Chattanooga VitalStim Plus User manual

VitalStim® Plus
Four Channel
Electrotherapy System
User Manual
Operator and
Installation
Instructions
Rx only

1
VitalStim® Plus Electrotherapy System
TABLE OF CONTENTS
INTRODUCTION ....................................2
FORWARD ...........................................2
PRECAUTIONARY INSTRUCTIONS ....................2
GENERAL TERMINOLOGY............................3
SYSTEM SOFTWARE SYMBOLS ......................3
DEVICE MARKINGS ..................................4
INDICATIONS FOR USE..............................5
ELECTROTHERAPY, sEMG AND sEMG TRIGGERED
STIMULATION .......................................5
DEVICE DESCRIPTION...............................7
PRODUCT DESCRIPTION ............................7
OPERATOR INTERFACE...............................8
GENERAL WARNINGS AND PRECAUTIONS ...........9
CAUTION NOTICES ..................................9
WARNING NOTICES.................................10
DANGER NOTICES ..................................11
DETAIL DEVICE DESCRIPTION ......................12
COMPONENTS .....................................12
JACK PANEL ........................................13
OPERATOR REMOTE SWITCH........................13
SETUP INSTRUCTIONS .............................14
THERAPY SYSTEM STARTUP........................14
SYSTEM SPECIFICATIONS ..........................15
SYSTEM SPECIFICATIONS AND DIMENSIONS .......15
POWER.............................................15
WAVEFORMS .......................................16
PATIENT PREPARATION ............................17
ELECTRODE PLACEMENT GENERAL.................17
VITALSTIM® ELECTRODES ..........................17
PATIENT PREPARATION .............................17
DEVICE USER INTERFACE...........................19
SCREEN DESCRIPTION ..............................19
HOME SCREEN .....................................20
UTILITIES AND OPTIONS ...........................21
TREATMENT SCREENS ..............................22
ELECTROTHERAPY OPERATION VITALSTIM,VMS ...23
sEMG OPERATION ..................................24
sEMG+VMS OPERATION.............................27
PATIENT DATA ......................................29
RESOURCE LIBRARY................................31
TROUBLESHOOTING...............................32
TROUBLESHOOTING................................32
ACCESSORIES .....................................33
REPLACEMENT ACCESSORIES.......................33
INTERNATIONAL ORDERING INFORMATION ........34
MAINTENANCE ....................................35
CLEANING THE VITALSTIM PLUS ....................35
CALIBRATION REQUIREMENTS......................35
EXPECTED DEVICE LIVE AND DISPOSAL.............35
INSTRUCTION FOR SOFTWARE UPGRADE ..........35
COPY OF MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
SERVICE AND WARRANTY..........................36
WARRANTY REPAIR/OUT OF WARRANTY REPAIR ....36
WARRANTY.........................................37
APPENDIX 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
ELECTROMAGNETIC COMPATIBILITY EMC .........38
ELECTROMAGNETIC COMPATIBILITY EMC TABLES . 39

2
VitalStim® Plus Electrotherapy System
This manual is intended for users of VitalStim® Plus
Electrotherapy System. It contains general information
on operation, precautionary practices, and maintenance.
In order to maximize use, eciency, and the life of the
system, please read this manual thoroughly and become
familiar with the controls, as well as the accessories before
operating the system.
Specications put forth in this manual were in eect at
the time of publication. However, owing to DJO’s policy of
continual improvement, changes to these specications
may be made at any time without notication on the part
of DJO.
Before administering any treatment to a patient, the
users of this equipment should read, understand and
follow the information contained in this manual for each
mode of treatment available, as well as the indications,
contraindications, warnings and precautions. Consult
other resources for additional information regarding the
application of electrotherapy.
FOREWORD
NOTE: Throughout this manual, “NOTE”indicators provide
helpful information regarding the particular area of
function being described.
CAUTION
Text with a “CAUTION”indicator explains possible
safety infractions that have potential to cause minor or
moderate injury or damage to the equipment.
Text with a “WARNING”indicator explains possible safety
infractions that will potentially cause serious injury and
equipment damage.
Text with a “DANGER”indicator will explain possible safety
infractions that are imminently hazardous situations that
would result in death or serious injury.
The precautionary instructions found in this section and
throughout this manual are indicated by specic symbols.
Understand these symbols and their denitions before
operating this equipment. The denitions of these symbols
are as follows:
PRECAUTIONARY INSTRUCTIONS
WARNING
DANGER
INTRODUCTION

