Algovita Spinal Cord Stimulation System MRI Procedure Guidelines… · 2020-01-02 · • Induced...

ONLY

Read this manual before performing an MRI scan on a patient implanted with an Algovita Spinal Cord Stimulation System.

Algovita® Spinal Cord Stimulation SystemMRI Procedure Guidelines

0300-000175-001 Rev 05 SCS MRI Procedure Guidelines.indd 1 8/5/19 6:07 PM

Algovita® is a registered trademark of Nuvectra Corporation.

This manual is a supplement to the Algovita Spinal Cord Stimulation System manuals which include detailed warnings, cautions, and instructions.

Symbols Glossary

Symbol ExplanationTitle: MR ConditionalStandard: ASTM F2503-13 Reference Number: 3.1.111

Description: An item with demonstrated safety in the MR environment within defined conditions. Title: MR UnsafeStandard: ASTM F2503-13 Reference Number: 3.1.141

Description: An item which poses unacceptable risks to the patient, medical staff, or other persons within the MR environment.

ONLY

Title: Rx OnlyStandard: 21 CFR Part 801.109 paragraph (b)(1) Description: Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.Title: ManufacturerStandard: ISO 15223-1 Reference Number: 5.1.12

Description: Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

1. ASTM F2503-13: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment2. ISO 15223-1:2016 Medical Devices – Symbols to be used with medical device labels, labeling and information to be supplied Part 1: General

Requirements


Algovita Spinal Cord Stimulation System

MRI Procedure Guidelines i

Contents

1. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

2. Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

3. Algovita SCS MR Conditional System Components and Implant Locations . . . . . . . . . . . . . . . . . . . .4

4. Patient Eligibility Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

5. Patient Preparation for MRI Scan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

6. Post MRI Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Appendix A – Take the Stimulator Out of Storage Mode After an MRI Scan . . . . . . . . . . . . . . . . . . . . . . .10


ii MRI Procedure Guidelines



MRI Procedure Guidelines 1

1. IntroductionRead this manual before performing a Magnetic Resonance Imaging (MRI) scan on a patient with an implanted Algovita Spinal Cord Stimulation (SCS) System. This manual is intended for use by physicians and other healthcare professionals managing patients with an Algovita SCS System, as well as radiologists and technicians performing MRI scans on these patients. The scope of this is manual is MRI procedures performed on patients implanted with Algovita SCS MR Conditional System components using an MRI system with a closed bore, horizontal field, and a static magnetic field strength of 1.5 T; other MRI conditions have not been evaluated for compatibility with the Algovita SCS System.

ContraindicationsDo not perform an MRI scan on patients with:

• Algovita SCS System components not listed in Table 1 or Table 3, or with components implanted in different locations than those listed in Table 1 or Table 3.

• Abandoned neuromodulation components or broken, intermittent, or fragmented leads.• An Algovita SCS Trial Stimulation System or with any Algovita SCS System components that are not fully implanted as

excessive heating of the lead electrodes could occur, which can result in tissue damage or serious patient injury.• Any lead impedance measurements that are coded red or yellow, indicating high or low impedance. Refer to the

Clinician Programming Manual for instructions on conducting impedance tests.• Do not perform an MRI scan if the patient’s body temperature is above 38° C (100° F). An elevated body temperature

in conjunction with tissue heating caused by an MRI scan increases the risk of excessive heating, which can result in tissue damage or serious patient injury.

Warnings• Do not use MRI systems that are open-sided, vertical field, or with static magnetic field strengths other than 1.5 T as

the Algovita SCS System has not been evaluated under those conditions. Doing so could damage the Algovita SCS System components, cause warming of the stimulator, or induce stimulation (energy) into the leads, which may cause unintended or uncomfortable sensations such as tingling, shocking, jolting, discomfort, or pain.

• Do not use gradient systems producing gradient slew rates greater than 200 T/m/s as the Algovita SCS System has not been evaluated under those conditions. Doing so could damage the Algovita SCS System components, cause warming of the stimulator, or induce stimulation (energy) into the leads which may cause unintended or uncomfortable sensations such as tingling, shocking, jolting, discomfort, or pain.

• Place the patient in the prone or supine position. Do not position the patient in other positions, such as his or her side (called the lateral decubitus position) within the MRI bore. Scanning patients in positions other than prone or supine has not been evaluated and could cause excessive heating during an MRI scan, which can result in tissue damage or serious patient injury.

