PowerDot PD-02 Operator Instructions Manual

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PowerDot PD-02 Muscle Stimulator

Operator’s Instructions For Use

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INTENDED USE

PowerDot PD-02 uses electrical muscle stimulation (EMS) (also known as neuromuscular electrical
stimulation or NMES) and transcutaneous electrical nerve stimulation (TENS) technologies to stimulate your
muscles and nerves for therapeutic purposes.

For your convenience, you can operate PowerDot PD-02 wirelessly using PowerDot Doctor mobile
application running from your iPad. Additionally, you can also prescribe/schedule certain stimulation
programs for your pa ti ent s to be ex ec ute d by th em in the ir home environment using PowerDot Patient mobile
application from their iOS or Android mobile devices.

Indications for Use

PowerDot PD-02 stimulator is a prescription device which is intended to be used following the directions of a
healthcare provider. The device can be either used by the therapist in healthcare facility setting (when
operated from PowerDot Doctor mobile application) or by patient/lay operator in a home environment (when
operated from PowerDot Patient mobile application).

PowerDot PD-02 has the following indications for use:

NMES

- Retarding or preventing disuse atrophy

- Maintaining or increasing range of motion

- Re-educating muscles

- Relaxation of muscle spasms

- Increasing local blood circulation

- Prevention of venous thrombosis of the calf muscles immediately after surgery

- Stimulation of healthy muscles in order to improve or facilitate muscle performance

TENS

- Symptomatic relief and management of chronic, intractable pain

- Post-surgical and post-trauma acute pain

- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or

normal household and work activities

Caution: Federal law restricts this device to sale by or on the order of a practitioner licensed
by the law of the State in which he/she practices to use or order the use of the device.

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Safety Guidelines

1. Counter-indications

Do NOT use PowerDot PD-02 for the patients with the following conditions:

 Cardiac stimulator (pacemaker), implanted defibrillator or other implanted electronic device. Such use

could cause electric shock, burns, electrical interference or death.

 Body-worn electro mechanical medical devices, i.e. insulin pump.
 Serious arterial circulation problems in lower limbs.
 Abdominal or inguinal hernia
 Symptomatic local pain relief unless etiology is established or pain syndrome has been diagnosed
 Cardiac arrhythmia (do not use on chest)

2. Additional Precautions

 Use caution for patients with suspected or diagnosed heart problems
 Use caution for patients with suspected or diagnosed epilepsy
 Use caution in the presence of the following:

- when there is a tendency to hemorrhage following acute trauma or fracture

- following recent surgical procedure when muscle contraction may disrupt the healing process

- over a menstruating or pregnant uterus

- over the skin areas which lack normal sensation

 Depending on the judgement of the responsible physician, the device may only be applied under supervision and with

the parameters defined by the responsible physician. Otherwise the exercise may be too strenuous for the patients with:

- hypertension (> stage 2), ischemic heart disease and cerebrovascular diseases

- cardiovascular diseases

- pregnancy. Safety of powered muscle stimulators for use during pregnancy has not been established.

- under 16 years of age

 Proceed with caution after recent surgery
 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 alternate conductive medium, or alternate electrode placement

3. Adverse Effects

- Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.

- Potential adverse effects with TENS are skin irritation and electrode burns.

4. General Safety Measures

 Read all instructions for operation before treating a patient.
 The long-term effects of chronic electrical stimulation are unknown.


TENS is not effective for pain of central origin (including headache).

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 TENS waveforms have no curative value.
 TENS is a symptomatic treatment, and as such, suppresses the sensation of pain which would otherwise serve as a

protective mechanism.

 Stop treatment immediately if patient experiences discomfort or pain.
 The choice of the therapy parameters to program, of the stimulation programs and electrode placement is restricted to

the responsible physician or therapist. It is the physician’s or therapist’s decision whether or not to use the device on a
specific patient.

 Do not apply stimulation if you patient has progressive cancer or near any cancerous tumour. The increased metabolism,

caused by certain modes of stimulation, is likely to encourage cancer cells to spread.

 Proceed with caution if stimulation is applied to areas of the skin whose level of sensation is lower than normal.
 Do not apply stimulation to a person who cannot express themselves.

 Stimulators should be kept out of the reach of children

5. Device Operating Safety Measures

 Do not charge PowerDot PD-02 device while the device remains placed on/attached to any part of the pa tient’s body.

 The patient must be familiar with the ways to terminate their stimulation session, if needed. Patients unable to operate

the emergency stop function (either by pressing button on the device or by unplugging lead cables from the device), e.g.
paralytic patients, must never be left unattended during therapy.

 During the muscular contraction phase it is recommended to hold the extremities of the stimulated limbs to avoid any

shortening of the muscle during contraction, which could cause cramps.

 Never begin an initial stimulation session on a person who is standing. The first five minutes of stimulation must

always be performed on a person who is sitting or lying down. In rare instances, people of a nervous disposition may
experience a vasovagal reaction. This is of psychological origin and is connected with a fear of the muscle stimulation
as well as surprise at seeing one of their muscles contract without having intentionally contracted it themselves. A
vasovagal reaction causes heart to slow down and blood pressure to drop, which produces a feeling weakness and a
tendency towards fainting. If this does occur, all that is required is to stop the stimulation and for the person to lie down
with the legs raised until the feeling of weakness disappears (5 to 10 minutes).

 Do not wind cables around the neck. Tangled cables can cause strangulation.
 Do not apply stimulation during sleep.
 Do not use PowerDot PD-02 while driving, operating machinery, or during any activity in which involuntary muscle

contractions may put the patient at undue risk of injury.

6. Co-existence and Environmental Safety Measures

 Do not use PowerDot PD-02 in the areas where an explosion hazard may occur. An explosion hazard may result from

the use of flammable anesthetics, skin cleansing agents and disinfectants as well as in the oxygen-rich environments.

 Do not use device in water or in a humid atmosphere (sauna, bath, shower etc.) that would cause electr ical failure.

 Do not use PowerDot PD-02 at altitudes of over 9,800 feet.

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 Do not use PowerDot PD-02 if patient is connected to a high-frequency surgical instrument as this could cause skin

irritations or burns under the electrodes.

 Do not use PowerDot PD-02 in the close proximity of medical devices such as MRI, CT, diathermy, X-Ray as well as

RFID equipment (e.g. electromagnetic security systems) as those could alter the current generated by PowerDot PD-02,
cause tissue damage, and can result in severe injury or death. If you have any doubts when using PowerDot PD-02
device in close proximity to another medical device, please contact the device manufacturer.

 Do not use the PowerDot PD-02 within 3 feet of short wave or microwave devices as this could alter the currents

generated by the stimulator. If you are in any doubt as to the use of the stimulator in close proximity to another medical
device, seek advice from the manufacturer.

 Do not apply stimulation with PowerDot PD-02 near the area of an implant, such as cochlear implants, pacemakers,

skeletal anchorage or electric implants. This could cause an electrical shock, burns, electrical interference or death.

 Do not apply stimulation with PowerDot PD-02 close to metal. Rem ove jewelry, pierc ings, belt buckles or any other

metallic product or device in the area of stimulation.

• Disconnect the electrode pads from the device before using electrosurgical equipment, or a defibrillator, to avoid

cutaneous burns from the electrodes and destroying the device.

• Apply caution when using PowerDot PD-02 near electronic surveillance equipment (e.g. cardiac monitors, ECG

alarms), as there is a risk they may not work properly whilst the electrical stimulation device is being used.

• Do not use PowerDot PD-02 in areas in which unprotected devices are used to emit electromagnetic radiation. Portable

communications equipment can interfere with the device.

7. Electrode Pads Placements Safety

NEVER attach electrodes:

• Transcerebrally, or on the eyes

• On the front and sides of the patient’s neck or mouth because this could cause severe muscle spasms resulting in closure

of your airway, difficulty in breathing, or adverse effects on heart rhythm or blood pressure

• Stimulation should not be applied over the carotid sinus nerve particularly in patients with a known sensitivity to the
carotid sinus reflex.

