Abbott Neuromodulation SJMX599EPG External Pulse Generator User Manual 37 5284 015

Advanced Neuromodulation Systems Inc., dba. St. Jude Medical Neuromodulation Division External Pulse Generator 37 5284 015

Contents

User Manual Part 1

St. Jude Medical™ External Pulse Generator
Model 3599
Clinician's Manual
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CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its
subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St.
Jude Medical,
Inc. and its related companies. © 2014 St. Jude Medical, Inc. All Rights Reserved.
For a listing of patents for St. Jude Medical neuromodulation products, visit http://patent.sjmneuro.com.
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Contents
Prescription and Safety Information ................................................................................... 1
Intended Use ............................................................................................................................ 1
Indications for Use .................................................................................................................... 1
Contraindications....................................................................................................................... 1
Warnings .................................................................................................................................. 2
Precautions ............................................................................................................................... 3
Adverse Effects ......................................................................................................................... 5
Product Description .......................................................................................................... 6
Overview of the EPG and EPG Header ........................................................................................ 8
Package Contents...................................................................................................................... 9
Getting Started ................................................................................................................ 10
Overview of the EPG Procedure .................................................................................................10
Replacing the EPG Batteries .....................................................................................................11
Checking the Status of the EPG Batteries ...................................................................................16
Setting Up Communication Between the EPG and the Clinician Programmer and Patient
Controller ..............................................................................................................................17
EPG Indicator Light ...................................................................................................................18
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Starting and Stopping Stimulation ............................................................................................. 18
Using the EPG ................................................................................................................ 21
Connecting the Multilead Trial Cable to the EPG ........................................................................ 21
Disconnecting the Multilead Trial Cable from the EPG ............................................................... 23
Securing the Leads or Extensions ............................................................................................. 24
Connecting the EPG Header to the EPG .................................................................................... 24
Connecting the Leads or Extensions to the EPG Header ............................................................. 25
Securing the EPG .................................................................................................................... 28
Programming the EPG .................................................................................................... 29
Caring for the EPG .......................................................................................................... 29
Handling the EPG .................................................................................................................... 29
Cleaning the EPG .................................................................................................................... 29
Storing and Transporting the EPG ............................................................................................. 30
Service and Ordering Information .................................................................................... 31
Customer Service Information .................................................................................................. 32
Ordering Information................................................................................................................ 33
Appendix A: Product Specifications ................................................................................. 34
EPG with Header ..................................................................................................................... 34
Appendix B: Regulatory Statements ................................................................................ 36
Declaration of Conformity ......................................................................................................... 36
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Battery Disposal Guidelines .......................................................................................................36
Statement of FCC Compliance ...................................................................................................37
Statement of Compliance With License-Exempt RSS Standard (Canada) ......................................38
Antenna Guidance Statement (Canada) .....................................................................................38
Statement of Compliance With Interference-Causing Equipment Standard (Canada) ....................38
Identification Information for Product Registration ......................................................................38
Product Classification Statement (CISPR 11, Class B).................................................................39
Wireless Technology Information ...............................................................................................39
Radio Transmitter, Cables, Transducers ....................................................................................40
Quality of Service for Wireless Technology ..................................................................................41
Appendix C: Electromagnetic Compatibility Guidelines ..................................................... 44
Appendix D: Symbols and Definitions .............................................................................. 54
Appendix E: CE Mark Date .............................................................................................. 57
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Prescription and Safety Information
Read this section to gather important prescription and safety information.
Intended Use
The St. Jude Medical trial stimulator is intended to be used externally with St. Jude Medical-approved
trial leads and extensions to deliver stimulation to one or more neurological structures for a maximum of
30 days.
Indications for Use
The St. Jude Medical™ trial neurostimulation system is indicated as an aid in the management of
chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with
the following: failed back surgery syndrome and intractable low back and leg pain.
Contraindications
This neurostimulation system is contraindicated for patients who are unable to use the system.
Neurostimulation should not be used on patients who are poor surgical risks, such as those with
multiple illnesses or active general infections.
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Warnings
The following warnings apply to these components.
Other system components. Refer to the individual system component manuals for additional warnings
and precautions related to those devices.
Diathermy therapy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound
diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system.
Energy from diathermy can be transferred through the implanted system and cause tissue damage at
the location of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components.
This damage could result in loss of therapy, requiring additional surgery for system implantation and
replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation
system is turned on or off.
