EU

F

REEDOM

S

PINAL

C

ORD

S

TIMULATOR

L

EAD

I

NSTRUCTIONS FOR

U

SE

M

ODEL

N

UMBERS

: FRT4-A001, FRE4-A001

E

XPLANATION OF

S

YMBOLS ON

P

RODUCT OR

P

ACKAGE

Device reference identification

Consult instructions for use

Use by Do not reuse

Manufacturing date

Manufacturer

Lot number

Do not resterilize

Do not use if package is damaged

Keep out of light, Keep dry

Lead length

Sterilization: ethyleneoxide gas

Caution

Warning

European Authorized

Representative

MR Conditional

Australian Sponsor

Temperature limits

Quantity of product included in package

0344

This symbol means that the device fully complies with

European Directive AIMD

90/385/EEC.

English

Page | 2

T

ABLE OF

C

ONTENTS

EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE ...................................................................... 2

DESCRIPTION ........................................................................................................................................ 4

INDICATIONS ........................................................................................................................................ 4

CONTRAINDICATIONS ........................................................................................................................... 5

PRECAUTIONS ...................................................................................................................................... 5

ADVERSE EVENT SUMMARY ................................................................................................................. 5

CLINICAL COMPENDIUM ....................................................................................................................... 6

TRIAL LEAD TO PERMANENT LEAD TRANSITION .................................................................................... 8

PACKAGE CONTENTS ............................................................................................................................ 9

DEVICE SPECIFICATIONS ..................................................................................................................... 10

INSTRUCTIONS FOR USE ..................................................................................................................... 12

P

REPARING FOR SURGERY

............................................................................................................................ 12

P

LACING A LEAD

........................................................................................................................................ 13

T

ESTING

S

TIMULATION

I

NTRAOPERATIVELY

.................................................................................................... 17

A

NCHORING THE

T

RIAL

L

EAD

....................................................................................................................... 19

A

NCHORING THE

P

ERMANENT

L

EAD

.............................................................................................................. 20

L

EAD

E

XPLANT

P

ROCEDURE

......................................................................................................................... 22

MRI INFORMATION ............................................................................................................................ 23

1.5-T

ESLA

/64-MH

Z

MRI C

ONDITIONS

......................................................................................................... 23

3.0-T

ESLA

/128-MH

Z

MRI C

ONDITIONS

....................................................................................................... 24

P

REPARATION FOR THE

MRI

EXAMINATION

.................................................................................................... 24

D

URING THE

MRI

EXAMINATION

.................................................................................................................. 25

P

OST

-MRI

EXAMINATION REVIEW

................................................................................................................ 25

CONTACT INFORMATION .................................................................................................................... 26

Refer to the User Manual for information on how stimulation works, how to use the

Malibu Wearable Antenna Assembly, warnings, and precautions.

English

Page | 3

D

ESCRIPTION

The Freedom Spinal Cord Stimulation System is used for Spinal Cord Stimulation (SCS) to aid in the relief of chronic, intractable pain of the trunk and/or limbs. The therapy utilizes pulsed electrical current to stimulate nerves near the spinal cord in order to inhibit the transmission of pain signals to the brain. The system consists of a neurostimulation lead that is placed in the epidural space of the patient and an external power unit, the Malibu Wearable Antenna

Assembly (WAA) that transmits power wirelessly through the skin to the implanted lead. The implantable lead is a sealed, self-contained system that can include or be mated to a receiver that generates stimulation waveforms to create an electrical volume conduction from the electrode array at the distal end of the lead. The Malibu WAA is the external power unit that is programmable to allow for adjustment of stimulation parameters including the waveform pulse rate, duration, and amplitude.

I

NDICATIONS

The Freedom SCS System is indicated for use as a therapy for:

• Failed Back Surgery Syndrome (FBSS);

• Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or

Causalgia;

• Radicular Pain Syndrome or Radiculopathies;

• Post Laminectomy Pain;

• Multiple Back Surgeries;

• Unsuccessful Disk Surgery or Spinal Decompression Surgery;

• Degenerative Disk Disease (DDD) / herniated disk pain refractory to conservative and surgical interventions;

• Peripheral Causalgia;

• Epidural Fibrosis; and,

• Arachnoiditis or Lumbar Adhesive Arachnoiditis.

