Medtronic 60831 Instructions for Use

CARDIOBLATE® BP2

Surgical Ablation Device

60831

Instructions for Use

Caution: Federal law (USA) restricts

this device to sale by or on the order of a
physician.

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

Lot Number

Quantity

Open Here

Consult Instructions for Use

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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Figure 1

Adjustable parallel jaws, 7 cm (2.76 in) in length

1.

2. Seven cm (2.76 in) electrodes with embedded weeping polymer,
5 cm (1.97 in) of which is malleable

3. 300° rotation of jaw assembly

4. Flexible neck

5. Trigger

6. Trigger lock with raised thumb slide

7. Molded handle

8. Saline fluid delivery tubing 304.8 cm (10 ft) in length with a female
luer for connection to standard IV tubing systems

9. Electrical cable 304.8 cm (10 ft) in length that terminates into a multi­pin connector

2

CARDIOBLATE® BP2

Surgical Ablation Device

Model

60831

Description

The Cardioblate® BP2 Surgical Ablation Device is a hand-held, single-

bipolar, radiofrequency ablation device for use in cardiac surgery. It

use,
has a saline irrigation system to deliver fluid at the contact point between
the tissue and electrode to cool the tissue during radiofrequency energy
delivery. The device is intended for intermittent operation.

Sterile, nonpyrogenic, disposable, single use only.

Indications for Use

The Cardioblate® BP2 Surgical Ablation Device is intended to ablate
cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications

The Cardioblate® BP2 Surgical Ablation Device should not be used for:

■

patients that have active endocarditis at time of surgery

■

ablation in a pool of blood (eg, through a purse string suture
on a beating heart) (Effects of this type of ablation are
unknown.)

Adverse Effects

Possible adverse effects related to the ablation of cardiac tissue in
combination with open heart surgery are:

■

tissue perforation

■

extension of extracorporeal bypass

■

perioperative heart rhythm disturbances (atrial and/or
ventricular)

■

postoperative embolic complications

■

pericardial effusion or tamponade

■

injury to the great vessels

■

valve leaflet damage

■

conduction disturbances (SA/AV node)

■

acute ischemic myocardial event

■

thrombus formation

■

nerve damage

■

unintentional burns

■

pericarditis

■

pleural effusion

■

esophageal perforation

■

death

■

coronary sinus perforation

■

coronary artery spasm

■

atrial lead dislodgement

■

hypotension

■

pulmonary vein stenosis

■

cerebrovascular accident

■

transient ischemic attack

■

blood loss

Warnings

Do not activate device if saline is not flowing freely. The cooling of
the outer tissue prevents the charring and tissue desiccation that
may occur when applying radiofrequency energy without irrigation.

Instructions for Use English 3

The device may be damaged before or during the procedure by improper
handling or other intervening acts. If damaged, the device may fail to
function properly, and may result in the following medical complications
including, but not limited to:

■

damage to the physiological conduction system

■

peripheral tissue ablation due to breach of insulation
covering

Device shall be removed from the patient before defibrillation.

representation or warranty is made that failure or cessation of function

No
of the device will not result in an adverse event, or that medical
complications (including perforation of cardiac tissue) will not follow the
procedure, or that the use of the device will in all cases restore adequate
cardiac function.

Precautions

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

of a physician.
Proper surgical procedures and techniques are necessarily the

responsibility of the medical professional. Each surgeon must evaluate
the appropriateness of any procedure based on his or her own medical
training and experience, and the type of surgical procedure.

Patient and procedure selection is solely a medical responsibility and the
outcome is dependent on many variables including patient pathology,
surgical and perfusion procedures.

Use caution to avoid trauma to tissues not within the target area of
ablation.

Purge air from system to ensure saline fluid flows from the electrodes
during use.

Separation of electrodes from tissue contact during activation will result
in a high impedance shutdown placing generator power condition to OFF.
Placing electrodes in direct contact during radiofrequency energy
activation results in a low impedance shut down and places the generator
power condition to OFF. In both situations, three short audible alarm
beeps will be heard. Refer to the Cardioblate generator technical manual
for reset instructions.