Electrosurgery devices. Electrosurgery devices should not be used in close proximity to an implanted
neurostimulation device. Contact between an active electrode and an implanted lead or extension can
cause direct stimulation of the tissue at the electrode site and cause severe injury to the patient. If use
of electrocautery is necessary, first turn off the neurostimulation system.
Implanted cardiac system. Physicians need to be aware of the risk and possible interaction between a
neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator.
Electrical pulses from a neurostimulation system may interact with the sensing operation of an
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implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or
prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1)
maximize the distance between the implanted systems; (2) verify that the neurostimulation system is
not interfering with the functions of the implanted cardiac system; and (3) avoid programming either
device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system
settings that interfere with the functions of the implantable cardiac system.
Magnetic resonance imaging (MRI). Patients with an EPG should not be subjected to MRI.
Pediatric use. Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing. Safety and effectiveness of neurostimulation for use during pregnancy and
nursing have not been established.
System components. The use of non-St. Jude Medical components with this system may result in
damage to the system and increased risk to the patient.
Power supply. Use only the CR2450 batteries supplied with the device. CR2450 batteries have a
nominal voltage of 3V and nominal capacity of at least 600 mAh.
Precautions
The following precautions apply to these components.
General Precautions
Clinician Training. Clinicians should be experienced in implanting neurostimulation devices and should
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have undergone sufficient surgical and device implantation training.
Patient Selection. It is extremely important to select patients appropriately for neurostimulation.
Thorough psychiatric screening should be performed. Patients should not be dependent on drugs and
should be able to operate the neurostimulation system.
Infection. Follow proper infection control procedures and inform patients to avoid showering and
touching the bandages.
Handling and Implementation
Single use only. The EPG header is intended for single use only.
Exposure to liquids. Device components should be stored where they will not be exposed to liquids or
excessive moisture, which can damage the package materials and components.
Care and handling of components. Use extreme care when handling system components prior to use.
Excessive heat, traction, bending, and twisting, or the use of sharp instruments may damage
components and cause them to fail.
Package or component damage. Do not use the device if the package or components show signs of
damage. Return any suspect components to St. Jude Medical for evaluation.
System testing. To ensure correct operation, the system should always be tested before the patient
leaves the surgery suite.
Device modification. The equipment is not serviceable by the customer. To prevent injury or damage to
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the system, do not modify the equipment. If needed, return the equipment to St. Jude Medical for
service.
Component disposal. Dispose of the EPG header and pouch with other medical waste. Return the EPG
to St. Jude Medical for safe disposal when necessary.
Hospital and Medical Environments
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of a neurostimulation
system, although no testing has been done and no definite information on radiation effects is available.
Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If
radiation therapy is required, disconnect the EPG from the leads or extensions. Damage to the system
may not be immediately detectable.
Adverse Effects
The use of a neurostimulation system involves risks. In addition to those risks commonly associated with
surgery, the following risks are also associated with use of a neurostimulation system:
Unpleasant sensations or motor disturbances, including involuntary movement, caused by
stimulation at high outputs (If either occurs, turn off stimulation on your EPG immediately.)
Undesirable changes in stimulation, which may be related to cellular changes in tissue around the
electrodes, changes in electrode position, loose electrical connections, or lead failure
Stimulation in unwanted places
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Allergic or rejection response to device materials
Product Description
The St. Jude Medical™ External Pulse Generator (EPG) is an external trial generator that when
connected to trial neurostimulation leads delivers therapeutic stimulation to parts of the body. The EPG
communicates wirelessly with system programmers and controllers.
The EPG header connects directly to the EPG for a neurostimulation trial. The EPG header can hold one
or more leads or extensions with up to 16 electrodes total.
NOTE:
For more information about the neurostimulation system, see the clinician’s programming
manual for this system.
NOTE:
The EPG is supplied nonsterile and is intended to be used multiple times. The EPG header is
also supplied nonsterile, but is single use only.
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NOTE:
In this document, the term "clinician programmer" refers to the St. Jude Medical™ Clinician
Programmer device, "patient controller" refers to the St. Jude Medical™ Patient Controller
device, "clinician programmer app" refers to the St. Jude Medical™ Clinician Programmer
app, and "patient controller app" refers to the St. Jude Medical™ Patient Controller app.
