Training Module 2 – Treatment in Practice Dialysis System SW 8.09.13 Training Module 2 – Treatment in Practice Ref: Operator’s Manual SW 8.09.13 Chapter 1 – General Description Chapter 3 – Machine dressing and Priming Chapter 4 – Double Needle Hemodialysis Treatment

HD Treatment in Practice 2018-02-17 HD Treatment in Practice Treatment Type Selection Prescription Settings Timer reminder Automatic Blood Pressure monitoring (BPM) Low Consumption Mode Treatment start A/V limits pressure handling Stop treatment Automatic rinseback Unload Artiset HD Treatment in Practice The second Hands-on will include and deal with: Ref: Operator’s Manual SW 8.08 Service code 6998397 Chapter 1 – General Description Chapter 3 – Machine Dressing and Priming Chapter 4 – HD-DN Treatment Important Note: This presentation does not relieve any user of the Artis Dialysis System from his or her duty to carefully read the full text of the Operator’s Manual before using the system. . Important: Please note that the SW change to 8.09.13 of this presentation does not change the content of the training of the Artis Dialysis System for users.

Treatment Type selection 2018-02-17 Treatment Type selection Treatment Type selection Operator’s Manual, section 1.4.1. and 3.4.2 Artis starts up in the preset Treatment Type. The different Treatment Types require dedicated ArtiSets, which means the Treatment Type must be confirmed before the ArtiSet loading procedure is initiated when a Treatment Type other then the preset should be performed. 3 3

Treatment Type Confirmation Point Auto-priming Setup Wait for Pt connection Pt Connection Treatment AFB K HDF Post HD DN  HD SN (change disposable) 33% started HD DN  HD SN (Change Circuit, replacing cassette and treat. type) HD SN  HD DNDP (Switch) Connect Patient button pressed Treatment Type Confirmation point Ref: Operator’s Manual section 3.4.1, 3.4.2, 3.5, HD-SN 6.1 and Special Procedures 8.19-21 The AFBK treatment must be confirmed before 33% of the Preparation phase is completed while the HDF post treatment must be confirmed before Auto-Prime is started (on-line priming). During the preparation phase it is possible to switch between HDDN and HDSN (and vise versa) via Special Procedures and Unload cassette. After the patient is connected in HD-DN there are 2 alternatives changing to SN mode; SNSP by installing an expansion chamber (emergency procedure) SNDP by changing the circuit (via Special Procedure – Change Circuit – Change Treatment Type to HDSN – Load and Auto-Prime a HD-SN-HC cassette) Also when a HD-SN ArtiSet is loaded and prepared patient connection may be performed in SN or DN Highlight: Also when the HD-SN-HC ArtiSet is loaded and prepared it is possible to switch to DN mode and run a DNDP treatment without changing the ArtiSet. It is possible to switch from SN to DN mode without changing the ArtiSet

Prescription Settings 2018-02-17 Prescription Settings 1. 2. Prescription Settings Operator’s Manual, section 1.4.4 and section 3.4 The exclamation marks on the Treatment Time and UF Volume select buttons indicate that those two parameters are mandatory to set / confirm - the Connect Patient button will not become available if those parameters are not confirmed Treatment Time and UF Volume set buttons are also available on the Fluid Screen Other fluid related parameters can also be accessed via the Fluid Screen button bar by pressing “Fluid Settings” The blood related parameters can also be accessed via the Blood Screen. Specifically notice Diascan and Hemoscan is recommended to be activated by preset On the Prescription screen press: Parameter buttons to set treatment related parameters Function buttons to access the respective sub-screen for settings and activation © YEAR, Legal owner

2018-02-17 Time Reminder Options Timer Settings screen The Reminder Options Operator’s Manual, section 1.4.4.1 Three different reminders can be set with the possibility to be automatically repeated; the repeat function must be manually deactivated in the setting screen The stopwatch icon is displayed in the System Icon area When time is elapsed, a confirmable notification is displayed and an information signal is triggered (every 90 sec) Highlight Time countdown starts immediately the timer is activated As an example, if a heparin flush is needed every half an hour, I should activate the time reminder/repeat at treatment start Prescription screen Time countdown starts immediately after the timer is activated

