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SURGICAL
TECHNIQUE
OsteoCool™ RF Ablation System
and Bone Access Kits

Medtronic
Spinal and Biologics Business
Worldwide Headquarters
2600 Sofamor Danek Drive
Memphis, TN 38132

Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132

The surgical technique shown is
for illustrative purposes only. The
technique(s) actually employed in each
case will always depend upon the medical
judgment of the surgeon exercised
before and during surgery as to the best
mode of treatment for each patient.

Consult instructions for use at this
website www.medtronic.com/manuals.

Please see the package insert for the
complete list of indications, warnings,
precautions, and other important medical
information.

Note: Manuals can be viewed using a
current version of any major internet
browser. For best results, use Adobe
Acrobat™ Reader with the browser.

(901) 396-3133
(800) 876-3133
Customer Service: (800) 933-2635

medtronic.com

© 2017 Medtronic. All rights reserved. UC201605782b EN PMD016254-4.0

CONTENTS

OSTEOCOOL RF ABLATION SYSTEM AND BONE ACCESS KITS
SUBHEAD

	 3	 System Setup
	 6	 Patient Positioning
	 6	OsteoMAPSM Technique
Using Bone Access Kits — Spine
	 8	OsteoMAPSM Technique Using
Bone Access Kits — Sacrum,
Iliac, and Acetabulum
		9 Sacrum
		10 Iliac
		11 Acetabulum
	12	Use of the Precision Drill —
Spine
	14	Use of the Precision Drill —
Sacrum, Iliac, and Acetabulum
	16	Probe Selection and Tube Kit
Preparation
	17	 Filling the OsteoCool™ Tube Kit

3

19		Connecting the Probe to
the Tube Kit
20		Connecting to the Connector Hub
	21	Performing RF Ablation — Spine
	23	Performing RF Ablation — Sacrum,
Iliac, and Acetabulum
	25	Optional Track RF Ablation
	26	Optional Temperature
Monitoring with the Independent
Thermocouple
	26	Performing RF Ablation Using
Custom Settings
	27	Bone Access for Subsequent
Procedures
	27	General Safety Guidelines
	28	Product Ordering Information
	28	Important Product Information

1

SYSTEM
SETUP
The OsteoCool™ RF Ablation System is
indicated for palliative treatment in spinal
procedures by ablation of metastatic
malignant lesions in a vertebral body.
It also is intended for coagulation and
ablation of tissue in bone during surgical
procedures, including palliation of pain
associated with metastatic lesions
involving bone in patients who have
failed or are not candidates for standard
therapy.
The system contains an RF generator,
peristaltic pump, and the connector
hub, which provides two channels
for the use of the OsteoCool™ RF
ablation probes and two channels for
use of the OsteoCool™ independent
thermocouples.

The OsteoCool™ RF ablation probe
uses a coaxial, bipolar technology that
delivers localized tumor ablation and
automatically moderates power to keep
RF heating within the desired treatment
range, reducing risks of potential thermal
damage to adjacent structures.
The active tip of the RF ablation probe
is internally cooled with circulating
water. RF energy heats the tissue
while circulating water moderates the
temperature in close proximity to the
active tip. This combination creates
large volume lesions without excessive
heating at the active tip.

The OsteoCool™ RF ablation probes are
sterile and intended for single use.
The OsteoCool™ Bone Access Kit is a
single-use device intended to contact
body tissues. Do not reuse, reprocess, or
resterilize.
The OsteoCool™ independent
thermocouple is for optional
temperature monitoring at or near the
site of ablation.
A physician using this equipment must
be familiar with bony anatomy, imageguided procedures, and bone access
techniques.
Refer to the OsteoCool™ Instructions
for Use for complete generator and
pump setup.

Important
This guide does not replace the information in the Instructions for Use provided
with the components of the OsteoCool™ RF Ablation System, OsteoCool™ RF
Ablation Probes, OsteoCool™ Bone Access Kits, and the OsteoCool™ Independent
Thermocouple. The Instructions for Use includes important information such as
warnings, precautions, contraindications, and troubleshooting. It is important to read
the Instructions for Use and these precautions carefully prior to device operation.
Additional help information can be accessed through the “help” button located on the
generator screen.

