Chapter 14: Product Specifications
Alarms
Air-In-Line, Battery Very Low, Close Roller Clamp, Con-
tainer Empty, Downstream Occlusion, Door Open, Hold
Time Exceeded, KVO, Low Battery Warning, System Error.
Air-in-Line Alarm
> 100 microliter bubble
Free-Flow Protection
Passive, set-based
Memory
Permanent data retention after the pump is turned off unless
the battery is depleted or disconnected, or unless the Data
Retention Defaults have been otherwise selected in the
Biomed Options.
Environmental Operating
Eimits
659 F to 105° F (18° C to 40° C)
Maximum Bolus Volume
(Microbore Tubing)
0.047 ml at 399 ml/hr (75 mmHg)
0.086 ml at 399 ml/hr (750 mmHg)
0.053 ml at 500 ml/hr (400 mmHg)
0.097 mi at 750 ml/hr (750 mmHg)
Maximum Time to Occlu-
sion Alarm
24 min at 0.1 ml/hr (75 mmHg)
33 sec at 399 ml/hr (75 mmHg)
6 hours at 0.1 mi/hr (750 mmHg)
ACCURACY TEST TRUMPET CURVES
The Outlook™ 200, operated with B. Braun Medical Inc. Horizon® IV Pump Sets, maintains
a volumetric accuracy with delivery errors not exceeding +/-5% for any one hour period over
a 72 hour period. The following graphs (or Trumpet Curves) are provided to illustrate the
results of Outlook 200 volumetric accuracy tests. Additional testing results may be obtained
from the manufacturer upon request.
TRUMPET CURVE CREATION
The Trumpet Curves were developed in accordance with IEC 601-2-24, dated 1998, which
defines data collection and manipulation methods.
e The Trumpet Curves were created in the following manner:
* Fluid from the Outlook is collected at the set flow rates over a defined time period.
・
Every 30 seconds, the cumulative weight of the fluid is recorded.
*
The data from the second hour of delivery (show as T1 here) are divided into
observation windows and the average flow rate accuracy within those windows is
calculated.
*
The maximum positive and negative flow rate accuracy values (as they deviate from
the set rate) are then picked out of the thirty accuracy values and plotted on the curve at
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