Gambro Dasco RFMOD GAMBRO RF MODULE User Manual Start ENG

15-1

Chapter 15: Alarms and Troubleshooting

15.1 Alarm System

The machine has been designed to recognize and control various types of

malfunctions and faults. There are three ways in which the operator is

advised 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 bottom

side 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 alarms

The alarms are classified according to their triggering cause, the part of

the machine affected and the type of intervention required from the

operator. Each alarm class is characterized by a specific visual and

audible alarm signal. The classes of Alarms will be described in

decreasing order of importance, i.e. the first is the most serious type of

alarm.

Class A: Alarms related to the safety of the patient, caused by internal

machine processes, requiring operator intervention to remove the cause,

returning the process data to the operating limits. They may be identified

by:

• A Visual alarm signal with a flashing Red light of 4-4 modulation (one

flash 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 by

an operator error on the machine controls or caused by machine

conditions requiring operator intervention. These require operator

intervention. 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 Manual

Cod. 6992200 - Rev. / 15-2

• A Visual alarm signal with a flashing Yellow light of 1-7 modulation (a

flash 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 control

errors that may revert to normal without the need for operator intervention.

They usually require the intervention of a Service technician. They may be

identified by:

• A Visual alarm signal with a flashing Yellow light of 1-7 modulation (a

flash 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 error

condition, 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 (a

flash 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 to

transitory control errors which usually revert to normal without operator

intervention. If these errors persist, the machine is probably not functioning

properly and a Service technician must be notified. They may be identified

by:

• A Visual alarm signal with a flashing Yellow light of 1-7 modulation (a

flash 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 the

three types of indicators available and then take an appropriate action.

Chapter 15: Alarms and Troubleshooting

15-3 Cod. 6992200 - Rev. /

15.3 Levels of operator intervention

When an alarm condition occurs, the operator may be able to manually

deal with the problem, depending on its class.

The specific actions to take are described for each individual alarm. Four

types of intervention are possible:

• MUTE

• CONFIRM

• OVERRIDE

• RESET

15.3.1 Mute

It is possible to temporarily (for about 2 minutes) deactivate the audible

alarm 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 of

each 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 Confirm

The CONFIRM operation forces a removing of the alarm, it clears the

audible and visible feedbacks as well as the time counters used to

generate the alarm. Therefore, the Confirm condition restores the

functionalities which has been previously stopped, bringing back the

machine as before the alarm generation.

After having solved the alarm causes, the operator can confirm the alarm

by pressing the CONFIRM button, displayed on the right top side of the

Alarm 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 Manual

Cod. 6992200 - Rev. / 15-4

When the fault has been removed and the CONFIRM button pressed, the

conditions that have generated the alarm will be cleared and the previous

process will be resumed. However, if the safety conditions aren't still

satisfied, the alarm will reappear again.

15.3.2 Override

The Artis Dialysis System allows to OVERRIDE only the alarm related to a

Blood Leak Detection.

The OVERRIDE of this alarm can be performed to give the possibility to

ignore it and to continue the treatment. It is useful every time a recovery of

a dangerous situation requires the machine working, to reactivate some

functionality that was stopped due to the alarm presence.

To override the alarm, press the OVERRIDE button displayed in the Alarm

Area 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 of

time (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 OVERRIDE

state, the description relative to each fault is displayed in the Alarm Area.

15.3.3 Reset

Some alarms can be automatically RESET by the machine when there are

no more failures. In this cases, the confirm option is not available.

The RESET operation foresees an automatic removing of the alarm after

that the conditions that weren’t previously satisfied and that consequently

have 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 Troubleshooting

15-5 Cod. 6992200 - Rev. /

After an automatic alarm reset, the audible and visible feedbacks are

cleared and the functionalities, which have been stopped by the machine

at the start of the alarm, are restored again.

15.4 Guidelines to respond to an alarm situation

In case of an alarm condition, the operator should perform the following

actions:

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 of

the Touch Screen.

Figure 15-1. Alarm Area

3. If more than five alarms are triggered, it is possible to scroll the Alarm

window up and down using the Scroll Buttons.

4. Determine the cause of the alarm. If uncertain about the cause or the

appropriate response to the alarm, refer to the “15.6 Alarm

The 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 Manual

Cod. 6992200 - Rev. / 15-6

Troubleshooting” Section in this Chapter, for possible causes and

solutions. If a Help window is available, the “I+” button is displayed.

5. Correct the cause of the alarm as described in “15.6 Alarm

Troubleshooting”.

