Theragen ActaStim-S User manual
ActaStim-S Spine Fusion Stimulator
INSTRUCTIONS FOR USE
Dear ActaStim-S patient,
Your doctor has prescribed Theragen’s ActaStim-S Bone Growth Stimulator System
as an important part of your spine fusion surgery recovery plan. Here at Theragen,
we want you to know that we are here to help you on your path to recovery.
As a spine fusion patient myself, I had many of the same questions and concerns
that you have right now. How soon will I recover from surgery? When will I start
feeling normal again? Is what I’m feeling right now “normal”? How much activity is
enough and how much is too much?
Your doctor is the best person to answer those questions, but ActaStim-S will help
by giving your Doctor a very special insight into your day-to-day recovery through
the proprietary ActaStim Sync app that you will be using in conjunction with your
ActaStim-S device.
The ActaStim-S device is designed to be portable, convenient and comfortable.
Like a medication that you take every day, you won’t feel the stimulation working
êææ©©½¬Ä¤æ©Ú×êæ¬Þ¬¤Ä½©ÞÄÞ©ËöÄæËÄĈæ×æ¬ÄæÞö¬æ©¬½ü
use according to your doctor’s directions.
1
In an important Level I clinical trial, described in Section 8, a device having the
signal that ActaStim-S delivers was Þ©ËöÄ to increase spine fusion success
Þ¬¤Ä¬ĈÄæ½üËÃ×ÚæË×½Ëö©ÄêÞÞ¬Úæəæ]æ¬Ãɫ]¬ÞÞ¬¤Ä
æËêÞǽǿ©ËêÚÞday). Our ultimate goal is to help as many patients as possible
return to activities of ¬½ü½¬õ¬Ä¤ɋæ]æ¬Ãɫ]ö¬½½££æ¬õö©ÄêÞÞ
¬Ä¬æɋ
The ActaStim Sync app is your daily companion. You are able to track your pain
½õ½ÞɆúÄËæË£Þ׬Ĉ©¬õÃÄæÞɆÄÞüÄæ¬õ¬æüÄêÞ¤æ
from your ActaStim-S device. You will be able to produce a report that you can
share with your Doctor before, at and between your appointments to help them
fully understand how you are progressing day-to-day. This extra insight will
place
them in a better position to answer any questions that you have.
On behalf of the Theragen team, I would like to wish you the very best for your
recovery journey. We’re here to support you. Please let us know how we can help.
Yours in health,
9ɋ ©Ú¬ÞC꽬ą
CEO, Theragen Inc.
ǽ
TABLE OF CONTENTS
System Components
Safety Information
Prescribing Information
• Indications for Use
• Contraindications
• Warnings & Precautions
• Adverse Events
• Recommended Usage
Directions for Use
• General
• Placement of Electrodes
• Assembly of System
• Indicators and Troubleshooting Actions
°Normal Operation
°Connection Issue
°Charge Spare Battery
°Replace Battery
°Error
°End of Life
°Smart Phone Connection
°Mute Button
• Battery Charging
• Compliance and Activity Monitoring
• Electrode Care and Replacement
• Cleaning Instructions
Patient Counseling Information
Storage and Handling
Disposal Instructions
Clinical Information
Technical Information
Electromagnetic Compatibility
Symbol Descriptions
Warranty and Customer Care Information
4
5
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19
23
24
1 .
2 .
3 .
4 .
5 .
6 .
7 .
8 .
9 .
10 .
11 .
12 .
INFORMATION & SAFETY
3
1. SYSTEM COMPONENTS
&ÄÚæËÚ½ə½ËĤɆǿȃɎɚ
&ÄÚæËÚ½əÞ©ËÚæɆǼǽɎɚ
½æÚËÞəcü×ǼɅXêÄæ¬æüǼǻɆ
cü×ǽɅXêÄæ¬æüǽɚ
&ÄÚæËÚəÞ¬½õÚɚöɑ½æ½¬×
Battery
Charging Cable
Power Supply Block
ææÚü©Ú¤Úəö©¬æɚöɑûæÚBattery
Battery Charger Dock
½æÚË]©ËöÚËõÚÞəXêÄæ¬æüǽǻɆ
disconnect electrode lead wires from
Generator Cable before showering)
Travel Case
Xꬺ]æÚæ&ê¬əÄËæÞ©ËöÄɚ
.ÄÞæÚêæ¬ËÄÞ%ËÚgÞəÄËæÞ©ËöÄɚ
ǽ
3
ǿ
5
6
11
Ǽǽ
1b
1a
9
Ǽǻ
8
7
ǽ
8
5
1a 1b
ǿ
3 7
Ǽǻ
ǽ
6
9
INFORMATION & SAFETY
ǿ
Read all of these instructions before using
2. SAFETY INFORMATION
•Use the product only for its intended use.
