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•
Protect from damage, loose debris, dust,
frost and direct sunlight.
•
During First time use, after storage and
minimally on a semi-annual basis, perform
Functional check (See Section 3.0).
5.0 CLEANING and SPECIAL
INSTRUCTIONS
5.1 CLEANING
The DUPLOSPRAY MIS Regulator housing,
Foot Switch, and hoses can be cleaned
with many hospital approved (pH 7 neutral)
disinfectants.
In order for the device to operate safely and in
accordance with the intended use, the Regulator
must be cleaned, following each use, maintained
free of dirt and other debris.
5.2 SPECIAL INSTRUCTIONS
•
CAUTION: Do not use high pH (acid) or low
pH (caustic cleansers)
•
CAUTION: Do not allow cleaning solution
to enter Patient Vent (3) or Gas Outlet (5)
¿ ttings on front panel. Use Luer caps or
cover ¿ ttings with a lint free cloth.
•
CAUTION: Do not allow cleaning solution
to enter the Gas (DISS Female CO
connection (1); cover with a lint free cloth.
•
CAUTION: Do not allow disinfectants to pool
anywhere on the device such as on Flow
Meter (4).
•
CAUTION: Do not immerse or soak the
entire unit.
•
CAUTION: Do not use abrasive pads or
cleansers.
•
CAUTION: Do not process in automatic
washer or steam sterilizer.
6.0 REGULATOR REPAIR AND
MAINTENANCE
DUPLOSPRAY MIS Regulator internal
components are not user serviceable.
6.1 FUNCTIONAL CHECK
On a semi-annual basis, the DUPLOSPRAY
MIS Regulator should be checked for proper
operation by performing a functional check
(See 3.0 Functional Check).
6.2 MAINTENANCE CHECK
A maintenance check should be performed on
the DUPLOSPRAY MIS Regulator on an annual
basis.
6.3 MAINTENANCE SET UP
•
Attach Gas (DISS Female CO
(1) to CO
gas source and set gas supply
2
pressure to 100psi ± 5 (6.89 bar ± .35).
•
Place Foot Switch (2) À at in convenient
location.
•
While depressing Foot Switch (2), turn Flow
Control Knob, (6), clockwise and adjust À ow
to 10 L/min as indicated on Flow Meter, (4).
•
Connect a calibrated 0 – 30 psi pressure
gauge to the Gas Outlet (5).
•
While depressing the Foot switch (2), verify
calibrated pressure gauge reading agree
to 19psi ± 2 (1.31 bar ± .13). Flow gauge
should indicate 0 L/min after a momentary
jump.
•
Remove calibrated pressure gauge.
6.4 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 and indicated by the Flow Meter
(4).
•
With foot switch (2) released verify À ow
Meter ball (4) does not stick at top of Flow
Meter.
•
Connect a calibrated À ow meter for CO
a range of 0 - 10 L/min with an accuracy of
2% full scale to the Gas Outlet (5).
•
While depressing foot switch (2), turn Flow
Control Knob (6) to read 2 L/min on Flow
Meter (4).
•
The À ow on the calibrated À ow meter should
verify 2 L/min À ow within ± .5 L/min.
•
Remove calibrated À ow meter from Gas
Outlet (5).
6.5 VERIFY PATIENT VENT
•
Connect the tubing set from the
DUPLOSPRAY MIS Applicator to Gas outlet
(5) and Patient Vent (3). Join the Male/
Female Luer connections on the distal end of
the tubing set.
)
Note: A short single lumen tube set with
2
appropriate Male/Female Luer connections
may be a substituted for the above.
•
While depressing Foot Switch (2), turn Flow
Control Knob, (6), clockwise and adjust À ow
to 5 L/min as indicated on Flow Meter (4).
•
With Foot Switch (2) released, gas À ow must
stop and Flow Meter (4) goes to zero.
•
Remove Tubing set from Gas Outlet (5) and
Patient Vent (3).
6.6 CHECK FOR LEAKS
•
While depressing Foot Switch (2), turn Flow
Control Knob (6) to read 5 L/min on Flow
Meter (4).
•
Block Gas Outlet (5) with a luer cap, check
for internal leaks by observing the movement
of Flow Meter (4) ball. The ball will remain
at zero (after a momentary jump) if free of
leaks.
•
Remove Luer Cap from Gas Outlet (5).
6.7 SAFETY RELIEF VALVE OPERATION
CAUTION: Pressure above 22 psi (1.5 Bar) will
cause the Regulator's internal safety relief valve
to vent excess gas inside Regulator housing with
an audible signal.
Should the Safety relief valve actuate at anytime:
•
Con¿ rm incoming gas supply pressure to
) Connection
the device is set correctly to 100 psi ± 5
2
(6.89 bar ± .35).
•
Should the Safety relief valve continue to
actuate after the device input pressure s
con¿ rmed to be correct:
•
Immediately remove 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.
COPY
7.0 TERMS OF WARRANTY
The manufacturer warrantees devices against all
defects in material and workmanship that occur
within one (1) year after the date of sale.
Warranty claims will be processed by the
Manufacturer under the following conditions:
•
Inform Baxter immediately of malfunction.
Please provide the serial number of the
device when reporting.
•
Observe all instructions regarding storage
with
2
and return of the device.
•
Present a legible copy of the invoice for the
device in question, which clearly shows date
of sale.
•
Describe in as much detail as possible
suspected defects or malfunctions
experienced by user.
ATTENTION: The warranty will not be applicable
if warnings, intended use, and cleaning
instructions for the device are not followed as
stated herein.
The manufacturer and the supplier of the device
deny liability, if:
•
The device is not used in accordance with
instruction manual.
•
The defect was not caused by manufacturer
or persons and service companies
authorized by manufacturer.
8.0 RETURN OF DEVICES
Reasons for return:
1. Results of the ¿ rst-time use are unsatisfactory/
unsafe.
2. Defective device
Call Baxter Customer Service using the contact
information shown on the base of the device or
contact your local Baxter representative to obtain
a Return Authorization (RA) Number prior to
returning. Product returns not accepted without a
Return Authorization number.
When returning a device, clean it carefully
and pack it in the original package. If the
original package is no longer available,
request appropriate packaging through Baxter
customer service using contact information
on base of device or contact your local Baxter
representative.
9.0 DISPOSAL OF DEVICES
The DUPLOSPRAY MIS Regulator has no
electrical components or hazardous materials in
its construction.
Clean the DUPLOSPRAY MIS Regulator to
remove any potential biohazard contamination
prior to disposal.
•
Do not dispose of DUPLOSPRAY MIS
Regulator as unsorted municipal waste.
•
Collect DUPLOSPRAY MIS Regulator
separately as Used Medical Waste.
•
Use collection and return systems available
to you.
For more information on return, recovery or
recycling of DUPLOSPRAY MIS Regulator,
contact your local Baxter representative.
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