Device Description; Indications For Use - Smith & Nephew SPIDER Modo De Empleo

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Device Description

The Smith & Nephew Ankle Arthroscopy Accessory, used with the
SPIDER Limb Positioner, is used to position a patient's leg for Ankle
Arthroscopy procedures. With a patient in the supine position the
SPIDER and Traction Accessory control the position and amount of
traction on the ankle.

Indications for Use

The Ankle Arthroscopy Accessory is indicated for use during ankle
arthroscopy procedures.
Warnings
• Failure to do the following may result in injury to the patient
and/or health care professional.
• It is the responsibility of the surgeon to be familiar with
the appropriate surgical techniques prior to the use of this
product.
• Do not exceed 50 lbs (22.7kg) weight on the SPIDER arm.
• Sterilize prior to first use.
• Ensure that all accessories have completely cooled after
autoclaving.
• Be sure not to contaminate the sterile field. Movements close
to or below the table level must be watched closely for sterile
field contamination.
• Do not let patient's skin touch the accessory if cautery is to be
used.
• Do not apply excessive amounts of Traction.
• Do not grasp the SPIDER over the Quick Connect Release
Buttons as this can disengage the Quick Connect Locks and
disconnect the limb from the SPIDER.
• Grasp the SPIDER slender arm and traction accessory before
stepping on the pedal. The SPIDER can fall to the ground when
the pedal is stepped on if the limb is not held or if the quick
connect button has been accidentally pressed.
• Care must be taken when applying the Ankle Stabilization Kit
to ensure sufficient circulation is maintained in the patient's
foot and ankle.
• Always hold the patient's foot or the Traction Accessory Collar
before stepping on the Foot Pedal.
• Single use stabilization kits are supplied as a Radiation
Sterilized Product.
• Single use stabilization kits are not to be reused or used if
packaging has been damaged. Failure to comply may result in
patient injury and/or infection.
• To ensure the understanding of the safe use of the SPIDER
Limb Positioner for ankle procedures, please read the SPIDER
Limb Positioner, Traction Accessory and Ankle Arthroscopy
Accessory Instructions for Use.
• Always use Smith & Nephew Ankle Stabilization Kits. Failure to
use the kits or improper use can cause injury to the patient.
2
80-99-01 Rev. E
Precautions
U.S. Federal law restricts this device to sale by or on the order
of a physician.
• When connected to the SPIDER the air or nitrogen pressure should
be set to 100-110 psi (6.8–7.6 Bar).
• If air pressure is lost, the SPIDER will remain rigid until the foot
pedal is activated.
• Always use Smith & Nephew stabilization kits; failure to use the kits
or improper use can cause injury to the patient.
• Do not autoclave the SPIDER.
Instructions for Use
1. The SPIDER is positioned 15" (37.5cm) from the foot of the O.R.
table on the non-operative side rail. The SPIDER is rotated to the
horizontal position facing toward the foot end of the table (Figure 1).
Figure 1. Orientation of SPIDER on O.R. table
2. After intubation, the patient must be positioned so the operative
foot is within 6 inches (15cm) from the foot of the O.R. table.
3. Place a counter traction support under the thigh of the operative
leg.
4. Once the patient is prepped and draped, insert the male post
of the sterile Piggy Back into the female receptor on the SPIDER.
Drape the SPIDER with the SPIDER Drape from the Smith & Nephew
Ankle Stabilization Kit (Figure 2). Ensure a new sterile kit is used for
each surgery.
A
Figure 2. Ankle Stabilization Kit
A. SPIDER Drape B. Ankle Stabilization Strap
Ankle Arthroscopy Accessory
Piggy Back
B
Instructions for Use