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Attachment A: Baxter Infusion Pumps – Operator’s Manual Excerpts Product Family Colleague
Operator’s Manual Excerpts Page 8-9: WARNING There is a risk of under-infusion if a downstream occlusion occurs while an air bubble, 1.9 cm (0.75 inch) or larger, is within the pumping mechanism between the upstream occlusion sensor and the downstream occlusion sensor, but not under the Air in Line sensor. In this particular situation, the pump may not detect air in the line or the downstream occlusion and may continue to pump without delivering medication or alarming. Page 9-3: Technical Specifications Component Nominal Downstream Occlusion Values for Alarm
EVO IQ LVP
Description Downstream Occlusion Alarm sensitivity is a configurable option. Rate range in mL/hr <21 21-200 >200 103 mmHg (2 psig) 258 mmHg (5 psig)
207 mmHg (4 psig) 414 mmHg (8 psig)
310 mmHg (6 psig) 569 mmHg (11 psig)
465 mmHg (9 psig)
620 mmHg (12 psig)
775 mmHg (15 psig)
Minimum Moderate Maximum
Page 9-7: WARNING 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. Page 1-6: Compatible IV Sets Use of unapproved administration sets can impact the delivery of an infusion. Unapproved sets can cause inaccuracy to properties of an infusion including, flow rate, occlusion detection, or air in line detection.
Page A-8: Flow Rate Range Accuracy 0.1 – 100 mL/h ±5%* 100.1 – 1200 mL/h ±7.5%* *For any one hour period or 0.5 ml delivery (whichever is larger in volume), over 72 hours or maximum 3 liters (maximum vlume recommended over a continuous infusion) at least 85% of the observed values (95% confidence) will lie within the limits shown for the indicated settings. Standard conditions: • Ambient temperature: 22°C ± 2°C (71.6°F ±3.6°F) • Solution container height: ±508 mm (+20 inches), ±50 mm (±1.97 inches) • Distal positive pressure: 0 mmHg
The Evo IQ Large Volume Pump will maintain a flow rate volumetric accuracy as listed in table above, when used at the standard environmental conditions as described. The Evo IQ Large Volume Pump should be used at standard conditions whenever possible. If used at non-standard environmental conditions that extend beyond the standard environmental conditions as described above, the flow rate volumetric accuracy may deviate beyond the nominal flow rate volumetric accuracy. The impact of back pressure and environmental temperature on flow rate accuracy is shown in Table A-12 on page A-7 with result based on 25 mL/h flow rate. Page A-9:
FA-2021-008
Baxter is a registered trademark of Baxter International Inc.
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Attachment A: Baxter Infusion Pumps – Operator’s Manual Excerpts Time to detect a Downstream Occlusion and a Bolus Volume release will generally increase under the following conditions: longer distances to the occlusion point, additional fluid volumetric area (from filter or other components within the IV set length), hotter room temperatures and higher Downstream Occlusion Pressure Thresholds or Limits.
EVO IQ SRY
Page 1-7: CAUTION Use only administration sets that have an appropriate pressure rating that is greater than the Occlusion Detection setting chosen for the infusion. This may be indicated by the P symbol on the administration set labeling as defined by standard ISO 8536-9, Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment. The accuracy claim in Evo IQ SYR IFU related trumpet curve are made through clearly demonstration of set that was used to obtain the accuracy curve. The impact of distal back pressure on flow rate accuracy was demonstrated in Table A-13. Page A-11: Note Occlusion alarm pressure, alarm delays, and bolus volume may vary depending on test conditions, temperature, and occlusion tube length. Operating the device above the standard test temperature or with longer IV set lengths will cause the time to occlusion alarm to increase.
FA-2021-008
Baxter is a registered trademark of Baxter International, Inc.
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