Chapter 15: Alarms and Troubleshooting

15-7 Cod. 6992200 - Rev. /

15.5 Alphabetic List of Alarms

The 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 NO

80% Maximum Substitution Volume

Reached 551 E YES

90% Maximum Substitution Volume

Reached 552 E YES

Acid/Acetate Concentrate Container

Empty 1AYES

Acid/Acetate Concentrate Error 369 A NO

Air Detector Cleaning Required 583 A YES

Air Detector Inspection Required 584 A YES

Air in Blood T0 Failure 385 A YES

Air in Hydraulic Pathway (LD1) 33 E NO

Air in Hydraulic Pathway (LD2) 35 E NO

Air in Venous Line 4 A NO

Arterial Infusion Line Open 519 E YES

Arterial Line Clamped 517 E YES

Arterial Pressure Below Treatment

Min. Limit 306 A YES

Arterial pressure high 305 A YES

Arterial pressure high 457 A YES

Arterial pressure low 384 A YES

Arterial pressure out of range 11 A YES

Arterial Pump Segment Not Correctly

Loaded 586 E YES

Autoscheduled Disinfection/Rinse

Program not Performed 562 A YES

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Cod. 6992200 - Rev. / 15-8

Backup battery failure 183 E YES

Bicarbonate Concentrate Error 370 A NO

BiCart cartridge empty 21 A YES

Bioslave Subsystem Communication

Error 296 E NO

BLD Sensitivity Loss 170 E YES

Blood Cassette presence required 507 A NO

Blood in Dialysate 28 A NO

Blood Lines Clamped 509 A YES

Blood pump cover open 8 B NO

Blood pump rotor error 13 B YES

Blood Pump Rotor Error 363 A YES

Blood pump speed error 12 B YES

Blue Dialysis Fluid Tube Incorrect

Position 330 B NO

BPM Diastolic pressure alarm 46 A YES

BPM failure 30 A YES

BPM Heart rate alarm 66 A YES

BPM Measurement failure 31 A YES

BPM Systolic pressure alarm 132 A YES

Cassette Repositioning Failed 557 E YES

CDF1 Ultrafilter Lower Switch Error 61 E NO

CDF2 Ultrafilter Lower Switch Error 563 E NO

Chemical Process Not Properly

Performed: Disinfectant Tank Empty 533 A YES

Communication Protective Cond. Cell

Stopped 449 A YES

Communication Select Cond. Cell

Stopped 450 A YES

Conductivity too high 463 A NO

Conductivity too low 462 A NO

Dialysate pH high 40 A NO

ALARM MESSAGE CODE CLASS CONFIRM

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Dialysate pH low 368 A NO

Dialysate Pressure High 146 B YES

Dialysate Pressure Low 540 B YES

Dialysis fluid flow high 44 A NO

Dialysis fluid flow low 373 A NO

Dialysis fluid flow too low 425 A YES

Dialysis fluid temp high 134 A NO

Dialysis fluid temp low 377 A NO

Dialysis fluid temp too high 460 A NO

Dialysis fluid temp too low 461 A NO

Dialyzer Inlet Pressure High 87 A YES

Dialyzer Inlet Pressure Low 94 A YES

Dialyzer Outlet Pressure High 88 A YES

Dialyzer Outlet Pressure Low 95 A YES

Dialyzer Pressure Maximum 114 A NO

Dialyzer Pressure Minimum 115 A NO

Diascan measurement error 536 A YES

Diascan: Autocalibration Failure 528 B NO

Diascan: Low Clearance 530 D YES

Diascan: Low Kt/V 531 D YES

Diascan: Measurement Failure 529 B YES

Disinfection not Properly Performed 534 B YES

Flowmeter Alignment Failed 506 A YES

Fluid path obstruction 206 A YES

Fluid Removal Complete 53 B YES

Hemoconcentration Risk 524 E YES

Hemocontrol Error 554 A YES

Hemocontrol: BV% not available 234 B YES

Hemocontrol: Early on Prescription 230 B YES

Hemocontrol: High Na Concentration 231 B YES

ALARM MESSAGE CODE CLASS CONFIRM

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Cod. 6992200 - Rev. / 15-10

Hemocontrol: Late On Prescription 229 B YES

Hemocontrol: Low Na Concentration 232 B YES

HEMOSCAN Autocalibration Failure 473 B NO

HEMOSCAN: DARK Out of Range 223 C NO

HEMOSCAN: L/H Out of Range 226 C NO

HEMOSCAN: Minimum Blood Volume 191 E NO

HEMOSCAN: TEST Out of Range 225 C NO

Heparin infusion complete 58 B YES

Heparin pump lower limit reached 69 E NO

Heparin pump overload 55 A NO

Heparin pump speed error 70 B YES

Heparinization Not Initiated 71 B YES

Hydraulic Centralise Acetate

Connector Type One 565 E NO

Hydraulic Centralise Acetate

Connector Type Two 566 E NO

Hydraulic Sensor Dirty (LP) 34 E NO

Incorrect bicarbonate concentrate 18 B NO

Incorrect bicarbonate concentration 23 A NO

Incorrect bicarbonate concentration 366 A NO

Incorrect bicarbonate concentration 464 A NO

Incorrect bicarbonate concentration 465 A NO

Incorrect BiCart Holder Arms Position 22 B NO

Incorrect Cassette line connections or

clamps status 542 A YES

Incorrect concentrate connector 2 B NO

Incorrect conductivity measured 62 A NO

Incorrect conductivity measured 375 A NO

Incorrect fluid conductivity detected 496 A NO

Incorrect venous or arterial line

position in clamp 205 A NO

Insert the HEMOSCAN cuvette 454 B NO

ALARM MESSAGE CODE CLASS CONFIRM

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15-11 Cod. 6992200 - Rev. /

Insufficient water supply 100 A NO

Isolated UF Completed 570 D YES

Isolated UF target loss will not be

achieved 581 E NO

Leakages H 548 E YES

Leakages I 549 E YES

Leakages Test (A) Failure 467 E YES

Leakages Test (B) Failure 468 E YES

Leakages Test (C) Failure 469 E YES

Leakages Test (D) Failure 470 E YES

Leakages Test (E) Failure 498 E YES

Leakages Test (F) Failure 499 E YES

Leakages Test (G) Failure 500 E YES

Left Blue EvaClean door incorrect

position 416 B NO

Line Not Connected in EvaClean Port

or Access Line Open 518 E YES

Low blood pump speed 204 A YES

Low Disinfectant Level in last Clean

Cart Process 504 E YES

Low Heparinization 573 A YES

Low Temperature 81 D NO

Maximum Substitution Volume

reached 546 A YES

Maximum Substitution Volume

reached 553 E YES

MAXIMUM TEMPERATURE LIMIT 90 A NO

Na or Bic Settings result in

conductivity out of range 401 E NO

New Ultra Scan is suggested 545 E YES

No power - Using battery backup 353 A NO

No Power - Using Battery Backup 415 A YES

Not Performing UF 443 E YES

ALARM MESSAGE CODE CLASS CONFIRM

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Cod. 6992200 - Rev. / 15-12

On line blood restitution: wrong Ultra

Cassette configuration 579 A YES

On line Prime - Incorrect Ultra or

Blood cassette configuration 580 A YES

On-line door incorrect position 423 E NO

Patient Venous Line Incorrect Position 547 E YES

PDr Pressure High 452 A YES

PDr Pressure Low 453 A YES

Power Failure: Check Power Supply 550 E YES

Pre Filter Pressure High 541 A YES

Preparation can not proceed until

dressing is complete 576 E NO

Preparation Completed 559 E YES

Preparation not Completed - Incorrect

Condition on Acetate Distribution 476 A YES

Preparation not Completed - Incorrect

Condition on Bicarbonate Distribution 477 A YES

Preparation not Completed - Incorrect

Condition on D1 Flow Rate 474 A YES

Preparation not Completed - Incorrect

Condition on TcA 475 A YES

Pressure Alarm Limits Still Expanded 525 E NO

Priming Completed

(See NOTE 1)560 E YES

Pump speed too high 10 A YES

Pump speed too low 362 A YES

Red Dialysis Fluid Tube Incorrect

Position 331 B NO

Reminder - HDF Substitution Still

Disabled 526 E YES

Reminder - Still In Isolated UF 479 E YES

Reminder - Still in Pause Therapy 329 E YES

Reminder - Wrong Dip Switches 502 E YES

Reminder: 558 E YES

ALARM MESSAGE CODE CLASS CONFIRM

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15-13 Cod. 6992200 - Rev. /

Residual Check Reminder 582 E YES

Right Red EvaClean door incorrect

position 417 A NO

Saline Bag Not Connected 515 E YES

Saline Bag Empty 585 E YES

Select Bag Holder Incorrect Position 411 D NO

Select Cart Holder Arms Incorrect

Position 3BNO

Sensor Bar Door Open 424 E NO

Smart Scan - High QD 514 D YES

Smart Scan - Low QB 512 D YES

Smart Scan - Low QD 513 D YES

Smart Scan – Low Real QB 577 D YES

Still in bypass 302 E YES

SUPPLY VOLTAGE INCORRECT 187 E NO

System Pressure out of range 522 A YES

T1 Test Arterial Pressure 447 E YES

T1 Test Arterial Pump/ABD 419 E YES

T1 Test Conductivity Cells Failed 445 E YES

T1 Test Flow Meters 422 E YES

T1 Test Pre Filter Pressure 418 E YES

T1 Test Temperature Failed 444 E YES

T1 Test Venous Pressure 446 E YES

Timeout on Data Reception 532 D YES

TMP High 68 A YES

TMP Low 142 A YES

TMP Set too Low 567 E NO

TMP Maximum Limit 527 E NO

Tool not Connected 561 E YES

Treatment can not begin until the

ultrafilters have been replaced 571 A NO

ALARM MESSAGE CODE CLASS CONFIRM

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Cod. 6992200 - Rev. / 15-14

Treatment Time Complete 51 B YES

UF Deviation 505 A NO

UF rate higher than expected 145 A YES

UF rate lower than expected 379 A YES

UF target will not be achieved 60 B NO

Ultra Inlet Tube Clamped 556 A YES

Ultra Scan aborted: TMP Set and

Upper Limit Updated 543 E YES

Ultra Scan completed: TMP Set and

Upper Limit Updated 544 E YES

Ultrafilter Cover Error 564 E NO

Ultrafilter Replacement Reminder 402 D YES

Venous Flow Maximum 413 A YES

Venous Flow Minimum 412 A YES

Venous Infusion Line Open 587 A YES

Venous Line Clamped 516 E YES

Venous line not in patient sensor 364 A NO

Venous Pressure Below Treatment

Min. Limit 459 A YES

Venous pressure high 155 A YES

Venous pressure low 382 A YES

Venous Pressure Not Decreasing 472 A YES

Venous Pressure Not Increasing 351 A YES

Venous pressure out of range 153 A YES

Venous pressure too high 154 A YES

Venous pump cover is open 149 B NO

Venous pump rotor error 158 B YES

Venous pump rotor error 521 A YES

Venous pump speed error 157 B YES

Water Leakage 539 A NO

Wrong A/V or System Pressure Offset 319 E YES

ALARM MESSAGE CODE CLASS CONFIRM

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15-15 Cod. 6992200 - Rev. /

Wrong Acid/Acetate Connector 568 E NO

Wrong Arterial and Venous Treatment

Limits 503 A YES

Wrong Bicarbonate Connector 569 E NO

Wrong Disinfectant used in Chemical

Disinf. 578 A YES

Wrong disposable configuration on

Ultra Cassette holder 508 A NO

Wrong Single Needle Clamps Position 574 A YES

The 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 CONFIRM

WARNING

!

NOTE 1

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Cod. 6992200 - Rev. / 15-16

15.6 Alarm Troubleshooting

The Alarm Area gives all the necessary instructions to respond to most of

the alarm situations. Under certain circumstances, however, the alarm

system could not give detailed information.

Therefore, additional information are provided in this section for each of

the alarms listed in the previous table.

The alarms below are listed according to their technical code number.

ACID/ACETATE CONCENTRATE CONTAINER EMPTY 1

Reason

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 Troubleshooting

15-17 Cod. 6992200 - Rev. /

INCORRECT CONCENTRATE CONNECTOR 2

Reason

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 Manual

Cod. 6992200 - Rev. / 15-18

SELECT CART HOLDER ARMS INCORRECT POSITION 3

Reason

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 Troubleshooting

15-19 Cod. 6992200 - Rev. /

AIR IN VENOUS LINE 4

Reason

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 Manual

Cod. 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 Troubleshooting

15-21 Cod. 6992200 - Rev. /

BLOOD PUMP COVER OPEN 8

Reason

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 Manual

Cod. 6992200 - Rev. / 15-22

PUMP SPEED TOO HIGH 10

Reason

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 Troubleshooting

15-23 Cod. 6992200 - Rev. /

ARTERIAL PRESSURE OUT OF RANGE 11

Reason

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.