Maximum storage temperature: 40°C (104°F)
Storage relative humidity: 5% to 85%, noncondensing
This device was designed for single patient use only. Do not reuse,

reprocess, or resterilize this product. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device
and/or create a risk of contamination of the device, which could result in
patient injury, illness, or death. Multiple uses can result in the occlusion
of the irrigation openings and affect the device’s performance. To prevent
this from occurring, the generator has the capability to detect previously
used ablation devices and will not allow their reuse.

It is the responsibility of the user to dispose of the devices in accordance
with local regulations and hospital procedures.

Due to the presence of phthalates in the product, the clinician must weigh
the medical benefits of product use against the drawbacks of phthalate
exposure for male children and pregnant or nursing women.

Connections to External Devices

1. Connection to the Cardioblate generator is as follows:
a. Position the multi-pin connector of the bipolar device so the

alignment indicator matches the generator port indicator.

b. Insert the multi-pin connector of the bipolar device into the device

port on the generator until it locks in place. Do not force the
connection.

Note: Connect to RF generators (only IEC / EN 60601-1
Type CF) with the following specifications:

4 Instructions for Use English

RF power output
(Transmurality

Mode)
RF power output fre-

quency
Maximum RF volt-

age, between elec­trodes

Note: If additional devices are to be used, refer to their specific
instructions for connections to external devices.

Sterile normal saline, commercially available pressure cuff, and IV

2.
tubing set are required for use with the bipolar device. These are not
included with the Cardioblate® BP2 Surgical Ablation Device.

Model 60880/60890 Model 68000

25 - 40 W
(automatically varying)

479 - 489 kHz 468 - 478 kHz

159 Vrms 180 Vrms ±10%

15 - 40 W
(automatically vary-

ing)

Instructions for Use

1. Inspect the package and device to ensure the expiration date has not
passed and damage has not occurred to the device during shipping
and handling. Do not use the device if the packaging or device is
damaged or if the expiration date has elapsed. Open the package
and transfer the device onto the sterile field utilizing aseptic
technique.

2. Uncoil both the saline delivery tubing and the electrical cable carefully
to avoid kinking and tangling.

3. Attach the saline delivery tubing female luer connector to an IV tubing
set and 1000 mL bag of sterile normal saline. (0.9% normal saline is
recommended because it provides a low impedance pathway for the
radiofrequency energy to the tissue.)

4. If both a bipolar and monopolar device are being used, remove the
sterile caps from the “Y” connector (Model 10004D) provided and
attach the female luer of both devices. Then insert the IV line into the
“Y” connector.

Figure 2.

Insert a 1000 mL bag of 0.9% normal saline into commercially

5.
available pressure cuff and inflate to between 150 and 300 mm Hg.

6. Open the IV line and squeeze the trigger to purge the system of air
until fluid is seen coming from the electrodes on the bipolar device.
Release the trigger to stop IV flow.

Instructions for Use English 5

1

2

2

1. 7 cm (2.76 in) active
electrodes

2.

5 cm (1.97 in) malleable

Figure 3.

7. a. Attach the bipolar electrical cable to the generator per
instructions outlined in “Connections to External Devices.”

b. Shape

the electrodes as required for the targeted tissue. Engage
the lock and squeeze the trigger to bring the electrodes together.
Grip the electrodes with both hands to shape them. Care should
be taken to ensure the electrodes are as parallel as possible. If
the electrodes are out of alignment greater than 4 mm, the ability
of the device to create a transmural lesion across the entire
electrode length may be affected.

c. Release the lock by moving it backward and open the electrodes.

Use the flexible neck and 300° roll to assist in positioning the
electrodes on the targeted tissue. Once the electrodes are
correctly positioned, engage the lock and squeeze the trigger to
bring the electrodes in full contact with the tissue. The lock must
be engaged to ensure accurate transmurality readings.

d. Confirm the generator selector is placed on the bipolar device.

8. Prior to tissue ablation:
a. Squeeze the trigger and make certain that saline is flowing freely

out of the electrodes. Continuous flow of saline is necessary
during ablation to cool the outer tissue. Cooling of the outer tissue
prevents charring and tissue desiccation and allows
radiofrequency energy to be delivered deeper into the tissue to
more effectively create transmural lesions.

