Candela GentleLASE 9914-00-0880 Service Manual

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Candela Corporation Proprietary

GentleLASE

(MGL)

Service Manual

Models: 9914-00-0880

9914-00-0890

9914-00-0910

9914-00-0930

Candela Corporation

530 Boston Post Road

Wayland, MA 01778-1886

Telephone (508) 358-7637

8501-00-1741, Revision A

July 2003

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Page 1 Candela Corporation Proprietary GentleLASE (MGL) Service Manual Models: 9914-00-0880 9914-00-0890 9914-00-0910 9914-00-0930 Candela Corporation 530 Boston Post Road Wayland, MA 01778-1886 Telephone (508) 358-7637 8501-00-1741, Revision A July 2003...
Page 2 GentleLASE Service Manual Candela Corporation Proprietary Toll Free (800) 733-8550 ext.336 (Technical Assistance) Toll Free (800) 73-LASER (Customer Service) Page 2 PROPRIETARY 8501-00-1741 Revision A...
Page 3 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.
Page 4 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...
Page 5 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...
Page 6 GentleLASE Service Manual Candela Corporation Proprietary Assembly Drawings/BOMs Cont. Revision 7122-00-3306 Bom, DCD Option Assembly, ................B 7122-99-3306 DCD Option Assembly...................A 7122-00-3316 Bom, DI Heat exchanger Assembly ..............A 7122-99-3316 DI Heat exchanger Assembly................A 7122-00-3317 Bom, Heater Manifold Assembly ................03 7122-99-3317 Heater Manifold Assembly..................A...
Page 7 Candela Corporation Proprietary GentleLASE Service Manual SECTION FIVE REFERENCE 8501-00-1741, Revision A PROPRIETARY Page vii...
Page 8 GentleLASE Service Manual Candela Corporation Proprietary Page viii PROPRIETARY 8501-00-1741 Revision A...
Page 9 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.
Page 10 Contents 1. Before you get started - general information How to use this manual ........Deﬁnitions of expressions used in this manual .
Page 11 Alarm function of the parameter buttons ..... . . 3:18 Override possibilities ......... 3:20 Stand-by group .
Page 12 Conﬁrm treatment end ....... 4:25 If desired, start emptying BiCart or BiCart, SelectCart and SelectBag .
Page 13 Operation ..........Curve Setting/Change/Cancellation: .
Page 14 Measurement mode ........11:6 Alarm limit for clearance .
Page 15 Hygiene - Rinse/Drain ........12:25 Performing Rinse/Drain program .
Page 16 Operation ..........13:18 Transportation and storage .
Page 17 Figures 2. Description - the machine and its components Figure 2:1 Blood monitor ........Figure 2:2 Fluid monitor .
Page 18 Figure 9:1 BVS, relative blood volume graph ....Figure 9:2 BVS, relative blood volume graph ....Figure 9:3 BVS, combination of graphs .
Page 19 Chapter 1 Before you get started - general information How to use this manual ........Deﬁnitions of expressions used in this manual .
Page 20 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.
Page 21 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.
Page 22 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.
Page 23 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.
Page 24 → → → 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.
Page 25 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. •...
Page 26 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;...
Page 27 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.
Page 28 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.
Page 29 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.
Page 30 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.
Page 31 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...
Page 32 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.
Page 33 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.
Page 34 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...
Page 35 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...
Page 36 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.
Page 37 Chapter 2 Description - the machine and its components Blood monitor ..........BM 200 - Single Pump, BM 202 - Double Pump .
Page 38 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.
Page 39 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.
Page 40 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.
Page 41 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.
Page 42 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.
Page 43 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.
Page 44 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.
Page 45 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.
Page 46 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.
Page 47 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...
Page 48 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.
Page 49 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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Page 51 Chapter 3 Controlling the machine - general guidelines Operator’s panel ..........Hygiene group .
Page 52 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.
Page 53 Figure 3:1 Operator’s panel HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Controlling Program version 8.xx...
Page 54 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.
Page 55 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.
Page 56 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.
Page 57 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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Page 59 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.
Page 60 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”...
Page 61 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.
Page 62 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...
Page 63 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)
Page 64 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...
Page 65 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.
Page 66 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.
Page 67 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.
Page 68 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.
Page 69 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...
Page 70 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.
Page 71 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.
Page 72 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.
Page 73 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 .
Page 74 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.
Page 75 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...
Page 76 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.
Page 77 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...
Page 78 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.
Page 79 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...
Page 80 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.
Page 81 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.
Page 82 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.
Page 83 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.
Page 84 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.
Page 85 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”...
Page 86 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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Page 88 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.
