Enraf-Nonius CD-ROM Endomed 182 Manual de usuario

Marca: Enraf-Nonius

Modelo: CD-ROM Endomed 182

Tipo: Manual de usuario

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:

Pre-

programmed

treatment

protocols:

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

Page 10 of 52 EN109-1634750-40 IFU

Endomed 182 Type 3

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.

Page 21 of 52 EN109-1634750-40 IFU

Any electrodes that have current densities exceeding 2 mA/cm² may require the special

attention of the operator.

Repeated use of pre-gelled electrodes leads to rapid loss of conductivity and deteriorating

adhesiveness.

The loss of adhesion and drying of the gel will cause the edges to begin lifting which can

dramatically increase current density; cause uneven distribution of current across the

electrode surface, increasing the risk of burn; and potentially result in electrode movement.

Changes that occur in self-adhesive electrodes over time result in an unsafe situation where

skin irritation and patient discomfort can occur.

Self-adhesive electrodes should never be shared between patients.

Clean the device and its accessories regularly to maintain hygienic safety.

Before performing any user maintenance, switch off the device and disconnect the plug from

the mains supply.

Do not spray the cleaning agent directly on the glass panel.

Do not use cleaning agents that contain strong alkalis, lye, acid, detergents with fluoride or

detergents with ammonia.

Do not allow any liquids to penetrate the device or its accessories while cleaning and

disinfecting!

Dry all sockets and connectors that have become wet before any further use!

Mechanical shocks /or vibrations MUST be avoided while cleaning the device

Do not drop the device.

The device should not be used when mechanical damage is noticed. This includes damaged

cable insulation.

In the event that an error message or warning appears, immediately stop all use of the device.

Shutdown and restart the device. If the problem persists contact the supplier or Enraf-Nonius

B.V. for service. Errors and warnings indicate an internal problem with the device that must be

tested by a field service technician certified by Enraf-Nonius B.V before any further operation

or use of the system.

Use of a device that indicates an error or warning may pose a risk of injury to the patient,

user, or extensive internal damage to the system.

In case of display failure or other obvious defects, unplug the device immediately and notify a

certified service technician.

In the case of ingress of liquids, unplug the device from the Mains supply and have it checked

by an authorized person.

Opening of the equipment by unauthorized agencies is not allowed and will terminate any

claim to warranty.

The manufacturer will not be held responsible for the results of maintenance or repairs by

unauthorized persons!

Only service Technicians authorized by Enraf-Nonius can perform maintenance or modify this

equipment according to Service Information.

Maintenance shall not be performed on the equipment when equipment is in use or

connected to a patient.

It is recommended to have the Endomed 182 checked yearly by authorized personnel of

Enraf-Nonius or by its authorized distributor.

Medical electrical devices such as the Endomed 182 are subject to special precautions with

regard to electromagnetic compatibility (EMC) and must be installed and commissioned in

accordance with the EMC advice given in the instructions for use.

Use of this equipment adjacent to or stacked with other equipment should be avoided because

it could result in improper operation. If such use is necessary, this equipment and the other

equipment should be observed to verify that they are operating normally.

Page 22 of 52 EN109-1634750-40 IFU

Use of accessories, transducers and cables other than those specified or provided by the

manufacturer of this equipment could result in increased electromagnetic emissions or

decreased electromagnetic immunity of this equipment and result in improper operation.

Portable RF communications equipment (including peripherals such as antenna cables and

external antennas) should be used no closer than 30 cm to any part of the Endomed 182,

including cables specified by the manufacturer. Otherwise degradation of the performance of

this equipment could result.

The Endomed 182 should only be operated with the original power cable specified in the list

of contents delivered. Operating the device with any other power cable can lead to increased

emissions or reduced interference immunity of the device.

Page 23 of 52 EN109-1634750-40 IFU

10 Operation

Set up

Do not use the device after extreme temperature fluctuations!

Frequently Used Functions

Selecting the Clinical Protocols (only applies to Endomed 182 Type 2 and 3), Favorite and Manual

Operation buttons in the touch screen.

Switch On

• Switch the unit On by pushing the On/Off Button at the back of the unit.

• After switching on the device, a welcome screen will be displayed while the device performs a

self-test.

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

When the unit is switched on all vital functions are controlled via an internal microprocessor. During

the functioning of the unit the actual output of the current is measured continuously and compared

to the requested output. Whenever a faulty situation is detected the unit will switch off the current

immediately.

