Navy Experimental Diving Unit NEDU TR 03-21

321 Bullfinch Rd. December 2003

Panama City, FL 32407-7015

EVALUATION OF INTRAVENOUS THERAPY DEVICES IN THE

HYPERBARIC CHAMBER

Navy Experimental Diving Unit

Authors: D. F. Stanga DISTRIBUTION STATEMENT A:

HMC / SCW / DSW Approved for public release;
Principal Investigator distribution is unlimited.
 REPORT DOCUMENTATION PAGE
1a. REPORT SECURITY CLASSIFICATION 1b. RESTRICTIVE MARKINGS
Unclassified
2a. SECURITY CLASSIFICATION AUTHORITY 3. DISTRIBUTION/AVAILABILITY OF REPORT
DISTRIBUTION STATEMENT A: Approved for public release;
distribution is unlimited.
2b. DECLASSIFICATION/DOWNGRADING AUTHORITY

4. PERFORMING ORGANIZATION REPORT NUMBER (S) 5. MONITORING ORGANIZATION REPORT NUMBER(S)

NEDU TECHNICAL REPORT No. 03-21
6a. NAME OF PERFORMING 6b. OFFICE SYMBOL 7a. NAME OF MONITORING ORGANIZATION
ORGANIZATION (If Applicable)
Navy Experimental Diving Unit 02
6c. ADDRESS (City, State, and ZIP Code) 7b. ADDRESS (City, State, and Zip Code)
321 Bullfinch Road, Panama City, FL 32407-7015
8a. NAME OF FUNDING 8b. OFFICE SYMBOL 9. PROCUREMENT INSTRUMENT IDENTIFICATION
SPONSORING ORGANIZATION (If Applicable) NUMBER

BUMED 6.4
8c. ADDRESS (City, State, and ZIP Code) 10. SOURCE OF FUNDING NUMBERS
PROGRAM PROJECT TASK WORK UNIT ACCESSION
2300 E. Street N.W., Washington D.C. 20372-5300 ELEMENT NO. NO. NO. NO.
FT00-10

11. TITLE (Include Security Classification)

EVALUATION OF INTRAVENOUS THERAPY DEVICES IN THE HYPERBARIC CHAMBER

12. PERSONAL AUTHOR(S)

DARYL F. STANGA, HMC /DSW /SCW , USN

13a. TYPE OF REPORT 13b. TIME COVERED FROM 14. DATE OF REPORT (MMM/YYYY) 15. PAGE COUNT
Technical Report 2001 to 2003 December 2003 12
16. SUPPLEMENTARY NOTATION

17. COSATI CODES 18. SUBJECT TERMS (Continue on reverse if necessary and
identify by block number)
FIELD GROUP SUB-GROUP Hyperbaric chamber, safe intravenous pump (IV), medical
equipment

19. ABSTRACT:
Ventilators, cardiac monitors, intravenous (IV) pumps, and other equipment are being evaluated to meet a U.S.
Navy–identified need to improve patient care levels in the hyperbaric environment. Though the MTP MILITARY is
currently the only IV pump that has been found suitable for use in the hyperbaric chamber, a search of the
market has identified three pumps that afford increased capability for patient care. This report presents
results from a series of tests conducted to increase the IV pump options available to commands operating
hyperbaric chambers. The pumps evaluated each have capabilities that may make them appealing in different
operational scenarios.

20. DISTRIBUTION/AVAILABILITY OF ABSTRACT 21. ABSTRACT SECURITY CLASSIFICATION

¦ ¦ UNCLASSIFIED/UNLIMITED ¦X¦ SAME AS RPT. ¦ ¦ DTIC USERS Unclassified

22a. NAME OF RESPONSIBLE INDIVIDUAL 22b. TELEPHONE (w/Area Code) 22c. OFFICE SYMBOL

NEDU Librarian (850) 230-3100

i
 CONTENTS

Page

Report Documentation Page.............................................................................. i

Contents ............................................................................................................... ii

SECTION:

Introduction ........................................................................................................... 1
Methods ................................................................................................................. 1
General............................................................................................................ 1
Experimental Design and Analysis.............................................................. 1
Equipment and Instrumentation................................................................... 3
Results ................................................................................................................... 3
Discussion............................................................................................................. 5
Conclusions/Recommendations ........................................................................ 6
References ............................................................................................................ 9

ii
 INTRODUCTION

Since the U.S. Navy has identified a need to improve its level of patient care in
hyperbaric environments, ventilators, cardiac monitors, intravenous (IV) pumps, and
other equipment are being evaluated to meet this need.

