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INSTRUCTIONS FOR USE
TABLE OF CONTENTS
1 INTRODUCTION .............................................................................................................................................. 2
2 SYMBOLS ........................................................................................................................................................ 3
3 DEVICE COMPONENTS ................................................................................................................................... 5
4 PACKAGE CONTENTS ...................................................................................................................................... 7
5 INSTALLATION ................................................................................................................................................ 8
6 INTENDED USE AND INTENDED USER ............................................................................................................ 9
7 INDICATIONS ................................................................................................................................................ 10
8 CONTRA-INDICATIONS ................................................................................................................................. 11
9 PRECAUTIONARY INSTRUCTIONS ................................................................................................................. 12
10 OPERATION .................................................................................................................................................. 14
11 APPLICATION INFORMATION ....................................................................................................................... 21
12 MAINTENANCE AND TROUBLESHOOTING ................................................................................................... 22
13 SPECIFICATIONS ........................................................................................................................................... 24
14 CONTACT ...................................................................................................................................................... 26
15 PRODUCT LIABILITY ...................................................................................................................................... 27
16 READJUSTMENT ELECTRODE ARMS ............................................................................................................. 28
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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.
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.
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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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
Next
Channel B
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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MANUAL OPERATION
SCENARIO 2-SMART MODE IS OFF
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.
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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