Navigation

Home Menu

The Home menu gives access to all functions of the unit. The Home menu provides a structured

access to all therapies available within the unit, with appropriate parameter defaults. The Endomed

182 is equipped with touch screen technology. Just select a menu item by touching the button to

navigate to the next screen. You can navigate back to the previous screen by touching the back

button at the top of the screen.

• Select “Clinical Protocols”

to start working with

preset protocols. This does

not apply to Endomed 182

Type 1.

• Select “Favorites” to use a

manually saved protocol

• Select “Manual Operation”

to set all parameters

manually

• Select “System Settings” to

enter the settings menu

Endomed 182 Type 1 home

Endomed 182 Type 2 and 3

home menu

Page 24 of 52 EN109-1634750-40 IFU

System Settings

Select System Settings in the Home Menu, to adjust various settings, check the software version or

restore the device to factory defaults. The options Acoustic Feedback, Buzzer Tone and Buzzer

Duration are only available in the Endomed 182 Type 2 and 3.

Set Language

1) Select “System Settings”

2) Select “Language”

3) Select the preferred

language with the 

buttons.

4) Push OK to confirm and to

return to the previous menu

Set Brightness

To change the Brightness of

the screen:

1) Select “Brightness”

2) Adjust the brightness via

the  buttons.

Range: 10 – 100%

3) Push OK to confirm and to

return to the previous menu

Page 25 of 52 EN109-1634750-40 IFU

System Info

1) Select “System Info”

In the next screen information

about the unit can be found.

The currently installed

software version is shown.

2) Push BACK to return to the

previous menu

Acoustic Feedback

Endomed 182 Type 2 and 3:

Select this option to turn on

or off audio signals at the end

of treatment.

1) Select “Acoustic Feedback”

2) Turn Acoustic Feedback On

or Off

3) Push BACK to return to the

previous menu

Page 26 of 52 EN109-1634750-40 IFU

Buzzer Tone and Buzzer Duration

Endomed 182 Type 2 and 3:

1) Select “Buzzer Tone” or

“Buzzer Duration”

Buzzer Tone provides access to

7 different tunes to signal the

end of a treatment.

Buzzer Duration provides

access to 7 different intervals

to signal the end of a

treatment.

Maintenance

Restore Factory Defaults will

delete any favorites stored on

the device and clear any

system settings, returning the

device in its original factory

state.

The Service menu is intended

for Enraf-Nonius qualified

service organizations and can

only be entered with an

access code.

Tank Cleaning will activate the

pump. See chapter 12

Maintenance and

troubleshooting. (Applies only

to Endomed 182 Type 3.)

1) Select “Maintenance”

(Applicable for Endomed 182

Type 2 and 3)

Page 27 of 52 EN109-1634750-40 IFU

Manual Operation Endomed 182 Type 1

The Endomed 182 Type 1 has one output channel. See chapter 11 for connection of electrodes.

1) Select “Manual Operation” in

the Home Screen

Select (K) to set treatment time

Select (L) to set intensity

2) Set treatment time

Option: 3 s / 10 s / 60 s

Or via the  buttons

3) Set intensity

Option: 1 mA / 3 mA / 5 mA

Or via the  buttons

4) Press the Start button (or the

foot switch when connected) to

start treatment

5) Press the Stop button (or the

foot switch when connected) to

stop treatment.

Treatment stops automatically

when the treatment time has

elapsed.

Page 28 of 52 EN109-1634750-40 IFU

Clinical Protocols

For the Endomed 182 Type 2 and 3 a list of common electrotherapy treatments can be found under

Clinical Protocols. These evidence-based protocols have been created by professional and expert

operators after years of experience in the field.

The pre-set clinical protocols are adjustable and rewritable. See chapter 11 for connection of

electrodes.

1) Select “Clinical Protocols” in

the Home screen to activate

the list

2) Select the  button to

scroll through the list.

3) Select  icon for more

information about the

protocol

4) Select the chosen Clinical

Protocol to go to the

Parameter Screen

Protocol information screen

5) Touch the  button to

scroll through the pages

6) Select OK to go to the

parameter screen or BACK to

return to the Clinical

Protocols menu

Page 29 of 52 EN109-1634750-40 IFU

7) The parameter screen shows

all parameters at a glance

8) The pre-set clinical protocol

parameters can be adjusted

9) Push the channel tab 1 or 2

at the bottom of the screen to

change the intensity level

10) Adjust the intensity level via

the  buttons

11) Push OK to confirm and

return to the previous screen

12) The protocol will start after

setting the intensity level

13) The protocol can be

stopped by pressing the stop

icon (A) on the touchscreen.

