Merit Medical ClassicSheath Splittable Hemostatic Introducer System - Manual (Page 2)

2
Classic
sheath
™
Adverse Events
Adverse events may include, but are not limited to the
following:
Use Sterile Technique A suggested procedure:
1. Peel open package and place contents in sterile
field.
2. Prep skin and drape in area of anticipated
veni-puncture.
3. Flush the needle, sheath, and dilator prior to use.
4. Insert the dilator into the sheath until the dilator
cap attaches to the sheath hub.
5. Insert the needle into vessel. Verify the needle po-
sition by observing venous blood return.
6. Aspirate the needle using the syringe.
7. Remove the syringe and insert soft tip of
the guidewire through the needle into the
vessel. Advance the guidewire to required depth.
Leave an appropriate amount of the guide-
wire exposed. At no time should the guidewire
be advanced or withdrawn when resistance is
met. Determine the cause of resistance before
proceeding. Fluoroscopic verification of the
guidewire’s entrance into the superior vena cava
and right atrium is suggested.
8. Hold the guidewire in place and remove needle.
Do not withdraw the guidewire back into the
needle as this may result in separation of the
guidewire.
9. Thread the dilator/sheath assembly over the
guidewire.
10. Advance the dilator/sheath assembly with a
twisting motion over the guidewire and into
the vessel. Fluoroscopic observation may be
advisable. Attaching a clamp or hemostat to
the proximal end of the guidewire will prevent
inadvertently advancing the guidewire entirely
into the patient.
11. Once assembly is fully introduced into the
venous system, remove the dilator cap from the
sheath by rocking the dilator cap off the sheath
hub.
12. Slowly retract the guidewire and dilator, leaving
the sheath in position. The sheath will reduce the
loss of blood and the inadvertent aspiration of air.
13. Aspirate all air from the sheath by using a
syringe connected to the sideport.
14. Flush the introducer with saline through the side-
port. If the introducer is to remain in place during
lead positioning and testing, periodic flushing is
advised.
15. Introduce pacemaker lead or catheter through
the sheath and advance it into position.
16. Flush sheath with saline immediately before
peeling sheath away in order to minimize
backbleeding.
17. Split sheath by sharply snapping the sheath
hub tabs and peeling sheath tube apart while
withdrawing it from the vessel.
• Air embolus
• Blood loss
• Vessel damage
• Infection
• Pneumothorax
• Hemothorax
• Pacing lead
displacement
This device is intended for one time use only.
Read instructions prior to use.
CAUTION: Federal (U.S.A.) Law restricts this
device to sale by or on the order of a physician.
For U.S.-California Only.
Proposition 65, a State of California voter initiative,
requires the following notice:
WARNING: This product and its packaging have been
sterilized with ethylene oxide. This packaging may
expose you to ethylene oxide, a chemical known to the
state of California to cause cancer or birth defects or
other reproductive harm.
Indications
For the introduction of various types of pacing leads
and catheters.
Warnings
• This product is sensitive to light. Do not use if
stored outside the protective outer carton.
• Store in a cool, dark, and dry place.
• Infusion through the sideport can be done only
after all air is removed from the unit.
Precautions
• Do not alter this device in any way.
• Single Use Devices: This single-use product
is not designed or validated to be reused.
Reuse may cause a risk of cross-contamination,
affect the measurement accuracy, system
performance, or cause a malfunction as a result
of the product being physically damaged due to
cleaning, disinfection, re-sterilization, or reuse.
• Aspiration and saline flushing of the sheath and
dilator should be performed to help minimize the
potential for air embolism and clot formation.
• Indwelling introducer sheaths should be
internally supported by a catheter, pacing lead,
or dilator.
• Dilators, catheters, and pacing leads should be
removed slowly from the sheath. Rapid removal
may damage the valve resulting in flow of blood
or air through the valve.
• Never advance or withdraw the guidewire or
sheath when resistance is met. Determine the
cause by fluoroscopy and take remedial action.
• When injecting or aspirating through the sheath,
use the sideport only.
Instructions for Use
Splittable Hemostatic Introducer System