SPIDER Traction Accessory English Companion Guide Rev D

Foreword The Smith & Nephew SPIDER Limb Positioner has been designed to provide ideal positioning of the operative limb during surgery. Its design allows intra-operative position changes to be made in the sterile field by the surgeon. The SPIDER allows the surgeon full control of the position of the patient’s limb without the aid of a surgical assistant. The Traction Accessory has been designed to measure and adjust the tension on an arm or leg during a surgical procedure requiring traction. It is a component used as part of the SPIDER Limb Positioning System connected between the SPIDER and a terminal connector. This guide provides a brief description of the manufacturer’s suggested positioning and operation. The attending surgeon will determine the use of this product during surgery.

Table of Contents Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Adjusting Rotation During Surgery. . . . . . . . . . . . . . . . . 5

Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

90° Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Cleaning/Sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

For Further Information. . . . . . . . . . . . . . . . . . . . . . . . . . 6

Setup for Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back Cover

Applying and Adjusting Traction . . . . . . . . . . . . . . . . . . 4

Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back Cover

Components

1.

Traction Scale

6. Locking Cam

2. Fine Traction Collar

7.

Rotation Collar

3. Teflon Bushing

8.

Male Quick Connect

4. Quick Connect Release Button

9.

Rotation Cam

5. Female Quick Connect

SPIDER Traction Accessory

Instructions for Use

79-99-02 Rev. D

3

Warnings • Sterilize prior to use. • The Traction Accessory must be autoclaved for surgical procedures. • Always grasp the patient’s limb, traction accessory, or slender arm of the SPIDER before stepping on the pedal. • Avoid grasping the SPIDER in the quick connection area. Unintentional release can occur causing the SPIDER to fall to the ground. • Do not exceed 50 lbs (22.67 Kg) weight on the SPIDER arm including traction. • Weight limit on the SPIDER when fully extended is 50 lbs (22.67 Kg) including traction. • 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. • Ensure the patient’s skin does not touch the connection bars if cautery is to be used. • Always use Smith & Nephew stabilization kits. Failure to use the kits or improper use can cause injury. • Ensure that the traction accessory has cooled completely after sterilization prior to patient contact. • Thicker structures take longer to cool after autoclaving, ensure that entire device is cool prior to use in surgery. • The surgeon is responsible for monitoring the traction applied to the patient. Care must be taken to ensure excessive traction is not placed on the patient’s limb for extended periods of time. • Do not autoclave the SPIDER.

Figure 1.  Traction Accessory in Start Position (*****)

2. During the setup of the SPIDER the Traction Accessory is inserted into the Piggy Back after the SPIDER Arm has been draped (Figure 2). Ensure the SPIDER Distal Lock and the Piggy Back Lock are engaged to prevent unintentional release. The terminal accessory (Lateral Shoulder Bar, Elbow Bar, etc.) can then be inserted into the Female Quick Connect of the Traction Accessory. After the units are connected the Lock is engaged behind the Quick Connect Release Button.

Figure 2.  Traction Accessory inserted into the SPIDER

WARNING: Thicker structures take longer to cool ensure that entire device is cool prior to use in surgery.

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 Limb Positioner, please read this manual.

Applying and Adjusting Traction 1. Traction is applied in two stages and is reflected on the Traction Scale (Figure 3) to an accuracy of +/- 3 lbs (1.5kg).

Setup for Surgery WARNING: The Traction Accessory must be autoclaved for surgical procedures (see page 6). 1. The Traction Accessory must be prepared for surgery by rotating the Fine Traction Collar counterclockwise until it is just below the start position (*****). (It is preferred to have the Traction Collar one full turn counterclockwise from the start position.) This exposes most of the Teflon Bushing under the Rotation Collar. It allows the travel required for fine traction control (Figure 1).

4

79-99-02 Rev. D

Figure 3.  Traction Scale showing no traction

SPIDER Traction Accessory

Instructions for Use

2. Gross traction is accomplished by grasping the blue collar of the Traction Accessory and the Slender Arm of the SPIDER and pulling to pretension the patient’s limb (Figure 4).

Figure 8.  External Rotation

90° Connector Figure 4.  Applying gross traction

3. Fine traction is increased by rotating the Fine Traction Collar in a clockwise direction (Figure 5). Traction is decreased by rotating the Fine Traction Collar counterclockwise direction. If the SPIDER is released and moved, the traction reverts to zero and gross and fine traction must be reapplied.

Figure 5.  Rotating Traction Collar applies fine traction

The 90° Connector (Figure 9) can be used in place of the Traction Accessory (Figure 10) for any procedure where the measurement and adjustment of fine traction are not required. The 90° Connector allows for the same rotational control as the Traction Accessory.

Figure 9.  90° Connector

Adjusting Rotation During Surgery The Traction Accessory has an added function that allows for an intra-operative adjustment of the rotational alignment of the limb. During surgery the surgeon can release the Rotation Cam (Figure 6) on the Traction Collar and rotate the patient’s limb. Once the desired positioning is obtained the Rotation Collar can be locked in place, securing the patient’s limb (Figures 7–8). Figure 10.  Traction Accessory

WARNING: The surgeon is responsible for monitoring the traction applied to the patient. Care must be taken to ensure excessive traction is not placed on the patient’s limb for extended periods of time.

Figure 6.  Release Rotation Cam to rotate the operative limb

Figure 7.  Internal Rotation

SPIDER Traction Accessory

Instructions for Use

79-99-02 Rev. D

5

Cleaning/Sterilization

For Further Information

• Disconnect the Traction Accessory from the SPIDER and any terminal adapter.

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

• Clean the Traction Accessory by wiping it down in any mild detergent. • The Traction Accessory is fully submersible in any mild detergent. • Autoclave and store the sterile components including the Traction Accessory. The components should be repacked in a sterile manner for the next procedure. If the sterile components are to be used immediately, ensure that all the components have sufficiently cooled. Be aware that thicker metal sections take longer to cool. • Clean and sterilize according to 79-99-04 Cleaning and Sterilization Instructions. Autoclave Type

Gravity

Minimum Exposure Time 10 minutes

Pre-Vac 3 minutes

Minimum Temperature: 132 - 134° C (270 - 272° F) Note: Allow at least 20 minutes to cool at room temperature. CAUTION: Do not autoclave the SPIDER.

6

79-99-02 Rev. D

SPIDER Traction Accessory

Instructions for Use

Warranty This product has a standard 12-month parts and labor warranty against manufacturing defects.

Service Smith & Nephew is committed to providing the highest level of service on our products. If there are any problems, contact us immediately and we will work to find the best solution possible.

U.S. Patent Number: 6,491,273

European Representative Smith & Nephew Medical Limited 101 Hessle Road Hull HU3 2BN United Kingdom [email protected]

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

www.smith-nephew.com +1 978 749 1000 +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service

©2014, 2017 Smith & Nephew, Inc. All rights reserved. 01/2017 79-99-02 Rev. D