press the Kt/V button once and the first Diascan screen will be shown. 2. Press the lit Arrow button below Diascan; the text will flash. 3. Turn the Set knob clockwise one step and SINGLE will be shown.
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Result The measurement result values are summarised and displayed as numerical values on the third Diascan screen. Read off the measurement result values there or, if further information is desired, on the corresponding Diascan screen, by pressing the Kt/V button once, twice or three times. Refer to information below “The first screen”, “The second screen”...
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Continuous measuring of clearance Procedure 1. Press the Kt/V button once and the first Diascan screen will be shown. 2. Press the lit Arrow button below Diascan; the text will flash. 3. Turn the Set knob clockwise step by step until desired intervals for the measuring are shown (15, 30 or 60 minutes).
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Result The measurement result values are summarised and displayed as numerical values on the third Diascan screen. Read off the measurement result values there or, if further information is desired, on the corresponding Diascan screen, by pressing the Kt/V button once, twice or three times. Refer to information below “The first screen”, “The second screen”...
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Single Kt/V and clearance measurement check Procedure 1. Press the Kt/V button once and the first Diascan screen will be shown. 2. Press the lit Arrow button below Diascan; the text will flash. 3. Turn the Set knob clockwise one step and SINGLE will be shown.
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Figure 11:14 Diascan, distribution volume set The single Kt/V and clearance measurement check will be performed on an appropriate occasion chosen by the machine. The occasion chosen is dependent on when the self-calibrations of the machine are to be performed. The Kt/V button will light up (steady light) during the period of time when the measurement check is being performed.
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Continuous measuring of Kt/V and clearance Procedure 1. Press the Kt/V button once and the first Diascan screen will be shown. 2. Press the lit Arrow button below Diascan; the text will flash. 3. Turn the Set knob clockwise step by step until desired intervals for the measuring are shown (15, 30 or 60 minutes).
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6. Press the lit Arrow button below VOLUME; the text will flash and --- (zero) will be shown. The distribution volume is now to be set to a correct value for the individual patient, using the Set knob. If desired, it is possible for the machine to carry out a distribution volume calculation using the Watson formula, see "The second screen", "Distribution volume calculation using the Watson formula"...
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Result The measurement result values are summarised and displayed as numerical values on the third Diascan screen. Read off the measurement result values there or, if further information is desired, on the corresponding Diascan screen, by pressing the Kt/V button once, twice or three times. Refer to information below “The first screen”, “The second screen”...
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Chapter 12 Hygiene and maintenance General hygiene and maintenance ....... 12:2 Glossary of disinfection terms .
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General hygiene and maintenance The contents of this chapter concern the hygiene and maintenance of the AK 200 S that should be carried out by the operator of the machine. CAUTION No other maintenance than that mentioned in this chapter shall be performed by the operator/user of the machine.
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Glossary of disinfection terms Disinfection is removal or reduction of bacteria in the fluid path of the dialysis machine. Decalcification is removal of calcium and magnesium carbonate precipitates in the fluid path, originating from the bicarbonate dialysis fluid. Cleaning is removal of fats, proteins and organic material, originating from the patient and located mainly in the fluid path of the machine downstream the dialyzer.
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Disinfection history When the Heat disinf or Chem disinf button is pressed a list of the most recently performed disinfection programs (both heat and chemical disinfection programs) will be displayed on the screen. The last performed disinfection program is shown at the top of the screen. The 50 most recently performed disinfection programs can be displayed, scroll up and down by using the Set knob.
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Schedule for hygiene and maintenance The schedule below is recommended for use by the operator/user of the AK 200 S. This recommendation is to keep a high level of performance of the machine. It is also a guideline for maintaining the hygiene of the fluid path and the outside of the machine to ensure the safety of the patient.
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Any Heat disinfection program can be exchanged to a Heat disinfection program in combination with CleanCart C or liquid citric acid. Heat disinfection can be replaced by Chemical disinfection but note that decalcification with CleanCart C or liquid citric acid has to be performed at least after every third treatment.
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Characteristics of different disinfection, decalcification and cleaning agents The table below summarizes the characteristics of some generic substances used for internal disinfection, decalcification and cleaning of the AK 200 S. For more specific information about a certain commercial product, see manufacturer’s information. Disinfection, decalcification and cleaning Efficiency on inorganic Efficiency on...
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Hygiene - Heat disinfection General - Heat disinfection During the Heat disinfection program (HEAT) the inlet water is heated up and flushed through the fluid monitor. The program begins with a rinse in order to rinse out possible residues from concentrates used in the preceding treatment.
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acid. The program is performed in a similar way as Heat disinfection program with CleanCart. Note • In order to enable the cleaning agents to remove fats, proteins etc. efficiently, cleaning should be carried out after decalcification. Note For further details; see “Data and specifications/Disinfection and Cleaning”.
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Performing Heat disinfection program Note • The Heat disinfection program can be interrupted at any time by pressing the Rinse/Drain button for 3 seconds. The machine will then interrupt the procedure and finish off with a rinse and drain sequence. Note Before starting Heat disinfection program •...
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5. Switch off the machine by pressing the ON/OFF button for 3 seconds. If a new treatment is to be started, press the flashing Rinse/Drain button to start a new function check instead of switching off the machine. Performing Heat disinfection program with CleanCart Note •...
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5. If an automatic switch off is required, press the ON/OFF button for 3 seconds. If preset, the CleanCart cartridge can be left in the holder until next function check is started. 6. When the program is complete and the machine has been drained, the Rinse/Drain button starts to flash.
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6. If an automatic switch off is required, press the ON/OFF button for 3 seconds. 7. When the program is complete and the machine has been drained, the Rinse/Drain button starts to flash. 8. Switch off the machine by pressing the ON/OFF button for 3 seconds. If a new treatment is to be started, press the flashing Rinse/Drain button to start a new function check instead of switching off the machine.
