Gambro Dasco RFMOD GAMBRO RF MODULE User Manual Start ENG

Gambro Dasco GAMBRO RF MODULE Start ENG

Users Manual

15-1Chapter 15: Alarms and Troubleshooting 15.1 Alarm SystemThe machine has been designed to recognize and control various types ofmalfunctions and faults. There are three ways in which the operator isadvised of an alarm condition: • An Audible alarm signal; • A Visual alarm signal with a flashing light at the top of the machine; • An Alarm Message, displayed in the Alarm Area on the left bottomside of the Touch Screen. The alarms are referenced by number,located on the left side of the alarm message. 15.2 Alarm Classification 15.2.1 Classes of alarmsThe alarms are classified according to their triggering cause, the part ofthe machine affected and the type of intervention required from theoperator. Each alarm class is characterized by a specific visual andaudible alarm signal. The classes of Alarms will be described indecreasing order of importance, i.e. the first is the most serious type ofalarm. Class A: Alarms related to the safety of the patient, caused by internalmachine processes, requiring operator intervention to remove the cause,returning the process data to the operating limits. They may be identifiedby:• A Visual alarm signal with a flashing Red light of 4-4 modulation (oneflash of 4/8 second, followed by a 4/8 second pause).• An Audible alarm signal with a 4-4 modulation.• An Alarm Message on the top of the Alarm Area.Class B: Alarms not related to the safety of the patient, caused directly byan operator error on the machine controls or caused by machineconditions requiring operator intervention. These require operatorintervention. They may be recognized by:If more than one alarm occurs at the same time, they are automatically prioritized by the system. The machine will restart the interrupted action only after all the alarms have been solved. NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-2• A Visual alarm signal with a flashing Yellow light of 1-7 modulation (aflash of 1/8 of a second, followed by a pause of 7/8 second).• An Audible alarm signal with a 1-7 modulation.• An Alarm Message on the top of the Alarm Area.Class E: Alarms not related to the safety of the patient, caused by controlerrors that may revert to normal without the need for operator intervention.They usually require the intervention of a Service technician. They may beidentified by:• A Visual alarm signal with a flashing Yellow light of 1-7 modulation (aflash of 1/8 second, followed by a pause of 7/8 second).• An Audible alarm signal with a 1-7 modulation.• An Alarm Message on the top of the Alarm Area.Class D: Alarms not related to the safety of the patient or to an errorcondition, caused by machine state requiring the attention of the operator.They may be identified by:• A Visual alarm signal with a flashing Yellow light of 1-7 modulation (aflash of 1/8 second, followed by a pause of 7/8 second).• An Audible alarm signal with a 1-7 modulation.• An Alarm Message on the top of the Alarm Area.Class C: Alarms not related to the safety of the patient, caused due totransitory control errors which usually revert to normal without operatorintervention. If these errors persist, the machine is probably not functioningproperly and a Service technician must be notified. They may be identifiedby:• A Visual alarm signal with a flashing Yellow light of 1-7 modulation (aflash of 1/8 second, followed by a pause of 7/8 second).• An Alarm Message on the top of the Alarm Area.The operator can therefore identify the class of alarm with the aid of thethree types of indicators available and then take an appropriate action.
Chapter 15: Alarms and Troubleshooting15-3 Cod. 6992200 - Rev. / 15.3 Levels of operator interventionWhen an alarm condition occurs, the operator may be able to manuallydeal with the problem, depending on its class. The specific actions to take are described for each individual alarm. Fourtypes of intervention are possible: • MUTE• CONFIRM• OVERRIDE• RESET 15.3.1 MuteIt is possible to temporarily (for about 2 minutes) deactivate the audiblealarm signal, by pressing the MUTE key on the Hard Key Panel. It is important to consider that during the MUTE status:• The LED on the MUTE key switches ON. • The Audible alarm is deactivated. • The Visual alarm remains. • The Alarm Message remains in the Alarm Area with the description ofeach alarm. It is possible to remove the MUTE status:• Automatically: when the time has elapsed. • Manually: by pressing the MUTE key. 15.3.1.1 ConfirmThe CONFIRM operation forces a removing of the alarm, it clears theaudible and visible feedbacks as well as the time counters used togenerate the alarm. Therefore, the Confirm condition restores thefunctionalities which has been previously stopped, bringing back themachine as before the alarm generation. After having solved the alarm causes, the operator can confirm the alarmby pressing the CONFIRM button, displayed on the right top side of theAlarm Area. If a new alarm is triggered, different from the previous one, during a MUTE status, the MUTE status will be automatically removed. NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-4When the fault has been removed and the CONFIRM button pressed, theconditions that have generated the alarm will be cleared and the previousprocess will be resumed. However, if the safety conditions aren't stillsatisfied, the alarm will reappear again. 15.3.2 OverrideThe Artis Dialysis System allows to OVERRIDE only the alarm related to aBlood Leak Detection. The OVERRIDE of this alarm can be performed to give the possibility toignore it and to continue the treatment. It is useful every time a recovery ofa dangerous situation requires the machine working, to reactivate somefunctionality that was stopped due to the alarm presence. To override the alarm, press the OVERRIDE button displayed in the AlarmArea when the Blood in Dialysate alarm is triggered. It is important to consider that during an override period:• Some of the safety mechanisms are disabled for a limited period oftime (about 2 minutes); • The Audible and the Visual alarm signals are maintained; • The Alarm Message is still displayed in the Alarm Area. If one or more additional faults cause an alarm during the OVERRIDEstate, the description relative to each fault is displayed in the Alarm Area. 15.3.3 ResetSome alarms can be automatically RESET by the machine when there areno more failures. In this cases, the confirm option is not available. The RESET operation foresees an automatic removing of the alarm afterthat the conditions that weren’t previously satisfied and that consequentlyhave generated an alarm, are satisfied again for a specified time interval,dependent on the alarm itself. Press the CONFIRM button to clear the alarm only after having removed the causes of the alarm, as described on the message displayed on the Alarm Area. During an OVERRIDE status, the operator is responsible for monitoring of the parameters that have been overridden. WARNING!WARNING!
Chapter 15: Alarms and Troubleshooting15-5 Cod. 6992200 - Rev. / After an automatic alarm reset, the audible and visible feedbacks arecleared and the functionalities, which have been stopped by the machineat the start of the alarm, are restored again. 15.4 Guidelines to respond to an alarm situationIn case of an alarm condition, the operator should perform the followingactions:1. Press the MUTE key to silence the Audible Alarm, if desired. 2. Observe the Alarm Message in the Alarm Area on the left bottom ofthe Touch Screen. Figure 15-1. Alarm Area3. If more than five alarms are triggered, it is possible to scroll the Alarmwindow up and down using the Scroll Buttons. 4. Determine the cause of the alarm. If uncertain about the cause or theappropriate response to the alarm, refer to the “15.6 AlarmThe alarm message can be marked in:• blue, if the alarm is intended to notify or remind the operator about specific machine condition/end of procedures.• red, in all the other conditions.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-6Troubleshooting” Section in this Chapter, for possible causes andsolutions. If a Help window is available, the “I+” button is displayed.5. Correct the cause of the alarm as described in “15.6 AlarmTroubleshooting”.
Chapter 15: Alarms and Troubleshooting15-7 Cod. 6992200 - Rev. / 15.5 Alphabetic List of AlarmsThe table below contains a list of all the alarms in alphabetical order,indicating:• The message that appears on the Touch Screen;• The Technical Code;• The Class;• The possibility or not to CONFIRM the alarm. ALARM MESSAGE CODE CLASS CONFIRM<< GENERAL SYSTEM FAILURE>> XXX A NO80% Maximum Substitution Volume Reached 551 E YES90% Maximum Substitution Volume Reached 552 E YESAcid/Acetate Concentrate Container Empty 1AYESAcid/Acetate Concentrate Error 369 A NOAir Detector Cleaning Required 583 A YESAir Detector Inspection Required 584 A YESAir in Blood T0 Failure 385 A YESAir in Hydraulic Pathway (LD1) 33 E NOAir in Hydraulic Pathway (LD2) 35 E NOAir in Venous Line 4 A NOArterial Infusion Line Open 519 E YESArterial Line Clamped 517 E YESArterial Pressure Below Treatment Min. Limit 306 A YESArterial pressure high 305 A YESArterial pressure high 457 A YESArterial pressure low 384 A YESArterial pressure out of range 11 A YESArterial Pump Segment Not Correctly Loaded 586 E YESAutoscheduled Disinfection/Rinse Program not Performed 562 A YES
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-8Backup battery failure 183 E YESBicarbonate Concentrate Error 370 A NOBiCart cartridge empty 21 A YESBioslave Subsystem Communication Error 296 E NOBLD Sensitivity Loss 170 E YESBlood Cassette presence required 507 A NOBlood in Dialysate 28 A NOBlood Lines Clamped 509 A YESBlood pump cover open 8 B NOBlood pump rotor error 13 B YESBlood Pump Rotor Error 363 A YESBlood pump speed error 12 B YESBlue Dialysis Fluid Tube Incorrect Position 330 B NOBPM Diastolic pressure alarm 46 A YESBPM failure 30 A YESBPM Heart rate alarm 66 A YESBPM Measurement failure 31 A YESBPM Systolic pressure alarm 132 A YESCassette Repositioning Failed 557 E YESCDF1 Ultrafilter Lower Switch Error 61 E NOCDF2 Ultrafilter Lower Switch Error 563 E NOChemical Process Not Properly Performed: Disinfectant Tank Empty 533 A YESCommunication Protective Cond. Cell Stopped 449 A YESCommunication Select Cond. Cell Stopped 450 A YESConductivity too high 463 A NOConductivity too low 462 A NODialysate pH high 40 A NOALARM MESSAGE CODE CLASS CONFIRM
Chapter 15: Alarms and Troubleshooting15-9 Cod. 6992200 - Rev. / Dialysate pH low 368 A NODialysate Pressure High 146 B YESDialysate Pressure Low 540 B YESDialysis fluid flow high 44 A NODialysis fluid flow low 373 A NODialysis fluid flow too low 425 A YESDialysis fluid temp high 134 A NODialysis fluid temp low 377 A NODialysis fluid temp too high 460 A NODialysis fluid temp too low 461 A NODialyzer Inlet Pressure High 87 A YESDialyzer Inlet Pressure Low 94 A YESDialyzer Outlet Pressure High 88 A YESDialyzer Outlet Pressure Low 95 A YESDialyzer Pressure Maximum 114 A NODialyzer Pressure Minimum 115 A NODiascan measurement error 536 A YESDiascan: Autocalibration Failure 528 B NODiascan: Low Clearance 530 D YESDiascan: Low Kt/V 531 D YESDiascan: Measurement Failure 529 B YESDisinfection not Properly Performed 534 B YESFlowmeter Alignment Failed 506 A YESFluid path obstruction 206 A YESFluid Removal Complete 53 B YESHemoconcentration Risk 524 E YESHemocontrol Error 554 A YESHemocontrol: BV% not available 234 B YESHemocontrol: Early on Prescription 230 B YESHemocontrol: High Na Concentration 231 B YESALARM MESSAGE CODE CLASS CONFIRM
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-10Hemocontrol: Late On Prescription 229 B YESHemocontrol: Low Na Concentration 232 B YESHEMOSCAN Autocalibration Failure 473 B NOHEMOSCAN: DARK Out of Range 223 C NOHEMOSCAN: L/H Out of Range 226 C NOHEMOSCAN: Minimum Blood Volume 191 E NOHEMOSCAN: TEST Out of Range 225 C NOHeparin infusion complete 58 B YESHeparin pump lower limit reached 69 E NOHeparin pump overload 55 A NOHeparin pump speed error 70 B YESHeparinization Not Initiated 71 B YESHydraulic Centralise Acetate Connector Type One 565 E NOHydraulic Centralise Acetate Connector Type Two 566 E NOHydraulic Sensor Dirty (LP) 34 E NOIncorrect bicarbonate concentrate 18 B NOIncorrect bicarbonate concentration 23 A NOIncorrect bicarbonate concentration 366 A NOIncorrect bicarbonate concentration 464 A NOIncorrect bicarbonate concentration 465 A NOIncorrect BiCart Holder Arms Position 22 B NOIncorrect Cassette line connections or clamps status 542 A YESIncorrect concentrate connector 2 B NOIncorrect conductivity measured 62 A NOIncorrect conductivity measured 375 A NOIncorrect fluid conductivity detected 496 A NOIncorrect venous or arterial line position in clamp 205 A NOInsert the HEMOSCAN cuvette 454 B NOALARM MESSAGE CODE CLASS CONFIRM
Chapter 15: Alarms and Troubleshooting15-11 Cod. 6992200 - Rev. / Insufficient water supply 100 A NOIsolated UF Completed 570 D YESIsolated UF target loss will not be achieved 581 E NOLeakages H 548 E YESLeakages I 549 E YESLeakages Test (A) Failure 467 E YESLeakages Test (B) Failure 468 E YESLeakages Test (C) Failure 469 E YESLeakages Test (D) Failure 470 E YESLeakages Test (E) Failure 498 E YESLeakages Test (F) Failure 499 E YESLeakages Test (G) Failure 500 E YESLeft Blue EvaClean door incorrect position 416 B NOLine Not Connected in EvaClean Port or Access Line Open 518 E YESLow blood pump speed 204 A YESLow Disinfectant Level in last Clean Cart Process 504 E YESLow Heparinization 573 A YESLow Temperature 81 D NOMaximum Substitution Volume reached 546 A YESMaximum Substitution Volume reached 553 E YESMAXIMUM TEMPERATURE LIMIT 90 A NONa or Bic Settings result in conductivity out of range 401 E NONew Ultra Scan is suggested 545 E YESNo power - Using battery backup 353 A NONo Power - Using Battery Backup 415 A YESNot Performing UF 443 E YESALARM MESSAGE CODE CLASS CONFIRM
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-12On line blood restitution: wrong Ultra Cassette configuration 579 A YESOn line Prime - Incorrect Ultra or Blood cassette configuration 580 A YESOn-line door incorrect position 423 E NOPatient Venous Line Incorrect Position 547 E YESPDr Pressure High 452 A YESPDr Pressure Low 453 A YESPower Failure: Check Power Supply 550 E YESPre Filter Pressure High 541 A YESPreparation can not proceed until dressing is complete 576 E NOPreparation Completed 559 E YESPreparation not Completed - Incorrect Condition on Acetate Distribution 476 A YESPreparation not Completed - Incorrect Condition on Bicarbonate Distribution 477 A YESPreparation not Completed - Incorrect Condition on D1 Flow Rate 474 A YESPreparation not Completed - Incorrect Condition on TcA 475 A YESPressure Alarm Limits Still Expanded 525 E NOPriming Completed(See NOTE 1)560 E YESPump speed too high 10 A YESPump speed too low 362 A YESRed Dialysis Fluid Tube Incorrect Position 331 B NOReminder - HDF Substitution Still Disabled 526 E YESReminder - Still In Isolated UF 479 E YESReminder - Still in Pause Therapy 329 E YESReminder - Wrong Dip Switches 502 E YESReminder: 558 E YESALARM MESSAGE CODE CLASS CONFIRM
Chapter 15: Alarms and Troubleshooting15-13 Cod. 6992200 - Rev. / Residual Check Reminder 582 E YESRight Red EvaClean door incorrect position 417 A NOSaline Bag Not Connected 515 E YESSaline Bag Empty 585 E YESSelect Bag Holder Incorrect Position 411 D NOSelect Cart Holder Arms Incorrect Position 3BNOSensor Bar Door Open 424 E NOSmart Scan - High QD 514 D YESSmart Scan - Low QB 512 D YESSmart Scan - Low QD 513 D YESSmart Scan – Low Real QB 577 D YESStill in bypass 302 E YESSUPPLY VOLTAGE INCORRECT 187 E NOSystem Pressure out of range 522 A YEST1 Test Arterial Pressure 447 E YEST1 Test Arterial Pump/ABD 419 E YEST1 Test Conductivity Cells Failed 445 E YEST1 Test Flow Meters 422 E YEST1 Test Pre Filter Pressure 418 E YEST1 Test Temperature Failed 444 E YEST1 Test Venous Pressure 446 E YESTimeout on Data Reception 532 D YESTMP High 68 A YESTMP Low 142 A YESTMP Set too Low 567 E NOTMP Maximum Limit 527 E NOTool not Connected 561 E YESTreatment can not begin until the ultrafilters have been replaced 571 A NOALARM MESSAGE CODE CLASS CONFIRM
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-14Treatment Time Complete 51 B YESUF Deviation 505 A NOUF rate higher than expected 145 A YESUF rate lower than expected 379 A YESUF target will not be achieved 60 B NOUltra Inlet Tube Clamped 556 A YESUltra Scan aborted: TMP Set and Upper Limit Updated 543 E YESUltra Scan completed: TMP Set and Upper Limit Updated 544 E YESUltrafilter Cover Error 564 E NOUltrafilter Replacement Reminder 402 D YESVenous Flow Maximum 413 A YESVenous Flow Minimum 412 A YESVenous Infusion Line Open 587 A YESVenous Line Clamped 516 E YESVenous line not in patient sensor 364 A NOVenous Pressure Below Treatment Min. Limit 459 A YESVenous pressure high 155 A YESVenous pressure low 382 A YESVenous Pressure Not Decreasing 472 A YESVenous Pressure Not Increasing 351 A YESVenous pressure out of range 153 A YESVenous pressure too high 154 A YESVenous pump cover is open 149 B NOVenous pump rotor error 158 B YESVenous pump rotor error 521 A YESVenous pump speed error 157 B YESWater Leakage 539 A NOWrong A/V or System Pressure Offset 319 E YESALARM MESSAGE CODE CLASS CONFIRM
Chapter 15: Alarms and Troubleshooting15-15 Cod. 6992200 - Rev. / Wrong Acid/Acetate Connector 568 E NOWrong Arterial and Venous Treatment Limits 503 A YESWrong Bicarbonate Connector 569 E NOWrong Disinfectant used in Chemical Disinf. 578 A YESWrong disposable configuration on Ultra Cassette holder 508 A NOWrong Single Needle Clamps Position 574 A YESThe use of Remote Alarm device does not release the operator from the responsibility to observe the alarms triggered by the machine.For this alarm, the audible signal is not triggered.ALARM MESSAGE CODE CLASS CONFIRMWARNING!NOTE 1
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-16 15.6 Alarm TroubleshootingThe Alarm Area gives all the necessary instructions to respond to most ofthe alarm situations. Under certain circumstances, however, the alarmsystem could not give detailed information.Therefore, additional information are provided in this section for each ofthe alarms listed in the previous table.The alarms below are listed according to their technical code number. ACID/ACETATE CONCENTRATE CONTAINER EMPTY 1Reason for Alarm The Acid Pump cannot reach the set conductivity value.Machine Actions • The dialysis fluid goes into Bypass;• The Acid Pump (PA) is stopped.Possible Cause Suggested Action 1. The Acid concentrate canister is empty. 1. Replace the empty Acid canister with a new one. Refer to the “Section 7.6: Change Acid” of this Operator’s Manual for detailed information on the special procedure.Press the CONFIRM button to continue. 2. Massive air leak from the Acid concentrate canister. 2. Check and if necessary replace the Acid concentrate canister with a new one. Refer to the “Section 7.6: Change Acid” of this Operator’s Manual for detailed information on the special procedure.Press the CONFIRM button to continue. 3. The Acid pick-up tube connector is not connected to the concentrate canister. 3. Verify that the Acid pick-up tube connector is properly connected to the concentrate canister.Press the CONFIRM button to continue. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-17 Cod. 6992200 - Rev. / INCORRECT CONCENTRATE CONNECTOR 2Reason for Alarm The Acid Concentrate Connector is not in the proper position, or it is not fully inserted into its Concentrate Connector Port.Machine Actions In DIALYSIS:• The phase currently running stops;• The concentrate pump PA is stopped;• The dialysis fluid goes into Bypass.In ADR:• The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Acid Concentrate Connector is in the wrong position, or not fully inserted into its Concentrate Connector port. 1. Verify the right connector position in relation to the machine phase.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-18 SELECT CART HOLDER ARMS INCORRECT POSITION 3Reason for Alarm The Select Cart Holder Arms are in the wrong position or not closed securely.Machine Actions • The phase currently running stops;• All the pumps are stopped;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Select Cart Holder Arms are in the wrong position, or not closed securely. 1. Verify the correct position of the Select Cart Holder Arms in relation to the machine phase. In Dialysis, Rinsing and Disinfection: Position the connector correctly. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-19 Cod. 6992200 - Rev. / AIR IN VENOUS LINE 4Reason for Alarm Air has been detected in the Venous Patient Line.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. Air in the Venous Patient Line. 1. Clamp the Venous Patient Line under the Venous Line Clamp; 2. Clamp the venous dialyzer line; 3. Attach a sterile luer-lock syringe to the venous infusion line; 4. Unclamp the venous infusion line and create a negative venous pressure (-50 mmHg) with the syringe (See NOTE 1); 5. When the machine opens the Venous Line Clamp, clamp the venous infusion line, unclamp the Venous Patient Line and unclamp the venous dialyzer line (See NOTE 2); 6. If bubbles are still present, repeat the procedure; 7. Start the Arterial pump by pressing the “Blood Pump On/Off” key on the hard key panel; 8. If needed, adjust the chamber levels (See NOTE 3).Call for service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-20 Do not allow the venous pressure inside the venous chamber to decrease below -150 mmHg.After unclamping the venous dialyzer line, the Venous Line Clamp will close again if:• The venous pressure reaches 60 mmHg• The venous pressure exceeds 40 mmHg for more than 5 seconds.Refer to "Chapter 7: Special Procedures" for better explanations on the adjust chamber levels procedure.NOTE 1 NOTE 2 NOTE 3
Chapter 15: Alarms and Troubleshooting15-21 Cod. 6992200 - Rev. / BLOOD PUMP COVER OPEN 8Reason for Alarm The Arterial pump cover is open.Machine Actions • The Arterial Pump is stopped;• The UF Rate is automatically set to zero.Possible Cause Suggested Action 1. The Arterial pump cover is open. 1. Close the Arterial pump cover.Be sure the Arterial pump cover is securely latched. 2. The magnet is dirty. 2. Carefully clean the magnet placed behind the Arterial pump cover with a cloth dipped in a disinfectant solution.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-22 PUMP SPEED TOO HIGH 10Reason for Alarm The Blood flow is higher than the Pump speed set value or than the maximum permitted value.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero. Possible Cause Suggested Action 1. The Blood Pump speed is different from the set value. 1. Press the CONFIRM button to restart the Blood Pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-23 Cod. 6992200 - Rev. / ARTERIAL PRESSURE OUT OF RANGE 11Reason for Alarm The arterial pressure is beyond the upper or lower limit of the sensor.Machine Actions • The Blood Pump is stopped;• The UF Rate is automatically set to minimum.Possible Cause Suggested Action 1. Restriction of blood flow from the Patient’s Vascular Access or in the Arterial Patient Line. 1. Check for restriction of blood flow in the Arterial Patient Line, i.e. kinks, clamps, clotted arterial needle, poor flow from the Patient’s Vascular Access; The alarm clears when the arterial pressure is in the proper range.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. Arterial pressure decreased somewhat during a treatment due to hemoconcentration and/or inadequate heparin delivery to the patient and a resulting pressure drop increase for a given needle at a fixed blood flow rate. 2. Attention should be given to revaluation of the needle size, the blood flow rate and the heparin dosage;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-24 BLOOD PUMP SPEED ERROR 12Reason for Alarm The Blood Pump is not turning at the requested speed. Machine Actions • The Blood Pump is stopped;• The UF Rate is automatically set to zero.Possible Cause Suggested Action 1. The pump segment is jamming the rotor of the blood pump. 1. Verify the correct placement of the pump segment into the rotor.Press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-25 Cod. 6992200 - Rev. / BLOOD PUMP ROTOR ERROR 13Reason for Alarm The arterial hall sensor is not detected properly. Machine Actions • None.Possible Cause Suggested Action 1. The Arterial pump segment is not correctly inserted into the rotor. 1. Verify that the Arterial pump segment is correctly inserted into the rotor.Press the CONFIRM button.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-26 INCORRECT BICARBONATE CONCENTRATE 18Reason for Alarm The Bicarbonate Concentrate Connector is in the wrong position or not fully inserted into its Concentrate Connector Port.Machine Actions In DIALYSIS:• The concentrate pumps (PA, PB, PSel) shall be stopped;• The phase currently running stops;• The dialysis fluid goes into Bypass.In ADR:• The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Bicarbonate Concentrate Connector is in the wrong position. 1. Dialysis: verify that the Bicarbonate Concentrate Connector is connected to its Concentrate Connector Port (BiCart Treatment only), the Concentrate Canister or the Central Bicarbonate Port. 2. The Bicarbonate Concentrate Connector is not fully inserted into its Concentrate Connector Port. 2. ADR: verify that the Bicarbonate Connector is connected securely to its Concentrate Connector Port.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-27 Cod. 6992200 - Rev. / BICART CARTRIDGE EMPTY 21Reason for Alarm The BiCart Cartridge is either empty or not connected properly; as a result the Bicarbonate Pump cannot reach the set conductivity value.Machine Actions • The Bicarbonate Concentrate Pump (PB) is stopped;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The BiCart Cartridge is almost empty. 1. Replace the BiCart according to the BiCart Change procedure. 2. The Bicarbonate powder is not well distributed in the BiCart Cartridge. 2. Tap the bottom of the BiCart Cartridge to evenly distribute the powder. 3. The BiCart Cartridge is in the wrong position. 3. Verify the correct position of the BiCart into its holder.Repeat the BiCart Change procedure.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-28 INCORRECT BICART HOLDER ARMS POSITION 22Reason for Alarm The BiCart Holder Arms are in the wrong position or not closed securely.Machine Actions In DIALYSIS:During the dialysis fluid preparation phase:• The phase currently running stops;• The concentrate pump PB is stopped.During treatment: • The phase currently running stops;• The dialysis fluid goes into Bypass.In ADR:• The phase currently running stops;• All the pumps are stopped. Possible Cause Suggested Action 1. The BiCart Holder Arms are in the wrong position, or not closed securely. 1. Verify the correct position of the BiCart Holder Arms in relation to the machine phase.Call for Service if alarm persists.