The protocol stops

automatically when the

treatment time has elapsed.

Page 30 of 52 EN109-1634750-40 IFU

Manual Operation Endomed 182 Type 2 and Type 3

With Manual Operation personal parameter settings can be defined for electrotherapy.

The Endomed 182 Type 2 and 3 has two independent output channels. To select the output

channel, touch the channel tab on the bottom of the screen. See chapter 11 for connection of

electrodes.

1) Select “Manual Operation” in

the Home Screen

2) Select the desired Current

Wave Form; the parameter

screen will appear

3) Depending on the selected

Current Wave Form various

parameters can be set.

Setting Parameters: Frequency

1) Select Frequency (B)

2) Adjust Frequency via the

 buttons

Range: 1 Hz – 200 Hz

3) Push OK to confirm and

return to the parameter

screen

Page 31 of 52 EN109-1634750-40 IFU

Setting Parameters: Burst Frequency

1) Select Burst Frequency (C)

2) Set Burst Frequency

Option: 1 Hz / 2 Hz / 4 Hz

3) Push OK to confirm and

return to the parameter

screen

Setting Parameters: Modulation Frequency

1) Select Modulation

Frequency (D)

2) Adjust Modulation

Frequency via the 

buttons

Range: 1 Hz- 180 Hz

3) Push OK to confirm and

return to the parameter

screen

Page 32 of 52 EN109-1634750-40 IFU

Setting Parameters: Modulation Time

1) Select Modulation Time (E)

2) Set Modulation Time

Option:

1-1 seconds

6-6 seconds

1-30 seconds

3) Push OK to confirm and

return to the parameter

screen

Setting Parameters: Treatment Time

1) Select Treatment Time (F)

2) Set treatment time via the

 buttons

Range: 0 to 60 minutes

3) Push OK to confirm and

return to the parameter

screen

Page 33 of 52 EN109-1634750-40 IFU

Setting Parameters: Vacuum Module

With the Endomed 182 Type 3

it is possible to use vacuum

electrodes

1) Select Vacuum (G)

2) Set vacuum parameters

Option: pulsed mode 1 Hz /

pulsed mode 2 Hz /

continuous

3) Adjust the pressure of the

vacuum cups via the 

buttons

The vacuum cups are

automatically selected when

the pump starts to run

Setting Parameters: Intensity

1) Push the channel tab 1 or 2

(H) at the bottom of the screen

to set the intensity level (after

setting the treatment time)

2) Adjust the intensity level via

the  buttons

3) Push OK to confirm and

return to the previous screen

4) The program will start after

setting the intensity level

5) The program can be stopped

by pressing the stop icon on

the touchscreen. The program

stops automatically when the

treatment time has elapsed.

Page 34 of 52 EN109-1634750-40 IFU

Setting Parameters: Balance Control

For 4P Interferential the

balance control option is

available after Intensity has

been set.

With balance control the

intensity of Channel 1 relative

to Channel 2 can be increased

or decreased. An increase of

the intensity of Channel 1 will

automatically decrease the

intensity of Channel 2 and vice

versa.

1) Select Balance Control (I)

2) Set Balance Control

parameters

3) Push OK to confirm and

return to the parameter screen

Setting Parameters: Vector View

For 4P Isoplanar Vector a

vector view screen is available

after treatment has started.

1) Select Vector View (J)

In this screen an animation of

rhythmic shrinking and

swelling rings can be seen as

well as the remaining

treatment time and intensity

level.

Page 35 of 52 EN109-1634750-40 IFU

Favorites

Prior to the execution of a modified clinical protocol or manual setting, it can be saved for later use

under favorites.

When all parameters in the treatment screen are completely set as required, you can choose to save

the settings as favorites by pressing the store button.

Favorites can be stored as long as treatment has not been started.

1) Push Store (M) to save the

program settings

2) Select the program number

via the  buttons

20 store locations are available

for the Endomed 182

3) Push OK to confirm

4) Enter a name for your

favorite

5) Push OK to save the favorite

Page 36 of 52 EN109-1634750-40 IFU

Loading and Deleting Favorites

1) Select “Favorites” in the

Home menu

2) To load a program select a

Favorite via the  buttons

The parameter screen will

appear

3) To delete a Favorite press

the delete button (N) and

select the Favorite to be

removed via the  buttons

4) Press OK to permanently

delete the Favorite

Page 37 of 52 EN109-1634750-40 IFU

11 Application information

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.

Any electrodes that have current densities exceeding 2 mA/cm² may require the special

attention of the operator.