English

Page | 4

C

ONTRAINDICATIONS

Patients contraindicated for the Freedom SCS System are those who:

• Are poor surgical risks;

• Are pregnant;

• Are unable to operate the SCS system;

• Are exposed to short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy; and,

• Are occupationally exposed to high levels of non-ionizing radiation that may interfere with the therapy delivered.

P

RECAUTIONS

The Freedom SCS System could be impacted by operational changes to the Malibu Wearable

Antenna Assembly (WAA) through interference by strong electromagnetic interference (EMI) sources (e.g. diathermy, electrocautery, MRI, radio-frequency ablation, etc.). Should the system ever stop or change performance characteristics as a suspected result of EMI, turn off the system immediately and remove the source of EMI from proximity. Refer to the User

Manual for a detailed list of precautions.

A

DVERSE

E

VENT

S

UMMARY

Implanting a neurostimulation system has risks similar to other spinal procedures. If you are on anticoagulation therapy you might be at greater risk for postoperative complications such as hematomas that could result in paralysis.

In addition to those normally associated with surgery, implantation of a neurostimulation system includes the following risks:

• Allergic or immune system response implanted materials

• Infection;

• Lead erosion through the skin or lead migration;

• Leakage of cerebrospinal fluid;

• Loss of therapy effectiveness;

• Epidural hemorrhage, hematoma, or paralysis;

• Radicular chest wall stimulation;

• Change in stimulation, possibly related to cellular changes around the electrode(s), migration of lead position, electromagnetic interference, or lead fracture.

English

Page | 5

C

LINICAL

C

OMPENDIUM

P

RIMARY

A

UTHOR

T

ITLE

F

EATURE

A

DDRESSED

N

K

EY

R

ESULTS

Allegri, M.

2004

Prospective Study of the Success and Efficacy of Spinal Cord

Stimulation

Pain Reduction,

Quality of Life

170

• After 12 months, patients reported an average of 43% reduction in VAS scores, and

70% of patients reported improved quality of life.

Alo, K.

2002

Alo, K.

2003

Barolat, G.

2001

Bell, G.

1997

Kay, D. 2001

Kim, S. 2001

Four Year Follow-up of Dual

Electrode Spinal Cord

Stimulation for Chronic Pain

Pain Reduction,

Paresthesia

Coverage, Device

Survival

33

• Patients reported an average of

40% reduction in VAS scores and 89% paresthesia coverage.

• Patient satisfaction with the therapy was measured as 63%.

Spinal Cord Stimulation for

Complex Pain: Initial Experience with a Dual Electrode,

Programmable, Internal Pulse

Generator

Paresthesia

Coverage, Patient

Satisfaction,

Adverse Events

20

• Patients reported an average of

77.5% paresthesia coverage.

• Patients reported an average of

55% reduction in VAS scores and a satisfaction rating of 80%.

Epidural Spinal Cord Stimulation with a Multiple Electrode Paddle

Lead Is Effective in Treating

Intractable Low Back Pain

Pain Reduction,

Quality of Life,

Patient Satisfaction

41

• After

12-months, patients reported a 37% reduction in

VAS scores, and 88% were satisfied with the therapy.

Cost-effectiveness analysis of spinal cord stimulation in treatment of failed back surgery syndrome

Cost-Effectiveness NA

• The average patient notices a cost saving, when compared to a typical surgical intervention, at 5.5 years for IPG and 3.9 years for RF.

• Patients who have stellar success notice cost savings within 2.1 years for IPG and 1.4 years for RF.

Spinal Cord Stimulation - A

Long-Term Evaluation in

Patients with Chronic Pain

Spinal Cord Stimulation for

Nonspecific Limb Pain Versus

Neuropathic Pain and

Spontaneous Versus Evoked

Pain

Device Survival,

Adverse Events

Pain Reduction,

Device Survival

70

• Substantial pain relief was reported in 60% of patients.

• Half of the SCS systems were revised within 3 years of implantation.

74

• After 1 year, 83% of patients reported greater than 50% pain relief.

English

Page | 6

P

RIMARY

A

UTHOR

Kumar, K.

1997

Kumar, K.

2003

Leveque, J.

2001

Mironer, Y.

2008

North, R.

