Diapact CRRT Technical Training 03112020 Training document no

Diapact® CRRT Technical Training 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 1

Nine Types Of Therapies For The Patient One Hand Operation Universal tool for a wide range of therapies • 4 continuous therapies: • SCUF • CVVHD • CVVHFD • 3 intermittent therapies: • HF • HD • HFD • 2 plasma therapies: • PEX • PAP 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 2

Continous Therapies 1. Slow Continous Ultrafiltration 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 3

Continous Therapies 2. CVV Hemofiltration 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 4

Continous Therapies 3. CVV Hemodialysis 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 5

Continous Therapies 4. CVV High-Flux Dialysis 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 6

CVVHFD The Principle Of Substitution By Backfiltration 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 7

Intermittend Therapies 1. Hemofiltration 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 8

Intermittend Therapies 2. Hemodialysis 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 9

Intermittend Therapies 3. High-Flux Dialysis 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 10

Plasma Therapies 1. Plasma Exchange 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 11

Plasma Therapies 2. Plasma Adsorbtion/Perfusion 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 12

Special Functions • therapy change during treatment • dilution change (postdilution « predilution) • flexible adjustment of parameters • ratio monitoring of filtrate flow vs. blood flow • automatic substitution-flow reduction in case of UF problems • re-calibration of blood leak detector • ramping of the pumps 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 13

Special Functions • bag movement function • safe exchange of bags • bag change volume • automatic temporary blood flow reduction in case of pressure problems • end of therapy on intermittent HF • different sounds for alarms and messages 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 14

Hidden Functions Hidden functions are selected by pushing the buttons V, BE and an additional button simultaniously: • BP + display backlight brighter • BP - display backlight dimm • EQ TSM mode • up contrast up • down contrast down • SC language selection • 5 skip priming (if the function is enabled) • 6 service overview • Enter Reset 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 15

General Information Diapact® CRRT is a system for extracorporeal blood treatment, especially for the use in emergency situations where a steady supply of purified water is not available. The simplified user interface and intelligent software incl. full automatic filling and priming and automatic level regulation help to keep personnel requirements to a minimum. The Diapact® CRRT has three pumps and an electronic weighing system which constantly controls and monitors the patient ‘s fluid balance. A trouble-free balancing increases the efficiency of the treatment and results in advancement of cost-value ratio. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 16

General Information Because the Diapact® CRRT works with sterile solutions in bags and a complete set of disposable tubes, no disinfection procedure is required after the treatment. The choice of the filter leaves to the user. The solutions are wormed by the integrated plate warmer. Apart from the continuous treatment of patients in acute need of dialysis, the Diapact® CRRT system can be used to carry out intermittent hemofiltration and high-flux dialysis treatments in patients with chronic renal disease. The default parameters of each therapy (e. g. pressure limits) are changeable at any time. With this system, diffuse and convective transport can be combined by using highly permeable membranes. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 17

General Information The Diapact® CRRT system monitors the filtration and back filtration mechanism in the filter. As a result, the volume of substitution solution required is reduced. The single load cell of Diapact® CRRT enabled a recirculation of solution for more effective using of dialysate. To complete therapy choice of Diapact® CRRT, Plasmaexchange as well as Plasma-Adsorption-Perfusion are available for the user with this system. Diapact® CRRT System can be supplemented with Option Perfusor Interface for flexible anticoagulation. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 18

Therapy Change With SETUP CHANGE the user can change from CVVH or HF to CVVHD, CVVHFD, HD or HFD as well as from CVVHD, CVVHFD, HD or HFD to CVVH or HF during therapy. For this activate the function THERPY END in menu selection and after that the function SETUP CHANGE. Follow the instructions of the guideline in the display and confirm the THERAPY EXCHANGE by activating and EQ confirming. All therapy data survive after therapy exchange. To continue therapy the user has simply to adapt the blood flow and to confirm the blood leak calibration. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 19

