Terumo TERUFUSION TE-SS830P, Instruction Manual

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Test data for flow rate characteristics and occlusion characteristics is shown below.
Tests were conducted based on IEC 60601-2-24:2012 (EN 60601-2-24:2015). For details, refer to IEC 60601-2-24:2012 (EN 60601-
2-24:2015).
Flow Rate Characteristics
Start-up curves and trumpet curves, which are used as typical explanations of flow rate characteristics, are shown. The data below
is representative examples measured for flow rates of 1 mL/h and 5 mL/h with a new TERUMO syringe (50 mL).
Note
• Flow rate characteristics are correlated with the syringe. Depending on the combination of syringe and pump, the same data as
the representative example may not be obtained.
1. Start-up curve
The discharge quantity measured every 30 seconds for a 2-hour measurement period is converted into flow rate values is
shown. These graphs show characteristics from immediately after the start of solution delivery to when flow rate has stabilized.
<Flow rate: 1 mL/h>
2
1
0
0 20 40 60 80 100 120
Fl
ow r
a
te
(m
L
/h
)
Time (min)
<Flow rate: 5 mL/h>
10
5
0
0 20 40 60 80 100 120
Fl
ow r
a
te
(m
L
/h
)
Time (min)
2. Trumpet curve
Data for the latter one hour of the 2-hour measurement period is shown, with the horizontal axis showing the observation
window time (minutes) and the vertical axis showing the maximum and minimum flow rate error for each observation window.
The narrower the region enclosed between the top and bottom solid lines (the so-called trumpet curve) is, the less pulsatory
motion there is.
<Flow rate: 1 mL/h>
+15%
+10%
+5%
+0%
-5%
-10%
-15%
0 5 10 15 20 25 30 35
Fl
o
w
r
a
te e
rr
o
r (
%
)
Observation window time (min)
Flow rate error = +0.09% <Flow rate: 5 mL/h>
+15%
+10%
+5%
+0%
-5%
-10%
-15%
0 5 10 15 20 25 30 35
Fl
o
w
r
a
te e
rr
o
r (
%
)
Observation window time (min)
Flow rate error = +0.86%
3. Influence of pressure on the lower side of the pump (back pressure) on flow rate accuracy
The table below shows the maximum deviation of flow rate accuracy under normal condition with either -13.3kPa or 13.3kPa of
back pressure.
-13.3kPa (13.3kPa) of back pressure is equivalent to the condition where the pump is located approx. 136 cm higher (lower)
than the patient (in the case of water).
Back pressure (kPa) Maximum deviation of values (%)
-13.3 +1.0
+13.3 -0.7
Device Characteristics