The system may be mounted on a rolling cart or a desk stand (see following instructions).

Desk Stand Assembly and Equipment Mounting
1. Assemble the desk stand by sliding the pole into
the base and tightening the set screw with the
provided Allen wrench (Figure 1).

RF-Generator
Mount

2. Position the desk stand on a stable surface and in
close proximity to an electrical source.
3. Mount the pump by sliding the quick connect
bracket on the back of the pump down the
opposite mounting bracket located on the
bottom of the desk stand (Figure 2a). Mount the
generator by sliding the quick connect bracket
on the back of the generator down the opposite
mounting bracket located on the top of the desk
stand (Figure 2b).
4.  Proceed to cable connection.

Pump
Mount

Front View

Please note that the anatomy included in this guide reflects some of the most
common locations for metastatic bone tumors — spine, pelvis, and hip — but it is not
all inclusive of areas in which the OsteoCool™ system can be used. The OsteoCool™
RF Ablation System is indicated for the palliative treatment in spinal procedures
by ablation of metastatic malignant lesions in a vertebral body. It is also intended
for coagulation and ablation of tissue in bone during surgical procedures, including
palliation of pain associated with metastatic lesions involving bone in patients who
have failed or are not candidates for standard therapy.

Isometric View

2b

2a

Figure 1
2

Figures 2a (Pump Bracket) and
2b (Generator Bracket)
3

Cart Mounting

Connect Cables and Power on the Generator and Pump

1.  Position the cart in proximity to an electrical source.

2. Connect power cables to the back of both the
generator and pump.

2. Lock the wheels on the cart before mounting
the devices.

a. Connecting Power Cables with the Desk Stand:
Route the cable to the backside of the pole and use
the clips on the desk stand to manage the power and
USB cables (Figure 5a).

3b
Generator
Quick Connect
and Release

3. Mount the pump by sliding the quick connect bracket
on the back of the pump down the opposite mounting
bracket located on the bottom of the cart (Figure 3a).

b. Connecting Power Cables with the Cart:
The cart is provided with cables that are fed through
the cart pole. Attach the connections located near the
mounting brackets to the back of the generator and
pump. The socket end of the cables, which come out
near the bottom of the cart pole, should be connected
directly to the power cables provided with the generator
and pump.

	Mount the generator by sliding the quick connect
bracket on the back of the generator down the
opposite mounting bracket located on the top of the
cart (Figure 3b).
4.  Do not adjust the position of the mounting brackets.
5.  Proceed to cable connection.

Power Switch

3.  Plug both power cables into a surge protector/power strip.

Figure 5a

4. Turn on the generator using the power switch located on the
back of the device (Figure 5b).

3a

	Note
	The circular power button located on the front (top right
corner) of the device is to initiate radiofrequency ablation,
not to turn on power to the generator.

Pump
Quick Connect
and Release

5. After turning on the generator, turn on the pump using the
power switch located on the back of the device.
	Note
Turning on the pump before turning on the generator is not
recommended as it could lead to system error.
Figures 3a and 3b

6. Following the on-screen setup instructions, connect the
connector hub to the front of the generator (Figure 6).

Connect Cables and Power on the Generator and Pump
1. After assembly, connect pump and the generator with the
connector cable to USB ports on the back of both pump and
generator (Figures 4a and 4b).
	Plug the USB type A plug to the generator, and the USB type
B plug into the pump.

USB Port
(for connecting
generator to
pump)

Figure 6

Type B
Type A
Figure 4a

Figure 4b
4

5

Figure 5b

PATIENT POSITIONING
1.	 Place the patient in the prone position for access to the spine.
Note: For access to other areas of bone, a supine or lateral
patient positioning may be more effective for gaining
appropriate access.
2.	Using appropriate image guidance, confirm the target location
for treatment and proceed with the necessary skin incision(s).