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Cod. 6992200 - Rev. / 15-24

BLOOD PUMP SPEED ERROR 12

Reason

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 Troubleshooting

15-25 Cod. 6992200 - Rev. /

BLOOD PUMP ROTOR ERROR 13

Reason

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 Manual

Cod. 6992200 - Rev. / 15-26

INCORRECT BICARBONATE CONCENTRATE 18

Reason

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 Troubleshooting

15-27 Cod. 6992200 - Rev. /

BICART CARTRIDGE EMPTY 21

Reason

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 Manual

Cod. 6992200 - Rev. / 15-28

INCORRECT BICART HOLDER ARMS POSITION 22

Reason

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 Troubleshooting

15-29 Cod. 6992200 - Rev. /

INCORRECT BICARBONATE CONCENTRATION 23

Reason

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 Manual

Cod. 6992200 - Rev. / 15-30

BLOOD IN DIALYSATE 28

Reason

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 Troubleshooting

15-31 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 Manual

Cod. 6992200 - Rev. / 15-32

BPM FAILURE 30

Reason

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 Troubleshooting

15-33 Cod. 6992200 - Rev. /

BPM: MEASUREMENT FAILURE 31

Reason

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 Manual

Cod. 6992200 - Rev. / 15-34

AIR 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 Troubleshooting

15-35 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 Manual

Cod. 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 Troubleshooting

15-37 Cod. 6992200 - Rev. /

DIALYSATE PH HIGH 40

Reason

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 Manual

Cod. 6992200 - Rev. / 15-38

DIALYSIS FLUID FLOW HIGH 44

Reason

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 Troubleshooting

15-39 Cod. 6992200 - Rev. /

BPM: DIASTOLIC PRESSURE ALARM 46

Reason

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 Manual

Cod. 6992200 - Rev. / 15-40

TREATMENT TIME COMPLETE 51

Reason

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 Troubleshooting

15-41 Cod. 6992200 - Rev. /

FLUID REMOVAL COMPLETE 53

Reason

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 Manual

Cod. 6992200 - Rev. / 15-42

HEPARIN PUMP OVERLOAD 55

Reason

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 Troubleshooting

15-43 Cod. 6992200 - Rev. /

HEPARIN INFUSION COMPLETE 58

Reason

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 Manual

Cod. 6992200 - Rev. / 15-44

UF TARGET WILL NOT BE ACHIEVED 60

Reason

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 Troubleshooting

15-45 Cod. 6992200 - Rev. /

CDF1 ULTRAFILTER LOWER SWITCH ERROR 61

Reason

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 Manual

Cod. 6992200 - Rev. / 15-46

INCORRECT CONDUCTIVITY MEASURED 62

Reason

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 Troubleshooting

15-47 Cod. 6992200 - Rev. /

BPM HEART RATE ALARM 66

Reason

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 Manual

Cod. 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 Troubleshooting

15-49 Cod. 6992200 - Rev. /

HEPARIN PUMP LOWER LIMIT REACHED 69

Reason

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 Manual

Cod. 6992200 - Rev. / 15-50

HEPARIN PUMP SPEED ERROR 70

Reason

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 Troubleshooting

15-51 Cod. 6992200 - Rev. /

HEPARINIZATION NOT INITIATED 71

Reason

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 Manual

Cod. 6992200 - Rev. / 15-52

LOW TEMPERATURE 81

Reason

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 Troubleshooting

15-53 Cod. 6992200 - Rev. /

DIALYZER INLET PRESSURE HIGH 87

Reason

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 Manual

Cod. 6992200 - Rev. / 15-54

DIALYZER OUTLET PRESSURE HIGH 88

Reason

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 Troubleshooting

15-55 Cod. 6992200 - Rev. /

MAXIMUM TEMPERATURE LIMIT 90

Reason

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 Manual

Cod. 6992200 - Rev. / 15-56

DIALYZER INLET PRESSURE LOW 94

Reason

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 Troubleshooting

15-57 Cod. 6992200 - Rev. /

DIALYZER OUTLET PRESSURE LOW 95

Reason

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 Manual

Cod. 6992200 - Rev. / 15-58

INSUFFICIENT WATER SUPPLY 100

Reason

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 Troubleshooting

15-59 Cod. 6992200 - Rev. /

DIALYZER PRESSURE MAXIMUM 114

Reason

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 Manual

Cod. 6992200 - Rev. / 15-60

DIALYZER PRESSURE MINIMUM 115

Reason

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 Troubleshooting

15-61 Cod. 6992200 - Rev. /

BPM SYSTOLIC PRESSURE ALARM 132

Reason

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 Manual

Cod. 6992200 - Rev. / 15-62

DIALYSIS FLUID TEMP HIGH 134

Reason

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 Troubleshooting

15-63 Cod. 6992200 - Rev. /

TMP LOW 142

Reason

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 Manual

Cod. 6992200 - Rev. / 15-64

UF RATE HIGHER THAN EXPECTED 145

Reason

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 Troubleshooting

15-65 Cod. 6992200 - Rev. /

DIALYSATE PRESSURE HIGH 146

Reason

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 Manual

Cod. 6992200 - Rev. / 15-66

VENOUS PUMP COVER IS OPEN 149

Reason

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 Troubleshooting

15-67 Cod. 6992200 - Rev. /

VENOUS PRESSURE OUT OF RANGE 153

Reason

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 Manual

Cod. 6992200 - Rev. / 15-68

VENOUS PRESSURE TOO HIGH 154

Reason

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 Troubleshooting

15-69 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 Manual

Cod. 6992200 - Rev. / 15-70

VENOUS PRESSURE HIGH 155

Reason

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 Troubleshooting

15-71 Cod. 6992200 - Rev. /

VENOUS PUMP SPEED ERROR 157

Reason

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 Manual

Cod. 6992200 - Rev. / 15-72

VENOUS PUMP ROTOR ERROR 158

Reason

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 Troubleshooting

15-73 Cod. 6992200 - Rev. /

BLD SENSITIVITY LOSS 170

Reason

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 Manual

Cod. 6992200 - Rev. / 15-74

BACKUP BATTERY FAILURE 183

Reason

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 Troubleshooting

15-75 Cod. 6992200 - Rev. /

SUPPLY VOLTAGE INCORRECT 187

Reason

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 Manual

Cod. 6992200 - Rev. / 15-76

HEMOSCAN: MINIMUM BLOOD VOLUME 191

Reason

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 Troubleshooting

15-77 Cod. 6992200 - Rev. /

LOW BLOOD PUMP SPEED 204

Reason

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 Manual

Cod. 6992200 - Rev. / 15-78

INCORRECT VENOUS OR ARTERIAL LINE POSITION IN CLAMP 205

Reason

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 Troubleshooting

15-79 Cod. 6992200 - Rev. /

FLUID PATH OBSTRUCTION 206

Reason

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 Manual

Cod. 6992200 - Rev. / 15-80

HEMOSCAN: DARK OUT OF RANGE 223

Reason

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 Troubleshooting

15-81 Cod. 6992200 - Rev. /

HEMOSCAN: TEST OUT OF RANGE 225

Reason

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 Manual

Cod. 6992200 - Rev. / 15-82

HEMOSCAN: L/H OUT OF RANGE 226

Reason

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 Troubleshooting

15-83 Cod. 6992200 - Rev. /

HEMOCONTROL: LATE ON PRESCRIPTION 229

Reason

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 Manual

Cod. 6992200 - Rev. / 15-84

HEMOCONTROL: EARLY ON PRESCRIPTION 230

Reason

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 Troubleshooting

15-85 Cod. 6992200 - Rev. /

HEMOCONTROL: HIGH NA CONCENTRATION 231

Reason

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 Manual

Cod. 6992200 - Rev. / 15-86

HEMOCONTROL: LOW NA CONCENTRATION 232

Reason

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 Troubleshooting

15-87 Cod. 6992200 - Rev. /

HEMOCONTROL: BV% NOT AVAILABLE 234

Reason

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 Manual

Cod. 6992200 - Rev. / 15-88

BIOSLAVE SUBSYSTEM COMMUNICATION ERROR 296

Reason

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 Troubleshooting

15-89 Cod. 6992200 - Rev. /

STILL IN BYPASS 302

Reason

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 Manual

Cod. 6992200 - Rev. / 15-90

ARTERIAL PRESSURE HIGH 305

Reason

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 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. 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 Troubleshooting

15-91 Cod. 6992200 - Rev. /

ARTERIAL PRESSURE BELOW TREATMENT MIN. LIMIT 306

Reason

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 Manual

Cod. 6992200 - Rev. / 15-92

WRONG A/V OR SYSTEM PRESSURE OFFSET 319

Reason

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 Troubleshooting

15-93 Cod. 6992200 - Rev. /

REMINDER - STILL IN PAUSE THERAPY 329

Reason

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 Manual

Cod. 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 Troubleshooting

15-95 Cod. 6992200 - Rev. /

RED DIALYSIS FLUID TUBE INCORRECT POSITION 331

Reason

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 Manual

Cod. 6992200 - Rev. / 15-96

VENOUS PRESSURE NOT INCREASING 351

Reason

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 Troubleshooting

15-97 Cod. 6992200 - Rev. /

NO POWER - USING BATTERY BACKUP 353

Reason

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 Manual

Cod. 6992200 - Rev. / 15-98

PUMP SPEED TOO LOW 362

Reason

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 Troubleshooting

15-99 Cod. 6992200 - Rev. /

BLOOD PUMP ROTOR ERROR 363

Reason

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 Manual

Cod. 6992200 - Rev. / 15-100

VENOUS LINE NOT IN PATIENT SENSOR 364

Reason

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 Troubleshooting

15-101 Cod. 6992200 - Rev. /

INCORRECT BICARBONATE CONCENTRATION 366

Reason

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 Manual

Cod. 6992200 - Rev. / 15-102

DIALYSATE PH LOW 368

Reason

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 Troubleshooting

15-103 Cod. 6992200 - Rev. /

ACID/ACETATE CONCENTRATE ERROR 369

Reason

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 Manual

Cod. 6992200 - Rev. / 15-104

BICARBONATE CONCENTRATE ERROR 370

Reason

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 Troubleshooting

15-105 Cod. 6992200 - Rev. /

DIALYSIS FLUID FLOW LOW 373

Reason

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 Manual

Cod. 6992200 - Rev. / 15-106

INCORRECT CONDUCTIVITY MEASURED 375

Reason

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 Troubleshooting

15-107 Cod. 6992200 - Rev. /

The use of liquid Bicarbonate concentrate is not currently

available.

NOTE

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 15-108

DIALYSIS FLUID TEMPERATURE LOW 377

Reason

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 Troubleshooting

15-109 Cod. 6992200 - Rev. /

UF RATE LOWER THAN EXPECTED 379

Reason

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 Manual

Cod. 6992200 - Rev. / 15-110

VENOUS PRESSURE LOW 382

Reason

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 Troubleshooting

15-111 Cod. 6992200 - Rev. /

ARTERIAL PRESSURE LOW 384

Reason

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 Manual

Cod. 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 Troubleshooting

15-113 Cod. 6992200 - Rev. /

AIR IN BLOOD T0 FAILURE 385

Reason

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 Manual

Cod. 6992200 - Rev. / 15-114

NA OR BIC SETTINGS RESULT IN CONDUCTIVITY OUT OF RANGE 401

Reason

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 Troubleshooting

15-115 Cod. 6992200 - Rev. /

ULTRAFILTER REPLACEMENT REMINDER 402

Reason

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 Manual

Cod. 6992200 - Rev. / 15-116

SELECT BAG HOLDER INCORRECT POSITION 411

Reason

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 Troubleshooting

15-117 Cod. 6992200 - Rev. /

VENOUS FLOW MINIMUM 412

Reason

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 Manual

Cod. 6992200 - Rev. / 15-118

VENOUS FLOW MAXIMUM 413

Reason

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 Troubleshooting

15-119 Cod. 6992200 - Rev. /

NO POWER - USING BATTERY BACKUP 415

Reason

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 Manual

Cod. 6992200 - Rev. / 15-120

LEFT BLUE EVACLEAN DOOR INCORRECT POSITION 416

Reason

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 Troubleshooting

15-121 Cod. 6992200 - Rev. /

RIGHT RED EVACLEAN DOOR INCORRECT POSITION 417

Reason

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 Manual

Cod. 6992200 - Rev. / 15-122

T1 TEST PRE FILTER PRESSURE 418

Reason

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 Troubleshooting

15-123 Cod. 6992200 - Rev. /

T1 TEST ARTERIAL PUMP/ABD 419

Reason

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 Manual

Cod. 6992200 - Rev. / 15-124

T1 TEST FLOW METERS 422

Reason

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 Troubleshooting

15-125 Cod. 6992200 - Rev. /

ON-LINE DOOR INCORRECT POSITION 423

Reason

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 Manual

Cod. 6992200 - Rev. / 15-126

SENSOR BAR DOOR OPEN 424

Reason

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 Troubleshooting

15-127 Cod. 6992200 - Rev. /

DIALYSIS FLUID FLOW TOO LOW 425

Reason

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 Manual

Cod. 6992200 - Rev. / 15-128

NOT PERFORMING UF 443

Reason

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 Troubleshooting

15-129 Cod. 6992200 - Rev. /

T1 TEST TEMPERATURE FAILED 444

Reason

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 Manual

Cod. 6992200 - Rev. / 15-130

T1 TEST CONDUCTIVITY CELL FAILED 445

Reason

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 Troubleshooting

15-131 Cod. 6992200 - Rev. /

T1 TEST VENOUS PRESSURE 446

Reason

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 Manual

Cod. 6992200 - Rev. / 15-132

T1 TEST ARTERIAL PRESSURE 447

Reason

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 Troubleshooting

15-133 Cod. 6992200 - Rev. /

COMMUNICATION PROTECTIVE COND. CELL STOPPED 449

Reason

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 Manual

Cod. 6992200 - Rev. / 15-134

COMMUNICATION SELECT COND. CELL STOPPED 450

Reason

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 Troubleshooting

15-135 Cod. 6992200 - Rev. /

PDR PRESSURE HIGH 452

Reason

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 Manual

Cod. 6992200 - Rev. / 15-136

PDR PRESSURE LOW 453

Reason

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 Troubleshooting

15-137 Cod. 6992200 - Rev. /

INSERT THE HEMOSCAN CUVETTE 454

Reason

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 Manual

Cod. 6992200 - Rev. / 15-138

ARTERIAL PRESSURE HIGH 457

Reason

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 Troubleshooting

15-139 Cod. 6992200 - Rev. /

VENOUS PRESSURE BELOW TREATMENT MIN. LIMIT 459

Reason

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 Manual

Cod. 6992200 - Rev. / 15-140

DIALYSIS FLUID TEMP TOO HIGH 460

Reason

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 Troubleshooting

15-141 Cod. 6992200 - Rev. /

DIALYSIS FLUID TEMP TOO LOW 461

Reason

for Alarm The temperature of the dialysis fluid measured by the ΓP conductivity cell

is lower than 32°C

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 Manual

Cod. 6992200 - Rev. / 15-142

CONDUCTIVITY TOO LOW 462

Reason

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 Troubleshooting

15-143 Cod. 6992200 - Rev. /

The use of liquid Bicarbonate concentrate is not currently

available.

