EN
Before using this device, read the 1.0 DESCRIPTION OF OPERATION
following information
A Review Applicator Instructions The DUPLOSPRAY MIS Regulator is a reusable,
for Use for additional information, non-sterile device consisting primarily of a gas
DUPLOSPRAY MIS |REGULATOR warnings and precautions. pressure regulator, flow control valve, flow meter
and a foot switch. The internal pressure regulator
is a fixed-output device that reduces 100psi + 5
INTENDED USE (6.89 bar + .35) incoming supply gas pressure to
The DUPLOSPRAY MIS Regulator is a
the device to a preset 19psi + 2 (1.31 bar + .13)
re-usable, non-sterile device intended for output pressure. A safety relief valve inside the
regulating gas flow of medical grade vaporous Regulator ensures a maximum output limit of
carbon dioxide to assist in the application of
22 psi (1.5 bar) cannot be exceeded. The safety
Baxter surgical sealants.
relief valve will safely vent inside the housing at
pressures above 22 psi (1.5 bar) with an audible
CONTRAINDICATIONS
signal. The pressure relief valve will reset
None
automatically when the over pressure condition
is removed.
WARNINGS/PRECAUTIONS
The user should be familiar with the contents of
1.1 CONTENTS OF CARTON
these instructions prior to using the device.
。 Regulator assembly (including pre-mounted
Regulator should only to be used with pole clamp) with Foot switch, and a Gas
DUPLOSPRAY MIS Applicators. (DISS Female CO,) Connection.
Only qualified personnel should operate this
2.0 SET UP
device.
Caution must be used when applying product Conditions: 55°F (13°C) to 80°F (27°C), 0% to
using pressurized gas. 60% RH
* Air or gas embolism has occurred with
The DUPLOSPRAY MIS Regulator comes with
the use of spray devices employing a pre-mounted Pole Clamp (7) that can be used
pressure regulator to administer fibrin
to mount device onto a stable pole.
sealants. This event appears to be related
to the use of the spray device at higher 2.1 SET UP REGULATOR
than recommended pressures and in 。 Attach Gas (DISS Female CO,) Connection
close proximity to the tissue surface. (1) to CO, gas source and set gas supply
When applying sealants using a spray pressure to 100psi + 5 (6.89 bar + .35).
DUPLOSPRAY REGULATOR device, be sure to use the flow rate
recommended in the Instruction for Use. 2.2 FOOT SWITCH
PARTS LIST e To avoid possible gas embolism, do not e Place Foot Switch (2) flat in convenient
Gas Connection spray directly into circulatory pathways. location.
一
Foot Switch Any application of pressurized gas is
N|
associated with a potential risk of air 3.0 FUNCTIONAL CHECK
Patient Vent Connection embolism, tissue rupture or gas entrapment
oao|a|aB| O
Flow Meter with compression, which may be life During first time use and minimally on a
threatening. semi-annual basis, conduct a functional check.
Gas Outlet to Applicator
Be sure to take appropriate measures to
Gas Flow Control Knob 3.1 VERIFY REGULATOR FLOW
address these risks by observing these
* While depressing Foot Switch (2), turn Flow
Pole Clamp
ONI
recommendations:
Control Knob (6), clockwise and back and
PN 0600134 - NIST B11 Connector Flow Rate 1.0 - 2.0 Liters per minute (L/min) verify flow is adjustable from 0 to 10 L/min
US List Number 0600123 minimum as indicated by the Flow Meter (4).
Distance 2cm 3cm 5cm * While depressing Foot Switch (2), turn Flow
recommended Control Knob, (6), clockwise and adjust flow
to 1.5 L/min as indicated on Flow Meter (4).
‧ When using pressurized spray devices,
® With foot switch (2) released verify flow
changes in blood pressure, pulse, oxygen
control ball does not stick at top of Flow
saturations, and end tidal CO, should be Meter (4).
monitored because of the possibility of
* Note: After successfully performing above
occurrence of air gas embolism.
procedure, the DUPLOSPRAY MIS
Connect to regulated CO, gas source only. Regulator is ready for use.
Supply pressure to device shall be set to 100 psi If flow is not verified:
+ 5 (6.89 bar + .35) and at a flow rate of 10 L/min * Immediately remove DUPLOSPRAY MIS
minimum. Regulator from service.
® Call Baxter Customer Service using the
Do not expose to temperatures below -4 °F
contact information shown on the base
(-20°С) , above 122 °F (50°C) , or to relative
of the device or contact your local Baxter
humidity (RH) above 95%.
representative.
Do not immerse or soak any part of the device.
4.0 STORAGE
Review Section #5 and #6 for additional
information regarding cleaning, maintenance and Conditions:
other vital information for use. ® Ambient indoor 55°F (13°C) to 95°F (35°C),
0% to 95% RH continuous.
