NIPRO SURDIAL 55 PLUS MACHINE

Technical Data:

Rotatable Monitor Touch screen 10.4”

Nominal Voltage: 230 V option 110 V +10%

Nominal Frequency: 50/60 Hz.

Dimensions (mm): 290x420x1365

Weight: 75 kg.

Water supply:

Pressure range: 0.5 – 7.4 kgf/cm2

Temperature range: 17 – 30 °C

Dialysis circuit:

Flow rate: 300 to 800 ml/min

Temperature range: 32 to 39 °C

(Accuracy + 0.8 °C)

Conductivity range: 130 to 200 mmol/l

(Conc. A: 50 – 160 mmol/l)

UF rate: 0; 0.10 – 5.00 l/h (accuracy + 30 g/h)

Extracorporeal circuit:

Blood pump: 7x10 mm roller

Delivery rate: 0; 10 to 600 ml/min.

Heparin pump: 0.1 – 9.9 ml/h

Bolus volume: 0.5 – 5 ml

Syringe selection: 10, 20 or 30 ml.

Air Detector: Min. 10 µl (Qb = 200 ml/min.)

Microbubble: 0.3 µl/min.

Venous pressure: -500 to +500 mmHg

Arterial pressure: -500 to +500 mmHg

Introduction

All the pictures shown in the present report were taken from an in-vivo dialysis therapy
of a female patient (pre dialysis weight: 54 kg; height: 156 cm. three times per week
treatment)

User Interface

Fig. 1: Main screen Nipro Surdial 55 plus

The main screen shows all the relevant parameters for therapy. From left to right we
can see the venous pressure with a value of 209 mmHg, arterial pressure with a value
of 0 mmHg (the machine has the option of deactivate the arterial and venous pressure,
because of the high working pressure range, this machine even allows the user works
with a venous pressure of 0 mmHg) and finally shows the dialysate pressure with a
value of 227 mmHg. (The TMP is not shown on the main screen, according to the
information obtained from the medical staff, they must calculate the value of the
transmembrane pressure)

The values shown below the pressure data correspond to the dialysis temperature, end
conductivity, sodium and bicarbonate.

On the right side of the screen we can see the actual UF volume (1.03 liters) the set UF
volume (3.00 liters), the UF rate (1.00 l/h). There are two values of remaining time, the
first one 1:58 h:min., the second one 2:28 h:min (Figure 1). The head nurse explained
that both values must be the same, but sometimes they forget to program them
correctly (Figure 2). The Nipro machine can calculate the end therapy time and this is
also shown on the screen (12:37 h:min)
 Fig.2: Main screen with remaining time values corrected

On the bottom side of the blue box are the options for programming the therapy
parameters. UF program, concentrate A program, concentrate B program, single
needle and Kt/V.

Fig. 3: UF program

In the UF program the machine shows the UF set volume, the average UF rate, the
remaining time of therapy, the actual UF volume, the actual UF rate and the graphic of
the UF profile divided into 12 steps.
 Fig. 4: UF profiles

The machine has 6 preset UF profiles divided into 12 steps that can be changed in any
time of the therapy as the Dialog profiles. The program of the UF profiles is
independent of the program of bicarbonate and sodium profiles.

Fig. 5: “A” program

In the menu program A, the medical staff can configure the Acid concentrate profile,
with 6 preset options available.
 Fig. 6: “B” program

In the program B the user can configure the bicarbonate profiles. There are 6 preset
options.

Single Needle

Fig. 7: Single Needle program

In the single needle program the user can configure de PV máx, PV min., High limit
alarm, low limit alarm; the machine shows the average blood flow and the average
volume per cycle.
The Nipro Surdial 55 plus machine also shows the pressure values in trends, venous
pressure, arterial pressure and dialysis pressure.

Fig. 8: Pressure Trends

The machine also has the Timer option (Figure 9), the user can configure the timer
interval, the sound duration and the melody for the timer.