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2. Confirm the choice by pressing the Heat disinf button for 3 seconds (the button lights up). The integrated Heat disinfection program with WRO 300 H will now be performed. For information about the program, see in the introductory part in these instructions. 3.
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Automatic start of Heat disinfection program The machine is equipped with an automatic start function for the Heat disinfection program. Whenever this is activated, and the machine has been turned off, the Heat disinfection program will be started at the programmed time (see below).
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4. Select the ready time (RDY TME) or the OFF function (see above) for that day by using the corresponding Arrow button and the Set knob. Proceed according to the above until a complete weekly program has been set. 5. Activate the function by pressing the Auto Heat button for 3 seconds (the button lights up).
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Hygiene - Chemical disinfection General - Chemical disinfection CAUTION Disinfectants may be toxic. The user must therefore take note of necessary precautions before use. The manufacturer’s instructions and recommendations have to be followed. Local regulations regarding the utilization of the different chemicals must be followed. After Chemical disinfection procedure a test for residues must have been performed prior to connecting a patient.
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Chemical disinfectants Chemical disinfectants may be harmful to the materials used in the fluid path of dialysis machines. Disinfectants may also contain additives that cause foaming or are difficult to rinse out. The disinfectants listed below are examples of chemicals recommended for use in the AK 200 S, i.e. they are compatible with the materials in the machine, provided that they are used in accordance with the recommendations in chapter “Technical data and specifications/Disinfection and Cleaning”.
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Performing Chemical disinfection program Before starting Chemical disinfection program • Check that the dialysis fluid tubes are connected to the safety couplings Procedure 1. Press the Chem disinf button briefly and select the desired program/chemical by using the corresponding Arrow button below the desired alternative on the information display.
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6. Do not switch the machine off until the Rinse/Drain procedure has started i.e. the Rinse/Drain button lights up. (See “Filling the machine with chemical disinfectant” below.) 7. When the program is complete and the machine has been drained, the Rinse/Drain button starts to flash. 8.
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8. Switch off the machine by pressing the ON/OFF button for 3 seconds. 9. If FORMAL program has been performed, the ultrafilter used in UFD kit must be changed prior to the following treatment. Alternatively perform additional rinse/drain procedures according to section “Residual test after Chemical disinfection”...
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Residual test after Chemical disinfection Before connecting a patient a residual test must be done on the prepared dialysis fluid. This is to make sure that the patient will not be exposed to chemical residuals after a chemical disinfection program. The residual concentration in the dialysis fluid must be below levels specified by the clinic or by national standards.
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Central Chemical disinfection The AK 200 S can be programmed to perform Central Chemical disinfection . In this mode, the machine receives disinfection solution through the central water supply system. The Central disinfection program in AK 200 S performs a drain and then a fill with disinfection solution.
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Hygiene - Rinse/Drain Performing Rinse/Drain program Note • The Rinse/Drain program can be interrupted at any time by pressing the Rinse/Drain button for 3 seconds. The machine will then interrupt the procedure and finish off with drain sequence. Note Before starting Rinse/Drain program •...
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5. Switch off the machine by pressing the ON/OFF button for 3 seconds. If a new treatment is to be started, press the flashing Rinse/Drain button to start a new function check instead of switching off the machine. Performing Rinse/Drain program with CleanCart Note •...
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5. If an automatic switch off is required, press the ON/OFF button for 3 seconds. If preset, the CleanCart cartridge can be left in the holder until next function check is started. 6. When the program is complete and the machine has been drained, the Rinse/Drain button starts to flash.
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Automatic start of Rinse/Drain program The machine is equipped with an automatic start function for the Rinse/Drain program. Whenever this is activated, and the machine has been turned off, the Rinse/Drain program will be started at the programmed time (see below). Before automatic start of Rinse/Drain program •...
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4. Select the ready time (RDY TME) or the OFF function (see above) for that day by using the corresponding Arrow button and the Set knob. Proceed according to the above until a complete weekly program has been set. 5. Activate the function by pressing Auto Rinse button for 3 seconds (the button lights up).
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Maintenance - the flow path The flow path The maintenance of the flow path with aspect to cleaning and decalcification is important in order to maintain the specified performance of the machine. Cleaning Fats, proteins and organic material originating from the patient may deposit down stream the dialyzer.
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Ultrafilter; how to change Note • Make sure that the ultrafilter is changed in an aseptic way. Note 1. Release the lower part of the ultrafilter holder by pulling the handle and pressing the latch downwards. 2. Remove the ultrafilter by pulling it gently downwards. 3.
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Ultrafilter replacement reminder By preset, an attention alarm can be generated when it is time for the ultrafilter to be changed. The reminder can appear when a preset number of days have passed or when a preset number of heat disinfection programs have been performed (or a combination of both) since the last change of ultrafilter.
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Maintenance - the exterior of the machine The outside Wipe the outside of the machine with a cloth moistened with ethanol (70%) or isopropanol (60%) in order to clean and disinfect it. Note • Do not use tenside-containing or iodine-based disinfectants. These solutions may crack or discolour most polymers.
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BPM cuff The instructions below concerns only the standard cuffs; No. 1 to No. 4. Use a damp cloth with 70% ethyl alcohol or 30 to 50% isopropyl alcohol for cleaning the surface of the cuff. Never put any solutions inside the cuff.
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Chapter 13 Technical data and specifications Performance and specification - Control System ....13:2 Blood Flow Control ........13:2 Air Detection .
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Performance and specification - Control System Note • When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the widest range is valid. • For the qualified technician the AK 200 S Service Manual is available. The Service Manual provides all the necessary information for the safe and required maintenance of the machine.
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Air Detection Sensitivity Bubbles larger than 1 µl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector. Venous drip chamber size 22 mm (diameter) Heparin Administration Heparinization 0/0.5 to 10 ml/h (±1 ml or 0.2 ml * heparinization time (h) or ±5%)
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Dialysis fluid preparation Temperature Dialysis Fluid Temperature 30-39 °C (+0,5/-1,5 °C) (+0,5/-2,0 °C) with UFD-kit at fluid flow < 500 ml/min. Accuracy is valid only if dialysis fluid temperature is greater or equal to ambient temperature. Temperature low alarm, can 28 to 40 °C (35°) be preset (Default) Temperature high alarm, can...
