BSNV-8 Adaptor Extension
1x8 adaptor extension kit
Instructions for use
Rx only
EMBSNV20
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
See also the Neuromodulation Symbols Reference, which is provided with product labeling
at http://manuals.medtronic.com for explanation of other symbols on product and package
labeling.
Reference ISO 15223-1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1 and ASTM F2503 Part 13, Standard
Practice for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment.
Magnetic Resonance (MR) Unsafe
ASTM F2503 [7.4.10]
Keep dry
ISO 15223-1 [5.3.4]
Keep away from sunlight
ISO 15223-1 [5.3.2]
EMBSNV20 2022-01-15 English 3
Medtronic and the Medtronic logo are trademarks of Medtronic.
Intellis™, Sequentia™, and Vanta™ are trademarks of a Medtronic company.
Third-party brands are trademarks of their respective owners.
4 English EMBSNV20 2022-01-15
Table of contents
Description 7
Intended purpose 7
Package contents 7
Compatibility 7
Contraindications 10
Warning – MRI eligibility 10
Warning – App version and MRI eligibility 10
MR Unsafe patient identification card 11
Cautions – Component handling 11
Device specifications 11
Instructions for use 13
Preparing for long-term system implant 13
Creating a pocket for the neurostimulator 13
Connecting system components to the adaptor for long-term system implant 14
Programming the system 16
Completing the implant procedure 17
Compatible leads and electrode numbering 17
Appendix: Trial procedures 21
Connecting the adaptor to the externalized lead or extension for the trial 21
Preparing components for the trial 22
Removing externalized components after the trial 23
EMBSNV20 2022-01-15 English 5
Information available for the system:
The information for prescribers manual provides information about
contraindications, warnings, precautions, adverse events,
sterilization, patient selection, individualization of treatment, and
component disposal. For customers in Japan, the appropriate
package insert provides information about safety, contraindications,
warnings, precautions, and adverse events.
The indications sheet provides information about indications and
related information. For customers in Japan, the appropriate
package insert provides information about indications.
The system eligibility and battery longevity manual describes
programming considerations and provides battery longevity
information to aid in the appropriate neurostimulator selection.
MRI guidelines provide information about any MRI conditions and
MRI-specific contraindications, warnings, and precautions for MRI
scans with the neurostimulation system.
Product manuals, such as programming guides, recharging guides,
and implant manuals provide device descriptions, package
contents, device specifications, product-specific warnings and
precautions, and instructions for use.
! USA
The clinical summary provides information about the clinical
study results for the neurostimulation system.
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Description
The Medtronic Model EMBSNV20 1x8 BSNV-8 adaptor extension is part of a
neurostimulation system for pain therapy.
In this manual, “adaptor” is used to refer to the BSNV-8 adaptor extension. “Extension” is
used to reference any non Medtronic extensions that may be present in the system.
Intended purpose
The BSNV-8 adaptor extension is intended to connect specific Boston Scientific™ and
Nevro™ leads or extensions to specific Medtronic neurostimulators to conduct electrical
stimulation as part of a spinal cord stimulation (SCS) system for long-term system implant
or for use in test or trial stimulation.
Package contents
The adaptor extension and accessories are supplied sterile and are single-use only.
BSNV-8 adaptor extension
▪
Connector boots, 1 x 8 (1 clear, 1 white radiopaque)
▪
Spare setscrews (2)
▪
Torque wrench
▪
Product literature
▪
▪
Warranty card
▪
Registration form
Compatibility
Refer to Table 1 and Table 2 for adaptor compatibility information. Do not use products with
the Medtronic BSNV-8 adaptor that are not listed in Table 1 and Table 2.
EMBSNV20 2022-01-15 English 7
Table 1. Compatibility with the Medtronic BSNV-8 adaptor extension
Component Compatibility
Boston Scientific
Leads and
Extensions
Note: xx = length (cm), xxE = length (cm) Trial Lead.