• When performing a head-only scan, do not place any part of the transmit/receive coil over any implanted Algovita SCS System components. Doing so may cause excessive heating of the implanted components, which can result in tissue damage or serious patient injury.

• Do not use an RF transmit body coil when performing a head scan, use only a head transmit/receive quadrature coil. Other transmit/receive coils (eg, linear coils) have not been tested and could cause excessive heating, which can result in tissue damage or serious patient injury.

• You must place the stimulator in storage mode. » MRI scans may damage stimulators not put in storage mode, which may result in replacement surgery. » Stimulation may be on if the stimulator is not in storage mode, which could result in uncomfortable or unintended

stimulation.• The effect of scanning patients with other implantable devices in conjunction with the Algovita SCS System has

not been evaluated. Contact the manufacturer of the additional medical device implants for questions about MR compatibility. Do not scan a patient with implantable devices known to be MR Unsafe.


2 MRI Procedure Guidelines

PrecautionsThe instructions in this manual apply only to a complete and functional Algovita SCS System composed solely of components listed in Table 1 and Table 3 that are implanted in MR Conditionally safe locations within the body. Other configurations have not been evaluated.

Advise the patient to bring the following to the MRI appointment:

• The most up-to-date patient ID card. MRI personnel will use the patient ID card to confirm the MR compatibility of the patient’s implanted neurostimulation system according to the manufacturer (Nuvectra) and model number.

• Their Programmer Charger, charging paddle, and Pocket Programmer for turning the stimulator off for the MRI procedure and back on post MRI procedure.External devices are MR Unsafe in the scanner (magnet) room – Do not allow the following Nuvectra external control devices into the MRI scanner (magnet) room. These devices contain ferromagnetic material, which can be affected by the MRI magnet. These devices are MR Unsafe:

» Programmer Power Cord » Pocket Programmer » Programmer Charger » Charging Paddle » Trial Stimulator (EPG) » Clinician Programmer » Patient Feedback Tool

Avoid performing an MRI scan on patients with recent implant incisions. The MRI magnetic field may exert force or torque on the Algovita SCS System causing patients to feel a tugging or vibration sensation.

Potential RisksPotential risks resulting from exposure to an MRI environment may include:

• Damage to the Algovita SCS System components causing the system to fail, potentially requiring components to be replaced.

• Warming of the stimulator and leads which may cause discomfort, pain, or burns.• Induced stimulation (energy) into the leads, which may cause unintended or uncomfortable sensations such as

tingling, shocking, jolting, discomfort, or pain.




2. Safety InformationA person with expert MRI knowledge needs to check that all procedures and MRI scan parameters in this manual are followed.

Always obtain the latest MRI guidelines. Contact Nuvectra Customer Service toll-free in the United States at 1-844-727-7897 or obtain the MRI guidelines on the Nuvectra website at www.nuvectramed.com. If not received directly from the website or in another manner from Nuvectra on the same day of the patient’s MRI appointment, the MRI guidelines may not be the most up-to-date version.

Types of Electromagnetic Fields Generated by MRI SystemsAn MRI system produces three types of electromagnetic fields that may interact with implanted device systems. All three of these fields are necessary to produce an MRI image. The three fields are defined as follows:

• Static magnetic field – This is a steady state non-varying magnetic field that is always present around an MRI machine, even when no scan is underway.

• Gradient magnetic fields – These low-frequency pulsed magnetic fields are present only during a scan. MRI equipment uses three orthogonal gradient magnetic fields to construct the 3-dimensional image.

• Radio Frequency (RF) field – This is a pulsed RF field that is present only during a scan. The RF field can be produced by a variety of transmission RF coils, such as a whole body transmit coil (that is built into the scanner) or an extremity coil (for example, a transmit/receive head coil).

MR Conditional Scan EnvironmentsNon-clinical testing has demonstrated the Algovita SCS System is MR Conditional for head-only and whole-body scan environments when specific MRI conditions are followed. If an MRI scan is performed in a condition other than what is described in this manual, it may result in serious risks such as tissue damage or severe patient injury. See Algovita SCS MR Conditional System Components and Implant Locations on page 4 for information on these conditions.

Image Artifacts and DistortionThe Algovita SCS MR Conditional System has minimal image distortion when the stimulator and the leads are out of the field of view. In non-clinical testing, the Algovita SCS MR Conditional System can have significant image distortion; up to 63 mm (2.5 in) can result when the stimulator and/or leads are within the field of view.