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Degassing Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-630 Acetate mode, can be preset mmHg) Minimum 75 mmHg absolute (Default) pressure Degassing pressure in -700 to -500 mmHg (±30 mmHg) (-580 Bicarbonate mode, can be mmHg) Minimum 75 mmHg absolute preset (Default) pressure Dialysis fluid preparation (BiCart Select mode only)
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Diascan Accuracy is valid in HD double needle and on-line HDF postdilution, for blood flows 200 to 500 ml/min and fluid flows 500 to 700 ml/min, UF profiling is allowed. Clearance, K 0 to 350 ml/min (±10%) Cumulated water volume 0 to 100 l (±10%) cleared of urea, Kt 0 to 3 (±10%)
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Heat disinfection Program with liquid citric acid Temperature 93 °C Concentration 20 % citric acid Concentration in machine 2 % citric acid; i.e. diluted 1 + 9 Consumption Approx. 200 ml (Approx. 230 ml with UFD-kit, (optional)) Fill up and mixing phase 15 minutes (18 minutes with UFD-kit, (optional)) Circulation phase...
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Low concentration Peracetic Acid Program Concentration of disinfec- 0.35 % peracetic acid tant (0.35 % peracetic acid with UFD-kit, (optional)) Concentration in machine 0.01 % ; i.e. diluted 1 + 34 (0.01 % ; i.e. diluted 1 + 34 with UFD-kit, (optional)) Consumption approx.
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Central Disinfection Program Concentration of disinfec- 0.1% peracetic acid or 0.5% available tant chlorine Concentration in machine Not diluted Consumption Approx. 3100 ml (Approx. 3600 ml with UFD-kit, (optional)) Dwell time Must be preset, maximum 20 min. for hypochlorite Total time 35 minutes (dwell time not included) (66 minutes (dwell time not included) with UFD-kit, (optional))
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Drain Maximum 5 m Drain (length of tube) Drain capacity Minimum 1.0 l/min Drain outlet Maximum 1.2 m above floor If the optional air-gap on the machine is used the distance between the air-gap and the drain must not be less than 0.3 m. For an electrically adjustable stand in its lowest position this means that the drain must not be higher than 580 mm.
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External serial interface: External connector P 63 : 8 pin REDEL contact, black. RS-232 or RS-422 compatible connection. Opto insulated fulfilling IEC 60601-1-1. Attached cable length 2.5 m unshielded. External equipment: Serial port for connection to PC used for logging and preset. RS-232 Max input voltage: ±...
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Battery Back-up Battery back-up of power 24 volt, 6.5 Ah supply Running time >15 minutes Fuse T 15 A HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Technical data and specifications 13:12 Program version 8.xx...
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Performance and specification - Supervisory system Note • When accuracy ranges are written as e.g. “(±1 ml/min or ±1%)” the widest range is valid. Note Blood Pressure Supervision The alarm limits below can be preset. The value put in brackets and in italics is the default value.
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Air Detection Sensitivity Bubbles larger than 1 µl will be trapped by the drip chamber. An alarm will be issued if the blood level falls below the middle of the air detector. Venous drip chamber size 22 mm (diameter) Heparin Administration Heparinization volume ±0.3 ml of set value (±1 ml or 0.2 ml * alarm limit...
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Ultrafiltration Dialysis fluid flow operating 300 - 700 ml/min range UF rate supervision -4.0 to +4.0 l/h (±2 ml/min) Accuracy ±5 ml/min verified at start-up. UF rate supervision, max ±1-10 ml/min, (±5 ml/min) allowed difference between control and protective system, can be preset (Default) Accumulated UF volume ±0.10 - 2.0 l (±0.80 l) or ±0.10 l/h * passed...
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Physical data Depth Approx. 610 mm Width Approx. 570 mm Total Height Adjustable heights 1175-1340 mm Five position stand 1152 - 1382 mm Floor Area 573 x 753 mm Weight Blood Monitor Approx. 17 kg Weight Fluid Monitor Approx. 40 kg Weight Stand Approx.
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Environmental data Operation If condensation occur when moving the equipment between locations with different temperatures and high relative humidity (e.g. outdoor and indoor locations), the inside of the equipment shall be allowed to dry before switching on the equipment. Ambient Temperature range +18 to +35 °C 15 to 85% RH Relative Humidity range Air Pressure range (atm.
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Immunity test IEC 60601 Compliance level Electromagnetic enviroment-guidance test level Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic discharge (ESD), ±8 kV Air ±8 kV Air tile. If floors are covered with synthetic IEC 61000-4-2 material, the relative humidity should be at least 30 %.
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Portable and mobile RF communications equipment should be used no closer to any part of the AK 200 S, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 Vrms IEC 61000-4-6...
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Recommended separation distances between portable and mobile RF communications equipment and the AK 200 S The AK 200 S is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AK 200 S can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AK 200 S as recommended below, according to the maximum output power of the communications equipment.
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Standards The machine complies with the following standards: IEC 60601-1 General requirements for safety, Class I, type B IEC 60601-2-16 Particular requirements for safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC 60601-2-30 Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment IEC 60601-1-2 Electromagnetic compatibility EN 1060-1 Non-invasive sphygmomanometers Part 1: General requirements...
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Chapter 14 Alarm list, Attention alarm list and Technical alarm list Alarm list ..........14:2 Attention alarm list .
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Alarm list Light: Steady Mute time: 2 min Additional information: Low limit: blood pump stopped, venous clamp closed (only when blood is detected). High limit: blood pump stopped, in SN mode arterial clamp closed. Buzzer only when blood is detected. If necessary, it is possible to override the alarm actions, see "Override possibilities"...
