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.
4.0 MATERIAL CHARACTERISTICS
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
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7.2 A Certificate of Conformance is required with each shipment to include quantity, material characteristics,
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
4 Trial 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
6 Trial 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
8 Trial 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
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 17
Changing the Batteries
1 2
4
3
Figure 8. Replacing the EPG batteries
To change the EPG batteries (Figure 8):
1. Using a Phillips screwdriver, loosen the screw on battery compartment cover.
2. Remove the battery compartment cover and batteries.
3. Insert the new batteries following the polarity diagram in the battery compartment.
4. Replace the battery compartment cover, then insert and tighten the screw.
18 Trial Stimulator Manual
EPG Care and Storage
EPG Care and Storage
e following recommendations are made for the care and storage of the EPG:
• Keep new batteries available.
• Replace low or depleted batteries.
• Do not drop the EPG. Protect the EPG from sharp objects and physical shocks. Mishandling
can permanently damage the EPG.
• e sensitive electronics of the EPG can be damaged by temperature extremes, particularly
high heat.
» Do not expose the EPG to excessively hot or cold conditions, including leaving the EPG in
your car or outdoors for extended periods of time.
» If the EPG is to be stored for a period of time, be careful that the storage temperature is not
less than -20°C (-4°F) or greater than 60°C (140°F).
General EPG Cleaning
• e EPG is not waterproof. Do not immerse the EPG in liquid or allow moisture to get inside
the case.
• If the EPG is dirty, clean the outside with a slightly damp cloth. Do not clean the EPG with
bleach, nail polish remover, or similar substances.
Cleaning the EPG After Use
Aer using the EPG for intraoperative test stimulation, clean the EPG before giving it to a patient
for a stimulation trial. Also clean the EPG when a patient returns the EPG aer a stimulation trial.
Follow your healthcare facility’s procedures in the cleaning of medical devices. If your healthcare
facility does not have a cleaning procedure:
1. Inspect the EPG for any dirt, debris or residue.
2. Clean the EPG, as appropriate, with hospital-grade isopropyl alcohol (IPA).
3. Before using the EPG, make sure it is clean and dry.
Cleaning the EPG Battery Contacts
e EPG battery contacts may be cleaned periodically with a cotton swab dampened with alcohol.
Do not use a pencil eraser or sandpaper.
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 19
EPG Service and Replacement
e components have no user-serviceable parts. Only Algostim, LLC should service or repair the
EPG. Do not attempt to open or repair the EPG. Unauthorized repairs will void the warranty.
If the EPG needs service or repair, contact Algostim Customer Service. When contacting Algostim
Customer Service, have the EPG serial numbers available. e serial number is located on the back
of the EPG.
Note: e Limited Warranty does not cover loss or the of the EPG or damage caused by misuse.
For additional information, refer to the Limited Warranty packaged with this manual.
Disposal
To dispose of the EPG, consult local regulations for proper disposal of AAA batteries and electronic
devices.
Return explanted leads, extensions, anchors to Algostim, LLC. Do not autoclave the components
or expose them to ultrasonic cleaning. Dispose of unreturned components according to local
environmental regulations.
20 Trial Stimulator Manual
Troubleshooting
Troubleshooting
e following tables cover stimulation and EPG troubleshooting. If you are having a problem with
your EPG and do not nd an answer in these tables, contact Algostim Customer Service.
Table 1. Stimulation and EPG Troubleshooting
Indication Possible Cause Possible Solution
You want to turn stimulation
o quickly, but stimulation
will not turn o.
You are not holding the Quick
Stimulation O button down
for the correct amount of time.
Make sure you are holding the Quick
Stimulation O button down for 2
seconds.
e EPG has malfunctioned. Press the tabs on either side of the trial
cable connector, and disconnect the trial
cable from the EPG.
e patient no longer feels
stimulation.
e strength of the active
program is too low.
Increase the strength of the active
program.
e EPG is turned o. Turn your EPG on.
Stimulation is o. Although unlikely, stimulation may have
been turned o by EMI from security
gates or other electronic devices. Verify
that stimulation is on.
e EPG batteries are depleted. Check the EPG battery charge level, and
change the batteries if needed.
A lead has moved or lead has
become disconnected from the
trial cable.
1. Turn the EPG o.
2. Inspect the trial stimulation system
connections and lead location.
e EPG Battery Status
Light or the Stimulation On/
O Light are ashing
To conserve battery power,
when the status lights are on,
they always ash.
e EPG will not turn on. You are not holding the EPG
On/O button down long
enough.
Make sure you are holding the EPG On/
O button down for 5 seconds.
e EPG batteries are depleted. Check the EPG battery charge level, and
change the batteries if needed.
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 21
Table 1. Stimulation and EPG Troubleshooting
Indication Possible Cause Possible Solution
e EPG will not turn o. You are not holding the EPG
On/O button down long
enough.
Make sure you are holding the EPG On/
O button down for 5 seconds. Holding
this button down for 2 seconds, turns
stimulation o.
e EPG has malfunctioned. Press the tabs on either side of the trial
cable connector, and disconnect the trial
cable from the EPG.
Algostim Customer Service
If you have any questions about an Algovita SCS System, call Algostim Customer Service toll-free
at 1-844-727-7897 within the United States.
Outside of the United States, call your product distributor for assistance. If additional assistance is
needed, contact Algostim Customer Service +1-214-618-4980.
