Enraf-Nonius Endomed 484 User manual

EN109-1498740-41 IFU

ENDOMED 484

EN109-1498740-41 IFU

May 4, 2021

Instructions for use

Page 2 of 56 EN109-1498740-41 IFU

Table of contents

1 Introduction ...................................................................................................................................................... 3

2 Description-symbols used and device markings ............................................................................. 13

3 Device components .................................................................................................................................... 15

4 Package contents ......................................................................................................................................... 16

5 Installation ...................................................................................................................................................... 18

6 Intended use and intended user ............................................................................................................ 20

7 Indications ...................................................................................................................................................... 22

8 Contraindications ......................................................................................................................................... 24

9 Precautionary instructions ........................................................................................................................ 26

10 Operation ........................................................................................................................................................ 27

11 Application information............................................................................................................................. 42

12 Maintenance and troubleshooting ........................................................................................................ 48

13 Specifications ................................................................................................................................................. 52

14 Contact ............................................................................................................................................................. 55

15 Product liability ............................................................................................................................................. 55

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1 Introduction

It is important to read the following instructions carefully before using your device properly

and safely. The manufacturer cannot be held responsible for the results of using this device

for any purposes other than described in these operating instructions.

If the use of this device may have caused or contributed to an undesirable event such as

death or serious injury to the user, the manufacturer AND the competent authority of the

Member State MUST be notified immediately!

Foreword

Thank you for purchasing the Endomed 484.

The Endomed 484 designed and manufactured by Enraf-Nonius B.V., offers a new dimension in

electrotherapy, made possible by advanced software design. The result is a device with extraordinary

versatility based on simplicity of operation.

This manual has been written for the owners and operators of the Endomed 484. In order to maximize

the use, efficiency and lifespan of your unit, please read this manual thoroughly and become familiar

with the controls as well as the accessories before operating the device.

Device Description

The Endomed 484 is a 4 channel electrostimulator for Pain Management (TENS and PENS) and Muscle

Stimulation (NMES). The device is intended for use by professional users only.

The device is part of the 4-series. The 4-series is a family of products for physical therapy. The devices

share an identical control panel equipped with a touch screen in a PC-ABS plastic housing. The

Endomed 484 is mains powered and can optionally be equipped with a battery for mains independent

operation for use in an ambulatory setting (e.g. home treatment). It has a modified front panel for

electrode connections (4 pairs of electrodes in total).

The Endomed 484 is equipped with a full color touch screen and a turning knob for easy operation

of the device. The graphic user interface allows for maximum operator comfort. The device includes

preset clinical guidelines (‘protocols’). Individual treatment parameters can also be set manually and

adjusted by the operator. All treatment parameters can be set and saved as favorites (personalized

settings) as a reference for future therapy sessions.

The 4 stimulation channels are fully independent channels that can be used in combination (linked)

or totally independent. The intensity can be regulated separately for each channel. Protocols can run

on linked or independent channels. When working with independent channels, up to four different

protocols can be performed simultaneously.

The following current wave forms can be selected:

• Asymmetrical Biphasic Pulsed Current

• Symmetrical Biphasic Pulsed Current

• Symmetrical Biphasic Pulsed Current with Interphase Interval

The electrical stimulation is applied to the skin via surface electrodes (TENS and NMES) or

percutaneous electrodes (PENS) with the objective to stimulate specific types of nerve fibers or

acupoints. Various sizes of electrodes (from point electrode with a surface of 0.3 cm2 to electrodes

with a surface of 96 cm2) are available to accommodate the size of the treatment area or anticipated

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treatment goal. Enraf-Nonius does not supply percutaneous electrodes (such as disposable

acupuncture needles or needle-like electrode pads).

In a TENS/PENS/NMES electrode circuit, one electrode is positively charged (anode) and the other

negatively charged (cathode). An action potential (nerve impulse) is initiated in the underlying nerve

fibers by the flow of current between two electrodes. The types of nerve fiber stimulated, and thus

the mechanisms of muscular stimulation, are determined by the stimulation parameters that are set

on the device.

TENS/PENS is believed to relieve pain by several mechanisms which involve the stimulation of specific

types of nerve fibers. TENS/PENS is regarded as a low frequency current with currents at a frequency

typically below 300 Hz.

The practice of NMES rests on the use of the pulsed electrical currents applied to skeletal muscles

with the objective to elicit contraction caused by the electrical depolarization of intramuscular nerve

branches. The main purpose of NEMS is to preserve and recover muscle function in patients and to

improve muscle strength in healthy individuals.

Principles of Operation

TENS (Transcutaneous Electrical Nerve Stimulation)

Transcutaneous Electrical Nerve Stimulation is a non-pharmacologic treatment for pain relief.