OSTEOMAP
TECHNIQUE USING
BONE ACCESS KITS — SPINE
1.	Insert the stylet into the cannula to
form the osteointroducer.
2.	Using fluoroscopic image guidance,
insert the osteointroducer at the
desired site.

3.	Using manual control and appropriate
image guidance, advance the
osteointroducer through the soft
tissues into the selected bone to the
desired depth.

5.	While holding the cannula, rotate
the handle 180 degrees counterclockwise to remove the stylet.
Proceed with the OsteoCool™
precision drill.

4.	A surgical mallet may be used
to augment the insertion of the
osteointroducer.

For bi-pedicular ablation, repeat the
steps above.

6

Note
Markings on the cannulas should
be used as reference marks
only. They are not intended to
replace the use of fluoroscopic
observation.

Note
The OsteoCool™ osteointroducer
offers an internal stylet that extends
beyond the distal end of the cannula.
This design is intended to provide a
visual indication under image guidance
of where the posterior margin of the
ablation zone with the OsteoCool™ RF
ablation probe will stop.

7

Caution
To maintain structural integrity, do
not advance the cannula without the
stylet fully inserted.

OSTEOMAP
TECHNIQUE USING
BONE ACCESS KITS — SACRUM,
ILIAC, AND ACETABULUM

SACRUM
One-probe approach:

1.	Insert the stylet into the cannula to form the osteointroducer.
2.	Using CT or fluoroscopic image guidance, insert the osteointroducer at the desired site.
3.	Using manual control and appropriate image guidance, advance the osteointroducer through the soft tissues into the
selected bone to the desired depth.
4.	A surgical mallet may be used to augment the insertion of the osteointroducer.
5. W
 hile holding the cannula, rotate the handle 180 degrees counterclockwise to remove the stylet. Proceed with the
OsteoCool™ precision drill.
For ablation using two probes, repeat these steps.

Two-probe approach:

8

9

ILIAC

ACETABULUM

One-probe approach:

One-probe approach:

Two-probe approach:

Two-probe approach:

Note
Markings on the cannula should be used
as reference marks only. They are not
intended to replace the use of CT or
fluoroscopic observation.

10

Note
The OsteoCool™ osteointroducer
offers an internal stylet that extends
beyond the distal end of the cannula.
The design is intended to provide a
visual indication under image guidance
of where the posterior margin of the
ablation zone with the OsteoCool™ RF
ablation probe will stop.

11

Caution
To maintain structural integrity, do not
advance the cannula without the stylet
fully inserted.

USE OF THE
PRECISION DRILL — SPINE
3.	Read the color marking on the
proximal end of the drill to aid in probe
selection. If the drill positioning is in
between color markings, advance or
retreat to a color marking. Select the
probe size that corresponds with the
color marking.

1.	After gaining access to the vertebral
body using the osteoinducer, advance
the precision drill down the cannula
lumen into the vertebral body.
2.	Using manual control and image
guidance, rotate clockwise and
advance the precision drill to the
desired depth. This depth will serve as
the anterior boundary for the ablation
zone.

	Note
	Markings on the drill should be used
as reference marks only. They are
not intended to replace the use of
fluoroscopic observation.

	Note
	The color markings on the proximal
shaft of the OsteoCool™ precision
drill correlate with sizes of the
OsteoCool™ RF ablation probes.

4.	Remove the precision drill from
the cannula lumen using clockwise
rotation. The target site is now ready
for ablation probe placement.
For bi-pedicular ablation, repeat
the steps above. Product testing
recommends a distance of 8–10 mm
between the distal tips of the probes to
yield the largest ablation zone.

12

13

USE OF THE
PRECISION DRILL — SACRUM,
ILIAC, AND ACETABULUM
Note
The color markings on the proximal shaft of the OsteoCool™
precision drill correlate with sizes of the OsteoCool™ RF
ablation probes.

1.	After gaining access into bone using the osteointroducer,
advance the precision drill down the cannula lumen into the
tissue.
2.	Using manual control and image guidance, rotate clockwise
and advance the precision drill to the desired depth. This
depth will serve as the anterior boundary for the ablation
zone.

