E/Z Load T-Tube Inserter
0123
Dispositif d’insertion pour tube en T de chargement E/Z
Inseritore per tubi a T con caricamento E/Z
E/Z Load T-Schlaucheinführer
Insertador de tubo en T para carga E/Z
REF 1352237
Product Information and Instructions
Informations et Instructions Concernant le Produit
Informazioni e Istruzioni per L’Uso
Produktinformationen und Answeisungen
Informacion sobre el Producto e Instrucciones de Uso
CUSTOMER SERVICE INFORMATION
For further information regarding the use of this product or to report any problems please contact:
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, FL USA 32216-0980
800-874-5797 or 904-296-9600
68E1296 C 11/10
EC REP
Authorized Representative (for EC regulatory matters):
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
e Netherlands
Phone: 011-31-45-566-8000
Fax: 011-31-45-566-8668
Rx Only
LOADING INSTRUCTIONS
1. Unscrew the cap at the end of the handle
and remove the E/Z load pin.
Slide Control
Expel
Cannulated
Shaft
Load
2. Move the slide control to the load
(rear) position.
3. Slide the T-tube into the
cannulated sha, and
place the E/Z load pin in
the T-tube arms. Slide into
4. Fold the arms of the T-tube
into the sha.
5. Replace the E/Z load pin in
the handle.
the slot on the sha
INTENDED USE/INDICATIONS
e E/Z Load T-Tube Inserter is intended for use for precise control in delivery and insertion of so elastomer T-style
myringotomy vent tubes.
CONTRAINDIC AT IONS
None known.
DESCRIPTION
E/Z Load T-Tube Inserter will accept modied T-tube lengths from approximately 6 mm to 12 mm overall. e internal
plunger, propelled by the slide control, expels the T-tube arms fully as the inserter is pulled away, leaving the T-tube in place.
e plunger will not fully eject the T-tube from the end of the cannulated sha, thus reducing the likelihood of placing the
T-tube through the tympanic membrane.
PRECAUT IONS
• e inserter is constructed of hard-coat aluminum and stainless steel for long life. Take care to protect the cannulated sha
from damage.
• Do not attempt to change the angle of the sha by bending. is sha is specially hardened to accommodate the plunger
mechanism, and bending will damage the sha. For custom adjustment of the preset angulation, return the product to Medtronic
Xomed with a sketch of the desired angle.
WARNING
is product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.
REPROCESSING INSTRUCTIONS (PER ISO17664:2004)
E/Z LOAD T-TUBE INSERTER
Warnings /
Precautions
Limitations Aer clea ning and sterilization, verify funct ionality prior to re-use.
INSTRUCTIONS
Point of Use is product is provided non-sterile and must be cleaned and sterilized before the rst use and any reuse.
Contain ment and
Transportation
Preparat ion for
decontamination
Cleani ng:
Automated
(Do NOT use
ultrasonic washer)
Cleani ng: Manual Soak in lukewarm (less than 43°C), mild (pH 7.0 - 8.5), enzymatic detergent and deionized water for a
Disinfec tion No particular requirements
Packaging No particular requirements
Sterilization
(Temperatures are
minimum required,
times are minimum
required)
Maintena nce,
Inspect ion and
Testing
Storage No particular requirements
Additional
Information
Note: e instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the produc t for re-use.
It remains the responsibility of the processor to ensure t hat the reprocessing as ac tually performed using equipment, materials and
personnel in the reprocessing facility achieve the desired result. is normally requires validation and routine monitoring of the process.
To prevent stains, use distilled or demineralized water, a nd use a neutral detergent, to reprocess these
instr uments
Rinse instrument immediately aer use in distilled or demineralized water
No particular requirements
It is recommended t hat instruments are reprocessed as soon as is practical following use.
Disas semble instruments as necessar y for eective cleani ng.
Remove instruments and equipment from any sterilizat ion trays before placing into washer baskets.
Orient devices following recommendations of washer/disinfector manu facturers.
Use alkaline or neut ral pH detergent recommended by washer/disin fector or detergent manufac turers.
ese products have been validated for eective 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. e therma l rinse shall be at least 10 minutes long at a mi nimum temperature of 60°C.
Examine inst ruments for any staining or deterioration; remove from use as appropriate.
Following cleaning, lightly lubricate instruments with movable par ts. Use a lubricant i ntended for
steril izable instru ments such as a water-soluble instrument milk. Do not use silicone spray.
minimum of 2 minutes, then clean ultrasonically in a lukewar m (less than 43°C), mild (pH 7.0 - 8.5),
detergent and deionized water for at least 30 seconds.
Rinse thorough ly with deionized water immediately and dry and wipe dry with a lint-free cloth.
Examine inst ruments for any staining or deterioration; remove from use as appropriate.
Following cleaning, lightly lubricate instruments with movable par ts. Use a lubricant i ntended for
steril izable instru ments such as a water-soluble instrument milk. Do not use silicone spray.
Note: When using an ultrasonic cleaner or a spray washi ng machine, follow the manufacturer’s
recommendations, particularly with regard to articulated instruments and positioning of instr uments.
Cycle:
Temperature:
Time:
Drying: 8 min or until visibly dry
EtO: Not validated STERR AD Sterilization: Not validated
Inspect components for any damage before and aer each use. If damage is observed do not use the
instr ument until it is repaired or replaced.
Aer clea ning and sterilization, verify funct ionality prior to re-use.
None
Gravity or Pre-vac
121°C
30 min
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