Algostim Algovita 4300 User manual
Material Specification
Title:
IFU, Algovita SCS, Trial Stimulator Manual for Clinicians
Document Number and Revision
0300-000026-06
Page 1 of 2
Prepared By:
Amy Kosbau
Approved By:
QIG Group
The information contained in this document is the sole property of QIG Group. Any reproduction in part or whole without the written permission of
QIG Group is prohibited.
Do not print the material specification notes pages when printing the literature piece.
Do not count the material specification notes pages in the literature piece page count.
1.0 PURPOSE
To define all parameters necessary to assure conformance to appropriate specifications.
2.0 SCOPE
This specification describes the configuration and content for the IFU, Algovita SCS, Trial Stimulator Manual for Clinicians
3.0 RESPONSIBILITY
It is the responsibility of the product development engineer, manufacturing engineer or labeling engineer to maintain this
document in accordance with Algostim requirements.
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4.1 Content: The content of the instructions for use document shall be defined in the files and PDF provided by
Algostim.
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4.7 Language Translation Requirements & Configuration:
4.7.1 English (en)
5.0 STORAGE CONDITION
Store in dry location.
Material Specification
Title:
IFU, Algovita SCS, Trial Stimulator Manual for Clinicians
Document Number and Revision
0300-000026-06
Page 2 of 2
QIG Group
The information contained in this document is the sole property of QIG Group. Any reproduction in part or whole without the written permission of
QIG Group is prohibited.
6.0 QUALITY CHARACTERISTICS
6.1 Clarity of Text: The text shall be easily readable and free of smears and smudges. Graphics content, layout and text
shall be consistent with that in the document (pdf) provided by the customer.
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slivers.
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7.0 PACKAGING/LABELING
7.1 Each package provided by the supplier shall be labeled with: Greatbatch part number, revision level of this
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Greatbatch part number, revision, PO, lot and date of manufacturing.
NOTE: Graphics Content and Layout to be shown and per Algostim file.
Algovita™
Spinal Cord
Stimulation
System
Trial Stimulator
Model 4300
External Pulse
Generator (EPG)
2014
ONL
Y
Trial Stimulator Manual for Clinicians
Refer to the Information for Prescribers Manual for indications, contraindications, warnings, pre-
cautions, adverse events, clinical study results, and related information.
Algovita™ is a trademark of QIG Group, LLC
FCC Information (US Only)
e following is communications regulation information about the Algovita Trial Stimulator and
Pocket Programmer.
Trial Stimulator FCC ID: 2ABU84300
Pocket Programmer FCC ID: 2ABU84100
ese devices comply with part 15 of the FCC Rules. Operation is subject to the following two con-
ditions: (1) ese devices may not cause harmful interference, and (2) ese devices must accept
any interference received including interference that may cause undesired operation.
Important: Changes and modications to the products not authorized by Algostim, LLC could void
the FCC certication and negate your authority to operate these products.
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 1
Contents
Explanation of Symbols Used on Packaging and Trial Stimulator 3
Introduction 5
Package Contents 5
Important Safety Information 6
Contraindications 6
Warnings 6
Precautions 7
Adverse Events 8
EPG Description 10
Turning the EPG On or Off 11
Quick Stimulation Off 12
Using the EPG During Intraoperative Test Stimulation 13
Connecting the Trial Cable to the EPG 13
Disconnecting the Trial Cable from the EPG 14
Stimulation Trial 15
Preparing the EPG for a Stimulation Trial 15
After the Stimulation Trial 15
Changing the EPG Batteries 16
Checking the Battery Charge Status 16
Changing the Batteries 17
EPG Care and Storage 18
General EPG Cleaning 18
Cleaning the EPG After Use 18
Cleaning the EPG Battery Contacts 18
EPG Service and Replacement 19
Disposal 19
Troubleshooting 20
Algostim Customer Service 21
Specications 22
Electromagnetic Compatibility Declaration 24
Wireless Information 28
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 3
Explanation of Symbols Used on Packaging and Trial
Stimulator
Symbol Explanation
2014
Conformité Européenne (European Conformity). is symbol means that the device fully
complies with European Directive AIMD 90/385/EEC and R&TTE Directive 1999/5/EC
ONL
Y
Caution: Federal Law (USA) restricts this device to sale on or by the order of a physician
is device complies with Part 15 of the Federal Communication Commission rules
Authorized representative in Europe
Caution
Consult instructions for use
Serial number
Manufacturer
Date of manufacture
Catalogue number
Model
Temperature limit
Humidity limitation
4Trial Stimulator Manual
Explanation of Symbols Used on Packaging and Trial Stimulator
Symbol Explanation
Fragile, handle with care
Keep dry
Atmospheric pressure limitation
Keep away from sunlight
Do not use if package is damaged
Non-ionizing radiation
Type BF equipment
Battery
Class II equipment
Not for general waste
Recycle
Contents
Telephone
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 5
Introduction
e Algovita™ Trial Stimulator Model 4300 (Figure 1) is part of the Algovita Spinal Cord
Stimulation (SCS) System, a rechargeable, 24-electrode, SCS system for the treatment of chronic
pain.
