Enraf-Nonius Tecarpuls-II User manual

Tecarpuls-II

EN109-1731750-40 IFU

0123

Instructions for use

Page 2 of 44 EN109-1731750-40 IFU

Figures

Front of the device

Fig. 1

1 Control unit

2 Intensity adjuster

3 Display

4 Therapy time adjuster

5 Slot for SD card

6 Handpiece with electrode

7 Common electrode

2

3

4

5

1

6

7

Page 3 of 44 EN109-1731750-40 IFU

Rear of the device

Fig. 2

Switches and 8 On/off switch

connection ports 9 Ventilation opening

10 Identification plate

11 NE connection port for:

11.1 Cable for common electrode with grey connection (4-pin)

11.2 Handpiece with grey connection (4-pin)

12 Active connection port for:

12.1 Cable for common electrode with white connection (8-pin)

12.2 Handpiece with white connection (8-pin)

13 Connection for power cable

10

9

8

13

11 / 11.1 / 11.2

12 / 12.1 / 12.2

9

Page 4 of 44 EN109-1731750-40 IFU

Screens / Display

Fig. 3

Display views

14 Status bar

15 Buttons on the screen

16 Buttons in the navigation menu

17 Buttons in the status bar

Fig. 4

Navigation bar

Description of

functions

(A) Back

Switches one page back or to the start-up

screen

(B) Therapy

Switches to the therapy screen

(C) Favourites

Switches to the Favourites area

(D) Protocols

Switches to Protocols

(E) Save

Switches to the Memory area

16

15

E

D

C

B

A

14

17

Page 5 of 44 EN109-1731750-40 IFU

Accessories

Fig. 5

Handpieces Handpiece with grey Handpiece with white

connection (4-pin) connection (8-pin)

Electrodes Resistive electrodes Capacitive electrodes

S: 30 mm S: 30 mm

M: 50 mm M: 50 mm

L: 70 mm L: 70 mm

Common electrodes Common electrode Common electrode self-

140 mm x 240 mm adhesive 105 mm x 200 mm

Common Common electrode cable with Common electrode cable

electrode cables grey connection (4-pin) with white connection

(8-pin)

Conductive cream Conductive cream

Holder Holder for electrodes and handpiece

Silicone sleeve Non-slip sleeve for handpiece

Page 6 of 44 EN109-1731750-40 IFU

Explanation of symbols

General warning sign: This symbol points out hazards on the device.

In the instructions for use this symbol indicates “Dangers and warnings”.

Caution!

In the instructions for use this symbol indicates "Caution" with regard to

possible damage of the device.

Products which are marked with the adjacent symbol may not be discarded

with household waste.

Note instructions for use

Follow instructions for use

Switch on/switch off symbol

Serial number

LOT number

Article number

GTIN number (identification number)

Manufacturer

Page 7 of 44 EN109-1731750-40 IFU

Date of manufacture

Indication of the quantity contained

Use by

Non-sterile

Device type BF

The device emits energy in the form of non-ionising electromagnetic

radiation.

CE mark with number of the notified body

Medical device

Do not reuse

Do not use if packaging is damaged

Protect from heat (sunlight)

Storage temperature range

Air humidity limit

Air pressure limit

Page 8 of 44 EN109-1731750-40 IFU

This side up

Fragile, handle with care

Protect from moisture

Maximum stacking height

Recyclable

Active

Active connection port

NE

NE connection port

Page 9 of 44 EN109-1731750-40 IFU

Contents

Figures .......................................................................................................................................................................... 2

Front of the device .................................................................................................................................................................. 2

Rear of the device ................................................................................................................................................................... 3

Screens / Display ..................................................................................................................................................................... 4

Accessories ................................................................................................................................................................................. 5

Explanation of symbols ......................................................................................................................................................... 6

1 Indications / Contraindications ............................................................................................................... 10

2 Side effects / Intended purpose / Mode of action .......................................................................... 11

3 Application information............................................................................................................................. 12

4 Warnings ......................................................................................................................................................... 14

5 Tecarpuls-II – in brief .................................................................................................................................. 16

