Enraf-Nonius CD-ROM Endomed 182 Benutzerhandbuch

Page 1 of 52 EN109-1634750-40 IFU

Endomed 182

EN109-1634750-40 IFU

September 21, 2020

Instructions for use

Page 2 of 52 EN109-1634750-40 IFU

Table of contents

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

2 Symbols .............................................................................................................................................................. 7

3 Device components ....................................................................................................................................... 9

4 Package contents ......................................................................................................................................... 13

5 Installation ...................................................................................................................................................... 15

6 Intended use and intended user ............................................................................................................ 16

7 Indications ...................................................................................................................................................... 17

8 Contra-indications ....................................................................................................................................... 18

9 Precautionary instructions ........................................................................................................................ 20

10 Operation ........................................................................................................................................................ 23

11 Application information............................................................................................................................. 37

12 Maintenance and troubleshooting ........................................................................................................ 44

13 Specifications ................................................................................................................................................. 48

14 Contact ............................................................................................................................................................. 51

15 Product liability ............................................................................................................................................. 51

Page 3 of 52 EN109-1634750-40 IFU

1 Introduction

Foreword

Thank you for purchasing the Endomed 182.

The Endomed 182, designed and manufactured by Enraf-Nonius B.V., offers a new dimension in

electrotherapy, made possible by advanced hardware and 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 182. 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 182 is a mains-powered electrostimulator and is equipped with a full color touch

screen. The graphic user interface allows for maximum operator comfort.

Three versions of the Endomed 182 are available:

Endomed 182 versions

Name:

Endomed 182 Type 1

Endomed 182 Type 2

Endomed 182 Type 3

Article

number:

1634903

1634901

1634902

Article

number base

unit:

1634910

1634900

Current

Wave Forms:

Direct current

TENS

• continuous biphasic pulsed

current (conventional TENS

mode)

• trains of biphasic pulsed current

(Burst TENS mode)

Interferential Current (IFC)

• 2-pole interferential

(bipolar) mode

• 4-pole interferential

(tetrapolar) mode

• 4-pole interferential

(tetrapolar) with Isoplanar Vector

TENS

• continuous biphasic pulsed

current (conventional TENS

mode)

• trains of biphasic pulsed current

(Burst TENS mode)

Interferential Current (IFC)

• 2-pole interferential

(bipolar) mode

• 4-pole interferential

(tetrapolar) mode

• 4-pole interferential

(tetrapolar) with Isoplanar Vector

Vacuum

Channels:

1

2

Pre-

programmed

treatment

protocols:

-

16

Page 4 of 52 EN109-1634750-40 IFU

The Endomed 182 Type 1 is a mains-powered single-channel electrostimulator for the application

of Percutaneous Electrolysis (PE) by means of low-intensity Direct Current (DC).

In PE, the Direct Current (also referred to as Galvanic Current) is applied through a needle that is

placed in the needle holder of a handpiece (the ‘applicator’ or cathode). The return electrode (or

anode) is a hand-held electrode (held by the patient) or another needle, depending on the treatment

to be performed.

The needle holder of the applicator (handpiece) enables the attachment of acupuncture needles

(sterile, single-use and disposable) of different length and diameter, necessary to ensure proper

placement in different areas (depending on the disorder to treat).

The handpiece is equipped with a start/stop button to begin or interrupt the flow of current manually.

The device delivers a continuous galvanic current with a maximum output of 15 mA.

The graphic user interface shows the following treatment parameters: current output level (mA), time

set for the application, actual current delivered (mC).

The user can set and adjust the output level of the current (mA) and the application time, depending

on the type of treatment.

The device does not offer any preset clinical protocol, but treatment parameters can be set and saved

as favorites (personalized settings) as a reference for future therapy sessions.

The device is a compact unit that comes with the following accessories: mains and connecting cables,

handpiece (applicator), return electrode, footswitch (optional) and product documentation.

Consumables such as disposable (acupuncture) needles are not delivered with the product.

Enraf-Nonius B.V. does not supply percutaneous electrodes or disposable acupuncture needles.

The Endomed 182 Type 2 and 3 include 16 preset clinical protocols for TENS and Interferential

currents. 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 Endomed 182 Type 3, is a stacked configuration that consists of a separate vacuum suction

module and an electrostimulator Endomed 182 Type 2. The vacuum module is placed under, and

connected to, the stimulator. The purpose of the module is to generate a vacuum which enables the

therapist to quickly and (more) easily secure (fixate) the stimulation electrodes to the patient. The

fixation is achieved by means of suction cups. The suction cups have integrated stimulation surfaces

that transfer the electrostimulation via moistened sponges to the target tissue.

