Capenergy C 50, C 100, C 200, C 300, C 400 User Manual

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

User Manual

Page 1 of 95

0120

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

User Manual

Page 2 of 95

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

Chapter 3
Installation

Chapter 4
Instructions for use

Chapter 5
Maintenance

Chapter 6
Accessories

Contains explanations and instructions
on how to use the CAPENERGY
devices in a secure and safe way.

Explains the electrical, locational, and
environmental requirements for the
installation of CAPENERGY equipment

Describes the use of the CAPENERGY
device

Explains the procedures for the correct
maintenance of the device and its
accessories.

Describes the accessories used with
the CAPENERGY equipment.

Chapter 7
Clinical application

Explains how to perform treatments with
CAPENERGY equipment.

User Manual

Page 3 of 95

Chapter 1

Description of the device

This chapter includes an overview of the CAPENERGY equipment family,
including its major components, controls, and technical specifications.

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.

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.

User Manual

Page 4 of 95

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

C 100

Ref. 5330001

C 200

Ref. 5330002

C 300

Ref. 5330003

C 400

Ref. 5330004

C 500

Ref. 5330005

Only manual capacitive or resistive device with 1 channel

Automatic or manual capacitive or resistive device with 1 channel

Automatic and manual capacitive and resistive device with 2
channels, for individual or combined use

Automatic and manual capacitive and resistive device with 3
channels, for individual or combined use

Automatic and manual capacitive and resistive device with 4
channels, for individual or combined use

Manual device for URO-GYNECOLOGICAL physiotherapy with
manual intracavitary probe

User Manual

Page 5 of 95

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.

User Manual

Page 6 of 95

3 4 5 6

1

2

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

User Manual

Page 7 of 95

1

2

3

7

8

5 6

4

2

3

1

6

7 5

4

8

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

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.

Figura 1.3. Channel

User Manual

Page 8 of 95

1 3 2

4

1 3 2

4

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.

User Manual

Page 9 of 95

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.

User Manual

Page 10 of 95

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.

User Manual

Page 11 of 95

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
C 400 4 562 mm x 211 mm x 420 mm 22,5 Kg
C 300 3 562 mm x 211 mm x 420 mm 20,3 Kg
C 200 2 220 mm x 211 mm x 420 mm 12,9 Kg

Dimensions

Weight

Max. Power

consumption

800VA
600VA
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.

User Manual

Page 12 of 95

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.

User Manual

Page 13 of 95

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.

Safety warning

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

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.

• 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

User Manual

Page 14 of 95

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.

User Manual

Page 15 of 95

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 short­circuit.

• 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.

User Manual

Page 16 of 95

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.

User Manual

Page 17 of 95

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.

User Manual

Page 18 of 95

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

User Manual

Page 19 of 95

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.

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

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

The upper cover of the device should not be touched for longer than a
minute.

User Manual

Page 20 of 95

Chapter 3

Installation

This chapter describes the electrical, spatial and environmental
requirements for the installation of CAPENERGY DEVICES.

The accessories must be in a perfect state when using them for treatments.
In case you detect any flaw, do not use the accessories and replace them by
new ones.

3.1 LOCATION OF THE DEVICE

The device should be located on top of the base that is supplied at the same time as the
device. (In case the model does not come with a base, please locate the device on a
stable table.).

Keep the device away from sources of heat. Maintain sufficient space around the device
in order to guarantee its correct ventilation. Make sure the grids of the back and lower
panel are never obstructed.

Safety warning

3.2 ELECTRICAL REQUIREMENTS

The CAPENERGY product range devices have been designed to work with the following
power supply voltage::

Single-phase 230V~ +/-10%, 4A, 50 Hz

The device is earthed by means of the earth conductor of the mains cord that is inserted
into the connector of the electrical installation. A correct ground connection is vital in
order to assure the device’s safety. Do not ever connect the device to an installation that
does not have a residual-current circuit-breaker.

The supply lines should be free of transitory voltage or current peaks or drops or
surcharges.

The devices incorporates protective fuses of 3,15 A for 230V~ voltage. Each device
contains 2 fuses. In case they melt down, they have to be replaced by fuses of the same
characteristics in order to guarantee safety and reduce fire hazard.

-

Precaution.

Make sure the power supply voltage is the correct one for CIM. Details can be
found on the label located on the back panel.