SC-2138-xx Linear™ (8-contact)
▪
SC-2158-xx Linear (8-contact)
▪
SC-2158-xxE Linear (8-contact)
▪
SC-2208-xx Linear ST (8-contact)
▪
SC-2218-xx Linear ST (8-contact)
▪
SC-2218-xxE Linear ST (8-contact)
▪
SC-2408-xx Avista™ MRI (8-contact)
▪
SC-2352-xx Linear 3-4 (8-contact)
▪
SC-2352-xxE Linear 3-4 (8-contact)
▪
SC-2366-xx Linear 3-6 (8-contact)
▪
SC-2366-xxE Linear 3-6 (8-contact)
▪
SC-2016-xx Infinion™ 16-Contact Lead and Splitter 2x8 Kit
▪
SC-2016-xxE Infinion 16-Contact Lead and Splitter 2x8 Trial Kit
▪
SC-2316-xx Infinion 16-Contact Lead Kit
▪
SC-2316-xxE Infinion 16-Contact Lead Kit
▪
SC-2317-xx Infinion CX 16-Contact Lead kit
▪
SC-2317-xxE Infinion CX 16-Contact Trial Lead kit
▪
SC-8120-xx Artisan™ 2x8 Surgical Lead Kit
▪
SC-8216-xx Artisan 2x8 Surgical Lead Kit
▪
Note: Infinion leads require a compatible 2x8 splitter.
Extension and Splitter Models:
SC-3138 8-Contact Extension
▪
▪
SC-3400 Splitter 2x8
8 English EMBSNV20 2022-01-15
▪
▪
97716
97715
LEAD3025-xx(B)
▪
Table 1. Compatibility with the Medtronic BSNV-8 adaptor extension (continued)
Component Compatibility
Nevro Leads and
Extensions
Medtronic
Neurostimulators
Medtronic
clinician
programmer
applications
(apps)
Magnetic
Resonance
Imaging (MRI)
Eligibility
Note: xx = length (cm).
Surpass™ Percutaneous Lead Model (8-electrode):
LEAD1058-xx(B)
▪
Surpass Surgical Lead Models (16-electrode):
LEAD3005-xx(B)
▪
LEAD3015-xx(B)
▪
Trialing Lead Model:
TLEAD1058-xx(B) Trialing Lead (8-electrode)
▪
Extension Model:
LEAD2008 Extension (8-contact)
▪
Medtronic Implantable Neurostimulator Models:
977006
▪
977005
▪
Medtronic External Neurostimulator (ENS) Model:
97725
▪
Refer to "Contraindications" on page 10 for the Medtronic
neurostimulator models that are not compatible.
See Table 2 for the compatible clinician programmer apps.
See the related app version warning on page 10.
None. Patients implanted with the adaptor are not eligible for MRI
scans. Refer to "Warning – MRI eligibility" on page 10 for more
information.
EMBSNV20 2022-01-15 English 9
available with Non
Medtronic leads
IntelliStim
IntelliStim
App model number,
(app name),
version
Model A71200
(Vanta)
version 2.0 or higher
Model A710
(Intellis)
version 2.0 or higher
Table 2. Compatible clinician programmer apps
Medtronic neurostimulators App features not
Vanta™ Model 977006
▪
implantable neurostimulator
Sequentia™ LT Model 977005
▪
implantable neurostimulator
Model 97725 ENS
▪
Intellis™ Models 97715 and 97716
▪
implantable neurostimulators
Contraindications
The Medtronic BSNV-8 1x8 adaptor extension (Model EMBSNV20) is contraindicated for
use with the following Medtronic devices:
Model 37022 external neurostimulator
▪
Implantable neurostimulator models 37701, 37702, 37703, 37704, 37711, 37712,
▪
37713, 37714, 97702, 97712, 97713, and 97714
Model A71300 version 1.0 stimulation trialing clinician programmer app
▪
Warning – MRI eligibility
Warning: Patients implanted with a Medtronic BSNV-8 adaptor extension are not
eligible for MRI scans. Physicians should not prescribe MRI for patients implanted with
a Medtronic BSNV-8 adaptor extension. This adaptor has not been tested for safety in
an MRI environment. No claims of safety are made for MRI scans involving modified
Medtronic neurostimulation system components or for Medtronic neurostimulation
systems that contain components or accessories that have not been tested for safety
in an MRI environment. MRI scans of such systems may cause heating of the lead
electrodes, resulting in tissue damage or serious patient injury.
