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ABSTRACT
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INTRODUCTION
As of this writing, hyperbaric facilities in the United
States do not have U.S. Food and Drug Administration
(FDA)-cleared large-volume infusion pumps for use
with monoplace or multiplace chambers. However,
patients receiving hyperbaric oxygen (HBO2) therapy
may require intravenous (IV) infusions during their
hyperbaric chamber sessions to support clinical care [1],
which might include crystalloid or antibiotics, or in the
case of critically ill patients, norepinephrine, vasopressin,
dobutamine, insulin, to name a few. To meet these
patient needs, the hyperbaric medicine facility ideally
should select, test, and approve a pump appropriate to
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KEYWORDS: hyperbaric oxygenation, intravenous infusion, hyperbaric oxygen therapy, drug infusion system
UHM 2016, Vol. 43, No. 1 THREE INFUSION PUMPS FOR MONOPLACE CHAMBERS
Facilities in the United States with monoplace
hyperbaric chambers have used the IVAC 530 (IVAC
Corporation, San Diego, California), the Hospira (formerly Abbott) Lifecare Hyperbaric Pump (Hospira,
Chicago, Illinois), and the Baxter Flo-Gard 6201
(Baxter Healthcare Corporation, Deerfield, IL) [1214]. Of these pumps, only the Lifecare Hyperbaric was
cleared by the FDA for hyperbaric chamber use, and
only the Flo-Gard 6201 is currently available (secondhand and unsupported by the manufacturer). For
monoplace chamber use, the Baxter Flo-Gard 6201
downstream occlusion setting must be increased for
hyperbaric operation [12].
In 2008, FDA cleared the Hospira Plum A+ Hyperbaric infusion pump for monoplace and multiplace use.
Hospira retired this device in 2014 and stopped selling
the associated infusion sets a few months later [15].
Following the pumps retirement, we searched for an
FDA-cleared infusion pump that could be used with
monoplace chambers.
We contacted ECRI Institute (Plymouth Meeting,
Pennsylvania, formerly, Emergency Care Research
Institute) for large-volume infusion pumps options with
configurable downstream occlusion settings. ECRI
Institute suggested the Z-800F (Zyno Medical LLC,
Natick, Massachusetts) and provided contact information for the pump manufacturer. We also learned that
a hyperbaric facility in Europe used the CME 323
Bodyguard Color Vision infusion pumps (Caesarea
Medical Electronics, Caesarea, Israel) with monoplace
chambers, although this pump is not yet FDA-cleared
for marketing in the United States. We evaluated
the performance of these two infusion pumps with
monoplace chambers, along with the Flo-Gard 6201
under a variety of infusion conditions.
METHODS
After the candidate pumps were identified, we contacted the pump manufacturers to request the loan of
equipment for testing. Both manufacturers agreed to
loan a pump and provide infusion sets for this testing.
Caesarea Medical Equipment also provided the proprietary software for management of the occlusion
setting. The Baxter Flo-Gard 6201 was used from our
own stock. The tested pumps, specifications and FDA
clearance status are presented in Table 1. ECRI In-
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FDA 510(K)
Specifications
Baxter Healthcare
Corporation
Deerfield, Illinois
K915522
Pump type
linear peristaltic
Pump tested
Flo-Gard 6201
Not currently
manufactured or
supported but infusion
sets are available
Flow rate
0.1-99.9 mL/hr in 0.1 mL increments
1-9999 mL/hr in 1 mL increments
Free-flow protection
set-based
Configurable occlusion setting
approximately 6-17 psig
occlusion setting can be mechanically
reset to >30 psig
Battery type
12 Volt, 2.0 Ah sealed lead-acid
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Caesarea Medical
Electronics
Caesarea, Israel
No FDA 510(K)
at this time
Pump type
piston pump
Pump tested
Body Guard 323
Color Vision CE
Flow rate
0.1-99.9 mL/hr in 0.1 mL increments
1-9999 mL/hr in 1 mL increments
Free-flow protection
set-based
Configurable occlusion setting
100 to 2000 mmHg
Battery type
rechargeable Li-polymer 7.4v or
two 9v alkaline battery pack
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K130690
Not cleared for
hyperbaric use
Pump type
linear peristaltic
Flow rate
1-1200 mL/hr in 1 mL increments
Free-flow protection
set-based
Configurable occlusion setting
4 to 30 psig
Battery type
rechargeable nickel-metal-hydride
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UHM 2016, Vol. 43, No. 1 THREE INFUSION PUMPS FOR MONOPLACE CHAMBERS
tention from back pressure [11, 12]. The CME infusion
set did not allow for this option, and that tubing ran the
full length from the pump to the 3-way stopcock at the
chamber hatch. Infusion sets and tubing were changed
every 72 hours in accordance with hospital policy.