2005:56

North, RB.

1991

Oakley, J.

2006

T

ITLE

Epidural spinal cord stimulation for treatment of chronic pain— some predictors of success

F

EATURE

A

DDRESSED

N

K

EY

R

ESULTS

Pain Reduction,

Device Survival,

Adverse Events,

Reduced Drug Use

235

• Patients who reported pain relief also reported improvements in quality of life and a decrease in medication dose.

• After approximately 5.6 years,

47% of patients reported a 50% reduction in pain.

Spinal Cord Stimulation for the

Treatment of Refractory

Unilateral Limb Pain Syndromes

Pain Reduction,

Reduced Drug Use,

Device Satisfaction

75

• After 2 years, 84% of patients reported greater than 50% pain relief, and 56% of patients reported a significant reduction in analgesic use.

• Of patients employed prior to onset of pain, 46% returned to work.

Spinal Cord Stimulation for

Failed Back Surgery Syndrome

Spinal cord stimulation for chronic, intractable pain:

Superiority of “multi-channel” devices

Pain Reduction

Pain Reduction,

Device Survival,

Adverse Event

16

• After 35 months, patient’s reported a mean VAS reduction of 37%.

Efficacy of a Single,

Percutaneous, Across Midline,

Octrode Lead using a "Midline

Anchoring" Technique in the

Treatment of Chronic Low Back and/or Lower Extremity Pain: A

Retrospective Study

Pain Reduction,

Paresthesia

Coverage, Patient

Satisfaction, Device

Survival

54

• Paresthesia coverage was reported as 89% coverage of the lower legs and buttocks area and 71% coverage of lower back coverage.

• Patients reported a 45% reduction in VAS scores.

Spinal Cord Stimulation Versus

Repeated Lumbosacral Spine

Surgery for Chronic Pain: A

Randomized, Controlled Trial

Pain Reduction 50

• Approximately 47% of patients reported that pain relief was reduced by at least 50% and were satisfied with the treatment.

62

• Patients reported a 50% reduction in VAS scores.

• Patient satisfaction was reported at 66%.

Transverse Tripolar Spinal Cord

Stimulation: Results of an

International Multicenter Study

Pain Reduction,

Device Survival,

Paresthesia

Coverage

56

• After 12 months, 53% of patients reported “good” to

“excellent” outcomes.

English

Page | 7

P

RIMARY

A

UTHOR

T

ITLE

Ohnmeiss, D.

2001

Van Buyten,

J. 1999

Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain

Treatment of Failed Back

Surgery Syndrome Patients with

Low Back and Leg Pain: A Pilot

Study of a New Dual Lead Spinal

Cord Stimulation System

A

F

EATURE

DDRESSED

Pain Reduction,

Quality of Life

Quality of Life

Villavicencio,

A. 2000

Laminectomy Versus

Percutaneous Electrode

Placement for Spinal Cord

Stimulation

Pain Reduction

N

K

EY

R

ESULTS

41

• Approximately 70% of patients reported satisfaction with the therapy, and 60% of the patients indicated that their conditions improved.

20

• Approximately 76% of patients reported a reduction or elimination of analgesic us, and

59% reported an increase in their daily activities.

41

• Approximately 53% of patients with the percutaneous lead experienced good results, while

100% of the patients with laminectomy leads experienced good results.

T

RIAL

L

EAD TO

P

ERMANENT

L

EAD

T

RANSITION

Before a permanent Freedom SCS System is prescribed to a patient, a trial system can be first implanted to evaluate the effectiveness of the therapy for the patient. A trial neurostimulator

(FRT4) can be implanted for such therapy evaluation; results should be reviewed at the end of the trial period to determine if the pain relief was satisfactory for the patient. Considerations before moving to a permanent implant may also include if the patient experiences any adverse events, if the patient has any difficulty operating the Malibu WAA, if the patient had sufficient and comfortable levels of paresthesia coverage and pain relief.

English

Page | 8

P

ACKAGE

C

ONTENTS

§

Lead – A neurostimulator lead for insertion into the epidural space.

§

Guide Wire – A flexible coiled wire used to create a pathway in the epidural space for the lead to follow.

§

Tuohy Needle – A 14-G needle designed for gaining access to epidural space.

