TREATMENT SAFETY AND EFFECTIVENESS CONTROL OF MODERN DIALYSIS MACHINES

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Emily Gregory
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1 TREATMENT SAFETY AND EFFECTIVENESS CONTROL OF MODERN DIALYSIS MACHINES Sarajevo, October 5 th, 2017

patient highly qualified technology and medical supplies are crucial to the quality of dialysis

2 Modern dialysis machines have evolved from the early cumbersome and inefficient devices to those with modern electronics and programmable features to allow the most efficient dialysis for the patient highly qualified technology and medical supplies are crucial to the quality of dialysis treatment The dialysis machines by Nipro offer the highest treatment quality and safety through modern technology.

The device has been equipped with a number of features useful to the nephrologists to verify the efficiency

3 When designing the new Surdial-X Dialysis machine, Nipro focused on the overall human kidney function, created a user friendly and logical platform incorporating the patient's current and future therapy needs. The device has been equipped with a number of features useful to the nephrologists to verify the efficiency of the treatment from a biochemical standpoint, and to monitor the patient s hemodynamic tolerance to the treatment

Ease of Use CE Certification August 2014 (Production

4 Surdial X General Information NIPRO HIGH-END Dialysis Machine V2 optimal Treatment Quality, Safety, Reliable, Ease of Use CE Certification August 2014 (Production September 2014) compact Housing rotatable 15' inch touch panel display

5 Blood pump Single needle pump Substitution pump Available as: HD( one or two pumps) HDF machine

6 Surdial X General Information HD Single needle (double pump + single pump) incl. Auto-SN HD Double needle HD On-line priming (without substitution line) DIF HD On-line reinfusion (without substitution line) DIF HD On-line bolus (without substitution line) DIF HDF online Double /Single needle Pre- or post dilution Online Priming Online Bolus and Reinfusion HF online Pre- or post dilution

7 Surdial X Easy To Use optimized nurse workflow auto preparation process auto insertion and extraction of bloodlines pump segments assisted blood line changes in all phases of the treatment half automatic level adjustment

8 Surdial X Easy To Use Automatic bicarbonate cartridge change in all phases of operation Auto on/off Assisted change to single needle mode Emergency button

Surdial X Technical Information Redesigned

9 Surdial X Technical Information Redesigned hydraulics and electronics Stable and established technical base Less energy consumption Clear separation between hydraulics and electronics Perfect accessibility for all components Safety technical inspection only every 2 years

10 Surdial X Activ Real-Time-Flowchart Any time can be directly operated on the screen by technician.

11 Surdial X Long Life Cut Filter CF1 CF2 Running time: Citric Acid: Peracetic Acid: 1800h 1200h

Surdial X Disinfection Low Disinfection Time: citric acid (29min) Other devices 37-45 min!

disinfection disinfection history consumption of disinfect is 43.4 ml (original concentration 6%, diluted 0.

12 Surdial X Disinfection Low Disinfection Time: citric acid (29min) Other devices min!! sodium hypochlorite (38min) peracetic acid (37min) Features: weekly disinfection program in-line heat disinfection disinfection history consumption of disinfect is 43.4 ml (original concentration 6%, diluted 0.1% ) consumption of acid concentrate is 26.0 ml (original concentration 50%, diluted 0.5% ) Other manufactures exp. BBraun ml

13 Surdial X ABPM Automatic Blood Pressure Monitor systolic/diastolic blood pressure, pulse and MAP manual/cyclic activation quick emergency function constant measurement in case of emergency automatic feedback control UF rate blood pump speed dialysate flow

14 Surdial X Profiling Profiles ultrafiltration profile sodium profile bicarbonate profile 8 to 12 sequences each bar is adjustable individual and combined use

15 Heparinization Compatible with 10, 20 and 30 ml syringes Up to 10 ml/min flow Manual bolus Auto bolus program Heparin stop time

(comprehensive data collection) Automatic calculation of ultrafiltration Volume with plausibility check PatientCardProgrammer