The method has been used to treat a variety of painful conditions. TENS is the application of electrical

current through electrodes placed on the skin for pain control. It can be applied with varying

frequencies, from low (< 10 Hz) to high (> 50 Hz). Intensity may also be varied from sensory to motor

intensities. Sensory intensity is when the patient feels a strong but comfortable sensation without

motor contraction. The type of stimulation delivered by the TENS unit aims to excite (stimulate) the

sensory nerves, and by so doing, activate specific natural pain relief mechanisms. For convenience, if

one considers that there are two primary pain relief mechanisms which can be activated: the Pain

Gate Mechanism and the Endogenous Opioid System. The variation in stimulation parameters is used

to activate these two systems. TENS as a treatment technique is non-invasive and has few side effects

when compared with drug therapy. TENS is administered via (carbon) rubber electrodes or adhesive

electrodes.

PENS (Percutaneous Electrical Nerve Stimulation)

Percutaneous Electrical Nerve Stimulation is a virtually painless method for the application of specific

TENS frequencies via two or more (acupuncture) needles and/or surface electrodes. Each pair of

needles that is inserted through the skin, functions as a pair of electrodes. The fundamental difference

between TENS and PENS is actually quite an important one, because PENS can directly target the

nerve endings that are causing pain. When a TENS procedure is used, the skin can often act as a

barrier and some of the electrical stimulation is lost through the skin’s natural defences, so a PENS

system can get straight to the root of the problem and none of the potency of the electrodes is lost.

This electrostimulation technique can be considered as a modern form of Electro acupuncture.

NMES (Neuromuscular Electrical Nerve Stimulation)

Neuro Muscular Electrical Stimulation is the use of electrical currents in a manner that produces a

smooth tetanic muscle contraction through stimulation of innervated muscle with or without limb

movement and/or functional improvement. The contraction often is a repeated pattern of stimulating

innervated muscles by depolarizing local motor nerves. The use of electrical current to improve

functional movements such as walking or grasping is often referred to as FES (Functional Electrical

Stimulation). Typically, this technique includes muscle activation as with NMES. Effects of NMES are

associated with muscle weakness or impaired motor function. NMES is used to activate, strengthen,

or retrain muscles in order to increase or hasten clinical outcomes for clinical indications such as:

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stroke rehabilitation, management of orthopaedic conditions (hip and knee arthroplasty, ACL-repair,

patellofemoral pain syndrome) and chronic disease management (COPD, and osteoarthritis).

Method of Operation

Current Waveforms

The Endomed 484 is capable of outputting the following waveforms:

- Asymmetrical Biphasic Pulsed Current

- Symmetrical Biphasic Pulsed Current

- Symmetrical Biphasic Pulsed Current with Interphase Interval

The biphasic nature of the pulse means that there is no net DC component (zero net DC), thus

minimizing any skin reactions due to the build-up of electrolytes under the electrodes.

The asymmetrical biphasic pulsed current waveform is characterized by variable phase duration and

variable pulse frequency. Its typical amplitude, duration and rate of rise and decay are unequal for

each phase with respect to the baseline. The waveform is fully balanced, i.e. the phase charges of

each phase are equal.

The symmetrical biphasic pulsed current waveform has a specified phase duration that applies to

both pulse phases, which doubles the amount of available energy with respect to the asymmetrical

pulsed current waveform.

The interphase interval, which is the elapsed time between two successive phases of a single biphasic

pulse, is an additional stimulation parameter that can be adjusted to influence the induced force of

contraction and muscle fatigue.

TENS/PENS

In this section the main treatment variables will be outlined.

Output Intensity (Amplitude)

The Endomed 484 can output a current intensity in the range of 0-140 mA. When the objective is to

elicit motoric reactions like in NMES, large size surface electrodes are used. However in PENS, smaller

(needle) electrodes are being used. It should be remembered that the area (size) of the electrode

affects the current density. Current density in turn is an important factor in determining the responses

of biological tissues. When using needle electrodes (electrodes with an extremely small area and at

the same time inserted in or through the skin) there is little resistance to the passage of the electrical

current. As a result, the current density is high.

The primary goal of both TENS and PENS therapy is to stimulate sensory nerves. As long as sufficient

current is passed through the tissues (skin), these nerves will depolarize. In other words, both

modalities can be effective for pain relieve. In TENS however, higher intensity (more mA’s) is needed

Fig. 1 Current waveforms

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to depolarize the sensory nerves whereas in PENS less current is sufficient. So, although it is

favourable to use a needle-electrode to obtain an analgesic effect, one must realize the influence on

current density when administering intensity. In view of the above and in order to provide additional

safety, the current output of the Endomed 484 is limited to max. 40 mA when choosing PENS.