3. Algovita SCS MR Conditional System Components and Implant LocationsMany components of the Algovita SCS System are “MR Conditional” which means patients with these components may undergo MRI scans only if the conditions outlined in this manual are strictly followed. To meet MR Conditional requirements, the Algovita SCS System must be fully implanted and be composed of at least an implantable pulse generator (stimulator) that is connected to a lead. If the implanted system contains any components not listed in Table 1 or Table 3, or are implanted in other locations, the system is considered untested for an MRI environment. Algovita SCS MR Conditional System components and their safe implant location are listed in the following tables.HEAD-ONLY SCANSA patient who is eligible for a head-only scan can have the anatomy contained within a transmit/receive head coil safely scanned, for the following components and conditions.

Table 1. Head-Only Algovita SCS MR Conditional System ComponentsComponent Model/Catalog Number MR Conditionally Safe Implant Location

Stimulator 3 x 8 2408 Buttocks, abdomen, or flankStimulator 2 x 12 2412 Buttocks, abdomen, or flank8 - Electrode Lead1 mm or 4 mm spacings in 45, 60 or 75 cm lengths

1081-45, 1081-60, and 1081-751084-45, 1084-60, and 1084-75

Epidural space (T1 or lower)

12 - Electrode Lead1 mm or 4 mm spacings in 45, 60 or 75 cm lengths

1121-45, 1121-60, and 1121-751124-45, 1124-60, and 1124-75 Epidural space (T1 or lower)

Paddle LeadLead with a 3-4-3-2 electrode configuration in 45 and 60 cm lengths

3000-45 and 3000-60 Epidural space (T1 or lower)

Paddle LeadLead with a 2 x 6 electrode configuration in 45 and 60 cm lengths

3101-45 and 3101-60 Epidural space (T1 or lower)

40 cm Lead Extension (1 x 8) 5208-40 Connected to the lead and stimulator40 cm Lead Extension (1 x 12) 5212-40 Connected to the lead and stimulatorLead Anchors 5400 Placed on the leadPort Plugs 5510 In the stimulator connector port

Table 2. Head-Only MR Conditions Condition Head-Only Scanning Condition Settings

Static Magnetic Field 1.5 TBore Type ClosedSpatial Field Gradient (maximum) 20 T/m (2000 gauss/cm)Rms dB/dt value (maximum) 42 T/sRF Coil Head transmit/receive, quadrature only (no RF transmit body coil)RF Power Normal operating modeSpecific Absorption Rate (SAR) ≤ 3.2 W/kg (1.45 W/lb)Gradients• Slew Rate (maximum)

≤ 200 T/m/s

Patient Position Prone or supine in the MRI boreContinuous Scanning (maximum) 30 minutes

Patient Monitoring

The patient must be monitored (visually and audibly) continuously during the scan. The scan must be terminated if the patient experiences pain or discomfort from unexpected device stimulation, device heating, or device displacement force.




WHOLE-BODY SCANSA patient who is eligible for a whole-body scan can have any part of the anatomy safely scanned for the following components and conditions.

Table 3. Whole-Body Algovita SCS MR Conditional System ComponentsComponent Model/Catalog Number MR Conditionally Safe Implant Location

Stimulator 3 x 8 2408 Buttocks, abdomen, or flankStimulator 2 x 12 2412 Buttocks, abdomen, or flank8 - Electrode Lead4 mm spacings in 60 cm length

1084-60 Epidural space

12 - Electrode Lead1 mm or 4 mm spacings in 60 cm length

1121-601124-60

Epidural space

Lead Anchors 5400 Placed on the leadPort Plugs 5510 In the stimulator connector port

Table 4. Model 1121-60 and 1124-60 Whole-Body MR ConditionsCondition Whole-Body Scanning Condition Settings

Static Magnetic Field 1.5 TBore Type ClosedSpatial Field Gradient (maximum) 17.1 T/m (1710 gauss/cm)Rms dB/dt Value (maximum) 56 T/sRF Coil Body transmit/receive (built-in), quadrature onlyRF Power Normal operating modeSpecific Absorption Rate (SAR) 2.0 W/kg (0.91 W/lb)Gradients• Slew Rate (maximum)

≤ 200 T/m/s


Patient Monitoring


Table 5. Model 1084-60 Whole-Body MR ConditionsCondition Whole-Body Scanning Condition Settings

Static Magnetic Field 1.5 TBore Type ClosedSpatial Field Gradient (maximum) 17.1 T/m (1710 gauss/cm)Rms dB/dt Value (maximum) 56 T/sRF Coil Body transmit/receive (built-in), quadrature onlySpecific Absorption Rate (SAR) 1.5 W/kg (0.68 W/lb)Gradients• Slew Rate (maximum)

≤ 200 T/m/s


Patient Monitoring




4. Patient Eligibility Conditions

Check the Most Recent MRI GuidelinesAlways obtain the latest MRI guidelines. Contact Nuvectra Customer Service toll-free in the United States at 1-844-727-7897 or obtain the MRI guidelines on the Nuvectra website at www.nuvectramed.com. If not received directly from the website or in another manner from Nuvectra on the same day of the patient’s MRI appointment, the MRI guidelines may not be the most up-to-date version.