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Light: Steady Mute time: 2 min Additional information: Temperature alarm. Dialysis Fluid bypassed. Buzzer only when blood is detected Possible cause: Low alarm: The machine has not yet stabilized the temperature after an interruption of the water supply. No power supply to the heating elements.
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Light: Steady Mute time: 2 min Additional information: Blood pump stopped, venous clamp closed. Buzzer only when blood is detected. If necessary, it is possible to override the alarm actions, see "Override possibilities" in chapter 3 of this manual. Possible cause: Low alarm: The arterial blood line is kinked or clotted between the arterial access and the arterial pressure measurement.
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Light: Steady Mute time: 1 min Additional information: Buzzer only when blood is detected Possible cause: The TMP during treatment depends mainly on five parameters: - UF-coefficient of the dialyzer - treatment time - UF-volume - blood flow - if HDF, infusion volume Changes in TMP during treatment depends on several different things: - changed UF value - changed treatment time...
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Light: Flashing Mute time: 2 min Additional information: Alarm limits are too wide. After 2.5 min an attention also appears. Will only appear when blood is detected. Possible cause: The alarm limits have been widened due to - a started or stopped blood pump - changed treatment time - changed UF volume - started or stopped ultrafiltration...
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Light: Steady Mute time: 2 min Additional information: The ∆BV is below the set alarm limit. Possible cause: The ultrafiltration rate or the accumulated ultrafiltration volume, tolerated by the patient, has been exceeded. Light: Steady Mute time: 2 min Additional information: Dialysis fluid flow bypassed.
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Light: Flashing Mute time: 2 min Additional information: A blood leak has been detected. The fault has been rectified, but the Blood leak button must be pressed in order to reset the alarm and to continue the treatment. Possible cause: Light: Steady Mute time:...
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Attention alarm list The attentions are described in alphabetical order. A-PICK UP TUBE IMPROPER POSITION Mute time: 2 min Additional information: Buzzer is delayed 2 min. Check pick-up tube and mode. ABSENT HEATER SUPPLY VOLTAGE Check fuses and connector Mute time: 2 min Additional information: Will only appear during disinfection...
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ARTERIAL PRESSURE LIMITS ADJUST Press ARTERIAL key Mute time: 2 min Additional information: Alarm limits are too wide: will only appear when blood is detected. ARTERIAL PUMP COVER NOT CLOSED Close cover Mute time: 2 min Additional information: Blood pump stopped. Venous clamp closed.
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B/ACETATE - PICK UP TUBE IMPROPER POSITION Mute time: 2 min Additional information: Buzzer is delayed 2 min. Check pick-up tube and mode BATTERY FAILURE Press LOW to confirm further use Mute time: Infinite Additional information: A reminder to change or recharge the battery. Must be confirmed in order to disappear.
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BLOOD PUMP(S) STOP TIME EXPIRED Press BLOODPUMP key Mute time: 2 min Additional information: Appears after 1 min: will only appear when blood is detected BPM FAILURE Turn off BPM Mute time: Infinite Additional information: An error is detected by the BPM. Turn the BPM off and then on again. BPM PRESS.
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BVS FAILURE Switch off BVS Mute time: 2 min Additional information: An error has been detected by the BVS. Turn the BVS off to continue the treatment. The cause of the attention alarm can either be that the patient’s Hemoglobin value is outside the specified range for the BVS to be active or a technical BVS error.
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BiCart HOLDER NOT CLOSED Close or check BiCart holder Mute time: 2 min Additional information: Buzzer is delayed 2 min. BiCart NOT ATTACHED TO HOLDER Attach or check BiCart Mute time: Infinite Additional information: Buzzer is delayed 2 min. Check if BiCart cartridge is empty. Check that the BiCart cartridge is properly primed by the machine, if not, remove the cartridge, close the latches and attach the cartridge again.
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CENTRAL CHEM DISINF. COMPLETED Press Rinse/Drain key Mute time: Infinite Additional information: Will appear when the preset dwell time in central disinfection has passed. CHANGE OF TREATMENT MODE FAILED Check settings, press LOW Mute time: Infinite Additional information: Appears when the machine was not able to automatically set treatment mode after acceptance of downloaded treatment parameters.
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CLEARANCE TOO LOW Mute time: Infinite Additional information: The measured clearance value is below the alarm limit set. Check cause, adjust treatment parameters to increase clearance or adjust alarm limit for clearance. The alarm limit for clearance is changed by pressing the Kt/V button once (to reach the first Diascan screen).
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CleanCart NOT ATTACHED TO HOLDER Attach or check CleanCart Mute time: 2 min Additional information: DECALCIFICATION REQUIRED XX hours since last decalc Mute time: Infinite Additional information: Buzzer is delayed 2 min. Will disappear as soon as priming is activated. The period of time between the last performed decalcification and the appearance of the attention alarm can be preset.
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DISCONNECT SYSTEM PRESSURE ress SN DATA key to confirm Mute time: 2 min Additional information: Further function check stopped. May appear during function check when blood lines are attached. DISCONNECT VENOUS PRESSURE Press VENOUS key to confirm Mute time: 2 min Additional information: Further function check stopped.
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Diascan FAILURE Turn OFF Diascan Mute time: Infinite Additional information: During function check: Appears when there is a technical error of the Diascan function; it is not possible to use the Diascan. Turn the Diascan off by pressing the Kt/V button once (to reach the first Diascan screen). Then press the lit Arrow button below Diascan and turn the Set knob anticlockwise until OFF appears.
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Diascan MEASUREMENT FAILED Press Kt/V to confirm Mute time: Infinite Additional information: The machine was not able to perform the measurement check. Confirm by pressing the flashing Kt/V button. If desired, reactivate the measurement check. Diascan NOT ACTIVE No measurement possible. Confirm Mute time: Infinite Additional information:...
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EMPTY AND REMOVE CleanCart Close holder Mute time: 2 min Additional information: Open the upper latch of the holder and wait until the CleanCart has been emptied. Remove the CleanCart and close the holder. This attention can be removed by preset. EXTRA PRIMING VOLUME ACHIEVED Check line in priming detector Mute time:...