Pulse Frequency

The Endomed 484 can deliver discrete ‘pulses’ of electrical energy. The rate of delivery of these pulses

are variable from 0.5 pulses per second (Hz) up to 200 Hz. This is a clinically effective range.

Theoretically, for delivering TENS, high frequencies (up to 200 Hz) should be optimum. Frequencies

in the range of 2-100 Hz are the most effective frequencies for PENS.

Pulse Duration

In addition to the stimulation rate, the duration (or width) of each pulse may be varied from 5 to 450

microseconds (μs). Recent evidence would suggest that this is possibly a less important control than

the intensity or the frequency and the most effective setting in the clinical environment is probaly

around 200 μs. The reason that such short duration pulses can be used to achieve these effects is that

the targets are the sensory nerves which tend to have relatively low thresholds (i.e. they are quite

easy to excite) and that they will respond to a rapid change of electrical state. There is generally no

need to apply a prolonged pulse in order to force a sensory nerve to depolarise, therefore stimulation

for less than a millisecond is sufficient.

Modulation Modes

The following stimulation patterns are available:

1) High Frequency TENS/PENS

Normal TENS/PENS usually uses stimulation at a relatively high frequency (80 – 130 Hz) and employs

relatively narrow (short duration) pulses, though as mentioned above, there is less support for

manipulation of the pulse width in the current research literature. Most patients seem to find best

effect at around 200 ms. The stimulation is delivered at ‘normal’ intensity - definitely there but not

uncomfortable. 30 minutes is probably the minimal effective time, but it can be delivered for as long

as needed. The main pain relief is achieved during the stimulation, with a limited ‘carry over’ effect –

i.e. pain relief after the machine has been switched off.

2) Low Frequency TENS/PENS

Lo TENS/PENS uses a lower frequency stimulation (2-5 Hz) with wider (longer) pulses (200-250 ms).

The intensity employed will usually need to be greater than with the traditional TENS/PENS - still not

at the patients threshold, but quite a definite, strong sensation. As previously, something like 30

Time

Stimulation

Intensity

Fig. 3 Lo TENS using stimulation at a ‘low’

frequency, typically between 2-5 Hz (pps)

Time

Stimulation Intensity

Fig. 2 Normal TENS using stimulation with ‘high’

frequency typically between 80-130 Hz (pps)

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minutes will need to be delivered as a minimally effective dose. It takes some time for the opioid

levels to build up with this type of TENS/PENS and hence the onset of pain relief may be slower than

with the traditional mode. Once sufficient opioid has been released however, it will keep on working

after cessation of the stimulation. Many patients find that stimulation at this low frequency at intervals

throughout the day is an effective strategy. The ‘carry over’ effect may last for several hours, though

the duration of this carry over will vary between patients.

3) Burst Mode TENS/PENS

As described in Fig. 4, the device is set to deliver traditional TENS/PENS, but the Burst mode is

switched in, therefore interrupting the stimulation outflow at rate of 2 - 3 bursts / second. The

stimulation intensity will need to be relatively high, though not as high as the brief intense TENS/PENS

– more like the Lo TENS/PENS. It is proposed that the application of Burst mode TENS/PENS can

effectively stimulate both the Pain Gate and the Opioid mechanisms simultaneously.

4) Modulated TENS/PENS

In modulation mode, the device delivers a less regular pattern of TENS/PENS stimulation in an

attempt to reduce or minimise the accommodation effects of regular, patterned stimulation.

Modulated patterns fluctuate between upper and lower limits over a fixed period of time.

The device can offer different methods of varying the stimulation pattern. The pulse frequency, the

output intensity (amplitude) and the pulse duration, or a combination of these methods can be

varied. The reseach evidence to date does not favour one variation method over another. This is

potentially most useful for patients who use TENS/PENS for hours a day, if for no other reason than

accommodation occurs at a slower rate and therefore less intensity adjustment may be required.

Time

e.g. Burst Mode at 3 Hz (with 100 Hz internal)

TENS

UNIT

A-Beta

fibers

A-Delta

fibers

Fig. 4

Stimulation (at around 100Hz) delivered in

BURST mode (at 2-3Hz) such that both the A-

Beta (due to 100Hz) and the A Delta (due to 2-

3Hz) are stimulated

Time

Stimulation Intensity

Time

Stimulation Intensity

Time

Stimulation Intensity

Fig. 5 Modulation Mode TENS/PENS

in which the stimulation pattern is varied in

order to reduce nerve accommodation.

