Capenergy C 50 User manual

User Manual
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User Manual
DIATHERMY EQUIPMENT
CAPENERGY
FAMILY MODELS
C 50, C 100, C 200
C 300, C 400, C 500
Copyright © CAPENERGY MEDICAL, SLU
TF01-01-B03-A3
REV C- 2015-02
Dec-2015
0120

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Index
Index 2
Introduction 3
Chapter 1 – Description of the device 4
Chapter 2 - Safety 14
Chapter 3 - Installation 21
Chapter 4 – Instructions for use 23
Chapter 5.- Maintenance 39
Chapter 6 - Accessories 48
Chapter 7 – Clinical application 53
Annexes
A – Identification of the CE mark 72
B – Certificate of Delivery and Installation 74
C – Clinical Casuistry Document 76
D – Breakdown Notification 80
E – Warranty Activation 82
F – Electromagnetic Compatibility Considerations (EMC) 83
G – Capenergy Equipment family 87
H – Intellectual Property 94

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INTRODUCTION
CAPENERGY devices are innovative radiofrequency diathermy devices for
physiotherapeutic applications.
This manual provides CIM users with all the necessary information on how to use the
devices, control descriptions, safety precautions, installation and maintenance so they
can use the system and take care of it in a correct way.
This manual does not substitute adequate training in the physiotherapeutic application of
CIM equipments. Capenergy Medical S. L. offers courses on the therapeutic use of the
CAPENERGY equipment range.
This manual includes the following contents:
Chapter 1
Description of the device A general description of the CAPENERGY equipment and its
technical specifications.
Chapter 2
Security Contains explanations and instructions on how to use the CAPENERGY
devices in a secure and safe way.
Chapter 3
Installation Explains the electrical, locational, and environmental requirements for the
installation of CAPENERGY equipment
Chapter 4
Instructions for use
Describes the use of the CAPENERGY
device
Chapter 5
Maintenance Explains the procedures for the correct maintenance of the device and its
accessories.
Chapter 6
Accessories Describes the accessories used with the CAPENERGY equipment.
Chapter 7
Clinical application Explains how to perform treatments with CAPENERGY equipment.

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Chapter 1
Description of the device
This chapter includes an overview of the CAPENERGY equipment family,
including its major components, controls, and technical specifications.
1.1. INTRODUCTION
CAPENERGY devices are diathermy machines that conduct radiofrequency currents
through contact electrodes for physiotherapeutic applications.
Radiofrequency diathermy occurs when a high frequency electric current circulates
through the human body. This type of high-frequency electrical stimulation produces no
muscle or nerve response: it generates a thermal effect depending on the density of the
circulating current. Thus, the device produces a controlled temperature rise in an area
causing hyperemia, which is one of the desired effects.
Since the 30s, radiofrequency diathermy has become a standard method of physical
therapy and it is being used in other areas of medicine and for surgical applications as
well.
Since the 80s, the offer of Resistive (Direct Coupling) and Capacitive Diathermy devices
has increased further on, with remarkable clinical satisfaction both for operators and
patients.
The RF current is coupled to the human body by means of an insulated or non-insulated
electrode –the active accessory–, which together with the body and the return electrode
–the passive plate– forms an electric circuit, which allows the passage of RF current
through the body areas situated between the two electrodes.
The number of available channels on the different models of the CAPENERGY product
range varies from one to four. When a model has several channels, these operate
independently. Each channel has a keyboard that lets you manage the parameters of
frequency and channel power. It also has two light columns that report the selected
power level and a qualitative indication of the power delivered by the channel.
Attention
All personnel that will use this device or perform maintenance on it should read
this manual thoroughly before attempting to use any model of the
CAPENERGY equipment family: C 400, C 300, C 200, C 100, C 500 or C 50.

