Halyard PMP-YYC-N Instrucciones De Uso página 5

• Operator's name
• Results of sterilization process monitoring (i.e., chemical, mechanical,
biological)
Cleaning and Decontamination
1. Ensure that blood and other contaminants do not dry on the
HALYARD* RF Probe and the HALYARD* RF Generator Connector Cable.
2. Remove the protective tube from the probe and follow the Instructions
below for each piece separately.
3. Rinse all parts with deionized water until colorless run-off water occurs.
Once the water runs clear soak the parts (except for the connectors)
in deionized water at 22°C-48°C for 1 minute. Remove the probe and
components from the water and scrub them with a soft bristle brush
until they are visually clean. Note: Do not let the connectors soak. Wipe
connectors as necessary until they are visually clean.
4. Soak the probe and components (except connectors) in an enzymatic
cleaning solution for 20 minutes. Ensure that the temperature of the
solution is below 55°C. Scrub again with a soft bristle brush, and rinse
thoroughly using deionized water until all traces of detergent residue
are removed.
5. Visually inspect the parts again for debris, if any is present repeat steps
3 and 4.
6. Dry the surface of the device on the outside with a clean, dry towel. Put
the protective tube back onto the probe and place all parts back in the
Sterilization and Storage Tray.
Sterilization
(All EXCEPT PMX-SAC-BAY)
The following sterilization methods have been validated for use with
HALYARD* RF Probes and RF Generator Connector Cables:
• Steam Sterilization
• Gravity Displacement Steam Sterilization
• STERRAD® Sterilization
Sterilization
(PMX-SAC-BAY)
The following sterilization methods have been validated for use with
HALYARD* PMX-SAC-BAY Generator Connector Cable:
• Steam Sterilization
• Gravity Displacement Steam Sterilization
Steam Sterilization
Prevaccum: Wrapped: 132°C-135°C (270°F-275°F) for 3-4 min.
Unwrapped: "flash" 132°C for 4 min.
Gravity Displacement Steam Sterilization
Wrapped: 132°C- 135°C (270°F - 275°F) for 15 minutes
Unwrapped: "Flash" 132°C- 135°C for 15 minutes
STERRAD® Sterilization
HALYARD* RF Probes and RF Generator Connector Cables may be sterilized with
the following STERRAD® systems:
• STERRAD® 100S
• STERRAD 50
• STERRAD 200
• STERRAD NX®
• STERRAD 100NX
All instructions given in the corresponding STERRAD® Sterilization System User's
Guide must be followed.
Note: The HALYARD* RF Probe and RF Generator Connector Cable should NOT be
sterilized within the autoclave case. Any validated tray recommended for use with
STERRAD® may be used.
Note: For effective sterilization, the protective tube MUST be removed during
sterilization and placed next to the probe in the tray.
Warning
Halyard Health has validated ONLY the previously mentioned cleaning
and sterilization methods for the HALYARD* RF Probe and
HALYARD* RF Generator Connector Cable. No other cleaning and
sterilization methods have been tested. If any other type of cleaning
or sterilization method is used on these products, it is up to the user to
verify sterility. Failure to properly clean the device can lead to patient
injury.
Troubleshooting
The following table is provided to assist the user in diagnosing potential
problems.
PROBLEM COMMENTS
No tem- In order to measure
perature
temperature the
measurement
entire system must
in treatment
be connected and all
mode devices must be in
good working order.
OR
Inaccurate,
erratic or
sluggish
temperature
reading in
treatment
mode
RF Probe
The fit of the probe
does not fit in the cannula is very
into the RF precise.
Cannula
In very rare
situations the
manufacturing of
the probe and/or
cannula may prohibit
the correct fit.
RF Probe Each of the connec-
Connector
tors is designed to
does not fit
connect in a specific
in RF Probe
way for safety rea-
Plug-In sons. If the connector
"keys" are out of line
the connectors won't
fit together.
RF Electrode
Due to the small
Breaks or
diameter shaft, the
Kinks
RF Electrode portion
of the HALYARD* RF
Probe can withstand
very little damage
due to handling.
Customer Service and Product Return Information
If you have any problems with or questions about this HALYARD* Equipment,
contact our technical support personnel:
Halyard Health
5405 Windward Parkway
Alpharetta, GA 30004 USA
E-mail: PMPorders@hyh.com
1-844-425-9273 (1-844-HALYARD)
Notes
In order to return products under limited warranty you must have a return
authorization number before shipping the products back to Halyard Health.
Limited Warranty
Halyard Health warrants that these products are free from defects in original
workmanship and materials. If these products prove to be defective in original
workmanship or original materials, Halyard Health, in its absolute and sole
discretion, will replace or repair any such product, less charges for transportation
and labor costs incidental to inspection, removal or restocking of product.
This limited warranty applies only to original factory delivered products that
have been used for their normal and intended uses. Halyard Health's limited
warranty shall NOT apply to Halyard Health's products which have been
repaired, altered or modified in any way and shall NOT apply to Halyard Health's
products which have been improperly stored or improperly installed, operated
or maintained contrary to Halyard Health's Instructions. The warranty period for
HALYARD* RF Probe and RF Generator Connector Cables is 90 days from the date
of purchase, unless otherwise stated.
TROUBLESHOOTING
Ensure that all connections
are made:
• probe to connector cable
• connector cable to
generator
• generator to power outlet
Check for an error message on
the generator.
Visually inspect the probe
or cable for damage. Ensure
that devices are dry and at
room temperature. If problem
persists, discontinue use.
Ensure that the stylet has been
removed from the cannula.
Ensure that the RF Electrode is
completely smooth and clean.
Check the gauge of the cannula
and ensure that the correctly
sized probe is in use.
Try another cannula of the
same size.
Check that the connector's
keys are lined up in the proper
orientation.
Ensure that the connectors are
clean and unobstructed.
Discard Immediately.
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