For Endomed 182 Type 2 and 3 the electrical stimulation can thus be applied to the skin via surface

electrodes: flexible rubber electrodes, self-adhesive electrodes or vacuum electrodes (Type 3 only),

with the objective to stimulate specific types of nerve fibers. Enraf-Nonius has various types and

sizes of electrodes (from point electrode with a surface of 0.3 cm2 to electrodes with a surface of 96

cm2) available to accommodate the size of the treatment area or the anticipated treatment goal.

Page 5 of 52 EN109-1634750-40 IFU

Current Wave Description

TENS

The asymmetrical biphasic pulsed current waveform is often used in TENS (Transcutaneous Electrical

Nerve Stimulation) applications. This 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 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.

To prevent accommodation to stimulation or to

improve patient tolerance, the pulse frequency

can be varied through frequency modulation.

Asymmetrical biphasic waveform TENS

Burst TENS

Burst TENS is applied if Conventional TENS proves ineffective, and is particularly suitable for the

treatment of deeper lying painful regions and cases of chronic pain. Burst TENS uses a relatively

large phase duration (150-200 μs), a low burst frequency (1-5 Hz) and a high frequency.

Strong, visible contractions should occur in the muscles whose innervation corresponds with that of

the painful region.

The pain-reducing effect generally does not appear for some twenty to thirty minutes, unlike the

effect of Conventional TENS, which usually occurs fairly rapidly. However, the effect lasts for

considerably longer than that of Conventional TENS after stimulation has ended. The pain-reducing

effect of Burst TENS is due to the release of endorphins at both spinal and supraspinal level.

If Conventional or Burst TENS give no or insufficient relief, Frequent Modulation can be used.

Frequency Modulation can also prevent accommodation.

Interferential current (IFC)

With the interferential current type, a medium frequency carrier frequency is used to pass the low

frequency stimulation (beat) frequency through the skin. The relatively low resistance of the skin to

the carrier frequency contributes to the patient comfort that is often associated with this current

type. Interferential currents are all AC currents without any residual DC components. Several

variations of the interferential current type are known, of which the following are available in the

Endomed 182 Type 2 and 3: 2-pole, 4-pole and 4-pole with isoplanar vector.

The two-pole method

In this method two electrodes are used and

superimposition of the two alternating currents takes

place within the equipment. The current leaving the

equipment is a fully modulated alternating current. In

the two-pole method the modulation depth is always

100%.

Bipolar interferential therapy

Page 6 of 52 EN109-1634750-40 IFU

The four-pole method (Classic Interferential)

With this therapy method four electrodes are used and

two non-modulated currents are generated. The

frequency of one channel is fixed at the carrier

frequency, while the other channel has a variable

frequency, based on the Beat frequency and Frequency

Modulation settings. Interference occurs where the two

currents intersect in the tissue. The modulation depth

(which determines the current amplitude of the

stimulation) depends on the direction of the currents,

and can vary from 0 to 100%. 100% modulation depth

only occurs at the diagonals (and hence at the

intersection) of the two currents. This is of course a

theoretical situation, based on the assumption that the

tissue is homogeneous. In reality, the tissue is

heterogeneous, so that the current balance between

the two channels has to be used to obtain the 100%

modulation depth. The current balance can also be

used to compensate for differences in sensation

occurring under the electrodes.

In the four-pole method, the modulation

depth is only 100% at the diagonals.

The four-pole method with Isoplanar vector

With the Isoplanar vector the total area between the 4

electrodes is optimal stimulated. The electrode

positioning can be done simple and quick. The

modulation depth is 100% everywhere.

Isoplanar Interferential can be used for the treatment

of problems which are located in a large area and

which are very difficult to locate. Isoplanar Interferential

is also used as a mild pre-treatment. After this

application the treatment is continued with a focus on

a smaller, more local area.

Isoplanar vector

Direct current

A direct current (DC) or galvanic current is a continuous current that has been used in medicine for

a number of therapeutic aims. The continuous current refers to the continuous flow of electric

charge via a current conductor between two points (electrodes) with different potentials (polarity),

which does not change direction over time. In contrast to alternating currents, the electrical charges

always flow in the same direction.