3
VitalStim® Plus Electrotherapy System INTRODUCTION
GENERAL TERMINOLOGY
The following are denitions for the terminology used throughout this manual. Study these terms to become familiar
with them for ease of system operation and control functionality of the VitalStim® Plus Electrotherapy System.
SYSTEM SOFTWARE SYMBOLS
VitalStim
VMS
sEMG
sEMG+VMS
Electrode Placement
Modality Description
Custom Protocols
Patient Data
Anatomical Library
Utilities
Back Arrow/Previous Screen
Forward Arrow/ Next Screen
Increase/Decrease Parameter
Scroll Up or Down in a text box
Select
Customize
Micro SD Card indicator
Hand switch indicator
Battery voltage level indicator
Bluetooth connection indicator

4
VitalStim® Plus Electrotherapy System
INTRODUCTION
DESCRIPTION OF DEVICE MARKINGS
The markings on the unit are assurance of its conformity to the highest
applicable standards of medical equipment safety and electromagnetic
compatibility. One or more of the following markings may appear on the
device:
Refer to Instructional Manual Booklet ............................
Neuromuscular Stimulation (STIM) and sEMG +Stimulation
should not be used by Patients tted with demand style cardiac
pacemakers...................................................
Testing Agency ...............................................
Electrical Type BF ..............................................
ON/OFF .......................................................
Remote Switch Jack.............................................
sEMG Reference Jack ............................................REF
Output channel Jack ............................................Ch
Back ..........................................................
Resource Library................................................
Home.........................................................
Manufacturer ’s Catalog Number for the Device..................... REF
Manufacturer ’s LOT/Batch Number...............................
Manufacturer ’s Serial Number of the Unit .........................
Name and address of Manufacturer ...............................
Date of Manufacture ............................................
Keep Dry ......................................................
Protection against ingress of solid foreign objects of 12.5mm and
greater ....................................................... IP20
Do not dispose in normal dustbin (see page 35 for instructions) .......

5
VitalStim® Plus Electrotherapy System
Indications
For VMS™ - VitalStim Waveforms and sEMG Triggered
Stimulation.
• Muscle re-education by application of external
stimulation to the muscles necessary for pharyngeal
contraction.
Intended Uses- VMS™ Waveform
VMS waveform is a square symmetrical biphasic waveform
with the application for use on the musculature of the
face.
The intended uses are:
Optional application of sEMG biofeedback with
Muscle Stimulation VMS™ waveform for prevention or
retardation of disuse atrophy, for muscle re-education,
and for relaxation of muscle spasms in the treatment of
swallowing musculature dysfunction in post-traumatic
conditions or after neurological insult with impaired
neuromuscular function.
Intended Uses- VitalStim Waveform
VitalStim waveform is a square symmetrical biphasic
waveform with interphase interval pulse with the
application for use on the swallowing musculature in the
anterior portion of the neck.
The intended uses are:
The VitalStim waveform intended uses are muscle re-
education of the swallowing musculature in the treatment
of dysphagia (swallowing problems) from any etiology
except mechanical causes that would need surgical
intervention (for instance, obstructing tumors). Non-
mechanical causes of dysphagia include: neurological and
muscle disorders; cardiovascular accidents; respiratory
disorders with swallowing complications; latrogenic
conditions (conditions caused by surgery); brosis/
stenosis arising from radiation; disuse due to stroke,
intubation, or birth-related anoxic injuries; and trauma
to the head and neck. This device is a prescription device
intended for use by or on the order of a physician or other
licensed health professional.
Intended Uses- Surface EMG
sEMG is surface biofeedback for use on the swallowing
musculature of the face and/or anterior portion of the
neck. The intended uses are:
The sEMG intended uses are surface electromyography
biofeedback for relaxation training and muscle re-
education.
Contraindications
The VitalStim® Plus Electrotherapy System should NOT be
used under the following conditions:
• This device should not be used when cancerous
lesions are present in the treatment area.
• Stimulation should not be applied over swollen,
infected, inflamed areas or skin eruptions, e.g.,
phlebitis, thrombophlebitis, varicose veins, etc.
• This device should be used with caution on patients
with cardiac demand pacemakers or other implanted
electronic devices.
• Stimulation should not be applied over the carotid
sinus nerve particularly in patients with a known
sensitivity to the carotid sinus reflex.
• Other contraindications are patients with the
following:
- who are severely demented and exhibit non-stop
verbalization. Constant verbalization could result in
aspiration during trials of oral intake.
- with significant reflux due to use of a feeding
tube. Such patients are prone to repeated cases of
aspiration pneumonia, and the device has not been
studied in this population.
- with dysphagia due to drug toxicity. Patients
suffering from drug toxicity could aspirate during
trials of oral intake.
- undiagnosed syndromes or until etiology is
established.
- carrying serious infectious disease and/or disease
where it is advisable, for general medical purposes,
to suppress heat or fevers.
• Safety has not been established for the use of
therapeutic electrical stimulation during pregnancy.
ELECTROTHERAPY, sEMG+VMS INDICATIONS
INDICATIONS FOR USE