NOTE

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 15-144

CONDUCTIVITY TOO HIGH 463

Reason

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 Troubleshooting

15-145 Cod. 6992200 - Rev. /

INCORRECT BICARBONATE CONCENTRATION 464

Reason

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 Manual

Cod. 6992200 - Rev. / 15-146

INCORRECT BICARBONATE CONCENTRATION 465

Reason

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 Troubleshooting

15-147 Cod. 6992200 - Rev. /

LEAKAGES TEST (A) FAILURE 467

Reason

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 Manual

Cod. 6992200 - Rev. / 15-148

LEAKAGES TEST (B) FAILURE 468

Reason

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 Troubleshooting

15-149 Cod. 6992200 - Rev. /

LEAKAGES TEST (C) FAILURE 469

Reason

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 Manual

Cod. 6992200 - Rev. / 15-150

LEAKAGES TEST (D) FAILURE 470

Reason

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 Troubleshooting

15-151 Cod. 6992200 - Rev. /

VENOUS PRESSURE NOT DECREASING 472

Reason

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 Manual

Cod. 6992200 - Rev. / 15-152

HEMOSCAN AUTOCALIBRATION FAILURE 473

Reason

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 Troubleshooting

15-153 Cod. 6992200 - Rev. /

PREPARATION NOT COMPLETED - INCORRECT CONDITION ON D1 FLOW RATE

474

Reason

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 Manual

Cod. 6992200 - Rev. / 15-154

PREPARATION NOT COMPLETED - INCORRECT CONDITION ON TCA 475

Reason

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 Troubleshooting

15-155 Cod. 6992200 - Rev. /

PREPARATION NOT COMPLETED - INCORRECT CONDITION ON ACETATE

DISTRIBUTION 476

Reason

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 Manual

Cod. 6992200 - Rev. / 15-156

PREPARATION NOT COMPLETED - INCORRECT CONDITION ON BICARBONATE

DISTRIBUTION 477

Reason

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 Troubleshooting

15-157 Cod. 6992200 - Rev. /

REMINDER - STILL IN ISOLATED UF 479

Reason

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 Manual

Cod. 6992200 - Rev. / 15-158

INCORRECT FLUID CONDUCTIVITY DETECTED 496

Reason

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 Troubleshooting

15-159 Cod. 6992200 - Rev. /

LEAKAGES TEST (E) FAILURE 498

Reason

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 Manual

Cod. 6992200 - Rev. / 15-160

LEAKAGES TEST (F) FAILURE 499

Reason

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 Troubleshooting

15-161 Cod. 6992200 - Rev. /

LEAKAGES TEST (G) FAILURE 500

Reason

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 Manual

Cod. 6992200 - Rev. / 15-162

REMINDER - WRONG DIP SWITCHES 502

Reason

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 Troubleshooting

15-163 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 Manual

Cod. 6992200 - Rev. / 15-164

LOW 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 Troubleshooting

15-165 Cod. 6992200 - Rev. /

UF DEVIATION 505

Reason

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 Manual

Cod. 6992200 - Rev. / 15-166

FLOWMETER ALIGNMENT FAILED 506

Reason

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 Troubleshooting

15-167 Cod. 6992200 - Rev. /

BLOOD CASSETTE PRESENCE REQUIRED 507

Reason

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 Manual

Cod. 6992200 - Rev. / 15-168

WRONG DISPOSABLE CONFIGURATION ON ULTRA CASSETTE HOLDER 508

Reason

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 Troubleshooting

15-169 Cod. 6992200 - Rev. /

BLOOD LINES CLAMPED 509

Reason

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 Manual

Cod. 6992200 - Rev. / 15-170

SMART SCAN - LOW QB 512

Reason

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 Troubleshooting

15-171 Cod. 6992200 - Rev. /

SMART SCAN - LOW QD 513

Reason

for Alarm The ratio Dialysis fluid flow rate/Blood flow rate (QD/QB) has been lower

than 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 Manual

Cod. 6992200 - Rev. / 15-172

SMART SCAN - HIGH QD 514

Reason

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 Troubleshooting

15-173 Cod. 6992200 - Rev. /

SALINE BAG NOT CONNECTED 515

Reason

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 Manual

Cod. 6992200 - Rev. / 15-174

VENOUS LINE CLAMPED 516

Reason

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 Troubleshooting

15-175 Cod. 6992200 - Rev. /

ARTERIAL LINE CLAMPED 517

Reason

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 Manual

Cod. 6992200 - Rev. / 15-176

LINE NOT CONNECTED IN EVACLEAN PORT OR ACCESS LINE OPEN 518

Reason

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 Troubleshooting

15-177 Cod. 6992200 - Rev. /

ARTERIAL INFUSION LINE OPEN 519

Reason

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 Manual

Cod. 6992200 - Rev. / 15-178

VENOUS PUMP ROTOR ERROR 521

Reason

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 Troubleshooting

15-179 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 Manual

Cod. 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 Troubleshooting

15-181 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 Manual

Cod. 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 Troubleshooting

15-183 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 Manual

Cod. 6992200 - Rev. / 15-184

DIASCAN: AUTOCALIBRATION FAILURE 528

Reason

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 Troubleshooting

15-185 Cod. 6992200 - Rev. /

DIASCAN: MEASUREMENT FAILURE 529

Reason

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 Manual

Cod. 6992200 - Rev. / 15-186

DIASCAN: LOW CLEARANCE 530

Reason

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 Troubleshooting

15-187 Cod. 6992200 - Rev. /

DIASCAN: LOW KT/V 531

Reason

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 Manual

Cod. 6992200 - Rev. / 15-188

TIMEOUT ON DATA RECEPTION 532

Reason

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 Troubleshooting

15-189 Cod. 6992200 - Rev. /

CHEMICAL PROCESS NOT PROPERLY PERFORMED: DISINFECTANT TANK

EMPTY 533

Reason

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 Manual

Cod. 6992200 - Rev. / 15-190

DISINFECTION NOT PROPERLY PERFORMED 534

Reason

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 Troubleshooting

15-191 Cod. 6992200 - Rev. /

DIASCAN MEASUREMENT ERROR 536

Reason

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 Manual

Cod. 6992200 - Rev. / 15-192

WATER LEAKAGE 539

Reason

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 Troubleshooting

15-193 Cod. 6992200 - Rev. /

DIALYSATE PRESSURE LOW 540

Reason

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 Manual

Cod. 6992200 - Rev. / 15-194

PRE FILTER PRESSURE HIGH 541

Reason

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 Troubleshooting

15-195 Cod. 6992200 - Rev. /

INCORRECT CASSETTE LINE CONNECTIONS OR CLAMPS STATUS 542

Reason

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 Manual

Cod. 6992200 - Rev. / 15-196

ULTRA SCAN ABORTED: TMP SET AND UPPER LIMIT UPDATED 543

Reason

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 Troubleshooting

15-197 Cod. 6992200 - Rev. /

ULTRA SCAN COMPLETED: TMP SET AND UPPER LIMIT UPDATED 544

Reason

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 Manual

Cod. 6992200 - Rev. / 15-198

NEW ULTRA SCAN IS SUGGESTED 545

Reason

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 Troubleshooting

15-199 Cod. 6992200 - Rev. /

MAXIMUM SUBSTITUTION VOLUME REACHED 546

Reason

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 Manual

Cod. 6992200 - Rev. / 15-200

PATIENT VENOUS LINE INCORRECT POSITION 547

Reason

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 Troubleshooting

15-201 Cod. 6992200 - Rev. /

LEAKAGES H 548

Reason

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 Manual

Cod. 6992200 - Rev. / 15-202

LEAKAGES I 549

Reason

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 Troubleshooting

15-203 Cod. 6992200 - Rev. /

POWER FAILURE: CHECK POWER SUPPLY 550

Reason

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 Manual

Cod. 6992200 - Rev. / 15-204

80% MAXIMUM SUBSTITUTION VOLUME REACHED 551

Reason

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 Troubleshooting

15-205 Cod. 6992200 - Rev. /

90% MAXIMUM SUBSTITUTION VOLUME REACHED 552

Reason

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 Manual

Cod. 6992200 - Rev. / 15-206

MAXIMUM SUBSTITUTION VOLUME REACHED 553

Reason

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 Troubleshooting

15-207 Cod. 6992200 - Rev. /

HEMOCONTROL ERROR 554

Reason

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 Manual

Cod. 6992200 - Rev. / 15-208

ULTRA INLET TUBE CLAMPED 556

Reason

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 Troubleshooting

15-209 Cod. 6992200 - Rev. /

CASSETTE REPOSITIONING FAILED 557

Reason

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 Manual

Cod. 6992200 - Rev. / 15-210

REMINDER: 558

Reason

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 Troubleshooting

15-211 Cod. 6992200 - Rev. /

PREPARATION COMPLETED 559

Reason

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 Manual

Cod. 6992200 - Rev. / 15-212

PRIMING COMPLETED 560

Reason

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 Troubleshooting

15-213 Cod. 6992200 - Rev. /

AUTOSCHEDULED DISINFECTION/RINSE PROGRAM NOT PERFORMED 562

Reason

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 Manual

Cod. 6992200 - Rev. / 15-214

CDF2 ULTRAFILTER LOWER SWITCH ERROR 563

Reason

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 Troubleshooting

15-215 Cod. 6992200 - Rev. /

ULTRAFILTER COVER ERROR 564

Reason

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 Manual

Cod. 6992200 - Rev. / 15-216

HYDRAULIC CENTRALISE ACETATE CONNECTOR TYPE ONE 565

Reason

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 Action

The 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 Troubleshooting

15-217 Cod. 6992200 - Rev. /

HYDRAULIC CENTRALISE ACETATE CONNECTOR TYPE TWO 566

Reason

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 Manual

Cod. 6992200 - Rev. / 15-218

TMP SET TOO LOW 567

Reason

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 Troubleshooting

15-219 Cod. 6992200 - Rev. /

WRONG ACID/ACETATE CONNECTOR 568

Reason

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 Manual

Cod. 6992200 - Rev. / 15-220

WRONG BICARBONATE CONNECTOR 569

Reason

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 Troubleshooting

15-221 Cod. 6992200 - Rev. /

ISOLATED UF COMPLETED 570

Reason

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 Manual

Cod. 6992200 - Rev. / 15-222

TREATMENT CAN NOT BEGIN UNTIL THE ULTRAFILTERS HAVE BEEN

REPLACED 571

Reason

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 Troubleshooting

15-223 Cod. 6992200 - Rev. /

LOW HEPARINIZATION 573

Reason

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 Manual

Cod. 6992200 - Rev. / 15-224

WRONG SINGLE NEEDLE CLAMPS POSITION 574

Reason

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 Troubleshooting

15-225 Cod. 6992200 - Rev. /

PREPARATION CAN NOT PROCEED UNTIL DRESSING IS COMPLETE 576

Reason

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 Manual

Cod. 6992200 - Rev. / 15-226

SMART SCAN – LOW REAL QB 577

Reason

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 Troubleshooting

15-227 Cod. 6992200 - Rev. /

WRONG DISINFECTANT USED IN CHEMICAL DISINF. 578

Reason

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 Manual

Cod. 6992200 - Rev. / 15-228

ON LINE BLOOD RESTITUTION: WRONG ULTRA CASSETTE CONFIGURATION 579

Reason

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 Troubleshooting

15-229 Cod. 6992200 - Rev. /

ON LINE PRIME - INCORRECT ULTRA OR BLOOD CASSETTE CONFIGURATION 580

Reason

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 Manual

Cod. 6992200 - Rev. / 15-230

ISOLATED UF TARGET LOSS WILL NOT BE ACHIEVED 581

Reason

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 Troubleshooting

15-231 Cod. 6992200 - Rev. /

RESIDUAL CHECK REMINDER 582

Reason

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 Manual

Cod. 6992200 - Rev. / 15-232

AIR DETECTOR CLEANING REQUIRED 583

Reason

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 Troubleshooting

15-233 Cod. 6992200 - Rev. /

AIR DETECTOR INSPECTION REQUIRED 584

Reason

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 Manual

Cod. 6992200 - Rev. / 15-234

SALINE BAG EMPTY 585

Reason

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 Troubleshooting

15-235 Cod. 6992200 - Rev. /

ARTERIAL PUMP SEGMENT NOT CORRECTLY LOADED 586

Reason

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 Manual

Cod. 6992200 - Rev. / 15-236

VENOUS INFUSION LINE OPEN 587

Reason

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 Troubleshooting

15-237 Cod. 6992200 - Rev. /

<< GENERAL SYSTEM FAILURE >>

System Blocking XXX

Reason

for Alarm This is a special alarm.

