Download NIBP Simulator Performance with the Advantage

NIBP Simulator Performance with the Advantage OEM NIBP Module
2015
When potential customers evaluate the Advantage
NIBP module with a view to develop manufacturing
procedures or check the BP results, often an NIBP
simulation or group of simulations are performed
using an NIBP simulator. Some customers will ask for
expected values. These values are dependent on
several factors including the type of NIBP simulator,
settings, age of the instrument, software version,
pneumatic setup and module configuration. Thus it is
difficult to provide meaningful min/max values without
testing under identical conditions.
This technical brief provides general limits expected
for 5 simulator brands at various settings with the
Advantage 2.0 Module Series. These limits were
derived using specific equipment arranged in a
precise manner. If these data are to be relied upon,
we recommend the test conditions be replicated
exactly. Even so, results may vary due to the
vagaries of the specific instrument. Additionally, this
tech brief will also explain why there are differences
between the BP values and the NIBP simulator target
values.
test methods are given in published regulatory
standards such as ISO 81060-2.
These
standards include pass criteria that do not
apply at all to measurements done with NIBP
simulators. Accuracy is determined from a
population of humans and the pass criteria in
clinical standards only apply to a population
of data, never a single measurement. An
NIBP simulator is a mechanical substitute for
a single data point.
3. On many NIBP simulators, the Advantage
module will output higher BP values on
hypertensive settings.
This is normal and
expected due to differences in oscillation
amplitude ratios in NIBP simulators and the
Advantage BP algorithm. Many NIBP simulators
choose to have the same ratio throughout the
entire pressure range. Our clinical evidence
shows this is not the case on humans so we
developed a dynamic ratio that changes based
on pressure. The net effect of this difference is
that for some NIBP simulator settings, the
Advantage module BP results will be somewhat
different than the target values.
NIBP Simulator Guidelines
It is important to remember the following NIBP
simulator guidelines when used with oscillometric
NIBP modules or monitors:
1. NIBP modules from different manufacturers will
give different results on the same simulator
setting. This is normal and expected primarily
due to a number of algorithm differences
between manufacturers.
THE OEM NIBP
MODULE THAT BEST MATCHES TARGET
VALUES IS NOT NECESSARILY MORE
ACCURATE.
Remember, NIBP simulators
cannot be used to measure clinical accuracy.
2. NIBP simulator target values should never be
considered as a standard of accuracy. All NIBP
simulator manuals explain or should explain that
the target values are approximations and should
only be used for measuring repeatability and
agreement. Accuracy is only measured using
human subjects and accuracy requirements and
4. The Advantage module will provide different
results on different NIBP simulators for the same
setting. This is normal and expected due to
simulator differences.
5. Offset tables are needed when evaluating the
performance between an NIBP module or
monitor and a certain NIBP simulator (provided in
this paper).
6. The Advantage module usually provides
measurement values EVEN IF AN ERROR
CODE OCCURS. For all error codes, these
measurement values should be disregarded and
considered unusable during any type of
evaluation.
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Protocol
It is important that the equipment and procedures
described in this section be replicated as closely as
possible. Deviating from them may result in data
inconsistent with these published performance limits.
The five NIBP simulators we chose are commonly
used by NIBP developers, medical monitoring
companies and biomedical engineering departments
throughout the world. They are as follows:
Simulator
Hypertensive
SimCube
Sys Dia Map
190 / 120
BP Pump 2
ProSim8
Uni-Sim
200 / 150 / 165 80
200 / 150 / 167 130
200 / 140 / 153 80
Accupulse HH
HR
70
200 / 150
80
Table 1a
Pronk Technologies SimCube – r5.1
Simulator
Fluke Biomedical BP Pump 2, V3.21
Normotensive
Sys Dia Map
Fluke Biomedical ProSim8
Rigel Uni-Sim
Clinical Dynamics Accupulse Plus Handheld (HH)
This is not a comprehensive list as we are aware of
others on the market. In the future, we may develop
additional information for other instruments.
Four preset simulations were chosen – hypertensive,
normotensive, hypotensive and a neonatal setting.
These settings represent a broad spectrum and fit into
most evaluation and manufacturing procedures. The
actual simulator target values for each setting are in
table 1. For most settings, there is a slight variation in
target values between simulators due to simulator
design.
Artifact settings were not selected since they typically
are not utilized during general manufacturing or
evaluation.
Ten Advantage 2.0 OEM NIBP modules were used to
derive the performance limits for these NIBP
simulators. Each simulator setting was performed
three times per module for a total of 30 simulations
per setting.