Chapter 15: Alarms and Troubleshooting15-29 Cod. 6992200 - Rev. / INCORRECT BICARBONATE CONCENTRATION 23Reason for Alarm The Bicarbonate Conductivity is beyond the set or permitted range.Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Bicarbonate pick-up tube connector is not well fitted to the Concentrate Canister. 1. Verify that the Bicarbonate pick-up tube connector is properly connected to the concentrate canister. 2. Massive air leak from the Bicarbonate Concentrate Canister. 2. Replace the Bicarbonate Concentrate Canister. 3. The BiCart is not well positioned in its holder. 3. Ensure the BiCart is securely placed in its holder.Call for Service if alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-30BLOOD IN DIALYSATE 28Reason for Alarm Blood has been detected in the dialysate by the Blood Leakage Detector.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. A break in the dialyzer membrane caused a blood leakage into the hydraulic circuit. 1. Press the OVERRIDE button. Some of the safety mechanisms shall be disabled for the subsequent 2 minutes.Visually check the dialysate for blood presence.If the results are positive, replace the dialyzer and the Blood Cassette. Follow the correct procedure to replace the extracorporeal circuit. 2. The blood leak sensor is dirty. 2. Press the OVERRIDE button. Some of the safety mechanisms shall be disabled for the subsequent 2 minutes.Visually check the dialysate for blood presence.If the results are negative and the alarm persists, stop the treatment.As soon as possible perform a chemical disinfection to clean the blood leak sensor.
Chapter 15: Alarms and Troubleshooting15-31 Cod. 6992200 - Rev. / 3. Massive air leak from the Red/Blue dialysis fluid tube connectors, as the BLD sensor could confuse air with blood. 3. Press the OVERRIDE button. Some of the safety mechanisms shall be disabled for the subsequent 2 minutes.Deactivate the dialysis fluid flow by pressing the “Dialysis fluid” action button. • the dialysis fluid goes into bypass;• the “Dialysis fluid” action indicator switches to grey.Verify that the Red/Blue dialysis fluid tube connectors do not leak and are securely fitted to the dialyzer.Activate again the dialysis fluid flow by pressing the deactivated “Dialysis fluid” action button.• the “Dialysis fluid” action indicator switches to green.Call for Service if the alarm persists.Possible Cause (Continued) Suggested Action (Continued)
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-32 BPM FAILURE 30Reason for Alarm The BPM System was calibrated incorrectly, is malfunctioning or is disconnected.Machine Actions • The Blood Pressure Monitoring system is stopped and the measurement is not available.Possible Cause Suggested Action 1. Temporary blockage of the device. 1. Press the CONFIRM button to remove the alarm.Do not perform any other Blood Pressure measurements. If the BPM Mode parameter is set to Auto, set it to Manual. At the end of the treatment: • switch the machine OFF, wait a few seconds and then switch the machine back ON;• take a Blood Pressure to verify if the BPM device is functioning correctly: if the result is negative, a service technician assistance is required.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-33 Cod. 6992200 - Rev. / BPM: MEASUREMENT FAILURE 31Reason for Alarm • The BPM System may have been unable to record a blood pressure measurement because of patient and/or Cuff conditions;• The BPM Tubing may be kinked or disconnected;• The BPM System may be leaking;• There may be a Hardware/Communication failure on the BPM System.Machine Actions • The Blood Pressure Monitoring System is stopped and the measurement is not available.Possible Cause Suggested Action 1. The tubing of the BPM cuff is kinked or disconnected. 1. Verify that the external tubing of the BPM cuff is connected and that there are no leaks or kinks.Press the CONFIRM button and retry the measurement. 2. The patient moved his arm too many times during the measurement. The BPM was unable to measure the blood pressure. 2. Press the CONFIRM button and retry the measurement. 3. The external tubing of the BPM cuff or the BPM cuff itself is leaking. 3. Replace the tubing of the BPM cuff and the BPM cuff with a new one. 4. There is a communication problem between the BPM cuff and the machine. 4. Repeat the blood pressure measurement.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-34AIR IN HYDRAULIC PATHWAY (LD1) 33 Reason for Alarm LD1 Level Sensor failed its test during dialysis preparation or an ADR process. The level sensor may have detected air, failed or needs to be cleaned. Machine Actions • The phase currently running stops;• The dialysis fluid goes into bypass;• All the pumps are stopped. Possible Cause Suggested Action 1. Massive air leak from an empty concentrate canister. 1. Check for empty Acid, BiCart or Bicarbonate canister. The alarm clears before patient connection. 2. Dirty LD1 level detector. 2. Perform a RINSE or a Chemical Disinfection to clean the sensor from deposits. 3. The concentrate tube is not in the proper position for the current phase of the machine. 3. Verify the proper placement of the concentrate tube for the current phase of the machine. 4. The BiCart holder arms are not in the fully closed position. 4. Place the BiCart holder arms in the closed position. Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-35 Cod. 6992200 - Rev. / HYDRAULIC SENSOR DIRTY (LP) 34 Reason for Alarm The LP Level Sensor failed its test during dialysis preparation or an ADR process. The level sensor may have detected air, failed or needs to be cleaned. Machine Actions • The phase currently running stops;• The dialysis fluid goes into bypass;• All the pumps are stopped. Possible Cause Suggested Action 1. Dirty LP level detector. 1. Perform a RINSE or a Chemical Disinfection to clean the sensor from deposits. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-36 AIR IN HYDRAULIC PATHWAY (LD2) 35 Reason for Alarm The LD2 Level Sensor failed its test during dialysis preparation or a cleaning process. The Level Sensor may have detected air, failed or needs to be cleaned. Machine Actions • The phase currently running stops;• The dialysis fluid goes into bypass;• All the pumps are stopped. Possible Cause Suggested Action 1. Massive air leak from an empty concentrate canister. 1. Check for empty Acid, BiCart or Bicarbonate canister. 2. Dirty LD2 level detector. 2. Perform a RINSE or a Chemical Disinfection to clean the sensor of deposits. 3. The Concentrate tube is not in the proper position for the current phase of the machine. 3. Verify that the concentrate tubes are in the proper position for the current phase of the machine. 4. The BiCart holder arms are not in the fully closed position. 4. Move the BiCart holder arms to the closed position to remove the alarm and to allow cleaning of the complete circuit.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-37 Cod. 6992200 - Rev. / DIALYSATE PH HIGH 40Reason for Alarm The dialysis fluid pH value exceeds the alarm threshold.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped. Possible Cause Suggested Action 1. The machine has run out of concentrates. 1. Replace the empty canister, then wait a few seconds for the machine to stabilize. 2. There is an air leak from the Acid or Bicarbonate Pick-up tube connector/BiCart. 2. Verify there are no air leaks from the the Acid and Bicarbonate Pick-up tube connectors/BiCart. 3. The Acid or Bicarbonate Pick-up tube connector has accumulated debris or salt crystals. 3. Rinse the accumulated debris from the Acid and Bicarbonate Pick-up tube connector. 4. The Acid or Bicarbonate Pick-up tube is not properly connected to the concentrate canister. 4. Verify that the Acid and Bicarbonate Pick-up tubes are securely connected and that no air bubbles are being drawn into the tube. 5. The solution in the concentrate canister is not a solution correct for hemodialysis treatments (Refer to the "Chapter 16: Specifications", in this Operator’s Manual). 5. Stop the dialysis preparation and replace the Blood Cassette and the dialyzer with a new Blood Cassette and a new dialyzer. Run a complete RINSE procedure. Replace the solution with the correct solution and then restart the dialysis preparation. 6. The solution in the concentrate canister is not correct or diluted. 6. Verify that the solution concentration is correct and if needed replace it with a correct solution. 7. The Acid Pick-up tube connector is not securely connected to its concentrate connector port (if using concentrate from a central delivery system). 7. Verify that the Acid Pick-up tube connector is securely connected to its concentrate connector port. 8. An incorrect type of dialysis fluid concentrate could be selected on the Fluid Settings sub-screen. 8. Verify that the correct type of dialysis fluid concentrate has been selected on the Fluid Settings sub-screen, otherwise select the correct concentrate combination.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-38 DIALYSIS FLUID FLOW HIGH 44Reason for Alarm The dialysis fluid flow is higher than the set value or than the maximum permitted flow.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped. Possible Cause Suggested Action 1. Unstable dialysis fluid flow has been detected by the machine. 1. Wait for a while, if the problem persists call for service for recalibration of the flowmeter. 2. There are deposits or debris inside the flowmeters of the machine. 2. Perform a Descaling or a Chemical Disinfection.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-39 Cod. 6992200 - Rev. / BPM: DIASTOLIC PRESSURE ALARM 46Reason for Alarm The diastolic pressure measurement made by the BPM device is outside the configured limits.Machine Actions • The Blood Pressure Monitoring system is stopped and the measurement is not available.Possible Cause Suggested Action 1. The diastolic pressure measurement, made by the BPM device, is outside the alarm limits set by the operator in BPM Settings sub-screen. 1. Press the CONFIRM button to remove the alarm message.Check in the BPM Settings sub-screen that the “Diastolic upper” and ”Diastolic lower” pressure limits are not too much restrictive.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-40 TREATMENT TIME COMPLETE 51Reason for Alarm Notification: the entered TREATMENT TIME has elapsed.Machine Actions • The UF Rate is automatically set to zero.Possible Cause Suggested Action 1. The TREATMENT TIME is complete. 1. Disconnect the patient. 2. Additional TREATMENT TIME may be needed. 2. Increase the set TREATMENT TIME to lengthen the treatment.Press the CONFIRM button to continue.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-41 Cod. 6992200 - Rev. / FLUID REMOVAL COMPLETE 53Reason for Alarm Notification: the patient's weight removal is complete.Machine Actions • The UF Rate is automatically set to minimum. Possible Cause Suggested Action 1. The programmed “TARGET UF VOLUME” has been reached. 1. Disconnect the patient or increase the set “TARGET UF VOLUME”, then select the UF button.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-42HEPARIN PUMP OVERLOAD 55Reason for Alarm The heparin syringe has reached the upper limit or the Heparin Line is clamped.Machine Actions • The Heparin Pump is stopped.Possible Cause Suggested Action 1. The syringe holder has reached the upper hardware limit while the heparin program is active. 1. Disable the heparin program and use the down arrow key to exit from the error situation. 2. The syringe holder has reached the upper hardware limit while the heparin program is not active. 2. Use the down arrow key to exit from the error situation. 3. The syringe holder has reached the upper hardware limit and the Heparin syringe is empty. 3. Disable the heparin delivery program, use the down arrow key to exit from the error situation. Pull out the syringe from the holder, refill the syringe and place it back on the holder. Restart the program. 4. Blocked heparin line. 4. Disable the heparin program, verify if the heparin line is blocked and remove the possible obstruction. Enable the heparin delivery program. 5. The syringe is defective. 5. Disable the heparin delivery program, pull out the defective syringe, prepare a new filled one, place it back on the holder. Restart the program. 6. Incorrect position of the syringe. 6. Ensure that the syringe is properly placed into the syringe holder.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-43 Cod. 6992200 - Rev. / HEPARIN INFUSION COMPLETE 58Reason for Alarm The programmed heparin “Stop Time” has been reached.Machine Actions • The Heparin Pump is stopped.Possible Cause Suggested Action 1. The Heparin delivery program is complete. 1. Enter the Heparin Settings sub-screen.Deactivate the heparin delivery program to remove the alarm or in case the patient needs more heparin, set a new value for the heparin “Stop Time”, lower than the previous one. 2. The programmed heparin “Stop Time” is greater than the programmed “Treatment Time”. 2. Set a new value either for the heparin “Stop Time” or for the “Treatment Time”, lower than the previous one.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-44UF TARGET WILL NOT BE ACHIEVED 60Reason for Alarm The remaining treatment time is not enough to reach the programmed “Isolated UF Volume”.Machine Actions • None. Possible Cause Suggested Action 1. The programmed Isolated UF volume has not been achieved due to many bypass conditions. 1. Press the “Isolated UF Settings” button on the Fluid screen.From the Isolated UF Settings sub-screen, change the “Isolated UF Time” and/or “Isolated UF Volume” parameters. 2. The “UF” action button has been deactivated for too long time, therefore the time left after its activation is not sufficient for the achievement of the set “Isolated UF Volume”. 2. Press the “Isolated UF Settings” button on the Fluid screen.From the Isolated UF Settings sub-screen, change the “Isolated UF Time” and/or “Isolated UF Volume” parameters.Then select the “Isolated UF” action button.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-45 Cod. 6992200 - Rev. / CDF1 ULTRAFILTER LOWER SWITCH ERROR 61Reason for Alarm The CDF1 first ultrafilter lower connector microswitch (SWLOWUF1) is indicating an error condition.Machine Actions • In ADR: The phase currently running stops;• In Dialysis fluid preparation: The machine will not continue until the microprocessor receives the correct signal from the switch;• In DIALYSIS: The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The CDF1 ultrafilter lower connector microswitch is indicating an error condition. 1. Check the correct position of the ultrafilter.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-46 INCORRECT CONDUCTIVITY MEASURED 62Reason for Alarm The conductivity of the dialysis fluid is above the allowed limit.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped. Possible Cause Suggested Action 1. The Acid or Bicarbonate concentrate canister is empty. 1. Supply appropriate concentrate to the relevant inlet connector.Wait for stability of the dialysis fluid flow. 2. The Acid or Bicarbonate pick-up tube connector(s) are not properly positioned into the concentrate canister(s). 2. Verify that the connector(s) are properly positioned into the proper canister(s).Wait for stability of the dialysis fluid flow. 3. Massive air leak from a concentrate canister. 3. Check and replace the concentrate canister.Wait for stability of the dialysis fluid flow. 4. The Acid or Bicarbonate pick-up tube connector(s) has accumulated debris or salt crystals. 4. Rinse the accumulated debris from the connector(s). 5. Inappropriate solution in the Acid concentrate canister. 5. Verify that appropriate concentrate has been used. 6. When using acid central delivery, the Acid or Bicarbonate pick-up tube connector is not securely connected to its concentrate connector port. 6. Verify that the Acid or Bicarbonate pick-up tube connector is properly positioned in its concentrate connector port.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-47 Cod. 6992200 - Rev. / BPM HEART RATE ALARM 66Reason for Alarm The BPM heart rate measurement is outside the established limits.Machine Actions The Blood Pressure Monitoring system is stopped and the measurement is not available.Possible Cause Suggested Action 1. The BPM heart rate measurement is outside the established limits. 1. Press the CONFIRM button to remove the alarm message.Check in the BPM Settings sub-screen that the “Max Heart Rate” and “Min Heart Rate” alarm limits are not too much restrictive.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-48 TMP HIGH 68 Reason for Alarm The TMP Upper Limit value has been exceeded.Machine Actions • The UF Rate is automatically set to zero;• The Venous Pump is stopped. Possible Cause Suggested Action 1. The TMP Upper Limit value is incorrect for the dialyzer used. 1. From the Fluid Settings sub-screen, verify that the correct TMP Upper Limit value was entered for the dialyzer used. 2. The blood flow rate is too high for the dialyzer used in the current operating condition. 2. Verify the correctness of the patient prescription (ultrafiltration rate).Decrease the blood flow, using the blood flow decrease key, if this operation is not in disagreement with the patient prescription (to decrease the venous pressure and avoid hemoconcentration). 3. The ultrafiltration value is too high for the dialyzer used in the current operating condition. 3. Verify the correctness of the patient prescription (ultrafiltration rate). 4. The transmembrane pressure is too high. 4. Consider increasing the dialysis fluid flow to increase the dialysis fluid pressure. 5. The extracorporeal circuit is clotting. 5. Check the extracorporeal circuit for clotting. Refer to your internal policy.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-49 Cod. 6992200 - Rev. / HEPARIN PUMP LOWER LIMIT REACHED 69Reason for Alarm The heparin pump has reached the lower limit.Machine Actions • The Heparin Pump is stopped.Possible Cause Suggested Action 1. The syringe holder has reached the lower hardware limit. 1. Use the up arrow key to exit from the error situation.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-50 HEPARIN PUMP SPEED ERROR 70Reason for Alarm The Heparin Infusion Rate is different from the expected one. Machine Actions • The Heparin Pump is stopped.Possible Cause Suggested Action 1. The actual heparin pump infusion rate is incorrect. 1. Press the CONFIRM button to restart the heparin pump. If the problem does not occur anymore, the heparin infusion will proceed according to the settings. 2. The actual heparin pump infusion rate is incorrect. 2. Press the CONFIRM button to restart the heparin pump. If the problem persists, the alarm will be displayed and the pump will be stopped again.To proceed with the infusion, deactivate the heparin program and infuse the heparin manually or using the “Heparin Syringe Positioning Keys”. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-51 Cod. 6992200 - Rev. / HEPARINIZATION NOT INITIATED 71Reason for Alarm The Heparin Delivery Program has not been activated.Machine Actions • None.Possible Cause Suggested Action 1. The heparin infusion was not enabled by the operator. 1. In Heparin settings sub-screen: • Press the “Heparin” action button to enable the heparin delivery program and• Press the CONFIRM button to remove the alarm. 2. No heparin delivery program is needed. 2. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-52 LOW TEMPERATURE 81Reason for Alarm This alarm appears if, in Chemical Disinfection with heating, the hydraulic circuit temperature falls below 35,5°C.Machine Actions • The process time will stop until the temperature measured in the hydraulic circuit reaches 36°C. Possible Cause Suggested Action 1. Temporary drop of the temperature. 1. No Action is required. The machine should heat automatically.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-53 Cod. 6992200 - Rev. / DIALYZER INLET PRESSURE HIGH 87Reason for Alarm Pressure higher than what is allowed has been detected at the Dialyzer Inlet Connector.Machine Actions • The phase currently running stops;• The P1 and P2 pumps are stopped; • All the pumps are stopped;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Red and Blue dialysis fluid tube connectors are in the wrong position. 1. Verify that the Red and Blue dialysis fluid tube connectors are in the proper position for the current phase of the machine, then press the CONFIRM button. 2. The Red and Blue dialysis fluid tube connectors are in the proper position, but not well inserted. 2. Verify that the Red and Blue dialysis fluid tube connectors are well fitted to the dialyzer or to the machine, depending upon the phase of the machine at that time, then press the CONFIRM button. 3. The external dialysis fluid tubes are kinked. 3. Verify that the external dialysis fluid tubes are not kinked, then press the CONFIRM button. 4. Massive presence of air inside the hydraulic circuit. 4. Verify the presence of air in the external dialysis fluid tubes. 5. The blood flow is too high, producing an overpressure within the hydraulic circuit. 5. Verify the correctness of the patient prescription (ultrafiltration rate).Decrease the blood flow, using the blood flow decrease key, if this operation is not in disagreement with the patient prescription. 6. Clotting or clogging in the blood side of the dialyzer. 6. Check for clotting or clogging in the blood side of the dialyzer. Replace the dialyzer if necessary. 7. The dialysis fluid flow rate is not correct for the current dialyzer. 7. From the Fluid Settings sub-screen, reduce the dialysis fluid flow rate. 8. Incorrect placement of the diaphragm between the Blood Cassette and the venous seal. 8. Perform a Cassette Repositioning Procedure (Refer to the "Chapter 7: Special Procedures", in this Operator’s Manual).Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-54DIALYZER OUTLET PRESSURE HIGH 88Reason for Alarm Pressure higher than what is allowed has been detected at the Dialyzer Outlet Connector.Machine Actions In DIALYSIS:• If the pressure is greater than 450 mmHg, the UF pump is driven at the current value and the phase currently running stops;• If the pressure is greater than 500 mmHg, the UF pump is driven at the current value and the phase currently running stops; • All the pumps are stopped;• The dialysis fluid goes into Bypass.In ADR: • The phase currently running stops;• All the pumps are stopped. Possible Cause Suggested Action 1. The dialysis fluid tube connectors are in the wrong position. 1. Verify that the dialysis fluid tube connectors are in the proper position for the current phase of the machine, then press the CONFIRM button. 2. The dialysis fluid tube connectors are in the proper position, but not well inserted. 2. Verify that the dialysis fluid tube connectors are well fitted to the dialyzer or to the machine, depending upon the phase of the machine at that time, then press the CONFIRM button. 3. The external dialysis fluid tubes are kinked. 3. Verify that the external dialysis fluid tubes are not kinked, then press the CONFIRM button. 4. The blood flow is too high, producing an overpressure on the hydraulic side of the machine. 4. Verify the correctness of the patient prescription (ultrafiltration rate). Consider reducing the blood flow if this operation is not in disagreement with the patient prescription. 5. Clotting or clogging in the blood side of the dialyzer. 5. Check for clotting or clogging in the blood side of the dialyzer. Replace the dialyzer if necessary. 6. Incorrect placement of the diaphragm between the Blood Cassette and the venous seal. 6. Perform a Cassette Repositioning Procedure (Refer to the "Chapter 7: Special Procedures", in this Operator’s Manual).Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-55 Cod. 6992200 - Rev. / MAXIMUM TEMPERATURE LIMIT 90Reason for Alarm The temperature measured by TP is greater than the following maximum values:• In DIALYSIS: 60°C (114.8°F)• In Chemical Disinfection: 42°C (107.6°F)• In Heat or Heat Citric Disinfection: 110°C (230 °F)Machine Actions • The heater is turned off;• The phase currently running stops;• All the hydraulic pumps are stopped;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The machine had a temporaneous unstable condition. 1. Verify the patient safety. Wait for the temperature to drop; the heater is automatically turned on. 2. The machine has malfunctioned. 2. Discontinue the dialysis treatment and call for Service. 3. The incoming water temperature is too high. 3. Check the incoming water temperature (Refer to the "Chapter 16: Specifications" in this Operator’s Manual).Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-56 DIALYZER INLET PRESSURE LOW 94Reason for Alarm Pressure lower than what is allowed has been detected at the Dialyzer Inlet Connector.Machine Actions In DIALYSIS:• The P1 and P2 pumps are stopped;• The dialysis fluid goes into Bypass.In ADR:• The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. Dialysis fluid tube connectors in the wrong position. 1. Verify the dialysis fluid tube connectors are in the proper position for the current phase of the machine, then press the CONFIRM button. 2. Dialysis fluid tube connectors in the proper position, but not well inserted. 2. Verify the dialysis fluid tube connectors are well fitted to the dialyzer or to the machine, depending upon the phase of the machine at that time, then press the CONFIRM button. 3. The external dialysis fluid tubes are kinked. 3. Verify the external dialysis fluid tubes are not kinked, then press the CONFIRM button. 4. The UF Rate is too high for the dialyzer used. 4. Check the proper UF Rate for the dialyzer used. Consider reducing the blood flow if this operation is not in disagreement with the patient prescription, then press the CONFIRM button. 5. Clotting or clogging in the blood side of the dialyzer. 5. Check for clotting or clogging in the blood side of the dialyzer. Replace the dialyzer if necessary. 6. The dialysis fluid flow is not correct for the current dialyzer. 6. Consider reducing the dialysis fluid flow rate.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-57 Cod. 6992200 - Rev. / DIALYZER OUTLET PRESSURE LOW 95Reason for Alarm Pressure lower than what is allowed has been detected at the Dialyzer Outlet Connector.Machine Actions In DIALYSIS:• If the pressure is lower than -350 mmHg, the UF Pump is stopped;• If the pressure is lower than -450 mmHg, the UF Pump is stopped;• All the pumps are stopped;• The dialysis fluid goes into Bypass.In ADR:• The phase currently running stops;• All the pumps are stopped. Possible Cause Suggested Action 1. The dialysis fluid tube connectors are in the wrong position. 1. Verify that the dialysis fluid tube connectors are in the proper position for the current phase of the machine, then press the CONFIRM button. 2. The dialysis fluid tube connectors are in the proper position, but not well inserted. 2. Verify that the dialysis fluid tube connectors are well fitted to the dialyzer or to the machine, depending upon the phase of the machine at that time, then press the CONFIRM button. 3. The external dialysis fluid tubes are kinked. 3. Verify that the external dialysis fluid tubes are not kinked, then press the CONFIRM button. 4. The blood flow is too high, producing an overpressure on the hydraulic side of the machine. 4. Verify the correctness of the patient prescription (ultrafiltration rate).Consider reducing the blood flow if this operation is not in disagreement with the patient prescription. 5. Clotting or clogging in the blood side of the dialyzer. 5. Check for clotting or clogging in the blood side of the dialyzer. Replace the dialyzer if necessary. 6. Incorrect placement of the diaphragm between the Blood Cassette and the venous seal. 6. Perform a Cassette Repositioning Procedure (Refer to the "Chapter 7: Special Procedures", in this Operator’s Manual).Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-58 INSUFFICIENT WATER SUPPLY 100Reason for Alarm The Inlet Water pressure is low.Machine Actions • All the Hydraulic Pumps are stopped;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. Pressure drop in the water distribution system. 1. Verify that there is adequate water pressure in the water distribution system. 2. The water inlet tube is disconnected. 2. Connect the water inlet tube to the proper water valve. 3. The water valve is closed. 3. Verify the water valve is open. 4. The incoming water filter is clogging. 4. Check the water filter in the machine for clogging. A clogged filter will decrease the amount of water flowing through the system.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-59 Cod. 6992200 - Rev. / DIALYZER PRESSURE MAXIMUM 114Reason for Alarm The dialyzer inlet pressure, measured by the PI pressure sensor, OR the dialyzer outlet pressure, measured by the PO pressure sensor, has exceeded the maximum limit.Machine Actions • The dialysis fluid goes into Bypass. Possible Cause Suggested Action 1. The dialysis fluid tube connectors are not in the proper position or are not well inserted. 1. Verify that the dialysis fluid tube connectors are in the proper position and are well fitted to the dialyzer or to the machine, depending upon the phase of the machine at that time. 2. The external dialysis fluid tubes are kinked. 2. Verify that the external dialysis fluid tubes are not kinked. 3. Massive presence of air inside the hydraulic circuit. 3. Verify the presence of air into the external dialysis fluid tube. Verify the dialysis fluid connectors are well fitted to the dialyzer or to the machine. 4. The UF Rate is too low. 4. Verify the correctness of the patient prescription (ultrafiltration rate). Consider reducing the Blood Pump speed if this operation is not in disagreement with the patient prescription. 5. Clotting or clogging in the dialyzer and/or Blood Cassette. 5. Check for clotting or clogging in the blood side of the dialyzer or in the Blood Cassette. Replace the dialyzer and the Blood Cassette if necessary. 6. The dialysis fluid flow rate is not correct for the current dialyzer. 6. Consider reducing the dialysis fluid flow rate. 7. Incorrect placement of the diaphragm between the Blood Cassette and the venous seal. 7. Perform a Cassette Repositioning Procedure (Refer to the "Chapter 7: Special Procedures", in this Operator’s Manual).Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-60 DIALYZER PRESSURE MINIMUM 115Reason for Alarm The dialyzer inlet pressure, measured by PI sensor, OR the dialyzer outlet pressure, measured by PO sensor, are below the minimum limit.Machine Actions • The UF Rate is automatically set to zero. Possible Cause Suggested Action 1. The dialysis fluid tube connectors not in the proper position or are not inserted well. 1. Verify that the dialysis fluid tube connectors are in the proper position and are well fitted to the dialyzer or to the machine, depending upon the phase of the machine at that time. 2. The external dialysis fluid tubes are kinked. 2. Verify that the external dialysis fluid tubes are not kinked. 3. Massive presence of air inside the hydraulic circuit. 3. Verify the presence of air in the external dialysis fluid tubes. Verify the dialysis fluid connectors are well fitted to the dialyzer or to the machine. 4. The UF Rate is too high for the dialyzer used. 4. Verify the correctness of the patient prescription (ultrafiltration rate). Consider increasing the Blood Pump speed if this operation is not in disagreement with the patient prescription. 5. Clotting or clogging in the dialyzer or the Blood Cassette. 5. Check for clotting or clogging in the blood side of the dialyzer or in the Blood Cassette.Replace if necessary. 6. The dialysis fluid flow rate is not correct for the current dialyzer. 6. Consider increasing the dialysis fluid flow rate.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-61 Cod. 6992200 - Rev. / BPM SYSTOLIC PRESSURE ALARM 132Reason for Alarm The systolic pressure measurement made by the BPM device is outside the configured limits.Machine Actions • The Blood Pressure Monitoring System is stopped and the measurement is not available.Possible Cause Suggested Action 1. The systolic pressure measurement made by the BPM device is outside the configured limits. 1. Press the CONFIRM button to remove the alarm message.Check in the BPM settings sub-screen that the (“Systolic upper”/”Systolic lower”) pressure limits are not too much restrictive.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-62DIALYSIS FLUID TEMP HIGH 134Reason for Alarm The temperature of the dialysis fluid is 2°C above the value set by the operator.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. A temporary instability of the dialysis fluid flow. 1. Wait for stability of the system. 2. The temperature of the dialysis fluid has exceeded the safety limits. 2. Check the incoming water temperature (Refer to the "Chapter 16: Specifications" in this Operator’s Manual). 3. The machine has recently been turned on and has not yet reached the operating temperature. 3. If the machine temperature remains high or low for more than 10 minutes, discontinue the dialysis treatment. 4. The machine has an internal malfunction. 4. Discontinue the dialysis treatment.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-63 Cod. 6992200 - Rev. / TMP LOW 142Reason for Alarm The current TMP value is below the lowest TMP safety limit. Machine Actions • The UF Rate is automatically set to zero;• The Venous pump is stopped.Possible Cause Suggested Action 1. The dialyzer used is not correct for the current treatment. 1. Verify the correctness of the patient prescription (ultrafiltration rate).Increase the blood flow, using the blood flow increase key, if this operation is not in disagreement with the patient prescription.Comply with the specifications of the dialyzer. 2. The Blood Pump is stopped. 2. Correct the action which caused the Blood Pump to stop and restart the Blood Pump. 3. The Red and Blue dialysis fluid tubes are blocked. 3. Check that the Red and Blue dialysis fluid tubes are not kinked or clamped. 4. The Blood Cassette is not well positioned or a pressure pod diaphragm has collapsed. The Pressure Sensor cannot read properly. 4. If the alarm condition persists, verify the Blood Cassette position.Verify that the pressure pod diaphragm is not collapsed.If required, perform a Cassette Repositioning Procedure (Refer to the "Chapter 7: Special Procedures", of this Operator’s Manual).Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-64 UF RATE HIGHER THAN EXPECTED 145Reason for Alarm The ultrafiltration rate (UFR) is above the value confirmed by the operator or the maximum permitted value.Machine Actions • The Venous Pump is stopped;• The dialysis fluid goes into Bypass;• Calibration request.Possible Cause Suggested Action 1. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect valves control. 1. Press the CONFIRM button and continue the treatment. 2. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect flowmeter reading. 2. Press the CONFIRM button and continue the treatment. 3. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect P2 pump flow or P2 reading. 3. Press the CONFIRM button and continue the treatment. 4. The machine could not perform an alignment of the D2 flowmeter during the treatment and the Ultrafiltration Mass Balance could be incorrect. 4. Press the CONFIRM button and continue the treatment.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-65 Cod. 6992200 - Rev. / DIALYSATE PRESSURE HIGH 146Reason for Alarm The pressure in the Ultrafilter is higher than the permitted limit.Machine Actions • The phase currently running stops;• The dialysis fluid goes into Bypass;• All the pumps are stopped.Possible Causes Suggested Action 1. The Ultrafilter is clogged. 1. During treatment: from the Fluid Settings sub-screen, decrease the dialysis fluid flow rate to continue with the dialysis process in progress.When the treatment is complete, replace the Ultrafilter according to the procedure. 2. The Red and Blue dialysis fluid tube connectors are not properly positioned. 2. Verify that the Red and Blue dialysis fluid tube connectors are properly positioned to the dialyzer or to the machine, depending upon the current machine phase. Press the CONFIRM button to restart the current operation of the machine.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-66VENOUS PUMP COVER IS OPEN 149Reason for Alarm The Venous Pump Cover is open.Machine Actions • The Venous Pump is stopped.Possible Cause Suggested Action 1. The Venous Pump Cover is open. 1. Close the Venous Pump Cover. Be sure the Venous Pump Cover is securely latched. 2. The magnet is dirty. 2. Carefully clean the magnet placed behind the blood pump cover with a cloth dipped in a disinfectant solution.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-67 Cod. 6992200 - Rev. / VENOUS PRESSURE OUT OF RANGE 153Reason for Alarm The measured venous pressure is outside the permitted range.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed; • The UF Rate is automatically set to minimum;• The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. Restriction of blood flow to the Patient’s Vascular Access or in the Venous Patient Line. 1. Check for restriction of blood flow in the Venous Patient Line, i.e. kinks, clamps, clotted venous needle, poor flow to the Patient’s Vascular Access;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.The alarm clears when the venous pressure is in the proper range. 2. Venous pressure has increased somewhat during a treatment due to hemoconcentration and/or inadequate heparin delivery to the patient, resulting in a pressure increase for a given needle at a fixed blood flow rate. 2. Attention should be given to revaluation of the needle size, the blood flow rate and the heparin dosage;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-68VENOUS PRESSURE TOO HIGH 154Reason for Alarm The measured venous pressure is above the maximum venous treatment limit.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero (typical value 100 ml/h); • The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. Restriction of blood flow to the Patient’s Vascular Access or in the Venous Patient Line. 1. Carefully check the Blood Cassette connections and assess the Patient’s Vascular Access.Check for restrictions, such as:• kinks in the Venous Patient Line;• closed clamps;• clotted venous needle.If necessary decrease the blood flow per clinical policy.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. If the alarm persists: • attach a sterile syringe to the Venous Infusion Line;• open the clamp on the Venous Infusion Line to decrease the pressure;• when the pressure stabilizes, close the clamp on the Venous Infusion Line and remove the syringe;• select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.