Page 7 of 52 EN109-1634750-40 IFU

2 Symbols

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 that the electrical and electronic components of the device can be

recycled and have to be disposed of 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.

Alternating current

Page 8 of 52 EN109-1634750-40 IFU

Connection electrode cable electrotherapy

Connections vacuum cables electrotherapy

“ON” (power)

“OFF” (power)

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.

Page 9 of 52 EN109-1634750-40 IFU

3 Device components

Endomed 182 Type 1

Endomed 182 Type 2

7

8

1

9

1

2

1

3

1

4

1

6

1

5

1

10

11

Page 10 of 52 EN109-1634750-40 IFU

Endomed 182 Type 3

12

13

16

15

14

17

18

19

21

20

Page 11 of 52 EN109-1634750-40 IFU

Parts Description

Numbered

Part

Description

Purpose

[1]

LCD Touch Screen

Color TFT display 4.3” with touch screen. Displays

the User Interface that allows the operator to

control the device and change parameters of

treatment protocols.

[2]

Connection Electrode holder

[3]

Connection blank earth

electrode

Connection for DC reference cable which connects

to the blank earth electrode

[4]

Blank earth electrode

Reference electrode

[5]

DC reference cable

Return electrode connection cable

[6]

Electrode holder

Handpiece for needle holder

[7]

Connection A

Connection for Vacuum Module (Endomed 182

Type 3 / Footswitch (Endomed 182 Type 1)

[8]

Connection B

Connection for Current Module

[9]

Current Module

Current Module with connection for adhesive and

rubber electrodes.

[10]

Connection 1 Current Module

Connection channel 1 for patient cable for adhesive

or rubber electrodes on Current Module Endomed

182.

[11]

Connection 2 Current Module

Connection channel 2 for patient cable for adhesive

or rubber electrodes on Current Module Endomed

182.

[12]

Vacuum electrode holder

Holder for vacuum electrodes.

[13]

Vacuum Module

Vacuum Module integrated with Endomed 182

with connections for adhesive or rubber electrodes

and vacuum electrodes.

[14]

Vacuum Module electrode

cables

Vacuum Module electrode cables need to be

connected to the Current Module [7] and [8]

connection for the correct functioning of the

Vacuum Module connections.

[15]

Upper connections Vacuum

Module

Connections channel 1 and 2 for patient cable for

adhesive or rubber electrodes on Vacuum Module.

[16]

Lower connections Vacuum

Module

Connections channel 1 and 2 for vacuum lead hose

for vacuum electrodes on Vacuum Module.

[17]

Mains switch

To switch the unit on and off

When turning the unit off the display remains

visible for a few seconds (low-energy method).

[18]

Reference label

Provides information of the device, such as type

and serial number.

[19]

Connector for Mains cable

Connect supplied Mains Cable here to power the

device.

[20]

Air outlet

Air outlet for Vacuum Module.

Page 12 of 52 EN109-1634750-40 IFU

Parts Description

Numbered

Part

Description

Purpose

[21]

Connection for water reservoir

This connection is used for connecting the water

reservoir. No vacuum can be created unless the

water reservoir is connected. The water reservoir

ensures that any excess water from the sponges is

collected, and cannot be blown out through the

pump. The reservoir should be emptied daily.

Please refer to the section on Maintenance.

Page 13 of 52 EN109-1634750-40 IFU

4 Package contents

Device

The package contents depend on the device ordered. The following models are available:

Article number

Description

1634903

Endomed 182 Type 1

1634901

Endomed 182 Type 2

1634902

Endomed 182 Type 3 (includes integrated Vacuum Module)

Standard accessories Endomed 182 Type 1

1634750

CD-ROM with Instructions For Use (PDF on CD-ROM)

1634751

Information Booklet

3444357

Power cord 250V/2.5 A, L=2.5 m, black

3444080

Electrode holder

3444582

Blank earth electrode

3444677

DC reference cable

Standard accessories Endomed 182 Type 2 and Endomed 182 Type 3

1634750

CD-ROM with Instructions For Use (PDF on CD-ROM)