Page 89 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.
Page 90 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.
Page 91 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.
Page 92 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.
Page 93 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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Page 95 Chapter 4 Hemodialysis, double needle treatment Double needle treatment ........Check before starting the machine .
Page 96 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. •...
Page 97 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”...
Page 98 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.
Page 99 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.
Page 100 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.
Page 101 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.
Page 102 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.
Page 103 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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Page 105 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.
Page 106 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.
Page 107 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.
Page 108 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).
Page 109 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).
Page 110 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.
Page 111 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.
Page 112 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).
Page 113 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.
Page 114 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.
Page 115 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.
Page 116 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.
Page 117 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.
Page 118 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;...
Page 119 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...
Page 120 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 •...
Page 121 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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Page 123 Chapter 5 Hemodialysis, single needle treatment Single needle treatment ........General .
Page 124 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.
Page 125 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.
Page 126 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".
Page 127 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”...
Page 128 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.
Page 129 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.
Page 130 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.
Page 131 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.
Page 132 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.
Page 133 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.
Page 134 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.
Page 135 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.
Page 136 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.
Page 137 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.
Page 138 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.
Page 139 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"...
Page 140 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.
Page 141 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.
Page 142 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).
Page 143 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.
Page 144 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.
Page 145 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.
Page 146 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.
Page 147 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 .
Page 148 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.
Page 149 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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Page 151 Chapter 6 Isolated UF HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Isolated UF Program version 8.xx...
Page 152 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"...
Page 153 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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Page 155 Chapter 7 Profiling Proﬁling of Na and HCO dialysis ﬂuid concentration ... . . Proﬁling of ultraﬁltration rate ........Operation .
Page 156 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.
Page 157 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.
Page 158 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.
Page 159 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.
Page 160 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.
Page 161 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.
Page 162 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.
Page 163 Chapter 8 Hemodiafiltration, low volume General ........... Protective system for low volume HDF .
Page 164 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”...
Page 165 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.
Page 166 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.
Page 167 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...
Page 168 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.
Page 169 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.
Page 170 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.
Page 171 Chapter 9 BVS - Blood Volume Sensor General ........... ∆BV text information .
Page 172 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.
Page 173 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 •...
Page 174 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.
Page 175 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 •...
Page 176 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 •...
Page 177 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.
Page 178 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...
Page 179 Chapter 10 BPM - Blood Pressure Monitor (option) General ........... 10:2 Patient factors which affect readings .
Page 180 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.
Page 181 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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Page 183 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.
Page 184 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.
Page 185 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 .
Page 186 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.
Page 187 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 ). •...
Page 188 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.
Page 189 Chapter 11 Diascan General ........... 11:2 Application .
Page 190 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.
Page 191 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.
Page 192 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.
Page 193 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.
Page 194 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.
Page 195 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.
Page 196 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.