Connection of electrodes

See chapter 3 for description of numbered parts.

Endomed 182 Type 1

• Connect the DC reference [5] cable to connection [3]

• Connect the blank earth electrode [4] to the DC reference cable [5]

• Use of blank earth electrode: during treatment the patient needs to hold the blank earth

electrode by hand

• Connect the electrode holder [6] cable to connection [2]

• Attach the needle (not supplied) to the electrode holder through the thread system, which

allows the electrode holder to be opened, the needle to be inserted and the electrode holder to

be closed

• The needle holder is equipped with a start/stop button to begin or interrupt the flow of current

manually.

Page 38 of 52 EN109-1634750-40 IFU

Endomed 182 Type 2

• Connect the patient cables to connection 1 [10] and/or connection 2 [11] on the Current

Module [9] (red plug into red connection, black plug into black connection).

• Connect the electrodes to the patient cable.

Endomed 182 Type 3

• For use of adhesive or rubber electrodes: connect the patient cables to the upper connections

[15] on the Vacuum Module [13] and connect the electrodes to the patient cables (red plug into

red connection, black plug into black connection).

• For use of vacuum electrodes: connect the vacuum lead hoses to the lower connections [16] on

the Vacuum Module [13] and connect the vacuum electrodes to the vacuum lead hoses (red

plug into red connection, black plug into black connection).

Treatment

Before treatment

• The skin of the area in question is cleaned (removal of grease) with soap or 70 % alcohol

• Shaving hairy skin is recommended

• Test the sensitivity of the treatment area

• Position the electrodes and/or sponges (do not forget to moisten)

• Follow the operating instructions in chapter 10 on how to adjust the settings and start and stop

the treatment

During treatment

• Intensity is set at the desired level

• The patient is regularly asked to report any sensations felt. If necessary, the treatment is

modified.

Ending treatment

• Treatment can be stopped by pressing the stop icon on the touchscreen. Treatment stops

automatically when the treatment time has elapsed.

After treatment

• Remove the electrodes and/or sponges

• Clean the patient’s skin with a towel or tissue

• The expected effects are checked (e.g. pain, circulation, and mobility)

• The patient is asked to comment subsequently on any reactions that may occur

Endomed 182 Type 1:

Percutaneous Electrolysis

Percutaneous Electrolysis (PE) is a non-pharmacologic, minimally-invasive treatment technique for

chronic tendinopathies and has few side effects compared to pharmaceutical intervention. PE is

generally well tolerated by most patients, and complications and adverse events are extremely rare.

However, patients should be informed of the potential risks associated with the application of

Percutaneous Electrolysis:

• The treatment might produce mild pain that normally lasts 48 to 72 hours

one of the most common intervention-related side effect is discomfort in the treatment area, caused

by the insertion of the needle. During the applications of galvanic current, the patients may

experience moderate to strong pain (depending on intensity used. Anesthetics are usually not locally

injected before percutaneous electrolysis, since the procedure is generally well-tolerated by patients

(the galvanic current application can be stopped at any time if the pain is not bearable). Besides, the

Page 39 of 52 EN109-1634750-40 IFU

use of syringes to introduce the anesthetics would substantially increase the overall invasiveness of

the intervention. However, the use of anesthetics remains a considerable option.

• Vasovagal reactions during and immediately after the intervention

Percutaneous Electrolysis affects the autonomous nervous system. As in any procedure involving

needling, vagal reactions (such as paleness, sweating, piloerection, and coldness in the skin) have

been reported during PE. There are several studies that include information on the potential risk of

possible vasovagal reactions. These reactions may be widely justified by the effect of needling and

not only by that of the current.

• Bleeding in area of needle insertion

After the treatment, a compressive bandage may be applied but this is normally not necessary.

The use of ice or intake of any anti-inflammatory drugs (NSAIDs) 72 hours after treatment is not

recommended as this would counter the anticipated therapeutic effect (initiate a controlled

inflammatory process).

Acupuncture needle

The use of high-quality, single-use, sterile acupuncture needles that have medical CE approval,

including the Notified Body number, is recommended. Enraf-Nonius does not supply any needles.

The needle should be compatible with the application of ultrasound guided electrolysis. For as far

as it concerns needle dimensions, always be sure to select the correct needle thickness and length

for the type of injury to treat.

• Needle diameter: 0.30 mm – 0.35 mm

• Handle outer diameter: 1.25 mm – 1.45 mm

• Needle body length: 20 mm – 100 mm

• Handle length: 25 mm – 30 mm

Foot switch

The Endomed 182 Type 1 has an optional foot switch which can be connected to connection A [7]

(see chapter 3).

