YY 0645-2018

1 Blood Pump Flow rate

Accury: less than ±10% of Nominal Range

Test method of Blood

Pump Flow rate Pressure：-200mmHg±50mmHg

2 Fluid Removal

Overall precision of
less than ±200mL in 8h
weight loss:

3 Syringe Pump
Accury: ±0.2 mL/h or 5% of the displayed
value,take the larger one
4 Venous pressure monitor

Accuracy: less than ±10mmHg

couldn't be set below 10 mmHg in

lower alarm limit
treatment

5 Arterial Pressure Monitor

Accuracy: less than ±10mmHg

6 TMP
 Accuracy: less than ±20mmHg

7 Working Noise

≤ 62dB
 Performances of Acusmart
< +- 10% up to -150mmHg of suction pressure
<20% up to -250mmHg of suction pressure
0.3% with respect to total treatment fluid
<0.2 mL/h of displayed value of 5 mL/h
< ±15 mmHg at the displayed value of -300 or
300 mmHg;
< ±4 mmHg at the displayed value of 0mmHg
unknown
< ±15 mmHg at the displayed value of -300 or
300 mmHg;
< ±4 mmHg at the displayed value of 0mmHg
Verdict Medica comment
We can check if, reducing maximum
pump speed to 300ml/min, we
F
remains in that limit. Otherise a
software modification is needed+
The total treatment fluid indicated
here is the sum of replacement
volume + effluent volume.
Considering a CVVH at high flow
F
rates, where you infuse 3000ml/h
and remove 3200ml/h, you get an
overall volume of 5l in 8h, that gives
a maximum error of 150g
Uncertain We will repeat internal test to
confirm requested accuracy
The accuracy can be bettere
expressed as the worst case between
±4mmHg or ±5%. Considerng the
normal operative range of [-200,
+200]mmHg, that definitions fulfulls
your needs. When pressure goes
F below -200mmHg for a long time
there can be small deviations due to
small air leakages, but that does not
happen in CRRT or hemofiltration,
where pressure values below
200mmHg raise alarms and hence
pumps are stopped
The minimum venous alarm
threashold can be modified if
needed, although 10mmHg is
Uncertain generally considered high: there are
patients where systemic pressure is
very low and even 5mmHg is too
high.
F See discussion for Venous Pressure
 This is a calculated pressure (Pven +
Ppre)/2 - Puf). Therefore theoretical
unknown Uncertain
error should be considered the worst
case between ±12mmHg or 15%

For sure below 62, but we have only

measurements done by ourselves,
inside our building, therefore
unknown Uncertain
overextimating the noise. If needed
we can ask for a measurement from
a certified lab
considering a CVVHD with high Considering a SCUF,
flow rates, let's say 6000ml/h of with a weight loss rate
dialysate and 6500 of effluen. In of 200ml/h:
this case 8h is not realistic: we Total fluid in 8h=
consider 4h as maximum time, 1600ml.
with a maximum error of 150g Error = 5g