Enraf-Nonius Curapuls Manuel utilisateur

20 July 2017 1670750-41

CURAPULS 670

081-400-268-40_EN Page 1 of 31

INSTRUCTIONS FOR USE

TABLE OF CONTENTS

1 INTRODUCTION........................................................................................................................................ 2

2 INTENDED USE AND INTENDED USER ....................................................................................................... 2

3 DEVICE COMPONENTS ............................................................................................................................. 3

4 PACKAGE CONTENTS ................................................................................................................................ 5

5 INSTALLATION .......................................................................................................................................... 6

6 INDICATIONS............................................................................................................................................ 8

7 CONTRA-INDICATIONS ............................................................................................................................. 8

8 PRECAUTIONARY INSTRUCTIONS ............................................................................................................ 10

9 OPERATION ............................................................................................................................................ 12

10 APPLICATION INFORMATION.................................................................................................................. 20

11 MAINTENANCE AND TROUBLESHOOTING ............................................................................................... 22

12 SPECIFICATIONS ..................................................................................................................................... 25

13 TECHNICAL ASSISTANCE ......................................................................................................................... 28

14 PRODUCT LIABILITY ................................................................................................................................ 28

15 DESCRIPTION-SYMBOLS USED AND DEVICE MARKINGS .......................................................................... 29

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1 INTRODUCTION

The CURAPULS 670, designed and manufactured by Enraf-Nonius B.V., offers a new

dimension in Pulsed Short-Wave Therapy (PSWT), made possible by advanced software

design. The result is a unit with extraordinary versatility based on simplicity of operation.

Soft tissue healing as a result of an increase in cellular metabolism and deep heating of

tissue is achieved with ease by means of inductive electrodes.

The CURAPULS 670 is equipped with a touch screen. The user-friendly interface includes

set protocols, parameters that can be set manually and favorites can be created and

stored for future use.

It is important to read the following instructions carefully before using

your CURAPULS 670. The manufacturer cannot be held responsible for the

results of using this device for any purposes other than described in these

operating instructions.

Should the use of this device lead 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 informed without delay!

2 INTENDED USE AND INTENDED USER

The CURAPULS 670 is a system intended to perform Pulsed Short-Wave Therapy (PSWT).

The CURAPULS 670 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.

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3 DEVICE COMPONENTS

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Numbered Part Description

1.

Wheels

2.

Foot

3.

Connector

for power cord

4. On/Off Switch

5.

Column

6.

Fixation points for electrode arms

7.

Connection electrode cables

8. Push Handle

9.

Touch Screen

10.

USB Connection

11.

Electrode Arm

lock

12. Wheel lock

13.

Electrode lock knob

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4 PACKAGE CONTENTS

Below mentioned Standard accessories will be contained in the main device packaging.

STANDARD ACCESSORIES

1x 1670901 Curapuls 670

1x 3444300 Power Cord/Mains Cable

1x 1462550 Electrode arm

1x 1670752 Instructions for Use- (on CD)

1x 1462571 Circuplode Ø 140 mm

1x 2570028 Coaxial Cable 150 cm 50 Ohm

OPTIONAL ACCESSORIES

Package contents Circuplode 90

1x 1462570 Circuplode Ø 90 mm

1x 2570028 Coaxial Cable 150 cm 50 Ohm

Package contents Circuplode E

1x 1462572 Circuplode E

1x 2570028 Coaxial Cable 150 cm 50 Ohm

CAUTION!

Use of accessories, electrodes 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.

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5 INSTALLATION

UNPACKING THE UNIT

The unit weighs approximately 22 kg, it must be unpacked by at least 2 persons.

INSPECTION

Immediately upon unpacking the unit, 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 chapter- Package Contents in this Instructions for Use).

 Check the external components and accessories for possible damage due to

transport.

WARNING!

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

DO NOT USE the device.

