ENDOTEK BIG 60 Instructions For Use

60ml Inflation Device
I N S T r U C T I O N S F O r U S E
DESCrIPTION:
The BIG60 Inflation Device is a 60ml disposable inflation device capable of producing
®
a maximum pressure of 12 ATM/BAR, fitted with a threaded plunger assembly with
a lock/release bar, a flexible high pressure tube, and a three-way medium pressure
stopcock. The BIG60 Inflation Device is designed to generate and monitor inflation
pressures over a range of -.68 to 12ATM/BAR (-10 to 176 psi) with an accuracy of 3%
ATM/BAR.
INTENDED USE:
This inflation device is used to inflate and deflate an angioplasty balloon or other
interventional device, and to measure the pressure within the balloon.
PrECAUTIONS:
• Inspect the BIG60 Inflation Device and packaging for damage prior
to use. Do not use product if opened or damaged. Confirm the product is
consistent with the package label. Contact Customer Service to report
and replace damaged product.
• For single patient use only. Do not reuse, reprocess, or resterilize. Reuse,
reprocessing, or resterilization may compromise the structural integrity
of the device and/or lead to device failure which, in turn, may result in
patient injury, illness, or death. Reuse, reprocessing, or resterilization
may also create a risk of contamination of the product 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 product may lead to injury, illness, or death of
the patient.
• Graduations on device barrel are for reference only and are not intended
for exact measurement.
INSTrUCTIONS FOr USE:
1. Prior to use, free the plunger tip by twisting the device plunger/handle
360 degrees clockwise.
2. To prep device, simply aspirate up to 60ml of contrast solution into the
syringe by pulling back on the device handle.
CAUTION: Inspect the device tubing and stopcock (if used) to ensure there is no
air in the system.
3. Remove any excess air by orienting the device upwards, squeezing the
trigger located on the device handle and pushing the handle forward.
Push forward until the device plunger tip is oriented with the black
arrow printed on the device barrel (approximately 35ml).
ATTACHINg THE INFLATION DEVICE TO THE BALLOON:
NOTE: Refer to the manufacturer's directions accompanying the balloon dilation
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 instructions for use.
2. Create a fluid-fluid connection between the balloon and the inflation
device extension tube and connect the luer connectors securely.
3. Squeeze the trigger and pull back on the handle to apply 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.
2. To increase pressure, rotate the handle clockwise until the desired
inflation pressure is reached. The locking mechanism maintains the
pressure.
CAUTION: Do not exceed 12 ATM.
NOTE: Loss of pressure may indicate a leak in the system.
3. To deflate the balloon (rotate the handle counter-clockwise to relieve
pressures above 6 ATM) squeeze the trigger and pull the handle back to
generate the desired negative pressure. Release the grip on the trigger
to lock the plunger in the negative pressure position.
STOrAgE: Store in a cool, dry place.
WArrANTY
The manufacturer warrants that reasonable care has been used in the design and manufacture
of this device. This warranty is exclusive and manufacturer makes no other representations or
warranties of any kind to customers, its end users, or to any third parties with respect to the device
and hereby expressly disclaims any and all other warranties, express or implied, statutory or
otherwise, including, but not limited to, infringement and the implied warranties of merchantability
and fitness for a particular purpose, even if manufacturer is aware of such purpose. Handling and
storage of this device, as well as other factors relating to the patient, diagnosis, treatment, implant
procedures, and other matters beyond the control of the manufacturer, directly affect the device
and the results obtained from its use. The manufacturer's obligation under this warranty is limited
to the replacement of the device. Under no circumstances shall manufacturer be liable to customer
or any other person or entity for any punitive, special, incidental or consequential damages directly
or indirectly arising from the use of this device. The manufacturer neither assumes, nor authorizes
any other person to assume for it, any other or additional liability or responsibility in connection
with this device. This warranty shall not apply, and manufacturer assumes no liability with respect
to, devices that have been (i) modified, changed, altered, misused, mishandled, repaired, reused,
reprocessed, refurbished or resterilized; (ii) subjected to improper maintenance, testing or storage,
accident, tampering, or inadequate protection against shock, vibration, excessively high or low
temperatures, overpressure, or physical, environmental or electrical stress; (iii) been used outside
the approved "Indications for Use" as cleared by the relevant competent authority, used contrary
to the use outlined in the device specifications, or in an application or environment for which such
device was not designed or contemplated; or (iv) distributed or used contrary to applicable federal,
state, local or regulatory standards.
rX only: CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Single Use
Caution: Consult accompanying document
Sterile if package is unopened or undamaged
Non-pyrogenic
Manufacturer:
Merit Medical Systems, Inc. South Jordan, Utah 84095 U.S.A.
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
www.merit.com
401997002/C ID 031513