Boston Scientific OptiCross HD Mode D'emploi page 5

MDU5 PLUS
Sterile Bag
Sterile Bag for MDU5 PLUS
Motordrive Unit
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.
WARNING
Contents supplied STERILE using a Radiation process. Do not use
if sterile barrier is damaged. If damage is found, call your Boston
Scientific representative.
For single 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 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.
After use, dispose of product and packaging in accordance with
hospital, administrative and/or local government policy.
Carefully read all instructions prior to use. Observe all
contraindications, adverse events, warnings, and precautions noted
in these directions. Failure to do so may result in patient complications.
Boston Scientific relies on the physician to determine, assess and
communicate to each patient all foreseeable risks of the procedure.
DEVICE DESCRIPTION
This device provides an efficient, conformal covering to fit the MDU5
PLUS motordrive.
Contents
MDU5 PLUS Sterile Bag (referred to as "bag")
INTENDED USE/INDICATIONS FOR USE
The MDU5 PLUS Sterile Bag is intended to cover the motordrive
during intravascular ultrasound procedures to maintain the sterile
field and prevent transfer of microorganisms, body fluids and
particulate material to the patient and healthcare worker.
CONTRAINDICATIONS
None known.
ADVERSE EVENTS
None known.
PRECAUTIONS
None known.
HOW SUPPLIED
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Handling and Storage
Store in a cool, dry, dark place.
DIRECTIONS FOR USE
A. Inspection Prior to Use
Before use, inspect the packaging for any violation of the sterile
barrier and inspect the bag for any damage or defects. Do not use
potentially contaminated or defective equipment. If the sterile barrier
integrity is compromised or the contents damaged, contact your
Boston Scientific representative.
Prior to use, verify product is within labeled shelf life. Do not
use product if the 'Use By' date has been exceeded. Dispose
of product and packaging in accordance with hospital,
administrative and/or local government policy.
B. Covering the MDU5 PLUS
Covering the MDU5 PLUS requires two people – one inside and
one outside the sterile field. Using appropriate sterile technique:
1. The non-sterile operator opens the pouch containing the bag.
2. The sterile operator removes the bag from the pouch.
3. The sterile operator unfolds the bag so the "Insert Here"
sticker is on one end and the faceplate is on the opposite end.
™
4. The sterile operator places their hands into the innermost
folds of the bag, opening the bag for MDU5 PLUS placement
by the non-sterile operator. The "Insert Here" sticker can be
used to easily locate the bag opening (Figure 3).
Figure 3. Opening the Bag
5. The non-sterile operator then places the MDU5 PLUS into
the opening, positioning the MDU5 PLUS so that the top of
the unit is aligned with the "This Side Up" sticker on the bag
(Figure 4).
Figure 4. Inserting the MDU5 PLUS
6. The sterile operator then grasps the covered MDU5 PLUS.
The non-sterile operator grips and pulls the tabs until the
bag is unfolded to its full length (Figure 5).
Figure 5. Unfolding the Bag
7. To position the bag, stop advancing the MDU5 PLUS into the
bag as soon as a snug fit is obtained. The sterile operator
does not need to advance the MDU5 PLUS all the way to the
bag's faceplate. It is normal to have space between the nose
of the MDU5 PLUS and the faceplate on the bag (Figure 6).
Figure 6. Positioned Bag
8. To attach the bag to the MDU5 PLUS, the sterile operator
should align the bag's faceplate with the nose of the MDU5
PLUS (Figure 7), and gently push to secure the connection.
Do not trap material between the faceplate and the nose.
Extra bag material around and beyond the connection is
normal (Figure 8).
Figure 7. Attaching the Faceplate
Figure 8. Attached Faceplate
9. When ready to insert the MDU5 PLUS compatible catheter,
remove the sticker from the faceplate and discard
appropriately (Figure 9).
Figure 9. Removing Sticker
10. The bagged MDU5 PLUS is now ready for use.
WARRANTY
Boston Scientific Corporation (BSC) warrants that reasonable
care has been used in the design and manufacture of this
instrument. This warranty is in lieu of and excludes all other
warranties not expressly set forth herein, whether express
or implied by operation of law or otherwise, including, but
not limited to, any implied warranties of merchantability or
fitness for a particular purpose. Handling, storage, cleaning and
sterilization of this instrument as well as other factors relating to
the patient, diagnosis, treatment, surgical procedures and other
matters beyond BSC's control directly affect the instrument and
the results obtained from its use. BSC's obligation under this
warranty is limited to the repair or replacement of this instrument
and BSC shall not be liable for any incidental or consequential
loss, damage or expense directly or indirectly arising from the
use of this instrument. BSC neither assumes, nor authorizes any
other person to assume for it, any other or additional liability or
responsibility in connection with this instrument. BSC assumes
no liability with respect to instruments reused, reprocessed
or resterilized and makes no warranties, express or implied,
including but not limited to merchantability or fitness for a
particular purpose, with respect to such instruments.
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Black (K) ∆E ≤5.0