User Manual

Page 21 of 95

3.3 ENVIRONMENTAL REQUIREMENTS

Air quality

CAPENERGY devices need to operate in a non corrosive environment. Corrosive
materials such as acids may damage the electric cables or electronic components.

Metal dust damages electrical devices.

Temperature and humidity

In order for the CAPENERGY devices to operate at their maximum capacity, it is
recommended to maintain the temperature in the room around 20-25ºC, with a relative
humidity lower than 80%. The atmospheric pressure should be maintained in the range
of 850mb to 1050mb.

3.4 ISOLATION TRANSFORMER.

The CAPENERGY product range: C50, C100, C200, C300, C400 and C500, must be
connected the power supply network using the isolation transfomer that is supplied with
them

User Manual

Page 22 of 95

Chapter 4

Instructions for use

This chapter describes how to use the CAPENERGY devices and the
menu system that allows selecting and performing various treatments.

4.1. MENU SYSTEM

The user interface is organized in a menu system that allows managing the device’s
configuration and working mode and accessing the information screens.

The navigation buttons and OK button of the screen keyboard, allows surfing through the
different menu options and selecting the desired one.

The following options are available:

 Basic mode
 Free treatment
 Guided treatment
 Information
 Configuration

The figure shows the flow diagram of the complete system menu.

User Manual

Page 23 of 95

Figure 4.1. Flow diagram of the complete system menu

BASIC MODE

User Manual

Page 24 of 95

FREE

TREATMENT

POWER

CONTROL

TEMPERATURE

CONTROL

INDICATION

CONTROL

ATHERMAL

ATHERMAL

MODERATE

MODERATE

THERMAL

THERMAL

FRANKLY

FRANKLY
THERMAL

THERMAL

SYSTEM

MENU

GUIDED

TREATMENT

TEMPERATURE

CONTROL

ATHERMAL

ATHERMAL

MODERATE

MODERATE

THERMAL

THERMAL

FRANKLY

FRANKLY
THERMAL

THERMAL

INFORMATION

CONTRE-INDICATIONS

MAINTENANCE

CONFIGURATION

SPANISH

ENGLISH

4.2. BASIC MODE

In this mode, only the basic working functions are available:

 Safety control
 Timer
 Status
 Functioning by power control
 Qualitative indication of the instantly delivered energy.

BASIC MODE screen

.

Figure 4.2. BASIC MODE screen

1.- Total treatment time

2.- Elapsed treatment time, expressed in minutes and seconds.

3.- Status.

User Manual

Page 25 of 95

BASIC MODE functions description:

Safety control

Control allowing the immediate interruption of the treatment. Works only when
the machine is ON and the outputs are active. When the button of the safety

control is pushed, the safety control warning is activated.
In this case, press the OK button to return to the STANDBY status.

Timer

Total treatment time in minutes

When the device is in STOP status, treatment time can be modified using
the buttons INCREASE / DECREASE treatment time..

Elapsed treatment time

When the device starts WORKING, the elapsed time counter starts running,
expressing elapsed time in minutes and seconds.

Status

The device’s status depends on various factors. The following table details the
possible statuses for the basic mode and how to activate them by means of the
keyboard.

User Manual

Page 26 of 95

STATUS ICON DESCRIPTION

The otuputs are deactivated.
STBY GRAPHIC

Allows:

 Modification of the chosen total treatment

time.

STANDBY

 Modification of the power or temperature

configuration of the disabled channels.

Procedure:

 Press the button WORKING / STANDBY

to change to WORKING status.

 Press the OK button to return to the main

menu.

The outputs are active.
WAVE GRAPHIC

WORKING

Allows:

 Power supply modification

Procedure:

 Press the WORKING/STANDBY button to

change to STANDBY status.

Treatment time has been completed.
STOP GRAPHIC

TIME

COMPLETED

 Warning finalized treatment time.
 The outputs have been deactivated.

Procedure:

 Press OK to go back to STANDBY
Safety control has been activated

ACTIVE

SAFETY

CONTROL

SAFETY CONTROL GRAPHIC
 Outputs have been deactivated.

Procedure:

 Press the OK button to return to

STANDBY.

Tabel 4.1. Statuses in BASIC MODE

User Manual

Page 27 of 95

Functioning by power control

The power output is established as a percentage of the maximum power by using
the INCREASE / DECREASE power buttons of the corresponding channel. This
can only be done when the device is in WORKING status.