Different modulation methods include:

(A) INTENSITY (AMPLITUDE)

(B) PULSE DURATION (WIDTH)

(C) FREQUENCY

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One of the first to investigate the combined application of acupuncture and electrical stimulation was

professor Han. He investigated the best settings to use for maximum production of the two central

opioid peptides that are associated with pain relief. His method is called Han stimulation.

Low Frequency stimulation at 2 Hz accelerates the release of enkephalin, whereas High Frequency

stimulation at 100 Hz selectively accelerates the release of dynorphin. The combination of these two

frequencies produces a simultaneous activation of the enkephalin and dynorphin systems, resulting

in a more effective therapy than stimulation at either one or the other frequency. The alternating

stimulation of the two systems induces a much more analgesic effect than that induced by a constant

frequency stimulation.

NMES

The main objective of NMES is to improve muscle strength in patients suffering from disuse atrophy

and in healthy individuals. The mechanism of NMES relates primarily to muscle fiber type and

stimulation frequency, though there are almost certainly other parameters that have an influence (e.g.

waveform, stimulation pattern, electrodes). Therefore, practitioners need to set the electrical

stimulation parameters prior to therapy.

The stimulation parameters, affecting muscle and nerve response, include:

• current waveform

• amplitude (stimulation intensity)

• current output CC

• pulse duration

• pulse frequency

• duty cycle (ON:OFF ratio)

• ramp times (up / down)

• electrical stimulation mode

• duration and frequency of treatment

• electrodes (type, size, and electrode placement)

Current waveforms

Biphasic current wave forms seem to be the most effective.

Some researchers have published evidence which supports the asymmetric over the symmetric

waveform because the asymmetric current produced more force output. However, force of

contraction is not only depending on the shape of the stimulating waveform: it is also determined by

the amplitude, frequency and duration of the pulse. To produce a contraction of a designated

intensity, it should be remembered that the shorter the pulse duration, the greater the pulse amplitude

needed (this is demonstrated in so-called Strength-Duration curve).

The therapist should adjust the waveform to produce a satisfactory contraction in as comfortable a

fashion as possible. Although it is not clear from the literature which waveforms are most acceptable,

patient preference must also be kept in mind when selecting an NMES current wave form.

Amplitude (stimulation intensity)

This is best used on a subjective rather than an objective basis. The most commonly used method to

achieve this is to gradually increase the stimulation intensity (with the patient making no contribution)

until a significant contraction is achieved with the machine alone. Once this level is established, the

patient is instructed to 'join in' with the stimulation patterns, which is straightforward if a patterned /

ramped stimulation is employed.

Setting current amplitude in NMES is critical because of the physiologic correlation between the current

amplitude and spatial motor unit (MU) activation, The higher the current amplitude used, the greater

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the number of motor units activated, and the larger the evoked muscle contraction output of force.

The higher the current amplitude, the higher the effectiveness of NMES for muscle strengthening in

both healthy individuals and patients.

Current output CC

Stimulators used for NMES are constant current type (CC-type) stimulators. This means that a set

currrent amplitude (e.g. 80 mA) remains constant (hence, the term constant current during treatment,

regardless of changes in tissue impedance over time).

The main advantage of CC-type stimulators is that they deliver predictable levels of electrical

stimulation, making therapy more predictable and comfortable for the patient.

Pulse duration

In NMES, the duration of pulses often ranges from 100-600 s. To produce a contraction of a

designated intensity, it should be remembered that the shorter the pulse duration, the greater the

pulse amplitude needed. Recent evidence would suggest that pulse duration is possibly a less

important control than the intensity or the frequency and the most effective setting in the clinical

environment is probably around 200 s. Stronger muscle contractions occur with 300-400 s pulses,

but these will also produce significant stimulation of sensory fibers.

Pulse frequency

The frequency is very important in NMES because the physiological correlate of frequency is temporal

MU activation. In other words: setting the pulse/burst/beat frequency is like setting the frequency at

which all the activated MUs will fire during the evoked muscle contraction. Pulsed biphasic current

may be delivered as pulses (pulse frequency) or bursts of pulses (burst frequency). Setting the

frequency between 30 and 60 Hz is necessary to obtain optimal temporal MU activation dduring the

fused tetanic muscle contraction, because research has established that the mean fusion frequency

for skeletal muscles is approximately 50 Hz (or pps/bups). lnitially, low frequencies (20 Hz) and short

contraction/ long relaxation times can be used to minimize muscle fatigue. It is worth noting that the

rate of muscle fatigue during NMES is greater than that seen during voluntary contraction.