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The user interface has a screen and a keyboard that allows you to manage several
functions: timer, connected accessories management, state management, energy and
temperature measurements and alarms.
The user interface is organized in a menu system that makes it possible to choose
between the different features available on the equipment.
As a security measure, CIM units have a security control which allows the patient to stop
the RF output of the device immediately.
Before using the equipment, it is important to read the manual.
Feel free to contact us should you have any further questions.
1.2. THE CAPENERGY EQUIPMENT FAMILY
CAPENERGY equipment can be applied to the patient by using manual electrodes
(capacitive / resistive) or automatic plates for rehabilitation treatments and dermatology.
CAPENERGY devices is manufactured in six different models:
C 50
Ref. 5330050
Only manual capacitive or resistive device with 1 channel
C 100
Ref. 5330001 Automatic or manual capacitive or resistive device with 1 channel
C 200
Ref. 5330002
Automatic and manual capacitive and resistive device with 2
channels, for individual or combined use
C 300
Ref. 5330003
Automatic and manual capacitive and resistive device with 3
channels, for individual or combined use
C 400
Ref. 5330004 Automatic and manual capacitive and resistive device with 4
channels, for individual or combined use
C 500
Ref. 5330005
Manual device for URO-GYNECOLOGICAL physiotherapy with
manual intracavitary probe

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1.3. INDICATIONS OF USE
CAPENERGY devices are used for physiotherapy. The following treatments can be
performed:
•Tendinopathy
•Muscle fiber ruptures
•Muscle spams
•Muscle contractures
•Articular ostoarthritic processes
•Pain
•Neuralgia
•Chronic Inflammation
•Fibrosis
•Acute & Chronic inflammatory processes
•Phlebology and oedema
•Injuries
•Cystocele, cystitis, pelvic pain, etc. In Uro-Gynecology
1.4. TREATMENT PARAMETERS
CAPENERGY devices allow the user to adjust the treatment parameters.
These parameters are:
Duration of treatment: Treatment time.
Power: Power delivered by the machine at each output as a percentage of the
maximum power available.
Temperature: Only for accessories with temperature sensor, the device has a
way of working that allows the user to set the target temperature which the sensor
should reach in the active accessory. Consequently, the machine automatically
adjusts the power to maintain the constant temperature read by the active sensor
accessory.

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1.5.- DESCRIPTION OF THE DEVICE
This section describes the C 400 unit, which is the most complete model of the range,
with all the available options described.
The other machines in the CIM range have a similar structure, differing only in the
number of available channels and accessories. See section 1.2 CAPENERGY
equipment Catalog for details.
C 400 is composed of equipment and accessories.
The machine is divided into the following parts:
Front Panel
Back Panel
Front Panel
The front panel contains the user interface and the connections for the different
accessories. See image below:
Figure 1.1. Front panel
1.- SCREEN
2.- SCREEN CONTROL BUTTONS
3.- CHANNEL 1
4.- CHANNEL 2
5.- CHANNEL 3
6.- CHANNEL 4
3
4
5
6
1
2

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SCREEN CONTROL BUTTONS
Figure 1.2. Screen control buttons
1.-START/STOP button with luminary status indicator:
-START (working): light on
-STOP (not working): light off
2.-Increase treatment time button
3.-Decrease treatment time button
4.-OK button
5.- Left button
6.- Up button
7.- Right button
8.- Down button
CHANNEL
Figura 1.3. Channel
1
2
3
7
8
5
6
4
2
3
1
6
7
5
4
8
1. Frequency selection button.
2. Temperature or power increase button
3. Temperature or power decrease button
4. Frequency indicator: 0,8MHz, 1,0MHz,
1,2MHz.
5. Luminary indicator of the selected
power percentage
6. Qualitative luminary indicator of the
immediately delivered power.
7. Active accessory connector.
8. Passive plate connector.

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Back panel
The back panel houses the connection for the safety control as well as the connection for
the network cable. This connector has safety fuses.
Also located in the back panel are the air inlets for the ventilators: they are covered by a
safety grid.
Figura 4. Back panel
1.- On/off switch.
2.- Mains cord connector with safety fuses.
3.- Equipment ID sticker
4.- Safety control connector.
1
3
2
4
1
3
2
4