16 Surdial X Network Unidirectional network connectivity already connected to several network systems (Diamant, Nexadia) Patient card read and write function possibility to program the treatment prescription Storage of treatment data of the last three treatment s (comprehensive data collection) Automatic calculation of ultrafiltration Volume with plausibility check PatientCardProgrammer external software for programming patient cards Bidirectional net connectivity machine hardware is already prepared software release 2017

should be drawn using the Slow Flow/Stop Pump Technique that prevents dilution of the blood with

17 Surdial X Blood Sampling Accurate measurement of changes in the pre/post BUN concentrations depends upon accurate blood sample collection To guaranty spkt/v accuracy The post-dialysis BUN samples should be drawn using the Slow Flow/Stop Pump Technique that prevents dilution of the blood with recirculated blood and minimizes the effects of urea rebound Indicates the optimal time for blood collection

18 Unique features

membrane as second endotoxin filter only valid with Elisio H Series dialyzer leak

19 Surdial X DIF (Dialysate Infusion Function) online priming in HD mode ultrapure dialysate dialyzer membrane filtration as redundant filtration step dialyzer membrane as second endotoxin filter only valid with Elisio H Series dialyzer leak check before priming cost reduction No saline bag needed in HD One cut - filter + Elisio

20 Surdial X DIF (Dialysate-Infusion-Function) Validation of Elisio H Series as second endotoxin filter: A highly concentrated solution of LPS (10L, target concentration in saline: EU/ml (~1.000 ng/ml) LPS of P. aeruginosa, was filtered dead-end with 500 ml/min from the extracapillary space (ECR, dialysate compartment) into the intracapillary space (ICR, blood compartment). Samples were taken at t= 0, 5, 10, 15, 20 min to determine LPS activity in a LAL test (Pyrogen 5000, Lonza GmbH, Cologne, Germany, lots: JL095C, JL045W, detection limit: 0.01 EU/ml) following SOP AA 013 of excorlab.

21 Surdial X DIF (Dialysate Infusion Function)

22 Surdial X CTS (Clean-Treatment-Start) No fluid intake for patient Simultaneous Arterio-Venous patient connection Simple, fast and automated connection Reduced nurse actions and risks during connection Conventional connection CTS

23 Surdial X CTS (Clean-Treatment-Start)

24 Surdial X SLED SLED - Slow Low Efficiency Dialysis 24h continues treatment (withouh chaning bloodlines) for acute dialysis intermittent or continious HD and HF pre or post dilution Blood flow rate < 200ml/min dialysate flow 100 ml/min cost efficiency

the individual patient (Hb, HcT, Protein, V) and treatment situation (blood flow,

25 Surdial X Max Sub special system for optimization of substitution-/filtration-flow to perform High- Volume HDF highest possible substitution- /filtration- flow considering the individual patient (Hb, HcT, Protein, V) and treatment situation (blood flow, dialyzer, heparinization) avoiding coagulation despite high hemoconcentration in the dialyzer

26 Surdial X Max Sub Determination of Max Sub in two steps: QB 300 ml Start Point = 30% Step 1 = 4 % Step 2 = 2 % TMP BP = 70 mmhg TMP SP = 70 mmhg

27 SX- Max Sub volume (Diamed Hospital-Skopje, results) DIALYZER QB UF Volume SUB Volume Conv. Volume Auto SUB TMP MIN MAX Elisio 17H , ,8 31,7 Elisio 19H , ,4 33,4 Elisio 21H , ,7 36,2 Elisio 25H , ,5 32,2 Polyflux 170H ,2 31,8

28 Bosnia trial results 2016 The behavior of the TMP is dependent on the treatment and patient conditions and has proved to be a good indicator to determine the maximum filtration rate individualized for each patient during the clinical study Within that we reached Sub Vol mean value 28.9 L and sub goal mean value 31.2 L with mean value of TMP mmhg Max Sub results met criteria of a high volume OL-HDF and confirmed individualized treatment with maximum filtration rate

30 Surdial X Kt/V Dose Detector Principle - multiple short sodium boli using the fact that urea and sodium have the same diffusion properties during each boli the conductivity before and after the dialyzer is measured the conductivity differences are used to calculate the clearance using the clearance the following parameters are calculated Kt/V Single Pool Kt/V Double Pool Kt/V Sodium Concentration in Plasma Water Urea Reduction Rate Kt

31 Surdial X Kt/V Dose Detector Principle - multiple short sodium boli

32 Surdial X Kt/V Dose Detector

report SX2 study 2014, Bosnia & Hercegovina.