§

Introducer Sheath – A 7Fr introducer sheath designed for insertion of the lead into the epidural space. The sheath is transparent to wireless power, and must be used during placement.

§

Stylet(s) – A stiff wire inserted into the lead body to aid in steering and positioning.

§

Sleeve Cap – A pellethane cap that creates a seal around the proximal end of the lead.

Additionally, the cap acts as an anchoring point to secure the lead(s) to connective tissue.

English

Page | 9

D

EVICE

S

PECIFICATIONS

The lead has electrodes on the distal end. The stylet is inserted into the proximal end of the lead to aid in positioning the lead as a steering element. The dimensions for the Freedom 4 trial version, FRT4, or permanent version, FRE4, are detailed in Table 1.

Model Number FRT4 FRE4

Lead Length

Lead Diameter

Electrodes

Number

Shape

Length

Electrode Spacing

Array Length

Connector

Radiopaque Marker

Maximum Recommended

Implant Depth

Implant Period 90 Days

45 cm

1.3 mm

4

Cylindrical

3 mm

4 mm

24 mm

Sleeve Cap

Yes

6 cm

TABLE 1. DEVICE SPECIFICATIONS FOR LEAD(S).

45 cm

1.3 mm

4

Cylindrical

3 mm

4 mm

24 mm

Sleeve Cap

Yes

6 cm

Permanent

English

Page | 10

The list of materials in contact with the tissue is detailed in Table 2.

Component Material

Lead

Flexible Circuit Board

Flexible Circuit Trace

Flexible Circuit Encapsulation

Electrodes

Insulation

Lead Tip

Adhesive

Guide Wire

Needle

Introducer Sheath

Stylets (curved, straight)

Handle

Wire

Sleeve Cap

Malibu

Antenna

Belt

Polyimide

Gold

Parylene C

Platinum-Iridium

Polyurethane

Polyurethane

Silicone

Stainless Steel

Stainless Steel

Pebax

Polytetrafluoroethylene

(PTFE)

Stainless Steel

Polyurethane

Copper

Thermoplastic Urethane

TABLE 2. MATERIAL OF LEAD KIT COMPONENTS.

Yes

Yes

No

Yes

No

Yes

Yes

No

No

Yes

Yes

Yes

Material Contacts

Human Tissue

No

No

Yes

English

Page | 11

I

NSTRUCTIONS FOR

U

SE

Implanting clinicians should be experienced in procedures that gain access to the epidural space. In addition they should be thoroughly familiar with all product labeling.

P

REPARING FOR SURGERY

Before opening the lead package, verify the package integrity, model number, and use-by date.

In the event that the package is damaged, do not use the product. In the event that the use-by date has expired, do not use the product. Contact Stimwave for further service.

C

AUTION

:

To reduce the risk of lead damage that my result in intermittent stimulation or loss of stimulation, requiring additional surgery to replace the lead:

§

Use only the needle and introducer sheath supplied in the kit.

§

Use a shallow needle-insertion angle (45 degrees or less) when inserting or withdrawing the needle into or out of the epidural space.

§

Do not bend, kink, or stretch the lead or stylet, which may damage the components.

§

Do not use any instrument to handle the lead. The force may compress the lead, resulting in the fracture of internal electronics or inability to insert or withdraw the stylet.

§

Use care when replacing a stylet, excessive pressure on the lead could damage the components, resulting in intermittent or loss of stimulation.

W

ARNING

:

Select a needle entry location that is not more than two vertebral spaces below the target stimulation site.

As with any spinal procedure, the risk of serious injury to the patient (e.g. hemorrhage, hematoma, or paralysis) increases as location of the selected needle insertion site progresses up the vertebral column – from a lower risk at a lumbar location to a higher risk at a cervical location. Select a vertebral location that provides the widest and easiest access to the epidural space during needle insertion to reduce the risk of serious patient injury resulting from direct trauma to the spinal cord.

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Page | 12

P

LACING A LEAD

1. If necessary, make an incision at the needle-entry site to the depth of the subcutaneous fascia.

2. Using a paramedian approach lateral to the midline, and under fluoroscopy, insert the introducer sheath and needle assembly into the epidural space at a shallow angle until you encounter resistance from the ligamentum flavum (See Figure 1).