Chapter 15: Alarms and Troubleshooting15-69 Cod. 6992200 - Rev. / 2. The venous pressure has increased somewhat during a treatment due to hemoconcentration and/or inadequate heparin delivery to the patient, resulting in a pressure increase for a given needle at a fixed blood flow rate. 1. Attention should be given to the revaluation of the needle size, the blood flow rate and the heparin dosage;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. If the alarm persists: • attach a sterile syringe to the Venous Infusion Line;• open the clamp on the Venous Infusion Line to decrease the pressure;• when the pressure stabilizes, close the clamp on the Venous Infusion Line and remove the syringe;• select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.Possible Cause (Continued) Suggested Action (Continued)
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-70 VENOUS PRESSURE HIGH 155Reason for Alarm The venous pressure is above the Venous Pressure Threshold as displayed in the Venous Pressure Alarm Window.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero; • The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. The venous pressure is above the allowed limit. 1. Carefully check the Patient’s Vascular Access, the Cassette connections and inspect for kinking of the Venous Patient Line.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the treatment.Press the “Close A/V Limits” button when the arterial and venous pressures are stable. 2. If the alarm persists: • attach a sterile syringe to the Venous Infusion Line;• open the clamp on the Venous Infusion Line to decrease the pressure;• when the pressure stabilizes, close the clamp on the Venous Infusion Line and remove the syringe;• select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-71 Cod. 6992200 - Rev. / VENOUS PUMP SPEED ERROR 157Reason for Alarm The Venous Pump is not turning at the requested speed. Machine Actions • None.Possible Cause Suggested Action 1. The pump segment is jamming the rotor of the venous pump. 1. Verify the correct placement of the pump segment into the rotor.Press the CONFIRM button to restart the venous pump.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-72VENOUS PUMP ROTOR ERROR 158Reason for Alarm The venous hall sensor is not detected properly. Machine Actions • None.Possible Cause Suggested Action 1. The Venous pump segment is not correctly inserted into the rotor. 1. Verify that the Venous pump segment is correctly inserted into the rotor.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-73 Cod. 6992200 - Rev. / BLD SENSITIVITY LOSS 170Reason for Alarm Deposits and/or debris collected on the Blood Leak Detector (BLD) are causing a loss of sensitivity.Machine Actions None.Possible Cause Suggested Action 1. An excessively high value is present at the receiver of the Optical Sensor, due to deposits on the detector. 1. Press the CONFIRM button to remove the alarm.Perform a Chemical Disinfection procedure to clean the Sensor.Call for Service if the alarm persists.After a “BLD Sensitivity Loss (#170)” alarm perform a Chemical Disinfection program before starting a new treatment.WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-74 BACKUP BATTERY FAILURE 183Reason for Alarm The T1 test performed by the machine on the Backup Battery has failed.Machine Actions • None.Possible Cause Suggested Action 1. The battery in the Battery Backup Kit needs to be replaced. 1. Press the CONFIRM button and continue with the treatment if the Battery Backup Kit is not required for this dialysis treatment.Replace the Battery when appropriate.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-75 Cod. 6992200 - Rev. / SUPPLY VOLTAGE INCORRECT 187Reason for Alarm The Protection Module detects a difference between the reference values and the Power Supply voltages after the Patient Connection.Machine Actions • GENERAL SAFE STATE.Possible Cause Suggested Action 1. Power supply failure during preparation. 1. If the alarm persists until the end of the function check/preparation phase, do not start the dialysis treatment.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-76 HEMOSCAN: MINIMUM BLOOD VOLUME 191Reason for Alarm The Hemoscan sensor detects blood volume lower than the “Alarm Limit” set value. Machine Actions • The dialysis process continues (See NOTE);Possible Cause Suggested Action 1. Great increase of the Hemoglobin concentration in the patient’s blood since the start of the treatment. 1. Take the appropriate clinical action. 2. The Hemoscan “Alarm Limit” value is incorrect for this patient. 2. Change the “Alarm Limit” value in the Hemoscan Settings sub-screen. Call for Service if the alarm persists.This alarm occurs in order to signal to the operator possible patient’s health risk.NOTE
Chapter 15: Alarms and Troubleshooting15-77 Cod. 6992200 - Rev. / LOW BLOOD PUMP SPEED 204Reason for Alarm The Blood Pump has been running at less than 50 ml/min for more than 30 sec.Machine Actions • None. Possible Cause Suggested Action 1. The Blood pump speed is less than 50 ml/min for more than 30 sec. 1. Press the CONFIRM button to remove the alarm. Increase the blood pump speed to more than 50 ml/min.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-78 INCORRECT VENOUS OR ARTERIAL LINE POSITION IN CLAMP 205Reason for Alarm The Venous/Arterial Patient Line has been incorrectly inserted into the Venous/Arterial Line Clamp.Machine Actions • None.Possible Cause Suggested Action 1. The Venous Patient Line is not correctly inserted into the Venous Line Clamp. 1. Remove and correctly re-insert the Venous Patient Line into the Venous Line Clamp. 2. The Arterial Patient Line is not correctly inserted into the Arterial Line Clamp. 2. Remove and correctly re-insert the Arterial Patient Line into the Arterial Line Clamp.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-79 Cod. 6992200 - Rev. / FLUID PATH OBSTRUCTION 206Reason for Alarm There is an excessive pressure in the Drain Tube. (Due to Drain Tube kinking/obstruction or bad connection)Machine Actions • The dialysis fluid goes into Bypass;• The heater is turned off;• The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. Obstruction or kinking in the Drain Tube. 1. Verify that the Drain Tube is not kinked or obstructed in any way. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-80 HEMOSCAN: DARK OUT OF RANGE 223Reason for Alarm Electronic malfunctioning of the Hemoscan Monitoring System. Machine Actions • None. • Hemoscan Monitoring disabled. Possible Cause Suggested Action 1. Internal malfunctioning of the Hemoscan Monitoring System. 1. From the Hemoscan Settings sub-screen, deactivate the Hemoscan function. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-81 Cod. 6992200 - Rev. / HEMOSCAN: TEST OUT OF RANGE 225Reason for Alarm Electronic malfunctioning of the Hemoscan Monitoring System. Machine Actions • None. • Hemoscan Monitoring disabled. Possible Cause Suggested Action 1. Internal malfunctioning of the Hemoscan Monitoring System. 1. From the Hemoscan Settings sub-screen, deactivate the Hemoscan function. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-82 HEMOSCAN: L/H OUT OF RANGE 226Reason for Alarm Electronic malfunctioning of the Hemoscan Monitoring System. Machine Actions • None. • Hemoscan Monitoring disabled. Possible Cause Suggested Action 1. Internal malfunctioning of the Hemoscan Monitoring System. 1. From the Hemoscan Settings sub-screen, deactivate the Hemoscan function. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-83 Cod. 6992200 - Rev. / HEMOCONTROL: LATE ON PRESCRIPTION 229Reason for Alarm A reduction in BV% has occurred, lower than expected and thus a lower Accumulated UF volume (weight loss) is reached.Machine Actions • None.Possible Causes Suggested Action 1. A reduction in BV% has occurred, lower than expected and thus a lower Accumulated UF volume (weight loss) is reached. 1. Press the CONFIRM button to remove the alarm message. If the alarm persists, set a lower Final BV value and/or a lower UF Volume value.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-84 HEMOCONTROL: EARLY ON PRESCRIPTION 230Reason for Alarm A reduction in BV% has occurred, lower than expected and thus a higher Accumulated UF volume (weight loss) is reached.Machine Actions • None.Possible Causes Suggested Action 1. A reduction in BV% has occurred, lower than expected and thus a higher Accumulated UF volume (weight loss) is reached. 1. Press the CONFIRM button to remove the alarm message.If the alarm persists, set a greater Final BV value and/or a greater UF Volume value.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-85 Cod. 6992200 - Rev. / HEMOCONTROL: HIGH NA CONCENTRATION 231Reason for Alarm The actual value of equivalent dialysis fluid sodium concentration has deviated from the path, calculated automatically by the system, by a quantity higher than the Na tolerance set.Machine Actions • None.Possible Causes Suggested Action 1. The actual value of equivalent dialysis fluid sodium concentration has deviated from the path, calculated automatically by the system, by a quantity higher than the Na limits set. 1. Press the CONFIRM button to clear the alarm. If the alarm persists, correct the Final Na value in the Hemocontrol Settings sub-screen, as suggested by the indications displayed.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-86 HEMOCONTROL: LOW NA CONCENTRATION 232Reason for Alarm The actual value of equivalent dialysis fluid sodium concentration has deviated from the path, calculated automatically by the system, by a quantity lower than the Na tolerance set.Machine Actions • None.Possible Causes Suggested Action 1. The actual value of equivalent dialysis fluid sodium concentration has deviated from the path, calculated automatically by the system, by a quantity lower than the Na limits set. 1. Press the CONFIRM button to clear the alarm. If the alarm persists, correct the Final Na value in the Hemocontrol Settings sub-screen, as suggested by the indications displayed.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-87 Cod. 6992200 - Rev. / HEMOCONTROL: BV% NOT AVAILABLE 234Reason for Alarm The HEMOSCAN™ is unable to supply a reliable Blood Volume.Machine Actions • None.Possible Causes Suggested Action 1. The HEMOSCAN™ is unable to supply a reliable Blood Volume. 1. Remove the causes which have stopped the measuring of the Blood Volume by the HEMOSCAN™ or wait.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-88 BIOSLAVE SUBSYSTEM COMMUNICATION ERROR 296Reason for Alarm An internal communication problem between the Master Module and the Bio Module occurred.Machine Actions • None.Possible Cause Suggested Action 1. Temporary communication problem. 1. Wait a few seconds for the alarm to be cleared. 2. If the alarm persists and the machine stops functioning. 2. Perform a Fast Recovery procedure during a dialysis treatment as described in the “7.4 Fast Recovery” section of this Operator’s Manual.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-89 Cod. 6992200 - Rev. / STILL IN BYPASS 302Reason for Alarm The machine has been in BYPASS for more than 6 minutes, either because the operator has deselected the ”DIALYSIS FLUID” button, or due to an internal machine malfunction that is blocking the machine in bypass condition.Machine Actions • None.In DIALYSIS: The alarm is active when the machine is in FULL ACTIVITY with blood detected in the Venous Patient Line. The alarm will be displayed on the Touch Screen 6 minutes after the machine is in BYPASS. Possible Cause Suggested Action 1. Bypass has been selected and not cleared during the treatment. 1. Take the machine out of BYPASS by selecting the ”DIALYSIS FLUID” button. 2. The machine is stuck in bypass. 2. Perform a Fast Recovery procedure during a dialysis treatment as described in the “7.4 Fast Recovery” section of this Operator’s Manual. 3. The “Start Treatment” button has not been pressed. 3. Confirm the mandatory parameters (UF Volume and Treatment Time), if not already done, and then press the “Start Treatment” button.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-90 ARTERIAL PRESSURE HIGH 305Reason for Alarm The measured arterial pressure is above the maximum arterial pressure threshold as displayed in the Arterial Pressure Alarm Window. Machine Actions • The Arterial and the Venous Pumps are stopped; • The Venous Line Clamp is closed; • The UF Rate is automatically set to zero; • The alarm limits are opened for both arterial and venous pressurePossible Cause Suggested Action 1. The Arterial Pressure Alarm Window needs to be set. 1. In the A/V Limit Settings sub-screen adjust the arterial pressure alarm limits;Press “Close A/V Limits” button: the machine automatically centralize the alarm window values around the current patient’s arterial/venous pressures;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. The Arterial Patient Line may have become disconnected from the patient. 2. Carefully check the Cassette connections and the Patient’s Vascular Access;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 3. Loss of diaphragm pressure between the Blood Cassette and the arterial pressure cone. 3. Perform a Cassette Repositioning Procedure, (Refer to the "Chapter 7: Special Procedures", in this Operator’s Manual).When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-91 Cod. 6992200 - Rev. / ARTERIAL PRESSURE BELOW TREATMENT MIN. LIMIT 306Reason for Alarm The measured arterial pressure is below the minimum arterial treatment limit.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero; • The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. The Arterial Pump speed is too fast. 1. Consider decreasing the blood flow if this operation is not in disagreement with the patient prescription.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. The Arterial Patient Line is kinked, clamped or restricted. 2. Check the Arterial Patient Line and the Patient’s Vascular Access for restrictions, such as:• kinks in the Arterial Patient Line;• closed clamps;• clotted arterial needle;• poor flow from the Patient’s Vascular Access.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 3. The arterial pressure decreased somewhat during a treatment due to hemoconcentration and/or inadequate heparin delivery to the patient, resulting in a reduced pressure for a given needle at a fixed blood flow rate. 3. Attention should be given to the revaluation of the needle size, the blood flow rate and the heparin dosage;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-92 WRONG A/V OR SYSTEM PRESSURE OFFSET 319Reason for Alarm The initial Arterial and Venous Pressure offset are out of range or they aren't yet been calculated.Machine Actions • The machine will stop at this point and will not proceed any further into the test.Possible Cause Suggested Action 1. If the Blood Cassette is filled with saline, it is possible to have a pressure different from 0 mmHg. 1. Clamp the prime line, the Arterial infusion line and the Venous infusion line.Open the Venous infusion line and the Arterial infusion line to the atmosphere. The pressures displayed on the Touch Screen should decrease toward 0 mmHg. 2. The Blood Cassette was installed incorrectly during the Venous/Arterial Pressure T1 Test. 2. The Venous Patient Line must be inserted into the Air Detector and the Sensor Bar door closed. The Blood Pump Cover must be closed.Reposition the Blood Cassette and restart the T1 test. 3. The Blood Pump Cover is open. 3. Close the Blood Pump Cover. Be sure the Blood Pump Cover is securely latched. 4. The magnet is dirty. 4. Carefully clean the magnet located behind the Blood Pump Cover, using a soft cloth dipped in Ethyl Alcohol (90°) or in Isopropyl Alcohol (70°). Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-93 Cod. 6992200 - Rev. / REMINDER - STILL IN PAUSE THERAPY 329Reason for Alarm The machine remains in PAUSE TREATMENT for more than 5 minutes.Machine Actions • None.Possible Cause Suggested Action 1. The operator has maintained the selection of PAUSE TREATMENT for more than 5 minutes. 1. Press the CONFIRM button to remove the alarm. Interrupt the PAUSE TREATMENT procedure and continue the treatment.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-94 BLUE DIALYSIS FLUID TUBE INCORRECT POSITION 330 Reason for Alarm The Blue Dialysis Fluid Tube Connector is not in the position required for the current operating phase.Machine Actions • All the hydraulic pumps are stopped;• Waits until the connector is in right position;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Blue Dialysis Fluid Tube Connector is not in the position required for the current operating phase. 1. Verify the correct position of the Blue Dialysis Fluid Tube Connector for the current operating phase.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-95 Cod. 6992200 - Rev. / RED DIALYSIS FLUID TUBE INCORRECT POSITION 331Reason for Alarm The Red Dialysis Fluid Tube Connector is not in the position required for the current operating phase.Machine Actions • All the hydraulic pumps are stopped;• Waits until the connector is in right position;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Red Dialysis Fluid Tube Connector is not in the position required for the current operating phase. 1. Verify the correct position of the Red Dialysis Fluid Tube Connector for the current operating phase. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-96VENOUS PRESSURE NOT INCREASING 351Reason for Alarm In Single Needle Single Pump mode, during the venous phase the venous pressure is not increasing as expected.Machine Actions • The Blood Pump is stopped.Possible Cause Suggested Action 1. The venous pressure is not increasing as expected. 1. Check if the Blood Cassette is properly loaded on the Cassette holder and if it is properly connected to the venous pressure pod. Press the CONFIRM button to restart the Blood Pump and remove the alarm. 2. The Venous/Arterial Patient Line could be kinked, clamped, restricted or have some leakages. 2. Check the Venous/Arterial Patient Line and the Patient’s Vascular Access for kinks, clamps or other restrictions.Press the CONFIRM button to restart the Blood Pump and remove the alarm. 3. The Blood Cassette and/or the SNSP conversion kit could have some leakages. 3. Check the line connections to these devices and ensure that the related clamps are closed.Press the CONFIRM button to restart the Blood Pump and remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-97 Cod. 6992200 - Rev. / NO POWER - USING BATTERY BACKUP 353Reason for Alarm The AC supply voltage has been interrupted in a machine equipped with the BATTERY BACKUP KIT.Machine Actions In RINSE:• The machine automatically switches OFF after 5 minutes.In DISINFECTION and in DIALYSIS:• The heater is turned off. Possible Cause Suggested Action 1. Interruption of the AC supply voltage in RINSE or DISINFECTION. 1. Switch OFF the machine. 2. Interruption of the AC supply voltage in DIALYSIS, during the Dialysis Fluid Preparation phase until Patient Connection. 2. Switch OFF the machine. 3. Interruption of the AC supply voltage in DIALYSIS, during the treatment phase. 3. Perform RINSEBACK to return the blood to the patient and then switch OFF the machine. 4. Interruption of the AC supply voltage in DIALYSIS, during EMPTYING or DESCALING. 4. Switch OFF the machine.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-98 PUMP SPEED TOO LOW 362Reason for Alarm The Blood pump speed is lower than the set value.Machine Actions • The Arterial and the Venous pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero. Possible Cause Suggested Action 1. The Blood pump speed is incorrect. 1. Press the CONFIRM button to re-start the Blood Pump. 2. The Blood Pump speed is too high for the “SN Pressure Min” and “SN Pressure Max” parameter values set by the operator. 2. Decrease the Blood pump speed or consider changing the “SN Pressure Min” and “SN Pressure Max” parameter values.Press the CONFIRM button to re-start the Blood Pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-99 Cod. 6992200 - Rev. / BLOOD PUMP ROTOR ERROR 363Reason for Alarm The Blood Pump is not functioning properly.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero. Possible Cause Suggested Action 1. If the alarm is displayed for the first time. 1. Press the CONFIRM button and continue the process. 2. If the alarm persists. 2. Perform a Fast Recovery procedure during a dialysis treatment as described in the “7.4 Fast Recovery” section of this Operator’s Manual. Then call for Service.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-100 VENOUS LINE NOT IN PATIENT SENSOR 364Reason for Alarm The machine is not detecting that the Venous Patient Line is present into the Air Detector housing or into the Venous Line Clamp (ONLY after Patient Connection).Machine Actions • The Blood Pump is stopped;• The UF Rate is automatically set to minimum;• The Venous Line Clamp is closed.Possible Cause Suggested Action 1. The Venous Patient Line is not properly inserted into the Air Detector housing or into the Venous Line Clamp. 1. Verify that the Venous Patient Line has been inserted correctly into the Air Detector housing and into the Venous Line Clamp.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-101 Cod. 6992200 - Rev. / INCORRECT BICARBONATE CONCENTRATION 366Reason for Alarm The Bicarbonate conductivity is below the set or permitted range.Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Bicarbonate concentrate canister. or the BiCart are almost empty. 1. Verify adequate levels of concentrates. If BiCart, replace as described in the related section of the "Chapter 7: Special Procedures", in this Operator’s Manual. 2. The Bicarbonate pick-up tube connector is not well fitted to the concentrate canister. 2. Verify that the Bicarbonate pick-up tube connector is well fitted to the proper concentrate canister. 3. Massive air leak from the Bicarbonate concentrate canister. 3. Replace the Bicarbonate concentrate canister. 4. The BiCart is not well positioned into its holder. 4. Ensure the BiCart is securely placed into its holder.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-102 DIALYSATE PH LOW 368Reason for Alarm The dialysis fluid pH value is below the alarm threshold. Machine Actions • The dialysis fluid goes into Bypass;• The Venous pump is stopped.Possible Cause Suggested Action 1. The concentrate canisters are empty. 1. Verify that none of the concentrate canisters are empty. 2. The solution in the concentrate canister is not correct or diluted. 2. Verify that concentrates are being used and are of the appropriate formulation for the selected treatment type.If using dialysis fluid concentrate solutions, replace the concentrates as needed, then wait a few seconds for the machine to stabilize.If using solutions other than concentrates during the dialysis fluid preparation:• Stop the dialysis preparation;• Replace the Blood Cassette and the Dialyzer;• Run a complete RINSE procedure;• Replace solutions;• Restart the dialysis fluid preparation. 3. Air leak from the Red/Blue pick-up tube connectors or the Red/Blue pick-up tube is not connected to the Concentrate Canister or the Red/Blue pick-up tube connector has accumulated debris or salt crystals. 3. If the alarm persists, verify that:• the Red and Blue pick-up tube connectors and Red and Blue pick-up tubes are free of leaks/holes and debris.• the Red/Blue pick-up tube connectors are securely connected to the appropriate concentrate connector port/canister.If necessary, rinse the accumulated debris from the Connector(s).Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-103 Cod. 6992200 - Rev. / ACID/ACETATE CONCENTRATE ERROR 369Reason for Alarm A discrepancy is indicated between the conductivity of the dialysis fluid both for the dialysis fluid flow and the rotation speed of the associated Pump(s). The actual Pump(s) speed does not match with the actual concentrate(s) used. Machine Actions • The dialysis fluid goes into Bypass.• The Venous Pump is stopped.Possible Cause Suggested Action 1. The type/dilution of the Acid Concentrate used is incorrect. 1. Verify that the correct type/dilution of Acid Concentrate is being used.Replace the Acid Concentrate as needed, press the CONFIRM button, then wait a few seconds for the machine to stabilize. 2. The concentrate Connector is not securely connected to its port/canister. 2. Verify that the Connector is securely connected to the appropriate port/canister. 3. The Acid Pump speed is incorrect. 3. If the machine does not stabilize, or if the machine has been switched from the Central Concentrate to an individual Concentrate Canister, then perform an Acid Pump Auto-calibration procedure.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-104 BICARBONATE CONCENTRATE ERROR 370Reason for Alarm A discrepancy is indicated between the conductivity of the dialysis fluid both for the dialysis fluid flow and the rotation speed of the associated Pump/Pumps. The actual Pump(s) speed does not match with the actual concentrate(s) used.Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The type/dilution of Bicarbonate Concentrate used is incorrect. 1. Verify that the correct type/dilution of Bicarbonate Concentrate is being used. Replace the Bicarbonate Concentrate as needed, press the CONFIRM button, then wait a few seconds for the machine to stabilize. 2. The Concentrate Connector is not securely connected to its port/canister. 2. Verify that the Connector is securely connected to the appropriate port/canister. 3. The dialysis fluid type selected in the “Fluid Settings“ subscreen is incorrect. 3. Ensure that the correct type of dialysis fluid has been selected on the “Fluid Settings“ subscreen. 4. The Bicarbonate Pump speed is incorrect. 4. If the machine does not stabilize, or if the machine has been switched from the Central Concentrate to an individual Concentrate Canister, then perform a Bicarbonate Pump Auto-calibration procedure.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-105 Cod. 6992200 - Rev. / DIALYSIS FLUID FLOW LOW 373Reason for Alarm The dialysis fluid flow is lower than the set value or than the minimum permitted flow.Machine Actions • The dialysis fluid goes into Bypass;• The Venous pump is stopped.Possible Cause Suggested Action 1. There are deposits or debris inside the flowmeters of the machine. 1. Perform a Chemical Disinfection.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-106INCORRECT CONDUCTIVITY MEASURED 375Reason for Alarm The conductivity of the dialysis fluid is below the allowed limit.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. Inappropriate solution in the Acid Concentrate Canister. 1. Verify that appropriate concentrate has been used for the selected treatment type. 2. Massive air leak from Concentrate Canisters/Connectors/Tubes or the Connectors are not securely connected to their Canisters/Ports or the Canisters/Connectors have accumulated debris or salt crystals. 2. If the alarm persists:• verify that Concentrate Canisters, Connectors and Tubes are free of leaks/holes and debris;• verify that the Connectors are securely connected to the appropriate Canisters/Ports;• if necessary, rinse the accumulated debris from the Canister(s)/Connector(s);• massive air leaks affect conductivity readings. 3. Inadequate Concentrates are being used. 3. If using dialysis fluid concentrate solutions, replace concentrates as needed then wait a few seconds for the machine to stabilize.If using solutions other than concentrates during dialysis fluid preparation:• stop the dialysis fluid preparation;• replace the Blood Cassette and the dialyzer;• run a complete ADR: RINSE procedure;• replace the solutions;• re-start the dialysis fluid preparation. 