Merit Medical Implantation Stylette - Manual (Page 2)

PERITONEal DIalySIS CaThETER
ImPlaNTaTION STylETTE
english
PRODUCT DESCRIPTION
the merit Peritoneal Dialysis (PD) Catheter implantation
stylettes, Cs-242, Cs-352, Cs-362 are intended to be used
with Flex-neck® Peritoneal Dialysis Catheters. Please refer to
appropriate instructions for use for complete implantations
instructions. Complete instructions are included in the
merit VP-211 and VP-411 y-teC implantation system Kits
(sold separately).
INDICaTIONS FOR USE
the PD Catheter implantation stylette is intended to be
used with the Flex-neck Peritoneal Dialysis Catheters to
stiffen the catheter during catheter insertion.
Px Only: CaUTION: Federal (U.s.a.) law restricts this device
to sale by or on the order of a physician.
PRECaUTIONS
• read manufacturer’s instructions prior to use.
• the medical techniques, procedures, and potential
complications stated herein do not give full and/or
complete coverage or descriptions. they are not a
substitute for adequate training and sound medical
judgment by a physician.
CaUTION
limits on reprocessing: repeated processing has minimal
effect on the PD Catheter implantation stylette as it is a
stainless steel instrument. end of life is normally deter-
mined by wear and damage due to use.
INSTRUCTIONS FOR USE
PD Catheter implantation stylette sterilization
PD Catheter implantation stylettes are reusable devices
that are intended to be sterilized by the user prior to use.
1. Point of use: remove excess soil with disposable cloth/
paper wipe.
2. Containment and transportation: no particular require-
ments. it is recommended that instruments are reprocessed
as soon as is reasonably practical following use.
3. Preparation for cleaning: no particular requirements.
4. Cleaning:
• Use enzol® (or comparable hospital-approved medical
device cleaning detergent) prepared according to
manufacturer’s recommendations (1 oz/gal) using cool
tap water.
• Fully immerse the PD Catheter implantation stylette in
the detergent and allowed to soak for a minimum of
10 minutes.
• Brush the PD Catheter implantation stylette using a
soft bristled brush.
• after brushing, rinse the PD Catheter implantation
stylette under clean running cool tap water until all
evidence of detergent is gone.
• rinse the PD Catheter implantation stylette under
running reverse osmosis/de-ionized (ro/Di) water until
all remaining visible detergent is removed.
• Dry with a soft, clean, lint-free cloth.
5. inspection: Visually inspect the PD Catheter implanta-
tion stylette with an unaided eye for signs of visible soil
or debris. also, visually inspect for damage and wear. PD
Catheter implantation stylette must have a smooth surface
and remain straight and undamaged.
6. Drying: ensure PD Catheter implantation stylette is com-
pletely dry before proceeding with sterilization instructions
below.
7. Packaging: Place each individual merit PD Catheter im-
plantation stylette in a single-use self-sealing autoclavable
pouch. ensure that the pouch is large enough to contain
the PD Catheter implantation stylette without stressing the
seals.
8. sterilization: Process packaged device in a steam
pre-vacuum autoclave unit using a 5 minute cycle at 132⁰
C (270⁰F) with a minimum dry time of 30 minutes or per
hospital protocol.
9. storage: no particular requirements.
NOTE: When sterilizing multiple instruments in one auto-
clave cycle, ensure that the sterilizer’s maximum load is not
exceeded.
NOTE: the instructions provided above have been validat-
ed by the medical device manufacturer as being CaPaBle
of preparing a medical device for reuse. it remains the
responsibility of the processor to ensure that the process-
ing as actually performed, using equipment, materials, and
personnel in the processing facility, achieves the desired
result. this requires validation and routine monitoring of
the process. likewise, any deviation by the processor from
the instructions provided should be properly evaluated for
effectiveness and potential adverse consequences.
enzol is a register trademark of Johnson & Johnson, new
Jersey
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