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FLUID PATH OBSTRUCTION Check drain tube Mute time: 2 min Additional information: A "blockage" has been detected. Check drain tubing. FLUID PATH OBSTRUCTION Check tubes and dialyzer paths Mute time: 2 min Additional information: A "blockage" has been detected. Check if particle filter after dialyzer is "clogged" by pressing Fluid bypass button - if attention disappears, the cause is probably the particle filter.
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FUNCTIONAL CHECK STOPPED Remove line from primingdetector Mute time: 2 min Additional information: The priming detector detects blood during blood monitor function check. Remove blood filled line from priming detector. If priming detector is malfunctioning, call for technical service. HDF KEY ERROR Press technical alarm key Mute time: 2 min...
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HIGH INLET WATER COND x.xmS/cm Press LOW to confirm low K+ Mute time: 2 min Additional information: Appears during function check if the inlet water conductivity is between 0.5 and 2.5 mS/cm. When this attention alarm appears, the operator must consult the attending physician before the attention alarm is confirmed and a treatment is started.
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INCORRECT ACETATE CONCENTRATE Check concentrate fluid Mute time: 2 min Additional information: Dialysis fluid flow bypassed INCORRECT ACIDIC CONCENTRATE Check concentrate fluid Mute time: 2 min Additional information: Dialysis fluid flow bypassed INCORRECT AUTO DISINFECTION TIME Check ready time parameters Mute time: 2 min Additional information:...
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INCORRECT CLEANING AGENT Check cause, press HEAT key Mute time: 2 min Additional information: An insufficient citric acid amount or incorrect selection of cleaning agent has been detected, check cause and press HEAT key shortly to repeat fill phase. If the RINSE key is pressed for 3 seconds, a post chemical rinse will start. INCORRECT CLEANING AGENT Check cause, press RINSE key Mute time:...
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INCORRECT DISINFECTANT Check cause, press RINSE key Mute time: 2 min Additional information: A too high disinfectant concentration has been detected, check cause and press RINSE key shortly to repeat fill phase. If the RINSE key is pressed for 3 seconds, a post chemical rinse will start. INCORRECT MAIN FLOW Mute time: 2 min...
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INCORRECT UF PARAMETER(S) Check parameter settings Mute time: Infinite Additional information: Buzzer is delayed 2 min. Max positive/negative pressure limit has been reached a) Increase UF-rate by adjusting time or UF volume (negative TMP) b) Decrease UF-rate by adjusting time or UF volume (positive TMP) INFUSION PUMP FAILURE Deactivate HDF to continue Mute time:...
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INFUSION RATE LESS THAN XX.X L/H Adjust SET value Mute time: 2 min Additional information: 0.3 l/h is the min "total UF-rate". When infusion volume + UF volume = less than 0.3 l/h, this attention appears. INFUSION RATE MORE THAN XX.X L/H Adjust SET value Mute time: 2 min...
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INFUSION VOLUME DEVIATION Check cause, press HDF key Mute time: 2 min Additional information: HDF procedure stops. Protective system has detected that the accumulated infusion volume during treatment measured up to this point is incorrect. This means that the patient weight loss during treatment is incorrect. The infusion pump and ultrafiltration are stopped.
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INSUFFICIENT WATER SUPPLY Check water supply Mute time: 2 min Additional information: Buzzer is delayed 2 min. The blood flow rate is decreased. It is however possible to increase the blood flow during the alarm state. Check water supply. ISOLATED UF PHASE COMPLETED Press ISOL UF key to complete Mute time: Infinite...
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LIMITED INPUT PUMP CAPACITY Adjust UF/TMP parameters Mute time: 2 min Additional information: AK 200 S cannot produce the min or max dialysis fluid pressure that is required a) Check for possible obstructed drain tube b) Check UF volume and UF rate c) If the attention remains, call for technical service.
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LOW FLOW HEAT ABORTED Press lit arrow to confirm Mute time: Infinite Additional information: This attention alarm appears when performing integrated Heat disinfection program with WRO 300 H. The Low Flow Heat phase (where the machine receives hot water from the WRO 300 H) will not start.
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MEAN BLOOD FLOW TOO LOW Check settings Mute time: 2 min Additional information: Measured blood flow is less than 70% of set blood flow. MINOR AIRLEAKAGE Check fluid connectors and tubes Mute time: Infinite Additional information: Buzzer is delayed 2 min. NEGATIVE UF RATE Check and press UF volume Mute time:...
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NO BACK-FILTRATION WARNING Press TMP to confirm Mute time: 2 min Additional information: The TMP low alarm limit is set below zero mmHg and no backfiltration warning will occur. This attention needs confirmation. This attention alarm can be activated by preset. NO BPM VALUES Check BPM cuff Mute time:...
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NO CUVETTE IN BVS Insert cuvette or switch off BVS Mute time: 2 min Additional information: Buzzer delayed 2 min. The cuvette of the blood line is not inserted in the holder or a blood line without a cuvette is used. In the later case turn the BVS off.
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PULSE RATE OUTSIDE ALARM LIMITS Check patient and press BPM key Mute time: Infinite Additional information: Pulse rate measurement value is outside the set alarm limits. Check patient. Confirm by pressing the flashing BPM button. The BPM screen will then be shown and the measured numerical value outside the set alarm limits will be flashing.
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STROKE VOLUME NOT ACHIEVED Check cause, press SN DATA key Mute time: 2 min Additional information: a) Check/adjust level in expansion chambers b) Check/adjust system pressure window c) Decrease stroke volume d) Check/adjust blood pump segment setting SelectBag FLOW NOT CALIBRATED Change concentrate alternative Mute time: 2 min...