• Counter-laterally, i.e. one stimulator should not be applied on opposite sides of the body.

• Transthoratically, to the patient’s front torso (i.e. chest or abs) and back torso (i.e. upper back, lower back)

simultaneously. Introduction of electrical current into the heart may cause cardiac arrhythmia.

• Over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis,
thrombophlebitis, varicose veins)

• Over, or in proximity to, cancerous lesions

8. General Electrode Pads Safety Measures

 Always use electrode pads supplied by the manufacturer. Other electrodes may have electrical properties that are

unsuitable for or may cause damage.

 For best results, wash and clean the s kin of any oil and dry it before attaching the elec trode pads.

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 For reasons of hygiene, each patient must have their own set of electrode pads. Do not use the same electrodes on

different patients.

 Contaminated electrode pads or hydrogel can lead to infection.

• Use of electrode pads with degraded hydrogel can result in burns to the skin.

• Do not place the electrode pads in water.

• Do not apply solvents of any kind to the electrode pads.

 Always stop the stimulation before moving or removing any electrode pads during a session, to avoid electrical shock to

the patient.

 Attach the electrode pads in such a way that their entire surface is in contact with the skin.

• 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 alternate conductive medium, or alternate electrode pad
placement. If redness of the skin is observed under the electrode pad, do not start another stimulation session on the same
area if the redness is still visible.

• Electrode pads usage and storage instructions are provided on the mylar bag with electrodes.

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PowerDot PD-02 Device & Accessories

1) Power/Stimulation indicator

2) Multifunction button

3) Micro USB connector (dual function: connects either leads or charging cable)

4) Charging indicator

5) Female magnetic pad connector

6) Lead cable with two female magnetic connectors

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Power/Stimulation Indicator (1):

Can be either WHITE (when the PowerDot is on or on standby mode) or ORANGE (when it’s being used for
stimulation).

Multifunction Button (2) Modes:

Multifunction Button carries out these PowerDot functions:

Multi-function Button

Action

PowerDot Initial State PowerDot Resulting State

Hold for ~1 second PowerDot is OFF (no lights) PowerDot is now ON (white light

is on)

Hold for ~1 second PowerDot is ON (white light is

on)

PowerDot is now OFF (no lights)

Quick Click PowerDot is in Stimulation

(orange light is on)

Stimulation stops (orange light is
ON )

Hold for 5 seconds Device is ON Full Factory Reset: activation lock

is released, , Power LED turns
OFF, after few seconds turns ON
again, blinks several times and the
PowerDot becomes OFF

Hold for 3 seconds Device is OFF Soft Reset: Activation lock is

released, Power LED blinks
several times

Micro-USB Connector (3):

PowerDot uses the same high voltage micro-USB connector (3) for lead cable connection and for charging.

If the device is being used for stimulation, it will immediately stop once the lead cables are disconnected
from the micro-USB connector.

Charging Indicator (4):

While the device is still charging, you will see the ORANGE Charging Indicator (4) next to the micro-USB
charging connector. Refer to the Recharging PowerDot section below for more information on PowerDot
charging.

Snap Connector (5):

Used to attach and hold the PowerDot device in place on the rectangular pad.

Lead Cable (6):

For an easier, more comfortable PowerDot stimulation, two lead cables of different lengths (10 cm and 30 cm)
(6) are provided with each PowerDot. These give you the option to choose the right cable to reach the muscle
group you’re targeting, depending on your physical measurements.

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Electrode Pads (7,8):

PowerDot supports 3 types of electrode pads – 5.5 cm (2.2”) diameter round pads, 4.5 cm (1.8”) diameter
round pads and 9x5 cm (3.5”x2”) rectangular pads.

PowerDot pads use unique skin biocompatible hydrogel with superb conductive qualities and adhesiveness.

The lifetime of PowerDot pads depends a lot on your individual skin properties, level of hairlessness and the
quality of maintenance. On average, each pad lasts for around 20 stimulation sessions. After that,
adhesiveness and conductive properties of the pads may start deteriorating.

Store the pads on the safety film, in a dry environment (either in the original zipper
plastic bag or inside the PowerDot carry case). Make sure you attach the pads to clean
and dry skin!

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o Secondly, you will be asked to look up and select stimulation program, up to 3 relevant muscle

groups or body areas and optionally select number of PowerDot devices to be used.

o Thirdly, you will be asked to select scheduling parameters, such as total duration of the program (in

days), periodization of the sessions, starting date, notifications settings (about missing or late
stimulation sessions).

o Fourthly, you can optionally mark stimulation sessions to be accessible for the Remote (home use)

stimulation from Patient Mobile App.

Be careful when confirming stimulation sessions for remote execution by the patient!

First, you have to make sure that your patients or their caregivers are prepared for and
capable of running unsupervised electrical stimulation sessions.

Specifically, they should be aware on to assemble, apply and control PowerDot PD-02,
are able to follow stimulation pad placements and stimulation positions
recommendations and are able to adjust their stimulation intensities in the controlled
manner.

They should be also aware of the product counter-indications, basic troubleshooting
and maintenance guidelines. Remote stimulation sessions are not for everyone!

o Finally, you will be asked to adjust stimulation parameters for the session (in the relevant ranges

only).

Use scheduled sessions functionality whenever a stimulation course is required for the specific patient.
Scheduled sessions’ parameters, listed above, can be always changed/re-adjusted if required.

Before commencing the stimulation, PowerDot Doctor App will be asking to turn on PowerDot PD-02 device
(or devices) which you are planning to use for the current stimulation session (please make sure the device
has been previously activated via Devices screen). Doctor App will automatically detect turned on devices,
connect to them, check for activation, display serial numbers and blink Power LED to confirm that right
PowerDot PD-02 device has been selected and associated with the session.

In addition, PowerDot Doctor App will automatically check for remaining battery level and lead cable
connection status for all the PowerDot PD-02 devices associated with the current session.

After the checks, Get Started button will appear, which means you can already launch the stimulation session.

6. Controlling A Stimulation

Using the PowerDot Doctor App, you can control your stimulation session from the Stimulation Dashboard,
which has the following controls available:

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Header Indicator (1) displays the remaining time for the total stimulation session, current stimulation phase
(if applicable), name of the stimulation program and stimulation phase (if applicable), and name of the patient
(if applicable).

Contraction/Rest Indicator (2) – for the stimulation programs (and individual phases) involving muscle
contractions, helps to understand time between and during contraction and rest intervals.

Intensity Adjustment controls – Tap on Intensity Inc rease (or “+”) (3) and Intensity Decrease (or “-“) (4)
buttons an accurate adjustment, or hold either button down for a faster adjustment.

Device-level Intensities Lock (6) and Channel-level Intensities Lock controls (5) synchronize intensity
changes either a) between PowerDot PD-02 devices (this applies only to the two-device Duo stimulation
mode) or (b) between two stimulation ch annels of individual PowerDot PD-02 device.

Both controls are enabled by default and can be used to fine-tune the intensity of your current stimulation
session. However, it’s best to use them only when you really need them (e.g. to address muscle imbalance).

Use Stop, Pause, Resume, Skip Phase controls to control the flow of the stimulation session. Skip Phase
control is only applicable to stimulation programs which are comprised of multiple and skippable stimulation
phases (e.g. such as Performance Strength program).

Switch Session Control (7) - allows you to switch between actively running stimulation sessions (on a
different patients). When switching between sessions, your iPad will be disconnecting from PowerDot PD­02(s) used in currently active session and re-connecting to PowerDot(s) being used in the newly selected
session.

Home Screen Control (8) – helps you to navigate back to PowerDot Doctor App Main Menu screen, so you
could select another patient and initiate a new stimulation session .