The only IV pump currently found suitable for use in the hyperbaric chamber is the
MTP® Military Transport Infusion Pump (Medical Technology Products, Inc.; Huntington
Station, NY). After researching the market and contacting several clinical hyperbaric
facilities, the Navy Experimental Diving Unit (NEDU) has identified three intravenous
pumps with features that may provide fleet commands with options that meet their
varied needs: the IMED Gemini PC-1®, the ALARIS Medsystem III® , and the Infusion
Dynamics Power Infuser. This report presents test results on and documents the safety
and performance of these three pumps, and, on those bases, evaluates what and how
each might contribute to fulfilling Navy needs for such units in hyperbaric settings.

METHODS

GENERAL

Testing was conducted both on the surface and at various depths in the NEDU
treatment chamber. The units were reviewed in several phases to evaluate their

1. technical information,
2. physical characteristics,
3. surface functioning at atmospheric pressure, and
4. test depth functioning.

EXPERIMENTAL DESIGN AND ANALYSIS

Following a search of military and civilian organizations to identify standards for

operating ventilators in a hyperbaric chamber, the U.S. Navy Diving and Manned
Hyperbaric System Safety Certification Manual was found to define such standards for
U.S. Navy hyperbaric chambers.1 The National Fire Protection Association (NFPA), in
its NFPA 99 Health Care Facilities, also provides standards for electronic devices used
in oxygen-enriched environments,2 a standard specifying current flows for operating
medical devices in O2-enriched environments.

Test Parameters

1. To determine whether the pumps could be safely exposed in the hyperbaric

environment, NEDU engineers inspected the units per NFPA 99 and the U.S.
Navy Diving and Manned Hyperbaric System Safety Certification Manual.1,2

1
 2. Unmanned pressure testing to a depth of 247 feet of seawater (fsw) was
conducted to ensure that increased pressures would not damage electrical
components of the units. Results were documented and reviewed.

3. If a unit had an internal battery, that battery was tested per NEDU Test Plan
01-23.3

4. Function testing was conducted on the surface to establish unit operating

characteristics and baseline operating parameters. The following
measurements of pump function and settings were taken:

For the ALARIS Medsystem III® and the IMED Gemini PC-1®

a. Flow rate at 20 mL/h (KVO), with total volume 20 mL

b. Flow rate at 100 mL/h, with total volume 100 mL

c. Flow rate at 400 mL/h, with total volume 400 mL

For the Infusion Dynamics Power Infuser*

a. Flow rate at 200 mL/h, with total volume 200 mL

b. Flow rate at 1000 mL/h, with total volume 1000 mL

c. Flow rate at 2000 mL/h, with total volume 2000 mL

* The Power Infuser is designed as a high-volume rehydration pump and

cannot be set to the levels of the other two pumps.

5. The IV pumps and calibrated containers were set up in the NEDU treatment
chamber, and results from the parameter settings were recorded at 30, 60,
and 165 fsw.

Test Parameters at Treatment Depths in the Chamber

On the surface, the IV pumps were set at one setting within their operating ranges. The
chamber was then compressed to 30, 60, and 165 fsw. Upon reaching each depth, the
inside tender monitored the units for one hour and measured each pump’s outp ut in the
calibrated cylinders. Each test was repeated four times at each setting at each depth,
and all results were recorded and reviewed.

2
EQUIPMENT AND INSTRUMENTATION

- Infusion Dynamics Power Infuser

- ALARIS Medsystem III®
- IMED Gemini PC-1®
- Three (3) 1000-mL calibrated cylinders
- NEDU treatment chamber

RESULTS

The batteries, tested per NEDU Test Plan 01-23, were found to be safe. Their
discharge times are listed in Table 1.

Table 1.
Operation after 24-hour charge
Pump Predive Duration Postdive Duration
IMED Gemini PC-1® 7 hours, 30 minutes 8 hours, 10 minutes
ALARIS Medsystem III® 8 hours, 10 minutes 8 hours, 0 minutes
Power Infuser 10 hours, 15 minutes N/A

The pumps were set up in the NEDU treatment chamber and operated at the specified
settings (see EXPERIMENTAL DESIGN AND ANALYSIS, Test Parameters, 4), and
pump outputs were measured and documented as shown in Table 2.