CONNECTION TO MAINS SUPPLY

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

 The flashing dot in the upper display [9] indicates that the unit is connected to the

mains supply and is on stand-by.

WARNING!

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.

To disconnect the device:

 Switch off the device using on/off button [4].

 Unplug the device from the wall socket.

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ATTACHING ELECTRODE ARMS

The electrode arms have to be mounted in the correct

way on the side of the device as shown in the picture.

The socket head screw wrench supplied should be used

to attach them.

ATTACHING ELECTRODES(CIRCUPLODES)

a. Loosen the electrode lock knob.

b. Push the electrode through the hole in the electrode arm until the electrode rod is

seen on the other side of the hole.

c. Tighten the Electrode Lock Knob.

d. Lock the rear end wheels and the Electrode arm lock to prevent movement of the

arm and Circuplode.

e. Attach the cable to the electrode.

f. Fit the cord of the electrode into the cable clip on the outside of the arm.

g. Plug the connector of the electrode cable into the output socket [7] on the rear

panel.

WARNING!

 To remove the cable from the electrode, make certain the power is off.

 While the electrode is being supported by the electrode arm, hold the electrode

while removing the cable to prevent the electrode from dropping to the floor.



Tighten arms so that

they do not move during therapy.



Observe the patient and the position of the arms at all times during therapy.

 Inform the patient that the arms are not supposed to move during therapy.

 Before using the unit, verify the patient is not in contact with the unit, the electrode

connection cable, the electrodes, or other devices or metal objects.

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6 INDICATIONS

The CURAPULS 670 can be used for the below mentioned symptoms or medical

conditions.

 Speeding the recovery of wounds,

 Increasing tissue extensibility,

 Decreasing oedema,

 Decreasing haematoma,

 Relieving inflammation,

 Relieving joint stiffness, and

 Relieving pain

7 CONTRA-INDICATIONS

The CURAPULS 670 SHOULD NOT be used during or for:

 Patients with Pacemakers

 Pregnancy

 Current tissue bleeding.

 Malignancy

 Active tuberculosis

 Treatment of the abdomen and pelvis during severe circulatory compromise

or deficit including ischaemic tissue, thrombosis and associated conditions

 Deep X Ray therapy or other ionizing radiations (in the last 6 months) in the

region to be treated.

 Patients who are unable to comprehend the therapist’s instructions or who

are unable to cooperate.

 Implanted metals

 Active epiphyseal regions in children

 Specialized tissues (e.g. eye and testes)

 Fever

 Bacterial infections

 Heart disorders

 Thermic sensibility disorders

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WARNING!

 Do not administer shortwave when a patient had an implanted lead in the past

unless you are sure that the implant and all leads in their entirety have been

removed. Note that leads are often left implanted after the implant is removed.

 It is considered safe to deliver a low dose (less than 5 Watts mean power) when

there is metal in the tissues. Metal plinths are generally considered acceptable

when the applied mean power is less than 5 Watts.

SIDE-EFFECTS

No Side effects are reported due to the use of CURAPULS 670.

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8 PRECAUTIONARY INSTRUCTIONS

WARNING!

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

practitioner.

 Keep yourself informed of the contra-indications.

 In the interest of physiotherapist safety, it is recommended that once the machine has

been switched on, the physiotherapist and all other personnel should keep at least 1 meter

from the operating machine, leads and electrodes. Pregnant physiotherapists or others

with concerns may want to ask a colleague to turn the CURAPULS 670 machine on. The

device will turn off automatically.

 Always perform a routine skin sensation test prior to a SWT application when a thermal

effect is anticipated (i.e. a mean power in excess of 5W).

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

electrical service receptacle conforming to the applicable national and local electrical

codes.

 Do not operate the unit in an environment of short-wave or micro-wave diathermy use as

this can result in burns beneath the electrodes.

 There may be potential difficulties in ensuring electromagnetic compatibility in domestic

and those directly connected to a low voltage power supply networks due to conducted as

well as radiated disturbances.