6
VitalStim® Plus Electrotherapy System
INDICATIONS FOR USE
Additional Precautions
• Caution should be used for patients with suspected
or diagnosed epilepsy
• Caution should be used for patients with suspected
or diagnosed heart problems
• Caution should be used in the presence of the
following:
- When there is a tendency to hemorrhage
following acute trauma or fracture
- Following recent surgical procedures when
muscle contraction may disrupt the healing
process
- Over areas of the skin that lack normal sensation
• Some patients may experience skin irritation or
hypersensitivity due to the electrical stimulation
or electrical conductive medium. The irritation can
usually be reduced by using an alternative conductive
medium or an alternative electrode placement.
• Electrode placement and stimulation settings
should be based on the guidance of the prescribing
practitioner
• Powered muscle stimulators should be used only with
the lead wires and electrodes recommended for use
by the manufacturer
• Isolated cases of skin irritation may occur at the site of
electrode placement following long term application
• The effective management of dysphagia by NMES
waveforms is highly dependent upon patient
selection by a person qualified in the management of
dysphagia
Adverse Eects
• Skin irritation and burns beneath the electrodes
have been reported with the use of powered muscle
stimulators

7
VitalStim® Plus Electrotherapy System DEVICE DESCRIPTION
PRODUCT DESCRIPTION
The VitalStim® Plus Electrotherapy System is a 2 Channel
sEMG and 4 Channel electrotherapy system used in
treating patients with oral-pharyngeal dysfunctions
(dysphagia) and disorders of the head and neck, with
Bluetooth connection to PC software.
To maximize functionality and life of VitalStim® Plus
Electrotherapy System, be sure to:
• Stay current with the latest clinical developments
in the field of electrotherapy, sEMG (Surface
Electromyography), sEMG + Stim (Surface
Electromyography with Triggered Stimulation) and
VitalStim therapy.
• Observe all applicable precautionary measures for
treatment.
NOTE: This equipment is to be used only under the
prescription and supervision of a licensed medical
practitioner.

8
VitalStim® Plus Electrotherapy System
DEVICE DESCRIPTION
OPERATOR INTERFACE
1. Color Display
2. BACK button
3. HOME button
4. Clinical Resource Library button
5. ON/OFF button
6. STOP button
7. START/PAUSE button
8. Ch1,Ch2,Ch3,Ch4 intensity buttons
9. Ch3 Lead Wire Connector (STIM)
10. Ch4 Lead Wire Connector (STIM)
11. Operator Remote Switch Connector
12. Ch2 Lead Wire Connector (sEMG or STIM)
13. Ch1 Lead Wire Connector (sEMG or STIM)
14. sEMG Reference Lead Wire Connector
15. Concealed button
16. Battery Compartment (Cover Removed)
17. Micro SD Card Slot
Front Controls
Micro SD card slot
Front Panel and Battery Compartment
VitalStim® Plus Electrotherapy System Operator Interface
contains all the functions and controls necessary for
operator access to all operator utilities, modalities, and
parameters for modication and system set up.
1
3
4
5
9
16
15
10
11
6
7
8
12
13
14
17
2