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When applying Switch Session and Home Screen Controls, you will be leaving current
stimulation session and disconnecting from currently used PowerDot PD-02 devices.
Although the devices will be continuing maintaining your stimulation session
parameters, you won’t be able to control them programmatically (e.g. adjust intensities or
stop/resume session using App controls) until your select your original stimulation
session and re-connect to your devices again. Re-connection is not immediate and it can
take up to 10 seconds, therefore, in all emergency situations, we strongly advice to get
yourself familiar and follow manual Terminating Stimulation protocols 2 and 3, as
provided below.

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f your patient experiences major discomfort or pain – PAUSE your stimulation session

and/or DECREASE intensities. For your patient’s safety, after a PAUSE, your

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timulation session will resume at only 80% of the previous intensity values.

7. Terminating Stimulation

It’s important to know the quick ways to stop the stimulation session when something unexpected happens
(e.g. pads get detached or partially detached; patient starts feeling pain; the stimulation area gets wet, etc.).

There are 3 main ways to immediately terminate stimulation:

1) The recommended/most commonly used option: Tap Pause or Stop on the Stimulation Dashboard

2) Alternatively press the Multifunctional Button on the PowerDot device

3) Or: quickly unplug the lead cable from PowerDot device

8. Carrying & Storing PowerDot

PowerDot PD-02 carry case is specifically designed for carrying and storing up to 2 PowerDot devices, their
lead cables and electrode pads.

To keep electrode pads clean and make them last longer, always re-attach them to the safety film in between
use, then store them in your carrying case pocket. You can use both sides of a single safety film to attach one
set of PowerDot electrode pads (one side for the rectangular pad and the other for the two round pads).

In multi-patient environment, it is always a good idea to mark patient pads with the patient name or initials on
the top surface or on the pads film, e.g. using resistant marker pen.

9. Deactivating PowerDot

PowerDots can be deactivated from your Doctor App either from within the Patient or or by manually
resetting the PowerDot device.

For manual deactivation: when PowerDot is OFF, press and hold Multi-function button for 3 seconds until
you see the power indicator blinking. Now you can activate your PowerDot.

Deactivation from the PowerDot Doctor App is performed from the Devices screen as per on-screen
instructions.

Upon successful deactivation, the power indicator will blink several times.

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Intensity Adjustment Guidelines

For TENS programs or less demanding NMES programs, you are generally required to progressively increase the
stimulation intensities until you see muscle twitches or feel comfortable sensation.

For the majority of NMES stimulation programs, that use powerful muscle contractions, the efficacy of the treatment
can be proportional to the maximum number of fibers being recruited, and, therefore, it is often required to adjust your
stimulation intensity to the maximum levels the patient can comfortably endure.

Keep in mind that the maximum intensity levels may vary, not only from one stimulation session to another, but also
within the course of a single stimulation session. It’s possible that patient’s muscles will adapt to stimulation at a
certain intensity level reasonably quickly. Various conditions, such as differences in skin’s dampness or sweat level, or
the rate of the electrode pad deterioration, may affect the intensity of stimulation.

During stimulation, it is important to maintain feedback with the patient to make sure that his/her
stimulation intensity settings are always in balance with the level of comfort on one side and efficiency of
stimulation on the other.

For efficiency in NMES and Performance sessions, based on patient feedback and feelings, try increasing
slowly intensities during the course of the session.

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Charging PowerDot

PowerDot PD-02 device can be recharged from any reliable USB connection (e.g. laptop, mobile phone charger, wall
USB charger, etc.). It takes around 60 minutes for the device to go from zero level to full charge.

NEVER charge PowerDot when it is attached to the patient’s body.

Always use an original charging cable provided with PowerDot.

NEVER charge PowerDot from unreliable or problematic sources.

When using 3

rd

party party USB AC chargers, we recommend unplugging the AC plug from the wall

before contacting PowerDot device.

PowerDot PD-02 uses UL 1642 and UN 38.3 certified built-in Lithium Polymer battery, which requires recharging
after approximately 5-6 hours of continuous usage. The battery will last for at least 500 charging cycles.

If you plan to store PowerDot PD-02, unused, for longer than six months, charge it to at least 50% every six months.

In the PowerDot Doctor App, the current battery charge level is displayed at the Stimulation and is also available on the
Devices screen.

When you see the ORANGE charging light next to micro-USB connector, this means PowerDot is currently charging.

Once PowerDot is fully charged, the ORANGE light will turn off.

17

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Stimulation Protocols

Stimulation protocols, accessible to doctors from PowerDot Doctor App, based on their intended use, can be divided into 3 main
groups:

1. NMES Rehabilitation Protocols

Disuse Atrophy

Protocol Name Indication For Use

Disuse Atrophy*

Retarding disuse atrophy

Description

Targeting slow twitch (Type I) muscle fibers to facilitate increases in muscle volume after long periods of immobilization or
diminished movement.

Contraction, sec
(allowed range)

Contraction, Hz
(allowed range)

Rest, sec

(allowed range)

Rest, Hz

(allowed range)

Ramp Up/Down, sec

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

5

(3-8)

40

(30-50)

5

(3-8)

4

(0-6)

2/0.5

(0.5-3)

208

(160-320)

25

(15-30)

Reinforcement Post Disuse Atrophy*

Stimulation of healthy muscles in order to improve

or facilitate muscle performance

To be used on previously atrophied muscles that have gained the volume. Increases strength and stability by targeting fast twitch
(type II) muscle fibers.

4

(3-6)

80

(60-100)

8

(5-12)

4

(0-6)

1.5/0.75
(0.5-3)

320

(208-432)

20

(15-30)

Reinforcement Post Disuse Atrophy (Agonist/Antagonist)

Stimulation of healthy muscles in order to improve

or facilitate muscle performance

To be used on previously atrophied muscles that have gained the volume. Increases strength and stability by targeting fast twitch
(type II) muscle fibers. Agonist/Antagonist sequencing.

4

(3-6)

70

(60-100)

4

(3-6)

4

(0-6)

1.5/0.75
(0.5-3)

320

(208-432)

15

(10-20)

Prevention of Disuse Atrophy*

Preventing disuse atrophy

Reproduces a series of slow twitch (Type I) targeted contractions comparable to the normal level of activity during a day.
To be used on the immobilized limb after surgery or bone fracture.

5

(3-8)

35

(30-50)

12

(9-18)

4

(0-6)

2/0.5

(0.5-3)

320

(208-432)

45

(30-60)

Prevention of Disuse Atrophy (Agonist/Antagonist)

Preventing disuse atrophy

Reproduces a series of slow twitch (type I) targeted contractions comparable to the normal level of activity during a day.
To be used on the immobilized limb after surgery or bone fracture. Agonist/Antagonist sequencing.

6

(4-8)

35

(30-50)

6

(4-8)

4

(0-6)

2/0.5

(0.5-3)

320

(208-432)

20

(15-30)

Muscle Re-education and Increasing Range of Motion

Protocol Name Indication For Use

Muscle Re-education, Level 1 (Slow Twitch ) *

Muscle re-education

Description

Targets re-education and muscle function improvements of slow twitch (Type I) muscle fibers.

Contraction, sec
(allowed range)

Contraction, Hz
(allowed range)

Rest, sec

(allowed range)

Rest, Hz

(allowed range)

Ramp Up/Down, sec

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

5

(3-8)

40

(30-50)

5

(3-8)

4

(0-6)

2/0.5

(0.5-3)

208

(160-320)

25

(15-30)

Muscle Re-education, Level 2 (Fast Twitch)*

Muscle re-education

Targets re-education and muscle function improvements of fast twitch (Type II) muscle fibers. Apply/schedule after at least 2 weeks
of usage of Level 1 program.

4

(3-6)

80

(50-100)

8

(5-12)

4

(0-6)

1.5/0.75
(0.5-3)

320

(208-432)

20

(15-30)

Neuro Rehab*

Muscle re-education

Targets facilitation and re-learning of motor skills for stroke patients.