The Main Board is blocked

Machine

Actions • GENERAL SAFE STATE

• The Touch Screen is blocked

In 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 Manual

Cod. 6992200 - Rev. / 15-238

15.7 Machine Malfunction Alarms

When a malfunction alarm occurs the following message is displayed in

the Alarm Area

MALFUNCTION

together 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 described

in the “7.4 Fast Recovery” section of this Operator’s Manual. If the

alarm persists, take note of the alarm code, switch the machine OFF

and 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 CODE

ADR PROCESS NOT INITIATED 63

ADR Process Timed Out 190

Air compressor failure 466

ARTERIAL PRESSURE DATA ERROR 307

Arterial Pressure Negative Offset Data Error 430

Arterial Pressure Offset Data Error 431

ARTERIAL SENSOR ERROR 6

BIC CONC DATA ERROR 398

Bicarbonate pump failure 110

!BIO FLOW data error 25

Blood flow data error 27

BLOOD LEAK DETECTOR CALIBRATION ERROR 167

Blood leak detector data error 26

BLOOD SLAVE COMMUNICATION ERROR 295

BLOOD SLAVE ERROR 130

Bubble Trap T1 Test 493

Chapter 15: Alarms and Troubleshooting

15-239 Cod. 6992200 - Rev. /

Concentrate pump failure 108

CONCENTRATION UM DATA ERROR 399

CONTROL DATA ERROR 327

Control Flowmeters Test Failed 497

CRC MESSAGE CHECK 471

D1 FLOWMETER FAILURE 300

D2 FLOWMETER FAILURE 301

DATA ERROR 43

Dialysate flow data error 45

Disinfection timeout error 67

EEPROM BLOOD ERROR 48

EEPROM CRC ERROR 173

EEPROM HYDRAULIC ERROR 49

Flow Meters Alignment Failure 535

Flowmeters alignment timeout 484

> GENERAL SAFE STATE < 64

HEATER PROTECTION ERROR

(See the NOTE below) 59

Hydraulic slave error 131

Incorrect Arterial Clamp Position 7

Incorrect disinfectant 112

Incorrect disinfectant 113

Incorrect Rinsing or Disinfection 510

Incorrect Venous Clamp Position 148

Invalid Rinsing or Disinfection 511

Low Flow In Degasser 84

Maximum Arterial Pressure Data Error 432

MAXIMUM BLOOD FLOW DATA ERROR 312

Maximum Blood Volume Reached 481

Maximum Venous Pressure Data Error 458

Min UF rate data error 164

MALFUNCTION CODE

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 15-240

Minimum Arterial Pressure Data Error 393

Minimum Venous Pressure Data Error 429

P1 Pump failure 104

P2 Pump failure 106

PAUSE THERAPY DATA ERROR 313

PC Pump failure 111

Pinch Calibration Edge Error 491

Pinch Calibration Out of Range 490

Pinch Calibration Time Out 492

Pinch Position Error 488

Pinch Position Out of Range 487

Pinch Position Time Out 489

Pinch valve wrong position optical sensor 1 494

Pinch valve wrong position optical sensor 2 495

PROTECTION MODULE DATA ERROR 185

PROTECTION MODULE SOFTWARE ERROR 182

PROTECTION SYSTEM FAILURE 120

PRSS Start Up Message Missing 480

Ps Out of Order 410

PWHO Out of Order 426

Select pump failure 486

Set value out of range 395

!S/N MAX PRESSURE Data Error 209

!S/N MIN PRESSURE Data Error 208

SODIUM CONC DATA ERROR 397

System Pressure Sensor Error 523

T1 Test BLD 434

T1 Test Cut 24 Volts Failed 440

T1 Test FPGA failed 485

T1 Test Pinch Valve 572

T1 Test Valves Command Failed 442

MALFUNCTION CODE

Chapter 15: Alarms and Troubleshooting

15-241 Cod. 6992200 - Rev. /

T1 Test Venous Clamp 441

T1 Test Water Presence Sensor Failure 537

Temperature data error 135

Temperature mismatch between Tp and Tca 538

Timeout on messages acknowledge 396

Treatment time data error 239

UF data error 143

UF data error 240

ULTRAFILTER PRESSURE SENSOR ERROR 147

Venous pressure data error 150

Venous Pressure Negative Offset Data Error 427

Venous Pressure Positive Offset Data Error 428

VENOUS SENSOR ERROR 159

If 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 CODE

NOTE

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Cod. 6992200 - Rev. / 15-242

16-1

Chapter 16: Specifications

Chemical Disinfection with hypochlorite is not currently available.

16.1 General Specifications

Following the main specifications related to Artis Dialysis System general

characteristics are reported.

16.1.1 Name

Artis Dialysis System.

16.1.2 Standards and Classifications

The Artis Dialysis System complies with the following classifications and

standards.

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 concerning

medical devices.

Notified body: British Standards Institution (BSI) with the notified body

number 0086.

The Artis Dialysis System must be used under the supervision of a

physician.

Do not use the Artis Dialysis System near flammable gas or

flammable anesthetic mixtures with air, with oxygen or with nitrous

oxide.

WARNING

!

WARNING

!

ARTIS Operator’s Manual

Cod. 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 Devices

NOTE

Chapter 16: Specifications

16-3 Cod. 6992200 - Rev. /

Radio Frequency Interference and Electromagnetic Environment

Requirements

The Artis Dialysis System needs special precautions regarding EMC and needs to

be installed and put into service according to the EMC information provided in the

Appendix A, of this operator’s manual.

FCC / Canada Radio Certification

The 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 for

compliance could void user’s authority to operate the equipment.

Operation is subject to the following two conditions: (1) This device may not cause

harmful interference, and (2) This device must accept any interference received,

including interference that may cause undesired operation. Changes or

modifications not expressly approved by the party responsible for compliance

could void the user’s authority to operate the equipment.

16.1.3 Power Supply

Main Characteristics

EN ISO 10993-1 • Biological evaluation of medical devices - Part

1: Evaluation and testing

EN ISO 10993-4 • Biological evaluation of medical devices - Part

4: Selection of tests for interactions with blood

EN ISO 10993-5 • Biological evaluation of medical devices - Part

5: Tests for in vitro cytotoxicity

EN 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 Values

Mains Voltage • 230/240 VAC (±10%)

• 115 VAC (±10%)

Frequency • 50/60 Hz (±5 Hz)

Medical Equipment Standardsa (Continued)

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-4

Power 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 the

accessories listed below) being connected to the machine, which

may cause the permitted leakage current to be exceeded.

Wait at least 5 seconds after switching OFF the machine before

turning it ON again.

The correct installation of a MEDICAL ELECTRICAL SYSTEM

requires that each SYSTEM component be individually connected

to the main power.

It is strongly recommended: NOT TO USE MULTIPLE

PORTABLE SOCKET-OUTLETS.

However, if using multiple portable socket-outlets, they must

comply with the IEC 60601-1-1 Standard and must NOT BE

PLACED 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 Values

WARNING

!

WARNING

!

WARNING

!

WARNING

!

Chapter 16: Specifications

16-5 Cod. 6992200 - Rev. /

Power failure

In case of a mains power failure, an audible alarm is triggered and the red lamp is

illuminated.

16.1.4 Physical Data

The physical data reported below must be considered approximated.

Wheels and Portability

The Artis Dialysis System is provided with 4 double wheels: two lockable wheels

on 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 for

proper disposal.

Parameter Dimensions

Height (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 Kg

Transportation • in horizontal position

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-6

16.1.5 Environmental Data

Operational Mode

Storage and Transportation

Before moving the Artis Dialysis System, check that the two locks

are released and remove infusion bags or any other weights or

hanging objects from the Infusion Pole or from the concentrate

container tray.

To avoid jolting, carefully move the Artis Dialysis System by using

the handles on the rear panel.

The machine could be damaged if handled in an improper way.

Parameter Values

Ambient 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 Values

Ambient Temperature Range • -20°C to +70°Ca

a. Temperatures above +50° C are allowed ONLY for maximum 12 hours

Relative Humidity Range • 10 to 95% rh (non-condensing)

Air Pressure Range • 500 to 1060 HPa

If condensation of Artis Dialysis System occurs when moving it

between locations with different temperatures and high relative

humidity (e.g. outdoor and indoor locations), the inside of the

machine shall be allowed to dry before switching it on.

WARNING

!

WARNING

!

WARNING

!

Chapter 16: Specifications

16-7 Cod. 6992200 - Rev. /

16.1.6 Software revision

This 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 following

ports:

During transportation and storage the Artis Dialysis System has to

be 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 Ethernet

Port • Used for connecting the machine to a

Personal Computer to interface with the

Communication System

RS232 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 device

Remote 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 Manual

Cod. 6992200 - Rev. / 16-8

Figure 16-1. Connectivity Panel

16.1.8 Shipping List

The 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 Shelf

Hour 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 machine

Adjustement of the infusion pole height must be done without bags

on the hooks.

Connectivity Panel (Continued)

NOTE

Chapter 16: Specifications

16-9 Cod. 6992200 - Rev. /

• BPM (Blood Pressure Monitoring)

• Central Concentrate Supply Kit

Accessories

• SNSP Expansion Chamber Holder

• CWP Adapter Kit

Do not assemble, install or use the Artis Dialysis System before

having carefully read this operator’s manual.

WARNING

!

ARTIS Operator’s Manual

Cod. 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 comply

with local standards and ISO 13959 standard.

