Spinal Modulation orporated MN0100 Trial Neurostimulator User Manual
Spinal Modulation, Incorporated Trial Neurostimulator
Contents
- 1. User Manual
- 2. Revised user manual
User Manual
Trial Neurostimulator
Model MN0100
Draft Physician Manual
Spinal Modulation, Inc.
1135 O’Brien Drive
Menlo Park, CA 94025 USA
Copyright © Month 2011 by Spinal Modulation, Inc. All Rights Reserved. No portion of this manual
may be
reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy-
ing, recording, or any information storage and retrieval systems, without the express written permission
of Spinal Modulation, Inc.
TableofContents
Explanation of Symbols on Product or Package Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . 3
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 4
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 6
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 6
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 6
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . 6
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 9
TNS Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . 13
Stimulation OFF Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . 13
3
ExplanationofSymbolsonProductorPackageLabeling
Model Number
Serial Number
Read the Instructions for Use
Contents of Package are Non-Sterile
Manufacturing Date
Manufacturer
Warning. Pay attention.
Turns all stimulation off on the TNS.
Protected against Electric Shock
Device is a Radio Transmitter
Consult the Instructions for Use
Limited Waterproof
4
Symbols,cont.
Store between –10°C and 50°C
Store between 0 and 93% humidity
Keep Dry
Diathermy – High energy heat: used to cut or cauterize during surgery, or a type of therapy.
Electromagnetic Interference (EMI) – Electrical signals that interfere with the device function.
MRI (Magnetic Resonance Imaging) – Medical imaging: produces electronic images of tissues and
organs.
Paresthesia – Tingling sensation felt during therapy delivery: produced by spinal cord stimulation.
Precaution – Situations of which the patient should be aware in order to avoid uncomfortable stimu-
lation and possible damage to the TNS device.
Program – Instructions or changes to stimulation settings that are programmed into the Programmer
and transmitted to the TNS device.
Spinal Cord Stimulation – Electrical pulses applied to the spinal cord to block pain signals to the
brain.
Stimulation – A pain therapy reference to small electrical pulses felt as a tingling sensation that
replaces pain signals.
Stimulation Level – Measure of stimulation: can be increased or decreased within a range specified
by the clinician.
Warning – Potentially serious hazard to be aware of to avoid situations that could cause injury or
death.
5
Introduction
This manual describes the care and use of the Trial Neurostimulator (MN0100).
IndicationsForUse
The Spinal Modulation Trial Neurostimulator System is intended as an aid in the management of
chronic pain.
Contraindications
Patients contraindicated for the Spinal Modulation Trial Neurostimulator System are those who:
Have an active implantable medical device including but not limited to
cardiac pacemakers and cardiac defibrillators
Are unable to operate the system
Are poor surgical risks
Are pregnant
Are under the age of 18
Description
The Trial Neurostimulator (TNS) attaches to the Connector Cable and delivers energy to the trial
leads. The TNS has a female locking connector that attaches to the Connector Cable, a standby
button that disables stimulation and a clip for the patient to attach the TNS to their belt or waist-
band.
6
The output ranges for the system are:
FREQUENCY BAND: The TNS device uses the one frequency band designated specifically for
implanted medical devices; the Medical Implant Communications Service (MICS) to communicate
with the Programmers. The MICS band operates from 402 MHz to 405 MHz. The Listen Before
Talk (LBT) protocol allows multiple pieces of equipment in the location to communicate at the
same time without interference.
The Clinical and Patient Programmers are used to communicate with the Trial Neurostimulator.
The Clinical Programmer is used to program the stimulation parameters in the TNS, as
determined by the physician. The TNS device delivers the programmed stimula-
tion parameters (energy) to the Leads.
The Patient Programmer is easy to use and allows the patient to adjust the stimulation
level within limits preset by the physician. It allows the patient to turn stimulation
off.
The Clinical and Patient Programmers are portable, hand-held devices powered by internal batteries.
The batteries are rechargeable using Programmer Charger MN3400 (provided) and a power outlet.
Parameter Range
Frequency (Hz) 4 – 100
Pulse Width (µs) 40 – 720
Amplitude (µA) 50 – 6000
7
Both Programmers come with a carrying case and should be kept dry. Images depicting the compo-
nents of the Spinal Modulation TNS System are shown in Figure 1.
The patient must be trained by their doctor before using the Patient Programmer and the NS
device.
The patient must not use their Patient Programmer until their doctor has set up the NS System.
The patient must not undergo any elective magnetic resonance imaging (MRI). If MRI is
necessary, the doctor should remove any lead(s) and disconnect the NS device. Use of MRI
near the lead(s) may dislodge the lead(s) or damage the NS device. If a voltage is induced
through the lead, it may cause uncomfortable (“jolting” or “shocking”) levels of stimulation.
8
Figure 1: The Trial Neurostimulator System
WARNINGS
TNS
Programmer
Connector
Cable
Lead
The patient must not undergo any diathermy (high energy heat) procedures. Diathermy could
injure the patient or damage the NS device.