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Overview of the EPG and EPG Header
Refer to the following figures for the EPG and EPG header features:
Figure 1. EPG features
1. Connector for multilead trial cable and
EPG header
2. Battery compartment panel
3. Indicator light
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Figure 2. EPG header features
1. Button
2. Port 1, electrodes 1-8
3. Port 2, electrodes 9-16
Package Contents
In addition to the product documentation, the EPG kit contains the following items:
1 EPG (Model 3599)
1 EPG header cap
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1 battery door
In addition to the product documentation, the Header Accessory kit contains the following items:
1 EPG header
2 CR2450 Batteries
Cleaning cloths
1 EPG pouch with adhesive
1 magnet (Model 1210)
Getting Started
This section provides a general overview of the EPG procedure and instructions for tasks, such as
replacing the batteries and setting up communication between the EPG and the clinician programmer
and patient controller.
Overview of the EPG Procedure
The following steps provide a general overview of the EPG procedure. Refer to the following sections for
more information about each of these steps.
1. Replace the EPG batteries.
2. Set up communication between the EPG and the clinician programmer and patient controller.
3. Implant the leads or extensions.
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4. Connect the leads or extensions to the multilead trial cable.
5. Connect the multilead trial cable to the EPG.
6. Test the system.
7. Disconnect the multilead trial cable from the EPG.
8. Disconnect the multilead trial cable from the leads or extensions.
9. Secure the leads or extensions and bandage the lead entry site.
10. Connect the EPG header to the EPG.
11. Insert the leads or extensions into the EPG header.
12. Place the EPG into the pouch and secure to the patient.
13. Program the system.
Replacing the EPG Batteries
The EPG uses two nonrechargeable CR2450 coin cell batteries. St. Jude Medical recommends
replacing the batteries before starting a new trial and only using the batteries included in the Header
Accessory kit.
NOTE:
Dispose of batteries safely. Do not treat them as household waste. Refer to the guidelines in
Appendix B for more information.
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To replace the batteries, follow these steps:
1. Disconnect the EPG header or multilead trial cable from the EPG if either is connected. Also, if the
EPG is communicating with the clinician programmer or patient controller, end the session. Refer
to the clinician’s programming or user’s controller manual for instructions.
2. Press and slide the battery compartment panel outward to open the battery compartment and
remove the panel.
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Figure 3. Battery compartment panel
3. Remove the batteries by either:
-turning the EPG over so the battery compartment is facing down and lightly tapping the EPG
in the palm of your hand, or
-pressing down on one side of the battery so the opposite side pops up, lifting the battery out,
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and repeating the process with the remaining battery.
4. Insert a new battery into the battery compartment, paying attention to the polarity directions
provided on the inside of the battery compartment.
5. Insert the second battery into the second battery compartment.
Figure 4. Inserting batteries into the battery compartment
6. Place the battery compartment panel flush to the EPG, lining up the tabs with the coordinating
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indentation.
Figure 5. Replacing the battery compartment panel
7. Slide the panel closed flush with the EPG until it snaps into place.
NOTE:
When you insert the batteries, the indicator light is solid. You must wait until the indicator
light is flashing or off to set up communication.
NOTE:
If you replace the batteries but the generator battery indicator on the clinician programmer
app or patient controller app indicates the batteries are low, make sure the batteries are
inserted correctly.
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Checking the Status of the EPG Batteries
Check the status of the EPG’s batteries using the clinician programmer app or the patient controller
app. Refer to the clinician’s programming or user’s controller manual for these directions.
NOTE:
Battery life depends on usage and stimulation settings, with batteries lasting at least 14 days
under nominal or practical high output tonic settings, with 500 ohm impedance and
stimulation on for 16 hours per day. (High output is based on actual patient use collected in
St. Jude Medical clinical studies, not the maximum device output.)
The following information provides general guidelines for the battery status:
The battery status icon on the clinician programmer app or patient controller app shows a
decreasing fill as the batteries are used.
A warning will appear on the clinician programmer app or patient controller app when the batteries
are critically low.
Stimulation will automatically turn off when the batteries cannot support stimulation. Replace the
EPG’s batteries to communicate with the EPG, turn stimulation on, change stimulation settings, or
retrieve stimulation usage information.
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NOTE:
If the batteries deplete during a trial, instruct the patient to refrain from replacing the
batteries to avoid disturbing the bandaging and lead position.
Setting Up Communication Between the EPG and the Clinician
Programmer and Patient Controller
Before starting the surgical procedure, set up communication between the EPG and the clinician
programmer and patient controller. The following steps outline the procedure for setting up
communication. For further instructions, refer to the clinician’s programming manual.
1. Place the magnet perpendicular to and centered directly over the front of the EPG for 10 seconds.
The indicator light on the EPG will start flashing.
2. Set up communication using the clinician programmer app or the patient controller app following
the directions shown on the screen.
After setting up communication, the EPG is paired with that clinician programmer and patient controller.