 Use of accessories, electrodes 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.

 Always determine the dosage based on the patient’s perception of heat. Any sensation

greater than mild warmth could cause a burn.

 Do not use this device in so called “Wet Rooms” (hydrotherapy rooms).

 Should any liquid or foreign object fall into the cabinet, turn off the power, unplug the unit

and have it checked by your nearest authorized service dealer before any further

operation.

 Good air circulation is essential to prevent internal heat build-up. Do not install the unit in

a location near the heat sources such as radiators or air ducts and prevent exposure to

direct sunlight.

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

surroundings. Do

not cover the ventilatio

n openings.

 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.

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 Care must be taken when operating this equipment around other equipment. Potential

electromagnetic or other interference could occur to this or to the other equipment. Try to

minimize this interference by not using other equipment in conjunction with it.

CAUTION!

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

with air, oxygen, or nitrous oxide.

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

amounts of dust, moisture, vibrations and mechanical shocks.

 Before administering any treatment to a patient, you should become acquainted with the

operating procedures for each mode of treatment available, as well as the indications,

contraindications, warnings and precautions. Consult other resources for additional

information regarding the application of shortwave therapy.

 Do not use the electrode arm with electrodes as handle to move the device. This may

damage the electrode arm and result in improper functioning of the device.

 Know the limitations and hazards associated with using any pulsed shortwave device.

Observe the precautionary and operational decals placed on the unit.

 In the case of ingress of liquids, unplug the unit from the mains supply and have it checked

by an authorized person (see the paragraph on technical maintenance).

 Use of controls or adjustments or performance of procedures other than those specified

herein may result in hazardous exposure to ultrasonic energy.

 Do not operate the CURAPULS 670 when connected to any unit other than Enraf-Nonius

B.V. devices.

 Do not drop the Circuplode as it may result in improper functioning of the device.

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9 OPERATION

OPERATION KEYS

Symbols used in the display panel

Home

Back

Play

Pause

Stop

Emergency Stop

Delete

Up

Down

Save

Info

Channel A

Channel B

Total Treatment Time

Pulse Repetition Frequency

Pulse Duration

Peak Power

Mean Power

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SET UP

WARNING!

Do not use the device after extreme temperature fluctuations.

Switch On

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 unit enters the “Home Menu” and is ready for use.

Home Menu

From the Home menu

, user can start a

treatment by selecting

 A preset clinical protocol, or by

 Retrieving a previously stored

favorite or

 Setting a protocol manually.

User can also set the desired system

settings from home menu.

MODE OF OPERATION

The device incorporates smart mode or conventional mode of operation.

In conventional mode (=smart mode off), peak power, pulse repetition rate, pulse duration

and treatment time can be set within the required range for the electrodes that can be

connected to the device. All these parameters are shown in the treatments screen. The mean

power that is the result from these parameters will be shown too.

In smart mode, all one needs to set is the mean power. Based on the best available evidence,

Enraf-Nonius has developed an algorithm that will select the appropriate Pulse repetition

frequency, Pulse duration and Peak power to go with your selected Mean power. The unique

incorporated slider bar will even help you decide on picking the right Mean power based on

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the character of the indication (Acute to Chronic scale) or the need for a non-thermal or

thermal treatment.

To select the mode of operation, go to system settings. By default, it is set to “On”.

PARAMETERS

1) The Peak power (or Pulse power):

The Peak power (or Pulse power) is the "height" of the pulse. This means the amount

of Watts delivered during the time that the pulse is "on". This parameter is

adjustable per 5 Watt

Circuplode 90 0-100 Watt

Circuplode 140 0-200 Watt

Circuplode E 0-200 Watt

2) Pulse repetition rate / (Pulse-)Frequency:

Pulse repetition rate (or Pulse Frequency) is the number of times that a pulse is "on"

per second.