Place the footswitch so that it can be reached easily during

treatment. The footswitch control unit is multi-directional so it is

not necessary to align the footswitch exactly.

To avoid damage, please note that only slight pressure needs to

be exerted on the switch. Use the front part of your foot, not the

heel to operate the footswitch.

Press the footswitch once to activate treatment. Press the

footswitch again to stop treatment.

Page 40 of 52 EN109-1634750-40 IFU

Endomed 182 Type 2 and 3:

TENS / IFC

Protocol for the safe application of TENS / IFC

• Check contraindications with patient

• Test skin for normal sensation using blunt/sharp test

• Device should be switched off and electric leads disconnected

• Set electrical characteristics of TENS / IFC while device is switched off

• Connect electrodes to pins on lead wire and position electrodes on patient’s skin

• Ensure device is still switched off and connect the electrode wire to the device

• Switch the device on

• Gradually (slowly) increase the intensity further until the patient experiences a strong but

comfortable tingling sensation

• This intensity should not be painful or cause muscle contraction

Protocol for the safe termination of TENS / IFC

• Gradually (slowly) decrease the intensity until patient experiences no tingling sensation

• Switch the device off

• Disconnect the electrode from the device

• Disconnect electrodes from the pins on lead wire

• Remove the electrodes from the patient’s skin

Endomed 182 Type 2 and 3:

Flexible rubber electrodes

We recommend using the flexible rubber electrodes in combination with the supplied sponge pads.

When properly moistened, the sponge pads ensure low impedance between the skin and the

stimulator during treatment and they are easily cleaned afterwards. Follow the guidelines below

when using these electrodes.

• Prior to initial use thoroughly rinse the sponge pads in warm tap water to remove the

impregnating agent.

• Before application, saturate the sponge pads with tap water. Preferred is to use a saline solution

instead because of the improved electrical conduction.

• The supplied sponge pads have three layers. With AC currents, apply one sponge layer between

the skin and the electrode for minimum resistance.

• Fix the electrode/sponge pad assembly to the patient using the supplied fixation straps.

Depending on the electrode size, use two or three wraps to maximize the contact surface. See

the illustrations below.

Wrong application of fixation straps, resulting

in poor electrical conductivity.

Correct application of fixation straps, resulting in good

electrical conductivity.

Page 41 of 52 EN109-1634750-40 IFU

• It is important that electrodes remain in complete contact without edges lifting throughout the

treatment.

• The Endomed 182 output mode is Constant Current (CC). This will maintain the set current

amplitude, even when the impedance of the sponge pads increases during treatment caused by

water evaporation.

• Keep the sponge pads well moistened (close to dripping when lightly squeezed) during

treatment. Remoisten when treatment exceeds 10 minutes.

• After use clean the sponge pads as described under “cleaning and disinfection”.

Endomed 182 Type 2 and 3:

Self-adhesive electrodes

Repeated use of pre-gelled electrodes leads to rapid loss of conductivity and deteriorating

adhesiveness.

The loss of adhesion and drying of the gel will cause the edges to begin lifting which can

dramatically increase current density; cause uneven distribution of current across the

electrode surface, increasing the risk of burn; and potentially result in electrode movement.

Changes that occur in self-adhesive electrodes over time result in an unsafe situation where

skin irritation and patient discomfort can occur.

Self-adhesive electrodes should never be shared between patients.

Self-adhesive electrodes have higher series impedance than flexible rubber electrodes. This can

cause the stimulator to terminate treatment at higher current amplitudes. When this occurs, it is

recommended to continue the treatment with flexible rubber electrodes, combined with properly

moistened sponge pads.

Page 42 of 52 EN109-1634750-40 IFU

Endomed 182 Type 3:

Vacuum electrodes

There is a choice of large, medium and small electrodes. The areas of the electrodes correspond to

those of the 4 x 6 cm, 6 x 8 cm and 8 x 12 cm flexible rubber electrodes. The vacuum electrodes are

sufficiently flexible to ensure optimum contact with the skin, but rigid enough to prevent any

changes in the contour of the part being treated, allowing full advantage to be taken of the

massage effect of the pulsed vacuum.

The massage effect resulting from the pulsed vacuum ensures a good blood flow through the skin

under the electrodes. This reduces the resistance of the skin and increases he effectiveness of the

stimulation current.

