Instructions For Use - BioSphere Medical EmboCath Plus Instructions D'utilisation

• Remove the Microcatheter from the hoop. Repeat
flushing of hoop if catheter is difficult to remove.
Inspect it prior to use to verify that it is undamaged
The hydrophilic infusion catheter must remain hydrated in
order to maintain lubricity.

INSTRUCTIONS FOR USE

• The EmboCath Plus Infusion Microcatheter should be
utilized coaxially over a steerable guidewire. Follow
the guidewire manufacturer's instructions for use.
The catheter may be used with a guide catheter/
sheath with a minimum internal diameter of 0.041
in. (1.04mm). A rotating hemostatic valve used in
conjunction with the guiding catheter will provide a
fluid-tight seal around the infusion catheter. Introduce
the infusion catheter and wire assembly through the
rotating hemostatic valve. Carefully tighten the valve
around the hydrophilic infusion catheter to prevent
backflow, allowing some movement through the valve
by the hydrophilic infusion catheter.
Overtightening of a hemostatic valve may cause
damage to the catheter.
• Advance the guidewire and hydrophilic infusion
catheter to a selected vascular site by alternately
advancing the guidewire and then tracking the
hydrophilic infusion catheter over the guidewire.
Note: To facilitate catheter handling, the proximal portion
of the hydrophilic infusion catheter does not contain
the hydrophilic coating. Greater resistance may be en-
countered when this portion of the hydrophilic infusion
catheter is advanced into the rotating hemostatic valve.
• To infuse, completely remove the guidewire from
the hydrophilic infusion catheter. Connect a syringe
with infusate to the hydrophilic infusion catheter hub
and infuse as required. Do not inject any fluid if air
bubbles are visible.
Note: Do not exceed Flow Rates/PSI as described in the
Flow Rate Table.
• Aspirate infusion catheter upon removal and discard.
CAUTION:
Federal (USA) law restricts this device to use by or on the
order of a licensed physician.
CONTRAINDICATIONS:
There are no known contraindications for the use of infusion
microcatheters.
STORAGE:
Store the EmboCath Plus Infusion Microcatheter in a cool,
dark, dry area.
COMPATIBILITY:
• The EmboCath Plus Infusion Microcatheter should be
used with steerable guidewires that are up to 0.025
inches in diameter.
• The EmboCath Plus Infusion Microcatheter is
compatible with microspheres of size range 700-900
μm and smaller.
• Catheters exhibited no detectable signs of material
degradation during bench testing when exposed
between 60 and 75 minutes to a mixture of the
following agents: 5mg mytomicin, 25mg doxorubicin,
50mg cisplatin, 0.25g fluorouracil, 5mL ethiodol, 5cc
sterile contrast and 1cc sterile water.
WARRANTY
BioSphere Medical warrants that reasonable care has been
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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 expressed or implied by
operation of law or otherwise, including, but not limited to,
any implied warranties of merchantability or fitness. Han-
dling, storage, cleaning and sterilization of this instrument, as
well as factors relating to the patient, diagnosis, treatment,
surgical procedures, and other matters beyond BioSphere
Medical's control, directly affect the instrument and the
results obtained from its use. BioSphere Medical's obligation
under this warranty is limited to the repair or replacement of
this instrument. BioSphere Medical is not liable for any inci-
dental or consequential loss, damage, or expense directly or
indirectly arising from the use of this instrument. BioSphere
Medical neither assumes nor authorizes any other person to
assume for it any other or additional liability or responsibility
in connection with this instrument.
BioSphere Medical assumes no liability with respect to
instruments reused, reprocessed or re-sterilized, and makes
no warranties, expressed or implied, including, but not limited
to, merchantability or fitness for intended use with respect to
such instrument.
All serious or life threatening adverse events or deaths
associated with use of EmboCath Plus should be reported
to the Competent Authority of the country where it occurred
and to the device manufacturer.
Information on packaging:
Symbol
Manufacturer: Name & Address
Use by date: year-month
Batch code
Catalogue number
Do not resterilize
Do not use if package is damaged
Keep away from sunlight
Keep dry
Do not re-use
Caution -
Refer to Instructions For Use
Sterilized using ethylene oxide
EC mark logo -
Notified body identification : 0459
Authorized Representative in
European Community
Maximum Guidewire
Maximum pressure
Radiopaque marker
3
Designation