•Do not use unapproved components. Only use system components provided with the
system or obtained from the company as supplies or replacements.
•In the case of a malfunction, contact Customer Support at 1-800-901-5667.
•WARNING: Do not attempt to repair or modify the device.
•Do not use system components with any other devices.
•Do not submerge or expose the device to liquids.
•Disconnect the generator while bathing, showering or swimming.
•Do not connect the battery charger to the wall outlet if wet.
•If the battery charger has fallen into water, unplug from the wall outlet before retrieving.
•Do not operate the battery charger if it has a damaged power cord or has been dropped
or immersed into water.
•Do not short circuit, crush, penetrate or otherwise damage the battery or connect
conductive materials across the battery terminals. These and other abuses can lead to
serious injury or burns.
•.£æ©¤ÄÚæËÚ¬ÞÄËæ¬Ä¤êÞɆÚÃËõæ©ææÚüɋc©¬Þö¬½½õˬ¬Ä¬æËÚÞəõ¬Þê½Ɇ
sound and vibration) from activating.
•Do not expose the system to prolonged heat, sunlight or cold. Normal operating
æÃ×ÚæêÚ¬ÞȀæËǿǻʷəǿǼæËǼǻǿʷ%ɚÄÄËÚýÞæËÚ¤ÄæÚÄÞ×ËÚææÃ×ÚæêÚ¬Þ
ɫǽȀæËȂǻʷəɫǼǾæËǼȀȃʷ%ɚɋ
•c©ÚÚǽ¤ÄÚæËÚ½ö¬Ú½Ä¤æ©Þɋ.£æ©Ú¬ÞÞ¬æêæ¬ËÄö©Úæ©Ú¬Þڬ޺ˣæ©
longer lead wire causing strangulation, use the shorter length.
•There is a USB connector available when the generator lead wire is removed from the
generator. This is for downloading device data by a physician or Theragen and is NOT TO
BE USED FOR CHARGING THE DEVICE.
•.£Äü橬Ĥ©××ÄÞæ©æ¬ÞêÄû×æËÚ¬ąÚÄææËö©æ¬ÞËÄæ¬Ä¬Äæ©Þ
instructions, contact Customer Support at 1-800-901-5667.
INFORMATION & SAFETY
5
3. PRESCRIBING INFORMATION
Description
æ]æ¬Ãɫ]×ÞÞÞÞ׬ĈêÚÚÄææöÄ橽æÚËÞ¬ÄËÚÚæË×ÚËÃË橽¬Ä¤ü
inducing a therapeutic, low level electrical current at the fusion site. Federal law restricts
橬Þõ¬æËÞ½üËÚËÄæ©ËÚÚˣשüÞ¬¬ÄɆ×ÚÞÚ¬×æ¬ËÄəYûɚËĽüɋc©¬Þõ¬¬ÞÄËæ
intended for re-sale.
Indications for Use
The ActaStim-S Spine Fusion Stimulator is a noninvasive bone growth stimulator indicated
as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two
levels. The device is Rx only, and intended for single patient use in adult patients only.
Contraindications
There are no known contraindications.
Warnings
Ú¬×úÚÞËÚÚ¬ËõÚæÚÞÃüõÚÞ½üąæüæ]æ¬Ãɫ]ɋc©
concomitant use of ActaStim-S and a pacemaker or cardioverter must be assessed on an
individual basis, such as with an electrocardiogram, prior to use. The patient should be
referred to a cardiologist for monitoring of pacemaker function while wearing the active
stimulator device. If there are any observable adverse changes in the pacemaker rhythm or
output, ActaStim-S should not be used.
c©Þ£æüÄąæ¬õÄÞÞË£æ]æ¬Ãɫ]¬Ä×Ú¤ÄÄæöËÃÄ©õÄËæÄÞæê¬ɆÄ
æ©ąæÞË£æ]æ¬Ãɫ]ËÄæ©ÃËæ©ÚËÚæ©õ½Ë׬Ĥ£æêÞÚêĺÄËöÄɋ×æ¬Äæ
who is either pregnant or is intending to become pregnant should be referred to her doctor
prior to treatment with ActaStim-S.