6 System set-up ................................................................................................................................................ 17

6.1 Mounting the cables ..................................................................................................................................................... 17

6.2 Self-adhesive electrode ............................................................................................................................................... 18

7 Configuration ................................................................................................................................................. 20

8 Operation Instructions ............................................................................................................................... 21

8.1 Application Recommendations ................................................................................................................................ 21

8.2 Performing the treatment ........................................................................................................................................... 22

8.3 Displays and buttons .................................................................................................................................................... 23

8.4 Protocols ............................................................................................................................................................................ 25

8.5 Favourites .......................................................................................................................................................................... 26

9 Technical information ................................................................................................................................. 27

10 Cleaning, disinfection ................................................................................................................................. 28

11 CE mark ............................................................................................................................................................ 30

12 Scope of delivery and accessories ......................................................................................................... 31

13 Device combinations .................................................................................................................................. 32

14 Safety and maintenance ............................................................................................................................ 33

14.1 Safety ................................................................................................................................................................................ 33

14.2 Maintenance .................................................................................................................................................................. 33

15 Functional test ............................................................................................................................................... 34

16 Safety check – Metrological control ..................................................................................................... 35

17 Malfunction, error message, troubleshooting, disposal ................................................................ 36

18 Manufacturer’s EMC declaration ............................................................................................................ 39

Valid for the device ThermoTK / Tecarpuls-II

These instructions for use are an integral part of the device. They must be stored with the device

and kept accessible at all times for anyone authorised to operate this device.

The instructions for use are valid as of November 2020.

Page 10 of 44 EN109-1731750-40 IFU

1 Indications / Contraindications

Indications

• Pain treatment in cases of acute and chronic pain

• Inflammation of the musculoskeletal system

• Improvement in blood circulation in the muscle tissue

• Muscle relaxation through reduction in tension of the muscles

• Tissue regeneration following physical activities

• Trigger points

Contraindications

• Pacemakers and all other active implants

• Hearing aids

• Metal implants and other metal objects in the electrical field, such as

copper IUDs

• Use in the region of malignant/benign tumours

• Pregnancy

• Thromboses

• Active osteoarthritis and inflammation

• Open wounds

• Treatment on mucous membranes

• Reduced skin or body temperature

• Treatment in the head region

• Treatment over the heart

• Epilepsy

• Angina pectoris

• Cardiovascular diseases

• Nervous disorders

• Neoplasms

• Blood clotting disorders

• Thrombophlebitis

• Abnormal temperature perception

Caution is indicated in the case of persons

• who have sensitivity disorders

• who are not able to adequately express pain

• who are under the influence of drugs and/or alcohol, as significant

circulatory stress and inadequate treatment reactions cannot be ruled out.

Page 11 of 44 EN109-1731750-40 IFU

2 Side effects / Intended purpose / Mode of action

Side effects

No side effects are known if correct dosages are used and attention is paid to

contraindications.

Intended purpose

Tecarpuls-II is a medical diathermy device for the external heating of tissues

on human skin with the purpose of an increase in tissue temperature and the

resultant improvement in blood circulation in the treatment area. It is used for

the treatment of selected diseases of the musculoskeletal system with the goal

of relieving pain or muscle cramps.

In addition, Tecarpuls-II is used in sports physiotherapy for

• Muscle relaxation

• Preparation of the muscle for physical exertion

• Prevention of injuries

• Counteraction in cases of muscle fatigue

• Treatment of direct or indirect trauma

Intended users

Tecarpuls-II is exclusively intended for medical professionals such as

physicians, therapists, medical paraprofessionals. There are no further

limitations for the users.

Target patient group

Tecarpuls-II should not be used on infants and young children.

Tecarpuls-II should not be used on patients who have the contraindications

listed. There are no further limitations with regard to the target patient group.

Mode of action

The device uses electromagnetic fields of 460 to 540 kHz to bring about an

increase in temperature through interaction with the tissue. In this process,

there is more output in tissues with a high degree of electrical resistance than

in more conductive tissues. In the capacitive mode, tissue structures which are

rather close to the surface (subcutaneous fat tissue and underlying muscle

tissue) are heated. By contrast, the resistive mode is used to heat deeper layers

(tendons, ligaments).

