SPIDER Leg Accessory Guide Rev F

English

SPIDER2™

SPIDER™ Leg Accessory

Limb Positioner

Instructions for Use

Device Description

• It is the healthcare professional’s responsibility to ensure that the amount and direction of forces do not pose any danger to the patient.

The Smith & Nephew SPIDER Leg Accessory has been designed to hold the operative foot during knee procedures when traction is not required.

• To ensure the understanding of the safe use of the SPIDER2 Limb Positioner, read the SPIDER2 Limb Positioner (126-99-01) manual.

Intended Users

• Ensure that all accessories have completely cooled after sterilization and prior to patient contact.

The SPIDER Leg Accessory is intended for use by healthcare professionals in accordance with these instructions for use. The use environment is a professional healthcare facility.

• Do not let patient’s skin touch the accessory if cautery is to be used.

The SPIDER™ Leg Accessory is compatible with the SPIDER Limb Positioner and the SPIDER2™ Limb Positioner.

Intended Use The SPIDER Leg Accessory is intended to be used during surgical procedures of the knee or femur (that do not require traction) to maintain the patient's lower limb position.

Indications for Use The SPIDER Leg Accessory is indicated for use with the SPIDER2 Limb Positioner during surgical procedures of the knee or femur that do not require traction.

Contraindications Target Patient Groups The targeted population is patients undergoing surgical procedures that require positioning of the limbs.

Warnings Failure to do the following may result in injury to the patient and/or health care professional. • This product is shipped non-sterile. It must be sterilized before the first use. It must be cleaned and sterilized before every subsequent use. • It is the healthcare professional’s responsibility to be familiar with the appropriate surgical techniques prior to the use of the product. • Read these instructions completely prior to use.

127-99-01 Rev. F

• Always use Smith & Nephew Stabilization Kits. Failure to use the kits or improper use can cause injury to the patient. • 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. • 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 patient’s foot and toes.

None known.

2

• Do not grasp the SPIDER2 over the Quick Connect Release Buttons as this can disengage the Quick Connect Locks and disconnect the limb from the SPIDER2.

Instructions for Use

Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a damaged device. • This product contains Nickel (Ni), which may cause allergic reactions.

Adverse Event Reporting If, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority. [email protected]

English

Instructions for Use

5. Connect the Leg Accessory to the 3D Connector by inserting the 3D Connector Ball into the Leg Accessory Ball Clamp (Figure 3). The Clamp must be fully open by rotating the Handle counterclockwise as far as possible. To close the clamp, rotate clockwise.

Figure 1.  SPIDER™ Leg Accessory components

A. Leg Accessory Purple handle for right leg Gold handle for left leg

Leg Stabilization Kit A. Foam liner B. Self Adhesive Bandage C. Drape

B. 3D Connector 1. Follow the SPIDER2™ preparation instructions in the SPIDER2 Limb Positioner manual (126-99-01). 2. Place the contents of the Leg Stabilization Kit on the sterile back table. 3. Attach the Foam Liner 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 2).

Figure 3.  Connect the Leg Accessory to the 3D Connector.

Note: 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 4).

Figure 4.  Loosening and tightening the Ball Clamp Handle.

6. If the Switch Drape is used, apply the Distal Activation Button to the top of the 3D Connector (Figure 5). Figure 2.  Disposable Liner attaches to Leg Accessory.

4. Insert the 3D Connector into the exposed Piggy Back. An audible click ensures it is secured. Ensure all of the connections are secure, and then lock the Quick Connect Locks.

Figure 5.  Adhere Distal Activation Button to the top of 3D Connector.

Instructions for Use

127-99-01 Rev. F

3

English 7. Loosen the Handle on the Leg Accessory by ½ of a turn, and then orient the Leg Accessory over the patient’s operative leg with the heel of the Leg Accessory lining up over the heel of the patient. 8. Place the foot of the patient's operative leg onto the SPIDER™ Leg Accessory. Ensure that the patient’s heel sits deep into the heel of the Leg Accessory. 9. Wrap the self adhering bandage around the foot, shin and SPIDER Leg Accessory. Do not over tighten (Figure 6).

Cleaning and Sterilization 1. Remove and discard all single-use components according to the facility protocol. 2. Follow instructions in the SPIDER2 manual (126-99-01) to clean the SPIDER2 Limb Positioner. 3. Clean and sterilize reusable accessories according to the SPIDER2 Accessories Cleaning and Sterilization Instructions (79-99-04). – Before returning or disposing of reusable accessories, clean and sterilize according to the SPIDER2 Accessories Cleaning and Sterilization Instructions (79-99-04).

Expected Service Life The SPIDER Leg Accessory is a reusable instrument. The functional life of these devices depends on various factors including frequency of use, the method and duration of each use, as well as post-operative methods and handling. Proper maintenance of your equipment is essential to achieve optimal performance over time.

Figure 6.  Wrap leg and accessory with Self Adhering Wrap.

Intraoperative Position Changes The patient’s leg can be repositioned intraoperatively by sterile surgical staff quickly and easily. 1. Leg position can be altered by grasping the operative foot and the 3D connector, stepping on the SPIDER2™ Foot Pedal, or pressing the Switch Drape Button, moving the leg to the desired position and stepping off the Foot Pedal or releasing the Button. 2. Rotation and repositioning of the foot is accomplished by loosening the Ball Clamp by turning the Handle half a turn in a counterclockwise direction, repositioning the foot and retightening the Handle (Figure 4). 3. To release the leg from the SPIDER2, turn the Handle counterclockwise as much as possible and pull the Clamp off of the Ball of the 3D Connector. The leg can then be manipulated and moved. To re-attach to the SPIDER2, place the Clamp back over the Ball of the 3D Connector and retighten the Handle by turning clockwise.

4

127-99-01 Rev. F

Instructions for Use

The SPIDER Leg Accessory should be inspected before procedural use. Smith & Nephew recommends returning the device for service if the below are indicated: • Ball clamp is damaged.

For Further Information If further information, including warranty, on this product is needed, contact Smith & Nephew Customer Service at +1 800 343 5717 in the U.S., or an authorized representative.

English

Symbols Glossary Medical Device

Consult Instructions for Use

CE mark

Authorized representative in the European community

Non-sterile

Prescription use only Leg Stabilization Kit

Caution Manufacturer Date of manufacture

CE mark Sterile Use-by date

Batch code Catalog number

Do not use if package is damaged

Serial number

Do not resterilize

Unique Device Identifier

Do not reuse

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

™Trademark of Smith & Nephew. +1 978 749 1000 Telephone +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service

U.S. Patent Number 6,491,273. www.smith-nephew.com ifu.smith-nephew.com

©2014, 2020 Smith & Nephew, Inc. All rights reserved. Instructions for Use

127-99-01 Rev. F

5