Precautions
c©Þ£æüÄąæ¬õÄÞÞË£æ]æ¬Ãɫ]¬Ä¬Ä¬õ¬ê½Þö¬æ©æ©£Ë½½Ëö¬Ä¤ËĬæ¬ËÄÞ©õ
ÄËæÄÞæê¬ɆÄæ©Ú£ËÚæ©Þ£æüÄąæ¬õÄÞÞË£æ]æ¬Ãɫ]¬Äæ©Þ
¬Ä¬õ¬ê½ÞÚêĺÄËöÄɅ
•spondylitis, infection, Paget’s disease
•cancer, diabetes mellitus, renal disease
INFORMATION & SAFETY
•trauma of the lumbar spine
•osteoporosis
6
Apply the electrodes after the skin has been cleaned and dried. If erythema develops at the
electrode sites, the electrodes should be relocated adjacent to the original sites. If the
Úæ¬ËÄËÞÄËæÚÞ˽õ£æÚǿȃ©ËêÚÞ£æÚÚ½Ëæ¬Ä¤æ©½æÚËÞɆæ©×æ¬ÄæÞ©Ëê½
be instructed to consult with the physician.
Do not submerge or expose ActaStim-S to water. The patient must be instructed to remove
ActaStim-S during bathing, showering or swimming.
Compliance with the treatment schedule, daily battery pack changes, and replacing the
½æÚËÞəǼæËȂüÞɚÞÄÚÞÞÄ欽£ËÚ×ÚË×Úõ¬£êÄæ¬ËÄɋc©¬ÞÞüÞæÃ
should only be used with components and replacement parts supplied by Theragen. Other
components, parts and accessories may not be compatible, and may damage ActaStim-S.
If any component does not function properly, contact Customer Support at
1-800-901-5667. No attempt should be made to modify or repair ActaStim-S.
Patients should be able to use ActaStim-S in accordance with the instructions for use. If a
patient cannot comply with these instructions for any reason, use of ActaStim-S is
not recommended.
Adverse Events
êڬĤÃê½æ¬ɫÄæÚ½¬Ä¬½ÞæêüË£ǾǿȄ×æ¬ÄæÞæÚæö¬æ©õ¬½¬õڬĤæ©
same output parameters as ActaStim-S for the indication listed above, skin irritation was
æ©ÃËÞæËÃÃËÄõÚÞąæÞÞˬæö¬æ©æ©êÞË£æ©õ¬ɋ.æËêÚÚ¬ÄȄ
×æ¬ÄæÞəǽɋȁʥË£æ©æÚ¬½×Ë×ê½æ¬ËÄɚɅǿ×æ¬ÄæÞæÚæö¬æ©æ©æ¬õõ¬ÄȀ
patients treated with the placebo device.
Recommended Usage
æ]æ¬Ãɫ]¬ÞÞ¬¤Äæ˽¬õÚǽȂǻüÞË£ËÄæ¬ÄêËêÞæ©Ú×êæ¬æÚæÃÄæ£ËÚǽǿ
©ËêÚÞ×Úüɋc©ÚËÃÃĬ½üæ©Ú×êæ¬æÚæÃÄæ¬ÞËÄæ¬ÄêËêÞ£ËÚǽǿ©ËêÚÞɋ
INFORMATION & SAFETY
INFORMATION & SAFETY
7
4. DIRECTIONS FOR USE
General
c©Þæ¬Ãê½æËÚĽ½Ë£æ©£Ë½½Ëö¬Ä¤¬ÄÞæÚêæ¬ËÄÞ©õÄÞ׬Ĉ½½üÞ¬¤Ä£ËÚÞ£Ɇ
comfortable and easy use by a patient. They include the required assembly, operation,
æÚËê½Þ©ËËæ¬Ä¤ÄìÄæÄÄəææÚü©Ú¤¬Ä¤Ä½Ä¬Ä¤ɚæ¬õ¬æ¬Þɋ
Begin using the stimulator immediately after reading the instructions for use and having
received instructions from the prescribing physician.
c©õ¬¬Þ¬ÄæÄ£ËÚêÞǽǿ©ËêÚÞ×ÚüêÄ欽æÚæÃÄæ¬ÞæÚìÄæË
complete by the prescribing physician. Compliance with the instructions provided by the
×ÚÞÚ¬¬Ä¤×©üÞ¬¬ÄÚڬ欽æË©¬õ¬Ä¤ąæ¬õæÚæÃÄæɋVÚË×ÚÚË£
ActaStim-S is also required for the proper function of ActaStim-S.
c©ÞüÞæéÞÄÞ¬¤Äæˤ¬õǽǿ©ËêÚÞË£æÚæÃÄæ£ÚËã꽽ü©Ú¤ææÚü
ÄÚËêæ¬Ä©Ú¤¬Ä¤ÄÞö×׬Ĥˣæ©ǽææÚ¬ÞõÚüǽǿ©ËêÚÞö¬½½©½×ÄÞêÚÄË
inadvertent gaps in treatment. Indicators are provided to demonstrate the latest point at
which a fully discharged battery will need recharging if treatment is to avoid being
interrupted.
Examine the skin for signs of irritation when replacing the electrodes. If irritation is present,
relocate the electrodes to a place adjacent to that site but still within the guidance.