The IV tubing from each pump was connected to a hyperbaric IV extension kit (pass-through) (041600503A,
Argon Medical Devices, Athens, Texas), passed through
the hatch of a 32-inch monoplace hyperbaric chamber
(3200, Sechrist Industries, Anaheim, California) in the
standard fashion (Figure 1). The extension kit tubing
was then luer-locked into a collection manifold consisting of three three-way stopcocks (AG7934, ICU
Medical, San Clemente, California) attached to 3-, 5-,
10- and 50-mL syringes with the plungers removed
(BD, Franklin Lakes, New Jersey). Air in the lines was
removed and saline brought to the zero level using a
flush syringe (306546, BD, Franklin Lakes, New
Jersey) on each three-way stopcock.
We tested pump performance at a range of flow rates
(1-, 2-, 5-, 10- and 100-mL/hour) at ambient pressure
and 2, 2.4, and 3 atm abs (Table 2). The chamber was
pressurized at 5 psi/minute, and pressure was measured using a digital absolute pressure gauge (DPG1000B100PSIA5, Cecomp Electronics, Libertyville,
Illinois) [16]. Some runs included 15-30 minutes of data
collection at ambient pressure to verify pump performance under normal conditions (Table 2). For the 30-60
minute tests at 2.0-3 atm abs, we turned the pump off
before chamber decompression to assess tubing distension, but for the longer carbon monoxide hyperbaric
oxygen treatment profile runs (140 minutes) [19], the
pump was left running through decompression (Table 2).
We recorded the saline volume delivered to the syringe manifold inside the chamber. Actual volumes
delivered were averaged for each flow rate and time
point and compared to the volume expected to be
delivered based on the programmed flow rate.
RESULTS
We collected data for 70 trials at ambient pressure
(30 minutes each). The mean delivered volumes at
30 minutes were very near expected for all flow rates
(Table 3). While 24 of 70 trials were not within 5%,
our experiment was not set up to measure volumes
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UHM 2016, Vol. 43, No. 1 THREE INFUSIoN PUMPS FoR MoNoPlACE CHAMBERS
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normal
saline
Baxter Interlink
System Continu-o
Solution Set
2C6537s
Baxter
Flo-Gard 6201
Occlusion setting
>30 psig
normal
saline
CME Body
Guard 323
Color VisionTM
CME
Infusion Set
SAMPLE
Occlusion setting
2000 mmHg
normal
saline
Zyno 800-F
Zyno Medical
Administration Set
B2-70071-P
Occlusion setting
Congurable
up to 2.4 atm
Disabled at 3 atm
Argon Hyperbaric
IV Extension Kits
041600503A
3-way stopcock
with open,
zeroed syringe
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UHM 2016, Vol. 43, No. 1 THREE INFUSION PUMPS FOR MONOPLACE CHAMBERS
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test
profile
Start pump
Atmospheric pressure for 30 minutes
Compression to target pressure at 5 psi/min
3 atm reached at minute 36
2.4 atm reached at minute 35
Maintain target pressure to minute 60
Stop pump
Decompress chamber
data recorded at
0 minutes (atmospheric pressure)
10 minutes (atmospheric pressure)
20 minutes (atmospheric pressure)
30 minutes (atmospheric pressure)
40 minutes (target pressure)
50 minutes (target pressure)
60 minutes (target pressure)
After chamber decompression
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2 atm (29.4 psia)
Start pump
Compression to target pressure at 5 psi/min
2 atm reached at minute 4
Maintain target pressure to minute 60
Stop pump
Decompress chamber
100 mL/hr
2.4 atm (35.4 psia)
2 atm (29.4 psia)
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Start pump
Atmospheric pressure for 15 minutes
Compression to target pressure at 5 psi/min
2.4 atm reached at minute 20
2 atm reached at minute 18
Maintain target pressure to minute 30
Stop pump
Decompress chamber
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1 mL/hr
Carbon monoxide profile
Start pump
Compress to 3 atm at 5 psi/min
3 atm reached at minute 6
Maintain 3 atm to minute 70
Decompress to 2 atm at 4 psi/min
Maintain at 2 atm to minute 135
Decompress chamber at 2 psi/min
Stop pump
10 mL/hr
Carbon monoxide profile
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mean volume
infused, mL
(% of expected)
Baxter
CME
Zyno
5
4
5
0.5 (100)
0.5 (100)
0.5 (100)
Baxter
CME
Zyno
6
6
6
1.0 (100)
1.1 (110)
1.0 (100)
flow rate
pump
trials
mean volume
infused, mL
(% of expected)
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10
Baxter 4
CME 4
Zyno 4
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5.0 (100)
5.3 (107)
5.2 (103)
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(30-minute infusion interval). Mean volumes are rounded to 1 significant digit, as we were unable to measure more precisely than per 0.1 mL.
