Page is loading ...
20 June 2017
1670750-40
CURAPULS 670
ENGLISH
081-400-268-40_EN Page 2 of 32
INSTRUCTIONS FOR USE
TABLE OF CONTENTS
1 INTRODUCTION .............................................................................................................................................. 3
2 INTENDED USE AND INTENDED USER ............................................................................................................ 3
3 DEVICE COMPONENTS ................................................................................................................................... 4
4 PACKAGE CONTENTS ...................................................................................................................................... 6
5 INSTALLATION ................................................................................................................................................ 7
6 INDICATIONS .................................................................................................................................................. 9
7 CONTRA-INDICATIONS ................................................................................................................................... 9
8 PRECAUTIONARY INSTRUCTIONS ................................................................................................................. 11
9 OPERATION .................................................................................................................................................. 13
10 APPLICATION INFORMATION ....................................................................................................................... 21
11 MAINTENANCE AND TROUBLESHOOTING ................................................................................................... 23
12 SPECIFICATIONS ........................................................................................................................................... 26
13 TECHNICAL ASSISTANCE ............................................................................................................................... 29
14 PRODUCT LIABILITY ...................................................................................................................................... 29
15 DESCRIPTION-SYMBOLS USED AND DEVICE MARKINGS .............................................................................. 30
ENGLISH
081-400-268-40_EN Page 3 of 32
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.
ENGLISH
081-400-268-40_EN Page 4 of 32
3 DEVICE COMPONENTS
ENGLISH
081-400-268-40_EN Page 5 of 32
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
ENGLISH
081-400-268-40_EN Page 6 of 32
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.
ENGLISH
081-400-268-40_EN Page 7 of 32
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.
ENGLISH
081-400-268-40_EN Page 8 of 32
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.
ENGLISH
081-400-268-40_EN Page 9 of 32
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
ENGLISH
081-400-268-40_EN Page 10 of 32
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.
ENGLISH
081-400-268-40_EN Page 11 of 32
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 ventilation 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.
ENGLISH
081-400-268-40_EN Page 12 of 32
• 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.
ENGLISH
081-400-268-40_EN Page 13 of 32
9 OPERATION
OPERATION KEYS
Symbols used in the display panel
Home
Back
Next
Accept
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
ENGLISH
081-400-268-40_EN Page 14 of 32
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
ENGLISH
081-400-268-40_EN Page 15 of 32
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.
ENGLISH
081-400-268-40_EN Page 16 of 32
(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.
ENGLISH
081-400-268-40_EN Page 17 of 32
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.
ENGLISH
081-400-268-40_EN Page 18 of 32
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.
ENGLISH
081-400-268-40_EN Page 19 of 32
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.
ENGLISH
081-400-268-40_EN Page 20 of 32
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.
/