Qualitative indication of the delivered instantaneous power

For each channel, the corresponding luminous indicator informs about the
instantly delivered energy on a qualitative level.

User Manual

Page 28 of 95

1 2

3 4

5 6

4.3. FREE TREATMENT

This is an advanced treatment mode. In this mode the following functions are available:

 Safety control
 Timer
 Status
 Qualitative indication of the instantly delivered energy.
 Accessory recognition
 Energy measurement
 Temperature measurement
 Control by power
 Control by temperature
 Treatment summary screen

FREE TREATMENT screen

Figure 4.3. FREE TREATMENT screen

1.- Timer. This window appears for all models.

2.- Status. This window appears for all models.

3.- Channel 1 This window appears for all models.

4.- Channel 2. This window only appears for C 200 and superior models.

5.- Channel 3. This window only appears for C 300 and C 400

6.- Channel 4. This window appears only for C 400

User Manual

Page 29 of 95

Screen detail FREE TREATMENT MODE

 Channel configured by POWER control

Figure 4.4. Channel configured by POWER control.

Screen detail FREE TREATMENT MODE

 Channel configured by TEMPERATURE control

Figure 4.5. Channel configured by TEMPERATURE control.

User Manual

Page 30 of 95

FREE TREATMENT function description

Safety control

Control allowing the immediate interruption of the treatment. Works only when
the machine is ON and the outputs are active. When the button of the safety

control is pushed, the safety control warning is activated. In this case, press the
OK button to return to the STANDBY status.

Timer

Total treatment time in minutes

When the device is in STOP status, treatment time can be modified using
the buttons INCREASE / DECREASE treatment time..

Elapsed treatment time

When the device starts WORKING, the elapsed time counter starts running,
expressing elapsed time in minutes and seconds.

Status

The device’s status depends on various factors. The following table details the
possible statuses for the basic mode and how to activate them by means of the
keyboard.

User Manual

Page 31 of 95

STATUS ICON DESCRIPTION

The outputs are deactivated.
STBY GRAPHIC

Allows:

 Modification of the chosen total treatment

time.

 Modification of the power or temperature

configuration of the disabled channels.

Procedure:

 Press the button WORKING / STANDBY to

change to WORKING status.

 Press the OK button to return to the main

menu.

The output are activated.
READY graphic

Allows :

 Modification of the disabled total treatment

time.

 Modification of the enabled power or

temperature.

Procedure :

 Press WORKING/STANDBY button to change

to STANDBY.

Treatment time has been completed
STOP Graphic

 Warning finalized treatment time
 The outputs have been deactivated

Procedure:

 Press OK to go back to STANDBY
Safety control has been activated.

SAFETY CONTROL graphic
 The outputs have been deactivated

Procedure :

 Press the OK button to return to the

STANDBY status.

Some accessories are wrongly connected
WARNING graphic
 While the device is WORKING, an accessory

has been connected or disconnected.

Procedure :

 Press the OK button to go to STANDBY.
No valid combination of accessories connected to
the device

EMPTY SQUARE graphic

Procedure:

 When connecting a valid combination of

accessories, the device will go in STANDBY
mode.

STANDBY

WORKING

COMPLETED

TIME

ACTIVE

SAFETY

CONTROL

UNALLOWED

CHANGE OF

ACCESSORY

NO

ACCESSORIES

Table 4.2. FREE TREATMENT statuses

User Manual

Page 32 of 95

Channel with an invalid combination of connected

Active plate with passive plate. Valid combination of

Qualitative indication of the instantaneous power delivered

For each channel, the corresponding luminous indicator informs about the
instantaneous power delivered on a qualitative level.

Accessory recognition.

The device recognizes the connected accessories, displaying the icon of the
connected accessories for each corresponding channel. When the device is in
WORKING mode, only those channels with a valid combination of accessories will
be activated.

ICON DESCRIPTION

Channel with a valid combination of connected accessories

accessories.
Active plate. Invalid combination of accessories.
Passive plate. Invalid combination of accessories
Intracavitary. Invalid combination of accessories.
Resistive. Invalid combination of accessories.

Capacitive. Invalid combination of accessories.

accessories.
Intracavitary with passive plate.

Valid combination of accessories.
Resistive with passive plate.