Verify Patient MRI Scan EligibilityTable 6 lists the patient eligibility conditions that must be met before performing an MRI scan on a patient implanted with an Algovita SCS MR Conditional System. The table includes suggested methods to verify each condition, of which a combination or all of the suggested methods may be used. The referring physician may also use the Algovita SCS System Patient Eligibility Checklist for Head-Only MRI Scans and/or the Algovita SCS System Patient Eligibility Checklist for Whole-Body MRI Scans to verify and communicate patient eligibility.

Table 6. Patient Eligibility Conditions and Verification Methods

MRI Scanning Condition Suggested Methods to ConfirmThe patient is aware of the potential risks of undergoing an MRI scan with an Algovita SCS System.

Review potential risks with patient.

Confirm that the patient’s Algovita SCS System components and their placement in a safe implant location are MR Conditional as listed in Table 1 and Table 3.

• Check patient records.• Check with the physician responsible for managing the patient’s Algovita

SCS System.

The patient has no abandoned neuromodulation components.

• Check patient records.• Verify by x-ray1.

There is no evidence of broken, intermittent, or fragmented leads (compromised stimulator-lead integrity).

Lead impedance measurement values, as measured by the Clinician Programmer, must be in the normal range (green). The impedance check must be completed within 48 hours of the MRI procedure and recorded on the patient checklist.

The leads are fully implanted in the epidural space. Verify by x-ray1.The stimulator is implanted in the buttock, abdomen, or flank.

• Examine the patient to determine the location of the stimulator. Ask the patient where they place the charging paddle.


If performing a head-only scan, all Algovita SCS System components are outside of the transmit/receive coil.


Confirm the patient has their Programmer Charger and charging paddle, and the Programmer Charger has enough charge to take the stimulator out of storage mode after the MRI scan.

Use the Programmer Charger to confirm the Programmer Charger is at least 51% charged (three or more bars).

10

P125–50% 50–75% 75–100%< 10% 10–25%




MRI Scanning Condition Suggested Methods to ConfirmThe stimulator has sufficient charge. Use the Programmer Charger or Pocket Programmer to confirm the

stimulator is at least 51% charged (three or more bars).

10P01

10

P110–25% 25–50% 50–75% 75–100%< 10%

Do not perform an MRI scan if the patient’s body temperature is above 38° C (100° F).

Confirm through normal hospital procedures.

Place stimulator into storage mode. Ensure that the Pocket Programmer and the Clinician Programmer are able to establish communication with the stimulator. Once the stimulator is placed into storage mode, confirm that the Pocket Programmer and the Clinician Programmer are no longer able to communicate with the stimulator.

The Programmer Charger, Clinician Programmer, charging paddle, Pocket Programmer, or any other external Algovita SCS System components are NOT present in the strictly controlled MR environment (Zones III and IV).

Confirm through normal hospital procedures for checking the MRI environment.

1. X-rays must be performed within 14 days of an MRI scan.

5. Patient Preparation for MRI ScanTable 7 lists the patient preparation conditions that must be met before performing the MRI scan. The table includes suggested methods to confirm each condition. Any or a combination of the suggested methods may be used.

Note: If a patient did not bring their Programmer Charger, the patient can still be scanned (a patient can turn stimulation off with their Pocket Programmer) but will not be able to bring their stimulator out of storage mode until they have access to a Programmer Charger and charging paddle.

Table 7. Patient Preparation ConditionsMRI Scanning Condition Suggested Methods to ConfirmThe stimulator has a charge level of at least 51%. Ensure that three or more bars display on the stimulator battery icon on the

Programmer Charger Home screen.

38

P110–25% 25–50% 50–75% 75–100%< 10%



MRI Scanning Condition Suggested Methods to ConfirmThe Programmer Charger has a charge level of 51% or more.

Ensure that three or more bars are displayed on the Programmer Charger battery icon at the bottom of the Home screen.