Warning – App version and MRI eligibility
Warning: Earlier versions of the A710 app do not contain the workflows needed to
correctly identify systems that use the adaptor and will incorrectly identify MRI
eligibility if used for new implants of the Model 97715 or 97716 neurostimulator with
the adaptor. To ensure that MRI eligibility is correctly identified for these
neurostimulation systems, verify that the A710 app version is 2.0 or higher prior to
beginning the procedure. Incorrect identification of MRI eligibility may allow a patient to
receive an MRI scan and may result in tissue damage or serious injury.
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MR Unsafe patient identification card
The adaptor package contains an MR Unsafe patient identification (ID) card that the patient
should retain for reference when prescribed MRI. This card supersedes any other cards the
patient may have when determining MRI eligibility. Give the completed MR Unsafe ID card
to the patient after implant and inform patients that MRI scans should not be performed with
their implanted system.
Cautions – Component handling
Caution: Do not bend, kink, or stretch the adaptor body, which may damage the
component.
Cautions:
Do not use saline or other ionic fluids at connections, which could result in a short
▪
circuit.
Before connecting components, wipe off any body fluids and dry all connections.
▪
Fluids in the connection may result in stimulation at the connection site,
intermittent stimulation, or loss of stimulation.
Device specifications
The Medtronic BSNV-8 adaptor extension has eight connector contacts on the distal end
and on the proximal end. The in-line distal end connects to a Boston Scientific or Nevro
lead or extension. The proximal end connects to a Medtronic neurostimulator.
Setscrew
Adaptor connector housing
Distal
Adaptor body
Figure 1. BSNV-8 adaptor extension.
EMBSNV20 2022-01-15 English 11
Adaptor connector contacts
Proximal
0 1 2 3 4 5 6 7
Table 3. Device specificationsa for the adaptor extension.
Description Model EMBSNV20
Expected lifetime 5 years
Resistance
b,c
Maximum 15.0 Ω
Length (overall) 20 cm
Surface area (includes connector boot)
14.6 cm
2
Distal endd (lead or extension)
Connector Octapolar (8 contacts), in-line
Contact spacing 2.5 mm
Contact diameter 1.3 mm
Outer diameter 5.3 mm
Proximal end (neurostimulator)
Connector Octapolar (8 contacts), in-line
Contact spacing 2.8 mm
Diameter 1.3 mm
Materials and substances to which the patient
can be exposed
a
All measurements are approximate.
b
Electrical resistance of this device only.
c
Resistance is proportional to length: long lengths have higher resistance that may limit the amplitude
(intensity).
d
The distal end of the adaptor is designed to be compatible with the contact spacing and contact diameter
of Boston Scientific and Nevro leads and extensions.
e
Discuss allergies or other intolerances related to the materials of construction with the patient before the
procedure.
f
The materials listed are ordered from the most to least amount.
g
Contains nickel. Nickel is used in mixtures of metals, such as stainless steel, and is a known allergen.
e,f
Silicone with and without barium sulfate
(radiopaque, white colorant), polyurethane,
titanium, stainless steel
g
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Instructions for use
Implanting physicians should be thoroughly familiar with all product labeling.
Notes:
Refer to the product labeling for any non Medtronic devices in the system for
▪
information about those devices, including instructions for use, contraindications,
warnings, cautions, and potential adverse events.