Manual Blood Pressure Monitoring 2018-02-17 Manual Blood Pressure Monitoring Manual Blood Pressure Monitoring Operator’s Manual, section 9.4 When a manual BPM is activated on the Treatment Overview screen the manual BPM button on the BPM Settings screen is automatically activated and vice versa Simultaneously on the Treatment Overview screen the BPM value box with the pulsating heart icon appears while on the BPM settings screen a pumping heart appears in the BPM value box. Highlight Point of time the blood pressure and pulse are displayed in the BPM value boxes and in the Report screen Event list Also the BPM values taken before treatment start are displayed in the Report Screen Treatment Overview screen BPM Settings screen Point of time, the blood pressure and pulse are displayed in the BPM value boxes and in the Report screen Event table

Automatic Blood Pressure Monitoring 2018-02-17 Automatic Blood Pressure Monitoring Set : Patient position Measuring interval Alarm limits When activated a clock appears on top of the heart icon in the BPM value box BPM Settings screen Auto BPM values are plotted in the trend graph on the BPM Setting screen BPM values are displayed on the Treatment Overview screen, the BPM Settings screen and are automatically transferred to the Report screen Event list Automatic Blood Pressure Monitoring Operator’s Manual, section 9.4 The first automatic BPM is taken when the Start Treatment button is pressed and the last one when the End Treatment button is pressed. As soon as the Start Treatment button is pressed all (manual and automatic) BPM values are plotted in the graph. Whenever a BPM fails, it is indicated by question marks and an X over the heart in the BPM value box

2018-02-17 Extra Prime During priming, accumulated priming volume is displayed in the Overview screen Priming setting sub-screen is accessed via the Blood screen “Priming Settings” button Extra Prime Operator’s Manual, section 3.6.6 The Extra Prime button becomes available when Auto-Prime is completed (or at the end of the Low consumption State) Extra Prime volume and BP speed can be preset - default volume is 250 ml and default BP speed is 250 mL/min – the PB speed is adjustable using the up/down hard keys (range 10 – 350 mL/min) Extra prime can be stopped at any time by manually deactivating the Extra Prime button - The “Priming Completed (#560)” Information Message appears – Extra Prime can still be continued by confirming the info message and reactivating Extra Prime button Specifically notice, as soon as the first Auto-Prime sequence is accomplished or Auto-Prime is interrupted, the “Reset Prime” button is available on the Auto-Prime Settings sub-screen – Activate the Auto-Prime button on the Overview screen Note: The Auto-Prime button will not become available if the T1 Arterial pump/ABD test is not completed successfully (alarm 419). Autopriming Settings sub-screen Blood screen

Chamber fluid levels – Auto-Prime completed Levels might need to be adjusted at the end of priming due to: Empty saline bag during the priming Patient lines not properly connected to EvaClean ports Infusion line clamps not closed Inappropriate priming volume for the dialyzer in use If the fluid levels are extremely low (see red line) Reset Prime in the Priming Settings sub-screen and activate Auto-Prime on the Treatment Overview screen If the fluid levels are not significantly lower or higher than frosted line Connect Patient and adjust the blood levels manually after treatment start (see next slide) Camber fluid levels – Auto-Prime completed Operator’s Manual, section 8.28.1 and 3.6.7 After the priming process, the fluid level in the arterial and venous chambers should be stabilized at approximately the bottom of the pressure transducers. Highlight The importance of checking and adjusting the chamber fluid levels when they are extremely low when Auto-Prime is completed. To adjust the fluid levels Reset Prime on the Auto-Prime Settings screen and activate the Auto-Prime button on the Treatment Overview screen. If auto-priming is not performed appropriately and levels are not correct, Reset Prime and reactivate the Auto-Prime button (check for sufficient volume in the saline bag)

Chamber blood levels – During treatment frosted line When adjusting the blood levels in the chambers during treatment: Attach a sterile luer-lock syringe to the respective chamber infusion line and adjust the level using the syringe Expand the A/V pressure limits but do not decrease the blood pump speed Gently aspirate or inject air to increase or decrease the fluid level and adjust to frosted line (suggested ideal level in chambers) Chamber blood levels – During treatment Operator’s Manual, section 8.28.2 The target fluid level in the chambers is indicated by a frosted line on the chambers. At the time the patient is connected and the blood flow increased, the blood levels in the chambers will adjust as a result of the Arterial and Venous pressures i.e. the Arterial chamber blood level will decrease (negative pressure) while the Venous chamber blood level will increase (positive pressure). Highlight It is important to check the chamber blood levels on a regular basis and adjust them whenever not optimal. For Operator safety, always recommend the use of a luer-lock syringe If the blood flow is reduced before the adjustment of the blood levels, remember the levels will be effected by the the pressure when the blood flow is re-established. Check and adjust the chamber blood levels on a regular basis during the treatment

