Instructions for Use

Description

Tournisec is a disposable, single use, non-sterile, latex free, form fitting medical undergarment worn by

the patient undergoing lower extremity surgery that acts as the padding for the tourniquet being used for

the procedure. Tournisec is provided in two sizes: Small (waist size ≤35”) - KFG108 and Large (waist size

≥36”) – KFG112. The form fitting nature prevents movement or twisting of the padding while the

tourniquet is placed. It also contains excess adipose tissue and genitals, allowing these structures to be

easily kept away from the tourniquet, making tourniquet application quick and efficient by one person.

After the tourniquet is applied over the Tournisec, the distal end of the Tournisec is everted and folded

back upon itself to secure the tourniquet so that it cannot slide down the extremity.

Indication for Use

Tournisec is a form fitting medical undergarment intended to facilitate the placement of a standard

pneumatic tourniquet on the lower extremity by serving as padding to prevent shifting, moving or

loosening of the tourniquet. Tournisec is a single patient-use medical device.

Precautions

Tournisec is not reusable and could cause product malfunction or risk of infection if reused. Once

removed from patient, dispose of according to hospital procedures.

Directions for Use

1. Select Tournisec size (Small or Large) appropriate for patient’s anatomy

2. Prior to entering the operating room, the patient will don the Tournisec as packaged with the

seams away from the skin

3. Over the Tournisec, loosely place the pneumatic tourniquet around the extremity at the desired

level on the thigh

4. Confirm genitals are not beneath the tourniquet

Note: These body parts can be tucked toward the contralateral side

Note: Look beneath the Tournisec, from the waist, to be sure no genitals are beneath the

tourniquet and, if needed, adjust the Tournisec or tourniquet accordingly

5. Complete application of the tourniquet following instructions for the tourniquet

6. Check again to confirm genitals are free of the tourniquet.

7. Pull the distal edge of the Tournisec leg proximally, folding it back over the tourniquet. (See figure

below)

8. Smooth the folded back edge of the Tournisec at the distal edge of the tourniquet