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5

(3-8)

40

(30-50)

15

(9-24)

0 4/2

(1.5-6)

208

(160-320)

20

(15-30)

Increase Range of Motion*

Maintaining or increasing range of motion

Targets increase in range of motion by creating contraction and movement in the antagonist muscle, thus causing maximum stretch
of the problematic muscle.

5

(3-8)

40

(30-50)

10

(6-16)

4

(0-6)

2/0.5

(0.5-3)

208

(160-320)

20

(15-30)

Spasticity Treatment*

Maintaining or increasing range of motion

Targets reduction of spasticity by inhibition of motor neurons of the spastic muscle via the reciprocal inhibition reflex. To be used
on the antagonist of the spastic muscle with the intensity sufficient to create movement to the maximum range of motion.

5

(3-8)

40

(30-50)

10

(6-16)

4

(0-6)

2/0.5

(0.5-3)

208

(160-320)

20

(15-30)

Specific Rehabilitation

Protocol Name Indication For Use

Hip Prosthesis, Level 1

Retarding disuse atrophy

Description

Targets improving stability and strength of Gluteus Maximus and Medius muscles following the orthopedic surgery of hip. Level 1 is
targeting slow twitch (Type I) muscle fibers.

Contraction, sec
(allowed range)

Contraction, Hz
(allowed range)

Rest, sec

(allowed range)

Rest, Hz

(allowed range)

Ramp Up/Down, sec

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

6

(4-8)

40

(30-50)

6

(4-8)

0 1.5/0.75

(0.5-3)

208

(160-320)

30

(20-40)

Hip Prosthesis, Level 2

Retarding disuse atrophy

Targets improving stability and strength of Gluteus Maximus and Medius muscles following the orthopedic surgery of hip. Level 1
is targeting fast twitch (Type II) muscle fibers. Use/schedule Level 2 at least 2 weeks after using Level 1 program.

4

(3-6)

80

(60-100)

10

(7-15)

0 1.5/0.75

(0.5-3)

208

(160-320)

15

(10-20)

Patellar Syndrome, Level 1

Retarding disuse atrophy

Targets increase of the stability of the knee and retardation of the disuse atrophy in Medial Vastus and larger Quadriceps muscle.
Level 1 is targeting slow twitch (Type I) muscle fibers.

6

(4-8)

40

(30-50)

6

(4-8)

0 1.5/0.75

(0.5-3)

208

(160-320)

30

(20-40)

Patellar Syndrome, Level 2

Retarding disuse atrophy

Targets increase of the stability of the knee and retardation of the disuse atrophy in Medial Vastus and larger Quadriceps muscle.
Level 2 is targeting fast twitch (Type II) musc le fibers. Use/schedule Level 2 at least 2 weeks after using Level 1 program.

4

(3-6)

80

(60-100)

10

(7-15)

0 1.5/0.75

(0.5-3)

208

(160-320)

15

(10-20)

Hemiplegia*

Maintaining or increasing range of motion

Targets re-learning of motor skills and reduction of spasticity. Features long ramp up time o the contraction and a long rest phase.
Can be used to complement traditional physiotherapy after a stroke.

10

(6-15)

45

(30-50)

20

(12-30)

0 4/2

(1.5-6)

208

(160-320)

20

(15-30)

Rotator Cuff, Level 1

Muscle re-education

Targets increase of the muscular function and neuro motor re-education of the rotator cuff. Use to treat disturbed range of motion,
shoulder tendopathies and pain around the shoulder. Training can be combined with active movements.

6

(6-15)

40

(30-50)

6

(4-8)

4

(0-6)

1.5/0.75
(0.5-3)

208

(160-320)

20

(15-30)

Rotator Cuff, Level 2

Muscle re-education

Targets increase of the muscular function and neuro motor re-education of the rotator cuff. Use to treat disturbed range of motion,
shoulder tendopathies and pain around the shoulder. Training can be combined with active movements. Apply/schedule after at least
2 weeks of using Level 1 program.

4

(3-6)

80

(60-100)

10

(7-15)

4

(0-6)

1.5/0.75
(0.5-3)

208

(160-320)

15

(10-20)

Post-ACL Treatment (Agonist/Antagonist)

Muscle re-education

Targeting improving active stability of the knee joint after rupture of the ACL. This is a contraction offset session: stimulation starts
on Hamstrings and then continues on the Quadriceps, preventing the risk of the anterior drawer.

3+6 40 8 4 1.5+3/0+0.75 320 25

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(30-50) (240-432)

Shoulder Subluxation

Prevention and retardation of atrophy

Targets stimulation of Deltoid and Supraspinatus muscles as prevention and treatment for atrophy of the sub-dislocated shoulder.

8

(6-10)

40

(30-50)

8

(6-10)

0 3/1.5

(1-5)

208

(160-320)

25

(20-30)

Back-Trunk Stabilization*

Muscle re-education

Targets stabilization of trunk and back muscles by stimulating abdominal or lumbar muscle groups. Suits patients with insufficiency
in the bank and trunk due to long term pain or neurological disorder. This program can be also combined with active movements.

6

(3-8)

40

(30-50)

12

(6-16)

4

(0-6)

2/1

(0.5-3)

208

(160-320)

30

(20-40)

Circulation, Relaxation of Muscle Spasms, Vascular

Protocol Name Indication For Use

Heavy Legs

Increasing local blood circulation

Relaxation of muscle spasms

Description

For use when swelling of the feet and ankle occurs together with a feeling of the legs being very heavy. Muscle contractions will
compress the deep veins of the legs and eject venous blood upwards. The stimulation will also help to overcome the tension and
tendency to cramp. To be used on calf muscles (Gastrocnemius).

Contraction, sec
(allowed range)

Contraction, Hz
(allowed range)

Rest, sec

(allowed range)

Rest, Hz

(allowed range)

Ramp Up/Down, sec

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

continuous 7/5/3

(7/7/7 min)

0 0 1/0.5 208

(160-320)

21

(15-30)

Capillarization

Increasing local blood circulation

Helps to make muscle fibers more resistan t to fatigue. Capillarization decreases the amount of lactic acid being produced and creates
a larger area of exchange and distribution of oxygen and metabolites.

continuous 8

(5-10)

0 0 1/0.5 208

(160-320)

25

(20-30)

De-contraction

Relaxation of muscle spasms

Post-surgical and post-trauma acute pain

Targets reduction of muscular tension by using very low stimulation frequency.

continuous 1 0 0 1/0.5 208

(160-320)

20

(10-40)

Arterial Insufficiency

Increasing local blood circulation

Targets arterial insufficiency of the lower limbs. Low frequency stimulation increases the capacity of the fibers to use the oxygen,
improves the tolerance while avoiding the tetanization and considerable fatigue. Electrodes are placed on the calf muscles
(Gastrocnemius) and popliteal nerve.

15

(10-20)

10

(7-12)

15

(10-20)

3

(0-6)

1/1

(0.5-1.5)

208

(160-320)

15

(10-20)

Prevention of Venous Thrombosis

Prevention of venous thrombosis

Targets achieving maximum drainage of the veins and combats the stasis. Uses short tetanic contractions separated by long active
pauses to increase the blood flow. Electrodes are placed on the calf muscles (Gastrocnemius) and popliteal nerve.

4

(3-5)

50

(40-60)

20

(15-25)

8

(6-10)

1.5/1.5
(1-2)

208

(160-320)

20

(15-30)

Cramp Prevention

Increasing local blood circulation

Relaxation of muscle spasms

Targeting cramps at calves. First sequence increases local blood circulation, second sequence provides relaxation to muscle tone.
Each sequence repeats 4 times.

continuous 8/3 x 4 (8

min/2 min)

(2-10)

0 0 1/0.5 208

(160-320)

40

20

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2. TENS Pain Management Protocols

By Type of Pain

Protocol Name Indication For Use

Acute Pain

Post-surgical and post-trauma acute pain

Description

High frequency TENS is a popular choice for the management of acute pains. Adjust pulse width to patient pain sensitivity level.