2018-02-17 Low Consumption State Reduction of water and concentrate consumption Should be activated in Service Level 2 Starts automatically 1-10 min (preset) after priming is completed Is stopped via the “End Low Consumption” button When stopped, the “Connect Patient” button becomes available with a short delay Low Consumption State Operator’s Manual, section 3.6.8 The aim of this feature is to reduce water and concentrate consumption Low consumption state: Qd = 300 ml/min The parameters related to the Low Consumption state can only be set in the Service 2 menu It is not possible to manually activate Low Consumption state Highlight Low consumption state is automatically re-entered if patient connection is not started within the preset time limit plus 5 minutes Treatment Overview screen Low consumption state is automatically re-entered if Connect Patient button is not pressed within the preset time limit plus 5 minutes

Patient Connection Three Patient Connection options 2018-02-17 Patient Connection Connect Patient button becomes available when Mandatory parameters are set and Auto-Prime is completed Check that the prescribed functions are activated before continuing Treatment Overview screen Three Patient Connection options Straight connection (both lines) Bleed-out connection with the venous line connected to the EvaClean Bleed-out connection with the venous patient line connected to a waste bag Confirm after connection Patient Connection Operator’s Manual, section 4.1 Some treatment functions cannot be activated after the “Start Treatment” button is pressed (verify treatment prescription before starting patient connection) Before patient connection, verify that no air is present in the Venous Patient line  If air is present perform an Extra Prime or a Reset Prime procedure. Disconnect priming line from venous infusion line (this entrance is used for removing air from venous patient line, alarm 4) – it may be connected to the arterial infusion line at this point If the bleed out connection is performed with the Venous Patient Line connected to the EvaClean Venous port, the manual cleaning procedure described in Op. Manual section 8.23 should be performed. If the “Connect Patient” button is not available: Auto-Prime is not completed Mandatory parameters are not confirmed (Prescription screen) The Blood Leak Detector T1 test is not successfully completed (alarm 170) - The treatment cannot be performed before a chemical disinfection program has been run on the machine.

2018-02-17 Blood detection When blood is detected in the venous patient sensor, the Blood Pump stops: Verify that the Arterial and Venous Patient lines are connected to the patient Restart the Blood Pump Start Treatment button becomes available Start Treatment Operator’s Manual, section 4.1

Start Treatment Press Start Treatment button 2018-02-17 Start Treatment Press Start Treatment button The Dialysis Fluid and UF buttons are displayed - indication bars are yellow lit Increase the Blood Pump speed per your unit policy Press Close the A/V pressure Limits key when the pressures have stabilized When the initial auto-test is completed: - Dialysis Fluid and UF flow rates are automatically activated (indication bars turn green) and the “Real TX Time” value on the Fluid Screen starts decreasing. Start Treatment Ref: Operator’s Manual, section 4.2 Specifically notice that as soon as the Start Treatment button is pressed Treatment time countdown starts The ADS performs a self test = a taration of the UF system The indication bars on the Dialysis Fluid and UF activation buttons is yellow lit (automatically booked) – turns green as soon as the self test is completed Specifically notice The green lit indication bar on the Dialysis Fluid action button together with a green fluid path to the dialyzer indicates that diffusion is ongoing and the Real TX Time value box (Fluid screen) is updated – Deactivating the Dialysis Fluid button (grey indication bar) stops diffusion and the dialyzer is by-passed The green lit indication bar on the UF action button indicates that ultrafiltration is on-going and the Acc. UF Volume value boxes (Overview and Fluid screens) are updated – Deactivating the UF button will stop ultrafiltration