NOTE: Do not use any other needle or introducer sheath other than the ones provided in the lead kit. Do not remove the introducer sheath from the epidural needle when driving

the needle into the epidural space.

FIGURE 1. INSERT THE INTRODUCER SHEATH AND NEEDLE ASSEMBLY INTO THE EPIDURAL SPACE.

English

Page | 13

FIGURE 2. INTRODUCER SHEATH AND NEEDLE ASSEMBLY IN EPIDURAL SPACE.

3. Confirm introducer sheath and needle location under fluoroscopy (See Figure 2).

4. After rotating the introducer sheath and needle assembly so that the beveled edge faces cephalad, remove the needle stylet.

5. Advance the introducer sheath and needle assembly to confirm entry into the epidural space (e.g. using the loss-of-resistance technique with air or sterile water).

6. For a second lead, repeat steps 1 – 5 noting these recommendations:

§

Implant the second lead parallel to the first lead and approximately 1 – 3 mm lateral of the physiological midline.

§

Introduce the second lead one vertebral space below the first lead to help prevent nicking or cutting the first lead and to allow sufficient space for suturing both lead and anchors.

§

Stagger the lead tips or place them several vertebral spaces apart, depending on the position that produces the most effective paresthesia.

English

Page | 14

C

AUTION

:

Do not use contrast media or saline flush. Contrast media may obscure the field of view and a saline flush may increase the difficulty of lead placement.

7. After inserting the guide wire through the needle, advance the guide wire no farther than 1 -3 cm past the needle tip. Next, remove the guide wire from the needle.

NOTE: If the guide wire track deviates from the intended pathway, steering and manipulating the lead will be more difficult.

8. Next, remove the needle while maintaining the position of the introducer sheath (Figure

3).

NOTE: The metal needle blocks the energy from the Malibu WAA and cannot be used during intraoperative stimulation.

FIGURE 3. INTRODUCER SHEATH REMAINS IN EPIDURAL SPACE WHILE THE NEEDLE IS REMOVED.

English

Page | 15

9. Using fluoroscopy, slowly insert the lead through the introducer sheath and advance the lead to the initial target placement site (See Figure 4). A stylet may need to be reinserted. The Introducer Sheath is RF transparent, and can be used throughout intraoperative testing of the lead.

NOTE: When using a curved stylet and resistance is encountered during lead advancement, exchange the curved stylet for the straight stylet and use short, firm movements to advance the lead.

FIGURE 4. PASS THE LEAD THROUGH THE INTERIOR LUMEN OF THE INTRODUCER SHEATH.

10. After verifying the lead position under fluoroscopy (anterior-posterior and lateral views), compare that location with the location that has the highest probability of paresthesia coverage.

NOTE: To increase lead stability, insert enough lead length to extend at least three vertebral bodies into the epidural space. Position the lead so that the center electrodes will be active if lead migration occurs.

English

Page | 16

T

ESTING

S

TIMULATION

I

NTRAOPERATIVELY

NOTE: This procedure requires a Malibu Wearable Antenna Assembly. The Malibu WAA is packaged in a separate kit. Refer to the User Manual for instructions on how to use the Malibu

WAA.

1. While holding the lead in place, disconnect the stylet handle from the lead (proximal end), and completely withdraw the stylet.

2. Place the Malibu Wearable Antenna Assembly in a sterile drape or sterile fluoroscope bag in the region directly above the most proximal implanted electrode (See Figure 5).

C

AUTION

:

To prevent possible uncomfortable or unexpected stimulation (jolting or shocking sensation):

§

Program parameter changes in small increments above the perception threshold

(the amplitude value(s) at which the patient first perceives paresthesia).

§

Decrease the amplitude(s) before: o Changing electrode polarities. o Placing the on the patient’s back. o Turning ON the neurostimulator.

3. Identify the most appropriate stimulation parameters, beginning at a medium pulse width and frequency range.

NOTE: The frequency, pulse width and amplitude are all parameters that collectively make up the stimulation therapy that the patient receives.

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Page | 17

FIGURE 5. INTRAOPERATIVE STIMULATION USING THE MALIBU WEARABLE ANTENNA ASSEMBLY.

