Medtronic 3531 Verify ENS (external neurostimulator) User Manual
Medtronic, Inc. Verify ENS (external neurostimulator)
User Manual
VERIFY
TM
EXTERNAL
NEUROSTIMULATOR
3531
User manual
! USA
Rx only
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
ImplantManual.xsl - IPGTemplate.fm
Template version: 12-13-2011
M943581A001 Rev X
2013-03
Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Medtronic Confidential
ImplantManual.xsl - IPGTemplate.fm
Template version: 12-13-2011
M943581A001 Rev X
2013-03
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
Conformité Européenne (European Conformity). This symbol means that the
device fully complies with MDD 93/42/EEC (NB 0123) and R&TTE Directive
1999/5/EC.
System meets the applicable Canadian (CAN/CSA-C22.2 No. 60601-1)
electrical safety standard requirements.
Do not reuse
Consult instructions for use
Serial number
Manufacturer
EC REP
Authorized representative in the European community
IEC60601-1/EN60601-1, Type BF equipment
Non-ionizing electromagnetic radiation
XXX °F
XX °C
-XX °F
-XX °C
Temperature limitation
For USA audiences only
Do not dispose of this product in the unsorted municipal waste stream. Dispose
of this product according to local regulations. See http://recycling.medtronic.com
for instructions on proper disposal of this product.
Chinese Standard (SJ/T11364-2006) Logo: Electronic Information Products
Pollution Control Symbol. (The date in this logo means the environmental
protection use period of the product.)
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Medtronic
®
is a trademark of Medtronic, Inc., registered in the U.S. and other countries.
Verify
TM
is a trademark of Medtronic, Inc.
Bluetooth
®
is a registered trademark of Bluetooth SIG, Inc.
! USA
FCC Information
The following is communications regulation information on the Model 3531 External
Neurostimulator.
FCC ID: LF53531
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
IMPORTANT: Changes or modifications to this product not authorized by Medtronic,
Inc., could void the FCC Certification and negate your authority to operate this
product.
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2) this
device must accept any interference, including interference that may cause undesired
operation of the device.
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Table of contents
Purpose of the device 5
Description 5
Package contents 5
Device specifications 5
Declaration of Conformity 8
Instructions for use 9
Pairing the external neurostimulator to the controller 9
Using the external neurostimulator during test stimulation 9
Replacing the external neurostimulator batteries 10
Using the external neurostimulator boot 12
Using the external neurostimulator belt 13
Device care and storage 15
Safety and technical checks 15
Refer to the indications sheet for indications and related information.
Refer to the appropriate information for prescribers booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment,
patient selection, use in specific populations, resterilization, and component
disposal.
Refer to the Test stimulation lead implant manual packaged with the test stimulation
lead for test stimulation-specific contraindications, warnings, precautions, adverse
events summary, individualization of treatment, patient selection, use in specific
populations, resterilization, and component disposal.
Refer to System Eligibility, Battery Longevity, Specifications reference manual for
neurostimulator selection, battery longevity calculations and specific
neurostimulator specifications.
! USA
Refer to the clinical summary booklet for information on the clinical study
results of the neurostimulation system and individualization of treatment.
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Purpose of the device
The Medtronic Model 3531 Verify External Neurostimulator (ENS) is used to evaluate a
Medtronic Sacral Neuromodulation (SNM) System during lead placement or test
stimulation.
Description
The Medtronic Model 3531 External Neurostimulator is a disposable, single-use device
equipped with Bluetooth wireless technology, and is part of a sacral neuromodulation
system.
Package contents
▪
External neurostimulator
▪
External neurostimulator boot
▪
AAAA alkaline batteries (4)
▪
Product literature
▪
! USA
Warranty card
Device specifications
The external neurostimulator (Figure 1) is a programmable device that delivers stimulation
through one or more leads (delivered through one lead at a time). The stimulation settings are
stored in programs. A program is a specific combination of pulse width, rate, and amplitude
settings acting on a specific electrode combination.
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Light-emitting diode (LED) ENS button
Output jack
Figure 1. Model 3531 External Neurostimulator.
Table 1. Operating values for the Model 3531 External Neurostimulator
a
Programmable parameter Operating values and ranges
b
Number of programs 1 to 3
Electrode configuration 1 to 4 electrodes as anode, cathode, or off
Amplitude 0 to 12.5 mA with 0.1-mA resolution
Amplitude – upper patient
limit
Programmed value to 12.5 mA (same resolution as amplitude)
Amplitude – lower patient
limit
0 mA to the programmed value (same resolution as amplitude)
Pulse width 60 to 450 µs (10-µs resolution)
Rate 3 to 130 Hz (1-Hz resolution between 3 and 30 Hz; 5-Hz
resolution between 30 and 130 Hz)
aSelection of parameters and values is limited by the controller with regards to appropriate applications,
therapies, and devices.
bOut-of-regulation detection may prevent the use of some parameter combinations.