Also note if there are any markers or indicators for the leads or extensions for
▪
distinguishing lead electrode numbering for connection to a neurostimulator.
Preparing for long-term system implant
1.
For new implants of the Medtronic Model 97715 or 97716 neurostimulator, verify that
the software version of the Model A710 clinician programmer app is version 2.0 or
higher prior to beginning the procedure. If needed, use the instructions provided by
Medtronic to upgrade the app.
Warning:
to correctly identify systems that use the adaptor and will incorrectly identify
MRI eligibility if used for new implants of the Model 97715 or 97716
neurostimulator with the adaptor. To ensure that MRI eligibility is correctly
identified for these neurostimulation systems, verify that the A710 app version is
2.0 or higher prior to beginning the procedure. Incorrect identification of MRI
eligibility may allow a patient to receive an MRI scan and may result in tissue
damage or serious injury.
2.
Confirm that the non Medtronic lead is compatible with the selected adaptor. Refer to
Table 1 on page 8 for compatibility information.
3.
Refer to the product labeling for the non Medtronic lead for instructions and
information specific to that lead.
4.
Before opening the adaptor package, verify the model number, use-by date, adaptor
length, and connector type.
Creating a pocket for the neurostimulator
Notes:
Refer to the neurostimulator implant manual for the proper subcutaneous pocket
▪
depth.
The neurostimulator should be placed on the opposite side of the body from another
▪
active implanted device and should be placed preferably on the right side of the body
to allow for future placement of cardiac devices on the patient’s left side.
1.
Make a small incision that will allow the neurostimulator to fit tightly in the
subcutaneous pocket.
Earlier versions of the A710 app do not contain the workflows needed
EMBSNV20 2022-01-15 English 13
2.
Use blunt dissection to create a subcutaneous pocket just large enough that the
neurostimulator and coiled excess lead or extension, as well as the adaptor, fit tightly
in the pocket.
Connecting system components to the adaptor for long-term system implant
Non Medtronic
Lead
Lead or extension bodies Adaptor extensions
Visually inspect the proximal end of the implanted lead or extension to ensure the
1.
connectors are clean and undamaged.
2.
Slip the narrow end of the connector boot onto the non Medtronic lead or extension
body with the wide end of the connector boot facing outward, exposing the contacts.
Note:
The connector boot prevents tissue ingrowth on the setscrew. A clear boot and
a white radiopaque boot are provided in the adaptor extension kit to distinguish lead or
extension bodies for lead electrode numbering when connecting to a Medtronic
neurostimulator.
Lead or extension
Figure 3. Connector boot on lead or extension to expose the contacts.
3.
Wipe the lead or extension connector with sterile gauze. If needed, use sterile (United
States Pharmacopeia [USP]) water. Dry the connector.
4.
Insert the lead or extension connector into the adaptor connector housing, while
visually aligning the contacts.
Notes:
Each contact must be aligned under each adaptor connector contact.
▪
During insertion, some resistance is typical.
▪
5.
Use the torque wrench from the adaptor kit to tighten the setscrew.
Connector boots
Ligature on wide end
Figure 2. Component connections.
Slide connector boot to expose contacts
Medtronic
Neurostimulator
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Cautions:
To avoid overtightening, use only the supplied torque wrench to tighten the
▪
setscrew. Overtightening the setscrew may damage the lead or extension
contacts and cause an open or short circuit, resulting in intermittent or loss
of stimulation.
Discard the torque wrench after making all connections. Reusing a torque
▪
wrench may result in undertightening or overtightening and subsequently,
intermittent or loss of stimulation.
6.
Slide the connector boot in the direction of the adaptor to cover the setscrew and
approximately half of the adaptor connector housing.
7.
Tie a ligature (using nonabsorbable suture) between the rings on the wide end of the
connector boot.
Cautions:
Do not tie ligatures around the adaptor body, which may damage the
▪
insulation.
Do not overtighten ligatures on the connector boot. Ligatures that are too
▪
tight may damage the connection.