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SelectCart NOT ATTACHED Attach or check SelectCart Mute time: Infinite Additional information: Buzzer is delayed 2 min. TMP LIMITS ADJUST Press TMP key Mute time: 2 min Additional information: Alarm limits are too wide: will only appear when blood is detected TOTAL UF-RATE TOO HIGH Adjust blood flow/infusion volume Mute time:...
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TREATMENT TIME EXPIRED Press TIME key to confirm Mute time: 2 min Additional information: When the flashing Time button is pressed, end of treatment will be confirmed and the TMP alarm limits will widen. UF RATE HIGHER THAN EXPECTED Adjust UF parameters Mute time: 2 min Additional information:...
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UF VOLUME DEVIATION Check cause, press UF volume Mute time: 2 min Additional information: The protective system accumulated measured UF volume (SUPERV) is outside LOW or HIGH limit. The ultrafiltration is stopped and the blood flow is decreased. It is however possible to increase the blood flow during the alarm state.
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UF VOLUME HIGHER THAN EXPECTED Adjust time or UF volume Mute time: Infinite Additional information: Max positive dialysis fluid pressure is reached (negative TMP). a) Partly clotted dialyzer? b) Partly kinked venous blood line? c) Technical problem? Correct the cause. d) Check UF volume and UF rate CAUTION Incorrect weight loss may occur if confirmation is done without...
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UNSTABLE CONDUCTIVITY Check SelectCart, press HIGH Mute time: 2 min Additional information: Appears in function check. It was not possible to complete conductivity test. The function check has been stopped. Check that the SelectCart cartridge is properly attached to SelectCart holder.
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WRO COMMUNICATION FAILURE Check WRO Mute time: Infinite Additional information: The communication between the AK 200 S and the WRO has stopped. Call for an authorized technician. WRO NOT READY Please wait Mute time: Infinite Additional information: Appears during function check, please wait. WRO inaccessible, check information on WRO.
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Technical alarm list ERROR! CALL SERVICE Additional information: Call service to investigate cause of alarm and the possibility of continuing treatment. In case of a technical error in the fluid monitor during treatment the blood flow will be decreased. It is however possible to increase the blood flow during the alarm state.
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TECHNICAL ERROR HEPARIN PUMP Heparin pump not in use Additional information: The technical symbol will remain lit during the treatment. When pressed, this information will be displayed. TECHNICAL ERROR HEPARIN PUMP Zero set value to continue Additional information: The heparin pump is broken. The treatment can be completed if the heparin set value is adjusted to 0.0.
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Chapter 15 Major changes in operator’s manual HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Major changes 15:1 Program version 8.xx...
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Major changes between program version 7.xx and 8.xx Chapter 1 A new section has been included; "How to use this manual". This is a brief explanation of how the chapters in the manual are structured and how they are intended to be used. A new manual symbol is also introduced in this section, in "Definitions of expressions used in this manual".
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Chapter 5 The chapter has been rewritten based on, and with referrals to, chapter 4. A glossary of single needle parameters and key terms has been added, as well as instructions on how to perform single needle/single pump treatment with pressure-controlled arterial and venous phases. Chapter 11 There is information included about the possibility for the machine to carry out a distribution volume calculation, displayed in litres, using the...
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This page is intentionally left blank HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Major changes 15:4 Program version 8.xx...
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Chapter 16 Index HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Index 16:1 Program version 8.xx...
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attaching ....4:11 list of blood lines ... . 1:14 Acetate button ....3:5 venous blood line .
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acetate concentrate ... 4:8 Function check ....4:3 acidic and liquid bicarbonate overview screen ... . 3:26 concentrate .
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System pressure transducer connector ....2:3, 5:5 Rear of the machine System pressure transducer protector 8:4 options included ... . . 2:8 without options .
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~ CANDELA CORPORATION PROPRIETARY ~ MiniGL FIRMWARE REQUIREMENT SPECIFICATION May 29, 2003 CANDELA CORPORATION 530 BOSTON POST ROAD WAYLAND, MASSACHUSETTS 01778-1883 1010-06-3020 Revision B2 Page 1 of 14...
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5.2.2 Displayed Control Variables ...........................11 DCD CONTROL (OPTIONAL)............................12 5.3.1 No DCD Connected (no treatment area cooling) ....................12 5.3.2 Internal DCD (Candela 1000g Canister) Connected ....................12 5.3.3 External DCD (External Large Cylinder) Connected....................12 5.3.4 Third Party Vendor Cooling............................12 DI TEMPERATURE CONTROL..........................13 SYSTEM SAFETY MONITOR COMPONENTS ......................13...
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Expected Head Energy I/O: Input/Output REFERENCES The following reference documents were used in the development of this requirement: • 8502-30-0010 CANDELA Firmware Standard Operating Procedure (FSOP) • 9914-90-0880 Mini-GL Engineering Design Specification • 9914-92-0880 Mini-GL System Requirement Specification • 9914-84-0880 Mini-GL Functional Block Diagram...
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• The system µP will operate at 8-MHz. • The firmware program will be programmed at CANDELA onto a 512K EPROM or FLASH memory device. Note that the board only supports the upper 256 Kbytes of program memory (ROM). •...
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~ CANDELA CORPORATION PROPRIETARY ~ • Battery backed system parameters and calibration data used by the firmware shall be stored in the non-volatile sector of RAM and will be checked at each power-up. • A hardware interlock prevents laser operation if the remote CDRH interlock is not inserted.
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~ CANDELA CORPORATION PROPRIETARY ~ Mini-GL State Diagram INITIAL System Initialized Checksum OK ROM CheckSum Failure Warmup WARMUP Timeout Non-Recoverable Fault System Requires FAULT Service Warm-up Fault Cleared Required CALIBRATION ACTIVATE Pulse Cal Complete Completed Warm-up Complete Calibration Required Calibration Not Required &...
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8) Keep UI parameters (Fluence, DCD…) same as previous power-up. If outside range, set to nominal parameters. – No messages are displayed that these changed. 9) Display the Candela Logo along with the firmware P/N and revision. 5.1.2 STANDBY STATE The firmware shall perform as follows when entering the STANDBY state: 1) Set the laser to the STANDBY state.