Frequency, Hz

(allowed range)

Burst Parameters

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

100

(80-150)

N/A 208

(32-320)

30

(15-60)

Fracture Pain

Post-surgical and post-trauma acute pain

Medium frequency/medium pulse width TENS is a good choice for treating sensitive fracture pains. Pain management helps to
prevent various complications such as pulmonary complications or thrombosis.

75

(60-80)

N/A 160

(128-240)

30

(15-60)

Chronic Pain

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

Chronic pains are handled well with low frequency Endorphinic TENS stimulation. Low frequency stimulation alleviates pain by
stimulating muscles to release the endorphins. In addition, muscle twitches also increase local blood circulation.

5

(1-8)

N/A 240

(160-320)

30

(15-60)

Radiating Pain
Projected Pain

Symptomatic relief and management of chronic,

intractable pain

Burst TENS is effective in managing various kinds of radiating (projected) pains such as mononeuropathy, central pain as well as for
deep muscular pains. High frequency pulses packaged into low frequency bursts alleviate pain by stimulating muscles to release the
endorphins. In addition, muscle twitches also increase local blood circulation.

80

(80-150)

5 pulses per burst, 2 bursts/sec

(5-10 ppb, 2-4 bursts/sec)

208

(160-320)

20

(10-40)

By Body Part

Protocol Name Indication For Use

Cervical Pain
Neck Pain

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

Description

For treating neck pain resulting from chronically contracted of Levator scapulae and/or superior Trapezius muscles. Low frequency
stimulation alleviates pain by stimulating muscles to release the endorphins. In addition, muscle twitches also increase local blood
circulation.

Frequency, Hz

(allowed range)

Burst Parameters

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

5

(1-8)

N/A 240

(160-320)

30

(15-60)

Lower Back Pain

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

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For treating lower back pain resulting from chronically contracted lumbar paravertebral muscles. Low frequency stimulation
alleviates pain by stimulating muscles to release the endorphins. In addition, muscle twitches also increase local blood circulation.

5

(1-8)

N/A 240

(160-320)

30

(15-60)

Lumbosciatica
Sciatica

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating lumbar pain originating from chronic contractions of the paravertebral muscles. Electrodes are placed over the sciatic
nerve root exit sites and on the lower part of the buttock/posterior face of the thigh. Low frequency stimulation alleviates pain by
stimulating muscles to release the endorphins. In addition, muscle twitches also increase local blood circulation.

5

(1-8)

N/A 240

(160-320)

30

(15-60)

Mononeuropathy
Central Pain
Deep Muscular Pain
Rhizopathy

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

Burst TENS is usually effective in managing various kinds of radiating (projected) pains, for conditions with reduced or changed
sensory of touch as well as for deep muscular pains. High frequency pulses packaged into low frequency bursts alleviate pain by
stimulating muscles to release the endorphins. In addition, muscle twitches also increase local blood circulation.

80

(80-150)

5 pulses per burst, 2 bursts/sec

(5-10 ppb, 2-4 bursts/sec)

208

(160-320)

20

(10-40)

Arthralgia

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating arthralgia pain: pain in or affecting a joint, caused by either degenerative or destructive processes. To avoid adaptation,
this protocol uses continuous variation of stimulation frequency at very short pulses.

50-150 Hz at 2 sec

(50-150 Hz at 2-5 sec)

N/A 48

(32-160)

20

(10-40)

Epicondylitis

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating epicondylitis pain. Epicondylitis is a tendinopathy which may result from repetitive gripping of the objects. To avoid
adaptation, this protocol uses continuous variation of stimulation frequency with short width pulses.

50-150 Hz at 2 sec

(50-150 Hz at 2-5 sec)

N/A 48

(32-160)

20

(10-40)

Lower Back Muscle Pain

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating lower back muscle pain. This protocol is recommended to shorten recovery and/or as symptomatic therapy. To avoid
adaptation, this protocol uses variation of stimulation frequency in medium range with medium width pulses.

40-100 Hz at 3 sec

(20-100 Hz at 2-5 sec)

N/A 240

(160-320)

30

(15-60)

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Muscle Pain

Symptomatic relief and management of chronic,

intractable pain

Post-surgical and post-trauma acute pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating all kinds of muscle pains. This protocol uses pulse width modulation, which creates undulating sensation and is generally
more comfortable than constant pulse width stimulation.

80 Hz at 2 sec

(60-150 Hz at 2-5 sec)

N/A 64-320

(32-432)

30

(15-60)

Knee Pain

Symptomatic relief and management of chronic,

intractable pain

Post-surgical and post-trauma acute pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating knee pain caused by the injury or by underlying medical conditions such as osteoarthritis, rheumatoid arthritis o

r

chondromalacia. This protocol uses pulse width modulation, which creates undulating sensation and is generally more comfortabl

e

than constant pulse width stimulation.

80 Hz at 2 sec

(60-150 Hz at 2-5 sec)

N/A 64-320

(32-432)

30

(15-60)

Shoulder Pain

Symptomatic relief and management of chronic,

intractable pain

Post-surgical and post-trauma acute pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating shoulder pain resulting from heavy repetitive lifting, sports injuries or underlying medical conditions such as arthritis,
tendinopathy and impingement. This protocol uses pulse width modulation, which creates undulating sensation and is generally more
comfortable than constant pulse width stimulation.

80 Hz at 2 sec

(60-150 Hz at 2-5 sec)

N/A 64-320

(32-432)

30

(15-60)

Joint Pain

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating various kinds of joint pains, especially in shoulders and knees. This protocol uses pulse width modulation, which creates
undulating sensation and is generally more comfortable than constant pulse width stimulation.

60 Hz at 2 sec

(50-100 Hz at 2-5 sec)

N/A 48-160

(32-240)

30

(15-60)

Lumbago

Symptomatic relief and management of chronic,

intractable pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating lumbago pain, the result of sharp and intense contractions of lower back muscle. This protocol produces very low
frequency stimulation twitches to reduce muscle tension during rest of the stimulated muscles.

1

N/A 208

(160-320)

20

(10-40)

Torticollis

Symptomatic relief and management of chronic,

intractable pain

23

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Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household

and work activities

For treating torticollis pain: a sharp pain in the neck, often accompanies by considerable reduction of the mobility of the cervical
region. This protocol produces very low frequency stimulation twitches to reduce muscle tension during rest of the stimulated
muscles.

1

N/A 208

(160-320)

20

(10-40)

By Type Of TENS

Protocol Name Indication For Use

Conventional TENS, High Frequency

Post-surgical and post-trauma acute pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

Description

High frequency TENS is a popular choice for the management of acute pains. Adjust pulse width to patient pain sensitivity level in the
treatment area. Can be altered with more comfortable Mixed Frequency TENS/Hans Stimulation and Medium Frequency TENS
protocols.

Frequency, Hz

(allowed range)

Burst Parameters

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

100

(80-150)

N/A 208

(32-320)

30

(15-60)

Conventional TENS, Medium Frequency

Post-surgical and post-trauma acute pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

Medium frequency TENS can be used as a more comfortable alternative to High Frequency TENS.

75

(60-80)

N/A 160

(128-240)

30

(15-60)

Acupuncture TENS
Endorphin TENS
Low Frequency TENS

Symptomatic relief and management of chronic, intractable

pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

This low frequency TENS protocol is generally used to manage chronic pains, can be varied with or accompanied by more comfortable
Burst TENS or less adaptive Low Range Frequency Modulated TENS protocols. Low frequency pulses alleviate pain by stimulating
muscles to release the endorphins. In addition, muscle twitches also increase local blood circulation.

5

(1-8)

N/A 240

(160-320)

30

(15-60)

Conventional TENS, High Frequency/Short Pulse

Post-surgical and post-trauma acute pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

High frequency TENS is a popular choice for the management of acute pains. Short pulse version should be used for the patients with
very sensitive treated areas. Can be also varied with Mixed Frequency TENS/Hans Stimulation protocol.