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1.6. ACCESSORIES
The accessories enable the application to the human body of the radiofrequency
currents generated by the device. The device makes use of the accessories’ monopole
topology.
Active accessory: This is the accessory that will be applied to the area under treatment.
There are different types of active accessories.
Insulated accessories: These accessories consist of a holder, which can be
straight or 90º, to which the insulated electrode is connected. The insulated
accessories are available in various diameters. These electrodes should be used
with a protective membrane or cover.
Available diameters
-Insulated electrode 33mm
-Insulated electrode 53mm
-Insulated electrode 65mm
Fixed position insulated accessories. Active plates: Have to be used with a
protective cover. These accessories are fixed to the treatment area by means of
electric bandages.
Non insulated resistive accessories: Theese accessories consist of a holder,
which can be straight or 90º, to which the non-insulated medical degree stainless
steel accessory is connected. The non-insulated accessories are available in
various diameters. These electrodes are used without a protective cover.
Available diameters
-Non-insulated electrode 33mm
-Non-insulated electrode 53mm
-Non-insulated electrode 65mm
Intracavitary acessory: Active accessory designed specially for rectal and
vaginal treatments.
Passive accessory: This accessory is the return plate that allows completing the
electrical circuit so the radiofrequency current can flow.

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1.7. SAFETY CONTROL
CAPENERGY devices are equipped with a safety control. When this safety control is
activated, the device automatically stops generating radiofrequency.
The Safety control acts at two levels simultaneously:
Electromechanical: Activates a relay installed in each channel, which cuts off the
passage of radiofrequency towards the output.
Software: When the safety control is activated, an alarm system is triggered
interrupting the treatment and displaying an alarm message on the equipment
screen.
1.8 SYSTEM SOFTWARE
The software installed on the CAPENERGY devices has the following functions:
It controls the functioning of the device.
It acts as an interface between the user and the device, enabling the selection
of the appropriate parameters for each treatment.

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1.9 SYSTEM SPECIFICATIONS
Electrical characteristics of the device:
•Supply voltage: 230V~
•Supply voltage type: single-phase alternative current (~).
•Power supply frequency: 50 Hz.
Characteristics of the radiofrequency output signal for each channel:
•Frequency:
-0,8MHz +/-25%
-1,0 MHz +/-25%
-1,2 MHz +/-25%
•Maximum output: 45 W +/-10% for a load of 06-j530 ohms to 1 MHz.
•Maximum output tension for a load of 106-j530 ohms: 345 efficient volts.
•Delivered power control: Double control by pulse width modulator and amplitude
control.
•Control signal (PWM) frequency: 10Hz.
Displayed values
•Delivered energy. Expresed in kilojoules. Tolerance +/-20%.
•Temperature in active accessories. Measurement tolerance of +/-2ºC in the
sensor located on the active accesory
Model Nº of channels Dimensions Weight Max. Power consumption
C 400 4 562 mm x 211 mm x 420 mm 22,5 Kg 800VA
C 300 3 562 mm x 211 mm x 420 mm 20,3 Kg 600VA
C 200 2 220 mm x 211 mm x 420 mm 12,9 Kg 400VA
C 100 1 220 mm x 211 mm x 420 mm 10,7 Kg 100VA
C 50 1 220 mm x 211 mm x 420 mm 10,7 Kg 100VA
C 500 1 220 mm x 211 mm x 420 mm 10,7 Kg 100VA
The weight referred to in the table above corresponds exclusively to the CIM console,
without taking into account the accessories or the foot. The foot weighs 20 kilos.
The manufacturer reserves the right to make the necessary estimated changes without
notice.

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1.10 ENVIRONMENTAL CONDITIONS
Environmental conditions during the use
When using the device, the following environmental conditions should be present:
•Temperature: 20ºC – 25ºC
•Relative humidity: less than 80%.
•Atmospheric presure: 850mb – 1050 mb
Condicones ambientales for stocking and transportation
•Temperature: 0ºC – 45ºC
•Relative humidity: less than 90%.
•Atmospheric presure: 850mb – 1050 mb
1.11 LIFE SPAN OF CAPENERGY DEVICES
CAPENERGY devices have a life span of 10 years.