Page 197 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.
Page 198 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.
Page 199 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. •...
Page 200 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.
Page 201 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.
Page 202 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...
Page 203 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.
Page 204 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.
Page 205 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”...
Page 206 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).
Page 207 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”...
Page 208 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.
Page 209 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.
Page 210 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).
Page 211 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"...
Page 212 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”...
Page 213 Chapter 12 Hygiene and maintenance General hygiene and maintenance ....... 12:2 Glossary of disinfection terms .
Page 214 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.
Page 215 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.
Page 216 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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Page 218 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.
Page 219 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.
Page 220 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...
Page 221 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.
Page 222 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”.
Page 223 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 •...
Page 224 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 •...
Page 225 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.
Page 226 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.
Page 227 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.
Page 228 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).
Page 229 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).
Page 230 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.
Page 231 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”.
Page 232 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.
Page 233 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.
Page 234 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”...
Page 235 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.
Page 236 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.
Page 237 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 •...
Page 238 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 •...
Page 239 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.
Page 240 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 •...
Page 241 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).
Page 242 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.
Page 243 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.
Page 244 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.
Page 245 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.
Page 246 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.
Page 247 Chapter 13 Technical data and specifications Performance and speciﬁcation - Control System ....13:2 Blood Flow Control ........13:2 Air Detection .
Page 248 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.
Page 249 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%)
Page 250 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...
Page 251 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)
Page 252 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%)
Page 253 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...
Page 254 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.
Page 255 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))
Page 256 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.
Page 257 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: ±...
Page 258 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...
Page 259 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.
Page 260 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...
Page 261 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...
Page 262 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.
Page 263 Materials in contact with water, concentrates and dialysis fluid Polymers Silicon rubber Santroprene PVC (Polyvinylchloride) PEEK (Polyetherketone) PEX (Polyethylene) PP (Polypropylene) PP (Polypropylene reinforced with talcum) PSU (Polysulphone) PVDF (Polyvinylidene ﬂuoride) PTFE (Polytetraﬂuoro ethylene) Metals Stainless steel SS2343 Stainless steel SS2353 Stainless steel SS2562 Titanium Platinum...
Page 264 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.
Page 265 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 %.
Page 266 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...
Page 267 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.
Page 268 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...
Page 269 Chapter 14 Alarm list, Attention alarm list and Technical alarm list Alarm list ..........14:2 Attention alarm list .
Page 270 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"...
Page 271 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.
Page 272 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.
Page 273 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...
Page 274 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...
Page 275 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.
Page 276 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:...
Page 277 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...
Page 278 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.
Page 279 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.
Page 280 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.
Page 281 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.
Page 282 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.
Page 283 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.
Page 284 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).
Page 285 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.
Page 286 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.
Page 287 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.
Page 288 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:...
Page 289 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:...
Page 290 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.
Page 291 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...
Page 292 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.
Page 293 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:...
Page 294 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:...
Page 295 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...
Page 296 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:...
Page 297 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...
Page 298 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.
Page 299 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...
Page 300 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.
Page 301 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.