100

(80-150)

N/A 48

(32-160)

20

(10-40)

Frequency Modulated TENS, High Range

Post-surgical and post-trauma acute pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

This protocol can for treatment of various chronic pain conditions such as arthralgia, epicondilitis, lower back muscle pains etc.
Modulation of frequencies helps to avoid adaptation. Adjust pulse width to patient pain sensitivity level in the treatment area.

24

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50-150 Hz at 2 sec

(50-150 Hz at 2-5 sec)

N/A 48

(32-160)

20

(10-40)

Frequency Modulated TENS, Medium Range

Symptomatic relief and management of chronic, intractable

pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

This protocol can be used for treatment of various chronic pain co nditions such as arthralgia, epicondilitis, lower back muscle pains etc.
Modulation of frequencies helps to avoid adaptation. Medium range modulation provides more comfortable stimulation than high range
option.

40-100 Hz at 3 sec

(20-100 Hz at 2-5 sec)

N/A 240

(160-320)

30

(15-60)

Frequency Modulated TENS, Low Range

Symptomatic relief and management of chronic, intractable

pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

This protocol is a more effective version of Low Frequency TENS and Burst TENS protocols for the long-term treatments as it avoids
adaptation via frequency modulation. Low frequency pulses alleviate pain by stimulating muscles to release the endorphins. In addition,
muscle twitches also increase local blood circulation.

1-8 Hz at 5 sec

(1-15 Hz at 3-10 sec)

N/A 240

(160-320)

30

(15-60)

Pulse Modulate d TENS, High Range

Symptomatic relief and management of chronic, intractable

pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

This protocol can used for treating of chronic pain conditions requiring higher levels of comfort such as muscle pain, sharp knee and
shoulder pains. It also creates massage like effect on certain muscle groups (such as Trapezius).

80 Hz at 2 sec

(60-150 Hz at 2-5 sec)

N/A 64-320

(32-432)

30

(15-60)

Pulse Modula ted TENS, Low Rang e

Symptomatic relief and management of chronic, intractable

pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

This protocol can used for treating of chronic pain conditions requiring higher levels of comfort. Low Range provides even more
pleasant/comfortable stimulation when comparing to High Range option, more suitable for treating of the joint pains.

60 Hz at 2 sec

(50-100 Hz at 2-5 sec)

N/A 48-160

(32-240)

30

(15-60)

Burst TENS

Symptomatic relief and management of chronic, intractable

pain

Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

Burst TENS is usually effective against radiating pain in the arms or legs (rhizopathy), for conditions with reduced or changed sensory
of touch, for deep muscular pain or when the post-treatment of TENS is too short. High frequency pulses packaged into low frequency
bursts alleviate pain by stimulating muscles to release the endorphins. In addition, muscle twitches also increase local blood circulation.

Burst TENS can be effectively altered with more aggressive Low Frequency/Endorphin TENS and less adaptable Low Range
Frequency Modulated TENS protocols.

80

(80-150)

5 pulses per burst, 2 bursts/sec

(5-10 ppb, 2-4 bursts/sec)

208

(160-320)

20

(10-40)

Mixed Frequency TENS
Hans Stimulation

Post-surgical and post-trauma acute pain

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Temporary relief of pain associated with sore and aching

muscles due to strain from exercise or normal household and

work activities

Mixed Frequency TENS is more comfortable and convenient form of High Frequency Conventional TENS. Also commonly referred as
Hans Stimulation. Can be altered with more aggressive High Frequency Conventional TENS protocol.

80/2, 3 sec each N/A 208

(32-320)

30

(15-60)

1 Hz TENS

Post-surgical and post-trauma acute pain

Relaxation of muscle spasms

Targets reduction of muscular tension by using very low stimulation frequency.

1

N/A 208

(160-320)

20

(10-40)

3. NMES Performance and Massage Programs

Protocol Name Indication For Use

Muscle Endurance*

Stimulation of healthy muscles in order to improve
or facilitate muscle performance

Description

Targets improvements of muscle endurance and fatigue resistance through activation of slow twitch (Type I) muscle fibers.

Contraction, sec
(allowed range)

Contraction, Hz
(allowed range)

Rest, sec

(allowed range)

Rest, Hz

(allowed range)

Ramp Up/Down, sec

(allowed range)

Pulse Width, uS
(allowed range)

Duration, min

(allowed range)

8

(6-10)

15

(30-25)

4

(3-5)

3

(0-6)

1/0.5

(0.5-2)

208

(160-432)

45

(35-60)

Strength Endu rance*

Stimulation of healthy muscles in order to improve

or facilitate muscle performance

Targets improvements of muscle capacity (strength endurance), ability to resist intense and prolonged effort, muscle tone and
definition. Works through activation of slow twitch (Type I) and some fast twitch oxidative (Type IIa) muscle fibers at medium
stimulation frequencies.

7

(5-10)

40

(30-50)

7

(5-10)

3

(0-6)

1.5/0.75
(0.5-3)

240

(160-432)

35

(25-45)

Resistance *

Stimulation of healthy muscles in order to improve

or facilitate muscle performance

Targets improvements of muscle ability to resist intense and prolonged effort, muscle hypertrophy. Works through activation of fast
twitch oxidative (Type IIa) muscle fibers at medium stimulation frequencies.

7

(5-10)

55

(45-65)

7

(5-10)

3

(0-6)

2/1

(0.5-3)

320

(160-432)

25

(20-30)

Strength*

Stimulation of healthy muscles in order to improve

or facilitate muscle performance

Targets improvements of muscle strength. Works through activation of fast twitch oxidative (Type IIa) muscle fibers at high
stimulation frequencies.

4

(3-8)

80

(70-100)

20

(15-40)

3

(0-6)

2/1

(0.5-3)

352

(160-432)

20

(15-30)

Explosive Strength*

Stimulation of healthy muscles in order to improve

or facilitate muscle performance

Targets improvements of explosive strength and power. Works through activation of fast twitch glycolic (Type IIb) muscle fibers at
very high stimulation frequencies.

3

(2-8)

120

(100-150)

30

(20-80)

3

(0-6)

2/1

(0.5-3)

400

(160-432)

15

(10-20)

Active Recovery

Increasing local blood circulation

Relaxation of muscle spasms

Targets acceleration of muscle recovery after intensive exercise. Increases local blood circulation, releases endorphins, provides
muscle relaxation.

210 (for each

phase)

(120-360)

10, 8, 5, 3, 2, 1

(1-10)

N/A N/A 1/1 208

(160-432)

18

(12-36)

Relaxation Massage

Increasing local blood circulation

Relaxation of muscle spasms

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Targets decrease in muscular tension. Provides effect of wellbeing and relaxation.

420 (for each

phase)

(300-720)

7,5,3

(1-10)

N/A N/A 1/1 208

(160-432)

21

(15-36)

Circulation Massage

Increasing local blood circulation

Helps to get rid of heaviness sensation and uncomfortable body tensions via increasing blood circulation in the target areas.

120 (for each

phase)

(90-240)

1,3,5,7,5,3,1,

1-7@5 sec

(1-10)

N/A N/A 1/1 208

(160-432)

16

(12-32)

De-contraction Massage

Increasing local blood circulation

Relaxation of muscle spasms

Enables de-contraction of the muscles through the comfortable low frequency vibrations that increase the blood circulation in the
treated region and improve oxygenation.

60, 60, 60, (30,

30, 30)x5,

(60,30,60,30)x2,

30

3,2,1,(1-5@5,

1-3@5, 1)x5,
(1-5@5, 1, 1-

3@5, 1)x2,1

N/A N/A 1/1 208

17

Dual Wave Massage

Increasing local blood circulation

Symptomatic relief and management of chronic,

intractable pain

Helps to get rid of heaviness sensation and uncomfortable body tensions via increasing blood circulation in the target areas.
Combines massage with TENS pain relief. Delivers a pleasant wave-like effect by isolating stimulation sequences between the
devices in Duo mode.