The stimulation frequency also affects force generation. Maximum forces are produced with tetanic

contractions at 60 – 100 Hz. However, these frequencies not only produce higher fatigue, but also

more discomfort and potential for muscle damage, especially with patients (tetanic stimulation is

widely researched with athletes/ fit individuals rather than patients suffering from muscle

dysfunction). Lower forces (about 65% force) are achieved with stimulation at lower frequencies of

20 Hz that produce much less fatigue. However, comparison of strength gains produced at 20 Hz, 45

Hz and 80 Hz in normal quadriceps femoris showed no significant difference.

Duty cycle (ON:OFF ratio)

The ON-time is the time, rneasured in seconds, during which electrical current is delivered to the

target muscle. Its duration corresponds to the duration of the volitional muscle contraction.

Conversely, the OFF-time is the time, also measured in seconds, during which there is no current

flowing in the target muscle. Its duration corresponds to the duration of the rest period between two

successive contractions. The relationship between ON-time and OFF-time is commonly expressed as

a ratio.

For example, setting a 10 second ON-time and a 30-second OFF-time would produce an ON:OFF

ratio of 10s:30s. Such a ratio means that the resting time between two successive evoked contractions

is three times longer than that of contraction time (1:3).

The ON:OFF ratio should be modified to match the fatigue characteristics of the muscle being

stimulated. A moderate ramp of 2-3 seconds should be used except in cases of high current

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intensities, where longer ramp-up and ramp-down times (5 seconds) may be more appropriate. There

is evidence that if the ON-time is 10 seconds then the OFF-time must be at least 60 seconds to avoid

fatigue. If the aim of treatment is to strengthen muscle then treatment can be progressed over a

number of sessions by increasing the frequency up to 100 Hz and altering the duty cycle so that the

contraction time is lengthened and the relaxation time reduced. Evidence suggests that the stronger

the induced contraction force in the muscle the greater are the strength gains. In addition, inducing

fatigue is an important component of any strengthening regimen (by altering the duty cycle),

although in early treatment sessions of weakened muscle the parameters are chosen to minimize

fatigue.

Equal cycles (1:1) are only used for the stronger / fit patients and in the end stage of the rehab

program. Higher ratios are used for the weaker patients to allow proper stimulation with a minimal

chance of fatigue. If muscles are weak or in poor state, long(er) rest times should be used. For instance,

if using NMES for 4-ceps in a very weak patient (after total knee operation) an ON-OFF ratio of 1:9 is

used at start and progressively reduced towards 1:1. So, 10 sec stimulation is followed by 90 sec rest.

The term ON:OFF ratio is not synonymous with duty cycle. However, setting the ON:OFF ratio

automatically sets up the duty cycle, which is defined as the ratio of ON-time to the combined ON

and OFF-times, expressed as a percentage. For example, an ON:OFF ratio of 10s:20s sets up a duty

cycle of 33% which means that the muscle contraction occurs during 10 s, which is 1/3 of the elapsed

time (30s) between two successive electrically evoked muscle contractions. To recap, an ON:OFF ratio

of 10s:20s means that the resting time between two successive evoked contractions is two times that

of contraction time. The corresponding 33% duty cycle implies that muscle contraction occurred

during 33% of the time during two successive evoked contractions.

Ramp times (up / down)

For proper NMES, the stimulator must be programmed such as to generate an evoked muscle

contraction, which resembles, or mimics, as closely as possible that generated during volitional effort.

A voluntary muscle contraction is a smooth contraction characterized by a short gradual rise and fall

of force at the beginning and end of contraction, respectively.

For an electrically evoked muscle contraction to mimic such a smooth contraction several parameters

need to be set on the electrical stimulator.

As shown in figure 6 the time course of a volitional contraction begins with a gradual upward ramping,

from the beginning to the plateau phase of the contraction, followed by a similar smooth downward

ramping at the end of contraction. The gradual increase of the stimulation strength at start and a

gradual decrease at the end of stimulation is more physiological and certainly more comfortable. The

(upward and downward) ramping effect is part of the full muscle contraction time or ON-time. To

mimic this volitional effect using NMES, practitioners need to adjust the ramp up and down times

accordingly.

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Fig. 6. Typical ramped stimulation pattern

Note the ON-time includes the ramp up and down times, as well as the time during which the

contraction is maintained relatively constant (plateau time or hold time). Setting ramp up and down

times within the ON-time mimics as closely as possible the gradual build up and relaxation phases

seen at the beginning and the end of a voluntary muscle contraction. Ramp up and down times are

usually set between 0.5 and 2 seconds to prevent the sudden, or jerky, rise and fall of evoked muscle

contractions, thus making its time course as smooth as possible. As shown in figure 6, ramp up times

are often longer (2 - 4 sec) than ramp down times (1 - 2 sec).