Note: While irrigation increases the effectiveness of
radiofrequency ablation, ablating in a pool of fluid can have a
detrimental effect. Radiofrequency energy can shunt between
the two electrodes and the transmurality algorithm may be less
effective. Suctioning of excessive fluid at the ablation site is
recommended to prevent this from occurring.

b. When using a bipolar device, the radiofrequency ablation

generator will default to the TRANSMURALITY control mode.

c. In the TRANSMURALITY mode, all generator parameters will be

automatically adjusted.

9. The current is activated in the device using the RF energy button or
the foot switch provided with the Cardioblate generator. The current
flows between the electrodes.

Table 1. Anticipated Energy Delivery at Various Tissue
Thicknesses

Tissue Thickness (7 cm length) Energy Delivered (W)

10. The lesion becomes visible by a white coloration on the tissue. In
TRANSMURALITY
once a transmural lesion is created. This is the indication to the
surgeon to stop ablating by releasing the foot switch or pressing the
RF energy power button on the generator.

1 mm 439±40
3 mm 505±25
5 mm 557±28

control mode, the generator will emit a solid tone

6 Instructions for Use English

0

2

0

3

04

0

5

06

07

08

0

9

0

01

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

0

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3

1

1. Average Impedance (Ohms)

Time (msec)

2.

3. Power (Watts)

Figure 4. Typical Tissue
Impedance Values with

Corresponding Power Levels.

(Approximate total energy

delivered 570 W)

11. Ablating beyond recommended ablation times may result in tissue
perforation.

Note: To prevent the porous jaws from drying out and clogging,
maintain the jaws immersed in saline or covered with a wet sponge
between ablations.

12.

Upon completion of the surgical procedure, disconnect the device
from the generator and discard.

Clinical Data on Conduction Block

In vitro testing was conducted creating lesion set on porcine atria. In vivo
testing was performed on porcine cardiac tissue for the Cardioblate BP2
Surgical Ablation Device. Transmural lesions were demonstrated with a
95/95 confidence level. The testing resulted in the following lesion
dimensions:

n=3

Max Transmurality Depth (mm) 2.4 ± 2.3
Lesion Length (cm) 3.2 ± 0.6
Lesion Width (mm) 2.8 ± 0.5

These results are consistent with a small, retrospective study conducted

two investigational centers of 69 patients during 2006-2007. Thirty-five

at
of those patients received cardiac tissue ablation using irrigated
radiofrequency (RF) energy. Of the 35 patients, 29 (82.9%) underwent
conduction block assessment confirming transmurality of cardiac tissue
lesions. The remaining 6 patients were not assessed.

Instructions for Use English 7

The following disclaimer of warranty applies to United
States customers only:

Disclaimer of Warranty

ALTHOUGH THE CARDIOBLATE® BP2 SURGICAL ABLATION
DEVICE, HEREAFTER REFERRED TO AS “PRODUCT” HAS BEEN
MANUFACTURED UNDER CAREFULLY CONTROLLED
CONDITIONS, MEDTRONIC HAS NO CONTROL OVER THE
CONDITIONS UNDER WHICH THIS PRODUCT IS USED.
MEDTRONIC, THEREFORE DISCLAIMS ALL WARRANTIES, BOTH
EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
MEDTRONIC
FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT,
FAILURE OR MALFUNCTION OF THE PRODUCT, WHETHER A
CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY,
CONTRACT, TORT OR OTHERWISE. NO PERSON HAS ANY
AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR
WARRANTY WITH RESPECT TO THE PRODUCT.

The exclusions and limitations set out above are not intended to, and
should not be construed so as to, contravene mandatory provisions of
applicable law. If any part or term of this Disclaimer of Warranty is held
to be illegal, unenforceable or in conflict with applicable law, by a court
of competent jurisdiction, the validity of the remaining portions of this
Disclaimer
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY

of Warranty shall not be affected, and all rights and obligations

8 Instructions for Use English

Europe

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United States

Manufacturer:
Medtronic, Inc.
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USA
Internet: www.medtronic.com
Tel. [phone]
Fax [phone]
Toll-free: 1-800-328-2518
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Medtronic
M940537A001 Rev. 1B