Disconnect the ActaStim-S generator during bathing, showering or swimming, and
reconnect as soon as practical following these activities. Either remove the electrodes or
cover the electrodes with the electrode covers during showering.
DIRECTIONS FOR USE
8
Placement of Electrodes
c©ÚÚǽæü×ÞË£½æÚËÞ×ÚËõ¬ɋËæ©æü×ÞÚÞ¬¤ÄæËöËÚºąæ¬õ½üɋJÄ
or other type may be preferred based on how well they stick to the skin and how easily they
can be removed.
½ÄÄÚüæ©Þº¬Äö©Ú橽æÚËÞÚæË×½ɋcÚ¬ÃìĤəÄËæÞ©õ¬Ä¤ɚËü
©¬Ú£ÚËÃ橽æÚË××½¬æ¬ËÄÚ¬ÞË£æÄ©½×£ê½ɋ©ËËÞËÄË£æ©ǽ½æÚË
types provided with the system.
Remove the electrode from the pouch and remove the plastic backing material from the
electrode. Place one electrode on the back, two to three inches to the left of the area of
the spinal fusion and the second electrode two to three inches to the right of the area
of the spinal fusion so that the electrodes are on the back, four to six inches apart.
Depending on the ability to move after surgery, it may be helpful to ask another person to
assist in placing these electrodes. The patient should consult their prescribing physician if
they have any questions or concerns regarding proper electrode placement.
If the skin becomes abnormally red at the electrode
sites, the electrodes should be moved adjacent to
the original sites. If the redness does not go away
£æÚǿȃ©ËêÚÞö¬æ©æ©½æÚËÞÚÃËõɆæ©
patient should contact their prescribing physician.
If there are issues with the electrodes remaining in
×½ɆæÚü橽æÚÄæ¬õ½æÚËæü×ÄɑËÚ
consider applying an electrode cover over the top
of the electrode.
DIRECTIONS FOR USE
9
Assembly of System
Choose the generator lead wire length that is most convenient for use. This will depend on
the location chosen to place or carry the generator. Please ensure that the spare length of
wire is not so long as to present a strangulation hazard.
Connect the end of generator lead wire that has the small block to
æ©ǽ׬ÄÞˣ橽æÚ˽ö¬ÚÞɋ
Note: This may be done before connecting the electrodes to
the back if that is easier to manage.
To remove the belt clip, pull the bottom of the curved end
approximately ¼” away from the generator so that the clip can be
pushed upwards until clear of the generator
If it is desired to attach the generator to a belt, waistband or pocket,
½Ëæ橽潬×ÄÞ½¬æ©ĉæެˣ橽¬×¬ÄæËæ©
generator until the retainer slides into the hole in the generator.
ËÄÄææ©Ëæ©ÚÄˣ橤ÄÚæËÚ½ö¬Úə½Ú¤Þæ½ËºɚæË
the generator.
DIRECTIONS FOR USE
Ǽǻ
ActaStim-S will go through a self-check routine and will immediately start delivery of
æÚæÃÄæɋc©Ú¬ÞÄËËÄɑËąêææËÄɋPlease do not insert the battery until you are ready
to start treatment.
To stop treatment, remove the battery.
Indicators and Troubleshooting Actions
Bluetooth Connection
Indicator
Battery Level
Indicator
Circuit
Incomplete
Indicator
Error/Malfunction
Indicator
“Mute”
Button
c©ææÚü=õ½ɆÚÚËÚɑC½£êÄæ¬ËÄĬÚê¬æ.ÄËÃ×½æ¬Ä¬æËÚÞ½ÞË©õÄ
accompanying vibration and audible buzzer in case the icons are not visible.
DIRECTIONS FOR USE
Insert a battery. The battery can only be properly inserted in one
orientation and incorrect insertion will be obvious, leaving a gap
between the bottom of the battery pack and the generator. Check
æ©ææ©Ú¬ÞÄËꤩ©Ú¤æËÞæÚææÚæÃÄæə¤ÚÄËÚÞ˽¬ËÚĤ
ææÚüÞææêÞɪÞפǼǿ£ËÚÞÚ¬×æ¬ËÄË£ææÚü¬Ä¬æËÚÞɚɋ
If not, try the other battery provided and charge the original.
Treating
Indicator
11
Normal Operation
s©ÄĈÚÞæËÄÄææ]æ¬Ãɫ]¤ËÞæ©ÚËꤩ޽£ɫ©º
routine which illuminates several of the indicators before reaching
a settled state.