Figure 1. Algovita Trial Stimulator Model 4300
e trial stimulator is the external pulse generator (EPG) for the Algovita SCS System. e EPG is
used by the physician during intraoperative test stimulation and is used by the patient as part of the
Algovita Trial Stimulation System.
e EPG allows the physician to program system congurations identical to either the Algovita
Stimulator Model 2408 (3x8 channel) or the Stimulator Model 2412 (2x12 channel).
e EPG is programmed using the Clinician Programmer. During a stimulation trial, the patient
controls the EPG using the Pocket Programmer.
Package Contents
• Trial Stimulator Model 4300
• Trial Stimulator Pouch
• AAA Batteries (2)
• Product Literature
6Trial Stimulator Manual
Important Safety Information
Important Safety Information
Contraindications
Diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy must not be used
on SCS patients. e energy generated by diathermy can be transferred through the SCS system,
causing tissue damage at the lead site which may result in severe injury or death.
Warnings
Electrocautery. Electrocautery devices should not be used in close proximity to an SCS trial
system. Contact between an active electrode and an implanted SCS system component can cause
direct stimulation of the spinal cord, which may result in severe injury to the patient
If use of electrocautery is necessary:
1. Turn the EPG o.
2. Use bipolar cautery.
3. Verify system and therapy function aer electrocautery use.
Electromagnetic Interference. Strong electromagnetic elds can potentially turn stimulation o
or change the strength of stimulation, which may cause an uncomfortable or jolting sensation. If
uncomfortable stimulation occurs, advise patients to move away from the area or turn stimulation
o.
Patients should also exercise care around:
• e detectors or security screeners such as those used at entrances or exits of department
stores, libraries, and other public establishments, and airport security screening devices.
Patients should exercise caution when approaching such a device and should request
assistance to bypass the device. If the patient must proceed through the device, the patient
should turn the EPG o and proceed with caution, moving through the center of the screener
as quickly as possible.
• Power lines or power generators
• Electric steel furnaces and arc welders
• Large, magnetized stereo speakers
• erapeutic magnets
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 7
Interaction with Implanted Sensing Stimulators and Other Implanted Devices. SCS systems
may interfere with the operation of implanted sensing stimulators such as pacemakers or
cardioverter debrillators (ICDs). If other implanted devices are indicated for the patient, careful
screening is required to determine if safe results can be achieved before permanently implementing
concurrent electrical therapies. e eects of implanted SCS systems on other implanted devices
are unknown.
Magnetic resonance imaging (MRI). Patients with the Algovita SCS system must not be exposed
to MRI. e electromagnetic eld generated by an MRI may forcefully dislodge the IPG or leads,
damage the IPG electronics, and induce voltage through the lead that may cause an uncomfortable
or jolting sensation or serious injury. e Algovita SCS System components have not been tested
for heating or migration in the MR environment. Introducing an Algovita SCS patient into an MRI
scanner may result in severe patient injury, death, or device malfunction.
Modication. Do not modify the EPG. Modication of any SCS system component may result in
damage to the system, compromised system integrity, and harm or injury to the patient.
Radio-frequency or microwave ablation. Safety has not been established for radiofrequency (RF)
or microwave ablation in patients who have an SCS system. Induced electrical currents may cause
heating, especially at the lead electrode site, resulting in tissue damage.
Precautions
System Interaction with Other Medical Treatments and Procedures. An IPG may interact with
the following therapies or procedures:
• Diagnostic x-rays. e eects of diagnostic x-rays on a stimulator are typically transient
because interference occurs only during the time of x-ray exposure. In some cases, the EPG
may need to be reprogrammed.
e following therapies or procedures may turn your stimulation o or may cause permanent
damage to your stimulator, particularly if used in close proximity to the EPG.
• Radiotherapy
• Lithotripsy
• External debrillation
• Radiation therapy
• Ultrasonic scanning
• High-output ultrasound
8Trial Stimulator Manual
Important Safety Information
• CT scans may damage the EPG if stimulation is on. CT scans are unlikely to damage the EPG
if stimulation is turned o.
If any of the therapies or procedures listed above are required by medical necessity:
• Adjust stimulation to its lowest level before the procedure or application then turn the EPG o.
• All equipment, including ground plates and paddles, must be used as far away from the EPG as
possible.
• Every eort should be taken to keep elds, including current, radiation, or high-output
ultrasonic beams, away from the EPG.
• Set equipment to the lowest energy setting clinically indicated.
• Verify SCS system and therapy function following treatment.