9
VitalStim® Plus Electrotherapy System GENERAL WARNINGS AND PRECAUTIONS
• Read, understand, and practice the precautionary and operating instructions.
Know the limitations and hazards associated with using any electrical
stimulation. Observe the precautionary and operational decals placed on the
unit.
• DO NOT operate this unit when connected to any accessories other than DJO
accessories specifically described in user or service manuals.
• DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the
buttons on the keypad.
• DO NOT disassemble, modify, or remodel the unit or accessories. This may cause
unit damage, malfunction, electrical shock, or personal injury.
• DO NOT permit foreign materials, liquids or cleaning agents to enter the unit,
including, but not limited to, inflammables, water, and metallic objects from
entering the unit, to prevent unit damage, malfunction, electrical shock, fire, or
personal injury.
• DO NOT operate theVitalStim Plus Electrotherapy System within the vicinity or
environment as any therapeutic microwave or RF shortwave diathermy system in
operation.
• Device is designed to comply with electromagnetic safety standards. However,
there is no guarantee that interference will not occur in a particular installation.
Harmful interference to other devices can be determined by turning this
equipment on and off.
• Inspect cables, lead wires and associated connectors before each use.
• This unit should be operated at 5°C to 40°C and 15% to 93% Relative Humidity.
The unit should be transported and stored at -25°C to 70°C and 0% to 90%
Relative Humidity.
• Place the patient in a comfortable position during VitalStim therapy session.
• Failure to use and maintain theVitalStim® Plus Electrotherapy System, and its
accessories in accordance with the instructions outlined in this manual will
invalidate the warranty.
• If you have difficulty operating the unit after carefully reviewing this user
manual, contact DJO or authorized DJO distributor for assistance.
• Use of parts or materials other than DJO’s can degrade minimum safety.
• Safe use of electrotherapy during pregnancy has not been established.
• Caution should be used for patients with suspected or diagnosed heart problems.
• Caution should be used for patients with suspected or diagnosed epilepsy.
• Caution should be used in the presence of a tendency to hemorrhage following
acute trauma or fracture, following recent surgical procedures when muscle
contraction may disrupt the healing process and over areas of skin which lack
normal sensation.
• Some patients may experience skin irritation or hypersensitivity due to electrical
stimulation or electrical conductive medium. The irritation can usually be
reduced by moistening the skin, using an alternative conductive medium or
electrode placement.
•
CAUTION CAUTION
• Inspect lead wires and associated connectors for signs of damage before each
use. Replace damaged lead wires immediately with new before any treatment is
applied.
• Electrode placement and stimulation settings should be based on the guidance
of the prescribing practitioner or other licensed health professional.
• Portable powered muscle stimulators should not be used while driving,
operating machinery, or during any activity in which involuntary muscle
contractions may put the user at undue risk of injury.
• Always check the stimulation controls before treating a patient.The stimulation
amplitude/intensity should always be adjusted gradually.