• Choose the appropriate electrode size for the body part to be treated

• Dampen the sponges. Squeeze them slightly to remove excess water, and place them in the

vacuum electrodes

• Select constant vacuum, this will ease the positioning of the electrodes

• Place the vacuum electrodes on a smooth surface (e.g. on a table)

• Turn the vacuum intensity up a little, so as to create a vacuum in the electrodes

• Now move the electrodes one by one from the smooth surface to the body of the patient

• Set the vacuum intensity to the desired value

• Follow the operating instructions in chapter 10 on how to adjust the settings and start and stop

the treatment

• Correct the vacuum intensity if necessary; a low vacuum is sufficient

• If required, select pulsed vacuum

Keep the sponge pads well moistened (close to dripping when lightly squeezed) during treatment.

Remoisten when treatment exceeds 10 minutes. After use clean the sponge pads as described

under Cleaning and Disinfection.

• When you use only one vacuum channel, close the other channel with one of the vacuum

cables not in use.

Continuous or pulsed vacuum

When a continuous vacuum is used, the vacuum pulse switches off as soon as the selected vacuum

pressure is reached, making the Vacuum Module virtually silent in operation. A control system

ensures that the vacuum remains constant. The pump switches on for short intervals during the

treatment to maintain the vacuum.

When pulsed vacuum is used, the pump is switched on and off intermittently. The pulsating rhythm

of the vacuum massage is continuously or pulsating (two possibilities) adjustable. Pulsating vacuum

is very useful for patients who are sensitive to the electric current, as the sensation of the current

tends to be suppressed.

Page 43 of 52 EN109-1634750-40 IFU

Current density

In the particular standard for Electrical Nerve and Muscle Stimulators, IEC 60601-2-10, it is

recommended not to exceed a current density of 2 mA r.m.s. / cm², otherwise skin irritations or

etching can occur.

To find the maximum recommended current amplitude in mA for the Interferential current

waveforms, multiply the electrode surface in cm² by two. For all other current waveforms, the

stimulator output current can never exceed 50 mA r.m.s. This implies that with an electrode surface

of 25 cm² the current density can never exceed 2 mA r.m.s. / cm². As a rule of thumb for smaller

electrodes, such as the 3.2 mm self-adhesives, the maximum current setting available on the

stimulator for a given current waveform should proportionally be reduced.

For a precise calculation of the r.m.s. value of a pulsed current waveform the following formula can

be used:

   

Note that electrodes should be placed with care, ensuring good electrical contact over the entire

electrode surface, and that the use of small electrodes in combination with high intensities may

cause skin irritations or etching.

Connection and disconnection reactions

Constant Current (CC) output characteristics may cause unpleasant connection and disconnection

reactions if the electrodes are not securely placed or lose contact with the skin. Make sure the

current amplitude is set to 0 mA when you apply or remove the electrodes.

Page 44 of 52 EN109-1634750-40 IFU

12 Maintenance and troubleshooting

Cleaning and Disinfection

Clean the device and its accessories regularly to maintain hygienic safety.

Before performing any user maintenance, switch off the device and disconnect the plug from

the mains supply.

Do not spray the cleaning agent directly on the glass panel.

Do not use cleaning agents that contain strong alkalis, lye, acid, detergents with fluoride or

detergents with ammonia.

Do not allow any liquids to penetrate the device or its accessories while cleaning and

disinfecting!

Dry all sockets and connectors that have become wet before any further use!

Mechanical shocks /or vibrations MUST be avoided while cleaning the device

Do not drop the device.

Device

To clean the unit, turn it off and unplug the power supply. Clean the unit with a

damp cloth. Do not use abrasive cleaners. A small amount of mild household

cleaning agent may be used, if needed.

Display Panel

The display panel contains an anti-reflective coating, which needs special care

when cleaned. Use a soft and dry cotton cloth or micro fiber tissue to clean the

panel. To remove fingerprints or grease, use a non-abrasive glass cleaning

agent. Apply a small amount of the cleaning agent to a soft cotton cloth and

then carefully clean the panel.

Electrodes,

electrode holder,

sponges and

accessories

Between patient uses, the rubber electrodes should be cleaned with lukewarm

water. To disinfect the electrodes or to remove stubborn stains of dirt, use a 70%

alcohol solution. The alcohol solution can cause the black color of the rubber

electrodes to be stained, but this does not affect the operation of the electrodes.

Between patient uses, the sponge pads should be washed in running tap water,

thoroughly drained and then dried. Damaged sponge pads should be replaced.

It is recommended that a sufficient amount of sponges be available to enable

complete drying before re-use – this will limit growth of water-borne bacteria.