Electrical stimulation modes

The Endomed 484 features a time delay switch, allowing channels to be triggered or activated

independently. This allows the practitioner to choose between the following stimulation modes:

1. Synchronous

2. Alternating

3. Asynchronous

4. P.E.M.S.

1. Synchronous

The synchronous mode is achieved by setting delay time (D) at zero seconds, with the ON and OFF

times of channel 1 equal to the ON and OFF times of channel 2 (e.g., D = 0 sec; channel 1: ON = 5

sec, OFF 15 sec; channel 2: ON = 5 sec, OFF = 15 sec). Both channels are thus synchronously activated

(ON) and deactivated (OFF) for the full duration of application. This mode allows synchronous

stimulation of two different muscle groups or two muscle parts within a muscle group.

2. Alternating (reciprocal)

The alternating mode is achieved by setting the delay time (D) equivalent to the ON time of channel

1, while setting the ON time of channel 1 equal to the OFF time of channel 2 (e.g., D = 5 sec; channel

1: ON = 5 sec, OFF = 15 sec; channel 2: ON = 15 s, OFF = 5 s). This setting results in a reciprocal

activation of both channels for the full treatment duration. Clinically speaking, it allows reciprocal or

alternating stimulation of two different muscles or muscle groups, such as the agonist versus the

antagonist.

3. Asynchronous

This overlapping mode is achieved by setting the delay time (D) value greater than zero seconds but

less than the ON time of channel 1, while keeping the ON and OFF times of both channels identical

(e.g., D = 3 sec; channel 1: ON = 5 sec, OFF = 15 sec; channel 2: ON = 5 sec, OFF = 15 sec). Both

channels now overlap as channel 2 is activated 3 seconds after channel 1, for the full duration of the

treatment session. Clinically speaking, this mode allows overlapping, or concomitant, stimulation of

two different muscles or muscle groups.

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4. P.E.M.S.

Progressive Electrical Muscle Stimulation offers the possibility to create a “normal functional”

sequential contraction of muscles within a movement chain. The P.E.M.S. mode is a special case of

the asynchronous mode, in which the surge program ends on all channels immediately. The specified

hold-time is the hold-time on channel 1.

Duration and frequency of treatment

The frequency of sessions and the number of contractions can also be increased over time and

generally follow the same principles as used in voluntary exercise strengthening programmes, that

is, 8-15 maximum contractions per session, for three to five sessions per week, over 3-6 weeks of

training.

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2 Description-symbols used and device markings

Symbol used

Description

Follow the instructions in the Instructions for Use.

It is important that you read, understand and observe the precautionary and

operating instructions

General Prohibition Sign.

Prohibition is used to mean “You MUST NOT”

Warning or Caution:

Indicates a hazardous situation which, if not avoided, could result in:

a. Death or serious injury to the patient (or)

b. Minor to moderate injury to the patient (or)

c. Damage to the equipment

General mandatory action sign.

Mandatory action is used to mean, “You must…”

Type BF applied part complying with the specified requirements to provide a

higher degree of protection against electric shock than that provided by type B

applied parts.

Temperature Range.

Indicates acceptable temperature range

Humidity Limits.

Indicates acceptable relative humidity

Atmospheric Pressure.

Indicates the range of atmospheric pressure to which the medical device can

be safely exposed.

Waste electrical items that can be recycled.

Indicates the electrical and electronic components of the device can be

recycled and has to be disposed separately.

Keep the device dry

Manufacturer name, address and date of manufacture.

Reference Number or Part Number

Serial Number

Indicates the serial number so that a specific medical device can be

identified.

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CE Mark along with number indicates conformity with European Council of

directive concerning Medical Devices and this device is under the direct

supervision of the Notified Body.

On-Off Switch

USB-connection

Do not unplug the Endomed 484 from mains power or turn off the device

when this symbol is displayed on the screen.

Connection electrode cable electrotherapy

Alternating current

“ON” (power)

“OFF” (power)

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3 Device components

Parts Description

Numbered

Part

Description

Purpose

[1]

Central controller with light ring

Use this controller to scroll through the pages

and to adjust the parameters. The light ring is

illuminated when the controller is ready to use.

ET-1

Electrotherapy output channel 1

Connection point for the patient cable

ET-2

Electrotherapy output channel 2

Connection point for the patient cable

ET-3

Electrotherapy output channel 3

Connection point for the patient cable

ET-4

Electrotherapy output channel 4

Connection point for the patient cable

[2]

LCD Touch Screen

User Interface that allows the operator to

control the device and change parameters of

treatment protocols.

[3]

Power supply source indication LED

Green: Device connected to mains supply.