10
VitalStim® Plus Electrotherapy System
GENERAL WARNINGS AND PRECAUTIONS
• U.S.A. Federal Law restricts these devices to sale by, or on the order of, a
physician or licensed practitioner. This device should be used only under the
continued supervision of a physician or licensed practitioner.
• Be sure to read all instructions for operation before treating patient.
• Care must be taken when operating this equipment around other equipment.
Potential electromagnetic or other interference could occur to this or to the other
equipment.Try to minimize this interference by not using other equipment in
conjunction with it.
• Electronic monitoring equipment (such as ECG monitors and ECG alarms) may
not operate properly when electrical stimulation is in use.
• Do not drop the unit on hard surfaces or submerge in water. These actions will
damage the unit. Damage resulting from these conditions is not covered under
the warranty.
• This device should be kept out of the reach of children.
• Use only cables and accessories that are specially designed for theVitalStim® Plus
unit. Do not use accessories manufactured by other companies on the VitalStim®
Plus unit. DJO is not responsible for any consequence resulting from using
products manufactured by other companies. The use of other accessories or
cables may result in increased emissions or decreased immunity of theVitalStim®
Plus unit.
• Contaminated electrodes, lead wires, and gel can lead to infection.
• Use of electrode with degraded hydrogel can result in burn to the skin.
• DO NOT operate this unit in an environment where other devices are being used
that intentionally radiate electromagnetic energy in an unshielded manner.
• Use of electrode on multiple patients can lead to infection.
• Stop treatment immediately if patient experiences discomfort or pain.
• Long term effects of chronic electrical stimulation are unknown.
• Stimulation should not be applied transcerebrally.
• Stimulation should not be applied over swollen, infected, and inflamed areas or
skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
• Stimulation should not be applied over, or in proximity
to, cancerous lesions.
• Using the supplied stimulation electrodes, the current density will not exceed
2mA/cm2. Using smaller electrodes or needle electrodes may lead to current
density greater than 2mA/cm2. In such cases, special caution is to be exercised
when adjusting the current level as too high values may cause skin irritation or
possibly burns. Consult the Electrode Current Density table in Appendix 3.
• TheVitalStim® Plus Electrotherapy System optional accessories are designed for
use only with the VitalStim® Plus Electrotherapy System.
• Medical electrical equipment needs special precautions regarding EMC. Portable
and mobile RF communication equipment can be affected by other medical
electrical devices. If you believe interference is occurring, please consult page 38,
Electromagnetic Compatibility, to assist in removing the interference.
• Common RF emitting devices (e.g., RFID) and electromagnetic security systems
(e.g., metal detectors) may interfere with the operation of theVitalStim® Plus
Electrotherapy System. TheVitalStim® Plus Electrotherapy System has been
tested in the presence of these types of devices and while no adverse event
occurred, the device should not be operated within the vicinity or environment
as another RF emitting device.
WARNING
• Powered muscle stimulators should be used only with the leads and electrodes
recommended for use by the manufacturer.
• Before administering any treatment to a patient you should become acquainted
with the operating procedures for each mode of treatment available, as well as
the indications, contraindications, warnings and precautions. Consult other
resources for additional information regarding the application of each mode of
treatment.
• Simultaneous connection of a patient to high frequency surgical equipment may
result in burns at the site of the stimulator electrodes and possible damage to
the stimulator.
• Keep electrodes separated during treatment. Electrodes in contact with each
other could result in improper stimulation or skin burns.
• Electrodes should be inspected before each use for resistance. (i.e. hydration
level, tack, discoloration and impurities) Follow the manufacturing guidelines on
electrode packaging.
• Long term effects of chronic electrical stimulation are unknown.
• Any patient may be treated with theVitalStim® Plus Electrotherapy System.
Extra care should be taken when this unit is used with children.
WARNING

11
VitalStim® Plus Electrotherapy System GENERAL WARNINGS AND PRECAUTIONS
• Stimulation should not be applied over the carotid sinus
particularly in patients with a known sensitivity to the
carotid sinus reflex.
• Use only electrodes and accessories designed specifically
for use with the VitalStim® Plus Electrotherapy System. Use
of other accessories and/or techniques not approved
under the VitalStim® Plus certification training may result
in death, injury, or adverse effects to patient or
undesirable and ineffective results.
DANGER

12
VitalStim® Plus Electrotherapy System
DETAIL DEVICE DESCRIPTION
The components of the VitalStim® Plus
Electrotherapy System are shown below.
COMPONENTS
Rubber Sleeve
Stand
Stylus
Lead wires
The available lead wires are shown below. Package
includes:
Blue Channel 1 lead wire
Green Channel 2 lead wire,
Orange Channel 3 lead wire
Cranberry Channel 4 lead wire
White sEMG reference Channel lead wire
Lead wire Clips (attached to lead wire)
Operator Remote Switch

13
VitalStim® Plus Electrotherapy System DETAIL DEVICE DESCRIPTION
JACK PANEL OPERATOR REMOTE SWITCH
1
2
3
4
5
6
1. Channel 1 (sEMG or Stimulation)
2. Channel 2 (sEMG or Stimulation)
3. sEMG Reference Channel
NOTE: Always use Reference wire (REF) with electrode
attached to body for precise sEMG measurement!
4. Remote Switch Connection
5. Channel 3 (Stimulation)
6. Channel 4 (Stimulation)
To operate the Patient Remote Switch, plug the remote
into the device on the Jack Panel, as shown below:
Once the switch is plugged into the device the switch
icon visible in the title line will turn from gray (not
connected) to white (connected)
• Operator Remote Switch to be used under supervision
of a physician or certified VitalStim user only.
CAUTION
After connecting the electrodes and setting up VitalStim
or VMS, complete the following steps to activate
Operator Remote Switch (activated switch indicated by
blue icon):
1. Connect Remote Control
2. Select the stimulation channel and adjust intensity
to desired level
3. Press and Release Remote Control button to activate
Manual Mode. Intensity will decrease to 0 mA
4. To start stimulation, press and hold the Remote
Control button
5. To stop stimulation, release the button
6. To adjust intensity level, press and hold the remote
control button while increasing or decreasing
intensity.