4. Increase the amplitude while asking the patient close-ended questions to identify the perception threshold (the amplitude at which the patient first perceives paresthesia), the discomfort threshold (the amplitude at which paresthesia is beyond the patient’s tolerance), and the paresthesia coverage.

NOTE: If good paresthesia coverage is not attained, change electrode settings before repositioning the lead to confirm the direction of lead movement.

5. If two leads were placed, repeat steps 3 – 4 for the second lead; optimize paresthesia coverage using both leads.

6. In the patient’s chart, document the lead position that provided appropriate stimulation coverage (i.e. record the settings and patient responses and include a fluoroscopic image of the final lead position).

English

Page | 18

A

NCHORING THE

T

RIAL

L

EAD

1. Tie ‘2-0 non-absorbable suture material (such as silk or some other type of braided polyester mesh) around the body of the device.

2. Tie the device to the skin using the suture material prepped in step 1.

3. Using a pair of sterile scissors cut the excess lead body length away from the implanted portion.

FIGURE 6. SUTURE THE LEAD BODY DIRECTLY TO CONNECTIVE TISSUE. CUT THE EXCESS TUBING OFF.

English

Page | 19

A

NCHORING THE

P

ERMANENT

L

EAD

4. Prepare the anchor site by making a 2 to 4 cm longitudinal incision around the introducer sheath shaft, dissecting down to the supraspinous ligament, and establishing hemostasis.

5. While maintaining the lead position, use minimal force to remove the introducer sheath while holding the lead in place by placing light pressure on the proximal end.

C

AUTION

:

Use minimal traction to remove the introducer sheath because quick or sudden removal may dislodge the lead.

6. Using a pair of sterile scissors cut the excess lead body length away from the implanted portion. Maintain at least 5 cm of lead body to allow for proper Sleeve Cap attachment

(See Figure 7).

FIGURE 7. CUT THE EXCESS LEAD BODY LENGTH AWAY WHILE MAINTAINING APPROXIMATELY 5CM FREE.

English

Page | 20

7. Slide the Sleeve Cap onto the proximal end of the lead and continue sliding the cap down until it reaches the final position (See Figure 8). Use care to maintain the lead position.

C

AUTION

:

Do not force the Sleeve Cap past the final position. This may damage the components, resulting in an improper seal.

FIGURE 8. SLIDE THE SLEEVE CAP ONTO THE PROXIMAL END OF THE LEAD.

8. Use 2-0 non-absorbable suture to secure the Sleeve Cap to the connective tissue (See

Figure 9).

NOTE: For larger patients where the Sleeve Cap cannot be sutured directly to connective tissue, sutures may be applied directly to the lead body with no risk of damaging the lead electronics.

FIGURE 9. THE SLEEVE CAP READY FOR SUTURES

9. Verify test stimulation parameters to ensure that the lead has not moved by performing intraoperative stimulation. If the lead has moved, reposition it.

10. Close the incision using standard surgical techniques and dressings.

English

Page | 21

L

EAD

E

XPLANT

P

ROCEDURE

1. Identify the incision site from the original implantation procedure, and confirm lead location using fluoroscopy.

2. Make an incision to the depth of the proximal end of the lead (also referred to as the

“tail”).

3. If applicable, cut sutures free of any tissue structures or scarring.

4. Remove the lead by slowly pulling on the proximal end.

5. After the lead has been removed, verify that all components are intact and that all implanted materials are accounted for.

6. Close the incision using standard surgical techniques and dressings.

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Page | 22

MRI I

NFORMATION

An MRI examination may be safely performed under certain specific requirements on a patient with the Freedom SCS lead, however, the Malibu Wearable Antenna Assembly (WAA) unit (e.g., the external component of this neuromodulation system) MUST NOT be present in the MR system room at ANY TIME. Failure to adhere to the specific requirements described in this manual can result in tissue damage, severe injury, or death. Please use the contact information found on the last page of this manual for additional questions.

W

ARNING

:

Remove the Malibu WAA from the patient before entering the MR system room. The strong magnetic field of the MR system could attract or otherwise damage the Malibu

WAA and in the process cause serious harm or damage to the MR system.