33 Trials: Evaluation of new device for chronic dialysis patients Surdial X, Final report study 2011, R.Macedonia The device has been proven to be efficient and safe for use during Clinic trial, Final report SX2 study 2014, Bosnia & Hercegovina. Observational study for software evaluation within improved dialysis machine for chronic dialysis patients (SURDIAL X - CE), Final report 2016/2017, Bosnia & Hercegovina

34 Results from the SX machine KT/V Dose Finder mean value showed 1.76 Kt/V mean value showed 1.64 Kt/Vsp mean value showed 1.84 Kt/Vdp mean value showed1.62 Kt [L] mean value showed 60.6 L URR [%] mean value showed % Eff. Dialysis Time [h:min] mean value showed 04:20 Total UF Volume [L] mean value showed 4.91L

35 Laboratory results: Kt/Vsp (Bloody) mean value showed 1.92 Kt/Vdp (Bloody) mean value showed 1.64 URR [%] mean value showed %

37 Under Development

38 Surdial X Recirculation Recirculation estimation Ratio calculation of dialysance/clearance and blood flow defined ratio will indicating recirculation indication via traffic light system

39 Surdial X BVM (Blood Volume Measurement) Launching in Octomber

Surdial X BVM (Blood Volume Measurement) The technique is based on the optoacoustic effect The optoacoustic effect is the formation of (Ultra-)sound after

The wavelength of light is chosen in a range where there is a significant absorption of hemoglobin and a low absorption of other blood components

40 Surdial X BVM (Blood Volume Measurement) The technique is based on the optoacoustic effect The optoacoustic effect is the formation of (Ultra-)sound after light absorption by a material sample. The wavelength of light is chosen in a range where there is a significant absorption of hemoglobin and a low absorption of other blood components (proteins, water). Blood absorbs the light and emits an ultrasonic wave. The amplitude of the emitted sound wave is proportional to the hemoglobin content of the blood sample. This allows the measurement of the relative change of hemoglobin concentration during a dialysis session

41 BVM trial results: Regulation of ultrafiltration based on relative blood volume changes using the Blood Volume Monitor (BVM) which helped to achieve the prescribed dry weight and prevents intradialytic hypotensive episodes. The results showed no significance and increasing the values of HCT accordingly UF, dialysis time and condition of the patient Satisfactory results in all treatments proved the safety, stability, and efficiency of the treatment without any complication during the sessions. HCT mean value showed pre 30.1% and post 30.7%

42 Surdial X Sampling Software sample for measure the water and dialysate quality taking dialysate samples (HD) by using the drain port taking dialysate samples (HDF) by using the online port Sampling bag with luer-lock connector available

43 Surdial X Sampling Software way of sampling: HDF Sampling HD Sampling

44 Conclusion: The machine showed stability and safety proving its effectiveness Reliable, easy to use Anticipated clinical and laboratory parameters (exams) fulfill the criteria about adequacy of dialysis (HD and HDF mode) Physiological parameters demonstrate cardiovascular tolerance and hemodynamic stability of patients Recovery time after the session with no significant changes and without influence on their quality of life Cost reduction (technical inspection only every 2 years, low disinfection time and consumption of disinfect, no saline bag needed in HD online, one cut filter in HD/DIF mode+elisio H as second filter)

Dialysis System DBB-07

Dialysis System DBB-07 The flexible solution Innovations for Human Care. 0123 Times are changing, we have the solution. DBB-07 Dialysis System The challenge The demand of dialysis treatment methods should