14
VitalStim® Plus Electrotherapy System
SETUP INSTRUCTIONS
Complete the following steps for initial setup of the
VitalStim® Plus Electrotherapy System:
1. Remove battery cover, insert batteries following
mode of insertion defined inside the compartment,
place back the cover.
NOTE: Battery cover should be closed prior to
turning the device ON.
2. Press the ON/OFF button located on the front of the
device:
THERAPY SYSTEM STARTUP
3. Select desired function on the Home Screen (shown
below).

15
VitalStim® Plus Electrotherapy System SYSTEM SPECIFICATIONS
Width...................................................3.8”(9.6 cm)
Depth...................................................1.4”(3.6 cm)
Height .................................................. 6.2”(16 cm)
Weight............................................... 0.75 lb (0.34kg)
POWER
Input ..................................... 6V (4x1.5V AA battery cells)
Max. Output Voltage(Patient) .............................70V (+0/-5V)
Mode of Operation......................................... Continuous
Output Intensity
The is theoretical standard measurement output current across purely resistive
loads at maximum intensity setting. PulseWidth and current measured as
shown across 2.8 kOhm loads. This measurements is also valid on a 500 Ohm
load, as theVitalStim® Plus is current controlled device. Any load between 500
Ohms and 2.8 kOhm will not aect the output measurements.Your output may
vary depending on parameter settings.
VitalStim® Waveform
Maximum Intensity: 25mA
Zero net DC component
Maximum charge per pulse: 7.5 µC
Electrical Type (Degree of Protection)
Electrotherapy & sEMG ....................................TYPE BF
NOTE: VMS™, VitalStim waveform output intensities are measured, specied,
and listed to peak, not peak to peak.
SYSTEM SPECIFICATIONS AND DIMENSIONS
GENERAL SYSTEM OPERATING AND STORAGE
TEMPERATURE
Operating conditions
The device will meet its requirement under the following conditions:
Temperature: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... 5° C to 40° C
Relative Humidity: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....15% to 95%
Atmospheric Pressure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 700hPa to 1060hPa
Transport and storage conditions
The device will remain in proper condition under the following conditions:
Temperature: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .-25° C to 70° C
Relative Humidity: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . max 90%
Atmospheric Pressure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 700hPa to 1060hPa

16
VitalStim® Plus Electrotherapy System
SYSTEM SPECIFICATIONS
WAVEFORMS
sEMG
VMS™
VMS is a symmetrical biphasic waveform with a 100 µsec interphase interval.
Because the pulse is relatively short, the waveform has a low skin load,
making it suitable for applications requiring high intensities, such as in muscle
strengthening protocols.
Output Mode ..............................................Electrodes
Output Intensity.............................0-25 mA (Constant Current)
Channel Mode .......................Continuous, Reciprocal, Co-Contract
Phase Duration.............................60-300 µsec (10 % accuracy)
Set Intensity .........................Individual Channel Intensity Setting
Cycle Time . . . . . . . . . . . . . . . . . . . . . . . . User Dened (ON time/OFF time 1-99s)
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-80 pps (5 % accuracy)
Ramp Up/Ramp Down .........................................0-3 sec
Treatment Time ............................................1-240 min
Available on Channels ...................................... 1, 2, 3, or 4
sEMG
sEMG reads and records the sEMG biofeedback activity of a muscle or muscle
group by sensing the electrical impulses generated during a voluntary muscle
contraction and relax cycle.
sEMG Range ............................0.2 to 2000 µV RMS (continuous)
Sensitivity ................................................0.1 µV RMS
Accuracy .................................. 6% of µV reading +/- 0.3 µV
Selectable Bandpass lter (3db Bandwidth)
Heart Beat Filter OFF
Reading below 235 µV ............... 18 Hz +/- 4 Hz to 370 Hz +/- 10%
Reading above 235 µV ............... 10 Hz +/- 3 Hz to 370 Hz +/- 10%
Heart Beat Filter On .............. 100 Hz +/- 5 Hz to 370 Hz +/- 10%
Notch Filter ..............................50 Hz - 33 dbs (0. 1% accuracy)
Common Mode Rejection Ratio .................130 dbs Minimum at 50 Hz
Available on Channels ..................................... 1 or 1 and 2
VitalStim™
VitalStim is a symmetrical square biphasic waveform with a 100 μs interphase
interval pulse with the application for use on the swallowing musculature in
the anterior portion of the neck.
Output Mode ..............................................Electrodes
Output Intensity.............................0-25 mA (Constant Current)
Channel Mode ............................................Co-Contract
Phase Duration................................300 µsec (10 % accuracy)
Set Intensity .........................Individual Channel Intensity Setting
Cycle Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ON time 57s , OFF time 1s
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 pps (5 % accuracy)
Ramp Up/Ramp Down ...........................................2 sec
Treatment Time ...............................................60 min
Available on Channels ...................................... 1, 2, 3, or 4

