Appendix C: Bolus Accuracy
149
SIGMA Spectrum Infusion System
Pump Operating Software Version 8.00
Operator’s Manual
For Use With MDL Version 8.0
APPENDIX C: BOLUS ACCURACY
The SIGMA Spectrum Infusion System may have an optional bolus mode of operation. This
feature allows the user to perform a BOLUS SETUP action. To utilize this feature, the Pump must
be programmed with either a specific rate or a specific amount to be delivered in a certain amount
of time.
If the Pump is currently operating in mL/hr delivery mode, the bolus rate value is entered in mL/hr
and the volume is entered in milliliter (mL). If the Pump is operating in a non-mL/hr delivery mode
(for example, mcg/kg/min), the bolus amount would be entered in mcg/kg; however, the
mL/hr
soft
key may be pressed in the setup screen to enter the bolus information in mL/hr format.
In either mode, the time is entered in minutes by default, but it can be programmed in seconds if
needed. Limits are placed on the minimum and maximum amount of time for the bolus delivery.
The limit constraints are contained within the software of the SIGMA Spectrum Infusion System
and are necessary to control the maximum or minimum flow rate of the bolus infusion.
The accuracy of the bolus volume is dependent on the resultant flow rate that is obtained from the
calculation of volume to be delivered in the time requested. For example, if the bolus volume is
300 mL, the maximum flow rate is obtained with a bolus time of approximately 18 minutes or a flow
rate of approximately 999 mL/hr. Using this bolus volume and delivering the volume in the shortest
amount of time, the mean value of 300 mL ±5% may be expected, whereas using a minimum
bolus volume (0.5 mL) and delivering the volume in a short amount of time (1 minute), the mean
value of 0.5 mL ±16% may be expected.
When tested in accordance with IEC 60601-2-24: 1998 Clause 50.106, the following are the
minimum, maximum and mean deviations in bolus volume for each corresponding setting:
Bolus
Delivery
(mL)
Bolus
Time (min)
Bolus
Rate
(mL/hr)
Mean
Deviation
from Set
Value
Percentage
Deviation
from Set
Value
Maximum
Positive
Deviation
Maximum
Negative
Deviation
0.5
1
30
0.015
6.02
7.11%
9.52%
300
18
999
-6.939
-2.51
1.83%
4.47%