Enraf-Nonius Curapuls User manual

CURAPULS 670

EN109-1670750-46 IFU

July 18, 2019

Instructions for use

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INSTRUCTIONS FOR USE 
 
TABLE OF CONTENTS 
INTRODUCTION .............................................................................................................................................. 3 
SYMBOLS ........................................................................................................................................................ 4 
DEVICE COMPONENTS ................................................................................................................................... 6 
PACKAGE CONTENTS ...................................................................................................................................... 8 
INSTALLATION ................................................................................................................................................ 9 
INTENDED USE AND INTENDED USER .......................................................................................................... 11 
INDICATIONS ................................................................................................................................................ 11 
CONTRA-INDICATIONS ................................................................................................................................. 12 
PRECAUTIONARY INSTRUCTIONS ................................................................................................................. 13 
OPERATION .................................................................................................................................................. 15 
APPLICATION INFORMATION ....................................................................................................................... 23 
MAINTENANCE AND TROUBLESHOOTING ................................................................................................... 24 
SPECIFICATIONS ........................................................................................................................................... 26 
CONTACT ...................................................................................................................................................... 29 
PRODUCT LIABILITY ...................................................................................................................................... 29 
READJUSTMENT ELECTRODE ARMS ............................................................................................................. 30 
  

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1 INTRODUCTION

We are pleased that you have purchased a CURAPULS 670.

The CURAPULS 670, is 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 properly and safely. The manufacturer cannot be held responsible

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

operating instructions.

If the use of this device may have caused or contributed to an undesirable event

such as death or serious injury to the user, the manufacturer and the Competent

Authority of the Member State MUST be notified immediately!

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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…”

Do Not Unplug the unit when this symbol is displayed on screen.

Indicates this device generates non-ionizing radiation.

Type BF Applied part.

Indicates devices that have conductive contact with the patient, or having medium

or long-term contact with the patient.

The push handle is designed to push the device. Be careful not to tip the device

over when pulling it.

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.

This is an electronic or electrical device. Dispose of this product according to local

regulations. This will help to recycle.

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Keep the device dry

Manufacturer name and address

Reference Number or Part Number

Indicates the serial number so that a specific medical device can be identified.

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.

Risk of crushing hands!

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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 knob

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 1670.901 Curapuls 670

1x 3444.300 Power Cord

1x 1462.550 Electrode arm

1x 1670.752 Instructions for Use (PDF on CD)

1x 1462.571 Circuplode Ø 140 mm

1x 2570.028 Coaxial Cable 150 cm 50 Ohm

1x 1670.751 Information Booklet

2x 3441.456 Pipe key 10mm

1x 6121.040 Hexagon wrench S4.0

2x 2994.064 Cable Clamp

OPTIONAL ACCESSORIES

1462.570 Circuplode Ø 90 mm

1462.572 Circuplode E

3441.337 Treatment chair, clear lacquered wood

3441.401 Treatment couch, clear lacquered wood

3441.338 Footrest, clear lacquered wood

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5 INSTALLATION

UNPACKING THE UNIT

The unit weighs approximately 27,2 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.

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.

Correct

Wrong

ATTACHING ELECTRODES(CIRCUPLODES)

• Loosen the electrode lock knob.

• Push the electrode through the hole in the electrode arm until the electrode rod is seen

on the other side of the hole.

• Tighten the Electrode Lock Knob.

• Lock the rear end wheels and the Electrode arm to prevent movement of the arm and

Circuplode.

• Attach the cable to the electrode.

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

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

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

DO NOT USE the device!

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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.

To disconnect the device:

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

• Unplug the device from the wall socket.

TRANSPORT CONDITION

When moving the device from one room to another,

please make sure the electrode arms are folded in

with the Circuplodes close to the device.

The push handle is designed to push the device.

Be careful not to tip the device over when pulling it.

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 electrode arms so that they do not move during therapy.

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

Inform the patient that the electrode 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.

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.

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.

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6 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.

7 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

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8 CONTRA-INDICATIONS

The CURAPULS 670 MUST NOT be used during or for:

• Patients with Pacemakers

• Pregnancy

• Current tissue bleeding.

• Malignancy

• Active tuberculosis

• Treatment of the abdomen and pelvis during menstruation.

• 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

SIDE-EFFECTS

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

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.

Do NOT use shortwave diathermy in patients with breast implants, as it has been

reported to cause tissue necrosis, skin erosion, and implant extrusion.

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9 PRECAUTIONARY INSTRUCTIONS

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

licensed practitioner.

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.

Keep yourself informed of the contra-indications.

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

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

meter from the operating device, leads and electrodes. Pregnant physiotherapists or

others with concerns may want to ask a colleague to turn the CURAPULS 670 device

on. The device will turn off automatically.

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.

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.

Do not cover the ventilation openings.

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.

Strictly follow the WARNINGS mentioned in the chapter “EMC Details”.

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.

Ensure that the electrode arms are folded when the device is moved from one room to

another. The push handle is made to push the device. Make sure that the appliance

does not fall over when the handle is pulled.

Make sure the power is turned off when you remove the cable from the electrode.

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

Observe the precautionary and operational decals placed on the unit.

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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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10 OPERATION

OPERATION KEYS

Symbols used in the display panel:

Home

Info

Back

Channel A

Accept

Total Treatment Time

Play

Pulse Repetition Frequency

Pause

Pulse Duration

Stop

Peak Power

Emergency Stop

Mean Power

Delete

Up

Down

Save

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SET UP

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

1) A preset clinical protocol, or by

2) Retrieving a previously stored

favorite or

3) 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

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”.

Do not use the device after extreme temperature fluctuations!

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PARAMETERS

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

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

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.

(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:

Circuplode 90

0-32 W

Circuplode 140

0-32 W

Circuplode E

0-64 W

64 Watt is the maximum total output for the 2 channels combined.

For example, if on one channel a Circuplode E is delivering 50 Watt, the Circuplode on the

second channel can only be programmed to deliver up to 14 Watt.

Note: If the selected total output power is more than 64W, the unit displays an error

message “The combined output power is too high”.

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

Treatment time: up to 30 minutes.

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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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MANUAL OPERATION

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.

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.

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Enraf-Nonius Curapuls User manual

Enraf-Nonius Curapuls User manual

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