Medtronic 49321 Instructions for Use

Cardioblate™ BP2 49321

Surgical Ablation Device

Instructions for Use

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

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property
of their respective owners.

Cardioblate, Covidien, LigaSure, Medtronic, TissueFect, Valleylab

Explanation of symbols on package labeling

Refer to the device labeling to see which symbols apply to this product.

Nonpyrogenic

Sterilized using ethylene oxide

Do not reuse

Do not resterilize

Do not use if package is damaged

Use-by date

Lot number

Quantity

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Consult instructions for use at this website

For US audiences only

Upper limit of temperature

Humidity limitation

Date of manufacture

Catalog number

Manufacturer

Type CF applied part

Contains di(2-ethylhexyl)phthalate (DEHP)

Authorized representative in the European Community

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1 Model

49321

2 Product description

The Cardioblate BP2 surgical ablation device is a hand-held, single-use, bipolar, radiofrequency (RF) ablation device for use in
cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue
during RF energy delivery. The device is intended for intermittent operation.

The Cardioblate BP2 surgical ablation device (Model 49321) is intended for use with the Covidien™ Valleylab™ FT10 FT series
energy platform with TissueFect™ technology (Model VLFT10GEN) with software version 3.0.0 or higher.

Sterile, nonpyrogenic, disposable, single use only. Sterilized using ethylene oxide.

Rated accessory voltage: 382 V

Figure 1.

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1 Adjustable parallel jaws, 7 cm (2.76 in) in length
2 7 cm (2.76 in) electrodes embedded in a porous polymer, 5 cm (1.97 in) of which is malleable
3 300° rotation of jaw assembly
4 Malleable neck
5 Trigger
6 Trigger lock with raised thumb slide
7 Molded handle
8 Saline fluid delivery tubing 304.8 cm (120 in) in length with a female luer for connection to standard IV tubing systems
9 Electrical cable 304.8 cm (120 in) in length that terminates into a multi-pin connector

3 Indications for use

The Cardioblate BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

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