22 Trial Stimulator Manual
Specifications
Specications
Table 2. Operating Values for Model 4300
Description Value
Number of programs 1 to 10
Number of sub-programs per program 1 to 4
Electrode conguration Up to two 12 electrode leads or three 8 electrode
leads
Amplitude – upper patient limit ±15.0 mA
Amplitude – lower patient limit ±0.017 mA
Pulse width 20 to 1500 μs (20-μs resolution)
Frequency – upper patient limit 2000 Hz
Frequency – lower patient limit 2 Hz
Table 3. Physical Characteristics for Trial Stimulator Model 4300
Description Value
Length 86.4 mm / 3.4 in
Width 51 mm / 2.0 in
ickness 22 mm / 0.85 in
Cable Connector 24 pin contact cable connector
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 23
Table 4. Electrical and Operating Characteristics for Trial Stimulator Model 4300
Description Value
Power source 2 AAA alkaline batteries 1.5v
Operating Type Continuous
Note: e Ground Pad port may be connected to a standard electrophysiology ground pad using a DIN 42-
802 1.5mm touch-proof connector, and is analogous to using the hermetic enclosure of the IPG in stimulation.
Table 5. Storage and Operating Conditions for Trial Stimulator Model 4300
Parameter Value
Operating temperature 10 to 40° Celsius (50-104°F)
Storage temperature -20 to 60° Celsius (-4 to 140°F)
Maximum humidity 10% to 85% non-condensing
Minimum atmospheric pressure 70 kPa
Maximum atmospheric pressure 106 kPa
Table 6. Component Materials for Trial Stimulator Model 4300
Component Material
EPG Acrylonitrile butadiene styrene
Polycarbonate
24 Trial Stimulator Manual
Electromagnetic Compatibility Declaration
Electromagnetic Compatibility Declaration
is section lists the EMC Declaration tables. e EPG is intended for use in the electromagnetic
environment specied below. e customer or the user of the EPG should assure that it is used in
such an environment. e EPG contains RF transmission and receiving capabilities; consequently,
it is possible that other portable and mobile RF communications equipment may interfere with the
EPG.
e trial cable (maximum length 213 cm [84 in]) and ground pad (maximum length 200 cm [79
in]) were included in the system testing to demonstrate compliance with the requirements of IEC
60601-1-2 2007. Use of accessories and cables other than those specically listed may result in
increased emissions or decreased immunity of the EPG.
e EPG should not be used adjacent to or stacked with other equipment. If adjacent or stacked
use is necessary, the EPG should be observed to verify normal operation in the conguration in
which it will be used.
Table 7. Guidance and manufacturer’s declaration – electromagnetic emissions
e EPG is intended for use in the electromagnetic environment specied below. e customer or the user
of the EPG should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 e EPG uses RF energy primarily for its internal
function. erefore, its RF emissions are very low and
are not likely to cause interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B e EPG is suitable for use in all establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations
/icker emissions
IEC 61000-3-3
Complies
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 25
Table 8. Guidance and manufacturer’s declaration – electromagnetic emissions
e EPG is intended for use in the electromagnetic environment specied below. e customer or the user
of the EPG should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 8 kV contact
± 15 kV
e EPG is a portable device
intended for use in hospital or home
environments as well as being carried
by ambulatory patients.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Not applicable Not applicable – Battery powered
device
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Not applicable Not applicable – Battery powered
device
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 s
Not applicable Not applicable – Battery powered
device
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
26 Trial Stimulator Manual
Electromagnetic Compatibility Declaration
Table 9. Guidance and manufacturer’s declaration – electromagnetic emissions
e EPG is intended for use in the electromagnetic environment specied below. e customer or the user
of the EPG should assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Not
applicable
3 V/m
Portable and mobile RF communications equipment should
be used no closer to any part of the EPG, including cables,
than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
Not applicable – Battery powered device
d=1.2 80 MHz to 800 MHz
d= 2.3 800 MHz to 2.5 GHz
where P is the maximum output rating of the transmitter in
watts (W) according to the transmitter manufacturer and d
is the recommended separation distance in meters (m).
Field strengths from xed RF transmitters, as determined
by an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked
with the following symbol.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects, and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which the
EPG is used exceeds the applicable RF compliance level above, the EPG should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the EPG.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3V/m.
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 27
Table 10. Recommended separation distances between portable and mobile RF
communications equipment and the EPG
e EPG is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. e customer or the user of the EPG can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the EPG as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.2
80 MHz to 800 MHz
d=1.2
800 MHz to 2.5 GHz
d=2.3
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: ese guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects, and people.
28 Trial Stimulator Manual
Wireless Information
Wireless Information
Table 11. Wireless Specications and Safety
Programmer wireless
technology operating
characteristics
e Clinician Programmer interacts with the EPG using MedRadio Band:
402-405 MHz.
e eective radiated power is below the limits as specied in:
Europe: EN ETSI 301 839-2
USA: FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219
e Clinician Programmer interacts with the EPG using
2.45 GHz.
e eective radiated power is below the limits as specied in:
Europe: EN ETSI 300 328
USA: FCC part 15.24
Stimulator wireless
technology
e EPG complies with emissions requirements per
R&TTE Standard EN 301 839-2 v13.1 (402MHz to 405MHz).
Wireless integrity e Algovita SCS System employs mechanisms to ensure integrity of the
communication area. e EPG will not respond to any device to which it is
not linked.
Note: is equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. ese limits are designed to provide reasonable
protection against harmful interference in a residential installation. is equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the
equipment o and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit dierent from that to which the receiver is
connected.
• Consult the dealer or an experienced radio/TV technician for help.
Algovita Spinal Cord Stimulation System
Trial Stimulator Manual 29
is 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 Meteorological 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. is 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 interference or that any
particular transmission from this transmitter will be free from interference.
30 Trial Stimulator Manual
Wireless Information
© 2014
All Rights Reserved
Part Number
0300-000026-06
1011440-001 Rev A
2014-05
Algostim, LLC
10675 Naples St. NE
Blaine, MN 55449
+1-214-618-4980
Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
(31) (0) 70 345-8570