Circuplode 90 26-400 Hz

Circuplode 140 26-400 Hz

Circuplode E 26-800 Hz

3) Pulse duration:

Pulse duration is the time that one pulse is "on" expressed in microseconds (us). This

could be explained as the width of a single pulse

Range:65-400 μs

4) Treatment time up to 30 minutes,

5) Mean power:

The mean power is determined by the peak power, the pulse duration and the pulse

repetition rate.

The mean power resulting from the parameters is calculated and displayed when the

device is in conventional mode.

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(When the device is in smart mode, the mean power can be selected. The device will

choose the appropriate parameters based on best available evidence.)

Range: (0-64 W)

Below picture shows the different parameters

CURAPULS 670 – Parameters

CLINICAL PROTOCOLS

When selecting Clinical Protocols, a list of

protocols will be displayed.

The indications are sorted top-down based on the

body part to be treated. This means they are listed

from head to toe

 Press to display the corresponding

treatment information.

 Press  icon to scroll up and scroll down

the page.

 Press to select the displayed

treatment.

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MANUAL OPERATION

Scenario 1-Smart Mode is On

Based on the best available evidence, Enraf-Nonius has developed an algorithm that will

select the appropriate Pulse repetition frequency, Pulse duration and Peak power to go with

your selected Mean power. The unique incorporated slider bar will even help you decide on

picking the right Mean power based on the character of the indication (Acute to Chronic

scale) or the need for a non-thermal or thermal treatment.

1. Select Manual Operation from the Home menu.

2. The Manual operation screen will be displayed as shown below.

3. Treatment parameters will be displayed for the active Channel tab.

4. In the example above, the active tab is channel A.

5. Press Channel Tab B to access the parameter settings for that channel.

6. Total treatment time, and Mean power are displayed.

7. Press the parameter you want to adjust. A new screen will open to allow you to select

the right value.

8. Adjust the required Treatment time via the  icon or by selecting one of the preset

values.

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9. The Mean power can be adjusted using  buttons or by using the slider bar.

Select the position on the slider bar based on the character of the indication (Acute to

Chronic scale) or the need for a non-thermal or thermal treatment. The corresponding

Mean power will be displayed

The device will set the appropriate underlying parameters for you (Pulse repetition

frequency, Pulse duration and Peak power).

10. Press to accept and go back to the treatment screen.

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Scenario 2-Smart Mode is Off

1. When the smart mode is off, all parameters can be set independently.

2. Treatment parameters will be displayed for the active Channel tab.

3. In the example above, the active tab is channel A. Press Channel Tab B to access the

parameter settings for that channel.

4. Total treatment time, Pulse repetition frequency, Pulse duration, Peak power and the

calculated Mean power are displayed.

5. Press the parameter you want to adjust. A new screen will open to allow you to select

the right value.

6. Adjust the value using the buttons or select one of the pre-set values.

7. If the mean power changes as a result of the selected parameter, this will be displayed

too.

8. Press to accept and go back to the treatment screen.

In the navigation bar of the treatment screen, the button will be available to store

these parameters as a favorite. Press to start treatment.

The Channel tab will show

 or to indicate whether the treatment is running, paused or stopped.

 A countdown timer which indicates how much time is left until completion of the

treatment.

 which electrode is connected (90mm, 140mm or E for Ellipse).

 the actual Mean power delivered to the patient.

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Treatment stops automatically when the treatment time has elapsed or can be stopped by

pressing the Stop key to stop the active channel or press the button to stop

both active channels at the same time.

FAVORITES

Your favorite can be retrieved by selecting Favorites in the Home menu and selecting it from

the list.

To delete a favorite, first press and then select the favorite to be deleted.

Before or after (not during) treatment, the selected parameters can be stored as a favorite.

Press in the navigation bar of the treatment screen and subsequently give the

favorite a name. The list of favorites that is automatically created is sorted A to Z.

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