SEPS

Indications, Safety, and Warnings

Indications

Use of the SEPS™ Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The SEPS Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The SEPS Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

Contraindications

Use of the SEPS Cranial Access Kit is contraindicated for patients with acute subdural hematomas, patients undergoing anticoagulant therapy, and is not designed, sold, or intended for use except as indicated.

Warnings and Precautions

• It is the responsibility of the physician to describe and explain the following warnings, precautions, risks, and complications to the patient and/or their representative(s) prior to proceeding with any surgical procedure.
• This SEPS Cranial Access Kit may include Lidocaine with epinephrine, ChloraPrep^® One-Step, and/or PVP ointment, all of which have expiration dates. The expiration dates of these products should be noted and expired solutions discarded and replaced.
• Use aseptic technique throughout procedures.
• Placement of the evacuating port must be carried out by a qualified physician to avoid penetration of the cerebral cortical surface during the drilling process, which requires standard surgical procedure and skill.
• Maintenance of sterility during the placement and subsequent handling of the evacuating port is essential. Sterile technique should be used at all times when inserting, correcting, or adjusting the evacuating port.
• Lint, fingerprints, talc, and other surface contaminants or residues from surgical gloves may cause foreign body or allergic reactions.
• Improper use of the hand drill including failure to properly secure the drill bit to the chuck, or failure to properly set and secure the safety stop collar to the drill bit may result in serious injury.
• Care must be taken to ensure that particulate contaminants are not introduced into the twist drill hole during insertion of the evacuating port. Failure to do so may result in improper performance of the system.
• Maintain the insertion site with regular meticulous redressing using aseptic technique.
• The evacuating port should be removed if the patient develops signs of irritation, or if there is suspicion of contamination or infection in the operative site.
• Patients undergoing external drainage must be constantly supervised and monitored for signs and symptoms of neurological deficiencies. Inadequate vigilance may lead to serious injury to the patient.
• Care must be taken to prevent pullout of the evacuating port or disconnection of the drainage tubing during patient movement.
• Kinks in the drainage tubing can impair the performance of the Subdural Evacuating Port System.
• If the twist drill hole, evacuating port, or drainage tubing becomes occluded and additional fluid drainage is indicated, needle aspiration of the remaining fluid collection is recommended (Refer to Instructions for Use – Needle Aspiration).
• Alternative options include burr evacuation or craniotomy.

Complications

In addition to the risks associated with any brain surgical procedure, such as bleeding, damage to surrounding brain tissue, seizures, stroke, or death, the following complications may also occur: foreign body reactions; bacterial contamination of the wound, wound abscess, fistula formation, and herniation of tissues at the site of the evacuating port; pneumocephalus; obstruction of the system by kinking the tubing or plugging the tubing or port with blood clots or bone particles, and disconnection of the system.

These complications, as well as persistent or recurring subdural effusion or inadequate placement of the evacuating port may require follow-up surgery such as the need to reposition the port, the placement of a second port, percutaneous needle aspiration or craniotomy.

Important Safety Information

Attention Consumers!
This therapy is not for everyone. Please consult your physician. A prescription is required.

Attention Physicians!
For further information, please contact your Medtronic NT sales representative.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. Refer to product package insert for instructions, warnings, precautions and complications.