4
1. Disconnect the RF Generator Connector Cable and RF Adapter Cable from
the generator.
2. Refer to Cleaning and Sterilization Instructions for processing devices.
Connections
(Fig. 2)
For the HALYARD* RF Version 3 Adapter Cable.
Cleaning and Sterilization Instructions
Danger
The HALYARD* RF Version 3 Adapter Cable, RF Probe and RF Generator
Connector Cable are shipped non-sterile and must be cleaned and steril-
ized as per this Instructions for Use prior to each use. Failure to properly
clean and sterilize the device can cause patient injury and/or the com-
munication of infectious diseases from one patient to another.
Important
The manufacturer recommends the user follow a quality control program for
each sterilization cycle that meets or exceeds American Operating Room Nurses
(AORN) Standards, Recommended Practices for Sterilization – 2013. This program
includes, but is not limited to recording:
• Type of sterilizer and cycle used
• Lot control number
• Load contents
• Exposure time and temperature, if not provided by a recording chart
• Operator’s name
• Results of sterilization process monitoring (i.e. chemical, mechanical,
biological
Cleaning and Decontamination
1. Ensure that blood and other contaminates do not dry on the
HALYARD* RF Version 3 Adapter Cable and the HALYARD* RF Generator
Connector Cable.
2. 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 HALYARD*
RF Version 3 Adapter Cable 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.
3. Soak the HALYARD*
RF Version 3 Adapter Cable (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.
4. Visually inspect the parts again for debris, if any is present repeat steps
2 and 3.
5. Dry the surface of the device on the outside with a clean, dry towel.
Place back in the Sterilization and Storage Tray.
Sterilization
The following sterilization methods have been validated for use with HALYARD*
RF Version 3 Adapter Cable and the HALYARD* RF Generator Connector Cable:
• Steam Sterilization
• Gravity Displacement Steam Sterilization
• STERRAD® Sterilization
• STERIS® V-PRO® Low Temperature Sterilization
i. Steam Sterilization
Prevaccum: Wrapped: 132°C - 135°C (270°F - 275°F) for 3-4 min.
Unwrapped: “Flash” 132°C (270°F) for 4 min.
ii. Gravity Displacement Steam Sterilization
Wrapped: 132°C - 135°C (270°F - 275°F) for 15 min.
Unwrapped: “Flash” 132°C - 135°C (270°F - 275°F) for 15 min.
iii. STERRAD® Sterilization
HALYARD* RF Version 3 Adapter Cable 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:
For STERRAD® Sterilization, the HALYARD* RF Version 3 Adapter
Cable should NOT be sterilized within the autoclave case. Any validated tray
recommended for use with STERRAD® may be used.
iv. STERIS® V-PRO® Sterilization
The HALYARD* RF Version 3 Adapter Cable may be sterilized with the
following STERIS® V-PRO® systems using the Lumen Cycle:
• AMSCO® V-PRO® 1 Low Temperature Sterilization System
• AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System
• AMSCO® V-PRO® maX Low Temperature Sterilization System
• V-PRO® 60 Low Temperature Sterilization System
All instructions given in the corresponding STERIS® Sterilization System
User’s Guide must be followed.
Warning
Halyard Health has validated ONLY the previously mentioned cleaning
and sterilization methods for the HALYARD* RF Version 3 Adapter
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
TROUBLESHOOTING
No temperature
measurement
in treatment
mode
OR
Inaccurate,
erratic or
sluggish
temperature
reading in
treatment
mode
In order to measure
temperature the
entire system must
be connected and all
wires must be in good
working order.
Ensure that all connections
are made:
• probes to connector
cables
• connector cable to
adapter cable
• adapter cable to
generator
• generator to power
outlet
Check for an error message
on the generator.
Visually inspect the probes,
cables, adapter cable and
generator for damage.
Adapter Cable
does not fit
Generator Plug-
In of connector
cable
Each of the connec-
tors is designed to
connect in a specific
way for safety rea-
sons. If the connector
“grooves” are out of
line the connectors
won’t fit together.
• Check that the
connector grooves are
lined up in the proper
orientation.
• Ensure that the con-
nectors are clean and
unobstructed.
• Check that version
label of the generator
located at the back
is V.3x
• Check that the cables
used are V1.x and V2.x
(14-pin)
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: [email protected]
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.
