Merit Medical basixTAU Instrucciones De Uso página 2

Inflation Device
DESCRIPTION:
The Merit basixTAU™ Inflation Device is a 20mL
disposable device fitted with a threaded plunger
assembly with lock/ release bar, a flexible high-pressure
extension tube, and a three-way medium pressure
stopcock. The basixTAU is designed to generate positive
and negative pressure, and monitor positive pressures
over a range of zero to +30ATM/BAR (zero to +441 PSI).
The basixTAU has an added "fold-out" handle feature
designed to provide a secondary mechanism for turning
the handle during inflation and deflation of angioplasty
balloons or other interventional devices.
: CAUTION: Federal (U.S.A.) law restricts this
device to use by or on the order of a physician.
INDICATIONS AND USAGE:
This inflation device is used to inflate and deflate an
angioplasty balloon or other interventional device, and
to measure the pressure within the balloon.
NOTE: This device has not been cleared for dispensing
fluids into the body.
INSTRUCTIONS FOR USE:
Before use, inspect the device and packaging to verify
that no damage has occurred as a result of shipping.
Prior to use, free the plunger tip by twisting the syringe
plunger/handle 360 degrees clockwise.
DEVICE PREPARATION:
1. To prepare the syringe, turn the device with gauge
facing down and aspirate up to 20mL of contrast
solution or other fluid into the syringe by squeezing
the trigger and pulling back on the handle.
CAUTION: Inspect the barrel, tubing, and stopcock
(if used) to ensure there is no air in the system.
2. Remove any excess air by orienting the syringe
upwards, squeezing the trigger located in the
syringe handle and pushing the handle forward.
REUSE PRECAUTION STATEMENT:
For single patient use only. Do not reuse, reprocess or
re-sterilize. Reuse, reprocessing or re-sterilization may
compromise the integrity of the device and/or lead to
device failure which, in turn, may result in patient injury,
illness or death. Reuse, reprocessing or re-sterilization
may also create a risk of contamination of the device and/
or cause patient infection or cross-infection, including,
but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the
patient.
ATTACHING THE INFLATION DEVICE TO THE
BALLOON:
NOTE: Refer to the manufacturer's directions
accompanying the balloon dilatation catheter or other
interventional device for specific information on use and
warnings for that device.
1. Prepare and test the balloon catheter according to
the catheter manufacturer's directions for use.
2. Create a fluid-fluid connection between the balloon
and the inflation syringe extension tube and
connect the Iuer connectors securely.
3. Squeeze the trigger and pull back on the handle to
apply a vacuum to the balloon.
BALLOON INFLATION AND DEFLATION:
1. To inflate the balloon, squeeze the trigger allowing
the plunger to return to the resting position (O
ATM/BAR). Release grip on the trigger, locking the
plunger into position. To increase pressure, rotate
the handle clockwise until the desired inflation
pressure is reached. The lock mechanism maintains
the pressure.
2. If desired, use the "fold-out" handle feature:
a. Open the handle by pulling down on
the white handle portion. Fold the
white portion out completely.
Figure 1
I N S T R U C T I O N S F O R U S E
3. To deflate the balloon, squeeze the trigger and pull
b. Reach into the white handle portion
and fold out the purple swivel handle
completely.
Figure 2
CAUTION: Rotating resistance will be lower due to
the mechanical advantage provided by the "fold
out" handle. Until the user is familiar with the hand
feel of the device, caution should be used during
inflation.
NOTE: Significant loss of pressure may indicate a
leak in the system.
CAUTION: To protect the threads of the lock release
handle, the device must be displaying 25 ATM or
lower before quick release mechanism is used to
deflate the angioplasty balloon.
back to generate a negative pressure. Release grip
on the trigger to lock the plunger in the negative
pressure position.
Caution: Federal (USA) law restricts this
device to sale by or on the order of a
physician.
Single use.
Do not use if package is damaged.
For electronic copy scan QR code or go
to www.merit.com/ifu and enter IFU ID
Number. For printed copy, call U.S.A or
E.U Customer Service.
Caution: Consult accompanying
documents. Read instructions prior
to use.
Do not re-sterilize
Sterilized using ethylene oxide.
Non-pyrogenic
ENGLISH