Valid combination of accessories.
Capacitive with passive plate.

Valid combination of accessories.

Table 4.3. Channel status icons and accessory icons.

Energy measure

Measure of energy delivered during the treatment, expressed in kilojoules.

Temperature measure

Measure of temperature in the active plate expressed in centigrade grades. This
function is only available for active accessories provided with a temperature
sensor.

User Manual

Page 33 of 95

Control by power

The output power is established as a percentage of the maximum power by using
the INCREASE / DECREASE power buttons of the corresponding channel. This
can only be done when the device is in WORKING status.

Control by temperature

In this mode, the user establishes the desired temperature value. The device
automatically regulates the power necessary to reach and maintain this
temperature, measured by the sensor of the active accessory.

This mode only functions in those channels that have accessories with
temperature sensors. Channels with sensor-less accessories connected to them
will function by power control.

The temperature value is established by using the INCREASE / DECREASE
temperature buttons of the corresponding channel.

Indications of the applicable temperature value

For guided treatments, there are three possible temperature options with the
following parameters:

1. Athermal: Corresponds to a power output of 50% with a minimum
generation of heat, indicated for those pathologies where the application of
heat is counter-indicated, especially in acute processes.

2. Moderate thermal: Corresponds to a power output of 75% with a
moderate generation of heat.

3. Frankly thermal: Corresponds to a power output of 100%. The patient will
perceive a strong thermic sensation.

User Manual

Page 34 of 95

FREE TREATMENT SUMMARY screen

When pressing the button OK after the treatment has come to an end, a SUMMARY
screen will pop up, displaying an overview of the parameters of the treatment that was
performed.

For each channel, the following information will appear:

 Connected accessories.
 Treatment temperature.
 Working frequency of the channel.
 Maximum instantaneous power output during the treatment.
 Average power output during the treatment.
 Total of energy delivered during the treatment.

Figure 4.6. FREE TREATMENT SUMMARY screen.

User Manual

Page 35 of 95

4.4. GUIDED TREATMENT

In this working mode, the device establishes prefixed power output and temperature
values in function of the selected option.

Once the selected option has been activated, the device displays the treatment screen.
From that moment on, the rest of the functions are the same as for the FREE
TREATMENT mode. Please see section 4.3 FREE TREATMENT..

Every application should be pleasant and bearable for the patient. Control
by indication does not free the operator from supervising or the patient
from giving feedback on excessive temperature increases. The patient has
the obligation to inform and to make use of the safety control

Indication control

Fixed values are established for the treatment time, percentage of power output and
working frequency.

There are three options (see table):

INDICATION

CONTROL

Table 4.4. Treatment parameters in case of control by indication.

Warning

Athermal

Moderate

thermal

Frankly thermal

Treatment time:
10 minutes
Selected power output: 50%
Working frequency:
0,8 MHz

Treatment time:
15 minutes
Selected power output: 75%
Working frequency:
1,0 MHz

Treatment time:
20 minutes
Selected power output: 100%
Working frequency:
1,2 MHz

User Manual

Page 36 of 95

Temperature control

Fixed values are established for the treatment time, temperature and working frequency.
There are three options (see table):

Treatment time:
10 minutes

Athermal

TEMPERATURE

CONTROL

Table 4.5. Treatment parameters in case of control by temperature.

The device automatically regulates the power output necessary to obtain and maintain
the prefixed temperature as detected by the sensor of the active accessory.

This option will be activated only in those channels that have accessories equipped with
a temperature sensor. Channels with sensor-less accessories will be configured
according to the parameters of the INDICATION CONTROL mode.

Moderate

thermal

Frankly thermal

Prefixed temperature: 37ºC
Working frequency:
0,8 MHz

Treatment time: 15 minutes
Prefixed temperature: 39ºC
Working frequency: 1,0 MHz

Treatment time: 20 minutes
Prefixed temperature: 41ºC
Working frequency: 1,2 MHz

4.5.- CONFIGURATION

Allows the selection of the desired language for the menu texts.

 Spanish
 English

User Manual

Page 37 of 95

4.6 - INFORMATION

This menu option gives access to points of interest for the user.
The information screen also displays a QR code through which the manufacturer’s

website can be accessed.

Figure 4.7.QR code .

The available menu options are:

Counter-indications:

Information screen with a list of counter-indications for using the device.

