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Medtronic / Products / Renal Care Products / Hemodialysis System and Accessories / Nikkiso DBB-EXA Hemodialysis System

Overview

The Nikkiso DBB-EXA hemodialysis system is a compact, user-friendly, and cost-effective dialysis machine that provides safe and effective hemodialysis. It also offers a variety of advanced treatments such as OHDF and OHF, as well as functionalities designed to help optimize patient wellbeing.

Features

Simplicity

  • Dialysis Fully Automated System (D-FAS) technology designed to reduce standard operational tasks and enable workflow optimization
    • One touch automated saline or on-line priming capabilities
    • One touch blood filling with or without UF (priming volume)
    • One touch emergency button with automatic minimum UF and optional bolus
    • Automatic washback without user intervention
  • User-friendly interface with intuitive graphic guidance and full text
  • Bi-directional contactless patient card
    • Simple and fully autonomous data management
    • Last three treatments can be accessed
  • Easy learning curve

Treatment optimization and safety

  • Decreased number of interactions with the machine leading to reduced potential for errors
  • Dialyzer Inlet Pressure (DIP) chamber
    • Pre-emptively removes air to help minimize extracorporeal circuit clotting
    • Monitors for potential issues in the extracorporeal circuit
  • Single Needle Single Pump on the fly
    • Easy transition from Double Needle Single Pump (DNSP) to Single Needle Single Pump (SNSP) HD on the go without changing the bloodline. No need for additional consumables
    • Simple and cost-effective procedure
  • Multiple configurable timers
    • Audible buzzers and visual displays – timer names can be customized
    • Up to 20 timers can be registered during a treatment, and four can run simultaneously
    • Let’s you perform tasks on time, every time
  • Cleaning and disinfection
    • Weekly program fully automates machine turn on/off with integrated cleaning
    • Multiple customizable cleaning programs to chose from
    • Non-captive disinfectant and descalant

Patient wellbeing

  • Blood Volume Monitor (BVM)
    • Can be programmed to drive automatic minimum UF
    • Continuous monitoring with no additional consumables
  • Dialysis Dose Monitor (DDM)
    • Positive long-term prognosis and improved quality of life (QOL) depends on the actual delivery of dialysis dose. Adequate dialysis dose may improve QOL([FOOTNOTE=Depner T, Daugirdas J, Greene T, et al. Dialysis dose and the effect of gender and body size on outcome in the HEMO study. Kidney Int. 2004; 65: 1386-1394.],[ANCHOR=],[LINK=]),([FOOTNOTE=Greene T, Daugirdas J, Depner T, et al. Association of Achieved Dialysis Dose with Mortality in the Hemodialysis Study: An Example of “Dose-Target Bias”. J Am Soc Nephrol. 2005; 16: 3371-3380.],[ANCHOR=],[LINK=]),([FOOTNOTE=Port FK, Ashby VB, Dhingra RK, et al. Dialysis Dose and Body Mass Index Are Strongly Associated with Survival in Hemodialysis Patients. J Am Soc Nephrol. 2002; 13: 1061-1066.],[ANCHOR=],[LINK=])
    • Continuous, non-invasive measurement method
    • Measurement starts automatically
    • Kt/v is displayed on the screen as a graph
    • URR is displayed (real-time measurement of dose from dialyzer)
  • Vascular Access Recirculation Rate Measurement
    • For detection and monitoring of recirculation to ensure a long-term assessment of vascular access
    • No additional devices or lab tests required
  • Blood Pressure Monitors (BPM)
    • iNIBP measurement time is shorter and target inflation pressure is lower, maximizing patient comfort([FOOTNOTE=Onodera, J; Kotake, Y; Fukuda, M et al. Validation of inflationary non-invasive blood pressure monitoring in adult surgical patients. J Anesth. 2011, 25(1), 127–130.],[ANCHOR=],[LINK=])
    • Blood pump speed and UF rate can be automatically reduced to customizable values if the SYS blood pressure alarm setting is reached
    • BPM external measurement – can be initiated by the Patient if feeling unwell, can be configured to trigger an automatic minimum UF
  • HaemoMaster
    • Automatic regulation of the UF rate (BV-UFC) and dialysis fluid conductivity (BV-COC) so that patients change in Blood Volume (dBV) follows the ideal curve – this could reduce the incidents of hypotensive episodes and the frequency of symptoms during the treatment([FOOTNOTE=Carlo Basile, Rosa Giordano, Luigi Vernaglione, et al. Efficacy and safety of haemodialysis treatment with the Hemocontrol biofeedback system: a prospective medium-term study. Nephrol Dial Transplant. 2001; 16: 328-334.],[ANCHOR=],[LINK=]),([FOOTNOTE=Santoro A, Mancini E, Paolini F, et al. Blood Volume Regulation During Hemodialysis. Am J Kidney Dis. 1998; 32: 739-748.],[ANCHOR=],[LINK=]),([FOOTNOTE=Santoro A, Mancini E, Basile C, et al. Blood volume controlled hemodialysis in hypotension-prone patients: A randomized, multicenter controlled trial. Kidney Int. 2002; 62: 1034-1045.],[ANCHOR=],[LINK=])
    • Monitors Plasma Refill Rate (PRR) – PRR ca help estimate adequate UF rate to stabilize dBV