When the electrodes are not being used, the sponge pads should be removed.

This increases the operational life of the rubber electrodes. We advise that you

keep an extra set of sponge pads in stock.

The blank earth electrode can be cleaned with a damp cloth. Use soap and

lukewarm water or alcohol solution.

The electrode holder can be cleaned with a damp cloth. Use lukewarm water

and a non-abrasive, non-invasive household cleaning agent or alcohol solution.

Do not put in autoclave.

Patient cable

and

DC reference

cable

Clean the patient cable with a damp cloth. Use lukewarm water and a non-

abrasive household cleaning agent. Do not use an alcohol solution. Check the

cable regularly for damages and/or bad electrical contact. We advise, keeping a

spare patient cable in stock.

Page 45 of 52 EN109-1634750-40 IFU

Vacuum

electrodes and

sponges

The vacuum electrodes and sponges should be cleaned with lukewarm water.

In the case of persistent dirt, and for disinfection, a 70% alcohol solution may

be used.

Sponges should be replaced regularly. It is recommended to keep sponges

and a spare electrode in stock.

Calcium scale can be deposited on the metal surfaces of the electrodes. This

has an insulating effect. In order to maintain optimum conductivity, these

surfaces should be regularly cleaned and polished.

Vacuum cables

Clean the vacuum cable with a damp cloth. Do not use an alcohol solution.

Check the cable regularly for damages and/or bad electrical contact. We

advise, keeping a spare vacuum cable in stock.

Cleaning the

water reservoir

and hoses

• Detach the vacuum cups from the vacuum cables.

• Place a container filled with a cleaning liquid (*) below the system.

• Place the peripheral ends of the cables in the container.

• Go to System Settings, Maintenance and select Tank Cleaning.

• The water reservoir will be filled with the cleaning liquid until the water

reservoir is full.

• Empty the water reservoir as described below (water reservoir full).

(*) The following registered products may be used for disinfecting the water reservoir:

BAKTONIL, BAKTOLAN to 5%, CHINOSOL to 1%, CHLORAMIN solution, DETTOL, ELMOCID Gamma

to 2%, PERODIN, ZEPHIROL to 5%.

Observe the application information of the corresponding manufacturer.

Troubleshooting

The device should not be used when mechanical damage is noticed. This includes damaged

cable insulation.

In the event that an error message or warning appears, immediately stop all use of the device.

Shutdown and restart the device. If the problem persists contact the supplier or Enraf-Nonius

B.V. for service. Errors and warnings indicate an internal problem with the device that must be

tested by a field service technician certified by Enraf-Nonius B.V before any further operation

or use of the system.

Use of a device that indicates an error or warning may pose a risk of injury to the patient,

user, or extensive internal damage to the system.

In case of display failure or other obvious defects, unplug the device immediately and notify a

certified service technician.

In the case of ingress of liquids, unplug the device from the Mains supply and have it checked

by an authorized person.

Page 46 of 52 EN109-1634750-40 IFU

Error messages

When the device is turned on, it will first execute a self-test. When an error is detected, both during

the self-test and during normal operation, a pop-up screen will appear on the display. When the

error is displayed, all outputs will be disabled. When this situation occurs, switch off the unit and

disconnect all accessories. Wait approximately 15 seconds and switch the unit back on.

When the error re-appears, stop using the device and contact the supplier.

Device needs to cool down before you can proceed

The temperature of the device is too high to start treatment. Remove the device from any potential

heat sources (such as direct sunlight) and let the device cool down. Restart the device to continue.

Insufficient or no output current

• Check the patient cable for breaks or poor contact.

• Ensure that the sponges are sufficiently damp.

• Clean the electrodes

• Check for poor contact

• In areas where the water is soft, it is possible that the water may conduct poorly resulting in

abnormally low currents. In this case it is possible to use a saline solution to improve the

conductivity of the water.

Water reservoir full

The water separation tank of the Vacuum Module is full. Continue the treatment with the standard

electrodes or empty the tank as follows:

• Set power line switch [17] Off (0).

• Detach the hose from the outermost hose nipple [21] and empty the reservoir.

• Reattach the hose to the hose nipple.

• Set power line switch [17] On (1).

Vacuum leak

There probably is a leak in the vacuum system. This error is usually preceded by a continuously

running pump trying to reach the set vacuum. To protect the system, the pump is automatically

stopped after a certain amount of time. Inspect the vacuum cables and electrodes, set the vacuum

back to zero and try again. If the failure persists, stop using the device and contact your supplier.