4. The Acid or Bicarbonate Connector is not properly positioned into the Central Concentrate port. 4. Verify that the Acid or Bicarbonate Connector is properly positioned into the Central Concentrate port on the front panel. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-107 Cod. 6992200 - Rev. / The use of liquid Bicarbonate concentrate is not currently available.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-108 DIALYSIS FLUID TEMPERATURE LOW 377Reason for Alarm The temperature of the dialysis fluid is 2°C below the value set by the operator.Machine Actions • The dialysis fluid goes into Bypass;• The Venous pump is stopped.Possible Cause Suggested Action 1. A temporary instability of dialysis fluid flow. 1. Wait a few seconds for the system to stabilize. 2. The temperature of the dialysis fluid has exceeded the safe limits. 2. Verify that the incoming water temperature is between 5.0°C - 32.2°C (41-90 degrees F).If the incoming water temperature exceeds the specified range, then adjust the temperature of the water source per clinical policy.If this alarm persists, then discontinue the dialysis treatment.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-109 Cod. 6992200 - Rev. / UF RATE LOWER THAN EXPECTED 379Reason for Alarm The ultrafiltration rate (UFR) is below the value confirmed by the operator or the minimum permitted value.Machine Actions • The Venous Pump is stopped;• The dialysis fluid goes into Bypass;• Calibration request.Possible Cause Suggested Action 1. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect valves control. 1. Press the CONFIRM button and continue the treatment. 2. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect flowmeter reading. 2. Press the CONFIRM button and continue the treatment. 3. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect P2 pump flow or P2 reading. 3. Press the CONFIRM button and continue the treatment. 4. The machine could not perform an alignment of the D2 flowmeter during the treatment and the Ultrafiltration Mass Balance could be incorrect. 4. Press the CONFIRM button and continue the treatment.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-110 VENOUS PRESSURE LOW 382Reason for Alarm The measured venous pressure is either below +10 mmHg or below the venous pressure threshold as displayed in the Venous Pressure Alarm Window.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero; • The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. If <10 mmHg, the Venous Patient Line may have become disconnected from the patient. 1. Carefully check the Patient’s Vascular Access, the Cassette connections and inspect for kinking of the Venous Patient Line.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-111 Cod. 6992200 - Rev. / ARTERIAL PRESSURE LOW 384Reason for Alarm The measured arterial pressure is below the minimum arterial pressure threshold, as displayed in the Arterial Pressure Alarm Window.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero; • The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. The Arterial pressure alarm window needs to be set. 1. In the A/V Limit Settings sub-screen adjust the arterial pressure alarm limits;Press “Close A/V Limits” button: the machine automatically centralize the alarm window values around the current patient’s arterial/venous pressures.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. The Arterial Patient Line may have become disconnected from the patient. 2. Carefully check the Cassette connections and the Patient's Vascular Access. When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 3. The Arterial Patient Line is kinked, clamped or restricted. 3. Check the Arterial Patient Line and the Patient's Vascular Access for restrictions, such as:• kinks in the Arterial Patient Line;• closed clamps;• clotted arterial needle; • poor flow from the Patient’s Vascular Access.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-112 4. Loss of diaphragm pressure between the Blood Cassette and the arterial pressure cone. 4. Perform a Cassette Repositioning Procedure (Refer to the "Chapter 7: Special Procedures", in this Operator’s Manual). When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. Call for Service if the alarm persists.Possible Cause (Continued) Suggested Action (Continued)
Chapter 15: Alarms and Troubleshooting15-113 Cod. 6992200 - Rev. / AIR IN BLOOD T0 FAILURE 385Reason for Alarm The T0 Test, related to the Air Detector sensor, has failed.Machine Actions • The Blood Pump is stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to minimum.Possible Cause Suggested Action 1. The T0 Test failed. 1. Press the CONFIRM button to remove the alarm. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-114 NA OR BIC SETTINGS RESULT IN CONDUCTIVITY OUT OF RANGE 401Reason for Alarm The Sodium or Bicarbonate Settings result in conductivity out of range.Machine Actions • The machine continues the treatment with the previous conductivity set; • The new set conductivity is not stored in the machine memory. Possible Cause Suggested Action 1. One of the formula input (Na set, HCO3 set, Concentrate set) causes the results out of range. 1. Change the value of the formula input.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-115 Cod. 6992200 - Rev. / ULTRAFILTER REPLACEMENT REMINDER 402Reason for Alarm The machine notifies that the ultrafilters should be replaced.Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The ultrafilters should be replaced. 1. Press the CONFIRM button to remove the alarm.If needed, replace the ultrafilters with new ones (Refer to the “7.18 Ultrafilter Change Procedure” section of this Operator’s Manual). Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-116 SELECT BAG HOLDER INCORRECT POSITION 411Reason for Alarm The Select Bag holder is in the wrong position.Machine Actions In DIALYSIS:• All hydraulic module pumps are stopped;• The dialysis fluid goes into Bypass;• Waits until the connector is in right position.In ADR:• The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Select Bag holder is in the wrong position. 1. Check the position of the Select Bag holder.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-117 Cod. 6992200 - Rev. / VENOUS FLOW MINIMUM 412Reason for Alarm The venous blood flow is lower than the expected set value.Machine Actions • The Venous Pump is stopped.Possible Cause Suggested Action 1. The Venous Pump speed is different from the set value. 1. Press the CONFIRM button to restart the Blood Pump.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-118VENOUS FLOW MAXIMUM 413Reason for Alarm The venous blood flow is greater than the expected set value.Machine Actions • The Venous Pump is stopped.Possible Cause Suggested Action 1. The Venous Pump speed is different from the set value. 1. Press the CONFIRM button to restart the Blood Pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-119 Cod. 6992200 - Rev. / NO POWER - USING BATTERY BACKUP 415Reason for Alarm A power failure occurred and therefore the battery back-up is used.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. Interruption of the AC supply voltage in DIALYSIS, during the Dialysis fluid Preparation phase until Patient Connection. 1. Switch OFF the machine. 2. Interruption of the AC supply voltage in DIALYSIS, during the treatment phase. 2. Perform RINSEBACK to return the blood to the patient and then switch OFF the machine. 3. Interruption of the AC supply voltage in DIALYSIS, before the patient connection or after the patient disconnection. 3. Switch OFF the machine.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-120 LEFT BLUE EVACLEAN DOOR INCORRECT POSITION 416Reason for Alarm The Left Blue EvaClean door position is wrong.Machine Actions The machine waits until the EvaClean Door is closed, in the meantime:In DIALYSIS: • All hydraulic module pumps are stopped;• The dialysis fluid goes into Bypass.In ADR:• The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Left Blue EvaClean door is open when it should be closed. 1. Verify that the door is closed. 2. The Left Blue EvaClean door is closed when it should be opened. 2. Verify that the door is opened.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-121 Cod. 6992200 - Rev. / RIGHT RED EVACLEAN DOOR INCORRECT POSITION 417Reason for Alarm The Right Red EvaClean door position is wrong.Machine Actions • The machine stops and waits for the EvaClean Door to be closed. Possible Cause Suggested Action 1. The Right Red EvaClean door is open when it should be closed. 1. Verify that the door is closed. 2. The Right Red EvaClean door is closed when it should be opened. 2. Verify that the door is opened.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-122 T1 TEST PRE FILTER PRESSURE 418Reason for Alarm The acquired inlet pressure value is out of range respect to the set point.Machine Actions • None.Possible Cause Suggested Action 1. The T1 test failed during preparation. 1. Verify that the dialysis fluid connectors are properly positioned to their bypass ports. Repeat the dialysis fluid preparation.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-123 Cod. 6992200 - Rev. / T1 TEST ARTERIAL PUMP/ABD 419Reason for Alarm The acquired flow value is out of range respect to the set point. Machine Actions • None.• If the alarm condition persists after the preparation phase, it will not be possible to start the treatment.Possible Cause Suggested Action 1. The T1 test failed during preparation. 1. Press the CONFIRM button to remove the alarm.Perform an Extra Priming procedure.Call for Service if the alarm persists.This alarm appears also in case the Arterial Pump cover is opened and then closed while the machine is performing the T1 Arterial Pump/ABD test. In this case, pressing the CONFIRM button, the alarm message is removed but if the “Reset Prime” button is pressed, the priming procedure gets stuck.To restore the priming procedure, proceed as follows: 1. Open the Arterial Pump Cover; 2. Close the Arterial Pump Cover; 3. Press the “Auto-Prime” button to start again the priming procedure.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-124 T1 TEST FLOW METERS 422Reason for Alarm The T1 test performed by the machine on the T1 Test Flow Meters has failed or it has exceeded the maximum allowed time for the execution.Machine Actions • None.• If the alarm condition persists after the preparation phase, it will not be possible to start the treatment.Possible Cause Suggested Action 4. The T1 test Flowmeter failed. 1. Press the CONFIRM button and wait for the new flowmeter test. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-125 Cod. 6992200 - Rev. / ON-LINE DOOR INCORRECT POSITION 423Reason for Alarm The Ultra Door position is wrong.Machine Actions • The phase currently running stops;• All the pumps are stopped;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Ultra Door is open when it should be closed. 1. Verify that the door is closed. 2. The Ultra Door is closed when it should be opened. 2. Verify that the door is opened.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-126 SENSOR BAR DOOR OPEN 424Reason for Alarm The sensor detected that the Sensor Bar Door is open. Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Sensor Bar Door is open when it should be closed. 1. Verify that the door is closed.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-127 Cod. 6992200 - Rev. / DIALYSIS FLUID FLOW TOO LOW 425Reason for Alarm The dialysis fluid flow is lower than the set value or than the minimum permitted flow.Machine Actions • The phase currently running stops;• All the pumps are stopped;• The dialysis fluid goes into Bypass. Possible Cause Suggested Action 1. There are deposits or debris inside the flowmeters of the machine. 1. Perform a Chemical Disinfection.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-128 NOT PERFORMING UF 443Reason for Alarm The UF button has been deselected during treatment.Machine Actions • None.Possible Cause Suggested Action 1. During treatment the operator has deselected the UF button (the machine doesn't apply UF for six consecutive minutes, so an alarm message will be displayed). 1. Press the CONFIRM button to remove the alarm message (pay attention that UF doesn't restart automatically).Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-129 Cod. 6992200 - Rev. / T1 TEST TEMPERATURE FAILED 444Reason for Alarm The T1 test performed by the machine on the Temperature has failed.Machine Actions • None.• If the alarm condition persists after the preparation phase, it will not be possible to start the treatment.Possible Cause Suggested Action 1. The T1 test Temperature failed. 1. Press the CONFIRM button and wait the machine to perform another Temperature test.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-130 T1 TEST CONDUCTIVITY CELL FAILED 445Reason for Alarm The T1 test performed by the machine on the Conductivity cells has failed.Machine Actions • None.• If the alarm condition persists after the preparation phase, it will not be possible to start the treatment.Possible Cause Suggested Action 1. The T1 test Conductivity failed. 1. Press the CONFIRM button and wait the machine to perform another Conductivity test.If the alarm persists, call for service.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-131 Cod. 6992200 - Rev. / T1 TEST VENOUS PRESSURE 446Reason for Alarm The T1 test performed by the machine on the Venous pressure has failed.Machine Actions • None.• If the alarm condition persists after the preparation phase, it will not be possible to start the treatment.Possible Cause Suggested Action 1. The T1 test Venous pressure failed. 1. Press the CONFIRM button and perform unload/load cassette for a new Venous pressure test.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-132 T1 TEST ARTERIAL PRESSURE 447Reason for Alarm The T1 test performed by the machine on the Arterial pressure has failed.Machine Actions • None.• If the alarm condition persists after the preparation phase, it will not be possible to start the treatment.Possible Cause Suggested Action 1. The T1 test Arterial pressure failed. 1. Press the CONFIRM button and perform unload/load cassette for a new Arterial pressure test.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-133 Cod. 6992200 - Rev. / COMMUNICATION PROTECTIVE COND. CELL STOPPED 449Reason for Alarm The communication between the Protective System and the conductivity cell Γp has failed.Machine Actions • None.Possible Cause Suggested Action 1. Temporary problem. 1. Press the CONFIRM button to remove the alarm.If the problem persists, disconnect the patient.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-134 COMMUNICATION SELECT COND. CELL STOPPED 450Reason for Alarm The communication between the Protective System and the conductivity cell GcP has failed. Machine Actions • None. Possible Cause Suggested Action 1. Temporary problem. 1. Press the CONFIRM button to remove the alarm.If the problem persists, disconnect the patient.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-135 Cod. 6992200 - Rev. / PDR PRESSURE HIGH 452Reason for Alarm The pressure of the dialysis fluid that is going to the drain, measured by the PD pressure sensor, is higher than the permitted value.Machine Actions • The phase currently running stops;• All the pumps are stopped;• The dialysis fluid goes into Bypass. Possible Cause Suggested Action 1. Temporary problem. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-136 PDR PRESSURE LOW 453Reason for Alarm The pressure of the dialysis fluid that is going to the drain, measured by the PD pressure sensor, is lower than the permitted value.Machine Actions • The phase currently running stops;• All the pumps are stopped;• The dialysis fluid goes into Bypass. Possible Cause Suggested Action 1. Temporary problem. 1. Press the CONFIRM button to remove the alarm. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-137 Cod. 6992200 - Rev. / INSERT THE HEMOSCAN CUVETTE 454Reason for Alarm The Hemoscan Cuvette is not inserted into the Sensor Bar door.Machine Actions • The appearance of the Auto-Prime Action button has been delayed.• None. Possible Cause Suggested Action 1. The cassette is loaded and the cover is open and/or the cuvette is not present. 1. Insert the Arterial Patient Line with the Hemoscan cuvette into the Sensor Bar. Firmly close the Sensor Bar door. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-138ARTERIAL PRESSURE HIGH 457Reason for Alarm The measured arterial pressure is above the maximum arterial treatment limit.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero; • The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. The Arterial Patient Line may have become disconnected from the patient. 1. Carefully check the Cassette connections and the Patient’s Vascular Access. When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. The Arterial Pump speed is too low. 2. Consider increasing the blood flow if this operation is not in disagreement with the patient prescription.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-139 Cod. 6992200 - Rev. / VENOUS PRESSURE BELOW TREATMENT MIN. LIMIT 459Reason for Alarm The measured venous pressure is below the minimum venous treatment limit.Machine Actions • The Arterial and the Venous Pumps are stopped;• The Venous Line Clamp is closed;• The UF Rate is automatically set to zero (typical value 100 ml/h); • The alarm limits are opened for both arterial and venous pressure.Possible Cause Suggested Action 1. Restriction of blood flow to the Patient’s Vascular Access or in the Venous Patient Line. 1. Carefully check the Blood Cassette connections and assess the Patient’s Vascular Access. Check for restrictions, such as: • kinks in the Venous Patient Line;• closed clamps;• clotted venous needle. If necessary decrease the blood flow per clinical policy.When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump. 2. The venous pressure has decreased somewhat during a treatment due to hemoconcentration and/or inadequate heparin delivery to the patient, resulting in a pressure decrease for a given needle at a fixed blood flow rate. 2. Attention should be given to the revaluation of the needle size, the blood flow rate and the heparin dosage;When the pressure stabilizes, select the alarm in the Alarm Area and press the CONFIRM button to restart the blood pump.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-140 DIALYSIS FLUID TEMP TOO HIGH 460Reason for Alarm The temperature of the dialysis fluid measured by the ΓP conductivity cell is greater than 41°C.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. A temporary instability of dialysis fluid flow. 1. Wait for stability of the system. 2. The temperature of the dialysis fluid has exceeded the safe limits. 2. Check the incoming water temperature (Refer to the "Chapter 16: Specifications" in this Operator’s Manual). 3. The machine has recently been turned on and has not yet reached the operating temperature. 3. If the machine temperature remains high or low for more than 10 minutes, discontinue the DIALYSIS. 4. The machine has an internal malfunction. 4. Discontinue the DIALYSIS.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-141 Cod. 6992200 - Rev. / DIALYSIS FLUID TEMP TOO LOW 461Reason for Alarm The temperature of the dialysis fluid measured by the ΓP conductivity cell is lower than 32°CMachine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. There are deposits or debris inside the flowmeters of the machine. 1. Perform a Chemical Disinfection.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-142CONDUCTIVITY TOO LOW 462Reason for Alarm The measured conductivity is below the desired set point. Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. Inappropriate solution in the Acid Concentrate Canister. 1. Verify that concentrates are being used and are of the appropriate formulation for the selected treatment type. 2. Massive air leak from Concentrate Canisters/Connectors/Tubes or the Connectors are not securely connected to their Canisters/Ports or the Canisters/Connectors have accumulated debris or salt crystals. 2. If the alarm persists: • verify that Concentrate Canisters, Connectors and Tubes are free of leaks/holes and debris; • verify that the Connectors are securely connected to the appropriate Canisters/Ports;• If necessary, rinse the accumulated debris from the Canister(s)/Connector(s);• massive air leaks affect the conductivity readings. 3. Inadequate Concentrates are being used. 3. If using dialysis fluid concentrate solutions, replace the concentrates as needed, then wait a few seconds for the machine to stabilize. If using solutions other than concentrates during the dialysis fluid preparation:• stop the dialysis fluid preparation;• replace the Blood Cassette and the dialyzer;• run a complete ADR: RINSE procedure;• replace the solutions;• re-start the dialysis fluid preparation. 4. The Acid or Bicarbonate pick-up tube connector is not properly positioned into the Central Concentrate port. 4. Verify that the Acid or Bicarbonate pick-up tube connector is properly positioned into the Central Concentrate port on the front panel.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-143 Cod. 6992200 - Rev. / The use of liquid Bicarbonate concentrate is not currently available.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-144 CONDUCTIVITY TOO HIGH 463Reason for Alarm The measured conductivity is above the desired set point.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. The Acid or Bicarbonate Concentrate canister is empty. 1. Supply appropriate concentrate to the relevant inlet connector. Wait for stability of the dialysis fluid flow. 2. The Acid or Bicarbonate pick-up tube connector(s) are not properly positioned to the concentrate Canister(s). 2. Verify the connector(s) are properly positioned to the proper Canister(s). Wait for stability of the dialysis fluid flow. 3. Massive air leak from the concentrate canister. 3. Replace the concentrate canister. Wait for stability of the dialysis fluid flow. 4. The Acid or Bicarbonate pick-up tube connector(s) has accumulated debris or salt crystals. 4. Rinse the accumulated debris from the connector(s). 5. Inappropriate solution in the Acid concentrate canister. 5. Verify that appropriate concentrate has been used. 6. When using central delivery acid, the Acid or Bicarbonate pick-up tube connector is not securely connected into its concentrate connector port. 6. Verify that the Acid or Bicarbonate pick-up tube connector is properly positioned in its concentrate connector port.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-145 Cod. 6992200 - Rev. / INCORRECT BICARBONATE CONCENTRATION 464Reason for Alarm The conductivity of the solution after the mixing of the bicarbonate and the select bag is below the setpoint fixed by the operator.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. The Bicarbonate Concentrate Canister or BiCart are almost empty. 1. Verify adequate levels of concentrates. If BiCart, replace as described in the related section of the "Chapter 7: Special Procedures", in this Operator’s Manual. 2. The Bicarbonate pick-up tube connector is not well fitted to the Concentrate Canister. 2. Verify the Bicarbonate pick-up tube connector is well fitted to the proper Canister. 3. Massive air leak from the Bicarbonate Concentrate Canister. 3. Replace the Bicarbonate Concentrate Canister. 4. The BiCart is not well positioned into its holder. 4. Ensure the BiCart is securely placed into its holder.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-146 INCORRECT BICARBONATE CONCENTRATION 465Reason for Alarm The conductivity of the solution after the mixing of bicarbonate and select bag is above the setpoint fixed by the operator.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped.Possible Cause Suggested Action 1. The Bicarbonate pick-up tube connector is not well fitted to the Concentrate Canister. 1. Verify the Bicarbonate pick-up tube connector is well fitted to the proper Canister. 2. Massive air leak from the Bicarbonate Concentrate Canister. 2. Replace the Bicarbonate Concentrate Canister. 3. The BiCart is not well positioned into its holder. 3. Ensure the BiCart is securely placed into its holder.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-147 Cod. 6992200 - Rev. / LEAKAGES TEST (A) FAILURE 467Reason for Alarm Failure of the leakages test on the PO, PFS, PD pressure sensors: pressure sensor out of calibration.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-148 LEAKAGES TEST (B) FAILURE 468Reason for Alarm Failure of the leakages test on the R1 pressure regulator: pressure regulator out of calibration.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-149 Cod. 6992200 - Rev. / LEAKAGES TEST (C) FAILURE 469Reason for Alarm Failure of the leakages test on the PDrain, PFS or PO pressure sensors: pressure failure.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-150 LEAKAGES TEST (D) FAILURE 470Reason for Alarm Failure of the leakages test on the PO, PFS and PD pressure sensors: negative calibration of pressure sensor.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test. 2. The Venous and Arterial Patient Lines are not properly connected to the EvaClean port. 2. Verify that the Venous and Arterial Patient Lines are properly connected.Press the CONFIRM button to repeat the current leakage test. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-151 Cod. 6992200 - Rev. / VENOUS PRESSURE NOT DECREASING 472Reason for Alarm In Single Needle Single Pump mode, during the venous phase the venous pressure is not decreasing as expected.Machine Actions • None.Possible Cause Suggested Action 1. The venous pressure is not decreasing as expected. 1. Check if the Blood Cassette is properly loaded on the Cassette holder and if it is properly connected to the venous pressure pod.Press the CONFIRM button to remove the alarm. 2. The Venous/Arterial Patient Line could be kinked, clamped, restricted or have some leakages. 2. Check the Venous/Arterial Patient line and the Patient’s Vascular Access for kinks, clamps or other restrictions.Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-152 HEMOSCAN AUTOCALIBRATION FAILURE 473Reason for Alarm Failure of the Hemoscan Autocalibration. Machine Actions • None. Possible Cause Suggested Action 1. Problem in the calculated coefficients in the autocalibration process of the Hemoscan. 1. Deactivate the Hemoscan. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-153 Cod. 6992200 - Rev. / PREPARATION NOT COMPLETED - INCORRECT CONDITION ON D1 FLOW RATE 474Reason for Alarm During preparation, the flow of the D1Control Flowmeter is not stable.Machine Actions • None.Possible Cause Suggested Action 1. Massive air in the hydraulic circuit. 1. Check that all the connectors are inserted in the machine. Then press the CONFIRM button. 2. Probable tubing popping upstream the D1 Control Flowmeter. 2. Switch off the machine. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-154 PREPARATION NOT COMPLETED - INCORRECT CONDITION ON TCA 475Reason for Alarm During preparation, the flow of the TcA Control Sensor is not stable.Machine Actions • None.Possible Cause Suggested Action 1. Probable drift of the Tp or TcA temperature sensor. 1. Press the CONFIRM button. If the problem persist, switch off the machine and call for service.