A/V Pressure Limit Handling 2018-02-17 A/V Pressure Limit Handling At treatment start: Follow operator’s message to close the predefined A/V Pressure Limits (this narrows the alarm limit window to a safe value) During treatment: Press Expand A/V Limits to open the pressure limits for a short period of time When closing the A/V pressure limits the alarm window automatically adjusts to the current pressures The A/V Limits are automatically expanded and closed when the blood pump speed is changed Treatment Overview screen Easy A/V Pressure Limit Handling Operator’s Manual, section 1.7.3.1 Close A/V Limits/Expand A/V Limits button is available on Overview and Blood Screens The A/V pressure limits must be closed manually : After “Start Treatment” is pressed After the A/V limits have been expanded by the Operator Following “Fast Recovery” procedure after “Start Treatment” is pressed When “# 525 Pressure limits still expanded” alarm occurs (in standard HD this alarm appears after 30 seconds) A/V limits are expanded & closed automatically: Each time arterial pump speed is changed At the end of cassette repositioning procedure After resolution of venous or arterial alarm After “#4 Air in venous line” alarm is resolved A/V Treatment Max. and Min. Pressure Limits can be adjusted via the blood screen in the A/V Limit Settings sub-screen Blood screen The pressure limits are not automatically closed when expanded by the operator

Expand/Close Pressure Limits 2018-02-17 Expand/Close Pressure Limits machine upper pV limit Expand Limits Close Limits Default values (can not be modified) mmHg machine upper pA limit 150 machine lower pA limit - 400 machine upper pV limit 450 machine lower pV limit 10 machine lower pV limit Expand/Close Pressure Limits Operator’s Manual, section 1.7.1 Blood screen

A/V Pressure Alarm Limit Window 2018-02-17 A/V Pressure Alarm Limit Window to widen/restrict the alarm window to move the alarm window up/down +/- alarm limit = reference pressure + upper interval value current value alarm limit = reference pressure – lower interval value Default values mmHg pA upper value 60 pA lower value -60 pV upper value 70 pV lower value 40 A/V Pressure Alarm Limit Window Operator’s Manual, section 1.7.1 To change the A/V pressure alarm high and low limits, press the respective bar graph available in the Blood screen and A/V Limit Settings sub-screen, to access the key pad. The Lower Interval value defines the lower interval within which the patient’s pressure is allowed to change without triggering alarms. The low arterial/venous pressure limit will be calculated as: Reference Pressure Value – Low Interval Value. Confirm = The new pressure alarm window limits are set Reset = The pressure alarm window limits are reset to their default values

A/V Treatment Max & Min Pressures 2018-02-17 A/V Treatment Max & Min Pressures Default values (can be modified in preset) mmHg pA treatment max limit pA treatment min limit - 300 pV treatment max limit 300 pV treatment min limit 10 pV treatment max. limit The range within which the dark green “window” may move during the treatment pV treatment min. limit A/V Treatment Max & Min Pressures Operator’s Manual, section 1.7.2 Setting the Upper intervals of A/V alarms limits to their extreme values might render the Alarm Management System useless. An improper setting of these intervals may prevent the Alarm Management System to detect possible alarm conditions related to air embolism in the case of a catheter or to blood loss. Blood screen

A/V Treatment Max & Min Pressures 2018-02-17 A/V Treatment Max & Min Pressures A/V Treatment Max & Min Pressures Operator’s Manual, section 1.7.2 The A/V Settings screen may also be reached via the Prescription screen Parameter select pad

Stop Treatment Stop Treatment Operator’s Manual, section 4.4 and 4.4.1 2018-02-17 Stop Treatment Stop Treatment Operator’s Manual, section 4.4 and 4.4.1 The “Stop Treatment” button is available in the button bar central position during the complete treatment. It is possible to stop the ongoing dialysis process at any time by pressing the Stop Treatment button It is possible to resume the treatment after the “Stop Treatment” button has been pressed and confirmed by pressing the “Continue Treatment” button appearing in the button bar 3:rd position (increase Treatment Time if applicable) When the set UF volume is achieved a notification appears – Confirm When the set Treatment Time is achieved a notification appears – Confirm Diffusion will continue and the “Real Treatment Time “ value box in the Fluid screen is continuously updated until The “Dialysis Fluid” button is manually deactivated or the “Stop Treatment” button is pressed.