Statistical analysis was done by
calculating the mean (average) and standard
deviation for each group of 30 simulations. The mean
shows the shift from the target value and the standard
deviation was used to determine the span between
the minimum and maximum limits. The limits are
based on 4 standard deviations. Due to differences in
how NIBP simulators re-create oscillometric pulses
and the tolerances to which they can be repeated,
some NIBP simulators have wider limits than others.
SimCube
BP Pump 2
ProSim8
120
120
120
120
120
Uni-Sim
Accupulse HH
/ 80
/ 80
/ 80
/ 80
/ 80
HR
70
80
60
80
80
/ 90
/ 93
/ 93
/ 93
Table 1b
Simulator
Hypotensive
Sys Dia Map
SimCube
BP Pump 2
80
80
80
80
80
ProSim8
Uni-Sim
Accupulse HH
HR
/ 40
/ 50 / 60
/ 50 / 60
/ 40 / 53
/ 50
70
80
80
80
80
Table 1c
Simulator
Neonatal
Sys Dia Map
HR
SimCube
BP Pump 2
70
60
60
60
60
95
120
120
120
120
ProSim8
Uni-Sim
Accupulse HH
/ 40
/ 30 / 40
/ 30 / 40
/ 30 / 40
/ 30
Table 1d
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Setup
When applicable, no internal volumes were engaged.
For all adult simulations, a 500mL rigid volume was
attached to the pneumatic setup.
Neonatal
simulations were performed with a #3 neonate cuff
wrapped tightly around a rigid cylinder within its range.
Note 1:
For the Accupulse Plus HH, the preset
Generic Adult Mode was used for
Normotensive setting.
Note 2:
For Pronk Technologies Sim-Cube and
Accupulse Plus HH simulators, the MAP
function is not available for these two units.
6 inches
15.2 cm
6 inches
15.2 cm
Volume
Tee Fitting
4.92 FT
1.5 meters
Module
The NIBP module being tested was connected to the
volume and simulator using a 5 ft (1.5m) length of
polypropylene tubing patient hose which is the same
type of hose provided in the Advantage development
kits (black patient hose). It has a durometer of 80
Shore A and inner diameter of 0.125 inches (3.2mm).
It is strongly advised not to use tubing that is lower in
durometer, has a smaller inner diameter or vary the
length by more than 20 inches (0.5m). Tubing to the
volume and simulator was 6 inches (15.2 cm) and was
the same silicone tubing used as the exit tubing on the
Advantage module manifold.
This tubing has a
durometer of 50 Shore A and inner diameter of 0.094
inches (2.4mm). Similar tubing material, durometer,
inner diameter and length should be used. Do not
decrease the durometer below 50 Shore A and do not
increase each length beyond 10 inches (25.4 cm).
NIBP Simulator
Results
The performance limits provided are for the latest
SunTech firmware (LX3.413) in the Advantage
module series. If you are testing modules with
previous firmware versions, please contact SunTech
Medical to see if these limits apply to your version.
Figure 1
Limits are provided for both measured and calculated
MAP. The module measures MAP during its data
collection process but can output either measured or
calculated MAP depending on the customer’s
preference. This is set at the factory and is not userselectable. Most customers get calculated MAP.
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Pronk SimCube, r5.1
Fluke BP Pump 2, SW Ver. 3.21
SYS
DIA
Meas.
MAP
Calc.
MAP
HR
SYS
DIA
Meas.
MAP
Calc.
MAP
HR
Setting
190
120
n/a
n/a
70
Setting
200
150
165
n/a
80
Mean
196
127
150
150
71
Mean
206
154
171
171
80
Std Dev
2.07
2.03
1.81
1.60
0.88
Std Dev
1.34
1.47
1.19
1.17
0.47
Hypertensive Limits
Hypertensive Limits
Min
Max
188
204
119
136
143
157
144
157
68
75
Min
Max
201
212
148
160
166
176
167
176
79
83
Setting
120
80
n/a
n/a
70
Setting
120
80
90
n/a
80
Mean
117
84
95
95
71
Mean
126
86
99
99
81
Std Dev
1.33
1.43
1.12
1.09
0.51
Std Dev
1.37
1.01
0.82
0.85
0.63
Normotensive Limits
Normotensive Limits
Min
Max
112
122
78
89
90
99
90
99
69
73
Min
Max
121
132
82
90
96
103
96
103
78
83
Setting
80
40
n/a
n/a
70
Setting
80
50
60
n/a
80
Mean
76
46
56
56
71
Mean
87
54
65
65
81
Std Dev
2.27
1.80
1.38
1.41
0.35
Std Dev
1.38
1.21
1.23
1.18
0.49
Hypotensive Limits
Hypotensive Limits
Min
Max
67
85
39
53
51
62
50
62
69
72
Min
Max
81
92
49
59
60
70
60
70
79
83
Setting
70
40
n/a
n/a
95
Setting
60
30
40
n/a
120
Mean
68
46
53
53
92
Mean
64
35
45
45
121
Std Dev
1.20
2.65
1.95
1.88
0.81
Std Dev
1.84
1.19
1.09
1.09
0.49
41
49
119
123
Neonatal Limits
Min
Max
63
73
35
57
45
61
Neonatal Limits
46
61
89
95
Min
Max
57
71
31
40
40
49
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Fluke ProSim8
Rigel – Uni-Sim
SYS
DIA
Meas.