Dilution Change With SET UP CHANGE the user can do a dilution exchange during therapy (from pre-dilution to post-dilution or the other way). For this activate the function THERPY END in menu selection and after that the function SETUP CHANGE. Follow the instructions of the guideline in the display and following activate or deactivate PRE-DILUTION. Deactivate SET UP CHANGE to return back to Parameter overview. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 20

Parameter Setting During Therapy 1/2 Each of the main parameters (UF-volume/plasma balance, UFrate/plasma balance rate, therapy time, sub volume/ dialysate volume/ plasma volume, sub flow/dialysate flow/plasma flow) can be set independently of the others. Automatically changed safety-relevant parameters (highlighted in black) has to be confirmed with EQ. Flashing parameters indicate a change but do not have to be confirmed separately. NOTE The zero setting of the volumes or of therapy time in all intermittent therapies (HF/HD/HFD/PEX/PAP) only causes the switching from volume control to rate control. That means that a zero setting of the weight reduction (e. g. UF-rate), of the substitution or the dialysate can only be done by changing the rate. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 21

Parameter Setting During Therapy 2/2 Intermittent Therapy A change in the flow rate automatically results in a change in volumes. A change in the volumes automatically results in a change in the flow rates. A change in therapy time automatically results in a change in the flow rates. PEX A change in the sub flow automatically results in a change in therapy time and the plasma balance rate (if set). A change in the plasma balance rate automatically results in a change in the plasma balance volume. A change in the sub volume automatically results in a change in therapy time and the plasma balance rate (if set). PAP A change in the plasma flow automatically results in a change in therapy. A change in the plasma volume automatically results in a change in therapy time. A change in therapy time automatically results in a change in the plasma flow. A change in the plasma balance volume automatically results in a change in the plasma balance rate. A change in therapy time automatically results in a change in the flow rates. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 22

Ratio Blood Flow/Filtrate If the ratio of blood flow to filtrate exceeds 25 % in continuous or intermittent therapies (postdilution) or 35 % in plasma therapies, the user will receive a warning. If this ratio exceeds 40 % during continuous or intermittent therapies (postdilution) or 50% during plasma therapies, an alarm will be given to the user and the balance pumps will stop. This ensures that the blood retains the necessary viscosity. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 23

Automatic Substitution Flow Reduction Automatic substitution flow reduction is an automatic parameter adaptation to the current filter state undertaken by the system. If the filtrate flow cannot be achieved, the following control mechanism for the filtrate pressure PD 2 sets in: If PD 2 pressure reaches a value 20 mm Hg above the set PD 2 min. value, the substitution flow will automatically be reduced as a function of the filter state. If the PD 2 values reaches the set PD 2 min. value, the user will be given the additional warning “Clotting danger”. If the PD 2 value exceeds the set PD 2 min. by over 50 mm. Hg, the user will be given the alarm “Clotting danger 914” with the instruction to reduce substitution or to increase the blood flow. The balance pumps will remain stopped while the blood pump continues to operate. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 24

BLD Leakage/Recalibration In the event of a non acknowledgable blood leakage alarm, the user has to check the filter for a possible filter rupture. To carry out precise examination of the filter, the user can take a filtrate sample containing at least 2 ml at the sample collection point in filtrate tube 2 and examine it. If no blood constituents are found in the filtrate sample, the blood leakage detector can be recalibrated as follows (example: rise in bilirubin): · Select “THERAPY END“ in the menu selection. Confirm with · and EQ. · In the new menu selection, select “BLOOD LEAKAGE CALIBRATION”. Confirm with · and EQ. · Select “Back to therapy“. Confirm with · and EQ. · Raise blood flow to initial value blood flow. · Start THERAPY. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 25

Ramping This function prevents the build-up of a secondary membrane on the membrane as a result of underpressure created by jerky pump starts. At the start of therapy, after every stop of the blood pump, and after some parameter changes in HF/PEX/PAP, the balance pumps run at reduced speed. To guarantee that the system does not fall below the minimum substitution volume, the flow is automatically increased slightly during therapy. The raising of the flow, as well as the continuous raising of the flow, depends on the frequency of RAMPING. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 26