Rinseback Follow Operator’s Message for 2018-02-17 Rinseback Follow Operator’s Message for Rinseback and Disconnect Patient procedure The accumulated rinseback volume is displayed in the Overview screen The Blood pump stops when the set rinseback volume is achieved Blood pump can also be stopped manually Extra Rinsback button becomes available Rinseback Settings sub-screen is accessed via the Blood screen Rinseback Operator’s Manual, section 4.5, 4.5.4 and 4.7 The Arterial pump speed can be adjusted anytime during the rinseback mode – press BP Increase/Decrease keys The rinseback volume can be changed anytime during the rinseback mode – go into Rinseback Settings sub-screen The Blood Pump automatically stops when Rinseback button is deactivated. At this time the “Extra Rinseback” button becomes available in the button bar 3:rd position. Highlight Drain Cartridge can be activated during Rinseback Drain Cartridge process is regarded as beeing slow – start as soon as the “Drain cartridge” button becomes available (button bar 7th position) – encourage Operators to note necessary treatment data while waiting Press the “Empty Circuit” button as soon as it becomes available in the button bar Central position when Disconnect Patient is confirmed Press the “Drain Cartridge” button as soon as it becomes available when the Rinseback is confirmed

2018-02-17 Unload ArtiSet Press “Unload Cassette” and Confirm The pump rotor turns to its horizontal position Open the Sensor bar door The cassette hooks are pushed out Wait for the blood pump to stop before opening the cover Release the A/V patient lines from the automatic clamps Release the heparin syringe and line Open the blood pump cover and remove the cassette Close the Sensor bar door and blood pump cover Unload ArtiSet Operator’s Manual, section 3.15 Highlight Wait for the blood pump to stop before opening the blood pump cover If not, the unloading might fail It is possible to activate a Disinfection/Rinse program before unloading the Cassette In order to shorten the time between treatments, start the Disinfection process as soon as possible It is possible to activate a Disinfection/Rinse program before unloading the Cassette

Manual unloading of the pump segment 2018-02-17 Manual unloading of the pump segment If the pump cover is opened before the blood pump has stopped, the pump segment may not be fully released Do not remove the cassette with the pump segment still in the pump rotor Manual unloading of the pump segment Operator’s Manual, section 8:29 and warning 19 section xxxviii In case the automatic pump segment unloading procedure fails, the machine is not able to detect it. In this case the operator has to proceed as follows: Open the Arterial Pump Cover; Push down the crank and turn the arterial pump rotor in a counter clockwise direction in order to complete the unloading procedure; When the pump segment has been unloaded, pull up the crank and close the Arterial Pump Cover. Extract the crank from the pump rotor Manually turn the pump rotor in a counter-clockwise direction while carefully releasing the pump segment Turn the pump rotor in order to align the crank with its axis and close the crank

2018-02-17 Nice to know ! Start Treatment - diffusion and UF flow rates start automatically when the initial UF system auto-test is completed Cartridges - do not have to be drained before removal Empty circuit - fluid and blood compartment are drained Unloading ArtiSet - do not open the blood pump cover before the pump segment is released EvaClean must be cleaned each time the Patient Connection procedure is performed keeping the venous patient line in to the EvaClean port until the machine detects blood (as per Operator manual) Nice to know

Hands on Module 2 Treatment time 60 min UF volume 1.0 L 2018-02-17 Hands on Module 2 Treatment time 60 min UF volume 1.0 L Heparin program Auto BPM 15 min Set two reminders - one on repeat End low consumption mode Connect Patient – straight connection Start Treatment Stop/Start UF Stop/Start diffusion Heparin bolus Stop Treatment and Auto-rinseback Drain Cartridges and Empty Circuit Rinse Unload Artiset Hands on Module 2 The Trainer’s Check List should be used and ticked off during the hands-on training By following the different hands-on prescriptions all function will have been practiced at the end of the course

Treatment type reference HD DN HC: Hemodialysis Double Needle, Hemocontrol HDF post: Hemodialfiltration Post dilution HD SN: Hemodialysis Single Needle HD SN DP: Hemodialysis Single Needle Double Pump HD DN DP: Hemodialysis Double Needle Double Pump

For the safe and proprer use of the devices referenced within, refer to warnings, Precautions and the complete Instructions For Use or the appropriate manual available by contacting customer support ArtiSet, Bicart, Select Cart, SelectBag One are Trademarks of Gambro AB. Gambro is an indirect subsidiary of Baxter International Inc.