Operators Manual Addendum
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COLLEAGUE Infusion Pump Operator’s Non-DeHP Manual Addendum
Chapter 1
Indications For Use The purpose of this addendum to the COLLEAGUE Volumetric Infusion Pump Operator's Manual is to:
Add the Volumetric Accuracy performance when the Colleague P1.7 infusion pump is used with Non-DeHP sets.
Add the deviations at 25 mL/hr from the accuracy stated per the requirements of Sub-clause 50.102 of IEC 60601-2-24 Part 2 when the Colleague P1.7 infusion pump is used with Non-DeHP sets.
Add the start-up graphs and trumpet curves for Non-DeHP set at 1 mL/hr and 25 mL/hr flowrate.
Note:
Store this addendum with your Operator's Manual. The Operator's Manual is incomplete without this addendum.
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COLLEAGUE INFUSION PUMP OPERATOR’S MANUAL ADDENDUM
Original Release 2021-04-15 1
Volumetric Accuracy of the System
Volumetric Accuracy of the System The pump, using the administration sets identified in the Colleague Operator's Manual & Colleague non-DeHP Compatible Sets List, maintains a Volumetric Accuracy as presented in Table 1: Table 1 Flow Rate Range
Volumetric Accuracy DeHP Accuracy
Non-DeHP Accuracy
0.1 to 0.9 mL/hr
±10%*
±15%*
1.0 to 9.9 mL/hr
±7%**
±12%**
10.0 to 800 mL/hr 801 to 1000 mL/hr
±10%** ±5%**
1001 to 1200 mL/hr
±15%*** Not approved for use
*For any one-hour period or for 0.5 mL of delivery. At least 90% of the observed values (95% confidence) will lie within the limits for the indicated settings. **For any one-hour period over 72 hours or 7.2 L, whichever occurs first. At least 90% of the observed values (95% confidence) will lie within the limits for the indicated settings. ***For any one-hour period over 3 hours. At least 80% of the observed values (95% confidence) will lie within the limits for the indicated setting.
Standard conditions:
Ambient temperature: 23°C ±2°C
Solution container height: +508 mm (+20 inches)
Test solution: Distilled water
Distal positive pressure: 0 mmHg
Needle: 18 gauge
Set Type: • DeHP: 2C8537S • Non-DeHP: FNC3220N, 2H8537, EMC9608, AMC9667, MRC1012P, ABC1499
Note that flow fluctuations can be caused by unusual conditions or combinations of conditions that may involve, but are not limited to, the following: position of the infusion container, fluid density, positive and negative pressure and the environment. Flow fluctuations are most likely to occur when the conditions mentioned above are exacerbated or when the pump is operated in conditions outside of its normal limits. Table 2 documents deviations at 25 mL/hr from the accuracy stated above per the requirements of Sub-Clause 50.102 of IEC 60601-2-24 Part 2.
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COLLEAGUE INFUSION PUMP OPERATOR’S MANUAL ADDENDUM
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Volumetric Accuracy of the System
Table 2
Accuracy Information Maximum Deviation** (DeHP)
Average Deviation (Non-DeHP)
Maximum Deviation** (Non-DeHP)
Variable
Condition
Average Deviation (DeHP)
Back Pressure
-100 mmHg
4.1%
6.9%
3.4%
9.3%
100 mmHg
-3.0%
5.8%
-3.3%
11.8%
300 mmHg
-6.9%
11.6%
-11.2%
14.8%
Solution Container Height
-500 mm
-1.8%
3.8%
-2.1%
5.3%
Temperature*
15° C
3.6%
8.2%
2.4%
6.8%
38° C
-0.3%
3.0%
-1.5%
6.9%
*Not required by standard **At least 90% of the observed values (95% confidence) will lie below the limits shown (worst case of 2-sided limits) for the indicated settings, represented as absolute values.
Each deviation is tested by using the standard test condition holding the other variables constant.
! WARNING !
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Rate accuracy can be affected by variations of fluid viscosity, fluid temperature, head height, or back pressure, or any combination thereof. Additional factors that may influence rate accuracy are administration set configuration and the duration of time the administration set is used.
COLLEAGUE INFUSION PUMP OPERATOR’S MANUAL ADDENDUM
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Accuracy Tests
Accuracy Tests Tested per Sub-clause 50.102 of IEC 60601-2-24 Part 2. Tested at 1 mL/hr SET CODE: EMC9608
Figure 1 Delivery Startup, First Two Hours, 1 mL/hr
Figure 2 Trumpet Curve, 2nd Hour of Delivery, 1 mL/hr
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COLLEAGUE INFUSION PUMP OPERATOR’S MANUAL ADDENDUM
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Accuracy Tests
Figure 3 Flow Accuracy, 72nd Hour, 1 mL/hr
Figure 4 Trumpet Graph, 72nd Hour of Delivery, 1 mL/hr
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Accuracy Tests
Tested at 25 mL/hr SET CODE: EMC9608
Figure 5 Delivery Startup, First Two Hours, 25 mL/hr
Figure 6 Trumpet Graph, 2nd Hour of Delivery, 25 mL/hr
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Accuracy Tests
Figure 7 Flow Accuracy, 72nd Hour, 25 mL/hr
Figure 8 Trumpet Graph, 72nd Hour of Delivery, 25 mL/hr
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COLLEAGUE INFUSION PUMP OPERATOR’S MANUAL ADDENDUM
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Accuracy Tests
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COLLEAGUE INFUSION PUMP OPERATOR’S MANUAL ADDENDUM
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