10

P125–50% 50–75% 75–100%< 10% 10–25%

Stimulation is off after placing the stimulator in storage mode.

When the stimulator is in storage mode, the Programmer Charger cannot communicate with the stimulator. To confirm that the Programmer Charger is not connected to the stimulator, tap Cancel on the Notification screen, and then on the Home screen. The message, “Not able to connect to stimulator.” redisplays.Note: Make sure the stimulator is paired with the Programmer Charger and the Programmer Charger is within 1 meter (3 feet) of the stimulator to ensure the Programmer Charger is not connected to a patient’s stimulator.

Notification

Not able toconnect to stimulator

Cancel Retry

--

P-->

The Programmer Charger, Clinician Programmer, charging paddle, Pocket Programmer, or any other external Algovita SCS System components are NOT present in the strictly controlled MR environment (Zones III and IV).

Check with the patient before they enter the strictly controlled MR environment (Zones III and IV) that they do not have their Programmer Charger, charging paddle, Pocket Programmer, or any other external Algovita SCS System components.

Inform the PatientDiscuss the potential risks of undergoing an MRI scan with an Algovita SCS System before performing the MRI scan. Remind the patient that their stimulator will need to be placed into storage mode for the duration of the MRI scan.

Inform the patient of the perceptible effects of undergoing an MRI scan with the Algovita SCS MR Conditional System. These effects include vibration, a tugging motion, or warming of the stimulator. If unintended induced electrical stimulation occurs, the patient could experience a tingling or jolting sensation. Instruct the patient to inform the technician if any of these effects become uncomfortable.

Confirm System Conditions and Perform the MRI ScanAfter confirming the MRI system is appropriate and the patient is eligible for an MRI scan (see Algovita SCS MR Conditional System Components and Implant Locations on page 4 and Patient Preparation for MRI Scan on page 7), perform the MRI scan according to institutional protocol.




6. Post MRI ProcedureConfirm that the patient did not experience any Algovita SCS System related adverse effects as a result of the MRI procedure. Report adverse events to Nuvectra by calling Nuvectra Customer Service toll-free at 1-844-727-7897 within the United States, or +1-214-618-4980 if outside of the United States.

After the patient has left the strictly controlled MR environment, the physician or Nuvectra Sales Representative should bring the patient’s stimulator out of storage mode. Instructions are included in Appendix A.

After the patient’s stimulator is out of storage mode, verify that the Algovita SCS System is operational. If the Algovita SCS System displays error messages or does not turn on, instruct the patient to contact Nuvectra.



Appendix A – Take the Stimulator Out of Storage Mode After an MRI Scan

The Algovita SCS System was placed into storage mode prior to the MRI scan and will need to be brought out of storage mode to provide stimulation.

To bring the stimulator out of storage mode:

1. Keep your Programmer Charger within 1 meter (3 feet) of your stimulator.2. Turn your Programmer Charger on.3. When the Not Able to Connect to Stimulator Notification screen appears, tap Cancel.

Notification

Not able toconnect to stimulator

Cancel Retry

4. Connect the charging paddle to the Programmer Charger. The icon becomes available.

>P

P

5. Tap on the Home screen. The Charge Status screen appears.Charge Status

Position charging paddle over stimulator

to charge battery

Cancel OK

>P




6. Tap OK on the Charge Status screen. The Charging in Progress screen appears.

>Charge Status

Charging inProgress

OK

Charge Status

Position paddle over stimulator to charge battery

Cancel OK

7. Slowly move the charging paddle over your stimulator, crossing the location of the stimulator at least twice before centering the charging paddle over your stimulator.

8. After the stimulator exits storage mode, the Programmer Charger automatically establishes communication with your stimulator and the Communication icon appears.Your stimulator is out of storage mode and the stimulator battery is charging.

>Charge Status

Charging inProgress

OK

Charge Status

Charging inProgress

OK

9. Tap the Home button to disconnect your Programmer Charger from your stimulator. 10. Reconnect your Programmer Charger by tapping the Communication icon or establishing a connection using your

Pocket Programmer. indicates your Programmer Charger is connected. indicates your Programmer Charger is not connected.




© 2019 All Rights ReservedPart Number 0300-000175-001 Rev 052019-08

Nuvectra Corporation10675 Naples St. NEBlaine, MN 55449Tel 1 844 727 7897Tel +1 214 618 4980Fax +1 716 759 5069www.nuvectramed.com


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Algovita Spinal Cord Stimulation System MRI Procedure Guidelines… · 2020-01-02 · • Induced...

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