ATP-1185-501

NASA CR-TEST REPORT

FLUID INFUSION SYSTEM

(NASA-CR-141565) FLUID INFUSION SYSTEM N75-15904(Beckman Instruments, Inc., Anaheim, Calif.)15 p HC $3.25 CSCL 20D

Unclas-- _. .G3_/3_ _Q89A_ .. _.

December 17, 1974

National Aeronautics and Space AdministrationLyndon B. Johnson Space Center

R&T Procurement BranchHouston, Texas 77058

BeckmanO INSTRUMENTS, INC.

SADVANCED TECHNOLOGY OPERATIONS

co ANAHEIM, CALIFORNIA 92806

CONTENTS

PARAGRAPH PAGE

1.0 INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . 1

2.0 ENGINEERING TESTING . . . . . . . . . ... .. . . . . . 12.1 Flow Tests . . . . . . . . . . . . . . . . . . . . . . . 12.1.1 Breadboard Flow Tests . . . . . . . . . . . . . . . . . . 12.1.2 Prototype Flow Testing. . ............... . 22.2 Bubble Alarm Tests. . .................. 72.3 Pneumatic System Performance. . ............. 7

3.0 ACCEPTANCE TESTING. . ....... .......... ... 73.1 Flow Tests . . . . . . .. . . . . . . . . . . . . . . . 73.2 Animal Testing. . .. .. . .. .... . . .... .. .. . 9

APPENDIX: ACCEPTANCE TESTING DATA SHEETS

ATPPAG 85-LA501 NOT-ii-

ATP-1185-501 -ii-

1.0 INTRODUCTION

This report describes and summarizes performance testing carried out in the

development of the prototype zero-g fluid infusion system under NASA-JSC

Contract NAS9-14080. Engineering tests were performed in the course of

development, both on the original breadboard device and on the prototype

system. This testing was aimed at establishing baseline system performance

parameters and facilitating improvements. Acceptance testing was then per-

formed on the prototype system to verify functional performance. Acceptance

testing included a demonstration of the fluid infusion system on a laboratory

animal.

2.0 ENGINEERING TESTING

The procedures followed and the results obtained in engineering tests are

described in sections 2.1 through 2.3.

2.1 Flow Tests

2.1.1 Breadboard Flow Tests

The most important system performance parameter is accuracy of flow regulation.

Early in the program, tests were made to establish the flow characteristics

produced by the currently most widely used technique--declining hydrostatic

head--and the ideal situation of constant fluid pressure applied uniformly

over the entire bag exterior. A pressure infusor currently available off

the shelf was also tested.

The technique used for measuring flow rate was simply timing the delivery into

a graduated cylinder. The volume increment used for this purpose was 5 ml for

low flow rates (5 ml/min. nominal), and 50 ml for higher flow rates (50 to 100

ml/min. nominal). Experimental accuracy inherent in this method is on the

order of 2 to 3 percent.

ATP-1185-501 -1-

Results of the early investigations are shown in Figures 1 and 2. The measured

flow rates (Figure 1) and the measured liquid pressure (Figure 2) in the bagsare shown as functions of the cumulative liquid volume expressed from the bag.

Figure 1 shows two useful baselines. Curve (1) represents a practical ideal--

flow is constant except for secondary effects due to elasticity of the fluid

bag walls. Curve (2) represents the results obtained ih current every-daypractice, and shows the substantial decline in flow rate that occurs as the

contents of a fluid bag are delivered. Figure 2 shows the flow curves obtained

from two devices: the hand-pumped Fenwal pressure infusor, and the original

Beckman breadboard fluid infusion system. A factor common to both was the fact

that the pneumatic pressure in the device was held constant and it was assumed

that this would result in constant liquid pressure. The curves show that this

was not the case, however. The Fenwal device did a better job of producing

constant flow because of the more conformal nature of the device-to-fluid bag

interface. Contact area between bag and pressure plate in the original bread-

board was highly variable, and this resulted in a severe decline in flow.

Discovery of this effect led to a new conceptual design that was embodied in

the prototype fluid infusion system.

2.1.2 Prototype Flow Testing

The superior pneumatic design adopted for the prototype system avoided the gross

flow rate errors noted previously. Large flow anomalies were sometimes noted in

the prototype engineering tests; however, these were associated with failure

modes rather than inherent deficiencies of the design, and they were eliminated.

One effect that was found to be systematic, however, was a slow decay in flow

at the lower flow rates. This is believed due to elasticity and dimensional

stability effects in the flexible tubing. No other consistent effects were

noted, and it was found possible to produce a constant flow within +8% at the

lower flow rates and ±5% at the higher flow rates. Some representative flow

curves obtained in engineering tests of the prototype system are shown in

Figures 3 and 4.

ATP-1185-501 -2-

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2.2 Bubble Alarm Tests

Tests were conducted to establish the operating threshold of the bubble/no

flow alarm on the modified Carolina Medical Electronics blood flowmeter. Air

bubbles were injected into the fluid stream through the septum of the drug

injection port using a microsyringe. Bubbles of measured size were injected,

and a determination made as to the size bubble that would always trip the

alarm, and the size that would trip the alarm about 50% of the time. At the

higher flow rates, a larger bubble is required for an alarm due to shorter

residence time in the flow probe. Results were as follows:

Nominal Flow Bubble Size for 0.5 Bubble Size for 1.0.Rate Alarm Probability Alarm Probability

5 ml/min. .02 ml .03 ml50 ml/min. .08 ml 0.1 ml

100 ml/min. .20 ml 0.25 ml

2.3 Pneumatic System Performance

The CO2-powered pneumatic system was proven out in initial operation of the

prototype system. No basic problems of gas bottle icing, materials compati-

bility, etc., were found. The ability of one 25-gram CO2 bottle to power the

system through a useful number of bag evacuations was verified by test. The

lower limit on usable CO2 bottle pressure was found to be 500 psi--i.e., if

bottle pressure is not at or above that pressure, a 2-bag run cannot be under-

taken with assurance that there will be enough gas in the system to complete

the run. The 25-gram bottle was found to consistently supply enough gas for

eight complete runs; i.e., to infuse a total of sixteen 500-ml fluid bags.

3.0 ACCEPTANCE TESTING

Acceptance testing of the unit was performed to demonstrate the performance

of the system and its suitability for clinical use.

3.1 Flow Tests

Flow tests were repeated using the engineering flow test procedures.. The

results obtained are shown in Figure 5, and test data sheets are in the

PRECEDING PAGE BLANK NOT FILMED

FR-1185-101 -7-

Appendix. The flow rate was adjusted upward on the low flow run once steady

low flow had been demonstrated.

3.2 Animal Testing

Use of the unit in a clinical environment was demonstrated by infusion of

750 ml of normal saline solution into a laboratory animal. The system was

operated normally, with complete delivery from the first bag and automatic

switching to the second bag. Flow rates over the entire range were selected

during the infusion, with the blood flowmeter being used to monitor flow rate.

The test was completed successfully.

PRECEDING PAGE BLANK NOT FILMED

FR-1185-101 -9-

APPENDIX

ACCEPTANCE TESTING DATA SHEETS

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