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Chapter 2
Safety
This chapter describes safety measures that should be observed when
using CIM and the warnings and precautions to be taken into account by
the user.
2.1 IN GENERAL
CAPENERGY devices are designed in a way that enables the safe application of
radiofrequency current to the human body. When used and maintained appropriately, the
system can be used by trained and qualified personnel in a completely safe way. .
All personnel involved in the use and maintenance of the device should be familiar with
the safety information contained in the manual.
The principal consideration should always be the safety of the patient, the operator and
other personnel.
During the design of the CAPENERGY product range, special attention was given to all
safety elements. What follows is a list of some of the device’s safety mechanisms:
•Intrinsically secure maximum levels of power density
•Safety control for the patient.
•“Watch dog” software safety timer: controls the correct functioning of the software
at all time.
2.2 TECHNICAL WARNINGS AND PRECAUTIONS
Use of the device
•The use of the device is restricted to qualified personnel only.
•The manufacturer cannot be held reliable for the incorrect use of the device.
•Instructions must be kept in the vicinity of the device.
•Before installing and using the device, carefully read the user manual.
•Please check in the annexes the indications on electromagnetic compatibility
according to standard : UNE EN60601-1-2
Safety warning
All personnel that is involved in the use or maintenance of CAPENERGY
devices should read and understand this manual in order to become familiar
with all the safety requirements before using the device.

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Manipulation and Maintenance
•Before connecting the device to the power supply network, make sure you have
the correct voltage: tension overloads may damage the device.
•Before cleaning or performing maintenance on the device, make sure the device
has been disconnected from the power supply.
•Manipulating the device in any way will automatically invalidate the warranty.
•WARNING: No modification of equipment is allowed
Accessories
•The accessories should be used exclusively with the device.
•If an accessory or consumable item presents flaws, it should be taken out of
circulation immediately.
•Periodically check the cables of the accessories to make sure they are in a perfect
state.
•Do not use extension wires for the mains cord.
•The resistive and capacitive electrodes must not be replaced from the electrode
holder when the outputs are actives. The electrodes have to be replaced when the
equipment is en the STANDBY status or turn-off..
External agents
•The device should never be used in the presence of inflammable gases or liquids.
•The device should not be exposed to atmospheric agents.
Technical assistance
•Technical assistance can be performed by the manufacturer or authorized
distributor only.
•The manufacturer and distributor can be held reliable for the product’s safety only
if all repairs, modifications and adjustments have been made by specifically
authorized personnel and the device has been used by qualified personnel only
and according to the safety instructions.
•Only personnel authorized by the manufacturer can service the device, especially
when the interior of the protective covers is concerned. This includes all kinds of
adjustments of the power supply, power and control phases, etc. Dangerous
voltages are present on the inside of the device.
•Before performing maintenance on the device, it should be disconnected from the
power supply. Servicing the device when it’s on, may be dangerous for the user
and / or damage the device.

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2.3 MAIN PRECAUTIONS AND WARNINGS FOR USE:
Regarding the patient:
•The device should not be used on persons with electronic implants such as
pacemakers.
•Do not use on patients with metal implants.
•The device should not be used on patients suffering from infectious bacterial
processes. In case of doubt, consult with a specialist.
•When treatments are performed, the equipment should be used on healthy skin
without wound
Regarding the accessories:
•Always try the distance between plates is greater than 4 cm, considering that
there must always be sufficient body mass between them. Prevent the heart is
between the plates.
••Put the plates always well supported and the contact to be full with the body,
always looking for the best contact, even in areas with marked changes in relief,
as clavicles, shoulders, etc. Otherwise, with partial contact, may be too much
power concentration in certain parts of the plates, with the risk of burn in skin. It is
very important that the fixation of plates with bands favors the good contact
between its surface and the skin. If the plate is arched in its central zone and only
held fixed by the tips, burns can be produced.
•The plates should never be applied closet o metal objects such as rings, watches
(it is recommendable for the patient to take them off during the treatment).
•When applying, removing or moving the plates, make sure the power output is set
to zero and that all outputs have been shut down. Non observance of this safety
measure may cause skin burns.
•The resistive electrodes should never enter in direct contact with the passive
plate. Non observance of this safety measure may cause the device to short-
circuit.
•The active plates should be used with the protective covers supplied by the
manufacturer.
Regarding the intracavitary accessory:
•The intracavitary accessory must be used with the protective probe cover supplied
by the manufacturer.
•The intracavitary accessory must be inserted into the vagina or the rectum before
increasing the power. You may then proceed with the manipulation.
•It’s convenient for the patient to dispose of the safety control from the first moment
of the treatment on when performing this type of endocavitary treatments.