60, 60, (30x4,

30x4)x5

5, 100, (1-8x4,

100x4)x5

N/A N/A 1/1 208

22

* Marked programs are preceded with 2 minutes Warm Up phase at 5-10 Hz stimulation and 3 minutes of Recovery at
5-1 Hz stimulation using 208 uS pulses.

For each stimulation program, you can adjust stimulation parameters within allowed ranges. Contraction/rest duty
cycles can be only adjusted proportionally to the proposed default values.

Adjusted stimulation programs will be saved and always available from the Sessions History screen (for ad hoc
sessions) or from the Scheduled Sessions screen (if the session has been previously scheduled).

To identify stimulation parameters for recommended intended use, manufacturer has used stimulation parameters and
programs from the number of substantially equivalent NMES and TENS devices, available on the market.

27

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Basic Troubleshooting

DEVICE DOESN’T TURN ON

PowerDot PD-02 is probably very low on the battery. Charge your PowerDot for a few hours.

DURING PRE-STIMULATON SET UP, POWERDOT(S) CANNOT BE FOUND (OR ARE NOT

CONNECTED) .

Check out Devices screen and make sure that PowerDot device you’re trying to use is in the list of active
devices.

Make sure your PowerDot is turned on (the white light is on in the device).

In some rare cases, you would be required to forget (remove) relevant PowerDot device from Bluetooth
Settings (use device serial number to identify the right one).

STIMULATION DOES NOT PRODUCE THE USUAL SENSATION

Check that your electrode pads are firmly attached to your body and are correctly positioned (as advised on
the Pre-Stimulation screen). Put the stimulation on pause, re-attach or reposition pads, then resume the
stimulation.

THE STIMULATION CAUSES DISCOMFORT OR A BURNING FEELING

If you’re using your standard intensity modes, than most probably your pads are worn out and and/or losing
their bonding strength. Pause the stimulation and re-attach your pads firmly, then resume stimulation. If the
same sensation continues, pause the stimulation again and replace your pads.

ELECTRODE PADS DON’T STICK TO THE BODY OR STIMULATION IS SURPRISINGLY WEAK

EVEN ON HIGHER INTENSITIES

Replace your electrode pads. Most probably they’re worn out. If it doesn’t work, check your lead cable for
physical damage. If there is any damage, replace the lead cable.

CAN’T ACTIVATE POWERDOT DEVICE OR IPAD STOPPED CONNECTING TO THE POWERDOT

 Remove relevant PowerDot(s) from Devices menu (use serial number to identify the right one(s)).
 Perform manual factory reset of your PowerDot (or PowerDots) by turning the device off and then

holding the button on the device for around 5 seconds, until you see power light blinking several times.

 Go to Bluetooth Settings and remove/forget relevant PowerDot(s) using device’s serial number.
 Terminate PowerDot Doctor App using Task Manager.
 Launch PowerDot Doctor App again and try to activate your device again.
 If after all steps above, you still experience connectivity problem, please send us your phone model,

OS version and the list of actions you have performed to [e-mail]. We will respond within 24
hours.

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PowerDot Maintenance

PowerDot PD-02 device, together with its accessories, should be kept in PowerDot carry case and carefully
stored on a secure surface and protected conditions listed in the Warnings above.

Keep replacing your electrode pads after 20 uses as recommended. Deteriorated &
worn out pads can cause major discomfort during stimulation, affect the effectiveness
and even lead to minor injury.

Cleaning: only clean PowerDot device using a dry soft cloth.

Keep PowerDot device and electrode pads away from water. Store them in a dry
place, in protective packaging or in the PowerDot carry case.

PowerDot PD-02 devices do not require calibration or verification of performance parameters. The
characteristics are systemically verified and validated for each device manufactured. Those characteristics are
stable and do not vary when used under normal conditions.

The manufacturer states that PowerDot cannot be repaired by personnel external to the company. Any work
of this nature carried out by personnel not authorized by the manufacturer will be classified as tampering with
the unit, releasing the manufacturer from any responsibility with regards to the warranty and hazards that the
operator or user may be exposed to.

PowerDot Warranty

PowerDot PD-02 is covered by a worldwide warranty of 2 years, which comes into effect on the date of
purchase of the device (proof of purchase is required).

The warranty does not apply to the electrode pads and carry cases. Within the warranty period, manufacturer
will replace your faulty PowerDot or accessories at no charge (except shipping & handling fees in some
cases), provided that the product:

 Has been used for the intended purpose and in the manner described in this manual

 Has not been conne cted to an unsuitab l e power source

 Has not been subjected to misuse or neglect

 Has not been modified or repaired

 Has not been damaged further by shock

Legal rights are not affected by this warranty.

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Technical Specifications

All electrical specifications are given for an impedance of 1000 Ω per channel.

Battery: 2x Lithium Polymer (LiPo) rechargeable 3.7 V, 210 mAh

Charging Input: 5V through USB Type C connection (custom USB charging cable is provided as part of

the package), I/P rating: 5Vdc 1-2.1A

Stimulation Channels: 2 independent, optically isolated

Stimulation Waveform: Bi-phasic rectangular with zero mean (under load)

Supported Stimulation Frequency Range: 1-150 Hz

Supported Sti mulation Puls e Width: 32-416 µs (for main/positive phase)

Maximum output voltage/amperage: 130 V/130 mA (+-5%)

Bluetooth: Built-in Bluetooth Low Energy 4.0

Electro-compatibility (EMC): ETSI EN 301 489-1/EN 301 489-17/EN 50385/EN 55011/IEC 60601-1-2

C RF Data:

 Operating Frequency Range: 2402 MHz-2480 MHz (ISM range)

 Modulation Type: GFSK with AFH

 Peak Transmit Power: -15.86dBm (0.026 mW)

 Channel Spacing/Number of Channels: 2 MHz, 40 channels (3 for advertising, 37 for data)

 Antenna Type: PCB Ante nna, 2 dBi (1.58 mW) gain

Mobile Application Compatibility:

 Android 5.0 Lollipop (or later) powered smart phone with Bluetooth Smart Ready compatibility
and High Definition (or better) touch screen

 Apple iPhone 4S/iPod 5

th

Gen/iPad 3rd Gen or newer smart phone/tablet powered by iOS 9.0 (or

later)

Device Dimensions: 55x55x13.6 mm

Device Weight: 30 g

Environment Specifications:

 Operating/Storage/Transport: Temperature from 0 C to +40 C

 Humidity: 10-90% RH

 Atmospheric pressure: from 700 hPa to 1060 hPa

Product Expected Lifetime: 5 years

Housing: ABS & TPU

30

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Limitations: product is not suitable for use in the environments with a high concentration of oxygen and/or
flammable liquids and/or flammable gas; do not use with equipment for electro surgery or short-wave or
microwave therapy; the device may be interfered by other equipment, even if that other equipment complies
with CISPR EMISSION requirements.

PowerDot PD-01 has been tested to the compliance with the following Emission and Immunity standards:

Emission:

STANDARD ITEM REMARKS

CISPR 11: 2011 Conducted Class B

Radiated Class B
IEC 61000-3-2:2014 Harmonic current emissions
IEC 61000-3-3:2013 Voltage fluctuations & flicker

IMMUNITY:

STANDARD ITEM IEC 60601-1-2 Test

Levels for Home

Healthcare

Environment

PowerDot PD-01

Test Levels

REMARKS

IEC 61000-4-2:2008 ESD ± 8 kV contact;

± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV air

±2 kV, ± 4 kV, ± 8
kV contact;
± 2 kV, ± 4 kV,
± 8 kV, ± 15 kV
air

No
performance
degradation
observed.

IEC 61000-4-3:2010 RS 10 V/m

80 MHz – 2.7 GHz
80% AM at 1 kHz

10 V/m
80 MHz – 5.785
GHz
80% AM at 1 kHz

No
performance
degradation
observed.