1634751

Information Booklet

3444357

Power cord 250V/2.5 A, L=2.5 m, black

3444021

Strap 250x3 cm

3444020

Strap 100x3 cm

3444129

(2x) Rubber electrodes 6x8 cm, 2 mm female, set of 2

1460266

Moist pads for rubber electrodes 6x8 cm, set of 4

3444211

(2x) Patient cable 2-core & 2 mm male plugs – black, with color clips

Additional standard accessories Endomed 182 Type 3

3444503

(2x) Vacuum electrodes Ø 60 mm, set of 2

3444505

Sponges Ø 65 mm, set of 4 (for vacuum electrodes Ø 60 mm)

3444507

(2x) Vacuum lead hose red

3444508

(2x) Vacuum lead hose black

Optional accessories Endomed 182 Type 1

1634810

Foot switch

Optional accessories Endomed 182 Type 2 and Endomed 182 Type 3

Adhesive electrodes

3444056

EN-Trode Ø 3,2 cm, 2 mm female,10 sheets of 4

3444135

EN-Trode Ø 5,0 cm, 2 mm female, 10 sheets of 4

3444057

EN-Trode 5x5 cm, 2 mm female, 10 sheets of 4

3444058

EN-Trode 5x9 cm, 2 mm female, 10 sheets of 4

3444222

Adhesive electrodes Ø 2,2 cm, 2 mm female, 10 sheets of 8

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

Page 14 of 52 EN109-1634750-40 IFU

Moist pads for rubber electrodes

1460273

Moist pads for rubber electrodes 4x6 cm, set of 4

1460266

Moist pads for rubber electrodes 6x8 cm, set of 4

1460275

Moist pads for rubber electrodes 8x12 cm, set of 4

Fixation straps

3444020

Strap 100x3 cm

3444021

Strap 250x3 cm

3444022

Strap 100x5 cm

3444023

Strap 250x5 cm

Point electrodes

3444180

Point electrode, 5 mm Ø, 2 mm female, pen model, incl. 10 conductive rubber

caps

Adapters

2523523

Adapter plug, 2 mm female, 4 mm male, black

2523524

Adapter plug, 2 mm female, 4 mm male, red

Patient cables

3444211

Patient cable 2-core & 2 mm male plug – black, with colored clips

Additional optional accessories Endomed 182 Type 3

Vacuum electrodes

3444503

Vacuum electrodes Ø 60 mm, set of 2

3444504

Vacuum electrodes Ø 90 mm, set of 2

3444509

Vacuum electrodes Ø 30 mm, set of 2

Sponges

3444505

Sponges Ø 65 mm, set of 4 (for vacuum electrodes Ø 60 mm)

3444506

Sponges Ø 95 mm, set of 4 (for vacuum electrodes Ø 90 mm)

3444516

Sponges Ø 30 mm, set of 4 (for vacuum electrodes Ø 30 mm)

Vacuum lead hoses

3444507

Vacuum lead hose, red

3444508

Vacuum lead hose, black

Ordering information

For the ordering data of the Endomed 182 and accessories we refer to the website

www.enraf-nonius.com.

Page 15 of 52 EN109-1634750-40 IFU

5 Installation

Inspection

In case any damage is noticed after unpacking the device, please immediately contact your

local distributor. DO NOT USE the device!

The unit should be installed in such a way, that its warmth can be passed on to the

surroundings.

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.

Unpacking

The Endomed 182 is specially packaged for transport in a single pack complete with filling which

has been specifically designed for safe transportation and storage.

• To remove the equipment from the pack, place the box on a smooth, flat surface.

• Open the top of the box and remove the polystyrene filling.

• Be very careful when removing the contents of the pack.

Device setup

Endomed 182 Type 2:

• Connect the cable from the Current Module [9] to Connector B [8].

Endomed 182 Type 3:

• Connect the cable from the Current Module [9] to Connector B [8].

• Connect the cable from the Vacuum Module [13] to Connector A [7].

Refer to chapter 3 – Device components in this manual.

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.

To avoid the risk of electric shock, this equipment must only be connected to a supply mains

with protected earth.

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

• Insert the mains cable into cable socket [19] and connect it to a wall socket.

Disconnection of mains supply

• 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.

• Disconnect the mains cable from the wall socket.

• Disconnect the mains cable from socket [19].

Page 16 of 52 EN109-1634750-40 IFU

6 Intended use and intended user

Intended use

Endomed 182 Type 1

The Endomed 182 Type 1 is a single-channel electrostimulator, intended and designed for use by

health professionals to perform Percutaneous Electrolysis (PE) by means of low-intensity Direct

Current (DC).