Main Requirements

Drain

Make the connection of the drain, as described in applicable local and

international standards, with an external pressure connector to avoid back flow.

Mantain an air clearance between the drain connector of the machine and the

drain itself.

Parameter Value Conditions

Pressure • 150 to 800 kPa /

Inlet Water

Demand

(Flow Rate)

• < 1 l/min /

Inlet Water

Conductivity • 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 Value

Drain 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: Specifications

16-11 Cod. 6992200 - Rev. /

16.2.2 Concentrate Connectors

The concentrate and disinfectant connectors on the Artis Dialysis System are

colour-coded as follows:

16.2.3 Dialysis Fluid

Dialysis Fluid Temperature

Connector Colour

Acid Tube Connector • Red, located on the machine front side

Disinfectant Tubes • Yellow and Clear, located on the

machine rear side

It is recommended to use concentrates which conform to the

requirements of the European Pharmacological Standards.

The control of alarm threshold and dialysis fluid conductivity

precision is of major medical importance in ensuring a safe

dialysis treatment.

Attention must be given to the safety hazards related to incorrect

choice of dialysis fluid concentrates.

Parameter Values

Range • +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 temperature

When the temperature of the dialysis fluid exceeds the alarm

threshold, the audible and visual alarms are triggered.

WARNING

!

WARNING

!

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-12

Dialysis Fluid Flow

Dialysis Fluid Pressure

Degassing

pH Supervision

Parameter Values

Dialysis 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, the

audible and visual alarms are triggered.

Parameter Values

Permitted Values • -350 to +480 mmHg

Accuracy • ± 25 mmHg

Alarm Limits • -350 to +480 mmHg

When the dialysis fluid pressure exceeds the alarm threshold, the

audible and visual alarms are triggered.

Parameter Values

Method of Degassing • Heating in combination with vacuum

pumping.

Pressure • < 150 mmHg (±10 mmHg) or dissolved gas in

dialysis fluid < 7.0 mg/l .

Parameter Values

Range • 1.0 to 13.0 ph units

Accuracy • ±0.2 ph units

WARNING

!

WARNING

!

Chapter 16: Specifications

16-13 Cod. 6992200 - Rev. /

Supported Concentrates

Ions Concentration

Concentrate 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, the

audible and visual alarms are triggered.

Parameter Values

Liquid concentrates • Acidic (A) concentrate for preparation of 8.4%

bicarbonate dialysis fluid

Dry concentrates • BiCart® Cartridge: Sodium Bicarbonate 8.4%

concentrate for preparation of 8.4 %

bicarbonate dialysis fluid

Ions Concentration

Na+ (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 Values

Na+ (Sodium)a

a.Can be set by the operator

• 130 to 160 mmol/l (±2.5%)

HCO3- (Bicarbonate)a• 24 to 38 mmol/l (± 5%)

Parameter Values

Range • -20 kPa to +50 kPa

Parameter Values

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-14

Total Conductivity

Conductivity of the Bicarbonate Solution

BiCart Cartridges (sodium bicarbonate cartridge - see specific instruction sheet)

can be used with the Artis Dialysis System.

Dialysis Fluid Pump Monitoring for Concentrate Exchange

The reference values for the speed of the acid/acetate and bicarbonate ceramic

pumps are defined during the corresponding calibration processes and represent

the 0% functioning point.

Parameter Values

Conductivity 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 correspondence

between the dialysis fluid conductivity, displayed by the machine

and the dialysis fluid solute content, verified by clinical laboratory

results, for each concentrate used for dialysis treatment.

This can be done by taking dialysis fluid samples at different

conductivity values (e.g. 13, 14, 15 mS/cm) and sending them to a

laboratory for analysis.

Carefully read the BiCart Cartridge Instructions for Use before

using the device. BiCart Cartridge may only be used by staff, who

are specially trained for hemodialysis treatments, using the Artis

Operator’s Manual.

BiCart Solution Conductivity Monitor

Parameter Value

Conductivity values

allowed • 2.2 to 3.8 mS/cm

Average accuracy • ±0.1 mS/cm

Alarms • ±5% of the conductivity value

WARNING

!

WARNING

!

Chapter 16: Specifications

16-15 Cod. 6992200 - Rev. /

A safety system is present to prevent concentrate exchange errors, by generating

an 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 Mode

Hemodiafiltration treatments performed by the Artis Dialysis System can be

controllable in Volume Control Mode (Post dilution): the total weight loss, the

Substitution Fluid Flow Rate and Treatment Time are set by the user while the

TMP pressure varies accordingly to the total Ultra-filtration rate (weight loss rate +

substitution fluid flow rate).

Parameter Value

Substitution 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 water

conforming to ISO 13959 and concentrates conforming to

European Pharmacopea, will have a microbiological fluid quality

of:

• Bacterial content less than 10E-6 CFU/ml,

• Endotoxin content < 0.03 IU/ml measured with an LAL assay.

NOTE

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-16

In 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) in

POST dilution mode

• Ratio between the Substitution Fluid Flow Rate and the Real Blood

Flow Rate (Qi/Qb) in PRE dilution mode

TMP in Volume Control Mode

The operator will be able to set the maximum alarm limit for the TMP, during an

Online treatment in volume control mode, in the following range:

• 0 mmHg to Absolute Maximum TMP, in steps of 10 mmHg

where the Absolute Maximum TMP is a pre-defined value set by a Service

technician in the following range:

• 0 mmHg to +500 mmHg in steps of 10 mmHg

Pressure Control Mode

Hemodiafiltration treatments performed by the Artis Dialysis System can be

controllable in Pressure Control Mode (Post dilution): the Total Weight Loss, the

TMP and the Treatment Time are set by the user while the Substitution Pump

Fluid 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 POST

dilution mode

• Ratio between the Substitution Fluid Flow Rate and the Real Blood

Flow Rate (Qi/Qb) in PRE dilution mode

Pressure Control Mode with Ultra Control

Hemodiafiltration treatments performed by the Artis Dialysis System can be

controllable in Pressure Control Mode (Post dilution) with Ultra Control: if the

related functionality has been selected in the Preset, then during the treatment,

the machine allows manual Ultra Scans or automatic Ultra scans. During an Ultra

Scan, the machine automatically increases the TMP from the initial value to the

value that maximizes the total Ultra-filtration.

In case of manual Ultra Scans, the Ultra Scan process is activated by the user and

automatically stopped by the machine as the optimum TMP is reached. A manual

Ultra Scan can also be stopped by the user.

In case of automatic Ultra Scans, three Ultra Scan processes are automatically

activated by the machine with a fixed timing and automatically stopped by the

machine as the optimum TMP is reached. An automatic Ultra Scan can also be

stopped by the user.

Chapter 16: Specifications

16-17 Cod. 6992200 - Rev. /

TMP in Pressure Control Mode

The operator will be able to set the maximum alarm limit for the TMP, during an

Online treatment in volume control mode, in the following range:

• 0 mmHg to Absolute Maximum TMP, in steps of 10 mmHg

where the Absolute Maximum TMP is a pre-defined value set by a Service

technician 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 following

operating ranges:

Parameter Values

Dialysis 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 rate

If the difference between the accumulated weight loss rate

measured by the Ultrafiltration System and the accumulated

weight loss rate measured by the Protective System of the

machine is greater than ±80 ml an audible and visual alarm is

triggered.

When this alarm is activated the Venous Pump is stopped and the

dialysis fluid goes into bypass.

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-18

Ultrafiltration Supervision

Following the alarm limits for the Ultrafiltration System control:

16.2.6 Blood Leak Detection

Besides the ultrafiltration, the patient’s weight change during

treatment is affected by other factors such as fluid and food intake,

perspiration, drug administration, infusion priming and rinseback

volumes, amongst others.

In addition, precise pre- and post-treatment weight are critical for

the proper assesment of the ultrafiltration during the treatment. If

these measurements are not accurate a discrepancy between the

achieved ultrafiltration during treatment and the patient’s weight

changes will occur.

Parameter Values

UF Volume Supervisiona

a. 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 Volume

Alarm 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 Values

Sensitivity • > 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 automatically

performed each time the machine enters the Preparation mode.

When the Blood Leak sensor test fails audible and visual alarms

are triggered .

NOTE

WARNING

!

Chapter 16: Specifications

16-19 Cod. 6992200 - Rev. /

16.2.7 Disinfection

16.2.7.1 Chemical Disinfectants

Following a list of the main chemical solutions that may be used with the Artis

Dialysis 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 conditions

and dialyzer characteristics.

Contact with cleaning and/or disinfection chemicals may pose a

risk of burns, skin irritation or other adverse reactions. Always

follow the chemical manufacturer's instructions when handling

these products or cleaning spills.

It is recommended to alternate the disinfection methods and/or the

disinfectants, in order to optimize cleaning, descaling and

disinfection of the machine.

For additional information contact your local representative.

Active Ingredient Trade Names

Sodium Hypochlorite • Bleach® 5%

• Amuchina™ 1.1%

Peracetic Acid • Dialox™ 0,35%

• Actril 0,06%

• Renalin 4%

• Oxagal 0,5%

Sodium Carbonate • CleanCart A

Citric Acid • CleanCart C

WARNING

!

WARNING

!

NOTE

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-20

16.2.7.2 Disinfection Programs

Following a list of the main disinfection programs allowable with the Artis Dialysis

System.

The indicated “Total Time” parameter includes all the phases of the different

disinfection processes (fill-up, circulation, drain and cooling).

Heat Disinfection

Heat Disinfection with CleanCarts

Central Heat Disinfection

To prevent damaging the machine, do not leave disinfectant

solutions 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 Values

Temperature • Max 99°C

Total Time • 34 min

Parameter Values

Heated Solution Concentration • Max. 2%, CleanCart-C

• Max. 0.5% CleanCart-A

Temperature • Max. 99°C

Total Time • 44 min

Parameter Values

Temperature • Max 99° C

Total Time • 34 min

WARNING

!

Chapter 16: Specifications

16-21 Cod. 6992200 - Rev. /

Chemical Disinfection - Peracetic Acid

Chemical Disinfection - Low Peracetic Acid

Chemical Disinfection - Sodium Hypochlorite

(Not currently available)

16.2.7.3 Rinsing

The Artis Dialysis System will automatically perform a Rinse process after any

Chemical 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 prior

to the dialyzer connection) conforms to international standards for residual

concentrations of disinfectant (European Pharmacological Standards and the

ANSI - AAMI RD62):

• Peracetic maximum 1 ppm

• Sodium Hypochlorite maximum 0.1 ppm

Parameter Values

Disinfectant Solution

Concentration after 1:35 dilution • Max. 0.10%

Disinfection Time • 16 min.

Rinse Time • 38 min.

Parameter Values

Disinfectant Solution

Concentration after 1:35 dilution • Max. 0.01%

Disinfection Time • 16 min.

Rinse Time • 27 min.

Parameter Values

Disinfectant Solution

Concentration after 1:35 dilution • Max. 0.2%

Disinfection Time • 16 min.

Rinse Time • 66 min.