Page 47 of 52 EN109-1634750-40 IFU

It is also recommended that a service history record is maintained. In some countries, this is even

obligatory.

On request a service manual can be made available containing: spare part list, descriptions,

calibration instructions and other information which will assist the user’s qualified technical

personnel to repair those parts of the equipment which are designated by the manufacturer as

repairable.

Expected Service Life

This device will remain suitable for its intended use as long as it is subjected to yearly maintenance

by a qualified service engineer as described in the service manual.

The service engineer will decide whether the device is suitable for use according to the specifications.

End of Life

The Endomed 182 contains materials which can be recycled and/or are noxious for the environment.

Technical Maintenance

Opening of the equipment by unauthorized agencies is not allowed and will terminate any

claim to warranty.

The manufacturer will not be held responsible for the results of maintenance or repairs by

unauthorized persons!

Only service Technicians authorized by Enraf-Nonius can perform maintenance or modify this

equipment according to Service Information.

Maintenance shall not be performed on the equipment when equipment is in use or

connected to a patient.

It is recommended to have the Endomed 182 checked yearly by authorized personnel of

Enraf-Nonius or by its authorized distributor.

Please ensure that you are well informed of the local rules and regulations regarding the

removal of equipment and accessories.

Page 48 of 52 EN109-1634750-40 IFU

13 Specifications

Technical data

Electrical info

Mains voltage

100 - 240 Volt

Frequency

50/60 Hz

Max. power output

50 VA

Dimensions (width x length x height)

Endomed 182 Type 1

14.5 x 17 x 9 cm

Endomed 182 Type 2

14 x 16 x 14 cm

Endomed 182 Type 3

14 x 22.5 x 17.5 cm

These values represent the dimensions of the

housings without communication cables, electrodes

or hose.

Weight Unit

Endomed 182 Type 1

710 gram

Endomed 182 Type 2

1460 gram

Endomed 182 Type 3

2750 gram

These values represent the weight of the housings

without electrodes and power cords.

Specifications Type 1

Channels

Output

Constant Current

Direct Current

Polarity

Negative

Intensity

0 – 15 mA

Treatment time

0 – 300 seconds

Specifications Type 2 and 3

Channels

Output

Constant Current

Intensity

0 -100 mA

Timer

0 – 60 min (in steps of 1 min)

2 pole interferential

Carrier wave

4 kHz

AMF frequency

1 – 200 Hz

Modulation frequency

0 – 180 Hz

Modulation program

1-1, 6-6, 1-30 seconds

4 pole interferential and isoplanar vector

Carrier wave

4 kHz

AMF frequency

1 – 200 Hz

Modulation frequency

0 – 180 Hz

Modulation program

1-1, 6-6, 1-30 seconds

Page 49 of 52 EN109-1634750-40 IFU

Asymmetrical biphasic pulsed current (TENS)

Pulse width

150 μs

Frequency

1 – 200 Hz

Modulation frequency

0 – 180 Hz

Modulation program

1-1, 6-6, 1-30 seconds

Burst frequency

1-2-4 Hz

Technical modifications reserved

Safety and performance standards

Medical device classification

IIa; Rule 9 Annex IX of 93/42/EEC

This equipment complies with all requirements of the

Medical Device Directive (93/42/EEC).

Safety class according to IEC 60601-1

Electrical safety class I

Mode of operation

Continuous

Applied parts

Type BF Applied part for electrotherapy.

Essential Performance

The essential performance is based on the standard 60601-2-10 where the maximum output of the

current and pulse energy is specified. Considering the different therapy forms, the essential

performance is built out of five requirements:

1) The maximum TENS current rms may not exceed 50 mA.

2) The maximum Interferential current rms may not exceed 100 mA.

3) The maximum TENS pulse energy may not exceed 300 mJ.

4) The maximum Interferential pulse energy may not exceed 300 mJ.

5) The maximum Direct current rms may not exceed 80 mA

The electrotherapy outputs shall remain within 20% of the set value.

Since the device is not life supporting it is allowed to fall into a safe state (no output) requiring

operator intervention to restart.

Environmental conditions

Environmental conditions for transport and storage

Environmental temperature:

–20° to +70° C

Relative humidity:

10 to 90% (non-condensing)

Atmospheric pressure:

500 to 1060 hPa

Environmental conditions normal use

Environmental temperature:

10° to 40° C

Relative humidity:

10 to 90 % (non-condensing)

Atmospheric pressure:

800 to 1060 hPa

Page 50 of 52 EN109-1634750-40 IFU

EMC Details