Chapter 15: Alarms and Troubleshooting15-155 Cod. 6992200 - Rev. / PREPARATION NOT COMPLETED - INCORRECT CONDITION ON ACETATE DISTRIBUTION 476Reason for Alarm The dialysis fluid cannot reach the condition required on the acetate conductivity.Machine Actions • None.Possible Cause Suggested Action 1. Massive air leak from the Acid Pick-up Tube. 1. Check the Acid Pick-up Tube. Then press the CONFIRM button. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-156 PREPARATION NOT COMPLETED - INCORRECT CONDITION ON BICARBONATE DISTRIBUTION 477Reason for Alarm The dialysis fluid cannot reach the condition required on the bicarbonate conductivity.Machine Actions • None.Possible Cause Suggested Action 1. Massive air leak from the Bicarbonate Pick-up Tube. 1. Check the Bicarbonate Pick-up Tube. Then press the CONFIRM button. Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-157 Cod. 6992200 - Rev. / REMINDER - STILL IN ISOLATED UF 479Reason for Alarm The simplified “Isolated UF” action button has been activated.Machine Actions • None. Possible Cause Suggested Action 1. More than 2 minutes have elapsed since the "Isolated UF" action button has been selected. 1. If the Isolated UF functionality is still desired press the CONFIRM button.Otherwise deactivate the function by pressing the activated "Isolated UF" action button.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-158 INCORRECT FLUID CONDUCTIVITY DETECTED 496Reason for Alarm The measured conductivity is outside the safety range limits.Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. Acid concentrate not correctly supplied. 1. Supply appropriate concentrate to the relevant inlet connector. Wait for stable condition. 2. Massive air leak from the Acid Concentrate Canister. 2. Check and if necessary replace the Acid Concentrate Canister. 3. Acid pick-up tube connector not connected to the Concentrate Canister. 3. Verify the Acid pick-up tube connector is well fitted into the proper Canister. 4. Bicarbonate not correctly supplied. 4. Replace the BiCart according to the BiCart Change procedure. 5. The Bicarbonate powder is not well distributed in the BiCart Cartridge. 5. Tap the bottom of the BiCart Cartridge to evenly distribute the powder. Wait for stable condition. 6. The BiCart Cartridge is in the wrong position. 6. Ensure the BiCart is securely placed into its holder.Repeat the BiCart Change procedure.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-159 Cod. 6992200 - Rev. / LEAKAGES TEST (E) FAILURE 498Reason for Alarm Failure of the leakages test on delivery of dialysis fluid in the hydraulic circuit and control of the patient weight loss.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test. 2. The Venous and Arterial Patient Lines are not properly connected to the EvaClean port. 2. Verify that the Venous and Arterial Patient Lines are properly connected.Press the CONFIRM button to repeat the current leakage test.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-160 LEAKAGES TEST (F) FAILURE 499Reason for Alarm Failure of the leakages test on delivery of dialysis fluid in the hydraulic circuit and control of the patient weight loss.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-161 Cod. 6992200 - Rev. / LEAKAGES TEST (G) FAILURE 500Reason for Alarm Failure of the leakages test on the PDrain, PFS or PO pressure sensors: negative pressure failure.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-162 REMINDER - WRONG DIP SWITCHES 502Reason for Alarm The Dip Switch configuration detected by the machine is incorrect.Machine Actions • None.Possible Cause Suggested Action 1. The machine is not properly configured. 1. Press the CONFIRM button. If the alarm persists, switch off the machine and call for service.
Chapter 15: Alarms and Troubleshooting15-163 Cod. 6992200 - Rev. / WRONG ARTERIAL AND VENOUS TREATMENT LIMITS 503 Reason for Alarm This alarm occurs after that the alarm #525 has been triggered and not resolved within the due time (after 30 seconds in HD; 60 seconds in HDF). The arterial and venous pressure treatment limits are open for a long time interval. Machine Actions • None.Possible Cause Suggested Action 1. The “Close A/V Limits” button has not been pressed within the due time. 1. Press the CONFIRM button to remove the alarm message. 2. The A/V pressure limits have not been automatically closed within the due time. 2. Carefully check the Patient’s Vascular Access and inspect the Arterial and Venous Patient Lines;Press the CONFIRM button to remove the alarm message. 3. The A/V pressures have exceeded the upper/lower intervals. 3. Carefully check the Patient’s Vascular Access and inspect the Arterial and Venous Patient Lines;Press the CONFIRM button to remove the alarm message. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-164LOW DISINFECTANT LEVEL IN LAST CLEAN CART PROCESS 504 Reason for Alarm The Clean Cart C dilution is not properly performed. Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Clean Cart Holder Arms are in the wrong position or not securely closed. 1. Verify the correct position of the CleanCart Holder Arms in relation to the machine phase. Press the CONFIRM button.Switch the machine OFF, wait at least five seconds, switch it ON again and repeat the procedure to perform. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-165 Cod. 6992200 - Rev. / UF DEVIATION 505Reason for Alarm The machine has detected an incorrect weight loss management.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped;• Calibration request.Possible Cause Suggested Action 1. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect valves control. 1. Press “Stop Treatment”;Perform a rinseback;Disconnect the patient. 2. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect flowmeter reading. 2. Press “Stop Treatment”;Perform a rinseback;Disconnect the patient. 3. Error in the Ultrafiltration Mass Balance in the Hydraulic Module, due to incorrect P2 pump flow or P2 reading. 3. Press “Stop Treatment”;Perform a rinseback;Disconnect the patient. 4. The machine could not perform an alignment of the D2 flowmeter during the treatment and the Ultrafiltration Mass Balance could be incorrect. 4. Press “Stop Treatment”;Perform a rinseback;Disconnect the patient.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-166 FLOWMETER ALIGNMENT FAILED 506Reason for Alarm Error in the Ultrafiltration Mass Balance in the Hydraulic Module.Machine Actions • The dialysis fluid goes into Bypass;• The Venous Pump is stopped;• Calibration request.Possible Cause Suggested Action 1. Temporary problem. 1. Press the CONFIRM button. If the problem persists disconnect the patient.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-167 Cod. 6992200 - Rev. / BLOOD CASSETTE PRESENCE REQUIRED 507Reason for Alarm The Blood Cassette is not detected by the presence switch.Machine Actions • None.Possible Cause Suggested Action 1. The Blood Cassette was not loaded properly by the operator. 1. Load the Blood Cassette.If after the loading of the Blood Cassette the error persists, call for Service. 2. The Blood Cassette does not fit the pressure transducer. 2. Repeat the loading procedure for the Blood cassette.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-168 WRONG DISPOSABLE CONFIGURATION ON ULTRA CASSETTE HOLDER 508Reason for Alarm The Ultra Cassette is not detected by the presence switch.Machine Actions • None.Possible Cause Suggested Action 1. The Ultra Cassette was not loaded properly by the operator. 1. Load the Ultra Cassette.If after the loading of the Ultra Cassette the error persists, call for Service. 2. The Ultra Cassette does not fit the pressure transducer. 2. Repeat the loading procedure for the Ultra cassette.Call for Service if the alarm persists.This alarm can be triggered also if the following sequence is performed: 1. “Switch to HD” special procedure; 2. “Change Circuit” special procedure; 3. Blood Cassette priming; 4. Reset Priming.In this case, the machine gets stuck and to solve the problem it is necessary to switch the machine OFF and then ON again.NOTE
Chapter 15: Alarms and Troubleshooting15-169 Cod. 6992200 - Rev. / BLOOD LINES CLAMPED 509Reason for Alarm The Blood lines are clamped or kinked. Machine Actions • The Arterial Pump is stopped;• The UF Rate is automatically set to zero;• The dialysis fluid goes into bypass.Possible Cause Suggested Action 1. The Blood lines are clamped or kinked. 1. Verify that the blood lines are not clamped or kinked, then press the CONFIRM button to continue the process.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-170 SMART SCAN - LOW QB 512Reason for Alarm The average blood flow rate (QB) value, measured during the last 5 minutes, is lower than 50 ml/min. Machine Actions • None. Possible Cause Suggested Action 1. The QB value, measured during the last 5 minutes, is lower then 50 ml/min. 1. Verify that the set QB value is the desired one; then press the CONFIRM button. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-171 Cod. 6992200 - Rev. / SMART SCAN - LOW QD 513Reason for Alarm The ratio Dialysis fluid flow rate/Blood flow rate (QD/QB) has been lowerthan 1.5 during the last 10 minutes. Machine Actions • None. Possible Cause Suggested Action 1. The ratio Dialysis fluid flow rate/Blood flow rate (QD/QB) has been lower than 1.5 during the last 10 minutes. 1. Increase the QD value in order to keep the ratio QD/QB between 1.5 and 3.Then press the CONFIRM button. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-172 SMART SCAN - HIGH QD 514Reason for Alarm The ratio Dialysis fluid flow rate/Blood flow rate (QD/QB) has been higher than 3 during the last 10 minutes.Machine Actions • None. Possible Cause Suggested Action 1. The ratio Dialysis fluid flow rate/Blood flow rate (QD/QB) has been higher than 3 during the last 10 minutes. 1. Decrease the QD value in order to keep the ratio QD/QB between 1.5 and 3.Then press the CONFIRM button. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-173 Cod. 6992200 - Rev. / SALINE BAG NOT CONNECTED 515Reason for Alarm The machine does not detect saline solution inside the Venous Patient Line during priming phase. Machine Actions • The phase currently running stops. Possible Cause Suggested Action 1. The machine does not detect saline inside the Venous Patient Line. 1. Check the Saline Bag clamp is open, then press the CONFIRM button. 2. The machine does not detect saline inside the Venous Patient Line. 2. Check that the Venous Line Clamp is open, then press the CONFIRM button. 3. The machine does not detect saline inside the Venous Patient Line. 3. Check that the pin of the Saline Bag is correctly broken. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-174 VENOUS LINE CLAMPED 516Reason for Alarm The Venous Patient Line is clamped or kinked. Machine Actions • The phase currently running stops. Possible Cause Suggested Action 1. The Venous Patient Line is clamped or kinked. 1. Check that the Venous Patient Line is not clamped or kinked, then press the CONFIRM button. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-175 Cod. 6992200 - Rev. / ARTERIAL LINE CLAMPED 517Reason for Alarm The Arterial Patient Line is clamped or kinked. Machine Actions • The phase currently running stops. Possible Cause Suggested Action 1. The Arterial Patient Line is clamped or kinked. 1. Check that the Arterial Patient Line is not clamped or kinked, then press the CONFIRM button. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-176 LINE NOT CONNECTED IN EVACLEAN PORT OR ACCESS LINE OPEN 518Reason for Alarm Line not connected or not correctly connected to the EvaClean Ports. Machine Actions • The phase currently running stops. Possible Cause Suggested Action 1. Line Not Connected to the EvaClean Ports. 1. Check that the arterial and Venous Patient Lines are correctly connected to the EvaClean port, then press the CONFIRM button. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-177 Cod. 6992200 - Rev. / ARTERIAL INFUSION LINE OPEN 519Reason for Alarm The clamp on the Arterial Infusion Line is open.Machine Actions • The phase currently running stops. Possible Cause Suggested Action 1. One of the clamps on the Arterial Infusion Lines is open. 1. Check that the clamps on the Arterial Infusion Lines are securely closed, then press the CONFIRM button. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-178 VENOUS PUMP ROTOR ERROR 521Reason for Alarm The Venous Pump is in failure. Machine Actions • None. Possible Cause Suggested Action 1. The Venous Pump is stopped. 1. Press the CONFIRM button to remove the alarm. . Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-179 Cod. 6992200 - Rev. / SYSTEM PRESSURE OUT OF RANGE 522 Reason for Alarm The system pressure is beyond the upper or lower limit of the sensor. Machine Actions • None. Possible Cause Suggested Action 1. A safety condition has not been satisfied when an alarm occurred. 1. Perform a Fast Recovery procedure during dialysis treatment (Refer to the “7.4 Fast Recovery” section of this Operator’s Manual). Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-180 HEMOCONCENTRATION RISK 524 Reason for Alarm The filtration ratio exceeds the allowed range. Machine Actions • None. Possible Cause Suggested Action 1. Filtration Ratio Out of Range. 1. Increase the Arterial pump speed. 2. Filtration Ratio Out of Range. 2. Decrease the Venous pump speed. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-181 Cod. 6992200 - Rev. / PRESSURE ALARM LIMITS STILL EXPANDED 525 Reason for Alarm • The operator has not pressed the “Close A/V Limits” button to close the pressure alarm limits within the due time (30 seconds in HD; 120 second in HDF). • After a change of the blood flow rate, the machine was not able to automatically close the A/V pressure limits within the due time (30s in HD; 120s in HDF) because the new A/V pressure values set are not consistent with the change of the blood flow rate, compared to the previous A/V pressure values set. Machine Actions • None. Possible Cause Suggested Action 1. The “Close A/V Limits” button has not been pressed within the due time. 1. Press the “Close A/V Limits” button: the machine automatically centralizes the alarm window values around the current patient’s arterial/venous pressures. 2. The A/V pressure limits have not been automatically closed within the due time. 2. Carefully check the Patient’s Vascular Access and inspect the Arterial and Venous Patient Lines;Press the “Close A/V Limits” button: the machine automatically centralizes the alarm window values around the current patient’s arterial/venous pressures. 3. The arterial or venous pump has been stopped by the operator or due to an alarm condition and restarted again. The A/V pressures have therefore exceeded the upper/lower intervals. 3. Carefully check the Patient’s Vascular Access and inspect the Arterial and Venous Patient Lines;Press the “Close A/V Limits” button: the machine automatically centralizes the alarm window values around the current patient’s arterial/venous pressures. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-182 REMINDER - HDF SUBSTITUTION STILL DISABLED 526 Reason for Alarm During On Line treatment phases, the HDF Substitution button remains Off for more than 5 min. Machine Actions • None. This alarm is triggered in the following cases:• At the beginning of the HDF Treatment, if the HDF Substitution button is not pressed within five minutes. When the alarm is confirmed the alarm disappears even if the HDF Substitution button is not activated.• Each time the HDF Substitution button is activated and then deactivated if it remains deactivated for 5 minutes. The alarm disappears when the CONFIRM button is pressed to confirm the alarm.Possible Cause Suggested Action 1. HDF Substitution still disabled. 1. Press the CONFIRM button to confirm the alarm;Press the HDF Substitution button to restart the infusion of substitution fluid. Call for Service if the alarm persists.NOTE
Chapter 15: Alarms and Troubleshooting15-183 Cod. 6992200 - Rev. / TMP MAXIMUM LIMIT 527 Reason for Alarm During On Line treatment phases, the TMP value exceeds the permitted max value. Machine Actions • None. Possible Cause Suggested Action 1. The TMP value is beyond the permitted max value. 1. Stop the UF and wait the TMP to drop. Check the pre dialyzer pressure. Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-184 DIASCAN: AUTOCALIBRATION FAILURE 528Reason for Alarm The DIASCAN autocalibration has failed: the autocalibration coefficient is out of the allowed range or the autocalibration has been interrupted because of prime start.Machine Actions • None.Possible Cause Suggested Action 1. There is a flowmeter instability. 1. Disable the Diascan deselecting the Diascan button. Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-185 Cod. 6992200 - Rev. / DIASCAN: MEASUREMENT FAILURE 529Reason for Alarm The DIASCAN has not been able to complete a measurement.Machine Actions • None.Possible Cause Suggested Action 1. The Diascan has not been able to complete a measurement. 1. To proceed with the Diascan measurement, press the CONFIRM button. 2. The Diascan has not been able to complete a measurement. 2. To stop the Diascan measurement, disable the Diascan deselecting the Diascan button.Call for Service if the alarm persists.The “Diascan: Measurement Failure (#529)“ alarm will be automatically reset if a Special Procedure is selected and confirmed.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-186 DIASCAN: LOW CLEARANCE 530Reason for Alarm This alarm wil be triggered in the following conditions:• If the Clearance Low Limit alarm threshold is active, the alarm wil be triggered whenever the Clearance value is below its threshold value;• If the Clearance Low Limit alarm threshold is not active, the alarm wil be triggered whenever the Clearance value is lower than 55% of Blood Flow. Machine Actions • None.Possible Cause Suggested Action 1. The clearance measured by the DIASCAN is below the threshold value set by the operator or the Clearance value is lower than 55% of Actual Blood Flow. 1. To proceed with the Diascan measurement, press the CONFIRM button. 2. The clearance measured by the DIASCAN is below the threshold value set by the operator or the Clearance value is lower than 55% of Actual Blood Flow. 2. To stop the Diascan measurement, disable the Diascan deselecting the Diascan button.Call for Service if the alarm persists.The “Diascan: Low Clearance (#530)“ alarm will be automatically reset if a Special Procedure is selected and confirmed.NOTE
Chapter 15: Alarms and Troubleshooting15-187 Cod. 6992200 - Rev. / DIASCAN: LOW KT/V 531Reason for Alarm The Forecast KT/V value is below the “Target Kt/V” value set by the operator (This alarm can be activated only when the distribution volume has been set).Machine Actions • None.Possible Cause Suggested Action 1. The Forecast KT/V value is below the “Target Kt/V” value set by the operator. 1. Check that:• The “Distribution Volume” value is properly set for the patient;• The current “Clearance” value is adequate to the treatment, according to the dialyzer used and to the patient’s vascular access; 2. Increase the “Treatment Time” in order to achieve the set “Target Kt/V” value or set a new value for “Target Kt/V” parameter.Then press the CONFIRM button.Call for Service if the alarm persists.The “Diascan: Low Kt/V (#531)“ alarm will be automatically reset if a Special Procedure is selected and confirmed.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-188 TIMEOUT ON DATA RECEPTION 532Reason for Alarm Temporary problem with the network.Machine Actions • None.Possible Cause Suggested Action 1. Temporary problem with the network. 1. Reload the prescription, then press the CONFIRM button. If the alarm persists, switch off the machine.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-189 Cod. 6992200 - Rev. / CHEMICAL PROCESS NOT PROPERLY PERFORMED: DISINFECTANT TANK EMPTY 533Reason for Alarm Chemical Disinfection process not correctly performed because the disinfectant tank is empty. Repeat the Chemical Disinfection process.Machine Actions • None.Possible Cause Suggested Action 1. The disinfectant tank is empty. 1. Check the level of the disinfectant tank:• If the disinfectant tank is empty, press the CONFIRM button and, at the and of the chemical disinfection procedure, replace the disinfectant tank with a new one. Repeat the disinfection procedure.• If the disinfectant tank is full, press the CONFIRM button and call for service.Call for Service if the alarm persists.When this alarm is triggered, the Chemical Disinfection process has not been correctly performed because the disinfectant tank is empty. Repeat the Chemical Disinfection process using a tank containing enough disinfectant solution.WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-190 DISINFECTION NOT PROPERLY PERFORMED 534Reason for Alarm The programmed chemical process set by the operator has been interrupted before the process completion.Machine Actions • None.Possible Cause Suggested Action 1. The disinfection process needs to be completed. 1. Press the CONFIRM button and start the process.If the alarm persists, call for service.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-191 Cod. 6992200 - Rev. / DIASCAN MEASUREMENT ERROR 536Reason for Alarm The DIASCAN has not been able to complete a measurement.Machine Actions • None.Possible Cause Suggested Action 1. The DIASCAN has not been able to complete a measurement. 1. Press the CONFIRM button and wait for the next Diascan measurement.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-192 WATER LEAKAGE 539Reason for Alarm A leakage was detected by the Water Leakage sensor in the hydraulic circuit.Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. A water leakage was detected in the hydraulic circuit. 1. If possible, start with the Rinseback procedure, otherwise switch off the machine.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-193 Cod. 6992200 - Rev. / DIALYSATE PRESSURE LOW 540Reason for Alarm The pressure in the Ultrafilter is lower than the permitted limit.Machine Actions • All the pumps are stopped;• The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Ultrafilter is clogged. 1. If in treatment, the dialysis process in progress can be continued by decreasing the dialysis fluid flow rate and pressing the CONFIRM button to restart the current operation of the machine.When the treatment is complete, replace the Ultrafilter according to the procedure. 2. The Dialysis fluid connectors are not properly positioned. 2. Verify that the Dialysis fluid connectors are properly positioned to the dialyzer or to the machine, depending upon the phase of the machine at that time.Press the CONFIRM button to restart the current operation of the machine.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-194 PRE FILTER PRESSURE HIGH 541Reason for Alarm The Pre Filter Pressure is higher than the allowed limit.Machine Actions • The UF Rate is automatically set to zero;• The Arterial Pump is stopped;• The Venous Line Clamp is closed.Possible Cause Suggested Action 1. The Venous Patient Line is clamped or kinked. 1. Check that the Venous Patient Line is not clamped or kinked.Carefully check the Venous Patient Line connections.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-195 Cod. 6992200 - Rev. / INCORRECT CASSETTE LINE CONNECTIONS OR CLAMPS STATUS 542Reason for Alarm The Ultra/Blood Cassette Line connections or the Ultra/Blood Cassette Line Clamps status is incorrect.Machine Actions • All the pumps are stopped.Possible Cause Suggested Action 1. The Venous/Arterial Patient Lines have not been inserted in the EvaClean Ports. 1. Check that the Venous/Arterial Patient Lines are inserted in the EvaClean Ports.Then press the CONFIRM button to remove the alarm. 2. The Venous/Arterial Dialyzer Line is not securely connected to the dialyzer. 2. Check that the Venous/Arterial Dialyzer Lines are firmly connected to the dialyzer.Then press the CONFIRM button to remove the alarm. 3. The Ultra Inlet Line is not securely connected to the Ultra Port. 3. Check that the Ultra Inlet Line is firmly connected to the Ultra Port.Then press the CONFIRM button to remove the alarm. 4. A line on the Ultra/Blood Cassette (Ultra Service Line, Rinseback Service Line or Venous/Arterial Infusion Lines) may be unclamped. 4. Check that the clamps on the Ultra Service Line, Rinseback Service Line and Venous/Arterial Infusion Lines are securely closed.Then press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-196 ULTRA SCAN ABORTED: TMP SET AND UPPER LIMIT UPDATED 543Reason for Alarm The Ultra Scan has been aborted: the TMP Set and the Upper Limit have been consequently updated.Machine Actions • None.Possible Cause Suggested Action 1. The Ultra Scan has been aborted: the TMP set and the Upper Limit have been consequently up-dated. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-197 Cod. 6992200 - Rev. / ULTRA SCAN COMPLETED: TMP SET AND UPPER LIMIT UPDATED 544Reason for Alarm The Ultra Scan has been completed: the TMP Set and the Upper Limit have been consequently updated.Machine Actions • None.Possible Cause Suggested Action 1. The Ultra Scan has been completed: the TMP set and the Upper Limit have been consequently up-dated. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-198 NEW ULTRA SCAN IS SUGGESTED 545Reason for Alarm Notification: the Ultra Scan has been completed.Machine Actions • None.Possible Cause Suggested Action 1. The Ultra Scan has been completed. 1. Perform a new scan and press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-199 Cod. 6992200 - Rev. / MAXIMUM SUBSTITUTION VOLUME REACHED 546Reason for Alarm The Maximum Substitution Volume has been reached: one liter has been saved for performing on-line restitution.Machine Actions • The HDF button is locked.Possible Cause Suggested Action 1. The Maximum Substitution Volume has been reached: one liter has been saved for performing on-line restitution. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-200 PATIENT VENOUS LINE INCORRECT POSITION 547Reason for Alarm The position of the Venous Patient Line is incorrect. Probably during priming the Venous Patient Line has not been inserted under the Venous Line Clamp.Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. The Venous Patient Line has not been inserted under the Venous Line Clamp. 1. Carefully check that the Venous Patient Line is under the Venous Line Clamp.Then press the CONFIRM button and continue the process.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-201 Cod. 6992200 - Rev. / LEAKAGES H 548Reason for Alarm Failure of the leakages test on the PDrain, PFS or PO: negative pressure failure on the internal bypass circuit.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected.Press the CONFIRM button to repeat the current leakages test. 2. The Venous and Arterial Patient Lines are not properly connected to the EvaClean port. 2. Verify that the Venous and Arterial Patient Lines are properly connected.Press the CONFIRM button to repeat the current leakage test.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-202 LEAKAGES I 549Reason for Alarm Failure of the leakages test on delivery of dialysis fluid in the hydraulic circuit and control of the patient weight loss.Machine Actions • The phase currently running stops;• All the pumps are stopped.Possible Cause Suggested Action 1. The Red and Blue Dialysis Fluid Tubes are not properly connected. 1. Verify that the Red and Blue Dialysis Fluid Tubes are properly connected. Press the CONFIRM button to repeat the current leakages test. 2. The Venous and Arterial Patient Lines are not properly connected to the EvaClean port. 2. Verify that the Venous and Arterial Patient Lines are properly connected.Press the CONFIRM button to repeat the current leakage test.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-203 Cod. 6992200 - Rev. / POWER FAILURE: CHECK POWER SUPPLY 550Reason for Alarm A Power Failure occurred during on-line treatment.Machine Actions • None.Possible Cause Suggested Action 1. A Power Failure occurred during on-line treatment. 1. Check the power supply, in case no recovery is possible:• Press the CONFIRM button to remove the alarm.• Switch to HD treatment;• Perform a rinseback procedure;• Switch off the machine.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-204 80% MAXIMUM SUBSTITUTION VOLUME REACHED 551Reason for Alarm The maximum substitution volume has been reached (allowed by the U2000 ultrafilter): the actual value reaches 80% of the maximum limit (150L).Machine Actions • None.Possible Cause Suggested Action 1. The maximum substitution volume has been reached: the actual value reaches 80% of the maximum limit (150L). 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-205 Cod. 6992200 - Rev. / 90% MAXIMUM SUBSTITUTION VOLUME REACHED 552Reason for Alarm The maximum substitution volume has been reached (allowed by the U2000 ultrafilter): the actual value reaches 90% of the maximum limit (150L).Machine Actions • None.Possible Cause Suggested Action 1. The maximum substitution volume has been reached: the actual value reaches 90% of the maximum limit (150L). 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-206 MAXIMUM SUBSTITUTION VOLUME REACHED 553Reason for Alarm Notification: the machine has stopped the substitution process in order to save the remaining one liter for performing on-line restitution.Machine Actions • The HDF button is locked.Possible Cause Suggested Action 1. The machine has stopped the substitution process in order to save the remaining one liter for performing on-line restitution. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-207 Cod. 6992200 - Rev. / HEMOCONTROL ERROR 554Reason for Alarm A failure on the Hemocontrol has been verified.Machine Actions The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. A failure on the Hemocontrol has been verified. 1. Deactivate the Hemocontrol, then press the CONFIRM button.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-208 ULTRA INLET TUBE CLAMPED 556Reason for Alarm The Ultra Inlet Line is clamped when it should not be.Machine Actions • None.Possible Cause Suggested Action 1. The Ultra Inlet Line is clamped. 1. Check the Ultra Inlet Line and remove any clamps.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-209 Cod. 6992200 - Rev. / CASSETTE REPOSITIONING FAILED 557Reason for Alarm In HDF mode, the Ultra Cassette Repositioning Procedure has failed.Machine Actions • None.Possible Cause Suggested Action 1. In HDF mode, the Ultra Cassette Repositioning Procedure has failed. 1. Press the CONFIRM button to remove the alarm and to restart the Arterial Pump.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-210 REMINDER: 558Reason for Alarm Notification: the set time has elapsed for the note entered on the keyboard window.Machine Actions • None.Possible Cause Suggested Action 1. The set time has elapsed for the note entered on the keyboard window. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-211 Cod. 6992200 - Rev. / PREPARATION COMPLETED 559Reason for Alarm Notification: the preparation process has been completed.Machine Actions • None.Possible Cause Suggested Action 1. The preparation process has been completed. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-212 PRIMING COMPLETED 560Reason for Alarm Notification: the Priming sub-process has been completed.Machine Actions • None.Possible Cause Suggested Action 1. The Priming sub-process has been completed. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-213 Cod. 6992200 - Rev. / AUTOSCHEDULED DISINFECTION/RINSE PROGRAM NOT PERFORMED 562Reason for Alarm The autoscheduled disinfection/rinse program has not been performed.Machine Actions • None.Possible Cause Suggested Action 1. The autoscheduled disinfection/rinse program has not been performed. 1. Press the CONFIRM button to remove the alarm message.Make sure that a Disinfection/Rinse program has been performed before starting a new treatment. 2. Following a Bacteriostatic Chemical disinfection, the scheduled Disinfection/Rinse program has not been performed because the machine has automatically performed a Rinse process instead of the program scheduled. 2. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.This alarm will be triggered each time the machine is switched on during the day in which the scheduled process has not been performed (although the alarm message has been confirmed). The alarm will be definitely removed the day after the one the process has been scheduled, only if the alarm message has been confirmed, otherwise it will continue to be triggered also in the subsequent days.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-214 CDF2 ULTRAFILTER LOWER SWITCH ERROR 563Reason for Alarm The CDF2 second ultrafilter lower connector microswitch (SWLOWUF2) is indicating an error condition.Machine Actions In ADR: • The phase currently running stops.Possible Cause Suggested Action 1. The CDF2 ultrafilter lower connector microswitch is indicating an error condition. 1. Check the correct position of the ultrafilter.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-215 Cod. 6992200 - Rev. / ULTRAFILTER COVER ERROR 564Reason for Alarm The ultrafilter cover is not placed correctly.Machine Actions In ADR: • The phase currently running stops.Possible Cause Suggested Action 1. The ultrafilter cover is not placed correctly. 1. Check the correct position of the ultrafilter cover.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-216 HYDRAULIC CENTRALISE ACETATE CONNECTOR TYPE ONE 565Reason for Alarm The Hydraulic Centralise Acetate Connector Type One is not placed correctly.Machine Actions In ADR: • The phase currently running stops.Possible Cause Suggested ActionThe Hydraulic Centralise Acetate Connector Type One is not placed correctly. 1. Check the correct position of the Hydraulic Centralise Acetate Connector Type One.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-217 Cod. 6992200 - Rev. / HYDRAULIC CENTRALISE ACETATE CONNECTOR TYPE TWO 566Reason for Alarm The Hydraulic Centralise Acetate Connector Type Two is not placed correctly.Machine Actions In ADR: • The phase currently running stops.Possible Cause Suggested Action 1. The Hydraulic Centralise Acetate Connector Type Two is not placed correctly. 1. Check the correct position of the Hydraulic Centralise Acetate Connector Type Two.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-218 TMP SET TOO LOW 567Reason for Alarm During dialysis, the TMP set is lower than the actual TMP measured.Machine Actions • The Venous Pump is stopped.• If the machine is performing UC scan, the procedure fails.Possible Cause Suggested Action 1. The TMP set is lower than the actual TMP measured. 1. Increase the TMP set value.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-219 Cod. 6992200 - Rev. / WRONG ACID/ACETATE CONNECTOR 568Reason for Alarm The position of the Acid Pick-up Tube Connector detected by the Protective Subsystem is wrong (probably there is a misalignment with the Hydraulic Subsystem).Machine Actions In ADR: • The phase currently running stops.Possible Cause Suggested Action 1. The Acid Pick-up Tube Connector is not placed correctly. 1. Check the correct position of the Acid Pick-up Tube Connector.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-220 WRONG BICARBONATE CONNECTOR 569Reason for Alarm The position of the Bicarbonate Pick-up Tube Connector is wrong.Machine Actions In ADR: • The phase currently running stops.Possible Cause Suggested Action 1. The Bicarbonate Pick-up Tube Connector is not placed correctly. 1. Check the correct position of the Bicarbonate Pick-up Tube Connector.Call for Service if the alarm persists.The use of liquid Bicarbonate concentrate is not currently available.NOTE
Chapter 15: Alarms and Troubleshooting15-221 Cod. 6992200 - Rev. / ISOLATED UF COMPLETED 570Reason for Alarm The machine notifies that the Isolated UF process has been completed.Machine Actions • The machine remains in Isolated UF with deactivated “UF” button.Possible Cause Suggested Action 1. The Isolated UF process has been completed. 1. Press the CONFIRM button to proceed with the next phase.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-222 TREATMENT CAN NOT BEGIN UNTIL THE ULTRAFILTERS HAVE BEEN REPLACED 571Reason for Alarm The machine notifies that the ultrafilters have to be replaced, otherwise the treatment cannot be performed.Machine Actions • None.Possible Cause Suggested Action 1. The ultrafilters have to be replaced. 1. Replace the ultrafilters with new ones (Refer to the “7.18 Ultrafilter Change Procedure” section of this Operator’s Manual). Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-223 Cod. 6992200 - Rev. / LOW HEPARINIZATION 573Reason for Alarm The volume of the Heparin infused is lower than the expected value.Machine Actions • None.Possible Cause Suggested Action 1. The volume of the Heparin infused is lower than the expected value. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-224 WRONG SINGLE NEEDLE CLAMPS POSITION 574Reason for Alarm The Protective Subsystem has detected the Arterial and Venous line clamps open at the same time.Machine Actions • None.Possible Cause Suggested Action 1. The Protective Subsystem has detected the Arterial and Venous line clamps open at the same time. 1. Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-225 Cod. 6992200 - Rev. / PREPARATION CAN NOT PROCEED UNTIL DRESSING IS COMPLETE 576Reason for Alarm The preparation can not proceed until the machine dressing procedure has been completed.Machine Actions • None.Possible Cause Suggested Action 1. The machine dressing procedure is not been completed. 1. Complete the machine dressing procedure, then press the CONFIRM button on the Confirm window.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-226 SMART SCAN – LOW REAL QB 577Reason for Alarm The actual Blood Flow rate value is less than 90% of the Pump speed set value for more than three minutes.Machine Actions • None.Possible Cause Suggested Action 1. The actual Blood Flow rate value is less than 90% of the Pump speed set value for more than three minutes. 1. Verify the set Arterial Pump speed and the arterial pressure. Decrease the arterial pressure or decrease the Arterial Pump speed.Press the CONFIRM button to remove the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-227 Cod. 6992200 - Rev. / WRONG DISINFECTANT USED IN CHEMICAL DISINF. 578Reason for Alarm A wrong conductivity has been detected during a Chemical disinfection process with peracetic/low peracetic. The machine assumes that a disinfection with hypochlorite has been performed and the “Next Installation of Rear Ultrafilter”, “Date of Installation” and “Remaining Hypchlrt Disinfs” parameter values are reset.Machine Actions • When the machine is switched ON again, an “Ultrafilter Change” procedure will be forced.Possible Cause Suggested Action 1. A wrong conductivity has been detected during a Chemical disinfection program with peracetic/low peracetic. 1. Press the CONFIRM button to remove the alarm. and let the disinfection program end.When the machine is switched ON again, the “Treatment can not begin until the ultrafilters have been replaced (#571)” alarm will be displayed. Solve the alarm as described in the related troubleshooting of this chapter.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-228 ON LINE BLOOD RESTITUTION: WRONG ULTRA CASSETTE CONFIGURATION 579Reason for Alarm During the On Line Rinseback the Ultra or Blood cassette is not properly configured (Incorrect Ultra or Blood Cassette line connections or clamps status).Machine Actions • The dialysis fluid goes into Bypass.Possible Cause Suggested Action 1. Incorrect Ultra or Blood Cassette line connections. 1. The Arterial patient line shall be connected to the Rinseback Service Line and the Clamp on the Rinseback Service Line shall be opened.Press the CONFIRM button. 2. Incorrect clamps status. 2. The clamps of the Arterial infusion lines shall be closed.Press the CONFIRM button.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-229 Cod. 6992200 - Rev. / ON LINE PRIME - INCORRECT ULTRA OR BLOOD CASSETTE CONFIGURATION 580Reason for Alarm During the On Line Priming the Ultra or Blood cassette is not properly configured (Incorrect Ultra or Blood Cassette line connections or clamps status). Machine Actions • The phase currently running stops.Possible Cause Suggested Action 1. During the On Line Priming the Ultra or Blood cassette is not properly configured. 1. Check that:• the Ultra Service Line clamp is closed and the cap is totally screwed; • the Rinseback Service Line clamp is closed and the cap is totally screwed;• the Venous and Arterial Infusion Line clamps are closed and the caps are totally screwed; • the Arterial and Venous Dialyzer Lines are properly connected to the dialyzer;• the Arterial and Venous Patient Lines are unclamped and properly connected to the EvaClean ports with the connector totally screwed;• the dialyzer, Ultra and Blood cassette are not re-used.Press the CONFIRM button.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-230 ISOLATED UF TARGET LOSS WILL NOT BE ACHIEVED 581Reason for Alarm The remaining Isolated UF time is not sufficient in order to be reached the programmed Isolated UF target loss.Machine Actions • None.Possible Cause Suggested Action 1. The Isolated UF target loss will not be achieved. 1. Press the “Isolated UF” action button. 2. Reduce the Isolated UF parameter values: “Time” and/or “Volume”.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-231 Cod. 6992200 - Rev. / RESIDUAL CHECK REMINDER 582Reason for Alarm Notification: A test for residues of disinfectant has to be performed while setting up the machine for the next treatment.Machine Actions • None.Possible Cause Suggested Action 1. After chemical disinfection and before attaching the concentrates to the machine, a test for residues of disinfectant on the dialysis fluid has to be performed. 1. Perform a test for residues of disinfectant on the dialysis fluid (Refer to the “7.17 Residual Test after Chemical Disinfection” section of this Operator’s Manual).Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-232 AIR DETECTOR CLEANING REQUIRED 583Reason for Alarm The Air Detector does not work with the maximum sensitivity because the Venous Patient line or the Air Detector is dirty.Machine Actions • None.Possible Cause Suggested Action 1. The Venous Patient Line is dirty or the Air Detector is defective. 1. Open the Sensor Bar door; 2. Remove the Venous Patient line from the air detector/patient sensor: an “Air in venous line (#4)” alarm will be triggered; 3. Carefully check that there is not air in the Venous Patient line; 4. Clean the Venous Patient line and the air detector/patient sensor; 5. Route again the Venous Patient line through the air detector/patient sensor; 6. Close the Sensor Bar door; 7. Press the CONFIRM button to clear the “Air Detector Cleaning Required (#583)” alarm; 8. Solve the “Air in Venous Line (#4)” alarm as described in the related troubleshooting of this chapter; 9. If the “Air Detector Cleaning Required (#583)” alarm persists, stop the treatment and perform a Manual Rinseback procedure.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-233 Cod. 6992200 - Rev. / AIR DETECTOR INSPECTION REQUIRED 584Reason for Alarm The Air Detector does not work with the maximum sensitivity because the Venous Patient line or the Air Detector is dirty.Machine Actions • None.Possible Cause Suggested Action 1. The Venous Patient Line is dirty or the Air Detector is defective. 1. Open the Sensor Bar door; 2. Remove the Venous Patient line from the air detector/patient sensor: an “Air in venous line (#4)” alarm will be triggered; 3. Carefully check that there is not air in the Venous Patient line; 4. Clean the Venous Patient line and the air detector/patient sensor; 5. Route again the Venous Patient line through the air detector/patient sensor; 6. Close the Sensor Bar door; 7. Press the CONFIRM button to clear the “Air Detector Inspection Required (#584)” alarm; 8. Solve the “Air in Venous Line (#4)” alarm as described in the related troubleshooting of this chapter; 9. If the “Air Detector Inspection Required (#584)” alarm persists, stop the treatment and perform a Manual Rinseback procedure.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-234 SALINE BAG EMPTY 585Reason for Alarm The Saline Bag is empty or the Venous Infusion Line is clamped or the Prime Line is closed or obstructed.Machine Actions • None.Possible Cause Suggested Action 1. The Saline Bag is empty. 1. Change the Saline Bag; 2. Press the CONFIRM button to clear the alarm. 2. The Venous Infusion line is clamped or the clamp on the Prime Line is closed. 1. Open the clamp on the Venous Infusion line or on the Prime line; 2. Press the CONFIRM button to clear the alarm. 3. The Prime Line is obstructed. 1. Adjust the Prime Line position to avoid obstructions; 2. Press the CONFIRM button to clear the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-235 Cod. 6992200 - Rev. / ARTERIAL PUMP SEGMENT NOT CORRECTLY LOADED 586Reason for Alarm The Arterial Pump Segment has not been properly loaded in the pump rotor or the clamp on the Arterial Infusion line is open.Machine Actions • None.Possible Cause Suggested Action 1. The Arterial Pump Segment has not been properly loaded in the pump rotor. 1. Press the CONFIRM button to clear the alarm; 2. Press the “Unload Cassette” button; 3. Press the CONFIRM button to start the unloading procedure; 4. Unload the cassette; 5. Perform again the loading cassette procedure. 2. The clamp on the Arterial Infusion line is open. 1. Close the clamp on the Arterial Infusion line; 2. Press the CONFIRM button to clear the alarm.Call for Service if the alarm persists.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-236 VENOUS INFUSION LINE OPEN 587Reason for Alarm The clamp on the Venous Infusion line is open.Machine Actions • None.Possible Cause Suggested Action 1. The clamp on the Venous Infusion line is open. 1. Close the clamp on the Venous Infusion line; 2. Press the CONFIRM button to clear the alarm.Call for Service if the alarm persists.
Chapter 15: Alarms and Troubleshooting15-237 Cod. 6992200 - Rev. / << GENERAL SYSTEM FAILURE >> System Blocking XXXReason for Alarm This is a special alarm.The Main Board is blockedMachine Actions • GENERAL SAFE STATE• The Touch Screen is blockedIn the alarm name, "xxx" means the internal code related to the alarm condition.Possible Cause Suggested Action 1. Main Board internal error. 1. If the alarm occurs during a disinfection/rinse program, during the set-up or during the priming procedure, switch the machine OFF and after few seconds turn it ON again. 2. Main Board internal error. 2. If the alarm occurs during a tretament, perform a Fast Recovery procedure as described in the “7.4 Fast Recovery” section of this Operator’s Manual.Call for Service if the alarm persists.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-238 15.7 Machine Malfunction AlarmsWhen a malfunction alarm occurs the following message is displayed inthe Alarm AreaMALFUNCTIONtogether with the Numerical Code of the alarm.If one of the malfunction alarm listed in the table below occurs:• during a treatment: perform a Fast Recovery procedure as describedin the “7.4 Fast Recovery” section of this Operator’s Manual. If thealarm persists, take note of the alarm code, switch the machine OFFand call for Service. • during a disinfection/rinse program: take note of the alarm code,switch the machine OFF and call for Service. Below is a list of all the machine malfunction alarms in alphabetic order,indicating:•The name of the alarm;•The Numerical Code. MALFUNCTION CODEADR PROCESS NOT INITIATED 63ADR Process Timed Out 190Air compressor failure 466ARTERIAL PRESSURE DATA ERROR 307Arterial Pressure Negative Offset Data Error 430Arterial Pressure Offset Data Error 431ARTERIAL SENSOR ERROR 6BIC CONC DATA ERROR 398Bicarbonate pump failure 110!BIO FLOW data error 25Blood flow data error 27BLOOD LEAK DETECTOR CALIBRATION ERROR 167Blood leak detector data error 26BLOOD SLAVE COMMUNICATION ERROR 295BLOOD SLAVE ERROR 130Bubble Trap T1 Test 493
Chapter 15: Alarms and Troubleshooting15-239 Cod. 6992200 - Rev. / Concentrate pump failure 108CONCENTRATION UM DATA ERROR 399CONTROL DATA ERROR 327Control Flowmeters Test Failed 497CRC MESSAGE CHECK 471D1 FLOWMETER FAILURE 300D2 FLOWMETER FAILURE 301DATA ERROR 43Dialysate flow data error 45Disinfection timeout error 67EEPROM BLOOD ERROR 48EEPROM CRC ERROR 173EEPROM HYDRAULIC ERROR 49Flow Meters Alignment Failure 535Flowmeters alignment timeout 484> GENERAL SAFE STATE < 64HEATER PROTECTION ERROR(See the NOTE below) 59Hydraulic slave error 131Incorrect Arterial Clamp Position 7Incorrect disinfectant 112Incorrect disinfectant 113Incorrect Rinsing or Disinfection 510Incorrect Venous Clamp Position 148Invalid Rinsing or Disinfection 511Low Flow In Degasser 84Maximum Arterial Pressure Data Error 432MAXIMUM BLOOD FLOW DATA ERROR 312Maximum Blood Volume Reached 481Maximum Venous Pressure Data Error 458Min UF rate data error 164MALFUNCTION CODE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 15-240Minimum Arterial Pressure Data Error 393Minimum Venous Pressure Data Error 429P1 Pump failure 104P2 Pump failure 106PAUSE THERAPY DATA ERROR 313PC Pump failure 111Pinch Calibration Edge Error 491Pinch Calibration Out of Range 490Pinch Calibration Time Out 492Pinch Position Error 488Pinch Position Out of Range 487Pinch Position Time Out 489Pinch valve wrong position optical sensor 1 494Pinch valve wrong position optical sensor 2 495PROTECTION MODULE DATA ERROR 185PROTECTION MODULE SOFTWARE ERROR 182PROTECTION SYSTEM FAILURE 120PRSS Start Up Message Missing 480Ps Out of Order 410PWHO Out of Order 426Select pump failure 486Set value out of range 395!S/N MAX PRESSURE Data Error 209!S/N MIN PRESSURE Data Error 208SODIUM CONC DATA ERROR 397System Pressure Sensor Error 523T1 Test BLD 434T1 Test Cut 24 Volts Failed 440T1 Test FPGA failed 485T1 Test Pinch Valve 572T1 Test Valves Command Failed 442MALFUNCTION CODE
Chapter 15: Alarms and Troubleshooting15-241 Cod. 6992200 - Rev. / T1 Test Venous Clamp 441T1 Test Water Presence Sensor Failure 537Temperature data error 135Temperature mismatch between Tp and Tca 538Timeout on messages acknowledge 396Treatment time data error 239UF data error 143UF data error 240ULTRAFILTER PRESSURE SENSOR ERROR 147Venous pressure data error 150Venous Pressure Negative Offset Data Error 427Venous Pressure Positive Offset Data Error 428VENOUS SENSOR ERROR 159If this alarm occurs during treatment: 1. Switch the machine OFF; 2. Perform a Manual Rinseback procedure as described in the “7.2 Manual Rinseback procedure in HD and HDF treatments” section of this Operator’s Manual.MALFUNCTION CODENOTE
This page is left intentionally blankCod. 6992200 - Rev. / 15-242
16-1Chapter 16: SpecificationsChemical Disinfection with hypochlorite is not currently available. 16.1 General SpecificationsFollowing the main specifications related to Artis Dialysis System generalcharacteristics are reported. 16.1.1 Name Artis Dialysis System. 16.1.2 Standards and ClassificationsThe Artis Dialysis System complies with the following classifications andstandards.Equipment Classifications • Class IIb (MDD 93/42/EEC)• Class I, Applied Part Type B (EN 60601-1) • Protection Class: IP21 (IEC 60529)• Not suitable for use in the presence of flammable anesthetics, or anesthetic mixtures with air or with oxygen or nitrous oxide. (EN 60601-1) • Continuous Operation (EN 60601-1) CE Marking• European Council Directive 93/42/EEC of 14 June 1993 concerningmedical devices. Notified body: British Standards Institution (BSI) with the notified bodynumber 0086. The Artis Dialysis System must be used under the supervision of aphysician. Do not use the Artis Dialysis System near flammable gas orflammable anesthetic mixtures with air, with oxygen or with nitrousoxide.WARNING!WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-2 International Standards • The CE marking by the manufacturer GAMBRO S.p.A. covers the equipment. • The compatibility of the Artis Dialysis System with the other accessories and disposables listed in this operator’s manual has been verified during product validation. • The CE-marking of this manual is only valid if the device which it describes is CE-marked. Medical Equipment Standardsa IEC 60601-1 • MEDICAL ELECTRICAL EQUIPMENT - Part 1: General Requirements for safety (Equivalent to EN 60601-1)IEC 60601-1-2 • MEDICAL ELECTRICAL EQUIPMENT - Part 1-2: General Requirements for safety- Collateral standard: Electromagnetic Compatibility - Requirements and tests (Equivalent to EN 60601-1-2)IEC 60601-1-4 • MEDICAL ELECTRICAL EQUIPMENT - Part 1-4: General Requirements for safety - Collateral standard: Programmable electrical medical systems (Equivalent to EN 60601-1-4)IEC 60601-1-6 • MEDICAL ELECTRICAL EQUIPMENT - Part 1-6: General Requirements for safety - Collateral standard: Usability (Equivalent to Harmonized standard EN 60601-1-6)IEC 60601-2-16 • MEDICAL ELECTRICAL EQUIPMENT - Part 2-16: Particular Requirements for the safety of hemodialysis, haemodiafiltration and haemofiltration equipment (Equivalent to EN 60601-2-16)IEC 60601-2-30 • MEDICAL ELECTRICAL EQUIPMENT - Part 2-30: Particular Requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment. (Equivalent to Harmonized standard EN 60601-2-30)EN 980 • Graphical Symbols for Use in the Labelling of Medical DevicesNOTE
Chapter 16: Specifications16-3 Cod. 6992200 - Rev. /Radio Frequency Interference and Electromagnetic Environment RequirementsThe Artis Dialysis System needs special precautions regarding EMC and needs tobe installed and put into service according to the EMC information provided in theAppendix A, of this operator’s manual. FCC / Canada Radio CertificationThe Artis Dialysis System has embedded a module approved with FCC ID: XD3-RFMOD, IC: 8313A-RFMOD.These devices comply with part 15 of the FCC rules.Changes or modifications not expressly approved by the party responsible forcompliance could void user’s authority to operate the equipment.Operation is subject to the following two conditions: (1) This device may not causeharmful interference, and (2) This device must accept any interference received,including interference that may cause undesired operation. Changes ormodifications not expressly approved by the party responsible for compliancecould void the user’s authority to operate the equipment. 16.1.3 Power SupplyMain CharacteristicsEN ISO 10993-1 • Biological evaluation of medical devices - Part 1: Evaluation and testingEN ISO 10993-4 • Biological evaluation of medical devices - Part 4: Selection of tests for interactions with bloodEN ISO 10993-5 • Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityEN ISO 10993-10 • Biological evaluation of medical devices - Part 10: Tests for irritation and delayed type hypersensitivity.EN ISO 10993-11 • Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.ANSI/AAMI SP10 • Electronic or automated sphygmomanometers.a. Independent internationally recognized experts have rigorously checked conformity with these standards. Parameter ValuesMains Voltage • 230/240 VAC (±10%) • 115 VAC (±10%)Frequency • 50/60 Hz (±5 Hz) Medical Equipment Standardsa (Continued)
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-4Power Consumption • Max. 10 A at 230/240 VAC • Max. 16 A at 115 VAC Power Supply Cord • Max. length 3 m. Mains Connector • Certified to IEC 60320/C19 Mains Plug • Earthed plug, 250 V AC (10-16 A), • Earthed plug 125 VAC (20 A)Dielectric Strength • Complying with clause 20 of IEC 60601-1 Battery Back-up • Voltage 24 volt, 7.2 Ah • Fuse: T 12 A Possible hazards may arise from equipment (other than theaccessories listed below) being connected to the machine, whichmay cause the permitted leakage current to be exceeded. Wait at least 5 seconds after switching OFF the machine beforeturning it ON again. The correct installation of a MEDICAL ELECTRICAL SYSTEMrequires that each SYSTEM component be individually connectedto the main power.It is strongly recommended: NOT TO USE MULTIPLEPORTABLE SOCKET-OUTLETS. However, if using multiple portable socket-outlets, they mustcomply with the IEC 60601-1-1 Standard and must NOT BEPLACED ON THE FLOOR. • Check that the Artis Dialysis System is properly grounded.• Do not remove the panels. If necessary, ask qualified staff to open panels. • Disconnect the machine from the main power supply before every cleaning, checking or maintenance operation. Parameter ValuesWARNING!WARNING!WARNING!WARNING!
Chapter 16: Specifications16-5 Cod. 6992200 - Rev. /Power failureIn case of a mains power failure, an audible alarm is triggered and the red lamp isilluminated. 16.1.4 Physical DataThe physical data reported below must be considered approximated. Wheels and PortabilityThe Artis Dialysis System is provided with 4 double wheels: two lockable wheelson the front side and two wheels without brake on the rear side. The locks are foot-operated:• to brake the machine, press the two locks completely down;• to release the brake, pull the two locks completely up.The Artis Dialysis System is provided with energy cells (batteries).When replacing these components, follow local regulations forproper disposal. Parameter DimensionsHeight (without Infusion Pole) • 1550 mm Infusion Pole Height • 1500 to 2000 mm. Max. load 10 Kg Width • 500 mm (excluded the EvaClean connector and dialyzer holder)• 660 mm (when the dialyzer holder is turned in the position used for transportation) Width of the base • 700 mm (included back-tray) Depth • 600 mm Depth of the base • 900 mm (included back-tray) • 700 mm (excluded back-tray)Floor Area • 0.405231 m2 Dry Weight • < 130 KgTransportation • in horizontal positionWARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-6 16.1.5 Environmental DataOperational Mode Storage and Transportation Before moving the Artis Dialysis System, check that the two locksare released and remove infusion bags or any other weights orhanging objects from the Infusion Pole or from the concentratecontainer tray. To avoid jolting, carefully move the Artis Dialysis System by usingthe handles on the rear panel.The machine could be damaged if handled in an improper way. Parameter ValuesAmbient Temperature Range • +18°C to +35°C (65°F to 94°F). Relative Humidity Range • 30 to 85 % rh Air Pressure Range • 795 to 1060 HPa Parameter ValuesAmbient Temperature Range • -20°C to +70°Ca a. Temperatures above +50° C are allowed ONLY for maximum 12 hoursRelative Humidity Range • 10 to 95% rh (non-condensing) Air Pressure Range • 500 to 1060 HPa If condensation of Artis Dialysis System occurs when moving itbetween locations with different temperatures and high relativehumidity (e.g. outdoor and indoor locations), the inside of themachine shall be allowed to dry before switching it on. WARNING!WARNING!WARNING!