Table 2. Physical characteristics of the Model 3531 External Neurostimulator
a
Description Value
Length 51 mm (2.0 in)
Length, including cable connector 58 mm (2.3 in)
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Table 2. Physical characteristics of the Model 3531 External Neurostimulator
a
(continued)
Description Value
Width 43 mm (1.7 in)
Thickness 15 mm (0.6 in)
Weight (with batteries) 53.9 g (1.9 oz)
Output jack 21 pin
Identification code NLM
aAll measurements are approximate.
Table 3. Electrical and physical characteristics for the Model 3531 External
Neurostimulator
Description Value
Power source AAAA alkaline batteries (2)
Battery life 14 days minimum for alkaline batteries
a
Operating type Continuous
Degree of protection against electrical
shock
Type BF
Degree of protection against fluid ingress IP24
b
Case material Polycarbonate/ABS blend plastic resin
Automatic shut off
c
Connector cable disconnected
aBattery life is based on 24-hour per day stimulation using 1 program: impedance = 1200 Ω,
amplitude = 4.2 mA, pulse width = 210 µs, rate = 14 Hz, and multiple communications between the
controller and the external neurostimulator.
bThe ENS device, with cable fully inserted and battery door side protected either by the device being
bandaged directly to the skin or by having the device in the boot or belt, meets the IP24 classification
for particulate and water exposure resistance. IP classification is IPN1N2, where: N1 is 2 =
protection of equipment against a solid foreign objects ≥ 12.5 mm diameter and N2 is 4 = protection
of equipment against ingress of water with harmful effects of splashing.
cUse the controller to turn the external neurostimulator on once the condition is resolved.
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Table 4. Storage, shipping, and operating conditions for the
Model 3531 External Neurostimulator
Parameter Storage Shipping Operating
Minimum temperature Room
temperature
-35 °C (-31 °F) 9 °C (49 °F)
Maximum temperature Room
temperature
57 °C (135 °F) 43 °C (110 °F)
Maximum humidity — 95% (non-
condensing)
a
95% (non-
condensing)
b
Minimum atmospheric
pressure
——50 kPa
Maximum atmospheric
pressure
— — 106 kPa
aTested at 30 °C (86 °F). Not tested at the maximum temperature.
bTested at 35 °C (95 °F). Not tested at the maximum temperature.
Declaration of Conformity
Medtronic declares that this product is in conformity with the essential requirements of Directive
1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 93/42/EEC
on Medical Devices.
For additional information, contact the appropriate Medtronic representative listed on the inside
back cover of this manual.
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Instructions for use
The external neurostimulator is used to evaluate lead placement and stimulation settings.
w
Warning: This device was designed for single patient use only. Do not reuse, reprocess,
or resterilize this product. Reuse, reprocessing, or resterilization may compromise the
structural integrity of the device and/or create a risk of contamination of the device, which
could result in patient injury, illness, or death.
#
Caution: The device is not certified for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide. The consequences of using the device
near flammable atmospheres are unknown.
#
Caution: Do not modify this equipment. Modification of this equipment can result in
damage to the device, causing the device to malfunction or become unusable.
#
Caution: Do not use the device in the proximity of equipment that generates
electromagnetic interference (EMI). EMI may cause a disruption in device function.
Examples of common medical sources of EMI are magnetic resonance imaging (MRI)
and lithotripsy. Powerful computer monitors, cell phones, x-ray equipment, and other
monitoring equipment may also generate EMI.
Note: Turn off and dispose of the external neurostimulator after defibrillation. For more
information on the effects of defibrillation on the neurostimulator, refer to the Information for
Prescribers Booklet.
Pairing the external neurostimulator to the controller
For instructions on pairing the external neurostimulator to the controller, refer to the
appropriate controller programming guide.
Using the external neurostimulator during test stimulation
When programming during test stimulation, keep the controller within 3 meters (10 feet) of the
external neurostimulator. The external neurostimulator does not attach to the controller.
Using the ENS button
The ENS button is used to place the external neurostimulator into discovery mode to establish
communication with a controller. It can also be used when you need to immediately turn off
the external neurostimulator. You must use the controller to turn on the external
neurostimulator. The ENS button is not an on/off control.
Press and hold the ENS button for at least three seconds to turn off the external
neurostimulator or to place the external neurostimulator into discovery mode.
Understanding the LED on the external neurostimulator
Once batteries are inserted into the external neurostimulator, the external neurostimulator
turns on, and the light-emitting diode (LED) shines continuously for a few seconds. When the
LED begins to blink, the external neurostimulator has completed initiation, has entered
discovery mode, and can be paired to a controller.