3.	Read the color marking on the proximal end of the drill to aid
in probe selection. If the drill positioning is in between color
markings, advance or retreat to a color marking. Select the
probe size that corresponds with the color marking.
Note
Markings on the drill should be used as reference marks only.
They are not intended to replace the use of CT or fluoroscopic
observation.
4.	Remove the precision drill from the cannula lumen using
clockwise rotation. The target site is now ready for ablation
probe placement.
For ablation using two probes, repeat the steps above.

A. Sacrum

B. Iliac

C. Acetabulum

A1

A2

B1

B2

C1

14

C2

15

PROBE SELECTION AND
TUBE KIT PREPARATION

FILLING THE OSTEOCOOL TUBE KIT
INSERTING IT INTO THE PUMP UNIT

Select the OsteoCool™ RF ablation probe size for the procedure.

Once a probe kit has been chosen, remove the tube kit and
probe from the sterile package and place in the sterile field.

	Note
	If the OsteoCool™ precision drill was used, select the probe size that
coordinates with the color marking on the drill shaft.

Fill the burette with sterile water
1. Fill the burette to the 70 mL mark with room temperature sterile water, using one of the following options:
Option 1 – Inject water through the port in the lid.
7 mm Active Tip
11×10 mm Ablation Zone

Option 2 – Remove the lid and pour the water directly into the burette.
Option 1 — Injecting sterile water using the lid port
	 a. Place sterile syringe in the port.

Option 2 — Removing the lid and pouring sterile water
directly into the burette
	 a. Open the lid by pressing in and up with your thumbs
around one of the three petals.

	 b. Inject 70 mL of sterile water at room temperature
into the burette.

	 b. Observe proper sterile handling technique while filling the
burette; do not place the lid of the burette on a non-sterile
surface.

10 mm Active Tip
17×13 mm Ablation Zone

	 c. The fill lines on the burette represent 70 mL and 80 mL
respectively.
	 d. After filling to between the lines, snap the lid back into
place on the burette.

15 mm Active Tip
23×18 mm Ablation Zone

20 mm Active Tip
29×21 mm Ablation Zone

16

17

CONNECTING
THE PROBE
TO THE TUBE KIT
2.	Put the burette into the pump unit’s burette holder.
	Warning
	DO NOT over tighten the connection. Maintain sterility of the
tubing’s inner pathway so if water is spilled in the sterile field,
sterility will not be compromised.

1. Pass the tubing and electrical connections on the probe out
of the sterile field.

3.	Open the pump head lid and thread the thicker tubing
from the bottom of the burette into the pump head
tube holder.

2. Remove the caps on the male and female luer locks for both
the tube kit and the chosen probe. Connect the appropriate
luer lock on the tube kit to the corresponding luer lock on the
probe.

4.	Ensure that the tubing is properly placed between the
notches and along the center channel beneath the
pump head.
	Warning
	Improper positioning of the tubing can pinch the tube
and restrict water flow.
5.	Close the lid to hold the tubing in place. Leave the luer
lock caps on the tubing until you are ready to connect
the probes, so the inner pathway of the tube kit
remains sterile.
Open lid

Closed lid holds tubing in place

18

19

CONNECTING TO
THE CONNECTOR HUB

PERFORMING RF ABLATION —
SPINE

The connector hub provides two channels for the use of the
ablation probes and two channels for use of the independent
thermocouples.

1.	The ablation probes come with a preassembled spacer. Discard or keep
the spacer, based on the bone access
tool used. Reference chart below:

The white ports (top) accept the RF ablation probes. The black
ports (bottom) accept the independent thermocouples.
1.	Connect the male connector on the ablation probe to the
female connector on the connector hub.
2.	Confirm via on-screen information that the probe has been
detected and is ready for use.
	Note
	The generator will quickly detect the probe and indicate a
“High Impedance” error while the probe is outside of tissue.
When the probe is placed in tissue, the “High Impedance”
error will disappear.

	Warning
	Never force the probe if you feel
significant resistance.