MAP
Calc.
MAP
HR
SYS
DIA
Meas.
MAP
Calc.
MAP
HR
Setting
200
150
167
n/a
130
Setting
180
140
153
n/a
80
Mean
210
159
176
176
131
Mean
180
142
155
155
81
Std Dev
1.76
1.93
1.46
1.36
1.41
Std Dev
1.36
0.99
1.00
0.96
0.57
Hypertensive Limits
Hypertensive Limits
Min
Max
203
217
151
167
170
182
170
181
126
137
Min
Max
175
186
138
146
151
159
151
158
78
83
Setting
120
80
93
n/a
60
Setting
120
80
93
n/a
80
Mean
130
87
101
101
61
Mean
121
84
96
96
81
Std Dev
1.07
1.13
1.03
1.02
0.51
Std Dev
0.94
0.92
0.85
0.76
0.57
Normotensive Limits
Normotensive Limits
Min
Max
125
134
83
92
97
105
97
105
58
63
Min
Max
117
125
80
88
93
99
93
99
79
83
Setting
80
50
60
n/a
80
Setting
80
40
53
n/a
80
Mean
87
56
66
66
81
Mean
81
44
56
56
80
Std Dev
1.39
0.94
1.09
1.01
0.71
Std Dev
0.91
1.84
1.30
1.29
0.57
Hypotensive Limits
Hypotensive Limits
Min
Max
82
93
52
59
62
70
62
70
78
84
Min
Max
77
85
36
51
51
61
51
61
78
83
Setting
60
30
40
n/a
120
Setting
60
30
40
n/a
120
Mean
58
38
45
45
120
Mean
61
33
42
42
121
Std Dev
2.24
1.35
1.44
1.42
0.68
Std Dev
0.52
1.42
1.04
1.03
0.76
38
47
118
124
Neonatal Limits
Min
Max
49
67
33
44
39
51
Neonatal Limits
39
51
118
123
Min
Max
59
63
27
39
38
47
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Conclusions
Accupulse Plus HH
SYS
DIA
Meas.
MAP
Calc.
MAP
HR
Setting
200
150
n/a
n/a
80
Mean
205
152
170
170
81
Std Dev
1.91
2.30
2.02
1.92
0.43
Hypertensive Limits
Min
Max
198
213
143
162
162
178
162
178
79
82
Setting
120
80
93
n/a
80
Mean
124
84
97
97
81
Std Dev
1.17
1.53
1.30
1.28
0.50
Lesser quality NIBP simulators can produce greater
variability in a set of measurements which is revealed
by the standard deviation. Higher standard deviations
will also have wider min/max limits.
All simulators used in this evaluation are acceptable
for NIBP simulation use with Suntech Medical
Advantage series NIBP modules.
We provide these limits and recommendations to
assist anyone using NIBP simulators with the
Advantage series of modules.
While we have
collaborated in the past with an instrument
manufacturer, our performance assessments are
completely independent. All recommendations herein
are based solely on scientific principles and actual
acquired data as well as significant clinical experience
with our Advantage series of OEM NIBP modules.
Normotensive Limits
Min
Max
120
129
78
90
92
103
92
102
79
83
Setting
80
50
n/a
n/a
80
Mean
85
52
63
63
81
Std Dev
1.31
1.36
1.27
1.13
0.49
Hypotensive Limits
Min
Max
80
90
47
58
58
68
59
68
79
83
Setting
60
30
n/a
n/a
120
Mean
69
19
36
36
121
Std Dev
1.86
1.67
1.36
1.29
1.03
31
41
117
125
Neonatal Limits
Min
Max
62
76
13
26
31
41
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