Component Compatibility. Use only the Clinician Programmer, or an Algovita patient
programmers and accessories in your Algovita SCS System to adjust stimulation. e eects of
non-Algovita components on an Algovita SCS System are unknown.
Flammable Atmospheres. Avoid using the EPG in ammable or explosive environments (eg,
an anesthetic mixture with air, oxygen, or nitrous oxide). Using a battery-powered device near
ammable or explosive atmospheres can produce a spark which may cause injury..
Adverse Events
ere are potential risks involved with any surgery. e possible risks of using a trial stimulation
system are similar to the risks that can occur with other spinal procedures. ese risks include:
• e most common risks are temporary pain at the incision or infection.
• ere is a small possibility of developing a cerebral spinal uid (CSF) leak.
• In rare cases bleeding (epidural hemorrhage), a blood clot (hematoma), or a pocket of uid
(seroma) may develop at the location where leads are placed.
• In rare cases, injury to the spinal cord may occur, resulting in paralysis.
• e use of blood thinners may increase the risk of complications such as blood clots
(hematomas), which may produce paralysis.
e possible risks of using a trial stimulation system to evaluate a treatment for chronic pain
include:
• e leads may shi or move from the location where they were originally implanted. Such a
change in location may cause changes in stimulation, sometimes unpleasant, and/or reduce
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 9
the pain relief provided by the SCS system.
• e SCS system may fail at some point, due to a random component or battery failure.
Examples of failure include lead or lead insulation break, loose connection, electrical short,
or component malfunction. A failure may reduce or stop the pain relief provided by the SCS
system.
• A patient may have an allergic reaction or become irritated by materials that are used to
manufacture the SCS system components. Signs of a negative reaction are persistent redness,
swelling, or warmth at the area where the system is implanted
• A patient may have ongoing pain in the area where a lead or extension is located.
• A patient may have unpleasant or painful stimulation. Such changes in stimulation may occur
if stimulation settings are changed too quickly, a lead moves or breaks, or there is a loose
electrical connection in your SCS system.
• A patient may experience weakness or numbness in areas below your SCS system location.
• A patient may experience changes in stimulation, painful stimulation, or problems with the
operation of the SCS system due to electromagnetic interference from other electrical devices,
medical equipment, or medical procedures.
10 Trial Stimulator Manual
EPG Description
EPG Description
Figure 2. EPG button and status lights
e button on the EPG (Figure 2) allows you to turn the EPG on and o and turn stimulation o.
Turn stimulation on using the Clinician Programmer or one of the patient programmers. e lights
on the EPG allow you to verify if the EPG or stimulation is on or o.
• EPG On/O —Turn the EPG on or o by pressing the button for 5 seconds.
• Quick Stimulation O —Turns stimulation o by pressing the button for 2 seconds.
• Stimulation On/O Light —Check if stimulation is on or o.
• EPG Battery Status Light —Check if the EPG is on and the battery charge level is above
25% (ashes green) or below 25% (ashes red).
• Ground Pad Connector Port—is port is used to connect an optional (electrophysiology)
ground pad to the EPG. e ground pad is required with the use of the Algostim Computer
Aided Stimulation Programming (CASP) feature. See the Clinician Programming Manual
for instructions on using CASP.
Ground Pad Connector Port
EPG On/Off
and Quick Stimulation Off
EPG Battery Status Light
Stimulation On/Off Light
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 11
Turning the EPG On or Off
Figure 3. Turning the EPG on or o
Before turning stimulation on, the EPG must be on (Figure 3).
To turn the EPG on:
• Press the EPG On/O button (Figure 3) and hold for approximately 5 seconds. Aer a short
delay, the EPG turns on, and the EPG Battery Status light ashes green. When the EPG turns
on, stimulation is o.
Notes:
» If the EPG Battery Status light ashes red, replace the EPG batteries. For instructions, see
Changing the EPG Batteries on page 16.
» Turn stimulation on using the Clinician Programmer or one of the patient programmers.
To turn the EPG o:
• Press the EPG On/O button (Figure 3) and hold for approximately 5 seconds. e EPG
Battery Status light turns o.
Note: e EPG On/O button and Quick Stimulation O button are the same button.
Pressing and holding the EPG On/O button for approximately 2 seconds turns stimulation
o.
EPG On/Off
EPG Off
EPG On (ashing)
12 Trial Stimulator Manual
Quick Stimulation Off
Quick Stimulation Off
Figure 4. Quickly turning stimulation o
To quickly turn stimulation o using the EPG:
• Press the Quick Stimulation O button (Figure 4) and hold for approximately 2 seconds. Aer
a short delay, stimulation turns o, and the Stimulation On/O light turns o.
Notes:
» e Clinician Programmer includes a Quick Stimulation O icon on stimulation screens,
and a Quick Stimulation O button on the top of the Clinician Programmer.