If everything is operating correctly the “treating” check mark will be illuminated green and
æ©ɵææÚü½õ½ɶ¬Ä¬æËÚö¬½½¬æ©Ú¤ÚÄə£ê½½ɚËÚËÚĤə©Ú¤Þ×ÚææÚüɚɋ
c©Þ¬Ä¬æËÚÞö¬½½æêÚÄËą£æÚǾǻÞËÄÞ½õ¬Ä¤½ÄºÞæË£¬ËÄÞɋVÚÞެĤæ©
mute button will re-illuminate the relevant icons. If ActaStim-S senses a change in state in
the interim, the relevant icons, audio and vibrate will automatically activate.
Connection Issue
.£æ©ɵ¬Úê¬æ¬ÄËÃ×½æɶ¬Ä¬æËÚ¬Þ¬½½êìÄæəËÚĤɚæ©Äæ©
¬Úê¬æ¬ÞÄËæËÃ×½æÄæÚæÃÄæ¬ÞÄËæ¬Ä¤×ÚËõ¬əæÚæ¬Ä¤
©ºÃÚºö¬½½ÄË欽½êìÄæɚɋc©¬ÞË꽩õǽêÞÞɅ
•c©Ú¬Þ¬ÞËÄÄææöÄ橽æÚËÞÄ橺ÄɑËÚ橽æÚË
½ÞÄ橤ÄÚæËÚ½ö¬ÚËÄÄæ¬ËĽ˺ÄɑËÚ橤ÄÚæËÚ½ö¬Ú
block and the generator. Check all connections to ensure they are complete.
•If all connections are complete then the circuit will be detecting that the resistance
×ÚËõ¬ü橽æÚˤ½ÄɑËÚ×æ¬ÄæɸÞËü¬ÞËêæެˣæ]æ¬Ãɫ]
Ë×Úæ¬Ä¤ÚĤɋ.æ¬ÞÃËÞ潬º½üæ©æ橬ÞËê½ÚÞê½æ£ÚËÃɅ
°The electrodes being too dry. Moisten them by applying a small amount of water
onto the skin facing surface and gently rubbing it into the surface.
°c©½æÚËÞÚ©¬Ä¤æ©Äˣ橬Úêޣ꽽¬£ə××ÚËû¬Ãæ½üǼæËȂüÞɚɋ
Use fresh electrodes.
°The skin not being clean and dry. Clean and dry the skin before re-applying
the electrodes
°Dehydrated skin. Skin resistance changes throughout the day as a body’s
hydration level changes. Remove ActaStim-S and hydrate well by drinking water
£ËÚÚɫ××½ü¬Ä¤æ]æ¬Ãɫ]£æÚÚËêÄǾǻìÄêæÞɋ
DIRECTIONS FOR USE
If none of the above eliminates the “circuit incomplete” icon, contact Customer Support
at 1-800-901-5667. Ǽǽ
Charge Spare Battery
s©Äæ©ææÚü½õ½¬Ä¬æËÚ¬ÞÞ˽¬əÄËæĉÞ©¬Ä¤ɚËÚĤ橬Þ
¬Ä¬æÞæ©ææ©ǽÄææÚüÞ©Ëê½ÞæÚææË©Ú¤¬£¬æ
hasn’t already done so. There is enough time left to charge a fully
depleted battery.
Replace Battery
s©Äæ©ææÚü½õ½¬Ä¬æËÚ¬ÞĉÞ©¬Ä¤ËÚĤɆæ©ææÚü
needs to be replaced with a more fully charged one. Ideally, the
battery being replaced should be re-charged at that time to avoid
any chance of disruption to treatment, but at the least should be
Ú©Ú¤ËÄæ©ËÚĤææÚü½õ½¬Ä¬æËÚĈÚÞæËÃÞËÄɋ
Error
.£æ©ÚÚËÚɑý£êÄæ¬ËĬËĬ½½êìÄæÞəËÚĤɚÚÃËõæ©
battery and replace it. If the problem persists, contact Customer
Support at 1-800-901-5667.
End of Life
£æÚǽȂǻüÞË£êÞæ]æ¬Ãɫ]ö¬½½ÞæË×Ë×Úæ¬Ä¤Ä橬Þö¬½½
¬Ä¬æüæ©ææÚü½õ½ɆÚÚËÚɑý£êÄæ¬ËÄĬÚê¬æ
¬ÄËÃ×½æ¬ËÄÞ½½ĉÞ©¬Ä¤ËÚĤɋYÃËõæ©ææÚüÄ
refer to disposal instructions.
Smart Phone Connection
This icon indicates that the generator is available for smart phone
connection via Bluetooth.