17
VitalStim® Plus Electrotherapy System
ELECTRODE PLACEMENT GENERAL
• Examine the skin for any wounds and clean the skin
• Apply the electrodes to the treatment area
• Ensure the electrodes are applied securely to the skin
• Ensure good contact between each electrode and the
skin
• Check the electrode contact regularly during the
treatment
• Examine the skin again after the treatment
• View the Electrode Placement recommendations in
the Treatment Review screen as a reference point only
prior to administering treatment
• Follow electrode manufacturer instructions
VitalStim® ELECTRODES
VitalStim® Electrodes are a self adhesive, disposable ,
electrodes designed specically for use with VitalStim®
Plus Electrotherapy System.
For reordering of the electrodes , refer to page 33.
PATIENT PREPARATION
PATIENT PREPARATION
Install VitalStim® Electrodes
1. Connect lead wires to VitalStim® Electrodes.
2. Leave protective backing on electrodes until
treatment area has been prepared.
Electrode Placement Guidance (as needed)
1. From the Home Screen, select desired modality
• VitalStim (Ch 1, 2, 3 and/or 4)
• VMS (Ch 1, 2, 3 and/or 4)
• sEMG (Ch 1 and /or 2)
• sEMG + Stim VMS (sEMG in Ch 1 and/or 2; Stim in Ch
1, 2, 3 and/or 4)
2. Select Electrode Placement icon
Connect the Lead wires.
1. Connect the lead wire(s) to the appropriate port(s) on
the device.
2. Press the“Back Arrow”button/icon to return to
desired screen.
3. Examine the skin for any wounds.

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VitalStim® Plus Electrotherapy System
4. Thoroughly cleanse the skin treating area. Open
the packet of electrodes and remove the Clean-
Cote® skin wipe. Apply the wipe to the skin area
where the electrodes will be positioned and allow
approximately 30 seconds for the area to dry. Discard
the wipe after use.
NOTE: Thorough cleaning of the treatment area to
remove any topical medication and cream film as
well as loose skin particles from the treatment area
is essential to obtain good skin contact and ensure
good conductivity during sEMG and sEMG + Stim
therapy.
Electrode Placement
1. Apply the electrode to the appropriate skin area or
as instructed at your VitalStim therapy certification
program.
2. Attach the lead wire strain relief clips to the patient’s
clothing in a position that allows ease of movement
and adequate strain relief for the lead wire.
For sEMG and sEMG + Electrical Stimulation OPERATION,
refer to page 24-28.
PATIENT PREPARATION CONTINUED
• Do not apply to broken skin
• Single patient use only
CAUTION
PATIENT PREPARATION

19
VitalStim® Plus Electrotherapy System DEVICE USER INTERFACE
SCREEN DESCRIPTION
Each screen contains the following areas:
Title Bar
Located at the top of each screen and lists the current
screen and previous screens back to the Home screen.
It also contains a SD card in Icon, Patient Remote Switch
status icon, Bluetooth connectivity and battery level icon.
Main Area
Located under the Title Bar, this area displays icons unique
to the current screen.
Channel Area
Located at the bottom of each screen, this screen displays
the following status information about each channel:
n/a: Indicates the channel is not (yet) available to be
selected
Available: Indicates the channel is available for use
Running: Indicates a treatment for the channel is
currently running
Paused: Indicates a treatment is currently paused
No contact: indicates open circuit which could be
caused due to poor electrode contact or fault with
lead wires being damaged or not connected properly
The image below shows the Home screen with modality
and resource icons.
Title Bar
Main Area
Channels