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~ CANDELA CORPORATION PROPRIETARY ~ 3) Set aiming beam ON. The user can set the aiming beam intensity to 3 different settings. The beam must always be visible while in Ready to meet “remote Ready Indicator” safety condition. 4) Prevent entry if the trigger switch is pressed, and display a warning message until trigger switch is released.
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~ CANDELA CORPORATION PROPRIETARY ~ 6) When a fault condition is cleared the system will enter the STANDBY state. 7) If the system is in maintenance mode, faults will be not be serviced, and the system will continue running. 1010-06-3020 Revision B2...
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~ CANDELA CORPORATION PROPRIETARY ~ USER INTERFACE 5.2.1 OPERATOR CONTROLS The firmware shall acquire operator input by monitoring the control panel touch screen. 1010-06-3020 Revision B2 Page 10 of 14...
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~ CANDELA CORPORATION PROPRIETARY ~ 5.2.1.1 Control Buttons The following display buttons are in the “Control” section (upper and lower portion) of the UI. 1) Standby - Places the system in STANDBY state. 2) Ready - Places the system in READY state.
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7) Allow use of either DCD (no spray of course) or non-DCD delivery systems. 5.3.2 INTERNAL DCD (CANDELA 1000G CANISTER) CONNECTED 1) HP and Canister Bubble detectors are tested for proper operation on entry into Ready. 2) DCD unit is detected when changed by a dedicated control signal.
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~ CANDELA CORPORATION PROPRIETARY ~ This option allows other cooling devices to be used. There is no synchronization provided. The Laser firmware operates as if there is no DCD connected. DI TEMPERATURE CONTROL To control the DI temperature, the firmware will: 1) Maintain DI temperature to +-2degC.
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HP Bubble Circuit Test didn’t detect a change in the signal (with DCD-enabled HP). 1 - BUBBLE DETECT (Internal [Candela] or External Cylinder DCD system must be installed) CIRCUIT FAULT Canister Bubble Circuit Test didn’t detect a change in the signal (with DCD-enabled HP).
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Candela Corporation MGentleLASE Installation Procedure MGentleLASE Installation Procedure 8503-01-0821, Revision A Candela Corporation Proprietary Page 1 of 8...
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4. Move the laser to the room that has been prepared for its use. Make sure the required space and electrical requirements are met. To prevent the laser system from moving inadvertently, lock each front wheel. 8503-01-0821, Revision A Candela Corporation Proprietary Page 3 of 8...
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5. The fluid lines within the laser must now be filled with water. To do this, turn the system on for 2 minutes. Then repeat steps 1-3 until the water level inside the reservoir remains at within ½ to 1 inch of top of reservoir. Page 4 of 8 Candela Corporation Proprietary 8503-01-0821, Revision A...
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The sound of the escaping gas may be quite loud. Only after the canister is fully seated will the gas stop venting out. 3. Place the cylindrical canister cap over the cryogen canister. 8503-01-0821, Revision A Candela Corporation Proprietary Page 5 of 8...
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4. Connect the cryogen output connector to the cryogen output receptacle on the front of the laser system as follows: Using both hands, push the knurled connector on the front of the laser system away from you while gently pushing the Page 6 of 8 Candela Corporation Proprietary 8503-01-0821, Revision A...
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Refer to figure 1 for foot/fingerswitch connection locations. 1. Remove the footswitch from its package. 2. Attach the tubing end to the bulkhead connector on the rear panel of the laser. 8503-01-0821, Revision A Candela Corporation Proprietary Page 7 of 8...
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Furthermore, if the system is allowed to get out of control when being moved, personal injury or physical damage could result. If it becomes necessary to relocate the GentleLASE PLUS, call Candela or the distributor for details. Failure to do so may result in damage to the system, and may void any warranty.
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TECHNICIANS HAVE RECEIVED APPROPRIATE TRAINING ON THE GENTLELASE LASER SYSTEM FROM CANDELA, AND WHO ARE FAMILIAR WITH THE SAFETY CONSIDERATIONS DISCUSSED IN THIS SECTION. USE OF CONTROLS OR ADJUSTMENTS OR PERFORMANCE OF PROCEDURES OTHER THAN THOSE SPECIFIED HEREIN MAY RESULT IN HAZARDOUS RADIATION EXPOSURE.
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Replace the window on the distal end of the Slider or Fiber. This allows for a more accurate calibration and improved performance of the laser. Complete the checklist below. Perform the tests on the “After” test data sheet. Page 4 of 6 Candela Corporation Proprietary 8503-01-0822, Revision A...
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Complete _________ 10. Verify the DCD Bubble circuit calibration. Complete _________ 11. Calibrate all spot sizes of both fibers. Complete _________ 12. Record the "After" test data sheet. Complete _________ 8503-01-0822, Revision A Candela Corporation Proprietary Page 5 of 6...
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Candela Corporation GentleLASE Flashlamp Replacement Procedure FLASHLAMP REPLACEMENT NOTE: Exercise extreme care. Cleanliness of optics is essential. Refer to Service Procedure 8503-01-0060 for optic cleanliness. For GL systems refer to drawings 7121-99-6700 and 7121-99-6780 for specific details. For GL Plus, GL 18mm and GL LE systems refer to drawings 7121-99-6700 and 7121-99-9390 for specific details.
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GentleLASE Flashlamp Replacement Procedure Candela Corporation Perform an alignment verification; for GL systems refer to Service Procedure 8503- 01-0610; for GL PLUS, GL 18mm and GL LE refer to Service Procedure 8503-01- 0690; for MGL refer to Service Procedures 8503-01-0825 and 8503-01-0826.
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Candela Corporation GentleLASE Flashlamp Replacement Procedure 8503-01-0560, Revision C PROPRIETARY Page 5 of 5...
