Enraf-Nonius CD-ROM Endomed 484 User manual

Type
User manual

This manual is also suitable for

EN109-1498740-41 IFU
ENDOMED 484
EN109-1498740-41 IFU
May 4, 2021
Instructions for use
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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).
Fig. 1 Current waveforms
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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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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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Fig. 6. Typical ramped stimulation pattern
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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
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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.
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5 Installation
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.
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.
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.
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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.
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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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Enraf-Nonius CD-ROM Endomed 484 User manual

Type
User manual
This manual is also suitable for

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