Description/Size

Part Number Directions

OsteoCool™ Bone Access Kit 10G 090

OCN002

Use with Spacer

OsteoCool™ Bone Access Kit 8G 090

OCN003

Use with Spacer

OsteoCool™ Bone Access Kit 10G 095

OCN004

Discard Spacer

OsteoCool™ Bone Access Kit 13G 100

OCN005

Discard Spacer

Remove spacer for use with
OCN004 and OCN005.

20

2.	Place the ablation probe through the
bone access cannula, ensuring it is
fully seated in the cannula.

Use spacer with
OCN002 and OCN003.

21

3.	Under image guidance, confirm the
proximal radiopaque marker has
fully surpassed the distal end of
the cannula.
	Warning
	Incorrect use of the spacer may result
in inadequate probe clearance from
the cannula.

PERFORMING RF ABLATION —
SACRUM, ILIAC, AND ACETABULUM
4.	When the screen shows “Ready,”
press the RF power button. Ablation
time is pre-set based on the active tip
size of the probe(s) being used.

Label Color

Product Code

Active Tip

Lesion Size

Ablation Time

Yellow

OCP107 and OCP207

7 mm

11 × 10 mm

6:30 min

Blue

OCP110 and OCP210

10 mm

17 × 13 mm

7:30 min

	 a. Pre-set ablation times are shown
at right.

Orange

OCP115 and OCP215

15 mm

23 x 18 mm

11:30 min

Green

OCP120 and OCP220

20 mm

29 × 21 mm

15:00 min

	Note
	Modifications to standard procedure
settings can be adjusted on the RF
generator user interface. Refer to
the user manual for instruction on
changing these settings.

Note
The ablation process will remain the same
for all bony anatomy. Follow steps 1–7 under
“PERFORMING RF ABLATION — SPINE” for
detailed instructions regarding this process.

One-probe approaches:

5.	Allow the generator to complete the
ablation, monitoring for error signs on
the generator screen.

A3

	 a. The ablation will terminate
automatically as soon as the set
ablation time is reached.
6.	After the ablation is complete, remove
the probe from the cannula and
detach from the tube kit. Discard as
biohazardous waste. Detach the tube
kit from the generator and discard as
biohazardous waste.
7.	The OsteoCool™ bone access
cannula is still in place and ready to
accept other instrumentation.
B3

C3

22

23

OPTIONAL TRACK
RF ABLATION
1.	To ablate the track, select “Retract” on the generator screen.

Two-probe approaches:

2.	 Press the RF power button.
3.	The screen will signal when the track ablation starts.
4.	Slowly pull back on the RF ablation probe and cannula
simultaneously (approximately 1–2 mm/second) or pull back and
track ablate while stationary. When the desired end point for track
ablation is reached, press the RF power button to stop RF delivery.
A4

	Warning
	Track ablation is the use of uncooled RF ablation during which time
the peristaltic pump is not circulating water. Ablating the track all
the way to the skin can result in skin burns. It is recommended to
end the track ablation prior to this point.

B4

C4

24

25

OPTIONAL
TEMPERATURE
MONITORING
WITH THE INDEPENDENT
THERMOCOUPLE
The independent thermocouple provides real-time temperature
information to gauge ablation zone margins and help prevent
thermal damage to adjacent critical structures. The temperature
detected by the independent thermocouple is displayed on the
generator screen.

BONE ACCESS
FOR SUBSEQUENT
PROCEDURES

GENERAL
SAFETY GUIDELINES
For desired tissue heating and anatomical access:
Avoid advancing the probe into bone tissue without first using
the introducer and drill to create a clear channel for the probe.
Forcing the probe through bone tissue may cause damage to
the probe.

The bone access can be used for subsequent physiciandirected procedures such as cementoplasty, sacroplasty,
vertebroplasty, or kyphoplasty. Confirm such procedures are
compatible with the OsteoCool™ Bone Access Introducer
length and gauge.

