Medtronic Skeeter Ultra-Lite Oto-Tool 3055601 Instrucciones De Uso página 5

Cleaning: Automated
Cleaning: Manual
Disinfection
Packaging
Sterilization
(Temperatures are
minimum required,
times are minimum
required)
Maintenance,
Inspection, and
Testing
Storage
Additional Information
Note: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It remains the responsibility of the
processor to ensure that the reprocessing is actually performed using equipment, materials and personnel in the reprocessing facility to achieve the desired result. This
normally requires validation and routine monitoring of the process.
Note: All validations performed per AAMI TIR12:2004, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical
device manufacturers.
Medtronic recommends incineration of devices that have directly or indirectly contacted patients suspected or confirmed with prions or a Transmissible Spongiform
Encephalopathy (TSE) such as Creutzfeldt‐Jacob disease (CJD).
RETURNS AND/OR REPAIRS
Contact Medtronic Xomed Customer Service at (800-874-5797) to obtain a Return Goods Authorization number (RGA#)
prior to shipping the Product to Medtronic Xomed. Please have the original invoice number or purchase order number
available to assist in verifying warranty information. The RGA# should be prominently displayed on the box and included on
all paperwork enclosed with the return and/or repair. All Product returned to Medtronic Xomed should be safely packed in
protective wrapping.
Customer must supply the Purchase Order number; the correct shipping and billing address; and either a completed Repair
Order Form or a statement of the problem or reason for return.
• Remove instruments and equipment from any sterilization trays before placing into washer baskets.
• Orient devices following recommendations of washer/disinfector manufacturers.
• Use alkaline or neutral pH detergent recommended by washer/disinfector or detergent manufacturers.
• These products have been validated for effective cleaning using an automatic washer/disinfector cycle
consisting of a minimum 44 minutes total time, including a pre-wash, main wash & rinse, and thermal
rinse. The thermal rinse shall be at least 10 minutes long at a minimum temperature of 60°C.
• Carefully clean with an enzymatic detergent. Do not fully immerse.
• The cannulated needle nose should be cleaned by immersing in the detergent solution up to the level of
the Bur Release button. Do not use any cleaning instruments in the cannulated shaft of the handpiece.
• Rinse by immersing the distal end of the handpiece (up to the Bur Release button) in distilled water, using
a gentle swirling motion to flush away residual cleaning solution. Avoid water accumulation in the motor
housing by shaking excess water out with a downward motion.
• Silicone spray or Pana Spray should be sprayed into the cannulated shaft of the handpiece prior to
sterilization. Apply silicone spray or Pana Spray
Release Button. Wipe away excess lubricant from the handpiece. Following this procedure will insure that
the bur release mechanism is well lubricated for proper functioning.
• Sterilize the handpieces immediately after cleaning.
Do not cold soak in gluteraldehyde.
• A standard, sterilization wrap may be used. In the US, an FDA approved surgical wrap must be used.
Ensure that the pack is large enough to contain the instrument without stressing the seals.
• In sets: Instruments may be loaded into dedicated instrument trays or general purpose sterilization trays.
Wrap trays using appropriate method.
• The sterilization parameters given below should be used for devices that are fully disassembled when
disassembly is possible. Use basic aseptic technique during post-sterilization assembly to maintain the
sterility of the instrument(s).
• All steam sterilization cycles have been validated in the wrapped configuration and instruments can be
sterilized wrapped or unwrapped.
Cycle Gravity
Temperature
121
°C
Time
30 min
Drying 8 minutes, or until visibly dry.
STERRAD
100S Compatible
100% EtO Sterilization
Parameters
• Inspect components for any damage before and after each use. If damage is observed do not use the
instrument until it is repaired.
• After cleaning and sterilization, verify functionality prior to re-use.
It is extremely important that the handpiece be rapidly and completely dried before storage to prevent
corrosion and residue deposits in the bearing and motor.
None
until surplus lubricant is noted on the outside of the Bur
Gravity Pre-vac
132 132
°C °C
10 min 4 min
Temperature
54 +/- 2°C
Ethylene oxide
600 +/- 25 mg/L
concentration
Aeration at
48-52°C for
8 hrs.
Pre-vac (FR/ Pre-vac
WHO) (UK)
134 134
°C °C
18 min 3 min
Relative
60 +/- 5%
Humidity
Gas Exposure
120
(full cycle)
minutes
EN
3