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Figure 2: Mean saline delivery at 1 and 2 mL/hour for each of 3 infusion pumps.
1 mL/hour 3 atm abs
During the 3-atm abs and 2.4-atm abs trials, the pumps ran at atmospheric pressure for 30 minutes, then the chamber
was compressed to the target pressure at 5 psi/minute. At Minute 60, the pumps were turned off, and the chamber was
decompressed. For the 2-atm abs trials, the pumps were turned on at chamber compression (5 psi/minute) and ran for
60 minutes. They were then turned off, and the chamber was decompressed.
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UHM 2016, Vol. 43, No. 1 THREE INFUSIoN PUMPS FoR MoNoPlACE CHAMBERS
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Figure 3: Mean saline delivery at 5 and 10 mL/hour for each of 3 infusion pumps.
5 mL/hour 3 atm abs
During the 3-atm abs and 2.4-atm abs trials, the pumps ran at atmospheric pressure for 30 minutes, then the chamber
was compressed to the target pressure at 5 psi/minute. At Minute 60, the pumps were turned off, and the chamber was
decompressed. For the 2-atm abs trials, the pumps were turned on at chamber compression (5 psi/minute) and ran for
60 minutes. They were then turned off, and the chamber was decompressed.
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1 mL/hour CO profile
10 mL/hour CO profile
during decompression [11, 12], even when rigid smallbore tubing was used. Saline delivery during this
present study was also negatively affected by tubing
compliance. As the chamber pressure increased, the
IV tubing expanded and the delivery of saline was
reduced. During decompression, as the chamber pressure decreased, the extra saline in the expanded tubing
was delivered as a bolus to the saline collection apparatus even though the pump was turned off. This
effect was observed even with the rigid, smallbore tubing in this study for two of the pumps
and would be magnified with standard IV tubing.
Drugs that are infused at low flow rates (<5 mL/hour),
such as vasoactive drugs or insulin, are likely to have
reduced delivery during chamber compression. Therefore, patients would not receive the expected volume
of drug during chamber compression and could receive
a bolus of drug during decompression. Clinicians
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UHM 2016, Vol. 43, No. 1 THREE INFUSION PUMPS FOR MONOPLACE CHAMBERS
administering these types of drugs at low infusion
rates during hyperbaric oxygen treatment should appropriately monitor patients for unexpected or adverse
effects of delayed drug delivery or decompression
bolus. One solution to overcome this problem is to
increase a low infusion rate during compression and
decrease the rate with decompression, titrating the
IV infusion rate to a clinical effect.
Taking the availability issues and this functional
limitation into consideration, any of these pumps may
be used for the monoplace chamber. Other factors
influencing pump acquisition include battery life,
maintenance and support. All three pumps operate on
standard 110-volt electrical power and a self-contained
rechargeable battery. For this experiment, the pumps
were plugged into wall power, and we did not
evaluate battery life.
LIMITATIONS
This study is limited by the number of infusion trials
we were able to perform. We evaluated only a single
pump from each manufacturer, and a study evaluating
multiple pumps of the same model may have found
inter-pump variability. Our measurement precision was
also limited, as we took the measurements visually,
through the chamber acrylic, and could not make measurements more precise than by 0.1-mL increments
for low flow rate experiments. We also acknowledge
the possibility of human error in these measurements.
However, the magnitude of effect observed during
compression and decompression was well within our
capability to measure, even at low flow rates.
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CONCLUSIONS
These three infusion pumps may be considered for
use by monoplace hyperbaric medicine departments
that treat patients who need intravenous infusions. For
hyperbaric practitioners in the United States the Z-800F
has a valid 510K number and is currently manufactured.
Although no longer manufactured or supported, the
Baxter Flo-Gard 6201 may be an alternative pump for
these practitioners. For services outside the United States,
the Body Guard 323 Color Vision can be considered.
Tubing compliance may affect drug delivery in
monoplace chambers, especially at low flow rates when
delivered volumes are minimal. We advise careful monitoring of patients receiving critical infusions, particularly during chamber compression and decompression.
Acknowledgments
The authors have received no financial support for this
research. Zyno Medical LLC, 177 Pine St., Natick, MA
01760, USA, and CME, Caesarea Medical Electronics,
16 Shacham St., POB 3009, Caesarea 3088900, Israel,
provided intravenous pumps by loan and donated infusions
sets for this investigation. ECRI Institute, 5200 Butler Pike,
Plymouth Meeting, PA 19462-1298, USA, provided
contact information and technical support.
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UHM 2016, Vol. 43, No. 1 THREE INFUSION PUMPS FOR MONOPLACE CHAMBERS
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REFERENCES
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