Chapter 16: Specifications16-7 Cod. 6992200 - Rev. / 16.1.6 Software revisionThis operator’s manual revision is related to the 6.04.11 software revision. 16.1.7 Connection of external equipment The Artis Dialysis System is provided with a Connectivity Panel (see "Figure 16-1.Connectivity Panel") for connection of external equipments, including the followingports: During transportation and storage the Artis Dialysis System has tobe kept in its original packing. • All external equipments connected to the Artis Dialysis System must be compliant with IEC 60950 or IEC 60601 series. Equipment not complying with IEC 60601 shall be kept outside the patient environment, as defined in the standard. • Any person who connects external equipments to signal input, signal output or other connectors has formed a Medical Electrical system and is therefore responsible for the system to comply with the requirements of IEC 60601-1-1. If in doubt, contact qualified technician or your local representative. Connectivity Panel 10/100 Base T EthernetPort • Used for connecting the machine to a Personal Computer to interface with the Communication SystemRS232 Serial Port (Not currently available) • Used for connecting the machine to a bed scale, WRO300 or WRO300H USB Port • Used for flash memories (only for service interventions)BPM Port • Used for connecting the BPM deviceRemote Alarm • Max voltage: 24 V AC • Max current: 500 mA External Water Valve (Not currently available) • Max voltage: 24 V DC • Max current: 500 mA WARNING!WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-8 Figure 16-1. Connectivity Panel 16.1.8 Shipping ListThe machine packaging contains the following components: • Artis Dialysis System • CD ROM of Artis operator’s manual• Installation Checklist • Water Inlet and Drain Tubes • Infusion pole (maximum load: 10 Kg or 22 lb) • Concentrate Wand• pH probe assembly • BPM Cuff• Top Tray• Chemical Container ShelfHour Meter • Displays the cumulative hours of machine operation (total time that power to the machine has been on)Potential Equalization Connector • Used for connecting a Potential Equalization Conductor to the machineAdjustement of the infusion pole height must be done without bagson the hooks. Connectivity Panel (Continued)NOTE
Chapter 16: Specifications16-9 Cod. 6992200 - Rev. /• BPM (Blood Pressure Monitoring)• Central Concentrate Supply KitAccessories• SNSP Expansion Chamber Holder• CWP Adapter KitDo not assemble, install or use the Artis Dialysis System beforehaving carefully read this operator’s manual. WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-10 16.2 Hydraulic Circuit Specifications 16.2.1 Water Supply The quality of the incoming water used by the Artis Dialysis System must complywith local standards and ISO 13959 standard. Main Requirements Drain Make the connection of the drain, as described in applicable local andinternational standards, with an external pressure connector to avoid back flow.Mantain an air clearance between the drain connector of the machine and thedrain itself. Parameter Value ConditionsPressure • 150 to 800 kPa /Inlet WaterDemand (Flow Rate)• < 1 l/min /Inlet WaterConductivity • 0 to 0.5 mS/cm /Temperature(Treatment) • +5°C to +35°C • +10°C to +35°C• +16°C to +35°C • Dialysis Fluid Flow Rate:300 to 800 ml/min (230V) • Dialysis Fluid Flow Rate: 300 to 750 ml/min (115V)• Dialysis Fluid Flow Rate:750 to 800 ml/min (115V) Temperature (Heat Disinfection) • +5°C to +93°C /Inlet Tube • Length: 5 m • Internal diameter: 8 mm /Parameter ValueDrain Flow Rate • Max. 1.2 l/min Drain Fluid Temperature • Max. 90°C Pressure • 0 to 13 kPa Drain Tube Length • Max. 5 m Drain Outlet Height • Max. 1.3 m above floor level
Chapter 16: Specifications16-11 Cod. 6992200 - Rev. / 16.2.2 Concentrate ConnectorsThe concentrate and disinfectant connectors on the Artis Dialysis System arecolour-coded as follows: 16.2.3 Dialysis Fluid Dialysis Fluid Temperature Connector ColourAcid Tube Connector • Red, located on the machine front sideDisinfectant Tubes • Yellow and Clear, located on the machine rear sideIt is recommended to use concentrates which conform to therequirements of the European Pharmacological Standards. The control of alarm threshold and dialysis fluid conductivityprecision is of major medical importance in ensuring a safedialysis treatment. Attention must be given to the safety hazards related to incorrectchoice of dialysis fluid concentrates. Parameter ValuesRange • +35.5°C (or +2°C above the inlet water temperature, whichever is greater) to +39.5°C Accuracy • +0.5°C/-1.8°C of the set value Alarm Limits • ±2 °C (±0.5°C) of the set value• Min. +34.5 °C (±0.5°C) • Max. +41 °C (±0.5°C)Protection system type • Monitoring of the dialysis fluid temperatureWhen the temperature of the dialysis fluid exceeds the alarmthreshold, the audible and visual alarms are triggered. WARNING!WARNING!WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-12Dialysis Fluid Flow Dialysis Fluid Pressure Degassing pH Supervision Parameter ValuesDialysis Fluid Flow Rate • 300 to 800 ml/min, in steps of 50 ml/min Accuracy • ± 2% of the set value Alarm Limits • ±10% (accuracy ±1%) of the set value • Min. 250 ml/min (±10 ml/min) • Max. 900 ml/min (±10 ml/min) When the dialysis fluid flow exceeds the alarm threshold, theaudible and visual alarms are triggered. Parameter ValuesPermitted Values • -350 to +480 mmHgAccuracy • ± 25 mmHg Alarm Limits • -350 to +480 mmHg When the dialysis fluid pressure exceeds the alarm threshold, theaudible and visual alarms are triggered. Parameter ValuesMethod of Degassing • Heating in combination with vacuum pumping. Pressure • < 150 mmHg (±10 mmHg) or dissolved gas in dialysis fluid < 7.0 mg/l . Parameter ValuesRange • 1.0 to 13.0 ph units Accuracy • ±0.2 ph units WARNING!WARNING!
Chapter 16: Specifications16-13 Cod. 6992200 - Rev. /Supported ConcentratesIons ConcentrationConcentrate Supply Pressure Alarm Limits • 6.5 to 7.6 ph units (±0.1 ph units) When the pH of the dialysis fluid exceeds the alarm threshold, theaudible and visual alarms are triggered. Parameter ValuesLiquid concentrates • Acidic (A) concentrate for preparation of 8.4% bicarbonate dialysis fluidDry concentrates • BiCart® Cartridge: Sodium Bicarbonate 8.4% concentrate for preparation of 8.4 % bicarbonate dialysis fluid Ions ConcentrationNa+ (Sodium) • 138 to 140 mmol/l (±2.5%) HCO3- (Bicarbonate) • 24 to 38 mmol/l (± 5%)K+• 0 to 4 mmol/l (± 5%) Ca2+ • 1 to 1,75 mmol/l (± 5%) Mg2+ • 0,375 to 0,75 mmol/l (± 5%) Cl-• 103,80 to 110,5 mmol/l (± 5%) CH3COO-• 2 to 3 mmol/l (± 5%) Glucose • 0 to 5,55 g/l (± 5%) Parameter ValuesNa+ (Sodium)aa.Can be set by the operator• 130 to 160 mmol/l (±2.5%) HCO3- (Bicarbonate)a• 24 to 38 mmol/l (± 5%)Parameter ValuesRange • -20 kPa to +50 kPaParameter ValuesWARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-14Total Conductivity Conductivity of the Bicarbonate SolutionBiCart Cartridges (sodium bicarbonate cartridge - see specific instruction sheet)can be used with the Artis Dialysis System. Dialysis Fluid Pump Monitoring for Concentrate ExchangeThe reference values for the speed of the acid/acetate and bicarbonate ceramicpumps are defined during the corresponding calibration processes and representthe 0% functioning point.Parameter ValuesConductivity measurings • 13.3 to 15.7 mS/cm Accuracy • ± 0.2 mS/cm Alarm Limits • 13.1 to 15.9 mS/cm It is responsibility of the user to determine the correspondencebetween the dialysis fluid conductivity, displayed by the machineand the dialysis fluid solute content, verified by clinical laboratoryresults, for each concentrate used for dialysis treatment.This can be done by taking dialysis fluid samples at differentconductivity values (e.g. 13, 14, 15 mS/cm) and sending them to alaboratory for analysis. Carefully read the BiCart Cartridge Instructions for Use beforeusing the device. BiCart Cartridge may only be used by staff, whoare specially trained for hemodialysis treatments, using the ArtisOperator’s Manual. BiCart Solution Conductivity Monitor Parameter ValueConductivity valuesallowed • 2.2 to 3.8 mS/cm Average accuracy • ±0.1 mS/cmAlarms • ±5% of the conductivity valueWARNING!WARNING!
Chapter 16: Specifications16-15 Cod. 6992200 - Rev. /A safety system is present to prevent concentrate exchange errors, by generatingan alarm in case the pump speeds are measured outside a range of ±10% to±17% of the reference value. 16.2.4 Substitution Fluid Volume Control ModeHemodiafiltration treatments performed by the Artis Dialysis System can becontrollable in Volume Control Mode (Post dilution): the total weight loss, theSubstitution Fluid Flow Rate and Treatment Time are set by the user while theTMP pressure varies accordingly to the total Ultra-filtration rate (weight loss rate +substitution fluid flow rate).Parameter ValueSubstitution Fluid Flow Rate • 1.2 to 19.8 l/h Online Produced Substitution Fluid • Max. 100 litres, in post-dilution (99L for treatment, 1L for restitution) Alarm Limits • 10% of the set substitution fluid flow rate or ±5 mL/min, whichever is greater OnLine Bolus(default) • 50 mL to 1000 mL, in steps of 10 mL (default 150 mL)OnLine Bolus Rate (default)Preset• 20 mL/min to 330 mL/min, in steps of 5 mL/min (150 mL/min) QF/QB (in Post-dilution)Preset • 30% to 50%, in steps of 1%, in Volume Control Mode. Default:40% • 30% to 60%, in steps of 1%, in Pressure Control Mode. Default:40%QF/QB (in Pre-dilution)Preset(not currently available)• 80% to 120%, in steps of 1%The On-line Substitution Fluid, prepared with inlet waterconforming to ISO 13959 and concentrates conforming toEuropean Pharmacopea, will have a microbiological fluid qualityof:• Bacterial content less than 10E-6 CFU/ml,• Endotoxin content < 0.03 IU/ml measured with an LAL assay. NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-16In online volume control treatments, the following ratios will always be displayed: • Ratio between the total Ultra-filtration rate (weight loss rate +substitution fluid flow rate) and the Real Blood Flow Rate (QF/QB) inPOST dilution mode• Ratio between the Substitution Fluid Flow Rate and the Real BloodFlow Rate (Qi/Qb) in PRE dilution modeTMP in Volume Control ModeThe operator will be able to set the maximum alarm limit for the TMP, during anOnline treatment in volume control mode, in the following range:• 0 mmHg to Absolute Maximum TMP, in steps of 10 mmHgwhere the Absolute Maximum TMP is a pre-defined value set by a Servicetechnician in the following range: • 0 mmHg to +500 mmHg in steps of 10 mmHgPressure Control ModeHemodiafiltration treatments performed by the Artis Dialysis System can becontrollable in Pressure Control Mode (Post dilution): the Total Weight Loss, theTMP and the Treatment Time are set by the user while the Substitution PumpFluid Flow Rate varies accordingly to the TMP. In online pressure control treatments, the following ratios will always be displayed:• Ratio between the total Ultra-filtration rate (weight loss rate + substitu-tion fluid flow rate) and the Real Blood Flow Rate (QF/QB) in POSTdilution mode• Ratio between the Substitution Fluid Flow Rate and the Real BloodFlow Rate (Qi/Qb) in PRE dilution modePressure Control Mode with Ultra ControlHemodiafiltration treatments performed by the Artis Dialysis System can becontrollable in Pressure Control Mode (Post dilution) with Ultra Control: if therelated functionality has been selected in the Preset, then during the treatment,the machine allows manual Ultra Scans or automatic Ultra scans. During an UltraScan, the machine automatically increases the TMP from the initial value to thevalue that maximizes the total Ultra-filtration. In case of manual Ultra Scans, the Ultra Scan process is activated by the user andautomatically stopped by the machine as the optimum TMP is reached. A manualUltra Scan can also be stopped by the user.In case of automatic Ultra Scans, three Ultra Scan processes are automaticallyactivated by the machine with a fixed timing and automatically stopped by themachine as the optimum TMP is reached. An automatic Ultra Scan can also bestopped by the user.
Chapter 16: Specifications16-17 Cod. 6992200 - Rev. /TMP in Pressure Control Mode The operator will be able to set the maximum alarm limit for the TMP, during anOnline treatment in volume control mode, in the following range:• 0 mmHg to Absolute Maximum TMP, in steps of 10 mmHgwhere the Absolute Maximum TMP is a pre-defined value set by a Servicetechnician in the following range:• 0 mmHg to +350 mmHg in steps of 10 mmHg 16.2.5 Ultrafiltration system The accuracy of the Ultrafiltration system will be guaranteed in the followingoperating ranges: Parameter ValuesDialysis Fluid Flow • 300 to 800 ml/min UF Rate • 0 to 3.0 l/h UF Rate Accuracy • ±50 ml/h UF Volume • 0 to 24 litres, in steps of 0.05 litres UF Volume Accuracy • ± 2.5% or ±50 ml/h * total treatment time, whichever is greater. TMP • -200 to +600 mmHg (±15 mmHg) Treatment Time • 00.30 to 08.00 (hour.minute), in steps of 5 minutes Protein Content • 0 to 120 mg/l Protection System Type • Monitoring of the ultrafiltration rateIf the difference between the accumulated weight loss ratemeasured by the Ultrafiltration System and the accumulatedweight loss rate measured by the Protective System of themachine is greater than ±80 ml an audible and visual alarm istriggered. When this alarm is activated the Venous Pump is stopped and thedialysis fluid goes into bypass.WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-18Ultrafiltration SupervisionFollowing the alarm limits for the Ultrafiltration System control: 16.2.6 Blood Leak Detection Besides the ultrafiltration, the patient’s weight change duringtreatment is affected by other factors such as fluid and food intake,perspiration, drug administration, infusion priming and rinsebackvolumes, amongst others.In addition, precise pre- and post-treatment weight are critical forthe proper assesment of the ultrafiltration during the treatment. Ifthese measurements are not accurate a discrepancy between theachieved ultrafiltration during treatment and the patient’s weightchanges will occur.Parameter ValuesUF Volume Supervisionaa. It is defined as the difference between the Actual UF Volume and the UF Vol-ume set by the operator. • < 540 ml UF Rate Alarm Limits • ±80 ml of the set value Accumulated UF VolumeAlarm limit • ±0.10 -2.0 I or ±0.10 l/h*passed treatment time (h), can be preset UF Rate Measurement • 0 to +3.0 l/h• Accuracy: ±5 ml/min verified at the Start-up Parameter ValuesSensitivity • > 0.35 ml/min (0.05 ml/min) , haematocrit 32%, ±2% Alarm response time • 5 seconds (±0.5 seconds) Detection Method • Optical Infrared System A Safety Test of the Blood Leak Optical Sensor is automaticallyperformed each time the machine enters the Preparation mode. When the Blood Leak sensor test fails audible and visual alarmsare triggered . NOTE WARNING!
Chapter 16: Specifications16-19 Cod. 6992200 - Rev. / 16.2.7 Disinfection 16.2.7.1 Chemical DisinfectantsFollowing a list of the main chemical solutions that may be used with the ArtisDialysis System for chemical disinfection: In the “Isolated UF” process or with the hydraulic circuit in bypass,the Blood Leak Alarm may be delayed, due to operating conditionsand dialyzer characteristics. Contact with cleaning and/or disinfection chemicals may pose arisk of burns, skin irritation or other adverse reactions. Alwaysfollow the chemical manufacturer's instructions when handlingthese products or cleaning spills. It is recommended to alternate the disinfection methods and/or thedisinfectants, in order to optimize cleaning, descaling anddisinfection of the machine.For additional information contact your local representative. Active Ingredient Trade NamesSodium Hypochlorite • Bleach® 5%• Amuchina™ 1.1%Peracetic Acid • Dialox™ 0,35% • Actril 0,06%• Renalin 4%• Oxagal 0,5%Sodium Carbonate • CleanCart ACitric Acid • CleanCart CWARNING!WARNING!NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-20 16.2.7.2 Disinfection Programs Following a list of the main disinfection programs allowable with the Artis DialysisSystem.The indicated “Total Time” parameter includes all the phases of the differentdisinfection processes (fill-up, circulation, drain and cooling).Heat Disinfection Heat Disinfection with CleanCarts Central Heat Disinfection To prevent damaging the machine, do not leave disinfectantsolutions in the machine for periods over the following limits:• 20 min for Sodium Hypochlorite based solutions at Disinfectant strength (Max. 0.2% concentration) • 20 min for Citric Acid based solutions at Disinfectant strength (Max. 2% concentration) • 20 min for Sodium Carbonate based solution at Disinfectant strength (Max. 0.5% concentration) • 72 hours for Peracetic Acid based solutions at Disinfectant strength (Max. 0.10% concentration) Parameter ValuesTemperature • Max 99°C Total Time • 34 min Parameter ValuesHeated Solution Concentration • Max. 2%, CleanCart-C • Max. 0.5% CleanCart-ATemperature • Max. 99°C Total Time • 44 min Parameter ValuesTemperature • Max 99° C Total Time • 34 min WARNING!
Chapter 16: Specifications16-21 Cod. 6992200 - Rev. /Chemical Disinfection - Peracetic Acid Chemical Disinfection - Low Peracetic Acid Chemical Disinfection - Sodium Hypochlorite(Not currently available) 16.2.7.3 RinsingThe Artis Dialysis System will automatically perform a Rinse process after anyChemical Disinfection Program and a drain of the circuit after any Rinse process. It is also possible to manually activate a rinsing process after a dialysis treatment. The effectiveness of Rinsing (measured at a point in the hydraulic circuit just priorto the dialyzer connection) conforms to international standards for residualconcentrations of disinfectant (European Pharmacological Standards and theANSI - AAMI RD62): • Peracetic maximum 1 ppm • Sodium Hypochlorite maximum 0.1 ppmParameter ValuesDisinfectant Solution Concentration after 1:35 dilution • Max. 0.10% Disinfection Time • 16 min.Rinse Time • 38 min.Parameter ValuesDisinfectant Solution Concentration after 1:35 dilution • Max. 0.01%Disinfection Time • 16 min.Rinse Time • 27 min.Parameter ValuesDisinfectant Solution Concentration after 1:35 dilution • Max. 0.2% Disinfection Time • 16 min.Rinse Time • 66 min.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-22 16.2.7.4 External CleaningIt is possible to clean the Artis Dialysis System externally without affecting theoriginal surface appearance using the following products:• Isopropanol 60% • Liquid soap • Ethanol 70% • Sodium Hypochlorite of 1.5% available chlorine The test procedures for the measurement of disinfection andrinsing efficiency are available, upon request, from themanufacturer’s quality control department. After a Chemical Disinfection program, a test for residues of disinfectant must be performed before attaching the concentrates to the machine to avoid the risk of blood hemolysis due to the exposure of the patient to the chemical residues.NOTE WARNING!
Chapter 16: Specifications16-23 Cod. 6992200 - Rev. / 16.3 Extracorporeal Blood Circuit 16.3.1 ArtiSet Blood Tubing SystemThe Blood Cassettes will allow the bloodlines to be positioned in a way designedto ensure a simple and effective system. The following Blood Cassettes are available for the Artis Dialysis System: Code Application Prime Line Patient Line Length113201 Double Needle NO about 235 cm107472 Prime Line / N/A112559 HDF Online NO about 235 cm• Refer to the Blood Cassette labeling for priming volume data. • Further information on suitable Blood Cassettes can be obtained by contacting your local representative. The use of the Blood Cassettes designed for Artis Dialysis Systemhas been tested and validated to provide safe and properfunctioning of the system. The appropriate Dialyzer and Blood cassette must be selectedaccording to the patient’s size and weight and to the treatmenttype.The decision must be taken by a physician.Before installing Gambro/Hospal Dialyzers and Blood Cassettes carefully read the related Instructions for Use.NOTE WARNING!WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-24 16.3.2 Blood PumpsThe Artis Blood Module is made up of two peristaltic pumps designed for dialysis,with pump segment inserts of 6.36 x 9.54 mm (0.25x0.38 in). To control the Blood Pumps, the Blood Module is provided with: • An Electronic Speed Control System to keep the speed constant, inde-pendently of load variations;• A light on the Hard Key Panel illuminated when the pumps are turningon (or when they are about to turn on, for example, after an automaticstop caused by an alarm);• A Pump Direction Monitor;• A system to automatically stop the Blood Pumps and close the VenousLine Clamp in case of air or foam detection;• A Safety Control when the Blood Pump Covers are opened;• Two cranks, one for each pump, for manual turning of the bloodpumps;• A Protective System to prevent overloads.This operator’s manual contains a number of references toaccessories and disposables for use with Artis Dialysis System.The Artis Dialysis System has been tested and validated for usewith accessories and disposables listed in this manual. Themanufacturer has not validated the use of accessories ordisposables other than those specified in this manual. TheManufacturer does not accept responsibility or liability for use ofaccessories or disposables other than those specified in thismanual. Depending on the circumstances, use of accessories ordisposables other than those specified may also reduce theManufacturer’s warranties for the Artis Dialysis System. The Manufacturer recommends the use of a dialyzer with dialysisfluid and blood connections that comply with ISO 8637. Do not use plate-type dialyzer. WARNING!WARNING!NOTE
Chapter 16: Specifications16-25 Cod. 6992200 - Rev. / Blood Pump Technical Characteristics 16.3.3 Blood Flow The Artis Dialysis System displays the following values related to the blood flow: • The blood flow set value• The blood flow actual value.The blood flow set value represents the theoretical blood flow rate in the extra-corporeal circuit calculated from the speed of the blood pump rotor and thegeometric characteristics of the pump segment. The blood flow actual value is the actual blood flow rate in the extra-corporealcircuit. The actual value is usually lower than the set value due to the negativepressure in the access line at the inlet to the pump. The negative pressure iscaused by the rotation of the pump itself and pressure drop linked to the motion ofblood in the line. The actual value coincides with the set value when the pumpinlet pressure (arterial pressure) is zero. The accuracy on the estimate, using GAMBRO Blood Cassette, is typically within±10% in the following conditions:• the pressure before the pump, given by the pressure in the arterialchamber of the cassette, is higher (less negative) than –150 mmHgand in the Actual Blood Flow range from 100 ml/min to 500 ml/min. The blood flow actual value is estimated by means of a mathematical algorithmtaking into account the pump segment characteristics of GAMBRO BloodCassette, the current pump speed and the pressure values in the extra-corporealcircuit. When using the Artis Dialysis System, stop the Blood Pumpsbefore touching the Blood Pump Rotors. Do not touch the blocking system. Parameter Value ConditionSpeed of Pump Rotor • 0 to 76 rpm approx. /Blood Flow Ramping UpCan be preset • 25, 50 or 100 ml/min, per second /Max actual Blood Flow (atmax rpm) • 500 ml/min • Arterial Pressure: 0 to -250 mmHgWARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-26 Double Needle The Artis Dialysis System will be able to calculate and display theaccumulated blood volume in the range 0 to 999 liters. A dedicated warning (Low Blood Pump Speed #204) exists inorder to avoid blood loss due to coagulation resulting frominterruption of blood flow. Parameter Values ConditionsAdult Blood CassetteActual BloodFlow • 10 to 500 ml/min • Arterial Pressure: 0 to -250 mmHgAccuracy • ±10% • ±20% or ±20 ml/min, whichever is greater• Arterial Pressure: 0 to -150 mmHg• Total Treated Blood Volume: 120 liters • Actual Blood Flow: 100 to 500 ml/min• Arterial Pressure: 0 to -150 mmHg• Total Treated Blood Volume: 120 to 200 liters• Actual Blood Flow: 100 to 500 ml/min Blood PumpSpeed • 10 to 580 ml/min, in steps of 10 ml/min /AccumulatedBlood Volume • 0 to 999 litres /NOTE WARNING!≤
Chapter 16: Specifications16-27 Cod. 6992200 - Rev. /Single Needle Single Pump Parameter Values ConditionsAverage BloodFlow • 10 to 220 ml/min, in steps of 10 ml/min /Accuracy • ±10 ml/min or ±20% whichever is greater • Arterial Pressure: 0 to -150• Treated Blood Volume: 120 LSN PressureMin • 150 to 360 mmHg /SN PressureMax • 190 to 400 mmHg /In Single Needle mode the stroke volume for each cycle isapproximately 20 ml.During a Single Needle Single Pump mode, the Artis DialysisSystem will be able to automatically control the Arterial/Venousphase commutation according to pressure measurement in theVenous Patient Line (see "Single Needle Pressure Monitoring"section in this chapter). In Single Needle mode, the blood recirculation rate at the level ofthe patient’s vascular access is influenced by the needle type orcatheter used. The blood recirculation rate is not due to the singleneedle cassette characteristics. ≤NOTE NOTE NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-28Single Needle Double Pump(Not currently available) 16.3.4 Heparin DeliveryThe Artis Dialysis System may be supplied with a syringe type infusion pumpwhich delivers heparin with a standard 30 ml syringe. Parameter Values ConditionsAverage BloodFlow • 10 to 220 ml/min /Accuracy • ±10 ml/min • ±10% • Blood Flow 100 ml/min • Blood Flow >100 ml/min StrokeVolumeaa. The Stroke Volume value is calculated from Pump Flow Rate and Time. • 20 to 50 ml (±15%), in steps of 1 ml • Cycle time: < 20 sec. AccumulatedBlood Volume • 0 to 99.9 litres (+/-0.6 l * treatment time (h) or +/-15%) /During a Single Needle Double Pump therapy, the Artis DialysisSystem will be able to automatically control the Arterial/Venousphase commutation according to pressure measurement andstroke volume achieved. Parameter ValuesHeparin DeliveryManagement • Linear: bolus delivered at a constant flow • Intermittent: bolus delivery at a set interval of time • Manual: single bolus delivered when the button is pressed• Extra Bolus: a bolus is delivered when the “Extra Bolus” Action button is pressed. Syringe Size • 30 ml Heparin DeliveryRate (Linear Mode) • 0 ml/h or 1.5 ml/h to 10.0ml/h, in steps of 0.1 ml/h Accuracy (on AccumulatedVolume) • ±1 ml or ±0.2 ml/h * heparinization time (h) or ±10% whichever is greater Bolus Amounts(default) • 0.5 to 10 ml, in steps of 0.5 mL (0.5 mL) ≤NOTE
Chapter 16: Specifications16-29 Cod. 6992200 - Rev. /Heparin Syringes Following a list of the main syringes allowed on the Artis Dialysis System: Bolus Delivery Rate • 0.08 ml/sStop Time (default) • 0 to total treatment time, in steps of 1 minute (30 min) Max. Counter Pressure • +900 mmHg Heparin DeliveryAlarm Limits • Accumulated Heparin Volume: ±40% of the set Heparin VolumeTo prime the Heparin line, 0.6 ml of heparin will be injected into theBlood Cassette. This will happen regardless of the type of heparindelivery program selected.Syringe Name Volume (ml) Internal DiameterTERUMO 30 23.1 mm (0.909 in)BD 30 PLASTIPAK 30 21.6 mm (0.850 in)PIC 30 LL 30 23.6 mm (0.929 in)ICO GAMMA PLUS/MONOSTERIL 30 23.9 mm (0.941 in)PENTA 30 30 21.8 mm (0.858 in)These diameters have been taken from samples from manycountries and are correct at the time of printing. However, themanufacturer cannot be held responsible for changes in syringedimensions that may occur. The user should periodically check thecorrelation between the stated and the actual diameters. DO NOT USE syringes without luer lock connection. Parameter ValuesNOTE WARNING!WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-30 16.3.5 Hemoscan Sensor The Artis Dialysis System provides a non-invasive mechanism to perform bloodvolume measurements, according to the following specifications: 16.3.6 Blood Pressure Monitor (BPM)The Blood Pressure Monitor is a non-invasive system to read the patient’s bloodpressure during a treatment (refer to the "Chapter 8: BPM" of this operator’smanual).In the table below the main specifications related to the blood pressure monitoroption are reported.The alarm limits below can be preset. The value put in brackets and in italics is thedefault value. The syringe infusion pump described above must be used ONLYfor the infusion of heparin. Parameter ValuesBlood Flow Rate • 180 to 500 ml/min Blood Temperature • 30 to 40°C Relative Blood Volume • -40% to +10% Accuracy (standard error) • ±3%Resolution • 0.1% Hemoglobin Value Range • 6 to 16 g/dl Parameter ValuesSystolic pressure rangea• +60 to +255 mmHg Low alarm limit • 60-255 mmHg (90 mmHg) High alarm limit • 60-255 mmHg (200 mmHg) Diastolic pressure rangea• +30 to +195 mmHg Low alarm limit • +30 to +195 mmHg (50 mmHg) High alarm limit • +30 to +195 mmHg (100 mmHg) Heart rate rangeb• 30 to 200 bpm Low alarm limit • 30 to 200 bpm (40 bpm) WARNING!
