Intended Use; Purpose; Indications; Contraindications - KLS Martin group marVac Instructions For Use Manual

3 Intended use

3.1

Purpose

The external line current detector is an accessory component of the marVac
smoke evacuators. It is used in combination with an electrosurgery or laser surgery device which has
neither a footswitch output nor a compatible MCB interface.
The fan of the smoke evacuator is switched on or off depending on the power consumption of the
connected surgical device.
We recommend recording the instruction in a medical device book. The medical device book can be
obtained from the manufacturer.
The operator may only operate the device if a functional test has previously been carried out at the
operating site by the manufacturer or by a person authorized by the manufacturer. In addition, a person
commissioned by the operator must have been instructed in the proper handling, use and operation as well
as in the permissible connection with other medical devices, objects and accessories. This responsible,
instructed person then trains staff to operate the device for the operator.
3.2

Indications

The indications result from the intended purpose.
3.3

Contraindications

No existing contraindications.
3.4

Clinical benefit

See IFU marVac / maxium smart Vac, section 1.8, "Accompanying Documents", page 36.
3.5

Possible adverse effects

See IFU marVac / maxium smart Vac, section 1.8, "Accompanying Documents", page 36.
3.6

Target patient population

See IFU marVac / maxium smart Vac, section 1.8, "Accompanying Documents", page 36.
3.7

Users

The products are to be used exclusively by qualified medical staff.
Cleaning, disinfection and sterilization are carried out by trained qualified staff in the processing unit for
medical products.
3.8

Environmental conditions during use

Use only in ORs under conditions appropriate for surgery or in medical facilities designed for this.
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marVac® / maXium® smart Vac iDetect external line current detector
Instructions for Use
® ®
and maXium smart Vac
Revision 04