Internal organs are barely heated, since they are often surrounded by a

protective layer of fat or other structures.

In comparison to the common electrode, there is compression of the field

lines in the smaller handpiece with the electrode. This is why it is used for

therapy.

Page 12 of 44 EN109-1731750-40 IFU

3 Application information

Prior to using the device on a patient, the user should become familiar with

the instructions for use and individual treatment methods to be used as well

as the indications/contraindications, warnings and application information.

Additional sources of information about the therapy should also be followed.

Please report any serious incidents which occur in connection with the product

to the manufacturer and competent authority.

Caution!

Tecarpuls-II should not be placed and used in hygienically critical medical

areas such as operating rooms, intensive care units or emergency

departments.

Caution!

Before use, ensure that the device is powered via a properly grounded mains

socket (electrical installation according to DIN VDE 0100 Part 710 or similar).

The device must only be operated with the supplied power cable. The power

cable must be protected against mechanical stress.

Caution!

Medical electric devices are subject to special precautionary measures with

regard to electromagnetic compatibility (EMC) and must be installed

according to the EMC information in the accompanying documentation. For

more information, see chapter 18 “Manufacturer's EMC declaration”.

Operation of this device in the vicinity of strong electromagnetic fields (e.g.

tomographs, X-ray or diathermy equipment) may interfere with the operation

of the device. Please keep a safe distance of 5 meters.

Tecarpuls-II is not suitable for use in areas with an explosive, flammable or

combustive environment.

During use, the device is to be located in a position allowing direct access to

the device´s central mains supply so that it can be disconnected from the

mains at any time.

To avoid the risk of electric shock, the plug must be disconnected from the

power supply before performing any cleaning or maintenance activities.

Inspect the device and applied parts before use. If there is any damage, it must

not be used.

Caution!

Only accessories provided by Enraf-Nonius B.V. which are intended for this

device may be used. This applies in particular to cables and electrodes.

Tecarpuls-II should not be combined with any other medical or non-medical

device.

During the service life of the device, no changes may be made to the device

or medical system.

Do not modify this device without written approval from the manufacturer.

Page 13 of 44 EN109-1731750-40 IFU

Caution!

If no SD card is inserted in the device, no images will be displayed in the

“Protocols” menu.

Page 14 of 44 EN109-1731750-40 IFU

4 Warnings

Treatment instructions regarding location, duration and intensity of the

treatment require medical knowledge and should be given only by authorised

physicians, therapists and medical paraprofessionals. These instructions must

be followed.

The patient must not be left unattended during the therapy.

Performing intercranial, transcardiac and cervical-occipital treatments is

prohibited. Failure to follow this information can lead to hazards to the

patient.

Simultaneously connecting a patient to the Tecarpuls-II system and a surgical

high-frequency device is prohibited. Failure to follow this information can lead

to hazards to the patient, in particular through burns under the electrodes.

Use in wet areas is not permitted and may in case of non-compliance lead to

considerable damage and endanger both the patient and the user.

Never use the handpiece without an electrode or with a damaged electrode.

Failure to follow this information can lead to hazards to the patient.

The common electrode must always have extensive contact with the patient. It

may otherwise lead to undesired compression of the field lines and thus injury

to the patient.

Attention should thus always be paid to contact of this electrode during

treatment.

The function of certain implanted electrical devices, for example, cardiac

pacemakers, can be disrupted through treatment with long-wave devices.

Patients should normally not undergo long-wave therapy if they have reduced

heat and pain perception in the body region intended for treatment.

Long-wave therapy should not be performed on patients through clothing. It

should also not be performed on patients who are wearing metal objects, such

as jewellery or clothing containing metal (for example, metal buttons, snap

fasteners or threads).

Patient body parts which contain metal implants (for example, a bone nail,

IUD, etc.) should normally be excluded from the treatment.

Page 15 of 44 EN109-1731750-40 IFU

Ensure that hearing aids and other electronic devices worn by the patient are

removed before treatment.