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2.4 COUNTERINDICATIONS
The use of CAPENERGY devices is counter-indicated in the following cases:
•Presence of pacemakers or other active implants, as cochlear implants, insuline
pump, etc.
•Implanted cables
•Angina
•Epilepsy
•Nervous diseases
•Pregnancy
•Lactation
•Cardiovascular dysfunction
•Neoplasm
•Insensibility to temperature ,even if only temporary
•Decompensated arteriopathies
•Active infectious bacterial processes
•Coagulation problems
•Presence of metal implants (consult with specialist)
2.5 SECONDARY EFFECTS
Healing crisis: If the patient has consumed drugs or other toxical substances (alcohol,
tobacco, etc.) or has a history of liver dysfunction (cirrosis, hepatitis, etc.), there may be
a side side effect at the time of treatment. It has been observed that the treatment may
favor the elimination process of these materials if the device is applied in areas where
there is toxicity. The symptoms are temporary, and can be asthenia, headache, diarrhea
or fatigue in general, depending on the nature of the item being removed. Therefore, it is
appropriate to recommend the intake of plenty of water and rest. At the time that the
circulating elements are removed, the patient returns to normal.
Skin Irritation: In the event of sensitive skin with microcirculation problems, or a history
of smoking, the application of this device may cause skin irritation, if the power applied
by the equipment is excessive. This could produce small microcapillary ruptures, when
there is a lack of capillary flexibility and the blood supply generated by the machine is too
high. For this reason, you should control the power of the device in the event that a
deficiency in the peripheral circulation is detected. Likewise, you may also cause skin
irritation reactions, or even burns if the operator uses the device to infuse different type
of substances (acids, oils, cryogenic substances, thermogenic, anesthetic or abrasive)
with different aims.

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2.6 ELECTRIC AND MECHANIC SAFETY
Maintain all CAPENERGY devices panels and covers closed. The removal of panels or
covers may create hazardous situations.
Inside the device, possibly dangerous high voltages are active. Panels or covers should
not be removed by any personnel other than the authorized technical services.
Never leave a CAPENERGY device on, open or unattended during maintenance.
CAPENERGY devices are heavy and may cause injuries when they are not manipulated
with sufficient care.
The device is earthed by means of the earth conductor of the network cable. Do not ever
connect the device to an installation without a residual-current circuit-breaker.
WARNING: To avoid electric shocks, this device should be connected only to a power
network equipped with an earth conductor.
When using the device it must be located in such a way that the connector of the mains
cord can be easily reached to disconnect it if it is necessary.

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2.7 LABEL
The following label can be found on the C 400 back panel, and accessories, respectively
C 400 label Accessories
Lebel of Isolation transformer of 700VA Lebel of Isolation transformer of 450VA
for devices C300 y C 400. for devices C50, C100, C 200 y C500
Figure 2.1
More detailed information on this matter can be found in Appendix A.
2.8 CLASSIFICATION OF THE DEVICE
•Sanitary device class according to directive 93/42/EEC
•Electric discharge protection: Class I, type BF.
•Protection against penetration of liquids: ordinary device.
•Device not valid for use in the presence of inflammable anesthetic blends.
•Operation mode: continuous

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2.9 MOVING THE DEVICE
All products pertaining to the CAPENERGY product range are equipped with a base on
wheels which allows to easily move the device around, and with breaks allowing to
secure the device.
Before moving any device, make sure all the cables and accessories have correctly been
gathered together and put away in the accessory tray that hangs from the base.
Move the device carefully to avoid obstacles hitting the base.
2.10 CONSIDERATION ON ELECTROMAGNETIC
COMPATIBILITY
The devices pertaining to the CAPENERGY product range: C400, C300, C200, C100,
C50 and C500, require special precautions with regard to electromagnetic compatibility
and need to be installed and used according to the electromagnetic compatibility needs
detailed in this manual.
See annex F for indications and precautions.
2.11 PRECAUTION: DEVICE HEATING DURING USE
When using the device for a long period of time, the upper cover may start heating and
reach temperatures higher than 48ºC.
Safety warning
In case it is necessary to move the CIM 300 or CIM 400, remove all the
accessories and put them away in the accessory tray that hangs from the
base before moving the device.
Safety warning
The upper cover of the device should not be touched for longer than a
minute.