Endotine SurgiWire Instruction Manual

SurgiWire™ Incisionless Dissector Instructions for Use

REF 19005

DESCRIPTION

The SurgiWire™ Incisionless Dissector consists of two Keith needles connected by a multi-strand Stainless Steel wire.

STERILIZATION

The product is pre-sterilized by gamma irradiation and intended for single use only. Do NOT resterilize the device.

INDICATIONS

The SurgiWire™ Incisionless Dissector is indicated for use in subcutaneous dissection of tissue planes in order to perform aesthetic procedures.

CONTRAINDICATIONS

1. Procedures in which blind dissections should not be performed.
2. Do not use in dissections below the Platysmal muscle or in other planes of dissection that are not subcutaneous.

PACKAGING and LABELING

The SurgiWire™ Incisionless Dissector is intended for single use only. The device should be accepted only if the factory packaging and labeling arrive intact. Do not use if packaging shows evidence of puncture(s), tampering, water contamination or other damage.

INSTRUCTIONS FOR USE

1. Remove the device from the package by slowly lifting both Keith needles towards you until all of the wire has been removed from the packaging.
2. Insert one Keith needle through the skin into the subcutaneous plane at the dermal level to access the desired plane of dissection. Undermine from Location #1 to Location #2 (Shown in Figure 1) in order to create one side of the desired dissection area.
3. The end of the Keith needle and the wire should exit through Location #2.
4. Reinsert the needle into the dermis at Location #2 (Shown in Figure 2). For best results, the needle should be reinserted into the exact location at which it exited the dermis.
5. Undermine from Location #2 to Location #3.
6. The end of the Keith needle and the wire should exit through Location #3.
7. Reinsert the needle into the dermis at Location #3 (Shown in Figure 3).
8. Undermine from Location #3 to Location #1.
9. The end of the Keith needle and the wire should exit through Location #1.
10. Cross the two ends (Keith needles) and gently apply an alternating oscillating motion from side to side to advance the wire loop towards Location #1 until the entire wire has been removed through Location #1 (Shown in Figure 4).

PRECAUTIONS

1. Surgeon caution and knowledge of anatomy is required due to blind dissection.
2. Use care around any existing implanted devices. Use of the SurgiWire™ Incisionless Dissector could dislodge some devices.
3. A type of hemostasis should be available at all times during the use of the device in the event a vessel is affected during the procedure.
4. Use care while dissecting to remain in the subcutaneous plane to avoid sensory, motor nerve or blood vessel damage.
5. Kinks in the wire will occur due to the oscillating motion. If the wire will be used for a second dissection on the same patient, keep the kinked portion of the device away from the tissue.

WARNINGS

1. DO NOT REUSE OR RESTERILIZE the SurgiWire™ Incisionless Dissector. This device is for SINGLE USE ONLY and MUST NEVER BE RE-USED. Resterilization may cause loss of function or failure of the device. Risks of re-use may include patient infection due to lack of sterility.
2. Exercise caution as the SurgiWire™ Incisionless Dissector device contains sharp ends that may catch or tear gloves.
3. Inspect all components for damage before use. Do not attempt to repair damaged components.

Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the order of a physician.

LBL -190-7211 Rev H