IEC 61000-4-4:2012 EFT ± 2 kV

100 kHz repetition
frequency

± 2 kV
100 kHz repetition
frequency

No
performance
degradation
observed.

IEC 61000-4-5:2014 Surge ± 0.5 kV, ± 1 kV ± 0.5 kV, ± 1 kV No

performance
degradation
observed.

IEC 61000-4-6:2013 CS 3V 0.15 MHz – 80 MHz

6V in ISM and amateur
bands between 0.15 MHz
and 80 MHz

80% AM at 1 kHz

10V 0.15 MHz –
80 MHz

80% AM at 1 kHz

No
performance
degradation
observed.

IEC 61000-4-8:2009 PFMF 30 A/m

50 Hz or 60 Hz

30 A/m
50 Hz

No
performance
degradation
observed.

IEC 61000-4-11:2004 Voltage

dips &
voltage
variation
s

Voltage Dips:

1) 0% U

T

; 0,5 cycle at 0º.
45º, 90º, 135º, 225º, 270º,
315º

2) 0% U

T

; 1 cycle;
Single phase at 0º

3) 70% U

T

; 25/30 cycles;

Single phase at 0º

As on the previous
column

Voltage Dips:

1) No
performance
degradation
observed

2) No
performance
degradation
observed

31

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Voltage Interruptions:

0% U

T

; 250/300 cycle;

3) No
performance
degradation
observed

Voltage
Interruptions:

Performance
degradation
(device stopped
charging) has
been observed
only during
voltage
interruption
testing, but no
degradation
observed after
the testing

Bluetooth Connectivity

The unique feature of PowerDot system is that PowerDot stimulators are controlled through Bluetooth Low
Energy wireless radio interface.

PowerDot PD-02 is specifically designed to be used together with PowerDot Doctor App, which is supported
for the selected Apple iPad devices.

Secure Pairing

Your PowerDot is paired with your iPad using secure 8 digit numeric code which, by design, prohibits any
other mobile phones or wireless devices to connect to your PowerDot. Secure pairing takes place during
PowerDot activation process (see Activating PowerDot above) and, once your PowerDot becomes active,
numeric activation code is written into PowerDot’s flash memory and gets verified by your PowerDot Doctor
App after every PowerDot restart.

All Bluetooth commands sent from your mobile phone to PowerDot device are securely encrypted using
Bluetooth AES-128 encryption protocol.

Disconnections and Quality of Service

PowerDot Doctor App and PowerDot PD-02 Bluetooth communication interface are specifically designed to
accommodate temporarily and permanent Bluetooth disconnections during a stimulation session.

PowerDot PD-02 device is capable of independent execution of a pre-loaded stimulation program with the
latest intensity values as well as implements automatic Bluetooth re-connec t ions.

In this regard, temporary radio frequency interference (e.g. caused by co-existence of multiple Bluetooth
and/or Wi-Fi devices in your range) should not affect the overall efficiency and safety of your stimulation
session.

Due to hardware-level emergency stop mechanisms (see Directions For Use), Bluetooth disconnections of
more permanent nature should not affect the safety of stimulation, and can only cause temporary
inconvenience by forcing you to postpone your planned stimulation session until a more favorable Bluetooth
connectivity environment is established.

32

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Like any wireless device, PowerDot PD-02 emits very low levels in t he ra dio frequ enc y ( RF) in terv al, a nd, is
therefore not likely to cause any interference with nearby electronic equipment (e.g. radios, computers,
telephones, etc.).

PowerDot PD-02 is designed to withstand foreseeable disturbances originating from electrostatic discharges,
mains supply magnetic fields, or radio frequency transmitters.

Despite this, it is not possible to guarantee that the stimulator will not be affected by strong RF (radio
frequency) fields emitting from other sources (such as in the proximity of working microwave oven).

Try not to use PowerDot closer than 1.5 meters to the working microwave oven as
radio interference from microwave is likely to cause disconnection between PowerDot
and your mobile phone.

Troubleshooting Wireless Connectivity

If you run into issues with Bluetooth wireless connectivity (e.g. your PowerDot PD-02 device becomes
unresponsive to PowerDot Doctor App commands during stimulation session or you were not able to connect
to your PowerDot and initiate stimulation), do not panic and consider terminating your stimulation session
manually by shortly pressing Power button on your PowerDot device.

PowerDot Doctor App has built-in re-connection and disconnection detection mechanism and, in most cases,
it will re-connect back to your PowerDot shortly and allow you to resume your stimulation using Resume
button on the stimulation screen.

If you fail to re-connect and resume stimulation after several attempts, consider stopping your stimulation
session using Stop button on the Stimulation Screen and postponing it for later.

33

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Used Symbols

SN Serial Number

Stand by

Attention

Direct Current (DC)

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IMPORTANT NOTE : (For Portable Device Configuration)

FCC Radiation Exposure Statement:
This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment for body­worn configuration in direct contact to the phantom.

The device complies with Part 15 of FCC. Operation is subject to the following conditions:
a. This device may not cause harmful interference, and
b. This device must accept any interference received, including interference that may cause undesired operation.
FCC ID: 2AC2KPD001201400SMT

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34

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EU Only Symbols:

This symbol on your PowerDot unit is to indicate conformity with the
requirements of the Medical Device Directive (94/42/EEC)

Manufacturer

EU Authorized representative

Internally powered device Class II with Type BF applied parts

Product subject to WEEE regulations concerning separate waste collection

Read the instructions for use carefully before using this device

IP22

IP Rating IP22

35

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Manufacturer & After-Sale Service:

Smartmissmo Technologies Pte Ltd

4 Shenton Way, #28-01 SGX Centre II

Singapore 068807

E-Mail: [e-mail]

Phone: [phone]

Contact for any assistance in setting up, using, maintaining, or reporting unexpected operation or events.

EU AUTHORISED REPRESENTATIVE:

Medical Technology Promedt Consulting GbmH,

Altenhostrasse 80, 66386, St. Ingbert, Germany

Electromagnetic Compatibility (EMC)

PowerDot PD-02 is designed to be used in home healthcare environments in accordance with the EMC safety
standard IEC 60601-1-2 (4th Edition) and with limitations, defined by the warnings and precautions in this
manual (e.g. operation near RFID emitters, working microwave ovens, etc.).

Examples of home healthcare environment include restaurants, cafes, shops, stores, markets, schools,
churches, libraries, outdoors (streets, sidewalks, parks), domiciles (residences, homes, nursing homes),
vehicles (cars, buses, trains, boats, planes, helicopters), train stations, bus stations, airports, hotels, hostels,
pensions, mus eums, theatr es.

PowerDot PD-02 is designed to support anticipated disturbance originating from electrostatic discharge,
magnetic fields for the power supply or radiofrequency emitters.

However, the performance of PowerDot PD-02 device can still affected by radi o frequenc y fields ori ginating
from other sources.

For more information about EMC emissions and immunity, contact the manufactur er.

The device should not be used adj acent to or st acked with other equip ment. If adja cent
or stacked use is necessary, the device should be observed to verify normal operation in
the configuration in which it will be used.

The use of accessories, transducers and cables others than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.

Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the PowerDot PD-02, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.

PowerDot PD-02 battery charging performance might degrade in the environments

36

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with frequent voltage interruptions (when charging from the wall adapter). To support
consistent and reliable charging, the usage of uninterrupted power supply (UPS) is
highly recommended, if operating in such environments.

The following device function is considered essential to the safety of the user: ability to maintain consistent
stimulation intensity (amplitude), pulse frequency and pulse waveform (both shape and width).

In case if the essential performance is lost or degraded due to electromagnetic disturbances, stimulation safety
and effectiveness can be compromised. Whenever the patient realizes unexpected change in any of
stimulation parameters, it’s is advised to terminate the stimulation session immediately by using one of the
methods provided in the Terminating Stimulation section.

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