DIRECTIONS FOR USE
13
DIRECTIONS FOR USE
Mute button
.£ê¬½ɑõ¬Úæ¬ËÄəɑrɚÄËæ¬Ĉæ¬ËĬީ××ĬĤɆÞ©ËÚæ×ÚÞÞ
ö¬½½Ãêææ©ɑr£ËÚȃ©ËêÚÞ¬£æÚæÃÄæ¬Þ¬Ä¤×ÚËõ¬ËÚ£ËÚ
15 minutes if treatment is not being provided. If ActaStim-S has
êæËÃ欽½üæêÚÄËąæ©¬Ä¬æËÚ½¬¤©æÞɆÞ©ËÚæ×ÚÞÞö¬½½
ÚÞæËÚ橬ĬæËÚ½¬¤©æÞ£ËÚǾǻÞËÄÞæË©ºÞææêÞɋ
Battery Charging
Decide whether the battery charger is to be laid down or to be
used with the dock. If it is to be used laid down, then connect the
charging cable to the bottom of the charger and to the power
supply block.
If the dock is to be used, insert the charger into the dock
ensuring it is fully inserted and connect the charging cable to the
dock socket and wall socket plug. Plug in the wall socket plug.
©Ú¤æ©ææÚüæÚËËÃæÃ×ÚæêÚəǽǿʷəȂȀʷ%ɚɚɋ©Ú¤¬Ä¤
may require up to 3 hours. Charging time may vary in warmer or
colder temperatures.
Remove the battery to be charged from the generator or if it has
already been removed, locate it.
Insert it into the battery charger.
The indicator on the front, plus the
light around the top will glow orange
for charging or green for fully
charged.
These light around the top can be
“muted” by pressing the button on
the front of the charger.
Ǽǿ
5. PATIENT COUNSELING INFORMATION
Compliance - Compliance with device use and care is critical to assure the proper function
Ë£æ]æ¬Ãɫ]ÄæËÄÞêÚąæ¬õæÚæÃÄæɋ
Battery ɫ©Ä¤æ©ææÚü××ÚËû¬Ãæ½üõÚüǽǿ©ËêÚÞËÚެĬæüæ]æ¬Ãɫ]ɋ
Charge the spare battery immediately on removal or at least when indicated by ActaStim-S
əËÚĤ½¬¤©æɚɋ
Electrodes - Replace the electrodes when needed and clean the electrode application sites
thoroughly with soap and water, and dry the site before applying the electrodes.
DIRECTIONS FOR USE
Compliance and Activity Monitoring
VÚÞެĤæ©CêæêææËÄ£ËÚǽÞËÄÞËÚÃËÚö¬½½æêÚÄËÄæ©
½êæËËæ©=ËöÄÚ¤üə=ɚ£æêÚĽ½Ëö]ÃÚæVÚËêæ
əV©ËÄɆc½æɆVɚæËËÄÄæÄÚËõÚõ¬©¬ÞæËÚüɋc©¬Þ
õ¬½¬½¬æü¬ÞËÄĈÚÃü橽êæËËæ©ËÄÄæ¬ËĬËĬ½½êìÄæ¬Ä¤
ə½êɚ£æÚ½¬Äº¬Ä¤½êö©¬½ÞææÚü¬Ä¤æËËÄÄæɋ
Y£ÚæËæ©Xꬺ]æÚæ&ê¬Ä£Ë½½Ëöæ©×ÚËÃ×æÞö¬æ©¬Äæ©
ActaStim Sync app to complete connecting and extract compliance
and activity data.
Electrode Care and Replacement
If removing the electrode temporarily for any reason, replace the plastic backing material to
protect them. Before replacing them on the back, check to see that the surface is still clean and
tacky. If not, apply a few drops of water to the skin facing surface and gently rub into the gel to
help rehydrate. If this does not improve the surface properties, use a new pack of electrodes as
Þê××½¬ɋcü׬½½üɆÄöÞæË£½æÚËÞÃüÚÙê¬Ú£æÚ£öüÞË£êÞəǼɫȂɚɋ
When supplies of electrodes are running low, contact Customer Support at 1-800-901-5667
for additional supplies.
Cleaning Instructions
gÞÃ×½Ëæ©æ˽Äæ©ÞüÞæÃəû½ê¬Ä¤æ©½æÚËÞº¬Ä£¬Ä¤ÞêÚ£ÞɚɋËÄËæ
use detergents or other cleaning products.
15
6. STORAGE AND HANDLING
c©ÞüÞæÃÞ©Ëê½ÞæËÚ¬ÄÚü×½ææÃ×ÚæêÚÞÄ˽ËöÚæ©ÄɫǽȀʷəɫǼǾʷ%ɚÄ
ÄË©¬¤©Úæ©ÄȂǻʷəǼȀȃʷ%ɚɋ
7. DISPOSAL INSTRUCTIONS
When the prescribing physician determines that treatment is complete ActaStim-S should
be disposed of according to local statutes and regulations or returned to Theragen for
proper disposal. The battery is a lithium ion rechargeable battery.