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Notes:
▪
The external neurostimulator will remain in discovery mode for 90 seconds, or until it
successfully pairs with a controller, at which point the LED will stop blinking and turn
off.
▪
The LED blinks whenever the external neurostimulator is in discovery mode, or when it
receives data from a controller.
▪
Refer to the appropriate programming guide for more information on using the
controller.
Replacing the external neurostimulator batteries
For instructions on checking the external neurostimulator batteries using the controller, refer
to the appropriate controller programming guide.
#
Caution: Do not leave depleted batteries in the external neurostimulator. The batteries
may corrode and cause damage to the electronic components.
#
Caution: If the device will not be used for several weeks, remove the batteries from the
device. A battery left in the device may corrode, causing damage to the electronic
components.
Notes:
▪
Before inserting batteries, check for signs of battery leakage. If any residue is present,
do not use.
▪
Stimulation settings may not reflect programming changes that were made prior to
replacing the batteries.
1. If the external neurostimulator is on, use the programmer to turn the external
neurostimulator off.
2. If the connector cable is attached to the external neurostimulator, disconnect the
cable.
3. If the external neurostimulator is in the external neurostimulator belt or boot, remove the
external neurostimulator from the belt or boot.
4. Press down lightly on the battery compartment cover, slide the cover outward, then
remove the cover (Figure 2).
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Figure 2. Removing battery cover.
5. Remove the depleted batteries, and insert new batteries. Correct battery polarity is
indicated inside the battery compartment (Figure 3).
Note: For optimal performance, use the same AAAA alkaline batteries as those supplied
by Medtronic.
Figure 3. Inserting new batteries.
6. Replace the battery compartment cover, then slide the cover inward until it snaps into
place (Figure 4).
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Figure 4. Replacing battery cover.
Notes:
▪
After the batteries are installed and the battery compartment cover is closed, the
external neurostimulator may take up to 6 seconds for device initiation. Stimulation
is not available until device initiation is complete.
▪
Dispose of depleted batteries according to local requirements.
7. Use the controller to turn stimulation on. For instructions on using the controller to
program the external neurostimulator, refer to the Medtronic Clinician Programming
Guide packaged with the controller.
Using the external neurostimulator boot
The external neurostimulator boot is a single-use accessory. The external neurostimulator boot
is attached to an adhesive pad, which can be used to adhere the external neurostimulator to
the patient's body.
Note: Schedule a visit during the test stimulation phase to replace the initial boot with a new
boot.
1. Ensure that no cable is attached to the external neurostimulator. The external
neurostimulator can not be inserted into the boot with a cable attached.
2. Insert the external neurostimulator into the boot (Figure 5).
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Figure 5. Inserting external neurostimulator into boot.
3. Clean the patient's skin, if necessary, at the location where the external neurostimulator
boot is to be placed.
4. Peel off the adhesive backing of the adhesive pad and apply the external
neurostimulator boot to the patient's skin. Press firmly to ensure complete contact and
adhesion.
Notes:
▪
If adhesive is dry or does adhere to the patient's skin, discard the boot and use a
different boot.
▪
The external neurostimulator belt cannot be used with the external neurostimulator
boot.
Using the external neurostimulator belt
The external neurostimulator belt is a single-use device that can be used to hold the external
neurostimulator near the patient's body.
1. Insert the external neurostimulator, with cable attached, into the pouch on the external
neurostimulator belt and snap the pouch closed (Figure 6).
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Figure 6. Inserting external neurostimulator into belt.
Note: Leave enough slack in the cable to allow the patient to adjust or move the belt as
needed without causing additional strain on the connections.
2. Coil and place any excess cable length into the pouch of the external neurostimulator
belt.
3. Fasten the external neurostimulator belt around the patient’s waist.
Note: The belt can be adjusted for patient comfort and fit.
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Device care and storage
▪
Keep new batteries available. For optimal performance, use the same AAAA alkaline
batteries as those supplied by Medtronic.
▪
Use the controller to check the external neurostimulator battery level daily. For
instruction on using the controller, refer to the Medtronic Clinician Programming Guide
packaged with the controller.
▪
Replace low or depleted batteries.
▪
Handle the device and system components with care. Do not drop, strike or step on the
device.
▪
Do not dismantle or tamper with the device or system components.
▪
Clean the outside of the device with a damp cloth when necessary. Mild household
cleaners will not damage the device or labels.
▪
Store the external neurostimulator at room temperature. Avoid extreme hot or cold
temperatures and direct sunlight.