Patients should not come into contact with conductive parts which are

grounded or which have a high capacity to ground and which may represent

undesired paths for the high frequency range. In particular, no beds or chairs

with metal frames should be used.

Cables to the electrode should be directed such that contact with the patient

or with conductive or energy-absorbing objects is avoided.

Non-ionising radiation is generated in the device.

Use the self-adhesive common electrode only for one treatment on a patient

and discard it after treatment. If used multiple times, there can be cross-

contaminations or poor adhesion which can result in burns!

Ensure that the handpiece with electrode is never directed towards the eyes

during operation.

Ensure that the handpiece with electrode is not directed at metallic surfaces

(such as a couch, washbasin, device housing, etc.).

Ensure that the device is not opened. Opening the device can generate life-

threatening voltage.

Ensure that the ventilation openings on the back of the device are kept clear.

Ensure that the power cable is immediately disconnected from the mains if

liquid or foreign bodies penetrate the housing.

Ensure that the device is inspected by an authorised service employee before

it is put back into operation.

To completely disconnect the device from the mains, pull the power cable out

of the socket.

If the output power appears to be too low or if no power can be adjusted, the

cause may be improper application of the neutral electrode or poor contact in

the connection of the neutral electrode. In this case, the correct application of

the neutral electrode and the connections must be checked before the output

power can be increased once again.

Page 16 of 44 EN109-1731750-40 IFU

5 Tecarpuls-II – in brief

What is Tecarpuls-II?

An ultramodern, innovative therapy system for deep heat therapy.

What does Tecarpuls-

II do?

During use, a high-frequency current, imperceptible to the patient, is

applied.

The high-frequency current penetrates into the tissue in the form of

electromagnetic energy and there it is converted into heat.

What are the benefits

of Tecarpuls-II?

The modern, clear colour display showing all therapy-related parameters

and the modern touch operation ensure enjoyment and motivation

during treatment.

Individual program start adjustment and clear, simple menus offer the

user maximum convenience.

The compact design enables space-saving work in an office and is

ideally suited for mobile use.

What's special about

Tecarpuls-II

Tecarpuls-II can be combined as an integrative therapy with nearly all

other manual therapy methods or also used as individual therapy.

Three easy-to-change electrodes of different sizes allow optimal

adaptation to the treatment area.

Note:

Use of the device is reserved for medical professionals

(such as physicians, therapists, medical paraprofessionals).

Page 17 of 44 EN109-1731750-40 IFU

6 System set-up

6.1 Mounting the cables

Note:

Note

Silicone sleeve:

Note:

One active and one neutral electrode (common electrode) are needed for

the therapy.

Independent of which method is selected for performing the treatment,

power is always emitted via the ACTIVE output and the patient electrical

circuit is closed via the neutral electrode.

The use of the silicone sleeve allows the handpiece to be guided more

conveniently by the user. This is pulled with the wider side onto the

electrode connection on the handpiece.

Tecarpuls-II offers various methods for performing the treatment.

Dynamic1: 1 dynamic electrode (only use “active” port!, otherwise

the dynamic electrode will not be detected)

+ 1 static common electrode

Dynamic2: 2 dynamic electrodes

Hands-free: 2 static self-adhesive electrodes

Ensure that the device is placed on a stable surface.

Note:

Make sure that the power switch of the device is set to “0”.

Connect power cable

Connect the power cable to the provided port (13) on the device and

connect the cable to the mains.

Note:

The device may only be connected to power outlets with a protective

contact.

Dynamic 1 method

1 dynamic electrode + 1 static common electrode

Connect handpiece

Connect the handpiece with the white connection to the white ACTIVE

connection port.

Note:

Ensure that an electrode is inserted in the handpiece and that it is

positioned correctly and completely on the handpiece.

Connect common

electrode with cable

Attach the plug connector of the cable to the tab of the common electrode

(reusable electrode or self-adhesive single-use electrode).

Connect common

electrode cable

Connect the common electrode cable with the grey connection to the grey

NE connection port.