Ensure that the end of the connector boot is secure to prevent tissue
▪
ingrowth on the setscrew.
8.
For connecting a second adaptor, repeat steps 1 to 7.
Cautions:
Do not pull the lead, extension, or adaptor taut. Allow enough slack to
▪
accommodate patient movement. Pulling the lead, extension, or adaptor
taut may result in a short or open circuit or migration of implanted
components.
Coil the excess adaptor body into a circular loop greater than 2 cm (0.8 in)
▪
in diameter. Do not use a U-shaped loop or bend (Figure 4). A circular loop
decreases the possibility of electromagnetic interference and its effects and
prevents kinking or damaging the lead body.
EMBSNV20 2022-01-15 English 15
≥ 2 cm
Figure 4. Coiling excess.
9.
Connect the proximal end of the adaptor to the Medtronic neurostimulator and insert
the assembly into the neurostimulator pocket. Refer to the Medtronic neurostimulator
implant manual for instructions on which socket to use for electrodes 0-7 and
electrodes 8-15.
Caution:
socket of the neurostimulator, and when attempting to remove, excess
resistance is felt, slightly advance the proximal end of the adaptor in the socket
and then rotate the adaptor to remove it. Before reinserting the adaptor
connector into the neurostimulator socket, wipe off any fluids and dry the adaptor
connector.
If the proximal end of the adaptor needs to be removed from the
Programming the system
For non Medtronic leads, the Medtronic clinician programmer app does not display an image
of the manufacturer’s lead electrode configuration on the programmer screen. Instead, the
clinician programmer app displays a basic electrode layout.
Use these instructions to program the components of the system and non Medtronic lead
configurations.
1.
Using the Medtronic clinician programmer app for the compatible Medtronic
neurostimulator, complete the initial workflow steps to enter patient and system
information. Refer to the appropriate Medtronic clinician programmer app guide for
instructions.
2.
On the
Lead Select
drag and drop it at the appropriate electrode numbers of the neurostimulator:
8 Electrode Percutaneous
▪
You can also use this option with a 1x16 percutaneous lead by adding
Electrode Percutaneous
8 Electrode Surgical
▪
screen, select the lead type from the
– Select for a 1x8 percutaneous lead.
twice to the
– Select for a 1x8 or 2x4 surgical paddle lead.
Lead Select
Non Medtronic
screen.
list, then
8
16 English EMBSNV20 2022-01-15
16 Electrode
▪
configurations (such as a 2x8 surgical paddle lead, a 5-6-5 surgical paddle lead, or
a 1x16 percutaneous lead).
Note:
When you select a non Medtronic lead, the clinician programmer app
automatically selects the
presence of the adaptor in the system.
3.
When the pop-up text box opens when a lead is selected, use the suggested identifier
given in Table 4 or Table 5 to identify the non Medtronic lead in the clinician
programmer app and on reports.
4.
If needed, repeat steps 1 to 3 for the second lead and adaptor.
5.
Select electrodes to program according to the electrode numbering given in Table 4
or Table 5 for the lead or leads implanted. Program stimulation parameters according
to the patient’s therapy needs. Refer back to the appropriate Medtronic clinician
programmer app guide for instructions.
Note:
The IntelliStim feature is not available for use with non Medtronic leads.
– Select for other percutaneous or surgical paddle lead
Extensions
box on the
Tip Location
screen to indicate the
Completing the implant procedure
1.
Close and dress all incisions.
2.
Ensure that a patient control device and a completed patient identification card are
given to the patient.
3.
Complete the device tracking and patient registration paperwork and return the
documents to Medtronic.
Compatible leads and electrode numbering
The adaptor is compatible with the leads listed in Table 4 and Table 5.
The tables contain the manufacturer’s lead model number and name, along with the
suggested identifier to use in the Medtronic clinician programmer app to identify the lead in
the app and on reports.
