Intended Use; Intended Purpose; Indications; Contraindications - KLS Martin group marSeal5 plus Gebrauchsanweisung

Bipolar Sealing System marSeal5 plus/ - Maryland
Instructions for Use

3 Intended Use

3.1

Intended Purpose

The bipolar sealing instrument marSeal5 plus is intended for permanent occlusion of veins, arteries and
tissue bundles, with subsequent dissection of the sealed tissue using the same instrument. The instrument
can be used in both open surgery and laparoscopy.
3.2

Indications

The indications result from the intended purpose.
3.3

Contraindications

• Tube ligation with the marSeal5 plus is not a reliable procedure for contraception
• Not for use on the appendix!
3.4

Clinical Benefit

Sealing of vessels and tissue bundles with subsequent separation and without instrument change.
3.5

Possible Adverse Effects

If used correctly, no product-specific side effects are known. The user is responsible for educating the
patient about the possible side effects and complications associated with the surgical procedure.
3.6

Residual Risks

The user is responsible for informing the patient about existing residual risks in connection with the use of
this product.
3.7

Patient Target Group

There are no restrictions regarding the patient target group.
3.8

Users

The products are to be used exclusively by qualified surgical staff.
Cleaning, disinfection and sterilization are carried out by trained qualified staff in the processing unit for
medical products.
3.9

Ambient Conditions during Application

Application is restricted to the OR under proper surgical conditions or to medical areas intended for this
purpose.
Revision 06 57