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

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Device Description

The Smith & Nephew SPIDER Leg Accessory has been designed to rigidly hold
the operative foot during knee procedures when traction is not required. The
SPIDER Leg Accessory is used with the SPIDER/SPIDER2 Limb Positioner.

Indications for Use

The SPIDER Leg Accessory is indicated for use during surgical procedures of the
knee or femur that do not require traction.
Warnings
Failure to do the following may result in injury to the patient and/or
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health care professional.
• It is the responsibility of the surgeon to be familiar with the
appropriate surgical techniques prior to the use of the product.
• It is the responsibility of the surgeon to ensure that the amount and
direction of forces do not pose any danger to the patient.
Do not exceed 50 lbs (22.7Kg) weight on the SPIDER arm.
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Sterilize prior to first use.
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Ensure that all accessories have completely cooled after autoclaving.
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Do not let patient's skin touch the accessory if cautery is to be used.
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Do not grasp the SPIDER/SPIDER2 over the Quick Connect Release
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Buttons as this can disengage the Quick Connect Locks and
disconnect the limb from the SPIDER/SPIDER2.
The Surgeon is responsible to ensure that the amount of padding will
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sufficiently protect the patient's soft tissues from the forces acting on
the limb.
• Single use stabilization kits are supplied as a Radiation Sterilized
Product.
Single use stabilization kits are not to be reused or used if packaging
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has been damaged. Failure to comply may result in patient injury and/
or infection.
To understand the full use of this product, read the SPIDER Leg
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Accessory Instructions for Use.
To ensure the understanding of the safe use of the SPIDER/SPIDER2
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Limb Positioner, read the SPIDER/SPIDER2 Limb Positioner Instructions
for Use.
• Care must be taken to ensure excessive force or pressure is not placed
on patient's limb for extended periods of time.
Care must be taken to ensure sufficient circulation is maintained in the
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patient's foot and toes.
Ensure that the Ball Clamp is not left in the released position after the
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Leg Accessory is connected to the 3D Connector.
Ensure that the Ball is fully inserted into the Clamp.
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Precautions
U.S. Federal law restricts this device to sale by or on the order
of a physician.
• To ensure the understanding of the safe use of the SPIDER/SPIDER2 Limb
Positioner for knee procedures please read the instruction manual.
• If the SPIDER is being positioned below the O.R. table, ensure the sterile
field is maintained as the SPIDER is raised and lowered during surgery.
• When connected to the SPIDER the air or nitrogen pressure should be set to
100-110 psi (6.8-7.6 Bar). The SPIDER2 does not require adjustment.
• 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.
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127-99-01 Rev. E
Components
A. Leg Accessory
Purple handle for right leg
Gold handle for left leg
B. 3D Connector
SPIDER/SPIDER2 Attachment
• The SPIDER/SPIDER2 is placed on the operative side of the O.R. table,
proximal to the patient's hip and oriented horizontally with the elbow joint
below the table top and the distal joint oriented toward the foot end of the
O.R. table (Figure 1).
Figure 1. SPIDER Horizontal on rail
• There is a right and left Leg Accessory. Use the one which will put the Ball
Clamp Handle on the medial side of the foot (Figure 2).
Figure 2. Loosening & tightening the Ball Clamp Handle
Instructions for Use
Sterile Preparation
1. The contents of the Leg Stabilization Kit are placed on the sterile back table.
2. The Foam Liner is attached to the Leg Accessory by pushing the end tab on
the black plate into the heel of the Accessory while positioning the hole in
the plate over the button on the sole of the Leg Accessory and clicking in
place (Figure 3).
Figure 3. Disposable Liner Attaches to Leg Accessory
Leg Stabilization Kit
A. Foam liner
B. Self Adhesive Bandage
C. SPIDER Drape
Instructions for Use
SPIDER Leg Accessory
Piggy Back