Merit Medical BasixCOMPAK Inflation Syringe - Manual

DESCRIPTION:
The Merit basixCOMPAK Inflation Syringe is a
20mL disposable device capable of producing
a maximum pressure of 30 ATM/bars, fitted
with a threaded plunger assembly with
lock/release bar, a flexible high pressure
extension tube, and a three-way medium
pressure stopcock. The basixCOMPAK is
designed to generate and monitor pressures
over a range of -1 to +30 ATM/BAR (-14.7 to
+441 PSI) with accuracy of ±1 ATM/BAR
(14.7 PSI).
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.
INSTRUCTIONS FOR USE:
Before use, inspect the device and packaging
to verify that no damage has occurred as a
result of shipping.
PRIMING WITH PRIMELOK ™
The PrimeLok allows purging of air and
excess fluid without squeezing the trigger.
The basixCOMPAK is
packaged with the
PrimeLok and with the
lock/release mechanism
in the disengaged
position.
1. To engage
PrimeLok, squeeze
trigger and slide
PrimeLok into
slot in plunger.
CAUTION: RX Only - Caution: Federal (USA)
law restricts this device to sale by or on the order of a
physician. / Attention: La loi fédérale américaine limite la
vente de cet article à des médecins ou sur ordonnance. /
Attenzione: La legge federale degli Stati Uniti limita la
vendita di quest’articolo ai medici o dietro ricetta medica. /
Achtung: Das Bundesgesetz der USA limitiert den Verkauf
dieses Artikels an Arzte oder gegen Rezept. / Precaución: La
ley Federal de los Estados Unidos de América (EEUU)
prohibe la venta de este producto sin prescripción médica.
/ Atencão: A Lei Federal dos EUA restringe a venda deste
dispositivo a, ou sob a prescrição de um medico. /
Waarschuwing: de wetgeving van de Verenigde Staten
bepaalt dat de verkoop van dit apparaat uitsluitend door of
op recept van een arts kan geschieden. / Försiktighet: l USA
förbjuder federala lagar att denna utrustning säljs av läkare
eller på ordination av läkare. / Vigtigt: Foderale
myndigheder i USA har bestemt, at denne artikel kun ma
saelges til læger eller på recept. / ¶ƒ√™√Г∏: ∞МВЪИО·ÓÈÎfi˜
ФМФЫФУ‰И·Оfi˜ ÓfiÌÔ˜ ВИЩЪ¤¯ВИ ЩЛУ ТПЛЫЛ ·˘ЩФ‡ ЩФ˘ В›‰Ф˘˜
ÌfiÓÔ ЫВ И·ЩЪФ‡˜ ‹ ¤У·УЩИ И·ЩЪИО‹˜ Ы‡УЩ·Б‹˜.
2. To prep syringe, simply
aspirate up to 20mL of
contrast solution into the
inflation syringe by
pulling back on
the handle.
CAUTION:
Inspect
the syringe tubing
and stopcock (if
used) to insure that
there is no air in the
system.
3. Push handle against
table to remove air in
syringe.
4. To disengage
PrimeLok, squeeze
handle and slide
PrimeLok out of slot.
This will allow the
trigger to lock in
position and the
device is now ready for use.
NOTE: The PrimeLok must be disengaged
before pressure can be maintained by the
lock/release mechanism.
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, maximum inflation
pressure, precautions, 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 luer
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 (0 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.
NOTE: 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.
2. To deflate the balloon, squeeze the trigger
and pull back to generate a negative pressure.
Release grip on the trigger to lock the
plunger in the negative pressure position.
Manufacturer:
Merit Medical Systems, Inc.
South Jordan, Utah 84095 1-801-253-1600
U.S.A. Customer Service 1-800-356-3748
Authorized Representative:
Merit Medical Ireland Ltd.
Parkmore Business Park West
Galway, Ireland
400612003/A
ID 102108
I N S T R U C T I O N S F O R U S E
Inflation Syringe
U.S. Patent Nos. 5,047,015 5,057,078 5,163,904 Other U.S. and Foreign Patents Pending.
ENGAGE
PRIMELOK
ENGAGED PRIMELOK
DISENGAGE
PRIMELOK