Skin Irritation - Examine the skin for irritation when replacing the electrodes. If irritation is
present, relocate the electrodes adjacent to the original sites. The patient should be
evaluated periodically to assess the skin for sensitivity.
Bathing - Disconnect ActaStim-S during bathing, showering or swimming. It should be
reconnected as soon as practical following these activities. Either remove the electrodes, or
cover the electrodes with the protective retainer patches, during showering.
DIRECTIONS FOR USE
16
TECHNICAL & WARRANTY
8. CLINICAL INFORMATION
Evidence from a randomized, prospective cilnical study of a device that delivers the same
Þ¬¤Ä½Þ橬Þõ¬ə]׬ĽVºɆVȃȀǻǻǽǽɑ]ǻǻȄɚɆöÞêÞæËÞê××ËÚæ%××ÚËõ½Ë£æ©¬Þ
device.
.Äæ©æÞæêüɆǾǿȄÞê·æÞö©Ë©½êÃÚ£êÞ¬ËÄöÚÄÚ˽½ÄÞ×½¬æ¬ÄæËæöˤÚËê×Þɋ
JĤÚËê×Ú¬õæÚæÃÄæö¬æ©æ©]׬ĽVºəæ¬õɚɆÄæ©Ëæ©ÚöÞ¤¬õÄÄ
¬Äæ¬õõ¬ə×½Ëɚɋ£æÚǼǽÃËÄæ©ÞɆȃȂÞê·æÞəȂȄʥɚ¬Äæ©æ¬õæÚæÃÄæ¤ÚËê×
©¬õ½êÃÚ£êÞ¬ËÄɆËÃ×ÚæËȁǿÞê·æÞəȁǼʥɚ¬Äæ©×½Ë¤ÚËê×ɋ
J£æ©ǾǿȄÞê·æÞÄÚ˽½¬Ä橽¬Ä¬½ÞæêüÄö©ËêÞæ©õ¬æ½ÞæËÄɆ
ĬÄû×Ú¬ÄÞº¬Ä¬ÚÚ¬ææ¬ËÄĬæ橬ÞÞÚÞËÄæËö¬æ©Úö£ÚËÃæ©Þæêüəǽɋȁʥɚɋ
J£æ©ÞĬÄÞê·æÞɆ£ËêÚöÚ¬Äæ©æ¬õ¤ÚËê×ÄĈõöÚ¬Äæ©×½Ë¤ÚËê×ɋ
c©ÚËæ©ÚÞê·æÞö¬æ©Úö£ÚËÃæ©ÞæêüêÞË£õÚÞõÄæÞɅËÄ׽˩
öËêĬģæ¬ËÄəÄËÄɫõ¬Ú½æɚɐËÄ׽˩ºÞ×ÞÃÞɐÄɆËÄæ¬õöÞ
“not progressing”.
¬¤©æÞê·æÞö©ËËÃ×½ææ©Þæêüû×Ú¬ÄõÚÞõÄæÞɅ
əǼɚ ½¤×¬Äə×½Ëɚɐ
əǽɚ ÚêÚÚÄæ׬ÄêæËËõÚɫæ¬õ¬æüə×½Ëɚɐ
əǾɚ ×ËÞæɫÞêÚ¤¬½öËêÄÞÚËÃəæ¬õɚɐ
əǿɚ Þê×ÚĈ¬½öËêĬÞÚê×æ¬ËÄ£ÚËÃÞæ×½Úæ¬ËÄə×½Ëɚɐ
əȀɚ ׬½£ÚæêÚɫÞÚöÚÃËõə×½Ëɚɐ
əȁɚ ׬½ÞÚö×½ÃÄæəæ¬õɚɐ
əȂɚ ÄÄêÚüÞý¬×׬Ĥə×½ËɚɐÄ
əȃɚ ½êĽÄÚõÄêÚËÃæ橤ڣæÞ¬æəæ¬õɚɋ
c©Þ¬¤©æÞê·æÞËÄæ¬Äê¬Äæ©ÞæêüɆÄöڬĽê¬Äæ©ąæ¬õÄÞÞ
analyses.