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-22

16.2.7.4 External Cleaning

It is possible to clean the Artis Dialysis System externally without affecting the

original 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 and

rinsing efficiency are available, upon request, from the

manufacturer’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: Specifications

16-23 Cod. 6992200 - Rev. /

16.3 Extracorporeal Blood Circuit

16.3.1 ArtiSet Blood Tubing System

The Blood Cassettes will allow the bloodlines to be positioned in a way designed

to ensure a simple and effective system.

The following Blood Cassettes are available for the Artis Dialysis System:

Code Application Prime Line Patient Line

Length

113201 Double Needle NO about 235 cm

107472 Prime Line / N/A

112559 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 System

has been tested and validated to provide safe and proper

functioning of the system.

The appropriate Dialyzer and Blood cassette must be selected

according to the patient’s size and weight and to the treatment

type.

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 Manual

Cod. 6992200 - Rev. / 16-24

16.3.2 Blood Pumps

The 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 turning

on (or when they are about to turn on, for example, after an automatic

stop caused by an alarm);

• A Pump Direction Monitor;

• A system to automatically stop the Blood Pumps and close the Venous

Line 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 blood

pumps;

• A Protective System to prevent overloads.

This operator’s manual contains a number of references to

accessories and disposables for use with Artis Dialysis System.

The Artis Dialysis System has been tested and validated for use

with accessories and disposables listed in this manual. The

manufacturer has not validated the use of accessories or

disposables other than those specified in this manual. The

Manufacturer does not accept responsibility or liability for use of

accessories or disposables other than those specified in this

manual. Depending on the circumstances, use of accessories or

disposables other than those specified may also reduce the

Manufacturer’s warranties for the Artis Dialysis System.

The Manufacturer recommends the use of a dialyzer with dialysis

fluid and blood connections that comply with ISO 8637.

Do not use plate-type dialyzer.

WARNING

!

WARNING

!

NOTE

Chapter 16: Specifications

16-25 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 the

geometric characteristics of the pump segment.

The blood flow actual value is the actual blood flow rate in the extra-corporeal

circuit. The actual value is usually lower than the set value due to the negative

pressure in the access line at the inlet to the pump. The negative pressure is

caused by the rotation of the pump itself and pressure drop linked to the motion of

blood in the line. The actual value coincides with the set value when the pump

inlet 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 arterial

chamber of the cassette, is higher (less negative) than –150 mmHg

and 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 algorithm

taking into account the pump segment characteristics of GAMBRO Blood

Cassette, the current pump speed and the pressure values in the extra-corporeal

circuit.

When using the Artis Dialysis System, stop the Blood Pumps

before touching the Blood Pump Rotors.

Do not touch the blocking system.

Parameter Value Condition

Speed of Pump Rotor • 0 to 76 rpm approx. /

Blood Flow Ramping Up

Can be preset • 25, 50 or 100 ml/min,

per second /

Max actual Blood Flow (at

max rpm) • 500 ml/min • Arterial Pressure:

0 to -250 mmHg

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-26

Double Needle

The Artis Dialysis System will be able to calculate and display the

accumulated blood volume in the range 0 to 999 liters.

A dedicated warning (Low Blood Pump Speed #204) exists in

order to avoid blood loss due to coagulation resulting from

interruption of blood flow.

Parameter Values Conditions

Adult Blood Cassette

Actual Blood

Flow • 10 to 500 ml/min • Arterial Pressure: 0 to -250

mmHg

Accuracy • ±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 Pump

Speed • 10 to 580 ml/min, in

steps of 10 ml/min /

Accumulated

Blood Volume • 0 to 999 litres /

NOTE

WARNING

!

≤

Chapter 16: Specifications

16-27 Cod. 6992200 - Rev. /

Single Needle Single Pump

Parameter Values Conditions

Average Blood

Flow • 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 L

SN Pressure

Min • 150 to 360 mmHg /

SN Pressure

Max • 190 to 400 mmHg /

In Single Needle mode the stroke volume for each cycle is

approximately 20 ml.

During a Single Needle Single Pump mode, the Artis Dialysis

System will be able to automatically control the Arterial/Venous

phase commutation according to pressure measurement in the

Venous Patient Line (see "Single Needle Pressure Monitoring"

section in this chapter).

In Single Needle mode, the blood recirculation rate at the level of

the patient’s vascular access is influenced by the needle type or

catheter used. The blood recirculation rate is not due to the single

needle cassette characteristics.

≤

NOTE

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-28

Single Needle Double Pump

(Not currently available)

16.3.4 Heparin Delivery

The Artis Dialysis System may be supplied with a syringe type infusion pump

which delivers heparin with a standard 30 ml syringe.

Parameter Values Conditions

Average Blood

Flow • 10 to 220 ml/min /

Accuracy • ±10 ml/min

• ±10% • Blood Flow 100 ml/min

• Blood Flow >100 ml/min

Stroke

Volumea

a. 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.

Accumulated

Blood Volume • 0 to 99.9 litres (+/-0.6 l *

treatment time (h) or +/-

15%)

/

During a Single Needle Double Pump therapy, the Artis Dialysis

System will be able to automatically control the Arterial/Venous

phase commutation according to pressure measurement and

stroke volume achieved.

Parameter Values

Heparin Delivery

Management • 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 Delivery

Rate (Linear Mode) • 0 ml/h or 1.5 ml/h to 10.0ml/h, in steps of 0.1

ml/h

Accuracy (on Accumulated

Volume) • ±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: Specifications

16-29 Cod. 6992200 - Rev. /

Heparin Syringes

Following a list of the main syringes allowed on the Artis Dialysis System:

Bolus Delivery Rate • 0.08 ml/s

Stop Time (default) • 0 to total treatment time, in steps of 1 minute

(30 min)

Max. Counter Pressure • +900 mmHg

Heparin Delivery

Alarm Limits • Accumulated Heparin Volume: ±40% of the

set Heparin Volume

To prime the Heparin line, 0.6 ml of heparin will be injected into the

Blood Cassette. This will happen regardless of the type of heparin

delivery program selected.

Syringe Name Volume (ml) Internal Diameter

TERUMO 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 many

countries and are correct at the time of printing. However, the

manufacturer cannot be held responsible for changes in syringe

dimensions that may occur. The user should periodically check the

correlation between the stated and the actual diameters.

DO NOT USE syringes without luer lock connection.

Parameter Values

NOTE

WARNING

!

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-30

16.3.5 Hemoscan Sensor

The Artis Dialysis System provides a non-invasive mechanism to perform blood

volume 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 blood

pressure during a treatment (refer to the "Chapter 8: BPM" of this operator’s

manual).

In the table below the main specifications related to the blood pressure monitor

option are reported.

The alarm limits below can be preset. The value put in brackets and in italics is the

default value.

The syringe infusion pump described above must be used ONLY

for the infusion of heparin.

Parameter Values

Blood 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 Values

Systolic 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: Specifications

16-31 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 pressure

thresholds are reached.

2. Linear or Intermittent Heparin Delivery: through programming of the

rate and timing of delivery.

3. Heparin Bolus Injection Characteristics

4. Blood Sensor before Venous Line Clamp: before blood detection by the

Blood Sensor or before starting the dialysis treatment, some alarms are

bypassed to allow easier filling of the extracorporeal and hydraulic circuits.

5. Ultra Control: in online treatments with Pressure control mode, it is

possible to activate the Ultra Control functionality (ref to “16.2.4

Substitution Fluid” section of this chapter)

6. Automatic Pump control: in online treatments with Volume or Pressure

control mode, each time that the substitution pump is stopped due to any

reasons, the machine automatically decreases the blood pump speed in

order to avoid venous pressure peaks.

16.3.8 Main Surveillance Devices

Following the specifications related to the main surveillance devices available with

the Artis Dialysis System.

Ultrasonic Air Detector

The 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 greater

Parameter Values

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-32

Arterial Pressure Monitoring

The Arterial Pressure Sensor is used for measuring pre-pump arterial pressure in

order to protect the patient from high negative arterial pressures between the

patient and the Arterial pump.

During a treatment, an Arterial Pressure alarm will be triggered if the pressure

measurements 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 Offset

Min Arterial Limit = Operating value - Arterial Negative Offset .

Parameter Values

Detection 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 will

automatically set the Extreme Alarm limits as the Minimum and

Maximum Arterial pressure limits.

Parameter Values

Operating 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: Specifications

16-33 Cod. 6992200 - Rev. /

Venous Pressure Monitoring (Double Needle Mode)

During a treatment, a Venous Pressure alarm will be triggered if the pressure

measurements 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 Offset

Min 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 (outside

the treatment mode) • Min: -500 mmHg

• Max: +300 mmHg

Maximum Arterial Alarm Limita• -100 to +150 mmHg, in steps of 10

mmHg

a. Can be preset

Modification of the Blood Flow Rate causes a fluctuation in the

Arterial Pressure and therefore an alarm may be triggered.

To prevent such an effect, following any start/stop of the Arterial

pump or change in the Blood Flow Rate the Arterial pressure

Alarm Window is automatically set wider for 30 seconds, in HD

treatments, or for 120 seconds, in HDF treatments. Its lower value

is set to -400 mmHg while the upper value is set to +150 mmHg.

Parameter Values

Operating 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 Values

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-34

Treatment 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 (outside

the treatment mode) • Min: -300 mmHg

• Max: +450 mmHg

Maximum Venous Pressure

Alarm Limit (Default)a• +150 to +350 mmHg, in steps of 10

mmHg (300 mmHg)

a. Can be preset

A Safety Test of the Venous Pressure Monitoring System is

automatically performed each time the machine enters the

Preparation mode.

Modification of the Blood Flow Rate causes a fluctuation in the

Venous Pressure and therefore an alarm may be triggered.

To prevent such an effect, following any start/stop of the Arterial

pump or change in the Blood Flow Rate the Venous Pressure

Alarm Window is automatically set wider for 30 seconds, in HD

treatments, or for 120 seconds, in HDF treatments. Its lower value

is set to -50 mmHg, while the upper limit is set to +450 mmHg.

Parameter Values

NOTE

WARNING

!

Chapter 16: Specifications

16-35 Cod. 6992200 - Rev. /

Single Needle Pressure Monitoring

In Single Needle mode, the Venous Pressure Sensor is used for measuring the

blood pressure in the Venous chamber for blood pump activation and

deactivation, according to set venous pressure values:

Monitoring of the Venous Pressure could not always detect the

disconnection of a venous needle from its access site, which may

result in extracorporeal blood loss to the environment. When a

venous needle disconnects from its access, pressure at the

venous monitoring side may only decrease by the pressure

maintained within the patient’s vascular access. This pressure

drop may be less than the width of the machine’s venous pressure

alarm window: in this particular case the disconnection of a

venous needle from its access site is not detectable by the

machine, even if pressure alarms and alarm windows are properly

set.