Maintenance:

Information screen with a list of maintenance operations.
This option also displays a QR code through which the manufacturer’s

website can be accessed for further information on technical assistance.

Figure 4.8. QR code

4.7.- SWITCHING OFF THE DEVICE

Before switching off the device with the on/off switch located at the back panel, the
operator must be make sure the device is not in WORKING mode.

User Manual

Page 38 of 95

Chapter 5

Maintenance

This chapter describes the procedures for a correct maintenance of the
device and its accessories.

CAPENERGY devices cannot be repaired by users. All repairs should be
made by the manufacturer or authorized personnel.

5.1 IN GENERAL

When using CAPENERGY DEVICES, the following matters regarding periodic
maintenance should be observed:

Before the treatment:

 The insulation of the active plate should be inspected carefully in search of

imperfections, damages of the surface, scratches on the insulation or any other kind
of flaw. Do not use the accessory if you detect any kind of damage to the surface of
the gel sleeve, protective membrane or active plate.

 The active plates have to be used with gel sleeves. Avoid folds on the inside when

applying the sleeve to the body, in order to avoid pores or cracks from forming.

 Any pore or crack in the gel sleeve means you have to get rid of the accessory and

replace it by a new one.

 The cables and connectors of the active and passive accessories have to be

inspected to assure their perfect condition. The accessories should not be used in
case any kind of damage or imperfection is detected and they should be replaced by
others in perfect conditions.

 The capacitive electrodes should be used with protective membranes to assure their

preservation.

 The gel sleeves and protective membranes are consumer goods subject to wear and

tear which may affect safety. Replace the sleeves and membranes by new ones if
you observe any flaws.

Warning

User Manual

Page 39 of 95

After the treatment:

 The resistive electrodes do not have to be used with a protective membrane. They

are best cleaned with a class IIa disinfecting product.

 The passive plates are not to be used with a gel sleeve. They are best cleaned with a

class IIa disinfecting product after each application.

 After each treatment, it is mandatory to carefully and correctly clean all the electrodes

and active and passive plates. This will considerably increase the life span of the
product.

 Do not use aggressive products such as acids, liquid ammonia, alcohol, etc. to clean

the external surfaces of the device.

 We recommend a periodical inspection of all the components of the device. Contact

your official distributor in case you detect any anomaly.

The disinfecting product used must be sanitary product of class IIa and it must be used
following the instructions of his manufacturer.

5.2 SPECIFIC CONSIDERATIONS FOR INTRACAVITARY
TREATMENT.

 Treatments carried out with intracavitary electrode require the use of an eco-cover or

covering sensor of anal and vaginal use, being very important when it is put on the
electrode the inside air is expelled for a better inductively coupled, recalling that for
these treatments is not required inner gel between the electrode and eco-covers or
covering sensor. The gel is only for outdoor use for better intracavitary sliding and to
favor the inductively coupled during treatment.

 Eco-covers or covering sensor of anal and vaginal use are recommended by

CAPENERGY MEDICAL validated for treatments to be performed. Any other material
used by professional expose to the risk of burns or bad inductively coupled of the
equipment under their full and sole responsibility.

 The recommended gel for use in intracavitary applications is validated by the

manufacturer with the presentation format single-dose sterile. Any other material
used by professional expose to the risk of burns or bad inductively coupled of the
equipment under their full and sole responsibility.

 References validated the eco-covers or covering sensor of anal and vaginal use, and

the gel in sterile single-dose of intracavitary use are specified in "6.1
ACCESSORIES".

User Manual

Page 40 of 95

5.3 MAINTENANCE ROUTINES INTERVALS

In the following table you will find an overview of the necessary periodical maintenance
routines for C 400 devices (and the entire product range).

Frequency Task Executed by

Each 5 years. General revision of the equipment.

After each

treatment

Before each

treatment

Monthly

Verification and checking of the
parameters of power, frequency and
temperature.
Clean the treatment accessories.

Inspection of the active plate’s gel sleeve.
Inspection of the insulation of the active

plate and the integrity of the passive plate.
Inspection of the insulation of the

capacitive electrodes.
Inspection of the accessories’ cables and

connections.
Check the correct functionality of the

safety control
Inspection of the central unit.

MANUFACTURER

USER

User Manual

Page 41 of 95

5.4 PROBLEM SOLVING

Problem Probable cause Action

The screen does not
light up when the
device is switched on.