Table 2.
Pump output volume as measured by calibrated cylinder
IMED Gemini DEPTH SETTING cycle 1 cycle 2 cycle 3 cycle 4 Standard
PC-1® (fsw) Deviation
0 20 mL/h 20 mL 20 mL 21 mL 20 mL 0.5
30 20 mL/h 20 mL 20 mL 20 mL 20 mL 0
60 20 mL/h 22 mL 22 mL 20 mL 20 mL 1.15
165 20 mL/h 20 mL 20 mL 20 mL 24 mL 2.0

0 100 mL/h 100 mL 102 mL 100 mL 100 mL 1.0

30 100 mL/h 100 mL 102 mL 102 mL 102 mL 1.0
60 100 mL/h 102 mL 102 mL 102 mL 102 mL 0
165 100 mL/h 103 mL 104 mL 104 mL 100 mL 1.90

0 400 mL/h 410 mL 405 mL 400 mL 415 mL 6.45

30 400 mL/h 430 mL 425 mL 415 mL 425 mL 6.29
60 400 mL/h 425 mL 415 mL 425 mL 425 mL 5.0
165 400 mL/h 400 mL 410 mL 412 mL 446 mL 20.03

3
 ALARIS DEPTH SETTING cycle 1 cycle 2 cycle 3 cycle 4 Standard
®
Medsystem III (fsw) Deviation
0 20 mL/h 20 mL 19 mL 20 mL 20 mL 0.5
30 20 mL/h 19 mL 20 mL 20 mL Alarm 0.58
60 20 mL/h 22 mL 20 mL 20 mL 20 mL 1.0
165 20 mL/h 20 mL 20 mL 20 mL 20 mL 0

0 100 mL/h 102 mL 102 mL 100 mL 102 mL 1.0

30 100 mL/h 100 mL 100 mL 100 mL 100 mL 0
60 100 mL/h 102 mL 100 mL 102 mL 102 mL 1.0
165 100 mL/h 102 mL 104 mL 100 mL 104 mL 1.91

0 400 mL/h 405 mL 410 mL 405 mL 405 mL 2.5

30 400 mL/h 400 mL 400 mL 410 mL Alarm 5.77
60 400 mL/h 410 mL 415 mL 425 mL 425 mL 7.5
165 400 mL/h 420 mL 410 mL 400 mL 412 mL 8.23

Power Infuser DEPTH SETTING cycle 1 cycle 2 cycle 3 cycle 4 Standard

(fsw) Deviation
0 200 mL/h 206 mL 208 mL 210 mL 198 mL 5.26
30 200 mL/h 168 mL 189 mL 184 mL 170 mL 10.34
60 200 mL/h 205 mL 198 mL 210 mL 200 mL 5.38
165 200 mL/h 200 mL 200 mL 200 mL 200 mL 0

0 1000 mL/h 890 mL 890 mL 950 mL 950 mL 34.64

30 1000 mL/h 1015 mL 1000 mL 1020 mL 1000 mL 10.31
60 1000 mL/h 910 mL 910 mL 920 mL Alarm 5.77
165 1000 mL/h 950 mL 960 mL 940 mL 960 mL 9.57

0 2000 mL/h 2000 mL 2050 mL 1990 mL 2000 mL 27.08

30 2000 mL/h 2050 mL 1980 mL 1850 mL 1900 mL 88.13
60 2000 mL/h 1925 mL 2000 mL 2050 mL 1870 mL 79.62
165 2000 mL/h 1950 mL 1800 mL 1700 mL 1820 mL 102.75

4
 DISCUSSION

Technical review of supporting documentation for each of the three IV pumps found no
components that caused significant concern about their use in the hyperbaric chamber.
When batteries were removed and evaluated, all were found to be safe and functional.
The IMED Gemini PC-1® and the ALARIS Medsystem III® pumps were placed on their
respective chargers for 24 hours to ensure that their batteries were fully charged. The
Power Infuser operates on AAA batteries, which already are authorized for chamber use
and do not require charging.

Each pump was operated until its battery discharge was low enough to cause a low
power alarm. The pumps were then pressurized 11 times, after which they were
reexamined. The IMED Gemini PC-1® and ALARIS Medsystem III® batteries were
recharged and operated until a low power alarm was given (see Table 1).

During testing at depth, low power alarms from the IMED Gemini occurred on two
occasions. Once, 30 minutes into the fourth cycle of 100 mL/h at 30 fsw, the alarm
sounded, but the pump continued to operate until the end of the test, with no apparent
change in the flow rate. The unit had been in operation for five hours at the time of this
alarm. The second alarm occurred 45 minutes into the fourth cycle of 11 mL/h at 60
fsw; again, the pump completed the cycle with no change in its flow rate.

