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DUPLOSPRAY MIS
REGULATOR
8
4
3
5
DUPLOSPRAY REGULATOR
PARTS LIST
1
Gas Connection
2
Foot Switch
3
Patient Vent Connection
4
Flow Meter
5
Gas Outlet to Applicator
6
Gas Flow Control Knob
7
Pole Clamp
8
PN 0600134 - NIST B11 Connector
US List Number 0600123
Before using this device, read the
following information
!
Review Applicator Instructions
for Use for additional information,
warnings and precautions.
INTENDED USE
The DUPLOSPRAY MIS Regulator is a
re-usable, non-sterile device intended for
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regulating gas À ow of medical grade vaporous
carbon dioxide to assist in the application of
2
Baxter surgical sealants.
CONTRAINDICATIONS
None
WARNINGS/PRECAUTIONS
The user should be familiar with the contents of
these instructions prior to using the device.
Regulator should only to be used with
DUPLOSPRAY MIS Applicators.
1
Only quali¿ ed personnel should operate this
device.
Caution must be used when applying product
using pressurized gas.
•
Air or gas embolism has occurred with
the use of spray devices employing
pressure regulator to administer ¿ brin
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sealants. This event appears to be related
to the use of the spray device at higher
than recommended pressures and in
close proximity to the tissue surface.
When applying sealants using a spray
device, be sure to use the À ow rate
recommended in the Instruction for Use.
•
To avoid possible gas embolism, do not
spray directly into circulatory pathways.
Any application of pressurized gas is
associated with a potential risk of air
embolism, tissue rupture or gas entrapment
with compression, which may be life
threatening.
Be sure to take appropriate measures to
address these risks by observing these
recommendations:
1.0 - 2.0 Liters per minute (L/min)
•
When using pressurized spray devices,
changes in blood pressure, pulse, oxygen
saturations, and end tidal CO
monitored because of the possibility of
occurrence of air gas embolism.
Connect to regulated CO
Supply pressure to device shall be set to 100 psi
± 5 (6.89 bar ± .35) and at a À ow rate of 10 L/min
minimum.
Do not expose to temperatures below -4 °F
(-20°C) , above 122 °F (50°C) , or to relative
humidity (RH) above 95%.
Do not immerse or soak any part of the device.
Review Section #5 and #6 for additional
information regarding cleaning, maintenance and
other vital information for use.
COPY
1.0 DESCRIPTION OF OPERATION
The DUPLOSPRAY MIS Regulator is a reusable,
non-sterile device consisting primarily of a gas
pressure regulator, À ow control valve, À ow meter
and a foot switch. The internal pressure regulator
is a ¿ xed-output device that reduces 100psi ± 5
(6.89 bar ± .35) incoming supply gas pressure to
the device to a preset 19psi ± 2 (1.31 bar ± .13)
output pressure. A safety relief valve inside the
Regulator ensures a maximum output limit of
22 psi (1.5 bar) cannot be exceeded. The safety
relief valve will safely vent inside the housing at
pressures above 22 psi (1.5 bar) with an audible
signal. The pressure relief valve will reset
automatically when the over pressure condition
is removed.
1.1 CONTENTS OF CARTON
•
Regulator assembly (including pre-mounted
pole clamp) with Foot switch, and a Gas
(DISS Female CO
2.0 SET UP
Conditions: 55°F (13°C) to 80°F (27°C), 0% to
60% RH
The DUPLOSPRAY MIS Regulator comes with
a pre-mounted Pole Clamp (7) that can be used
to mount device onto a stable pole.
2.1 SET UP REGULATOR
•
Attach Gas (DISS Female CO
(1) to CO
pressure to 100psi ± 5 (6.89 bar ± .35).
2.2 FOOT SWITCH
•
Place Foot Switch (2) À at in convenient
location.
3.0 FUNCTIONAL CHECK
During ¿ rst time use and minimally on a
semi-annual basis, conduct a functional check.
3.1 VERIFY REGULATOR FLOW
•
While depressing Foot Switch (2), turn Flow
Control Knob (6), clockwise and back and
verify À ow is adjustable from 0 to 10 L/min
minimum as indicated by the Flow Meter (4).
•
While depressing Foot Switch (2), turn Flow
Control Knob, (6), clockwise and adjust À ow
to 1.5 L/min as indicated on Flow Meter (4).
•
With foot switch (2) released verify À ow
control ball does not stick at top of Flow
should be
2
Meter (4).
•
Note: After successfully performing above
procedure, the DUPLOSPRAY MIS
gas source only.
Regulator is ready for use.
2
If À ow is not veri¿ ed:
•
Immediately remove DUPLOSPRAY MIS
Regulator from service.
•
Call Baxter Customer Service using the
contact information shown on the base
of the device or contact your local Baxter
representative.
4.0 STORAGE
Conditions:
•
Ambient indoor 55°F (13°C) to 95°F (35°C),
0% to 95% RH continuous.
) Connection.
2
) Connection
2
gas source and set gas supply
2
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