You will not need to pair them again unless another patient controller or more than four clinician
programmers are paired to the EPG.
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NOTE:
Store paired EPGs and patient controllers together to reduce the number of times you need to
set up communication.
EPG Indicator Light
The indicator light on the EPG will flash for the following reasons:
When batteries are inserted into the EPG
When a communication session with the clinician programmer app or patient controller app is
started
When the magnet is held for approximately 10 seconds over the EPG (signaling the EPG is ready
to pair with the clinician programmer or patient controller)
NOTE:
The EPG indicator light flashes faster when it is ready to pair than when batteries are inserted
or a communication session is started.
Starting and Stopping Stimulation
Use the clinician programmer app or the patient controller app to start or stop stimulation. The magnet
included with the EPG system may also be used to start or stop stimulation if the Magnet Mode is
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programmed to On/Off or Off.
To use the magnet, follow these steps:
1. Take the keeper bar off the magnet.
Figure 6. Magnet and keeper bar
1. Magnet
2. Keeper bar
2. Hold the magnet perpendicular to and centered directly over the EPG for 2 seconds.
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Figure 7. Holding the magnet over the EPG
3. Remove the magnet, replace the keeper bar, and store the magnet.
CAUTION:
Do not use the magnet provided with the system around magnetically sensitive items to
avoid damaging them.
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Using the EPG
Read this section for directions for use related to the EPG and EPG header. For directions for use of
other system components not covered in this document, see the clinician’s manual for the appropriate
device.
NOTE:
Well in advance of the surgical procedure, set up communication between the EPG and the
programmer and controller to ensure it is functional. Refer to "Setting Up Communication
Between the EPG and the Clinician Programmer or Patient Controller" for instructions.
CAUTION:
Before the EPG or associated components are used or secured to the patient,
determine if a patient may have an allergic reaction to the materials.
Connecting the Multilead Trial Cable to the EPG
The following information outlines the guidelines for connecting a multilead trial cable to the EPG. For
further instructions, refer to the clinician’s manual for the multilead trial cable.
1. Remove the EPG header cap to expose the EPG stimulator port.
2. Carefully slide the connector end of the multilead trial cable into the EPG stimulator port.
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CAUTION:
The EPG is not sterile. When connecting and testing the EPG with the multilead trial
cable, keep the EPG outside of the sterile field.
CAUTION:
To avoid delivering jolting stimulation to the patient, turn off stimulation before plugging
in the multilead trial cable.
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Figure 8. Inserting the connector into the EPG stimulator port
Disconnecting the Multilead Trial Cable from the EPG
The following steps outline the guidelines for disconnecting the multilead trial cable from the EPG. For
further instructions, refer to the clinician’s manual for the multilead trial cable.
1. Turn off stimulation on the EPG using the clinician programmer app.
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2. Grasp the connector end of the multilead trial cable and gently pull the connector from the EPG
stimulator port.
Securing the Leads or Extensions
The following information outlines the suggested procedure for securing the leads or extensions to the
patient:
Secure the leads or extensions and bandage the lead entry site. For further instructions, refer to
the clinician’s manual for the applicable leads or extensions.
Connecting the EPG Header to the EPG
The following information outlines the guidelines to connect the EPG header to the EPG:
Align the tab indentation on the EPG header with the tab on the EPG and carefully insert the EPG
header into the EPG body until it clicks into place.
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Figure 9. Connecting the EPG header to the EPG
Connecting the Leads or Extensions to the EPG Header
The following steps outline the suggested guidelines to connect a lead or extension to the EPG header:
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CAUTION:
Do not connect a lead or extension with body fluid or saline residue on its contacts
because corrosion can occur and cause failure of the system.
1. If any of the lead or extension contacts came in contact with body fluid or saline, thoroughly clean
the contacts with sterile deionized water or sterile water for irrigation and dry them completely.
CAUTION:
Do not bend the lead sharply or it may be damaged.
NOTE:
The EPG header comes with open ports and attached port plugs. Do not remove the port
plugs from the header. If only using one lead or extension, use the lower port labeled 1-8 and
insert a port plug in the unused port.
2. Push and hold the button on the EPG header to open the EPG header ports.
3. Using clean gloves, carefully slide the lead or extension into the EPG header until you reach a hard
stop and all the contact bands are fully inside the connector assembly and hidden from view.
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Figure 10. Insert the lead or extension fully into the EPG header
1. Fully inserted
2. Not fully inserted
4. Release the button to lock the lead or extension into place.
5. If applicable, repeat the previous steps to insert the remaining lead or extension. Do not disturb
the already inserted lead or extension.
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