Manoeuvrability and ergonomics

  • 15-inch flat touch screen with customizable layout
  • Slim dimensions and small footprint
  • Well laid-out extracorporeal circuit
  • Simple and easy brake pedal
  • Screen saver mode ideal for nocturnal sessions
  • Auto charting feature enables recording of parameters every 30 minutes

Cost-effective and environmentally responsible

  • Blood drain feature to reduce biomedical waste
  • Optimized energy use via integrated heat exchanger
  • Online priming, wash back and emergency bolus to save on saline cost
  • Reduced number of consumables to minimize waste and treatment cost
  • Inherited reliability and long MTBF (Mean Time Between Failure) to contain treatment cost and reduce downtime
Order Information
Item code Description Unit of Measure
DBB-EXA Hemodialysis System 1
Specifications
GENERAL DATA
DIMENSIONS 161 x 43 x 46 (H x W x D in cm)

Base: 51 x 74 (W x D in cm)
Weight Approx. 90 kg (incl. all options)
Water supply

Pressure: 1 to 7 bar at minimum 800 mL / min at maximum 3000 mL / min

Temp.: 5 to 30°C
Drain

Minimum drain capacity: 800 mL / min average

Height: 50 cm maximum

Temp.: 90 ° C maximum
Concentrate supply

Pressure: 0 to 0.5 bar

2 central acid concentrates
Power supply 110 to 120 VAC ±10 %, 50 to 60 Hz ±1 Hz (≈13 A)
Battery Ni-MH battery 24 V / 3200 mAh
External connection port

External output (staff call)

External input 1

External input 2

Nurse call switch

LAN/Network (RJ-45)

Serial interface (RS-232)

BPM start switch

USB

CF card type I
PAS Input interface for external alarming device (IEC PAS 63023) to stop extracorporeal and / or fluid circuit
Monitor 15 inch LCD
Hydraulic circuit
Dialysis fluid flow rate

Setting range:

Single ETRF 300 to 800 mL / min

Double ETRF 300 to 700 mL / min
Dialysis fluid temperature Setting range: 34.0 to 40.0 ° C
Dialysis fluid conductivity

Bicarbonate dialysis

Bicarbonate conductivity setting range: 2.3 to 7.0 mS / cm

Accuracy: ±0.1 mS / cm

Total conductivity setting range: 12.7 to 15.2 mS / cm

Accuracy: ±0.2 mS / cm

Acetate dialysis

Total conductivity setting range: 12.7 to 15.2 mS / cm

Accuracy: ±0.2 mS / cm
Transmembrane pressure (TMP)

Measurement range: -100 to +500 mmHg

Measurement accuracy: ±10 mmHg
Blood leak detector

Method: Optical

Sensitivity: 0.3 mL Blood / 1 L Dialysis fluid

(Blood: Hematocrit 32 ± 2 %; Dialysis fluid temperature: 37° C)
Ultrafiltration

UF rate: 0.00; 0.10 to 4.00 L / h

UF accuracy (Balance):

±30 mL / h (At dialysis fluid flow rate 300 to 500 mL / min)

±0.1 % of the dialysis fluid flow rate (At dialysis fluid flow rate 501 to 800 mL / min)
Dialysis Dose Monitor

Measurement principle: Absorptiometry

Applicable Treatment mode: HD, On-line HDF

Applicable Kt / V range: 0 to 3.0

Kt/V monitoring accuracy: ±0.1 (Kt / V 0 to 1)

±10 % (Kt / V 1 to 3)