Page 302 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:...
Page 303 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:...
Page 304 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.
Page 305 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.
Page 306 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...
Page 307 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:...
Page 308 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:...
Page 309 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.
Page 310 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...
Page 311 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.
Page 312 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.
Page 313 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.
Page 314 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.
Page 315 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...
Page 316 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".
Page 317 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...
Page 318 This page is intentionally left blank HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Major changes 15:4 Program version 8.xx...
Page 319 Chapter 16 Index HCEN9751 Revision.12.2005 AK 200 S Operator’s manual - Index 16:1 Program version 8.xx...
Page 320 attaching ....4:11 list of blood lines ... . 1:14 Acetate button ....3:5 venous blood line .
Page 321 acetate concentrate ... 4:8 Function check ....4:3 acidic and liquid bicarbonate overview screen ... . 3:26 concentrate .
Page 322 arterial pressure ... . . 3:31 blood ﬂow ....3:30 Latch for ﬁlter change ... 2:9 blood pump segment .
Page 323 System pressure transducer connector ....2:3, 5:5 Rear of the machine System pressure transducer protector 8:4 options included ... . . 2:8 without options .
Page 324 ~ 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...
Page 325 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...
Page 326 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...
Page 327 • 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). •...
Page 328 ~ 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.
Page 329 ~ 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 &...
Page 330 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.
Page 331 ~ 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.
Page 332 ~ 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...
Page 333 ~ 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...
Page 334 ~ 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.
Page 335 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.
Page 336 ~ 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.
Page 337 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).
Page 338 Candela Corporation MGentleLASE Installation Procedure MGentleLASE Installation Procedure 8503-01-0821, Revision A Candela Corporation Proprietary Page 1 of 8...
Page 339 MGentleLASE Installation Procedure Candela Corporation Page 2 of 8 Candela Corporation Proprietary 8503-01-0821, Revision A...
Page 340 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...
Page 341 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...
Page 342 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...
Page 343 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...
Page 344 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...
Page 345 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.
Page 346 Candela Corporation MGentleLASE Routine Preventative Maintenance Procedure MGentleLASE Routine Preventative Maintenance Procedure 8503-01-0822, Revision A Candela Corporation Proprietary Page 1 of 6...
Page 347 MGentleLASE Routine Preventative Maintenance Procedure Candela Corporation Page 2 of 6 Candela Corporation Proprietary 8503-01-0822, Revision A...
Page 348 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.
Page 349 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...
Page 350 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...
Page 351 Routine Preventative Maintenance Procedure Candela Corporation Page 6 of 6 Candela Corporation Proprietary 8503-01-0822, Revision A...
Page 352 Candela Corporation GentleLASE Flashlamp Replacement Procedure MGL & GentleLASE FLashlamp Replacement Procedure 8503-01-0560, Revision C PROPRIETARY Page 1 of 5...
Page 353 GentleLASE Flashlamp Replacement Procedure Candela Corporation Page 2 of 5 PROPRIETARY 8503-01-0560, Revision C...
Page 354 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.
Page 355 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.
Page 356 Candela Corporation GentleLASE Flashlamp Replacement Procedure 8503-01-0560, Revision C PROPRIETARY Page 5 of 5...
Page 357 Candela Corporation GentleLASE Handpiece Lens Replacement Procedure MGL & GentleLASE Handpiece Lens Replacement Procedure 8503-01-0600, Revision C PROPRIETARY Page 1 of 4...
Page 358 GentleLASE Handpiece Lens Replacement Procedure Candela Corporation Page 2 of 4 PROPRIETARY 8503-01-0600, Revision C...
Page 359 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.
Page 360 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.
Page 361 Candela Corporation MGentleLASE HVPS Calibration Procedure MGentleLASE HVPS Calibration Procedure 8503-01-0824, Revision A Candela Corporation Proprietary Page 1 of 5...
Page 362 MGentleLASE HVPS Calibration Procedure Candela Corporation Page 2 of 5 Candela Corporation Proprietary 8503-01-0824, Revision A...
Page 363 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...
Page 364 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...
Page 365 Candela Corporation MGentleLASE HVPS Calibration Procedure 8503-01-0824, Revision A Candela Corporation Proprietary Page 5 of 5...
Page 366 Candela Corporation MGentleLASE Head Detector Calibration Procedure MGentleLASE Head Detector Calibration Procedure 8503-01-0825, Revision A Candela Corporation Proprietary Page 1 of 4...
Page 367 MGentleLASE Head Detector Calibration Procedure Candela Corporation Page 2 of 4 Candela Corporation Proprietary 8503-01-0825 Revision A...
Page 368 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...
Page 369 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...
Page 370 Candela Corporation MGentleLASE Laser Rail Alignment Procedure MGentleLASE Laser Rail Alignment Procedure 8503-01-0826, Revision A Candela Corporation Proprietary Page 1 of 4...
Page 371 MGentleLASE Laser Rail Alignment Procedure Candela Corporation Page 2 of 4 Candela Corporation Proprietary 8503-01-0826, Revision A...
Page 372 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...
Page 373 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...
Page 374 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...
Page 375 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...
Page 376 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.
Page 377 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...
Page 378 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)
Page 379 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.
Page 380 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.
Page 381 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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Candela GentleLASE 9914-00-0880 Service Manual

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