1.	 Insert the thermocouple into the provided introducer.
2. 	Connect the male connector on the thermocouple to the female
connector on the connector hub.
3. 	Confirm via on-screen information that the thermocouple
(sensor) has been detected.
4. 	Access the site. Place the thermocouple in the tissue to be
monitored.

PERFORMING RF
ABLATION USING
CUSTOM SETTINGS
The OsteoCool™ system generator screen includes the ability to
change procedure settings. These settings should only be adjusted
by physician experts in RF ablation. To access the custom settings
on the generator, complete the following steps:
1. Press the “Settings” button.
2. Select “Procedure Settings.”
3. Edit settings based on procedural need. Each probe can be
individually adjusted by time, temperature, power limit, ramp
rate, and impedance cut off. Additionally, each independent
thermocouple sensor can be individually adjusted by
temperature.
4. Once desired settings have been achieved, press the “X” button
to return to the generator’s home screen user interface.

Indications for Use
Kyphon Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis,
cancer, or benign lesions using a cementoplasty (i.e., kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation
of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple
myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include
hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by
appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
Kyphon HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis,
cancer, or benign lesions using a cementoplasty (i.e., kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma
and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and
giant cell tumor. Pathologic fracture may include a symptomatic vertebral microfracture (as documented by appropriate imaging
and/or presence of a lytic lesion) without obvious loss of vertebral body height.

5. Proceed with the RF ablation procedure.
Note
All ablation zone sizing is based on default settings. Using custom
settings by manipulating the procedure settings will change the
ablation zone sizing. To reset the generator settings to default
settings, select the “Refresh” button.

26

27

PRODUCT ORDERING
INFORMATION

IMPORTANT PRODUCT
INFORMATION
§	The OsteoCool™ RF Ablation System is intended
for the palliative treatment in spinal procedures by
ablation of metastatic malignant lesions in a vertebral
body. It is also intended for coagulation and ablation
of tissue in bone during surgical procedures, including
palliation of pain associated with metastatic lesions
involving bone in patients who have failed or are not
candidates for standard therapy.

OsteoCool™ RF Ablation Capital Equipment
OsteoCool™ RF Generator

OC01

OsteoCool™ RF Pump

OC02

OsteoCool™ RF Pump Cable

OC03

OsteoCool™ Connector Hub

OC04

OsteoCool™ RF Ablation Probes
Probe Kit OsteoCool™ RF 17G 7 mm

OCP107

Probe Kit OsteoCool™ RF 17G 10 mm

OCP110

Probe Kit OsteoCool™ RF 17G 15 mm

OCP115

Probe Kit OsteoCool™ RF 17G 20 mm

OCP120

Dual Probe Kit OsteoCool™ RF 17G 7 mm

OCP207

Dual Probe Kit OsteoCool™ RF 17G 10 mm

OCP210

Dual Probe Kit OsteoCool™ RF 17G 15 mm

OCP215

Dual Probe Kit OsteoCool™ RF 17G 20 mm

OCP220

OSTEOCOOL RF ABLATION SYSTEM
AND BONE ACCESS KITS
NOTES:

	Risks of the system include damage to surrounding
tissue through iatrogenic injury as a consequence of
electrosurgery; pulmonary embolism; nerve injury
including thermal injury, puncture of the spinal cord
or nerve roots potentially resulting in radiculopathy,
paresis, and paralysis.
§	OsteoCool™ Bone Access Kits: Indicated for
percutaneous access to bone.
§	OsteoCool™ Independent Thermocouple: Intended
for measuring tissue temperature throughout an RF
ablation procedure.

OsteoCool™ Bone Access Kits
OsteoCool™ Bone Access Kit 10G 090

OCN002

OsteoCool™ Bone Access Kit 8G 090

OCN003

OsteoCool™ Bone Access Kit 10G 095

OCN004

OsteoCool™ Bone Access Kit 13G 100

OCN005

OsteoCool™ Carts and Stands
OsteoCool™ Cart Stand

OCA01

OsteoCool™ Desk Stand

OCA02

Temperature Monitoring
Thermocouple OsteoCool™ ITC 180 mm

OCN001

28

29



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