To assess the functional characteristics and establish the performance accuracy of the
units, each IV pump was operated at the surface. As the results of Table 2 show, the
Power Infuser is designed as a rehydration pump and is unable to deliver the small
volumes that the other pumps can. The ranges set during the testing represent low-,
mid-, and high-output ranges for each of the pumps.

Once the accuracy of the pumps was established, the chamber was compressed to 30
fsw, and the pumps were operated through four one-hour runs at each of the given drip
rates. The amounts collected in their calibrated cylinders were measured, and these
cylinders were emptied at one-hour intervals. After the cycles at 30 fsw were
completed, the chamber was compressed to 60 fsw, and all tests were repeated.
Because of concerns about the decompression status for the inside tenders, the first
cycles were for one hour, and the following three cycles at 165 fsw were shortened to
30 minutes, with the measured volume then doubled for charting purposes.

5
 CONCLUSIONS/RECOMMENDATIONS

All three pumps completed all testing with satisfactory results. Each of the three units
has particular features that address specific needs:

Infusion Dynamics Power Infuser. This small (9.8 cm x 7.0 cm x 5.0 cm), light
(330-g) infusion pump powered by six AAA batteries rated to last approximately
eight hours under typical operation can deliver fluids at rates from 0.2 to 6.0 L/h.
It uses a scuttle mechanism pump and can deliver fluids to the patient even when
the bag and unit are level with or below the patient. Tested by the U.S. Army, the
Power Infuser is certified for air medivac use4,5 and is well adapted to facilities
and units with limited available space, particularly to commands with
transportable recompression chamber systems (TRCS). Its small size allows the
unit to meet space limitations of deploying units. Medications, however, cannot
be delivered by this unit: the filter system in its infusion set will easily clog if any
substance other than IV solution is passed through it.

Infusion Dynamics Power Infuser

6
ALARIS Medsystem III®. This medium-sized unit (20.0 cm x 15.2 cm x 5.3 cm)
weighs 1828 g and is powered by a nickel cadmium battery with an expected
operating time of six hours or more when all three channels are operating. As a
hospital intensive care–level IV pump, the Medsystem III can deliver three
different medications or solutions simultaneously and can do so with great
precision, at rates from 0.01 to 9.9 L/h. Its dose rate calculation function is also
capable of delivering complex doses of medication. The pump is sensitive to air
in the lines, however, and is often difficult to clear and restart if air or occlusions
cause alarms to resound. This unit is a good choice for a hospital-based
chamber expected to treat patients with multiple and complex medical problems.

ALARIS Medsystem III®

7
IMED Gemini PC-1®. As a large unit (8.4 inches x 10.8 inches x 6.5 inches)
weighing 11.2 lb, this pump is rugged and versatile. Under normal rates of
operation, an internal lead acid battery can power the Gemini for five hours. This
unit, which is simple to operate and the least expensive of the pumps tested, can
deliver fluids and medications at rates from 0.01 to 9.9 L/h. As a hospital-level
pump with enough resilience to be transported to remote locations and into
adverse conditions, it is well suited for multifunction hyperbaric treatment units.
The pump worked well in all attitudes, both above and below the patient, and
since it has been used extensively in military medical facilities throughout the
world, most military healthcare providers as well as established biomedical repair
and maintenance personnel are familiar with it.

IMED Gemini PC-1®

8
 REFERENCES

1. Naval Sea Systems Command, U.S. Navy Diving and Manned Hyperbaric System
Safety Certification Manual, Publication SS800-AG-MAN-010/P-9290 (Arlington,
DC: NAVSEA, 1998).

2. National Fire Protection Association, NFPA 99 Health Care Facilities (Quincy, MA:
NFPA, 2002.

3. R. R. Lowe, D. F. Stanga, and G. Conley, Unmanned Evaluation of Batteries for Use

in Hyperbaric Chambers, NEDU TP 01-23, Navy Experimental Diving Unit,
November 2001.

4. Commander, U.S. Army Medical Materiel Agency, memorandum, Aeromedical

Certification of the Infusion Dynamics Power Infuser Model 100B-3A for the
MEDEVAC UH-60A Helicopters, MCMR-UAD (70-45a), dtd 10 Jul 2002.

5. D. R. Mandel, Testing and Evaluation for the Infusion Dynamics Power Infuser, Final
Report, U.S. Air Force 311th Human Systems Program Office/YAML, April 2003.