The accessories have
been applied correctly,
the device is ON and the
power has been set to the
maximum, but the power
indicating pilot light does
not light up.

When the equipment is
turned on, the following
message appears in the
screen:

ERROR #
During the treatment
appears the following
message:

OVERLOAD #

The socket does not
receive electricity.

One or two fuses have
melted down.

Electronic breakdown
The passive or active

plates are not
connected correctly.

The passive or active
plates are defect.

Electronic breakdown
A malfunctions has

been detected in the
initial test routine.

The selected power is
to high in the indicated
channel.

Electronic breakdown

Check whether the socket
receives electricity. Make
sure the mains cable is
connected correctly.

Replace the melted fuse(s)
of the network base.

Contact the technical
service department.

Make sure the passive plate
and active accessory are
connected correctly to their
corresponding connectors.

Change the passive plate
and active accessory to see
if this solves the problem.

Contact the technical
service department.

Contact the technical
service department.

Restart the treatment and
use a smaller power.

Contact the technical
service department.

User Manual

Page 42 of 95

Problem Probable cause Action

The device does not
recognize an accessory
or does not identify it
correctly.

The temperature level
of the active accessory
connected to a channel
is not correct.

The passive plate or
active accessory, are
not connected correctly.

Defect accessory.

Electronical breakdown.

The active accessory is
not connected correctly.

Defect accessory.

Electronical breakdown.

Make sure the passive plate
or active accessory are
connected correctly to their
corresponding connectors.

Try to connect the
accessory to another
channel. If the problem
persists, replace the defect
accessory for a good
working one.

Try to connect an
accessory that is identified
correctly when connected to
another channel. If it is not
identified correctly, contact
the technical service
department.

Make sure the active
accessory is connected
correctly to its connector.

Try the accessory in
another channel, if the
problem persists, replace
the defect accessory for a
new one.

Connect an active
accessory that works
correctly in another channel
to the channel you are
having problems with. If the
problem persists, contact
the technical service
department.

User Manual

Page 43 of 95

5.5 AVAILABILITY OF TECHNICAL INFORMATION

If requested, circuit diagrams, component lists, descriptions, instructions for calibration
and other information can be supplied in order to help adequately qualified personnel to
repair those parts of the device the manufacturer considers repairable.

Warning

CAPENERGY devices cannot be repaired by users. All
repairs should be made by the manufacturer or authorized

5.6 MANUFACTURER’S LIABILITY

CAPENERGY MEDICAL, S.L. is responsible for the safety, reliability and correct
functioning of the device only when:

 Assembly, extensions, adjustments, modifications or repairs are carried out by

personnel specifically authorized by CAPENERGY MEDICAL, S.L.

 The electrical installation of the rooms where the device is connected comply all

requirements.

 The device is used according to the instructions explained in detail in this manual.

The manufacturer cannot be held liable for damages caused to persons or effects
derived from an incorrect use of the device, lack of or incorrect maintenance or failure to
observe the guidelines contained in this manual.

5.7 MANUFACTURER’S WARRANTY

The devices of the CAPENERGY product range (console) has a 24 month warranty
period starting from the date of purchase. The warranty is invalidated if the device is
operated, serviced or manipulated by personnel unauthorized or negligence occurs
during use of the device.

The accessories (electrode holder, active and passive plates and capacitive and resistive
electrodes) have a warranty of 12 months from the date of purchase. This warranty is
invalidated by manipulations, interventions or modifications of the devices carried out by
unauthorized personnel or by negligent use of the accessories.

User Manual

Page 44 of 95

The consumable items (membranes and protecting sleeves) that enter into contact with
the patient’s body are subject to normal wear and tear and have a guarantee of 6 months
following the purchase only if they have not been used, have not been subject to
manipulations, interventions or modifications by unauthorized personnel and have not
been used in a negligent way.

The warranty is limited to repair free of charge and the replacement of those parts in
which Capenergy Medical, S.L.’s technical personnel detects possible manufacturing
defects.

This warranty does not cover parts, accessories or consumable goods subject to use
and/or wear and tear due to normal use or those parts, accessories or consumable
goods damaged due to an incorrect use or maintenance.