The patient must not remove the lead(s) or Connector Cable from their body. Removal of the lead
(s) or Connector Cable may result in an infection.
Changes in body position can affect the amount of stimulation felt, causing increased feelings of
pain or uncomfortable stimulation. The patient should use the Patient Programmer to adjust stimu-
lation levels or to turn stimulation off, if needed.
Under certain conditions, strong electromagnetic fields may affect the NS device, possibly affecting
the level of stimulation and causing discomfort. The patient should avoid theft detection devices at
store and library exits and security screeners at airports. The patient must not stand near the screen-
ing equipment.
Other equipment that may cause interference includes, but is not limited to: power generators, arc
welders and large magnetized speakers
The following precautions should be taken to avoid damage to and assure proper function of the Patient
Programmer and TNS device.
The patient should not drop or mishandle the Patient Programmer or TNS device. Physical damage
to the units may impair their function.
The patient should not wash or get the Patient Programmer or TNS device wet.
The patient should not shower or bathe with the TNS device. (A sponge bath is acceptable as long
as the TNS device does not get wet.). 9
PRECAUTIONS —DEVICES
The patient should not use abrasive or caustic cleaning products on the Patient Programmer or TNS
device.
The patient should not open the cases of the Patient Programmer or TNS device. Attempts to open
the cases may expose the units to elements that alter their function.
The patient should not place the Patient Programmer close to credit cards or other cards with mag-
netic strips, as the Patient Programmer contains a magnet and may demagnetize your cards. Also, the
patient should keep the Patient Programmer away from computer hard drives or magnetic storage
devices.
The patient should not operate the Patient Programmer or TNS device outside the temperature range
of -5°C to 45°C. Rapid temperature changes may affect device operation.
The patient should not store the Patient Programmer outside the temperature range of -10°C to
50°C.
The patient should not leave the Patient Programmer in a car or other places where temperatures can
exceed 50°C.
Failure of your NS System, although unlikely, is possible due to random component failure. If any
part of the TNS System stops working, contact your doctor during normal business hours.
The Patient Programmer and the TNS device must be returned at the end of the trial period. The
patient must not discard or burn the TNS device or Patient Programmer. Fire may cause its internal
battery to explode.
The patient should not try to replace the TNS device battery, even if the TNS device does not func-
tion. The internal battery for the TNS device must be replaced by Spinal Modulation personnel only.
10
The patient should not allow unauthorized use of your Patient Programmer. This may cause un-
wanted changes in the programming.
The patient should not use the Patient Programmer or NS in the presence of explosive or flammable
gases as this may cause serious injury.
The patient should be instructed to take the following precautions to maintain appropriate therapy dur-
ing this study:
Follow proper wound care techniques as instructed by their doctor.
Do not rub or exert pressure at the implant site as it may dislodge the leads or cause skin erosion.
Avoid excessive bending, twisting and stretching, and do not lift objects over ten pounds. These
activities may result in lead movement producing either understimulation or overstimulation.
Avoid driving a car or operating other potentially dangerous machinery while stimulation is turned
on. If sudden changes in stimulation were to occur, the patient may be distracted from vehicle or
device operation.
It is possible that the NS System may affect the operation of other implantable devices such as
pacemakers or implantable cardiac defibrillators. The physician should be aware of any other
implantable devices the patient may have or are scheduled to get.
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PRECAUTIONS –THERAPY
The patient’s other healthcare providers should be aware of their NS. They should not undergo
any elective medical procedures during the trial stimulation period. Some medical devices or
therapies, such as those listed below, may produce interference with the TNS System:
Electrocautery – Electric probe: to cauterize blood vessels and stop bleeding during
surgery.
Lithotripsy – High-output shock waves: breaks up gallstones and kidney stones.
Therapeutic Radiation – Ionizing radiation: to destroy cancer cells.
High-output ultrasound – High frequency sound waves: to treat bone and muscle
injuries, or to stimulate muscle or improve blood flow.
RF Ablation – Radio frequency energy: causes controlled tissue damage.
Microwave Ablation – High speed alternating electric field: causes controlled tissue
damage.
Dental procedures, electrolysis, static field therapeutic magnets and diagnostic X-ray.
The patient should designate a representative (family member or friend) to notify emergency
medical personnel of their trial stimulator, in case they require emergency care. The patient will
be provided with a Medical Alert Card to carry with them that will inform emergency medical
personnel that they have an NS.
If there is any concern regarding the proper function of the NS System, they should discontinue use and
contact their physician during normal business hours.
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TNSDeviceOverview
The TNS device connects to the lead(s) via the Connector Cable. The TNS is worn by the
patient for up to 30 days during the trial period. The TNS device has a clip to attach the de-
vice to clothing or a belt or the patient may choose to use a flexible, elastic bandage to secure
the TNS device during the trial period.