Chapter 16: Specifications16-31 Cod. 6992200 - Rev. / 16.3.7 Automatic Functions The following automatic functions are available with the Artis Dialysis System:1. Single Needle Single Pump: arterial/venous cycles occur through auto-matic blood pump transition when preprogrammed venous pressurethresholds are reached. 2. Linear or Intermittent Heparin Delivery: through programming of therate and timing of delivery.3. Heparin Bolus Injection Characteristics4. Blood Sensor before Venous Line Clamp: before blood detection by theBlood Sensor or before starting the dialysis treatment, some alarms arebypassed to allow easier filling of the extracorporeal and hydraulic circuits.5. Ultra Control: in online treatments with Pressure control mode, it ispossible to activate the Ultra Control functionality (ref to “16.2.4Substitution Fluid” section of this chapter)6. Automatic Pump control: in online treatments with Volume or Pressurecontrol mode, each time that the substitution pump is stopped due to anyreasons, the machine automatically decreases the blood pump speed inorder to avoid venous pressure peaks. 16.3.8 Main Surveillance DevicesFollowing the specifications related to the main surveillance devices available withthe Artis Dialysis System.Ultrasonic Air DetectorThe Blood Module has an Air Detector consisting of: • An Ultrasonic Sensor located into the right Sensor Bar;• A Transducer which carries out the auto-test every 250 ms;• A Visual and Audible Alarm which is activated if air is detected.High alarm limit • 30 to 200 bpm (120 bpm) Heart rate resolution • 1 bpm Cuff Pressure • Max.: 300 mmHg Cycle Time • Typical cycle time: 35 s. • Max.: < 160 s. a. Meets ANSI/AAMI SP-10. Mean error ±5 mmHg. Standard deviation 8 mmHg. b. Heart Rate Accuracy: ±2% or ±3 bpm, whichever is greaterParameter Values
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-32 Arterial Pressure MonitoringThe Arterial Pressure Sensor is used for measuring pre-pump arterial pressure inorder to protect the patient from high negative arterial pressures between thepatient and the Arterial pump. During a treatment, an Arterial Pressure alarm will be triggered if the pressuremeasurements are not within the following ranges:• Minimum and Maximum treatment limits;• Minimum and Maximum Arterial pressure limits, calculated as: Max Arterial Limit = Operating value + Arterial Positive OffsetMin Arterial Limit = Operating value - Arterial Negative Offset . Parameter ValuesDetection Method • An ultrasonic wave band crosses the fluid in the blood line. When air is present in the line, the signal received by the detector is modified in proportion to the volume of air present. When the signal goes above a fixed threshold, the microprocessor triggers a signal, which causes the Venous Line Clamp to close and the Blood Pumps to stop. Sensitivity • Bubble volume 20 micro liters (±1 micro liter), at max. flow rate In case of recovery procedures, the Artis Dialysis System willautomatically set the Extreme Alarm limits as the Minimum andMaximum Arterial pressure limits. Parameter ValuesOperating Range • -400 to +150 mmHg Accuracy • ±10 mmHg or ±10%, whichever is greater (in the range -400 mmHg to +20 mmHg)• ±20 mmHg (in the range +20 mmHg to +150 mmHg)Offset Values (Default)a• Positive: 10 to 100 mmHg, in steps of 5 mmHg (80 mmHg) • Negative: 10 to 80 mmHg, in steps of 5 mmHg (40 mmHg) ≥NOTE
Chapter 16: Specifications16-33 Cod. 6992200 - Rev. /Venous Pressure Monitoring (Double Needle Mode)During a treatment, a Venous Pressure alarm will be triggered if the pressuremeasurements are not within the following ranges:• Minimum and Maximum treatment limits;• Minimum and Maximum Venous pressure limits, calculated as: Max Venous Limit = Operating value + Venous Positive OffsetMin Venous Limit = Operating value - Venous Negative Offset Treatment Limits(Default)a• Min: -300 to -100 mmHg, in steps of 10 mmHg (-300 mmHg) • Max: -100 to +150 mmHg, in steps of 10 mmHg (0 mmHg) Extreme Alarm Limits (outsidethe treatment mode) • Min: -500 mmHg • Max: +300 mmHg Maximum Arterial Alarm Limita• -100 to +150 mmHg, in steps of 10 mmHg a. Can be presetModification of the Blood Flow Rate causes a fluctuation in theArterial Pressure and therefore an alarm may be triggered.To prevent such an effect, following any start/stop of the Arterialpump or change in the Blood Flow Rate the Arterial pressureAlarm Window is automatically set wider for 30 seconds, in HDtreatments, or for 120 seconds, in HDF treatments. Its lower valueis set to -400 mmHg while the upper value is set to +150 mmHg. Parameter ValuesOperating Range • -100 to +450 mmHg Accuracy • ±10 mmHg or ±10%, whichever is greater (in the range -20 mmHg to +450 mmHg) • ±20 mmHg (in the range -100 mmHg to -20 mmHg) Offset Values (Default)a• Positive: 10 to 70 mmHg in steps of 5 mmHg (70 mmHg) • Negative:10 to 40 mmHg in steps of 5 mmHg (40 mmHg) Parameter ValuesWARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-34Treatment Limits(Default)a• Min: 10 to 100 mmHg, in steps of 10 mmHg (10 mmHg) • Max: 150 to 350 mmHg, in steps of 10 mmHg (300 mmHg) Extreme Alarm Limits (outsidethe treatment mode) • Min: -300 mmHg • Max: +450 mmHg Maximum Venous PressureAlarm Limit (Default)a• +150 to +350 mmHg, in steps of 10 mmHg (300 mmHg)a. Can be presetA Safety Test of the Venous Pressure Monitoring System isautomatically performed each time the machine enters thePreparation mode. Modification of the Blood Flow Rate causes a fluctuation in theVenous Pressure and therefore an alarm may be triggered.To prevent such an effect, following any start/stop of the Arterialpump or change in the Blood Flow Rate the Venous PressureAlarm Window is automatically set wider for 30 seconds, in HDtreatments, or for 120 seconds, in HDF treatments. Its lower valueis set to -50 mmHg, while the upper limit is set to +450 mmHg. Parameter ValuesNOTE WARNING!
Chapter 16: Specifications16-35 Cod. 6992200 - Rev. / Single Needle Pressure Monitoring In Single Needle mode, the Venous Pressure Sensor is used for measuring theblood pressure in the Venous chamber for blood pump activation anddeactivation, according to set venous pressure values: Monitoring of the Venous Pressure could not always detect thedisconnection of a venous needle from its access site, which mayresult in extracorporeal blood loss to the environment. When avenous needle disconnects from its access, pressure at thevenous monitoring side may only decrease by the pressuremaintained within the patient’s vascular access. This pressuredrop may be less than the width of the machine’s venous pressurealarm window: in this particular case the disconnection of avenous needle from its access site is not detectable by themachine, even if pressure alarms and alarm windows are properlyset.To reduce the risk of needles disconnection:• ensure that venous needle and line are firmly secured to the access site area according to your clinic's protocol;• ensure that the patient's access is visible at all times during the dialysis treatment;• inspect frequently the patient's access;• adjust properly the venous pressure alarm window: the venous pressure alarm lower limit should be set as closely as practical to the actual patient’s venous pressure value without generating excessive nuisance alarms. Parameter ValuesOperating Range • +150 to 400 mmHg, in steps of 10 mmHg SN Pressure Min • 150 to 360 mmHgSN Pressure Max • 190 to 400 mmHgAlarm Limits • +10 mmHg to +450 mmHg The user must take precautions against the hazard of cross-contamination between patients by using only extracorporealcircuits that are not damaged.WARNING!WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-36Pre-Dialyzer Pressure 16.3.9 Safety system actuators The Artis Dialysis System is supplied with the following safety system actuators: Parameter ValuesOperating Range • -100 to +800 mmHg Accuracy • ±10 mmHg (in the Operating Range +300 mmHg to +800 mmHg) • ±20 mmHg or ±10%, whichever is greater (in the Operating Range -100 mmHg to +300 mmHg) Alarm Limits • 0 to +800 mmHg Arterial Line Clamp • Used for Single Needle modes Venous Line Clamp • Automatic closure when required by an alarm as part of a specific safety state;• Closure in Single Needle modes to reduce recirculation; • The Venous Line Clamp is fitted with a position sensor to ensure proper functioning of the clamp, and to assure that the Arterial Pump is stopped.
Chapter 16: Specifications16-37 Cod. 6992200 - Rev. / 16.4 Protective systemThe Protection System controls fault conditions which may be dangerous for thepatient, by placing the machine in a Safe State, as required by internationalregulations.For each of these conditions, an independent safety chain is implemented. Theconditions controlled are:• Final Dialysis Fluid Conductivity • Blood Pumps • Bicarbonate Dialysis Fluid conductivity • Degassing Pump Flow • Presence of blood in the Hydraulic Circuit • Concentrate Container Error • Dialysis Fluid Flow • Heparin Pump • Error in the Single Needle Mode (optional)•Maximum Dialyzer Pressure at the Dialyzer Inlet and Outlet • Minimum Dialyzer Pressure at the Dialyzer Inlet and Outlet • Heater Protection • Voltage Drop of greater than 20 seconds and less than 4 minutes• Voltage Drop of less than 20 seconds • Presence of Air in the Venous Patient Line • Profiling of Final Conductivity Activity (Not currently available)• Profiling of Ultrafiltration Rate Activity (Not currently available)• Temperature of the Dialysis Fluid • Ultrafiltration Flow • Ultrafiltrate Mass Balance • Venous Pressure higher than the maximum permitted • Venous Pressure outside the interval selected or less than theminimum permitted • Arterial Pressure lower than the minimum permitted
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-38• Arterial Pressure outside the interval selected or more than the maxi-mum permitted • Ultra Pure Water • Incorrect Voltage • Activity in Profiling Mode (Not currently available)• Activity of Diascan System • Control System Communication checking • Correct Sequence of T1 Tests • Power Failure • Long Bypass If, on encoutering a fault, the relevant safety state is not correctly configured, theprotection system places the machine in a General Safe State:1. The Venous Line Clamp is activated;2. The Power Supply to all other actuators, except those for visual and audi-ble alarms, is turned OFF.
Chapter 16: Specifications16-39 Cod. 6992200 - Rev. / 16.5 Disposal of discarded equipmentDiscarded electromedical equipment may not be disposed of together withmunicipal waste but must be collected separately in order to guaranteeecologically correct disposal to prevent dispersion of potential pollutants into theenvironment.Pay attention to the fact that some components of the machine (display, batteries,circuit boards, etc.) may contain toxic substances which, if released into theenvironment, pose a risk to the health of living organisms and the environmentitself.When discarding electromedical equipment used at or through healthcarefacilities, it may be returned directly to the local representative/distributor who hassupplied it.When discarding electromedical equipment used in private households, it may be:• returned free of charge to the distributor at the time of purchasing newequipment• sent to the specialized collection centres free of charge.Users who return electromedical equipment to the subjects identified aboveactively contribute to reuse, recycling and recovery of potentially still useablematerials and components and to reduction of the potential risks to theenvironment and human health. Abusive disposal of discarded equipment may be punishable by law.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-40 16.6 Preventive maintenanceTo keep the machine in good and safe working order, a periodicalpreventive maintenance of the Artis Dialysis System must be performedboth by the operator and by an authorized service technician.The operator is responsible for a regular preventive maintenance of thesolely machine external surface, whereas the machine internalcomponents preventive maintenance must be performed exclusively by anauthorized service technician. 16.6.1 Preventive Maintenance performed by the operatorDepending on the ambient conditions, the frequency and the averageduration of daily use of the Artis Dialysis System, the operator is requiredto perform periodical preventive maintenance procedures on the machineexternal surface. In particular, the operator has to perform:• External cleaning of the machine surface and outside components. Refer to the “12.9 External Cleaning” section of this Operator’s Man-ual for the procedures and agents to be used.• External disinfection of the water inlet tube. Refer to the “12.8 Water Inlet Tube disinfection” section of this Operator’s Manual for the related procedure.• External cleaning of the Touch Screen. Refer to the “12.9 External Cleaning” section of this Operator’s Manual for the related procedure.• Visual Inspection of the machine. Refer to the “12.11 Visual inspec-tion” section of this Operator’s Manual for the related procedure.• Cassette Panel O-Rings Inspection and Greasing. Refer “12.12 Cas-sette Panel O-Rings Inspection and Greasing” section Inspection and Greasing” of this Operator’s Manual for the related procedure.• Replacement of the U9000 ultrafilters. Please refer to “7.18 Ultrafilter Change Procedure” section of the Operator’s Manual. No other maintenance procedures than those mentioned above will be performed by the operator of the machine. The machine panels must ONLY be opened by a fully trained service technician.Stagnant water may contaminate the machine. If the machine is stored for more than 7 days, the water tube should be disinfected and rinsed before using it for treatment.WARNING!WARNING!
Chapter 16: Specifications16-41 Cod. 6992200 - Rev. / 16.6.2 Preventive Maintenance performed by an authorized service technicianThe ambient conditions, the frequency and the average duration of daily use ofthe Artis Dialysis System determine the maintenance frequency of the internalmachine components; however when a maximum of 4,000 working hours haselapsed (or at least once a year) a technical preventive maintenance is required. For a complete description of all the Technical Preventive MaintenanceProcedures as well as the replacement frequency of the single components, referto the “Preventive Maintenance” Section of the Artis Service Manual. Please find below the list of the spare parts that have to be compulsorily replacedat least once a year: The manufacturer does not accept any responsibility for damages caused by any operation carried out on the machine by unauthorized staff. Before replacing or checking any component in the Hydraulic Circuit, a Descaling procedure (i.e. a Heat with CleanCart-C disinfection) must be performed.Part/Assembly Sparepartcode SparePartReference ReplacementFrequencyAcid and Bicarbonatepick-up tube connectors(male and female)6987762 “Acid/BicTube ConnAE”Once a yearAir filter 6988430 “Filter 50Micron AE” Once a yearBlood Cassette pressurepodso-rings6987747 “External O-ring kit” Once a yearElectrovalves (EVC,EVD, EV1S) 6962468 “2 WaysolenoidValve Peek”Once a yearEvaClean gasket 6987671 “EvaCleanAssy AE” Once a yearFilter (250u) 6988158 “Filter 250Micron AE” Once a yearWARNING!WARNING!
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-42Filter (50u) 6988430 “Filter 50Micron AE” Once a yearHeparin syringe plungerlock 6988869 “Syringeplung. lockAE”Once a yearpH probe 6985089 “pH probe” Once a yearPRV Pressure regulator 6987978 “PRV AE” Once a yearRed and Blue dialysisfluid tube connectors(male and female)6988950 “Dial.connectorsmale AE”Once a year6988117 “Dial.connectorsAE”Once a yearUltrafilter holder O-rings 6989537 “Ultrafilterback holderAE”Once a year6987903 “Ultrafilterlower armsAE”Once a year6988984 “Ultrafilterupper holderAE”Once a yearBiCart Holder armsLower O-ring BiCart 6988125 “BiCartHolder AE” Once a yearUltra Port gasket 6987366 “Sensor BarUltra AssyAE”Once a yearYellow and cleardisinfectant connectors 6988026 “Yell/ClearDisinf ConnAE”Once a yearSelectCart Holder arms(not currently available) 6988786 “SelectCartHolder AE” Every two yearsPart/Assembly Sparepartcode SparePartReference ReplacementFrequency
Chapter 16: Specifications16-43 Cod. 6992200 - Rev. /Periodic Safety InspectionA safety inspection of the Artis Dialysis System is required at least once a yearand according to the local policies. Only trained and qualified technicians areauthorized to perform the safety inspection procedures. The inspection consists ofthe following tests: Parameter Performance ConditionsEarth Leakage Current 230/240V version230/240V version < 300 uA (typically = 250 uA)< 300 uA (typically = 180 uA)Normal conditionProtective Earthing 0.2 ohm maximum Between the protective earth pin in the mains plug and any accessible metal part that is protectively earthed.
ARTIS Operator’s ManualCod. 6992200 - Rev. / 16-44 16.7 Materials in contact with water, concentrates and dialysis fluid AISI 303 steel PES (Polyetheresulphone)AISI 304 steel PEX (Polyethylene)AISI 904 L PlatinumCarbon PolycarbonateCeramic, Aluminium oxide (Al2O3) PolyurethaneCeramic, Steatite 221 PP (Polypropylene reinforced with talcum)Ceramic, Zirconium oxide (ZrO2) PP (Polypropylene)Epoxy resin PPS (Polyphenysulphide)Ethylene propylene PSU (Polysulphone)Ferrite (Barium-Strontium-Ferrit) PTFEFiberglas reinforced polyamide PTFE (Polytetrafluoro ethylene)Fiberglas reinforced polypropylene PVC (Polyvinylchloride)Glass PVDF (Polyvinylidene fluoride)Graphite SantropreneLCP Silicon rubberNBR Stainless steel SS2343PEEK (Polyetherketone) Stainless steel SS2353Peek + CF Stainless steel SS2562Peek + GF TitaniumPPE + PS
Chapter 16: Specifications16-45 Cod. 6992200 - Rev. / 16.8 Diascan The Diascan™ system will be available in the following treatment modes:• Hemodialysis (DN) • Isolated UFFollowing the main specifications related to this functionality: Accuracy is valid in HD double needle and on-line HDF postdilution, for bloodflows 200 to 500 ml/min and dialysis fluid flows 500 to 800 ml/min.The conductivity of the dialysis fluid can be measured by the DIASCAN™ systemonly if the following parameters fall in the indicated ranges: Parameter Range Accuracy Resolution ConductivityIonic Dialysance 0 to 500 ml/min ±7 ml/minaa.Accuracy Standard Error for a 4 hour dialysis.1 ml/min /Plasma Sodium Concentration130 to 160 mmol/l ±3 mmol/la 1 mmol/l /Plasma Conduct. 13 to 16 mS/cm ± 0.05 mS/cmb0.01 mS/cm 13 to 16 mS/cm (0.05 mS/cm) Ionic Mass Bal -800 to 800 mmol (HD)b b.Positive values correspond to solutes removed from the patient.±25 mmola5 mmol -Depurated Vol 0 to 200 litres ±2 litresa 1.0 litres /KT/V 0 to 3 - 0.1 /Parameter RangeTemperature Range 30-45 °CConductivity Range 13 to 16 mS/cm (0.05 mS/cm)
This page is left intentionally blankCod. 6992200 - Rev. / 16-46
A-1Appendix A: Guidelines and Manufacturer's Declaration - Electromagnetic Emissions and Immunity A.1 Guidance and manufacturer's declaration A.1.1 Electromagnetic emissions The Artis Dialysis System is intended for use in the electromagnetic environmentspecified in the table below.The customer or the user of the Artis Dialysis System should assure that it is usedin such an environment. Emission test Compliance Electromagnetic environment - guidanceRF emissionCISPR 11 Group 1 Artis Dialysis System uses RF energyonly for its internal function. Therefore,its RF emissions are very low and arenot likely to cause any interference innearby electronic equipment.RF emissionCISPR 11 Class B The Artis Dialysis System is suitable foruse in all establishments, includingdomestic establishments and thosedirectly connected to the public low-voltage power supply network thatsupplies buildings used for domesticpurposes.Harmonic emissionsIEC 61000-3-2 Class AVoltage fluctuations/flicker emissions IEC 61000-3-3Complies
ARTIS Operator’s ManualCod. 6992200 - Rev. / A-2 A.1.2 Electromagnetic immunity The Artis Dialysis System is intended for use in the electromagnetic environmentspecified in the table below.The customer or the user of the Artis Dialysis System should assure that it is usedin such an environment. Electromagnetic immunityImmunity test IEC 60601test level Compliance level Electromagnetic environment - guidanceElectrostaticdischarge (ESD)IEC 61000-4-2• ±6 KV contact• ±8 KV air • ±6 KV contact• ±8 KV air Floors should be wood,concrete or ceramic tile.If floors are covered withsynthetic material, therelative humidity shouldbe at least 30%.Electrical fasttransient / burstIEC 61000-4-4• ±2 KV for power supply lines• ±1 KV for input / output lines• ±2 KV for power supply lines• ±1 KV for input / output linesMains power qualityshould be that of atypical commercial orhospital environment.SurgeIEC 61000-4-5 • 1 KV line(s) to line(s)• 2 KV line(s) to earth• 1 KV line(s) to line(s)• 2 KV line(s) to earthMains power qualityshould be that of atypical commercial orhospital environment.Voltage dips,shortinterruptionsand voltagevariations onpower supplyinput linesIEC 61000-4-11• <5 % UT (>95 % dip in UT) for 0.5 cyclesa• 40 % UT (60 % dip in UT) for 5 cyclesa• 70 % UT (30 % dip in UT) for 25 cyclesa• <5 % UT (>95 % dip in UT) for 5 sa• <5 % UT (>95 % dip in UT) for 0.5 cyclesa• 40 % UT (60 % dip in UT) for 5 cyclesa• 70 % UT (30 % dip in UT) for 25 cyclesa• <5 % UT (>95 % dip in UT) for 5 saMains power qualityshould be that of atypical commercial orhospital environment. Ifthe user of the ArtisDialysis System requirescontinued operationduring power mainsinterruptions, it isrecommended that theArtis Dialysis System bepowered from anuninterruptible powersupply or a battery.
Appendix A: Guidelines and Manufacturer's Declaration - Electromagnetic Emissions and ImmunityA-3 Cod. 6992200 - Rev. /Powerfrequency (50/60 Hz) magneticfield IEC 61000-4-8• 3 A/m • 30 A/m Power frequencymagnetic fields shouldbe at levelscharacteristic of a typicallocation in a typicalcommercial or hospitalenvironment.a. UT is the a.c. mains voltage prior to application of the test level.Electromagnetic immunityImmunity test IEC 60601test level Compliance level Electromagnetic environment - guidance
ARTIS Operator’s ManualCod. 6992200 - Rev. / A-4 Immunity test IEC 60601 test level Compliancelevel Electromagnetic environment guidanceConducted RFIEC 61000-4-6Radiated RFIEC 61000-4-3• 3 Vrms• 150 KHz to 80 MHz• 3 V/m• 80 MHz to 2.5 GHz• 10 Vrms• 10 V/mPortable and mobile RF communications equipment should be used no closer to any part of the Artis Dialysis System including cables, than the recommended separation distance calculated from the equation applicable to frequency of the transmitter.Recommended separationdistance d = 0.35 d = 0.35 80 MHz to 800MHzd = 0.7 800 MHz to 2.5GHzwhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.Interference may occur in the vicinity of equipment marked with the following symbol: PPP
Appendix A: Guidelines and Manufacturer's Declaration - Electromagnetic Emissions and ImmunityA-5 Cod. 6992200 - Rev. /a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To asses the electromagnetic environment due to fixed transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Artis Dialysis System is used exceeds the applicable RF compliance level above, the Artis Dialysis System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Artis Dialysis System.b. Over the frequency range 150 KHz to 80 MHz, field strength should be less than 10 V/m.• At 80 MHz and 800 MHz, the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.NOTE
ARTIS Operator’s ManualCod. 6992200 - Rev. / A-6 A.2 Recommended separation distances between portable and mobile RF communications equipment and Artis Dialysis SystemArtis Dialysis System is intended for use in the electromagnetic environmentwhere radiated RF disturbances are controlled. The customer or the user of ArtisDialysis System can help prevent electromagnetic interference by maintaining aminimum distance between portable and mobile RF communications equipment(transmitters) and Artis Dialysis System as recommended below, according to themaximum output power of the communications equipment. Rated maximum output power of transmitterSeparation distances according to frequency of transmitter (m)W150 KHz to 80 MHzd = 0.35 80 MHz to 800 MHzd = 0.35 800 MHz to 2.5 GHzd = 0.7 0,01 0.04 0.04 0.070,1 0.11 0.11 0.221 0.35 0.35 0.7010 1.11 1.11 2.21100 3.50 3.50 7.00For transmitters rated at maximum output power not listed above, therecommended separation distance d in metres (m) can be estimated using theequation applicable to the frequency of the transmitter, where P is the maximumoutput power rating of the transmitter in watts (W) according to the transmittermanufacturer.• At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, object and people.NOTE PPP

Navigation menu