The corresponding depiction of each lead shows the Medtronic electrode numbering on the
distal end of the lead to use when programming specific electrodes using a compatible
Medtronic clinician programmer app. This electrode numbering may differ from the
numbering used in the lead manufacturer’s product manuals.
Notes:
All surgical paddle leads are shown with electrodes facing down.
▪
Any lead using more than 8 electrodes requires two adaptors.
▪
The images of the leads in Table 4 and Table 5 are representative. The images show
▪
Medtronic electrode numbering to program Medtronic neurostimulators. Refer to the
lead manufacturer's product labeling for electrode measurements and spacing.
EMBSNV20 2022-01-15 English 17
Table 4. Boston Scientific leads compatible with the BSNV-8 adaptor extension
Boston Scientific
Model
SC-2016-xx
Name Suggested
Infinion 16 Lead and Splitter 2x8 Kit BSX2016
SC-2016-xxE
Identifier
BSX2016E
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
SC-2138-xx
Linear 8-Contact Lead (Percutaneous) BSX2138
SC-2158-xx
SC-2158-xxE
01234567
SC-2208-xx
Linear ST 8-Contact Lead (Percutaneous)
SC-2218-xx
SC-2218-xxE
SC-2408-xx
Avista MRI 8-Contact Lead (Percutaneous)
0123 4567
BSX2158
BSX2158E
BSX2208
BSX2218
BSX2218E
BSX2408
18 English EMBSNV20 2022-01-15
Table 4. Boston Scientific leads compatible with the BSNV-8 adaptor extension
Boston Scientific
Model
SC-2316-xx
SC-2316-xxE
SC-2317-xx
Name Suggested
Infinion 16 and Infinion CX 16-Contact Lead
Note: Infinion leads require a compatible
2x8 splitter.
SC-2317-xxE
(continued)
Identifier
BSX2316
BSX2316E
BSX2317
BSX2317E
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
SC-2352-xx
SC-2352-xxE
Linear 3-4 8-Contact Lead (Percutaneous) BSX2352
BSX2352E
01 23 4567
SC-2366-xx
SC-2366-xxE
Linear 3-6 8-Contact Lead (Percutaneous) BSX2366
BSX2366E
01 2 3 4 5 67
SC-8120-xx
SC-8216-xx
Artisan 2x8 Surgical Lead Kit (Surgical) BSX8120
08192103
11
12
5136147
4
15
EMBSNV20 2022-01-15 English 19
BSX8216
Table 5. Nevro leads compatible with the BSNV-8 adaptor extension
Nevro Model Name Suggested
LEAD1058
TLEAD1058
Surpass Percutaneous Lead
Surpass Percutaneous Trial Lead
Identifier
NV1058
NV1058T
01 234567
LEAD3005
LEAD3015
LEAD3025
Surpass Surgical Leads NV3005
8 9 10 11 12 13 14
0 1 2 3 4 5 6 7
NV3015
NV3025
15
20 English EMBSNV20 2022-01-15
Appendix: Trial procedures
Before opening the adaptor package, verify the model number, use-by date, adaptor length,
and connector type.
When the adaptor is used for a trial, the adaptor connects only to the external devices (for
example, external neurostimulator or trialing cable) and to the externalized ends of
implanted leads or extensions used for the trial period.
After the patient completes the trial to determine the effectiveness of stimulation in
managing pain, the adaptor used to connect the Medtronic external neurostimulator to the
non Medtronic lead or extension must be removed and discarded prior to system implant.
Use a new sterile adaptor for long-term system implant.
Warning
: Physicians should not prescribe MRI for patients undergoing a trial or test
stimulation period, or who have any neurostimulation system components that are not
fully implanted. Explant all trial components if an MRI scan is required. MRI has not
been tested on trial components and may cause heating of the lead electrodes,
resulting in tissue damage or serious patient injury.
Connecting the adaptor to the externalized lead or extension for the trial
Non Medtronic
Lead
Lead or extension bodies Adaptor extensions
Note:
The connector boot is optional for the trial.