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Candela Corporation GentleLASE Handpiece Lens Replacement Procedure HANDPIECE LENS REPLACEMENT NOTE: Exercise extreme care. Cleanliness of optics is essential. Refer to Service Procedure 8503-01-0060 for optic cleanliness. Refer to drawing 7121-99- 6980, 7121-99-7240, 7121-00-3350, or 7121-00-3351 for specific details. Remove Fiber assembly from Delivery System and laser. Place on an open flat surface.
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GentleLASE Handpiece Lens Replacement Procedure Candela Corporation second lens past the second o-ring. Remove the cap to verify that the lens does not come out, indicating proper lens seating. When shaken, a lens cap with properly seated lenses will not rattle.
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Secure the probe in position and connect its ground lead to chassis. On the HV CTRL screen, verify that the Charge Enabled button is highlighted. Highlighted is the enabled condition. Adjust the high voltage setting for Voltage = 2000V. 8503-01-0824, Revision A Candela Corporation Proprietary Page 3 of 5...
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Use the discharge stick to completely discharge the three PFN capacitors. Go to STANDBY. Remove all probes from the high voltage section and replace the plastic shield. Go to Standby state. Turn the laser off. Replace the laser box cover. Page 4 of 5 Candela Corporation Proprietary 8503-01-0824, Revision A...
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Candela Corporation MGentleLASE HVPS Calibration Procedure 8503-01-0824, Revision A Candela Corporation Proprietary Page 5 of 5...
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Candela Corporation MGentleLASE Head Detector Calibration Procedure MGentleLASE Head Detector Calibration Procedure 8503-01-0825, Revision A Candela Corporation Proprietary Page 1 of 4...
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MGentleLASE Head Detector Calibration Procedure Candela Corporation Page 2 of 4 Candela Corporation Proprietary 8503-01-0825 Revision A...
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Adjust the voltage until the OPHIR reads 38 – 42 Joules. Adjust the head detector high POT on the CPU I/O PCB, R35, until the head energy displayed on the laser display (MM Mode) equals the OPHIR energy within 0.5 J. 8503-01-0825, Revision A Candela Corporation Proprietary Page 3 of 4...
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13. Replace the fiber receptacle. 14. Replace the shutter and mount. 15. Replace the laser rail dust box. 16. Replace Delivery System. 17. Remove the energy meter and the Energy Meter Calibration Kit. Page 4 of 4 Candela Corporation Proprietary 8503-01-0825 Revision A...
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2.5 mm from the cross hair, then the difference is 0.5 mm and the beam is off center vertically by half this, or 0.25 mm. Vertical de-centering = ___________ mm (≤ 0.5 mm) Horizontal de-centering = _________mm (≤ 0.5 mm) 8503-01-0826, Revision A Candela Corporation Proprietary Page 3 of 4...
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Press Charge enabled so it is not highlighted on the HV Ctrl screen and pulse once to discharge the caps. Go to STANDBY. 10. Install the laser rail dust cover. Page 4 of 4 Candela Corporation Proprietary 8503-01-0826, Revision A...
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Must use MGL/GL+ brown ULTEM 12 mm distance gauge, 7121-00-9240 Rev B or higher. Do not use aiming beam. TOTAL PULSES ______________ HEAD PULSES ______________ CLEAR FAULT LIST AND RESET PULSE COUNTER(S) IF APPLICABLE 10-400-00144 Revision C Candela Corporation PROPRIETARY Page 1 of...
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23. Clean the exterior of the laser including the power cord. _______ 24. Complete and sign Data sheet, and next PM reminder. _______ 25. Insure the room is left in it’s original condition. _______ 8502-15-0208 Revision A Candela Proprietary Page 1 of 1...
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THESE GUIDELINES DO NOT TAKE THE PLACE OF THE OPERATOR’S MANUAL BUT SERVE AS SUGGESTIONS FOR TREATMENT WITH THE CANDELA GENTLELASE FAMILY OF LASERS. IT IS RECOMMENDED THAT TEST SPOTS ARE DONE AND TISSUE RESPONSE EVALUATED PRIOR TO FULL TREATMENT.
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Candela GentleLASE Family Of Lasers Treatment Guidelines For miniGentleLASE Models: 9914-0880 and 9914-0890 For miniGentleLASE Limited Edition Models: 9914-0910 and 9914-0930 6-20 40-80 40-80 6-16 40-80 40-80 8502-00-0858 Revision B Candela Proprietary Page 2 of 5...
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Candela GentleLASE Family Of Lasers Treatment Guidelines For miniGentleLASE Models: 9914-0880 and 9914-0890 For miniGentleLASE Limited Edition Models: 9914-0910 and 9914-0930 TELANGIECTASIA ( 2-3mm) TREATMENT GUIDELINES PT. SKIN SPOT SIZE FLUENCE *DCD *DCD COMMENTS TYPE (mm) (J/cm SPRAY (ms) DELAY (ms)
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Candela GentleLASE Family Of Lasers Treatment Guidelines For miniGentleLASE Models: 9914-0880 and 9914-0890 For miniGentleLASE Limited Edition Models: 9914-0910 and 9914-0930 GENERAL TREATMENT CONSIDERATIONS SUGGESTIONS FOR TREATMENT ALWAYS HOLD LASER HANDPIECE PERPENDICULAR TO SITE TO APPLY LASER ENERGY FOR HAIR REMOVAL PROCEDURES.
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Wear a laser mask to reduce breathing plume. § Keep room well ventilated to disperse hair odor. CANDELA does NOT recommend treating under the eyebrow as ocular damage may occur. Treating Specific Body Areas § Insert wet cotton in nose or ears during treatment to reduce DCD spray delivery beyond target.
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13019 CHECKED SCOTT MOGREN 12-10-01 This drawing contains confidential information TITLE 7111-80-2520 03 proprietary to Candela Corporation. It must not DATE 12-10-01 ENG ELEC OWEN SCHIRDUAN 12-10-01 be reproduced or disclosed to others or used in SCHEMATIC, DCD CANISTER PCB...
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