En - English - Integra Padget Manual Del Usuario

Padgett by Integra
®
Hand and Hand Fixation Device
CAUTION: Federal (USA) law restricts this device to sale by or on the order
of a licensed medical professional.
Description
The Padgett® by Integra® Miltex® Aluminum Orthopedic Hand is used for
reconstructive hand surgery and provides a more environmentally friendly
alternative to traditional lead hands and splints. The Aluminum Hand may
be used during x-ray and fluoroscopy procedures.
The Padgett by Integra Miltex Hand Fixation Device is used for
reconstructive hand surgery allowing fixation of single joints from carpus
to fingertips and has adjustable finger and wrist restraints to facilitate
achieving a customized fit for individual patient anatomical anomalies.
Indications for Use
The Padgett by Integra Miltex Orthopedic Hand and the Padgett by Integra
Miltex Hand Fixation Device are indicated for use for stabilization of the
hand during surgical procedures.
Contraindications
None Known
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Warnings
DO NOT flash sterilize the Padgett by Integra Miltex Orthopedic
•
Hand Fixation Devices. The instruments have not been validated for
flash sterilization.
Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD)
•
exposure.
The Padgett by Integra Miltex Aluminum Orthopedic Hand Fixation
•
Devices have not been validated to withstand the chemical and
thermal exposures recommended to eradicate prions.
Precautions
Read the Instructions for Use and keep them in a safe place.
•
Use the product only in accordance with its intended use, see
•
INDICATIONS FOR USE.
Use of an instrument for a task other than that for which it is
•
intended could result in a damaged or broken instrument, or one
which provides an unsatisfactory performance.
Instruments should be handled and operated by personnel
•
completely familiar with their use, assembly and disassembly.
Instruments must be rendered safe for handling, inspection and
•
assembly by wearing appropriate personal protection equipment
(PPE) as promulgated by OSHA & AORN.
2
Miltex Aluminum Orthopedic
® ®
Inappropriate use of instruments will lead to damage that is usually
•
not repairable.
Instruments must be thoroughly inspected upon receipt and prior
•
to use to assure proper functioning. Failure to make a complete
inspection to assure proper operation and function of instrument
may result in unsatisfactory performance.
Padgett by Integra Miltex Hand Fixation Device is supplied non-
•
sterile and must be pre-cleaned, cleaned, lubricated, visually
examined and sterilized prior to use. Please see pre-cleaning,
cleaning, visual examination, and sterilization procedures below.
Prior to each use, inspect the product for: loose, bent, broken,
•
cracked, worn, or fractured components.
Do not use the product if it is damaged or defective. Discard and
•
replace product if the coating is cracked or damaged.
Store products in a dry, clean and safe place.
•
Handle and dispose of in accordance with accepted medical
•
practice and applicable laws and regulations
Adverse Reactions
None Known
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Pre-Cleaning, Cleaning, and Sterilization Procedures
Before using the instruments pre-clean, clean (manual or
•
automated), dry, visually examine, and sterilize following the
procedures below.
Personnel should follow accepted guidelines as recommended in
•
ANSI/AAMI ST79:2006, A1:2008, A2:2009 -Comprehensive guide to
steam sterilization and sterility assurance in health care facilities.
Cleaning and Sterilization
Cleaning:
Device must be cleaned in accordance with standard institutional protocol
prior to sterilization as promulgated by OSHA and AORN.
Sterilization:
After cleaning, sterilize using the following parameters.
Double wrap the instruments in standard central supply wrap.
1.
Place wrapped instruments in a sterilization chamber and cycle per
2.
the following:
Sterilizer Type Configuration Temperature
Pre-Vacuum Wrapped
Gravity Wrapped
EN – English
Exposure Time
132°C (270°F) 4 minutes
121°C (250°F) 30 minutes