1.
Optional: Slip the narrow end of the connector boot onto the non Medtronic lead or
extension body with the wide end of the connector boot facing outward, exposing the
contacts.
Note:
A clear boot and a white radiopaque boot are provided in the adaptor extension
kit to distinguish lead or extension bodies for lead electrode numbering when
connecting to a Medtronic neurostimulator.
Connector boots
Ligature on wide end
Figure 5. Component connections.
Medtronic
Neurostimulator
EMBSNV20 2022-01-15 English 21
Slide connector boot to expose contacts
Lead or extension
Figure 6. Connector boot on lead or extension to expose the contacts.
2.
Wipe the lead or extension connector with sterile gauze. If needed, use sterile (United
States Pharmacopeia [USP]) water. Dry the connector.
3.
Insert the lead or extension connector into the adaptor connector housing, while
visually aligning the contacts.
Notes:
Each contact must be aligned under each adaptor connector contact.
▪
During insertion, some resistance is typical.
▪
4.
Use the torque wrench from the adaptor kit to tighten the setscrew.
Cautions:
To avoid overtightening, use only the supplied torque wrench to tighten the
▪
setscrew. Overtightening the setscrew may damage the lead or extension
contacts and cause an open or short circuit, resulting in intermittent or loss of
stimulation.
Discard the torque wrench after making all connections. Reusing a torque
▪
wrench may result in undertightening or overtightening and subsequently,
intermittent or loss of stimulation.
5.
Optional: Slide the connector boot in the direction of the adaptor to cover the setscrew
and approximately half of the adaptor connector housing.
6.
Optional: Tie a ligature (using nonabsorbable suture) between the rings on the wide
end of the connector boot.
7.
For connecting a second adaptor, repeat steps 1 to 6.
Preparing components for the trial
The patient’s response to the system and the efficacy of the system should be evaluated in
both a clinical and a home setting. Different electrode configurations should be evaluated at
various parameter settings during the trial period.
1.
Place a gauze bandage on the skin where the adaptor extension and Medtronic
external neurostimulator used for the trial will be placed on the patient.
2.
Connect the proximal end of the adaptor extension to the external neurostimulator
used for checking impedances. Refer to the product labeling associated with the
external neurostimulator for more information.
3.
Program the system. Refer to "Programming the system" on page 16 for information.
4.
Confirm the integrity of the lead-adaptor extension connection by checking the
impedance of all electrode pairs with the clinician programmer. Refer to the Medtronic
clinician programmer app guide for instructions.
22 English EMBSNV20 2022-01-15
5.
Coil excess lead or extension, as well as the adaptor body into a circular loop greater
than 2 cm (0.8 in) in diameter and place it under the external device.
Cautions:
Do not pull the lead, extension, or adaptor taut. Allow enough slack to
▪
accommodate patient movement. Pulling the lead, extension, or adaptor
taut may result in a short or open circuit or migration of implanted
components.
Coil the excess adaptor body into a circular loop greater than 2 cm (0.8 in)
▪
in diameter. Do not use a U-shaped loop or bend (Figure 7). A circular loop
decreases the possibility of electromagnetic interference and its effects and
prevents kinking or damaging the lead body.
≥ 2 cm
Figure 7. Coiling excess.
Secure the adaptor and external neurostimulator to the patient for the trial, allowing
6.
for strain relief. Refer to the product labeling associated with the external
neurostimulator for more information.
7.
Proceed with the trial.
Removing externalized components after the trial
After the trial, remove and discard all externalized components (including the external
adaptor) according to local regulations. Refer to the product labeling for the externalized
components for removal instructions.
EMBSNV20 2022-01-15 English 23
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
Tel. 1-763-505-5000
Toll-free 1-800-328-0810
*M963185A001*
© Medtronic 2022
All Rights Reserved
2022-01-15
M963185A001 Rev B
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