Bag Movement Function To avoid superfluous alarms and the resulting pump standstill, the Diapact® CRRT has a function which is actuated by slight movements of the unit during therapy. When this function is actuated, the balance pumps stop without an alarm and start again automatically when the initial weight (i. e. the weight before the movement of the unit or bag) is reached again. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 27

Bag Change It is possible to change the bag before the bag-change volume has been achieved at any time during therapy. Activate the function BAG CHANGE in the MENU SELECTION. The balance pumps will stop. The bag can now be changed without disturbing the scale and without an alarm. To start therapy again, deactivate only the function BAG CHANGE by pressing the enter button. The balance pumps will start. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 28

Bag Change Volume 1/2 With the function “bag change volume”, the user can define the volume of fluid at which the bag on the scale is to be changed. At a bag volume (sub/dialysate or UF) of “zero“, this function is not active and monitoring of the sub/dialysate bag is carried out via the air detector (AD): It is possible to select this function for the sub bag volume or for the UF-bag volume. A selection made by the user in the positive range in the parameter settings results in a sub bag volume, while a selection in the negative range results in a UF bag volume. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 29

Bag Change Volume 2/2 Example 1: Example 2: 2 bags á 4. 5 l substitution entry: sub bag volume: 9 l – 100 ml = 8. 9 l 2 UF bags á 7 l collecting volume entry: UF bag volume: -14 l To change from sub bag volume to UF bag volume or the other way during therapy the user has to confirm the zero at first by pressing due to safety reasons. At first time parameter setting the zero is default. On reaching of the setted volume the alarm “bag volume is over” (1020) occurs and the bags must be changed. Follow the instructions on the display. NOTE By using the sub bag volume we recommend to adjust the volume directly at the beginning of priming to calculate also the delivered sub volume during priming. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 30

Automatic Temporary Reduction Of Blood Flow When PA min is reached, blood flow automatically drops briefly to 60 ml/min. to prevent standstill of the blood pump caused by movement of the patient. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 31

Therapy End During Intermittent HF 1. Therapy end when the preselected treatment time has been reached The unit issues an alarm (balance-side alarm tone) and displays the message “Therapy time reached“ in the alarm field. The therapy is automatically interrupted. 2. Therapy end when the preselected substitution volume has been reached The unit issues an alarm (balance-side alarm tone) and displays the message "Substitution volume reached” in the alarm field. The therapy is automatically interrupted. 3. Therapy end when the preselected UF-volume has been reached The unit issues an alarm (balance-side alarm tone) and displays the message "UF volume reached” in the alarm field. The therapy is automatically interrupted. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 32

Therapy End THERAPY END is carried out in the same manner for all of therapy-ending modes. Now the field “THERAPY END” should be selected with the cursor. Therapy end is confirmed with “Enter” and the EQ button. The message “THERAPY END – blood return” appears in the status line. The blood pump should be stopped. The arterial line should be disconnected and connected to a 250 ml saline bag. Then start up the blood pump and reduce the flow to 100 ml/min. When the saline bag is empty, stop the blood pump and note the important data (e. g. substitution volume, UF volume, etc. ) Now disconnect the venous line from the patient and the unit can be switched off. The data are preserved for 4 houres; they can be called up by switching the unit on again. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 33

Alarm And Message Tones For better identification of the alarm situation, the Diapact® CRRT distinguishes between · blood-side alarms · balance-side alarms and · message tones Depending on the urgency, blood-side alarms are displayed with a continuous tone and balance-side alarms with an intermittent tone; message tones are displayed acoustically every 30 seconds. 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 34

The All-In-One Principle When It Matters, Everything Is Prepared Versatility is reassuring • easy to operate • versatile because fully equipped • available anytime • ready in an instant • mobile and independent of water sources • versatile therapy forms integrated • ideal for high volume therapies • economical, saves time and effort 03/11/2020 Training document, no update service This document may not be copied, partly or whole, or made be accessible to third parties without our permission and remains the property of B. Braun Medizintechnologie Gmb. H with all rights. Authors: Guenter Nissen Heiko Riemenschneider 35