17
9. TECHNICAL INFORMATION
Ùê¬×ÃÄæ½ÞÞ¬Ĉæ¬ËÄ
½ÞÞ¬Ĉæ¬ËÄɅ©Ú¤Úɫ½ÞÞ..Ɇ&ÄÚæËÚɪ.ÄæÚĽ½üVËöÚ
cü×××½¬VÚæÞɅcü×%ə½æÚËÞɆ&ÄÚæËÚ½ɚ
.VYæ¬Ä¤Ë£æ©]üÞæÃə&ÄÚæËÚɆææÚüɆ¤ÄÚæËÚ½Ɇ½æÚËÞɚɅ.Vǽǽö©ÚɅ
c©ĈÚÞæ©ÚæÚ¬Þæ¬ÄêÃڽˣǽÃÄÞËæ©Ʌ
•VÚËæ椬ÄÞæÞÞæË©āÚËêÞ×ÚæÞö¬æ©ĈĤÚ
•VÚËæ椬ÄÞæÞ˽¬£ËÚ¬¤ÄË·æÞË£ǼǽɆȀÃÃÓĤÚæÚ
c©ÞËÄ©ÚæÚ¬Þæ¬ÄêÃڽˣǽÃÄÞɅ
•Protected against vertically falling water drops when enclosure tilted up to 15°
CËË£Ë×Úæ¬ËÄɅËÄæ¬ÄêËêÞ
Output Waveform
ȁǻ;+āə×½êÞËÚìÄêÞǼǻʥɚÞ¬ÄêÞˬ½
ȀæËǼǻÃəÚɋÃɋÞɋɚæ¬Ã×ÄÞæöÄǼǻǻÄǿȀǻJ©ÃÞ
&ÚæÚæ©ÄǾÃəÚɋÃɋÞɋɚæ¬Ã×ÄÞæöÄǿȀǻJ©ÃÞÄȂȀǻJ©ÃÞ
18
Transport and Storage Conditions
ɫǽȀʷæËʏȀʷ
+5°C to +35°C at a relative humidity
ê×æËȄǻʥɆÄËÄɫËÄÄެĤɐ
ʕ ǾȀʷæËȂǻʷæöæÚõ×ËÚ
×ÚÞÞêÚê×æËȀǻ©V
Operating Conditions
ʏȀʷæËʏǿǻʷ
ǼȀæËȄǻʥ©êì¬æü
ȂǻǻæËǼǻȁǻ©V
Battery
c©Ú¤Ä×ɑÄɅǼǼǻǼɫǻǻǻǽ
r˽æ¤ɆÄËìĽɅǾɋȂr
׬æüɆÄËìĽɅǼɆȀȄǻé
Power Supply
CÄê£æêÚÚɅg..Ä
VɑDɅ]sCȁɫȀɫD+ɫǼǾȃ
.Ä×êæɅǼǻǻɫǽǿǻrɆǻɋȁɫǾɋǻɆȀǻɫȁǻ+ā
Jêæ×êæɅȀrɆǼɋǽ
TECHNICAL & WARRANTY
10. ELECTROMAGNETIC COMPATIBILITY
æ]æ¬Ãɫ]¬Þ¬ÄæÄ£ËÚêÞ¬Äæ©+ËÃ+½æ©ÚÄõ¬ÚËÄÃÄæəYÞæêÚÄæÞɆ£ÞɆ
Þ©Ë×ÞɆÞæËÚÞɆÃÚºæÞɆÞ©Ë˽ÞɆ©êÚ©ÞɆ½¬ÚÚ¬ÞɆËêæËËÚÞəÞæÚæÞɆÞ¬ö½ºÞɆ×ÚºÞɚɆ
Ë쬽Þə×ÚÃÄÄæËÚæÃ×ËÚÚüɚɆõ©¬½ÞɆÞææ¬ËÄÞɆ¬Ú×ËÚæÞɆÃêÞêÃÞÄæ©æÚÞɋ
.Äæ©ÞÄõ¬ÚËÄÃÄæÞæ©Ú¬ÞÄˬÄæ¬Ĉڬ޺ˣ½ËÞÞ¬ÄÞÞÄ欽×Ú£ËÚÃÄË£æ©
ActaStim-S device due to EM disturbances.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
WARNING:gÞË£ÞÞËÚ¬ÞĽÞËæ©Úæ©Äæ©ËÞÞ׬ĈËÚ×ÚËõ¬ü
Theragen of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Do not use unapproved components. Only use system components provided with the
system or obtained from the company as supplies or replacements.
WARNING: VËÚæ½Y%ËÃÃêĬæ¬ËÄÞÙê¬×ÃÄæə¬Ä½ê¬Ä¤×ڬשڽÞÞê©ÞÄæÄÄ
½ÞÄûæÚĽÄæÄÄÞɚÞ©Ëê½êÞÄ˽ËÞÚæ©ÄǾǻÃəǼǽ¬Ä©ÞɚæËÄü×Úæ
Ë£æ©æ]æ¬Ãɫ]ÞüÞæìĽê¬Ä¤½ÞÞ׬Ĉüc©Ú¤ÄɋJæ©Úö¬ÞɆ¤Úæ¬ËÄË£
the performance of this equipment could result.
TECHNICAL & WARRANTY
19
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Table of contents
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