The TNS device must be programmed by the physician or
company representative using a Clinical Programmer prior
to use. The TNS device will periodically check for com-
munication from the Patient Programmer. Using the
Patient Programmer, stimulation can be started by select-
ing a body region to receive stimulation. The level of
stimulation can be adjusted, and the stimulation can be
turned OFF. For detailed instructions on the use of the
Patient Programmer, see the Patient Programmer Manual.
STIMULATION OFF SWITCH
The TNS device has a button with a red marking
located on the top of the TNS device. This button may be
used to turn OFF stimulation on all leads, by pressing it for
more than 2 seconds. A Programmer is required to turn
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MAGNET ACTIVATION
Move the magnet located in the Programmer in a circular motion
over the top of the TNS to connect to the Patient Programmer or
the Clinical Programmer.
TNS DEVICE CARE
Tell the patient not to immerse their TNS device in water or pour
water over it. If cleaning is necessary, remove soil with a soft
damp cloth.
14
Magnet Location
RF Operating Frequencies. Nearby equipment emitting strong
magnetic fields can interfere with RF communication, even if the
other equipment complies with CISPR emission requirements.
The operating characteristics are as follows:
MICS band: 402-405 MHz. The effective radiated power is be-
low the limits as specified in
Europe: EN ETSI 301 839-2
USA FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219
FCC ID: Y8L-MN0100
15
This transmitter is authorized by rule under the Medical Device
Radiocommunication Service (in part 95 of the FCC Rules) and must
not cause harmful interference to stations operating in the 400.150–
406.000 MHz band in the Meteorological Aids (i.e., transmitters
and receivers used to communicate weather data), the Meteorologi-
cal Satellite, or the Earth Exploration Satellite Services and must
accept interference that may be caused by such stations, including
interference that may cause undesired operation.
This transmitter shall be used only in accordance with the FCC
Rules governing the Medical Device Radiocommunication Service.
Analog and digital voice communications are prohibited. Although
this transmitter has been approved by the Federal Communications
Commission, there is no guarantee that it will not receive interfer-
ence or that any particular transmission from this transmitter will be
free from interference.
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Your Spinal Modulation Neurostimulator System complies with the following International
Standards
IEC 60601-1: 2005
IEC 60601-1-11: 2010
IEC 60601-1-2: 2007
ISO 14708-1: 2000
ISO 14708-3: 2008
IEC 60601-1: 2005
IEC 60601-1-11: 2010
IEC 60601-1-2: 2007
ISO 14708-1: 2000
ISO 14708-3: 2008
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AUTHORIZED EUROPEAN REPRESENTATIVE
MediTech Strategic Consultants B.V.
Maastrichterlaan 127-129
6291 EN Vaals, Netherlands
COMPANY CONTACT INFORMATION
Spinal Modulation, Inc.
1135 O’Brien Drive
Menlo Park, CA 94025
U.S.A.
Telephone: (650) 543-6800 (24 hour support line)
Fax: (650) 327-2336
Email: clinicalsupport@spinalmodulation.com
18
Issue Potential Solutions
Understimulation or no stimulation
Verify the patient has checked the connections of the connector cable to the
TNS. They may have come loose and are no longer connected. The patient
should connect to the stimulator and turn the stimulation levels down on
each lead before reconnecting the cable.
The standby button may have been pressed. Connect to the stimulator and
re-enable each lead to turn stimulation on.
The patient may have activated a new Group. The patient should reconnect
to the stimulator and adjust the Group or stimulation levels on each lead
appropriately.
The magnet may have been held in place too long over the switch and
turned off stimulation. The patient should reconnect to the device and turn
each lead back on individually.
If the leads cannot be re-enabled, call your physician during normal busi-
ness hours.
Overstimulation
Postural changes can affect stimulation. Before laying down or stand-
ing up, the patient may need to adjust the stimulation levels.
Stimulation levels can change due to interference from anti-theft de-
vices, high power lines and large magnetized speakers. If this occurs,
the patient should be instructed to use the Patient Programmer to adjust
their stimulation setting.
AppendixI:TroubleshootingcontinuedAppendixI:Troubleshooting
19
Issue Potential Solutions
Unable to connect to the TNS using the
programmer.
Verify that the back side of the programmer and the magnet label
was put over the “label” side of the TNS. This is the side without
the belt clip. Hit “Connect” again. It should not take more the 30
seconds to connect.
The programmer may be too far away from the TNS, so bring the
programmer closer to the TNS and wait for connection. You may
have to activate the switch in the TNS using the magnet.
Verify that the patient has put the magnet of the programmer over
the correct side of the TNS. The patient may need to use the
stand alone magnet to activate the TNS instead.
Move to another location as there may be interference in your
current location and reconnect.
The programmer battery may be low. Charge the programmer
and then attempt to reconnect.
The battery of the TNS may need to be replaced. Call your
physician during normal business hours.
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