When a battery is present, it is

charged.

Orange: Device operating from battery

[4]

On / Off switch

This button is used to turn the device On or

Off.

[5]

Battery compartment

Compartment to place optional battery

[6]

USB Connection

Connection for USB-stick (do not connect to

PC). Used for software updates and to backup

and restore user data.

[7]

Connector for mains cable

with mains switch

Connect supplied mains cable here to power

the device.

0 Device disconnected from mains supply

1 Device connected to mains supply

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4 Package contents

1498981 1x Endomed 484

Standard accessories

Below you will find the Standard accessories that are present in the packaging:

1498740 1x CD-ROM with Instructions For Use (PDF on CD-ROM)

1498742 1x Information Booklet

3444290 1x Mains cable 230V-EUR

1498010 1x Device base (inclination support)

3444211 4x Patient cable 2-core & 2 mm male plugs - black, with color clips

xxxxxxx 8x self-adhesive electrode (EN-Trode) 5x5 cm, 2 mm female

xxxxxxx 8x self-adhesive electrode (EN-Trode) 5x9 cm, 2 mm female

3444180 1x Point Electrode, 2mm female connector, incl. 10 silicone conductive caps

3444182 2x Crocodile clamp with 2 mm female connector (set of 2)

Optional accessories

Cart

1468960 EN-Car U3 (gray)

Adhesive electrodes

3444222 Adhesive electrodes for stimulation & EMG, 10 sets of 8 pcs.

3444056 EN-Trode Ø 3,2 cm, 2 mm female, packing of 10 sheets of 4 pcs.

3444135 EN-Trode Ø 5,0 cm, 2 mm female, packing of 10 sheets of 4 pcs.

3444057 EN-Trode 5x5 cm, 2 mm female, packing of 10 sheets of 4 pcs.

3444058 EN-Trode 5x9 cm, 2 mm female, packing of 10 sheets of 4 pcs.

Point electrode

3444180 Point Electrode, 2 mm female connector, in transparent case, incl. 10

silicone conductive caps

3444181 Silicon conductive caps (set of 10 pcs) for 3444.180 (spare part)

Rubber electrodes

3444128 Rubber electrodes 4x6 cm, 2 mm female set of 2

3444129 Rubber electrodes 6x8 cm, 2 mm female set of 2

3444130 Rubber electrodes 8x12 cm, 2 mm female set of 2

3444380 Silicon electrode 5x5 cm

Moist pads for rubber electrodes

1460273 Moist pads for rubber electrode 4x6 cm, set of 4

1460266 Moist pads for rubber electrode 6x8 cm, set of 4

1460275 Moist pads for rubber electrode 8x12 cm, set of 4

Fixation straps

3444020 Strap 100x3 cm

3444021 Strap 250x3 cm

3444022 Strap 100x5 cm

3444023 Strap 250x5 cm

Page 17 of 56 EN109-1498740-41 IFU

Adapters

2523523 Adapter plug, 2 mm female/4 mm male, black (spare part)

2523524 Adapter plug, 2 mm female/4 mm male, red (spare part)

3444182 Crocodile clamp with 2 mm female connector (set of 2)

Patient cable

3444211 Patient cable, black, 2 core with 2mm male plugs & colored clips

Bag

3444675 Carrier bag

Battery

2501016 Battery Pb 12 V, 2 Ah (spare part)

Ordering Information

For the ordering data of the Endomed 484, standard accessories and optional accessories we refer

to the website www.enraf-nonius.com.

Page 18 of 56 EN109-1498740-41 IFU

5 Installation

Inspection

In case of damage from transport is noticed, contact your local distributor.

DO NOT USE the device!

Immediately upon unpacking the device, perform the following steps:

• Verify the delivery documents to make sure that the delivery is complete.

• Verify that the packaging contains all the items listed in the standard accessories list

(Refer to chapter 4 - Package Contents in this manual).

• Check the external components and accessories for possible damage due to transport.

Connection to mains supply

Use of any other cable other than the supplied cable is strictly PROHIBITED as it

affects patient safety and the proper function of the device.

Before connection of this unit to the mains supply, check that the mains voltage and

frequency stated on the identification plate of this apparatus corresponds with that of the

mains supply.

Make certain that the device is electrically grounded by connecting only to a grounded

electrical service receptacle conforming to the applicable national and local electrical codes.

Do not place the device in a location where the power cord could be tripped over or pulled

out during treatment!

Plug in the device to a wall socket using the mains cable.

• Insert the mains cable into socket and connect it to a wall socket.

• Set mains switch to On.

• Power LED indicator is lit green indicating that the device is connected to the mains supply.