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 Values

Operating Range • +150 to 400 mmHg, in steps of 10 mmHg

SN Pressure Min • 150 to 360 mmHg

SN Pressure Max • 190 to 400 mmHg

Alarm Limits • +10 mmHg to +450 mmHg

The user must take precautions against the hazard of cross-

contamination between patients by using only extracorporeal

circuits that are not damaged.

WARNING

!

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-36

Pre-Dialyzer Pressure

16.3.9 Safety system actuators

The Artis Dialysis System is supplied with the following safety system actuators:

Parameter Values

Operating 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: Specifications

16-37 Cod. 6992200 - Rev. /

16.4 Protective system

The Protection System controls fault conditions which may be dangerous for the

patient, by placing the machine in a Safe State, as required by international

regulations.

For each of these conditions, an independent safety chain is implemented. The

conditions 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 the

minimum permitted

• Arterial Pressure lower than the minimum permitted

ARTIS Operator’s Manual

Cod. 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, the

protection 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: Specifications

16-39 Cod. 6992200 - Rev. /

16.5 Disposal of discarded equipment

Discarded electromedical equipment may not be disposed of together with

municipal waste but must be collected separately in order to guarantee

ecologically correct disposal to prevent dispersion of potential pollutants into the

environment.

Pay attention to the fact that some components of the machine (display, batteries,

circuit boards, etc.) may contain toxic substances which, if released into the

environment, pose a risk to the health of living organisms and the environment

itself.

When discarding electromedical equipment used at or through healthcare

facilities, it may be returned directly to the local representative/distributor who has

supplied it.

When discarding electromedical equipment used in private households, it may be:

• returned free of charge to the distributor at the time of purchasing new

equipment

• sent to the specialized collection centres free of charge.

Users who return electromedical equipment to the subjects identified above

actively contribute to reuse, recycling and recovery of potentially still useable

materials and components and to reduction of the potential risks to the

environment and human health.

Abusive disposal of discarded equipment may be punishable by law.

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-40

16.6 Preventive maintenance

To keep the machine in good and safe working order, a periodical

preventive maintenance of the Artis Dialysis System must be performed

both by the operator and by an authorized service technician.

The operator is responsible for a regular preventive maintenance of the

solely machine external surface, whereas the machine internal

components preventive maintenance must be performed exclusively by an

authorized service technician.

16.6.1 Preventive Maintenance performed by the operator

Depending on the ambient conditions, the frequency and the average

duration of daily use of the Artis Dialysis System, the operator is required

to perform periodical preventive maintenance procedures on the machine

external 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: Specifications

16-41 Cod. 6992200 - Rev. /

16.6.2 Preventive Maintenance performed by an authorized

service technician

The ambient conditions, the frequency and the average duration of daily use of

the Artis Dialysis System determine the maintenance frequency of the internal

machine components; however when a maximum of 4,000 working hours has

elapsed (or at least once a year) a technical preventive maintenance is required.

For a complete description of all the Technical Preventive Maintenance

Procedures as well as the replacement frequency of the single components, refer

to the “Preventive Maintenance” Section of the Artis Service Manual.

Please find below the list of the spare parts that have to be compulsorily replaced

at 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 Sparepart

code SparePart

Reference Replacement

Frequency

Acid and Bicarbonate

pick-up tube connectors

(male and female)

6987762 “Acid/Bic

Tube Conn

AE”

Once a year

Air filter 6988430 “Filter 50

Micron AE” Once a year

Blood Cassette pressure

pods

o-rings

6987747 “External O-

ring kit” Once a year

Electrovalves (EVC,

EVD, EV1S) 6962468 “2 Way

solenoid

Valve

Peek”

Once a year

EvaClean gasket 6987671 “EvaClean

Assy AE” Once a year

Filter (250u) 6988158 “Filter 250

Micron AE” Once a year

WARNING

!

WARNING

!

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / 16-42

Filter (50u) 6988430 “Filter 50

Micron AE” Once a year

Heparin syringe plunger

lock 6988869 “Syringe

plung. lock

AE”

Once a year

pH probe 6985089 “pH probe” Once a year

PRV Pressure regulator 6987978 “PRV AE” Once a year

Red and Blue dialysis

fluid tube connectors

(male and female)

6988950 “Dial.

connectors

male AE”

Once a year

6988117 “Dial.

connectors

AE”

Once a year

Ultrafilter holder O-rings 6989537 “Ultrafilter

back holder

AE”

Once a year

6987903 “Ultrafilter

lower arms

AE”

Once a year

6988984 “Ultrafilter

upper holder

AE”

Once a year

BiCart Holder arms

Lower O-ring BiCart 6988125 “BiCart

Holder AE” Once a year

Ultra Port gasket 6987366 “Sensor Bar

Ultra Assy

AE”

Once a year

Yellow and clear

disinfectant connectors 6988026 “Yell/Clear

Disinf Conn

AE”

Once a year

SelectCart Holder arms

(not currently available) 6988786 “SelectCart

Holder AE” Every two years

Part/Assembly Sparepart

code SparePart

Reference Replacement

Frequency

Chapter 16: Specifications

16-43 Cod. 6992200 - Rev. /

Periodic Safety Inspection

A safety inspection of the Artis Dialysis System is required at least once a year

and according to the local policies. Only trained and qualified technicians are

authorized to perform the safety inspection procedures. The inspection consists of

the following tests:

Parameter Performance Conditions

Earth Leakage Current

230/240V version

230/240V version < 300 uA (typically = 250 uA)

< 300 uA (typically = 180 uA)

Normal condition

Protective 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 Manual

Cod. 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 Platinum

Carbon Polycarbonate

Ceramic, Aluminium oxide (Al2O3) Polyurethane

Ceramic, 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) PTFE

Fiberglas reinforced polyamide PTFE (Polytetrafluoro ethylene)

Fiberglas reinforced polypropylene PVC (Polyvinylchloride)

Glass PVDF (Polyvinylidene fluoride)

Graphite Santroprene

LCP Silicon rubber

NBR Stainless steel SS2343

PEEK (Polyetherketone) Stainless steel SS2353

Peek + CF Stainless steel SS2562

Peek + GF Titanium

PPE + PS

Chapter 16: Specifications

16-45 Cod. 6992200 - Rev. /

16.8 Diascan

The Diascan™ system will be available in the following treatment modes:

• Hemodialysis (DN)

• Isolated UF

Following the main specifications related to this functionality:

Accuracy is valid in HD double needle and on-line HDF postdilution, for blood

flows 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™ system

only if the following parameters fall in the indicated ranges:

Parameter Range Accuracy Resolution Conductivity

Ionic

Dialysance 0 to 500 ml/

min ±7 ml/mina

a.Accuracy Standard Error for a 4 hour dialysis.

1 ml/min /

Plasma

Sodium

Concentration

130 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 Range

Temperature Range 30-45 °C

Conductivity Range 13 to 16 mS/cm (0.05 mS/cm)

This page is left intentionally blank

Cod. 6992200 - Rev. / 16-46

A-1

Appendix 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 environment

specified in the table below.

The customer or the user of the Artis Dialysis System should assure that it is used

in such an environment.

Emission test Compliance Electromagnetic environment -

guidance

RF emission

CISPR 11 Group 1 Artis Dialysis System uses RF energy

only for its internal function. Therefore,

its RF emissions are very low and are

not likely to cause any interference in

nearby electronic equipment.

RF emission

CISPR 11 Class B The Artis Dialysis System is suitable for

use in all establishments, including

domestic establishments and those

directly connected to the public low-

voltage power supply network that

supplies buildings used for domestic

purposes.

Harmonic emissions

IEC 61000-3-2 Class A

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Complies

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / A-2

A.1.2 Electromagnetic immunity

The Artis Dialysis System is intended for use in the electromagnetic environment

specified in the table below.

The customer or the user of the Artis Dialysis System should assure that it is used

in such an environment.

Electromagnetic immunity

Immunity test IEC 60601

test level Compliance

level Electromagnetic

environment -

guidance

Electrostatic

discharge (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 with

synthetic material, the

relative humidity should

be at least 30%.

Electrical fast

transient / burst

IEC 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

lines

Mains power quality

should be that of a

typical commercial or

hospital environment.

Surge

IEC 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

earth

Mains power quality

should be that of a

typical commercial or

hospital environment.

Voltage dips,

short

interruptions

and voltage

variations on

power supply

input lines

IEC 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 sa

Mains power quality

should be that of a

typical commercial or

hospital environment. If

the user of the Artis

Dialysis System requires

continued operation

during power mains

interruptions, it is

recommended that the

Artis Dialysis System be

powered from an

uninterruptible power

supply or a battery.

Appendix A: Guidelines and Manufacturer's Declaration - Electromagnetic Emissions and

Immunity

A-3 Cod. 6992200 - Rev. /

Power

frequency (50/

60 Hz) magnetic

field

IEC 61000-4-8

• 3 A/m • 30 A/m Power frequency

magnetic fields should

be at levels

characteristic of a typical

location in a typical

commercial or hospital

environment.

a. UT is the a.c. mains voltage prior to application of the test level.

Electromagnetic immunity

Immunity test IEC 60601

test level Compliance

level Electromagnetic

environment -

guidance

ARTIS Operator’s Manual

Cod. 6992200 - Rev. / A-4

Immunity test IEC 60601

test level Compliance

level Electromagnetic

environment guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

• 3 Vrms

• 150 KHz to

80 MHz

• 3 V/m

• 80 MHz to 2.5

GHz

• 10 Vrms

• 10 V/m

Portable 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 separation

distance

d = 0.35

d = 0.35 80 MHz to 800

MHz

d = 0.7 800 MHz to 2.5

GHz

where 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:

P

Appendix A: Guidelines and Manufacturer's Declaration - Electromagnetic Emissions and

Immunity

A-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 Manual

Cod. 6992200 - Rev. / A-6

A.2 Recommended separation distances between portable and

mobile RF communications equipment and Artis Dialysis System

Artis Dialysis System is intended for use in the electromagnetic environment

where radiated RF disturbances are controlled. The customer or the user of Artis

Dialysis System can help prevent electromagnetic interference by maintaining a

minimum distance between portable and mobile RF communications equipment

(transmitters) and Artis Dialysis System as recommended below, according to the

maximum output power of the communications equipment.

Rated

maximum

output

power of

transmitter

Separation distances according to frequency of transmitter

(m)

W150 KHz to 80 MHz

d = 0.35 80 MHz to 800 MHz

d = 0.35 800 MHz to 2.5 GHz

d = 0.7

0,01 0.04 0.04 0.07

0,1 0.11 0.11 0.22

1 0.35 0.35 0.70

10 1.11 1.11 2.21

100 3.50 3.50 7.00

For transmitters rated at maximum output power not listed above, the

recommended separation distance d in metres (m) can be estimated using the

equation applicable to the frequency of the transmitter, where P is the maximum

output power rating of the transmitter in watts (W) according to the transmitter

manufacturer.

• 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

Gambro Dasco RFMOD GAMBRO RF MODULE User Manual Start ENG

Gambro Dasco GAMBRO RF MODULE Start ENG

Users Manual

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