Endomed 182 Type 2 and 3

The Endomed 182 Type 2 and 3 are 2 channel electrostimulators, intended and designed for use by

health professionals to perform Pain Management with IFC (Interferential current) and TENS

current.

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 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

Intended user

The Endomed 182 is intended to be used, and shall only be used, by or under the supervision of

professional users in the field of physical medicine and rehabilitation at professional healthcare

facilities.

Additionally for Endomed 182 Type 1:

If a health professional (physiotherapist, physician) is allowed and trained to use ultrasound-guided

galvanic electrolysis therapy, the health professional is allowed and trained to:

-> to perform needle punctures on a patient;

-> to use ultrasonography;

-> to use galvanic electrolysis therapy.

Page 17 of 52 EN109-1634750-40 IFU

7 Indications

Indications Endomed 182 Type 1

Percutaneous Electrolysis

Percutaneous Electrolysis (PE) can be used for the treatment of the following conditions:

• Patellar tendinopathy / patellar tendonitis (‘jumper’s knee’)

• Lateral elbow tendinopathy (tennis elbow)

• Medial elbow tendinopathy (golfer’s elbow)

• Myofascial Pain Syndrome / Triggerpoints

• Acute whiplash syndrome (AWS)

• Shoulder disorders (rotator cuff tendinopathies, Subacromial Pain Syndrome)

• Pubalgia (groin pain)

• Hamstring tendinopathy

• Achilles tendinopathy

• Fasciitis Plantaris / Heel Pain

Indications Endomed 182 Type 2 and 3

TENS

Relief of acute pain

• Postoperative pain

o Abdominal

o Thoracic

o p.o. orthopedic pain

• Labour pain and post-labour pain

• Dysmenorrhea

• Orofacial pain, including dental procedures

• Physical trauma, including fractured ribs and minor medical procedures

Relief of chronic pain

• Low back pain

• Arthritic pain, including osteoarthritis, rheumatoid arthritis

• Muscle pain, including myofascial pain, muscle tension, post-exercise soreness

• Neuropathic pain, including post amputation (phantom pain), post-herpetic, trigeminal

neuralgia

• Cancer pain, including metastatic bone pain

• Complex Regional Pain Syndrome

Interferential Current (IFC)

Relief of acute and chronic pain, such as:

• Postoperative pain /orthopedic pain

• Low back pain

• Neck pain

• Shoulder pain

• Arthritic pain, including osteoarthritis, rheumatoid arthritis

• Muscle pain, including myofascial pain, muscle tension, post-exercise soreness, and

fibromyalgia

Muscle Stimulation

• Muscle strengthening (in general)

• Faecal and urinary incontinence

Bowel Dysfunction

Increase local (cutaneous) blood flow

Page 18 of 52 EN109-1634750-40 IFU

8 Contra-indications

The Endomed 182 MUST NOT be used for the below mentioned symptoms or medical

conditions.

Contraindications Endomed 182 Type 1

Contraindications for use

• Infectious arthritis

• Heart disease / cardiac arrhythmia

• Pregnancy

• Skin ulcers and other skin infections

• Endoprosthesis and/or osteosynthesis

• Pacemakers

• Oncological processes

• Thrombophlebitis / history of vascular insufficiency in the legs

• Coagulopathy / anticoagulation drugs

• Blood dyscrasia

• Menstruation

• Needle phobia

• Fear of electrical stimulation

• Endocrine glands

• Patients with impaired sensitivity

• Patients with central and peripheral neurological disorders

• Patients with neurovegetative disorders

• Paediatric patients

• Complicated medical conditions

• Cognitive impairment

• Drug or alcohol abuse

Points where treatments should not be applied:

• Blood vessels

• Endocrine glands

• Organs

• Peripheral nerves (endoneurium)

• Head, eyes, neck and thorax or upper part of the back traversing the heart

Precautions Percutaneous Electrolysis

Regions that require special caution:

• Abdominal region

• Intercostal region (precaution against pneumothorax)

• Thoracic region (precaution against pneumothorax)

• Thoracic outlet (precaution against pneumothorax)

• Inguinal region, popliteal hollow (precaution against damaging neurovascular bundles)

Page 19 of 52 EN109-1634750-40 IFU

Contraindications Endomed 182 Type 2 and 3

Absolute contraindications:

• Undiagnosed pain

• Active implants (incl. cardiac pacemakers and implantable cardioverter defibrillators - ICDs)

• Tissue bleeding (haemorrhage)

• Patients who do not comprehend the practitioner’s / physical therapist’s instructions or who are

unable to co-operate

Relative contraindications (= local contraindications):

• Pregnancy (do not apply anywhere over abdomen/pelvic region)

• Malignancy (do not apply over active malignancy)

• Epilepsy (do not apply on neck or head)

• Cardiac disturbances such as dysrhythmias (do not apply through the chest)

• Electrode placement around the eyes

• Electrode placement over the anterior aspect of the neck or carotid sinus

• Electrode placement through the chest (i.e. anterior and posterior electrode positions)

• Electrode placement over testes

• Electrode placement over active epiphyseal regions in children

• Electrode placement over damaged skin or open wounds

• Electrode placement over dermatological lesions e.g. dermatitis, eczema or on frail skin

• Electrode position over areas where there is ischaemic tissue and/or thrombosis

Note: There are no known adverse effects of administering IFC / TENS on skin over or close to metal

implants. TENS / IFC can be used on the intact skin overlying implants containing metal, plastic, or

cement. Persons with joint replacements that include metal components have been treated with

electrostimulation with benefit and without adverse reactions.

Precautions TENS and IFC

Caution and precaution should be taken in case of:

• Areas with abnormal skin sensation (dysaesthesia)

o hypereasthesia (allodynia / hyperalgesia)

o hypoeasthesia

• Contact dermatitis

• Pregnant women

• Patients sensitive to autonomic reactions of TENS (e.g. nausea, light-headedness and fainting)

Potential adverse effects

Skin irritation and etching beneath the electrodes have been reported with the use of therapeutic

electrical stimulation.

Isolated cases of skin irritation may occur in patients with particularly sensitive skin. In case of an

allergic reaction to the electrode gel, suspend the treatment and contact a specialist. If during the

treatment signs of tachycardia and extrasystole appear, suspend the treatment and contact your

physician.

Page 20 of 52 EN109-1634750-40 IFU

9 Precautionary 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!

This device should be kept out of the reach of children.

The patient and the device must be in sight of the therapist at all times.

The device is not intended for use in so-called "wet rooms" (hydrotherapy rooms).

This equipment is not suitable for use in the presence of flammable anesthetics mixture with

air, oxygen, or nitrous oxide.

Do not expose the device to direct sunlight, heat radiated from a heat radiator, excessive

amounts of dust, moisture, vibrations and mechanical shocks.

This device should be used only under the continued supervision of a physician or licensed

practitioner.

In case any damage is noticed after unpacking the device, please immediately contact your

local distributor. DO NOT USE the device!

The unit should be installed in such a way, that its warmth can be passed on to the

surroundings.

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.

To avoid the risk of electric shock, this equipment must only be connected to a supply mains

with protected earth.

Do not use the device after extreme temperature fluctuations!

Before starting the treatment please make sure: you have read and understood the content of

this manual

Before starting the treatment please make sure: you strictly follow the WARNINGS and

CAUTIONS mentioned under precautionary instructions

Before starting the treatment please make sure: you have checked the patient for any possible

contra-indications.

Connection of accessories other than the ones supplied by the manufacturer can adversely

affect the safety of the patient and correct functioning of the equipment, and is therefore not

permitted.

To prevent infection, electrodes and sponge pads should not be used on broken skin.

During treatment, the patient may not feel unpleasant sensations amounting to pain. A mild

sensation of excitation is permissible.

If, as result of treatment, headache, vertigo, fatigue and/or other (autonomic nervous)

reactions develop, subsequent treatment should be given at a lower intensity.

It is recommended that diathermy machines (such as shortwave and microwave devices) are

kept at least one metre away from electrostimulation devices as the output of

electrostimulation devices can be affected by close proximity to an operating (pulsed)

shortwave or microwave machine.

Stimulation should not be applied across or through the head, directly on the eyes, covering

the mouth, on the front of the neck (especially the carotid sinus), or from electrodes placed

on the chest and the upper back or crossing the heart.

Application of electrodes near the thorax may increase the risk of cardiac fibrillation.

Simultaneous connection of a patient to a high frequency surgical medical electrical

equipment may result in burns at the site of the stimulator electrodes and possible damage

to the stimulator.

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