• Turn on the device with On / Off button.

• The device will initialize and perform a self-test. This may take a while.

• At the end of the self-test the device enters the Home menu and is ready for use.

Placing the optional battery

Do not interchange the black and red wires as this will damage your device!

The battery contains material that is noxious to the environment. Observe the local

regulations when disposing of the battery!

Due to the high current demand of electrotherapy applications, we recommend to explicitly

use batteries supplied by Enraf-Nonius B.V. (part number 2501.016).

• Remove the mains cable from the mains connector.

• Place the Endomed 484 device upside down and on a soft surface.

• Remove the two screws from the battery cover using a screwdriver.

• Slide and lift the battery cover.

• Align the battery on the bottom of the main unit with the polarity of battery terminals in the

correct position. The polarity is marked at the bottom of the battery compartment.

• Locate the black wire and attach it to the – terminal of the battery.

• Locate the red wire and attach it to the + terminal of the battery.

• Slide the battery upside down into the battery compartment taking care that the wires do not

get jammed.

• Place and slide the battery cover back into position.

• Secure the battery cover with the two screws using a screwdriver.

• Place the device back on its feet.

• Reconnect the mains cable to the power line connector.

Page 19 of 56 EN109-1498740-41 IFU

Operation from battery

• Leave mains switch in the Off position and turn on the device on using push button.

• Power LED indicator is lit orange, indicating that the device is operating from the battery.

• When you have finished the treatments, turn off the device using push button.

With the mains switch to On, the battery is automatically charged, independent of the state of the

On/Off push button. We recommend to use the apparatus from the powerline whenever possible.

This will increase the service life of the battery.

Disconnection of mains supply

Systems without a battery

• When you have finished treatment, turn the device off by setting the mains switch to Off. The

device is now disconnected from the mains supply.

Systems with a battery

• Turn off the device with On/Off button.

• Power indicator LED is still lit green, indicating that the device is still connected to the mains

supply and that the battery is being charged.

• Set mains switch to Off to stop charging and to disconnect the unit from the mains supply.

Page 20 of 56 EN109-1498740-41 IFU

6 Intended use and intended user

Intended use

The Endomed 484 is a 4 channel electro-stimulator designed for use by health professionals to ensure

electric stimulation treatments for Pain Management (TENS and PENS) and Muscle Stimulation

(NMES).

The Endomed 484 is a valuable supplement to medical and therapeutic treatment for use in

hospitals, clinics, general practices and at patient’s home by a therapist.

TENS and PENS

Pain Management by means of electrostimulation refers to:

- Symptomatic relief of chronic, intractable pain

- Management of pain associated with post-traumatic or postoperative conditions

- Relief of pain associated with arthritis

The electrical stimulation is applied to the skin via surface electrodes (TENS) or via percutaneous

electrodes (PENS) with the objective to stimulate specific types of nerve fibers. Pain relief (pain

modulation) can be achieved by:

1. blocking the information travelling along the nociceptive fibers (i.e. those that produce

pain) through stimulation of the large diameter afferent A fibers

2. through the release of the body’s endogenous opioids by stimulation of the small

diameter afferent and motor fibers

PENS / Electroacupuncture is a minimaly invasive treatment technique that requires special skills to

insert disposble acupuncture needles in/through the skin (=percutaneous) at specific points of the

body. Therefore this procedure should only be performed by medical professionalists that have a

profound knowledge and experience in the field of Traditional Chniese Medicine and/or

(Electro)Acupuncture.

Enraf-Nonius does not supply percutaneous electrodes (such as disposable acupuncture needles and

needle-like electrode pads). The user must ensure that sterile percutaneous electrodes for single use

are being used when applying PENS/Electroacupuncture and that such electrodes meet the standards

for medical devices and the requirements for electrode needles.

NMES

Goal of an NMES treatment is to elicit a strong muscle contraction through stimulation of the motor

nerve (A-alpha) with the objective to preserve and recover muscle function in patients and to improve

muscle strength in healthy individuals. The application of NMES for enhancing the control of

movement and posture falls under the field of functional electrical stimulation (FES). More specifically,

this therapeutic field focuses on the enhancement of impaired motor functions, such as hand

grasping, locomotion, and respiration, using complex transcutaneous and percutaneous electrical

muscle stimulation systems. The main purpose of FES is to enable motor function by replacing, or

assisting, a patient's voluntary ability to execute or control the impaired functions.

In clinical practice, NMES is used in different areas, specifically:

• Stroke Rehabilitation: for promoting muscle strengthening and functional recovery of limbs in

hemiplegia (e.g. shoulder subluxation, hand / upper extremity function, foot drop and gait re-

training);

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