Applicable URR range: 0 % to 100 %

URR monitoring accuracy: ±5 %
Endotoxin retentive filter (ETRF) EF-02D
Treatment options
Online HDF/HF

Substitution flow setting range: 0.00; 0.10 to 18.00 L / h (Online HDF)

0.00; 0.10 to 30.00 L / h (Online HF)

Flow rate accuracy: ±10 % of set value
Single needle treatment

Single needle single pump treatment

Single needle double pump treatment

SN control pressure: Upper limit: +400 mmHg

Lower limit: 0 mmHg
UF profiles 9 programmable profiles available
Conductivity profiles 9 programmable profiles available
Extracorporeal circuit
Arterial pressure monitoring

Measurement range: -300 to +500 mmHg

Measurement accuracy: ±10 mmHg
Venous pressure monitoring

Measurement range: -300 to +500 mmHg

Measurement accuracy: ±10 mmHg
Dialyser inlet blood pressure monitoring

Measurement range: -300 to +735 mmHg

Measurement accuracy: ±10 mmHg
Single needle pressure

Measurement range: -200 to +600 mmHg

Measurement accuracy: ±10 mmHg
Air detector

Method: Ultrasonic waves

Sensitivity: 0.02 mL (normal air bubbles) (At Blood flow rate: 250 mL / min)

0.0003 mL (microbubbles: blood / air mixture)

(At Blood flow rate: 250 mL / min)
Arterial blood pump (PUMP1)

Setting range: 40 to 600 mL / min

Flow rate accuracy: Set value ±10 % (inlet Pressure -150 mmHg P +150 mmHg)

Set value -20 to 0 % (inlet Pressure -200 mmHg P -150 mmHg)
Heparin pump

Setting range: 0.0 to 9.9 mL / h

Output rate accuracy: Set value ±10 %

Syringe type:

30 mL or 20 mL,

20 mL or 10 mL (optional)

Bolus volume: 0.0 to 9.9 mL
Venous blood pump / Substitution fluid pump (PUMP2)

Setting range: 40 to 600 mL / min

Flow rate accuracy: Set value ±10 % (inlet Pressure -150 mmHg P +150 mmHg)

Set value -20 to 0 % (inlet Pressure -200 mmHg P -150 mmHg)
Blood Pressure Monitor (BPM)

Pressure display range: 10 to 300 mmHg

Pressure display accuracy: Less than ±3 mmHg

Measurement range (adults):

Systolic blood pressure (SYS): 60 to 250 mmHg

Mean arterial pressure (MAP): 45 to 235 mmHg

Diastolic blood pressure (DIA): 40 to 200 mmHg

Pulse rate: 40 to 200 beats per minute

For iNIBP:

Pressure display range: 0 to 300 mmHg

Pressure display accuracy: Less than ±3 mmHg

Measurement range:

Adult systolic blood pressure (SYS): 40 to 280 mmHg

Mean arterial pressure (MAP): 10 to 280 mmHg

Diastolic blood pressure (DIA): 10 to 235 mmHg

Pulse rate: 30 to 200 beats per minute
Blood Volume Monitor (BVM)

Measurement principle : Near-infrared reflection method

Applicable blood flow rate range: 40 to 600 mL / min

Applicable hematocrit range: 15 to 50 %

Accuracy: ±2.3 dBV % (Double needle)
Vascular access recirculation rate measurement

Usable treatment modes: HD, ISO-UF, OHF, OHDF

Measurement range: 0~100 %

Measurement accuracy: ±10 (recirculation ratio %)

Measurement times: Maximum 5 times

Usable blood flow rate range: 100~600 ml / min

Usable hematocrit value range: BVM measurement range 15 to 50 %

Usable blood tubing lines: NIKKISO AV18-series
Accessories
Hook for concentrate bags Max. load 10 kg
Patient card

MIFARE Classic 4K

Capacity: 4096 bytes
Cleaning program
Disinfection and decalcification Heat disinfection with 50 % Citric acid
Disinfection and degreasing Sodium hypochlorite solution (Maximum 10 %)
Decalcification 30 % Acetic acid

 

*Specifications are valid for software version 1.6 or above and may differ depending on the DBB-EXA type (type A, B or C).

Specifications

Nikkiso DBB-EXA Dialysis Machine Brochure

User-friendly and cost-efficient dialysis monitor providing safe and adequate hemodialysis.

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