Advertisement
Available languages
Available languages
English_______________________________
Carefully read all instructions prior to use. Observe all contraindications,
warnings and precautions noted in these instructions. Failure to do so
may result in patient complications.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
I.
DEVICE DESCRIPTION
TM
The ProTrack
Microcatheter is designed to work as a standard infusion
catheter. The catheter can also be used as an exchange guide for
scaling-up thinner guidewires to thicker. All models have a removable
luer-lock hub and are packaged with a removable stylet. These features
TM
permit the ProTrack
Microcatheter to act as a guidewire. The critical
dimensions of the catheter can be found on the device label.
TM
The ProTrack
Microcatheter is designed with a radiopaque distal tip
marker that ensures precise tracking and placement of the catheter. The
TM
ProTrack
Microcatheter also has a soft distal tip area that promotes
easy tracking.
II.
INDICATIONS FOR USE
TM
The ProTrack
Microcatheter is intended to be used as an exchange
guide for converting guidewires or as a standard infusion wire.
III.
CONTRAINDICATIONS
TM
The ProTrack
Microcatheter is not recommended for use with any
condition that does not require an exchange guide for converting
guidewires or a standard infusion wire.
IV. WARNINGS
Only physicians with a thorough understanding of angiography and
percutaneous interventional procedures should use this device.
TM
The ProTrack
Microcatheter is supplied STERILE using an
ethylene oxide process. Do not use if the package is damaged.
TM
The ProTrack
Microcatheter is intended for single patient use
only. Do not attempt to sterilize and reuse the catheter. Reuse can
cause the patient injury and/or the communication of infectious
disease(s) from one patient to another. Failure to do so may result
in patient complications.
Laboratory staff and patients can undergo significant x-ray
exposure during interventional procedures due to the continuous
usage of fluoroscopic imaging. This exposure can result in acute
radiation injury as well as increased risk for somatic and genetic
effects. Therefore, adequate measures must be taken to minimize
this exposure.
V.
PRECAUTIONS
Do not attempt to use the ProTrack
thoroughly reading the accompanying Instructions for Use.
Interventional procedures should be performed only by physicians
thoroughly trained in the technique in a fully equipped
catheterization laboratory.
The sterile packaging should be visually inspected prior to use to
detect any compromise. Ensure that the packaging has not been
damaged. Do not use the equipment if the packaging has been
compromised.
Visually inspect the catheter to ensure there is no cracking or
damage to the insulating material. Do not use the equipment if
there is any damage.
TM
Do not use the ProTrack
indicated on the label.
Careful catheter manipulation must be performed to avoid cardiac
damage, or tamponade. Catheter advancement should be done
under fluoroscopic guidance. If resistance is encountered, DO
NOT use excessive force to advance or withdraw the catheter.
Do not bend the catheter. Excessive bending or kinking of the
catheter shaft may damage the integrity of the catheter and may
cause patient injury.
Care must be taken when handling the
catheter.
This device is not intended to be advanced through the vascular
system without fluoroscopic guidance.
Do not withdraw the ProTrack
cannula.
Do not exceed the maximum recommended pressure of 250 psi
(1.72 MPa).
Care must be taken to verify the dimensional compatibility of the
Microcatheter when used with other manufacturer's
TM
ProTrack
devices.
Baylis Medical Company relies on the physician to determine,
assess, and communicate to each individual patient all foreseeable
TM
risks of the ProTrack
Microcatheter.
Page 2 of 14
TM
Microcatheter before
Microcatheter after the "Use By" date
TM
Microcatheter through a needle
VI. ADVERSE EVENTS
Adverse events which may occur while using the ProTrack
Microcatheter include:
Vessel perforation
Vascular thrombosis
Vessel spasm
Drug reactions
Hemorrhage
Allergic reaction to contrast medium
Hematoma
Arteriovenous fistula
Pain and Tenderness
Thromboembolic episodes
Sepsis/Infection
VII. INSPECTION PRIOR TO USE
TM
Prior to use, the ProTrack
Microcatheter should be carefully examined
for damage or defects, as should all equipment used in the procedure.
Do not use defective equipment.
Microcatheter.
VIII. EQUIPMENT REQUIRED
Intracardiac procedures should be performed in a specialized clinical
setting equipped with a fluoroscopy unit, radiographic table, physiologic
recorder, emergency equipment and instrumentation for gaining
vascular access.
IX. DIRECTIONS FOR USE
1.
All instructions for equipment required should be carefully read,
understood, and followed.
complications.
TM
2.
The ProTrack
Microcatheter is supplied sterile. Remove the
catheter with its attached luer-lock hub from the pouch using sterile
technique.
3.
Ensure luer-lock hub is tightened securely.
TM
4.
The ProTrack
Microcatheter may be introduced into the
vasculature through an introducer sheath, through a catheter, or
over a wire. The radiopaque distal tip marker aids in fluoroscopic
visualization during procedural placement. An introducer device
may assist introduction of the ProTrack
hemostasis valve.
TM
5.
Once the ProTrack
Microcatheter has been negotiated into the
desired position, infusion of fluid agents can begin in accordance
with the manufacturer's instructions for dosage and duration. To
inject/infuse fluid, withdraw the mandrill or guidewire and attach the
infusion line or syringe to the luer-lock hub using standard
technique.
NOTE: Before injecting fluid, always verify that the luer-lock
hub is firmly attached to the ProTrack
NOT exceed the recommended maximum infusion pressure of
250 psi (1.72 Mpa).
6.
To position the luer-lock hub, turn the proximal end counter-
clockwise to loosen or clockwise to tighten. Proper placement of
the luer-lock hub should be approximately 3 cm from the injectable
proximal end of the ProTrack
X.
CLEANING AND STERILIZATION INSTRUCTIONS
TM
The ProTrack
Microcatheter is intended for single use only. Do not
clean or re-sterilize the ProTrack
XI. TROUBLESHOOTING
Bending and kinking of the catheter shaft may result in difficulty when
maneuvering the catheter. Excessive bending and kinking may also
cause patient injury. Care must be taken when handling the catheter.
If bends, breaks, or kinks in the catheter are apparent, discard
immediately
XII. CUSTOMER SERVICE AND PRODUCT RETURN
INFORMATION
If you have any problems with or questions about Baylis Medical
Equipment contact our technical support personnel.
NOTES:
1.
In order to return products you must have a return authorization
number before shipping the products back to Baylis Medical
Company.
2.
Baylis Medical will not accept any piece of used equipment
without a sterilization certificate. Ensure that any product being
returned to Baylis Medical has been cleaned, decontaminated
and sterilized as indicated in the user instructions before returning
it for warrantied service.
XIII.
LABELING AND SYMBOLS
DMR CIC 3.3 V-11 08-Mar-2018
Do not reuse the ProTrack
Failure to do so may result in
TM
Microcatheter through a
TM
Microcatheter. DO
TM
Microcatheter.
TM
Microcatheter.
Manufacturer
EU Authorized Representative
Sterile using ethylene oxide
TM
TM
Advertisement