Fig. 9: Timer configuration

Kt/V measurement

Fig. 10: Kt/V configuration

In the Kt/V configuration the machine takes the therapy time and blood flow as
preselected data.

In the second box of the screen the machine asks for the patient information. The No. 7
box refers to the number of patient, selecting this option all the Kt/V data is stored in
this identification number.

The user must configure the gender (male, female), the height of the patient (in cm.)
the weight (required data pre dialysis weight) and the age of the patient.

The three boxes below show the target Kt/V, the actual Kt/V and the projected Kt/V.

The graphic shows the Kt/V curve, the target, and the projection of the final result.

On figure 11, all the required data for the Kt/V (gender, height, weight, age) was of a
previous therapy (male patient, the current therapy was performed in a female patient),
not exactly the last therapy but any therapy performed before and where the data was
not erased (the day before or last week), the machine load the same information of
Kt/V therapy to therapy. It means that if the user forgot to configure the data of the
actual patient, the Kt/V will be the same almost for all therapies and for all patients.
 Fig. 11: Kt/V curve

As we noticed this wrong information about the patient data, the head nurse changed it
to the real information for a female patient. (Figure 12 and 13)

Fig. 12: Kt/V configuration for current patient

 Fig. 13: Kt/V curve for current patient

In the setting for female patients the formula does not ask for age data. Also the weight
can only be a whole number, the software does not accept to program decimal.

With all this Kt/V information of Nipro machine, we conclude that the Kt/V calculation is
based on the Watson formula for determining V (urea distribution volume) and with the
other parameters taken from the dialysis data; the machine calculates the Kt/V. As we
said before it seems only a calculation and not really an online or real time
measurement.

BPM

This module is similar to our ABPM, in the picture below the machine’s screen shows
the systolic pressure, diastolic pressure, the mean arterial pressure and the pulse. As
with the Kt/V data the Nipro Surdial 55 plus machine load the old patient data if the
user has not erased it before. The setting of data is using a security password.

Fig. 14: BPM data and setting

As we can see in figure 14, the local time is 11:03, but the time of the pressure
measurements are for example: 23:14, 23:25, 0:37 and 12:38. So it is difficult to know
exactly from which patients are these pressure measurements. In the upper right part
of the second box is the option to erase all data.

TECHNICAL INTERFACE

In the Technical interface screen the technician can chose between different options:
Setting, Maintenance, System configuration and Options. (Figure 15)

Fig. 15: Technician Interface

The access to the Technician interface is using a password.

In the Configuration menu the options are: Parameters, Density setting, markers setting
and CD set. (Figure 16)

Fig. 16: Configuration menu

In the Maintenance menu the options are: Dialysis data, warning setting, warning
suppression, flow diagram, density changing, features, tightness, use level, history,
filling procedure and calibration. (Figure 17)

Fig. 17: Maintenance menu

In the System configuration menu the options are: Function settings and setting colors.
(Figure 18)

Fig. 18: System Configuration menu

In the Options menu there are: options setting and communication port setting. (Figure
19)
 Fig. 19: Options menu

SAFETY CONCEPT?

• The Nipro Surdial 55 plus hemodialysis machine does not have the level
regulator option for venous, arterial and PBE pressure, according to the
brochure of the machine the PBE is an optional.
• As we can see in the Technical data, the range of venous pressure is -500 to
+500 mmHg, therefore the machine allows to work in therapy with a venous
pressure of 0 mmHg. As we know this is a low venous pressure for a patient’s
blood access.
• The safety clamp is integrated in one block with the air sensor. (Figure 20)

Fig. 20 Safety clamp and air sensor

• The machine does not have the icon for cleaning the touch screen. The touch
screen has a high sensitivity and there is the risk of pressing two icons at the
same time.
• The blood pump is controlled by a knob, this knob is easy to turn in both
directions in order to adjust the blood pump flow, sometimes the setting by
using the knob is difficult and it has not a secure stop. (Figure 21)

Fig. 21: Blood pump flow setting