MRI testing demonstrated the Freedom Spinal Cord Stimulator (SCS) Lead, Model FRE4 and

Model FRT4 are MR Conditional. A patient with each model of the implanted lead can be scanned safely under the following conditions (note, this information applies to cases where a single Freedom Spinal Cord Stimulator (SCS) Lead is implanted, only):

1.5-T

ESLA

/64-MH

Z

MRI C

ONDITIONS

• Use only a cylindrical bore, clinical MRI system with a static magnetic field of 1.5 T and

RF excitation frequency of 64-MHz.

• Enter the correct patient weight into the MR system console to ensure that the whole body averaged SAR is estimated correctly.

• The use of a transmit/receive body RF coil or transmit/receive head RF coil is permitted.

The MRI scan sequences must meet the following requirements. If they do not, the pulse parameters must be adjusted so that they comply with these requirements.

• Use MRI examination pulse sequence parameters that limit the MR system reported specific absorption rate (SAR) to 2.9 W/kg or less for all sequences.

English

Page | 23

3.0-T

ESLA

/128-MH

Z

MRI C

ONDITIONS

• Use only a cylindrical bore, clinical MRI system with a static magnetic field of 3.0 T and

RF excitation frequency of 128-MHz.

• Enter the correct patient weight into the MR system console to ensure that the whole body averaged SAR is estimated correctly.

• The use of a transmit/receive body RF coil or transmit/receive head RF coil is permitted.

The MRI scan sequences must meet the following requirements. If they do not, the pulse parameters must be adjusted so that they comply with these requirements.

• Use MRI examination pulse sequence parameters that limit the MR system reported specific absorption rate (SAR) to 2.9 W/kg or less for all sequences.

NOTE: The conditions provided are based on in-vitro testing and should result in a safe MRI examination of a patient with a single, implanted Freedom Spinal Cord Stimulator (SCS) Lead,

Model FRE4 or Model FRT4 when all instructions are carefully followed.

P

REPARATION FOR THE

MRI

EXAMINATION

The following steps are required prior to performing an MRI examination on a patient who has an implanted Freedom FRT4 or FRE4 component.

1. Allow at least six weeks from the date of implantation to the time of MRI examination.

2. Remove the Malibu Wearable Antenna Assembly (e.g., the external component of this neuromodulation system) from the patients before entering the MR system room.

3. Determine if the patient has any other implants or health conditions that would prohibit or contraindicate an MRI examination. Do not conduct an MRI examination if conditions or implants that would prohibit or contraindicate the MRI procedure are present. If the patient has another implant or device, the safety of performing MRI with the Freedom

SCS lead is unknown.

4. Instruct the patient to immediately inform the MR system operator (i.e., the MRI technologist) if any discomfort, stimulation, shocking, or heating occurs during the examination.

5. The patient must be conscious during the MRI examination in order to be able to inform the MR system operator of any heating, discomfort, or other problems.

6. Verify that all proposed MRI conditions comply with the specific requirements in this manual. If not, the MRI conditions must be modified to meet these requirements. If a particular parameter cannot be modified, do not perform the MRI examination.

English

Page | 24

D

URING THE

MRI

EXAMINATION

• The patient should be conscious during the MRI examination. Monitor the patient both visually and audibly. Check the patient between each MR imaging sequence.

Discontinue the MRI examination immediately if the patient is unable to respond to questions or reports any problems.

• Conduct the examination using only the MRI conditions that the MRI radiologist or MRI physicist has confirmed meets the requirements outlined in this manual.

P

OST

-MRI

EXAMINATION REVIEW

• Verify that the patient feels normal.

Verify that the Freedom SCS FRT4 or FRE4 is functional by responding to the Malibu WAA (i.e., lead combined with the external component).

English

Page | 25

C

ONTACT

I

NFORMATION

M

ANUFACTURER

Stimwave Technologies, Inc.

901 East Las Olas Boulevard, Suite 201

Fort Lauderdale, FL 33301

United States

Telephone: +1.800.965.5134

Fax: +1.800.965.5134

Internet: www.stimwave.com

05-0031-8 Published May 2015

E

UROPEAN

A

UTHORIZED

R

EPRESENTATIVE

Emergo Europe

Molenstraat 15

2513 BH, The Hague

Netherlands

A

USTRALIAN

S

PONSOR

Emergo Australia

Level 20

Tower II, Darling Park

201 Sussex Street

Sydney, NSW 2000

Australia

0344

2013

English

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