▪
The device and system components are not waterproof. Do not allow moisture to get
inside the device or system components. With the patient cable connected, the external
neurostimulator is water-resistant, but is not waterproof. Sponge baths are
acceptable.
▪
Dispose of depleted batteries and devices according to local requirements.
Safety and technical checks
Periodic safety and technical checks or periodic maintenance of the external neurostimulator
are not required.
The external neurostimulator contains no serviceable components. If the external
neurostimulator requires repair or is nonfunctional, send it to the appropriate address.
USA
Medtronic, Inc.
Neurological Division
MS N600
PO Box 1250
Minneapolis, MN 55440-9087
Europe, Africa, Middle East, and Asia-Pacific countries
Medtronic EOC
Medical Equipment Service Europe
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. 31-455664880
Fax 31-455668028
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Contacts:
Asia:
Medtronic International Ltd.
Tel. 02919-1362
Fax 02907-3998
Medtronic Asia Ltd.
Tel. (02)-548-1148
Fax (02)-518-4786
Australia:
Medtronic Australasia Pty. Ltd.
97 Waterloo Road
North Ryde, NSW 2113
Australia
Tel. +61-2-9857-9000
Fax +61-2-9878-5100
Toll free 1-800-668-6700
Austria:
Medtronic Österreich GmbH
Tel. 01-240440
Fax 01-24044-100
Belgium:
Medtronic Belgium S.A.
Tel. 02-456-0900
Fax 02-460-2667
Canada:
Medtronic of Canada Ltd.
Tel. (1-905)-460-3800
Fax (1905)-826-6620
Czech Republic:
Medtronic Czechia s.r.o.
Tel. 2-965-795-80
Fax 2-965-795-89
Denmark:
Medtronic Danmark A/S
Tel. 45-32-48-18-00
Fax 45-32-48-18-01
Finland:
Medtronic Finland Oy/LTD
Tel. (09)-755-2500
Fax (09)-755-25018
France:
Medtronic France S.A.S.
Tel. 01-5538-1700
Fax 01-5538-1800
Germany:
Medtronic GmbH
Tel. (02159)-81490
Fax (02159)-8149100
Greece:
Medtronic Hellas S.A.
Tel. 210-67-79-099
Fax 210-67-79-399
Hungary:
Medtronic Hungária Kft.
Tel. 1-889-06-00
Fax 1-889-06-99
Ireland:
Medtronic Ireland Ltd.
Tel. (01)-890-6522
Fax (01)-890-7220
Italy:
Medtronic Italia SpA
Tel. 02-241371
Fax 02-241381
Tel. 06-328141
Fax 06-3215812
Japan:
Medtronic Japan
Tel. 03-6430-2016
Fax 03-6430-7110
Latin America:
Medtronic, Inc.
Tel. (1305)-500-9328
Fax (1786)-709-4244
Norway:
Medtronic Norge AS
Tel. 067-10-32-00
Fax 067-10-32-10
Poland:
Medtronic Poland Sp. z.o.o.
Tel. (022)-465-69-00
Fax (022)-465-69-17
Portugal:
Medtronic Portugal, Lda.
Tel. 21-724-5100
Fax 21-724-5199
Russia:
Medtronic Russia
Tel. (8495) 580-7377
Fax (8495) 580-7378
Slovakia
Medtronic Slovakia, o.z.
Tel. 0268 206 911
Fax 0268 206 999
Spain:
Medtronic Ibérica, S.A.
Tel. 91-625-0400
Fax 91-650-7410
Sweden:
Medtronic AB
Tel. 08-568-585-00
Fax 08-568-585-01
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Switzerland:
Medtronic (Schweiz) AG
Tel. 031-868-0100
Fax 031-868-0199
The Netherlands:
Medtronic B.V.
Tel. (045)-566-8000
Fax (045)-566-8668
U.K.:
Medtronic U.K. Ltd.
Tel. 01923-212213
Fax 01923-241004
USA:
Medtronic, Inc.
Tel. (1763)-505-5000
Fax (1763)-505-1000
Toll-free: (1-800)-328-0810
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Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
www.medtronic.com
Tel. +1-763-505-5000
Fax +1-763-505-1000
Authorized Representative
EC REP
in the European Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. +31-45-566-8000
Fax +31-45-566-8668
Europe/Africa/Middle East
Headquarters
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.eu
Tel. +41-21-802-7000
Fax +41-21-802-7900
Asia-Pacific
Medtronic International Ltd.
Suite 1106-11 16/F, Tower 1, The Gateway
25 Canton Road, Tsimshatsui
Kowloon
Hong Kong
Tel. +852-2919-1362
Fax +852-2907-3998
Contacts for specific countries are listed inside this cover.
*M943581A001*
© Medtronic, Inc. 2013
All Rights Reserved
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