» If you are unable to turn stimulation o, press the tabs on either side of the trial cable
connector, and disconnect the trial cable from the EPG.
» e Quick Stimulation O button and the EPG On/O button are the same button.
Pressing and holding the Quick Stimulation O button for approximately 5 seconds turns
the EPG o.
» Turn stimulation on using the Clinician Programmer.
Stimulation Off
Stimulation On
(ashing)
Quick Stimulation Off
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 13
Using the EPG During Intraoperative Test Stimulation
Aer placing the leads and connecting the leads to the trial cable, connect the trial cable to
the EPG, turn the EPG on, then turn stimulation on using the Clinician Programmer. During
intraoperative test stimulation, use the Clinician Programmer to program the EPG. For additional
procedural instructions, see the system implant manual packaged with the lead. For programming
instructions, see the Clinician Programming Manual.
Connecting the Trial Cable to the EPG
Caution: e trial cable is a single-use component; do not resterilize the trial cable because of risk
of infection.
To connect the trial cable to the EPG:
1. Check that stimulation is o.
Caution: Connecting the trial cable to the EPG with stimulation on may cause an
uncomfortable or jolting sensation.
2. To prevent the lead from pulling out from the spine, secure the trial cable to the drape before
passing the end of the cable o the sterile eld.
3. Aer the cable end is passed o the sterile eld, tape the non-sterile end on top of the sterile
drape, to prevent the non-sterile cable end from falling back into the sterile eld.
4. With the arrow on the trial cable end and the Algovita logo facing the same direction, connect
the trial cable to the EPG (Figure 5).
Caution: Maintain adequate slack on the trial cable. Do not pull the trial cable taut. Pulling on
the cable may dislodge the lead, which may result in loss of stimulation.
Figure 5. Connecting the trial cable to the EPG
5. Turn the EPG on.
6. Turn stimulation on using the Clinician Programmer.
14 Trial Stimulator Manual
Using the EPG During Intraoperative Test Stimulation
Disconnecting the Trial Cable from the EPG
To disconnect the trial cable from the EPG:
1. If you want to save battery power, turn the EPG o.
2. While squeezing both tabs on the trial cable connector (Figure 6), gently disconnect the cable
from the EPG
Caution: Do not pull directly on the trial cable. Pulling on the trial cable may break a wire or
dislodge the lead. A broken wire or dislodged lead may result in loss of stimulation and may
require another trial procedure to replace the lead.
Figure 6. Disconnecting the trial cable
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 15
Stimulation Trial
e patient uses the EPG during the stimulation trial. For detailed instructions on preparing the
patient for a stimulation trial and evaluating a stimulation trial, see the system implant manual
packaged with the leads.
Preparing the EPG for a Stimulation Trial
Before beginning a new stimulation trial:
• Inspect the EPG and make sure it is not damaged.
• Clean the EPG. Follow your healthcare facility’s procedures in the cleaning of medical devices
or use the procedure Cleaning the EPG Aer Use on page 18.
• Make sure the EPG has new batteries installed.
• Make sure the EPG has been cleared of previously stored data. See the Clinician Programming
Manual for instructions on clearing data from the EPG.
After the Stimulation Trial
Aer the stimulation trial, the patient returns the trial stimulation system to the physician.
When returned, clean the EPG. Follow your healthcare facility’s procedures in the cleaning of
medical devices or use the procedure Cleaning the EPG Aer Use on page 18.
If you and the patient determine that an Algovita SCS system will be implanted, and you want
to move the program settings from the EPG to an IPG, see Swapping an EPG for an IPG in the
Clinician Programming Manual for information.
16 Trial Stimulator Manual
Changing the EPG Batteries
Changing the EPG Batteries
e EPG is powered by two AAA batteries. Replace the EPG batteries before each stimulation trial
or when the batteries are low or depleted. If the EPG loses power, the program settings remain at
the settings last programmed, whether set by the clinician or changed by the patient.
Caution: Do not leave depleted batteries in the EPG. e batteries may corrode and cause damage
to the electronic components. If the EPG is not to be used for several weeks, remove the batteries.
Checking the Battery Charge Status
e EPG has a ashing EPG Battery Status Light (Figure 7).
• When the battery charge level is above 25%, the light ashes green.
• When the EPG battery charge level is at or below 25%, the light ashes red. If the light is
ashing red, change the EPG batteries in order to maintain stimulation.
• If the EPG battery is depleted, the EPG will not turn on.
Figure 7. EPG Battery Status Light
Note: e Clinician Programmer may also be used to check the EPG battery charge status. See the
Clinician Programming Manual for detailed information.
EPG On (ashing)
and EPG Battery
Above 25%
EPG On (ashing)
and EPG Battery
Below 25%
EPG Off
Table of contents