Page 18 of 44 EN109-1731750-40 IFU

6.2 Self-adhesive electrode

Dynamic 2 method

2 dynamic electrodes

Connect handpiece

Connect the handpiece with the white connection to the white ACTIVE

connection port.

Connect the handpiece with the grey connection to the grey NE connection

port.

Note:

Ensure that an electrode is inserted in the handpiece and that it is

positioned correctly and completely on the handpiece.

Ensure that you have connected the same type of electrode to both

handpieces (either both capacitive or both resistive).

Note the size of the electrodes.

The following combinations are recommended:

S + M, M + L.

Hands-free method

2 static self-adhesive electrodes

Connect common

electrode cable

Connect the common electrode cable with the grey connection to the grey

NE connection port.

Connect the electrode cable with the white connection to the white ACTIVE

connection port.

Connect common

electrode with cable

Attach the plug connectors of the cable in each case to the tab of the self-

adhesive common electrode.

Connect electrode

with cable

Attach the plug connector of the cable to the tab of the self-adhesive

electrodes.

Switching device off

The device is switched off using the on/off switch (8).

To fully disconnect the device from the mains, the power cable must be

disconnected.

Caution!

All cables must be protected from pinching or other mechanical damage.

Page 19 of 44 EN109-1731750-40 IFU

Application

information

When using self-adhesive electrodes, observe the following application

information:

Warnings /

Precautions

1. After removing the electrode from the packaging, check to ensure it is

not damaged.

2. For the application of the electrodes, select muscles which are well

perfused.

3. Ensure that the application surfaces are thoroughly clean and dry.

4. Ensure that the electrodes have secure, even contact with the skin and

smooth down all edges. Prevent liquids from getting into the contact

area.

5. Connect the electrodes with the plug connector of the cables to the tab

provided.

6. Connect the cables to the connection ports on the device.

7. Remove the electrodes from the skin after use by slowly pulling them

off, starting at one corner. Tearing the electrodes off the skin quickly

can lead to skin damage.

• Inadequate skin contact over the entire adhesive surface of the

electrode can lead to skin burns or a decreased emission of power.

• The emission of very high power can lead to problems.

• Verify that patient skin contact is even and check clips, connection cable

and connections.

• Check all of the accessories you are using to conduct the therapy for

functionality. If no problem can be identified, replace the active

accessories prior to treatment.

• The electrodes should in no way be cut or modified.

• Store the electrodes dry, out of direct sunlight. The recommended

temperature for storage is between 5°C and 30°C.

• Do not use the electrode after the expiration date!

Page 20 of 44 EN109-1731750-40 IFU

7 Configuration

Note:

The following descriptions are based on the factory settings.

Configuration menu

Select configuration

Factory settings can be changed and individually adjusted in the

configuration menu.

Activating the “Configuration” button (1) opens the “Configuration" screen.

Welcome text

Language

Start

Screen saver

Sounds

Volume

Brightness

Coupling

Load default

Service

Software version

Activation of the “Welcome text” button opens the alphabetical keyboard

to enter a welcome text in the start-up screen.

Activating the “Language” button opens a selection window with different

languages.

Use the arrow buttons to scroll through the list. The desired language is

selected directly in the corresponding line.

By activating the “Start” button, the start settings “Protocols, Favourites and

Therapy” can be selected.

By activating the “Screen saver” button, the screen saver can be switched

on or off.

Sleep mode is deactivated by directly touching the display or turning the

left/right adjuster.

By activating the “Sounds” button, the signal sounds can be switched on or

off. If “Sounds off” is activated, the function for adjusting the volume is

deactivated.

Option to adjust the volume of the signal sounds. The adjustment can be

made using the arrow buttons.

Option to adjust the brightness of the screen illumination. The adjustment

can be made using the arrow buttons.

Option to adjust the limit value of the coupling (0 – 100%). The adjustment

can be made using the arrow buttons.

Activating the “Load default” button restores the factory default settings.

This menu can be accessed only by authorised persons.

Activation of the “Software Version” button opens a window with

information on the current software version.

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Enraf-Nonius Tecarpuls-II User manual

Enraf-Nonius Tecarpuls-II User manual

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