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

Device Description

The Smith & Nephew Traction Accessory has been designed to
measure and adjust the tension on a limb during a surgical procedure
requiring traction. The Traction Scale measures force in pounds and
kilograms to an accuracy of +/- 3 lbs. (1.5 kg). It is a component used
as part of the SPIDER Positioning System connected between the
SPIDER and a terminal connector.

Indications for Use

The Traction Accessory is indicated for use during surgical procedures
requiring traction.
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.
• It is the responsibility of the surgeon to ensure that the
traction used is not excessive.
• Do not exceed 50 lbs (22.6kg) weight on the SPIDER arm
including traction.
• Weight limit on the SPIDER when fully extended is 50 lbs
(22.67 Kg) including traction.
• Sterilize prior to use.
• The Traction Accessory must be autoclaved for surgical
procedures.
• Do not let patient's skin touch the accessory if cautery is to be
used.
• Always grasp the patient's limb, traction accessory, or slender
arm of the SPIDER before stepping on the pedal.
• 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.
• Avoid grasping the SPIDER in the quick connection area.
Unintentional release can occur causing the SPIDER to fall to
the ground.
• Ensure that the traction accessory has cooled completely after
sterilization prior to patient contact.
• Thicker structures take longer to cool after autoclaving.
• Single use stabilization kits are supplied as a Radiation
Sterilized Product.
• Be sure not to contaminate the sterile field. Movements close
to or below the table level must be watched closely for sterile
field contamination.
• If air pressure in the O.R. is lost the SPIDER will hold the joint
position until the pedal is released.
• 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.
• Always use Smith & Nephew stabilization kits. Failure to use
the kits or improper use can cause injury.
Instructions for Use
Traction Accessory
• To understand the full use of this product please read the
Traction Accessory Instructions for Use.
• To ensure the understanding of the safe use of the SPIDER
Limb Positioner, please read the SPIDER Limb Positioner
Instructions For Use.
• Care must be taken to ensure excessive traction is not placed
on patient's limb for extended periods of time.
• Do not autoclave the SPIDER.
• Always grasp the Slender Arm of the SPIDER, and the Fine
Traction Collar (Blue) when setting the gross traction on the
limb.
Precaution
U.S. Federal law restricts this device to sale by or on the order
of a physician.
Components
Figure 1. Traction Accessory
1. Traction Scale
3. Rotation Collar
5. Male Quick Connect
7. Female Quick Connect
9. Quick Connect Release Button
Instructions for Use
1. The Traction Accessory must be autoclaved for surgical procedures.
Prepare Traction Accessory for surgery by rotating Fine Traction
Collar counter-clockwise until it is just below the Start position
(******). It is preferred to have Traction Collar one full turn
counterclockwise from the Start position (******). This allows the
travel required for fine traction control (Figure 2).
Figure 2. Traction Accessory in Start Position (*****)
English
2. Fine Traction Collar
4. Rotation Cam
6. Teflon Bushing
8. Quick Connect Lock
79-99-01 Rev. F
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