Repairs derived from mechanical crashes, natural catastrophes, defects in the electrical
installation or improper use are not covered by warranty. Any kind of manipulation,
maintenance and / or repairs carried out by unauthorized personnel will automatically
invalidate the warranty..

5.8 OBSERVANCE OF THE WARRANTY CONDITIONS FOR
THE BUYER

1. The buyer commits to verifying the correct state of the merchandise within 24 hours

after reception.

2. Possible damages occurred during transport must be communicated immediately in

writing to the transport agency that has made the delivery as well as to the sender.
Anomalies and/or damages caused by transport are never covered by warranty.

3. The warranty is activated when the certificate of installation, duly signed by the

customer and the seller, is sent to the manufacturer. Failure to present this document
will mean all repairs and revisions of the device will be charged correspondently (will
not be free of charge), even within the period of warranty.

4. The warranty does not cover accessories subject to wear and tear (active and

passive plates, cables, electrodes, etc.) Nevertheless, if the customer detects and
informs about any defect in the accessories in a period of 30 days after purchase, the
accessories will be replaced by new ones prior return to the manufacturer of the
defect items.

5. The device has to be sent to the manufacturer / distributor in its original packaging. In

case the shipment is made by a transport agency, the wooden box has to be secured
on a pallet.

User Manual

Page 45 of 95

6. The warranty does not cover defects caused by negligence or lack of adequate care

during use due to the non-observance of the instructions detailed in this manual, be it
because of incorrect maintenance or any other circumstance that is not caused by
manufacturing defects.

7. The manufacturer cannot be held liable for damages to persons or objects derived

directly or indirectly from the lack of observance of all the prescriptions detailed in this
manual and specifically in regard to the use and maintenance of the device. The
guaranty does not provide, in any case, for the compensation of damages, of any
nature, suffered by persons or objects.

8. The warranty will become invalid and technical assistance will only be provided at the

customer’s charge, in the following cases:

 In case the buyer is unable to present the warranty certificate;
 In case the device has been given an inappropriate use;
 In case the serial number has been erased, tampered with or eroded;
 In case the casing of the device has been opened up by unauthorized

personnel;

 In case the device has been manipulated, even if only partially or only one of

its parts or components.

9. In case of assistance under warranty, all the costs and risks derived from the

transport of the device are at charge of the customer.

10. In case the technical service does not detect any manufacturing defects, all costs

derived from the revision will be at charge of the customer, even if the device is still
under warranty.

11. The warranty conditions cannot be modified by any other written or oral agreement.

12. Assistance under warranty can only be carried out by the manufacturer or certified

personnel specifically authorized to do so by the manufacturer..

13. We recommend you periodically revise your devices once the warranty period has

come to an end. We recommend you have this check-up every two years in order to
assure the correct working and efficiency of the device and its accessories.

User Manual

Page 46 of 95

5.9 TECHNICAL SERVICE

For any further information on the use of the device and / or technical service, please
contact us directly:

CAPENERGY MEDICAL S. L.

Av. Mare de Déu de Montserrat, 41 - Pasaje 1º Derecha
Polígono Industrial Font Santa
08970 Sant Joan Despí (Barcelona)
España (SPAIN)

Tel. : + 34 (93) 477.43.48
Fax : + 34 (93) 477.42.90
[email protected]

5.10 HOW TO DEAL WITH THE DEVICE AND ITS
ACCESSORIES AT THE END OF ITS LIFE CYCLE

Once the life cycle of the device has been completed, kindly dispose of it according to
the Waste Electrical and Electronic Equipment Directive (WEEE) , 2002/96/CE, this law
came into force in August, 13- 2005 in the European Community.

This directive set collection, recycling and recovery targets for all types of electrical and
electronics goods for reducing pollution.

User Manual

Page 47 of 95

Chapter 6

Accessories

This chapter details the accessories and consumable items available for C

400.

6.1 ACCESSORIES

The following table details the available accessories:
WARNING. The use of ACCESSORIES, electrodes and cables different from those

indicated in this manual may increase the EMISIONS or decrease the INMUNITY of the
equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and
C500.

Reference Description Image

080224 Mains cord

2,5 meters

5350070 Safety control

5350037

5350037 XL

5350038

5350038 XL

Active plate with
temperature sensor. (180
cm long)

(Optional)
Maximum length cable 200
cm

Passive plate (180 cm
long)

(Optional)
Maximum length cable 200
cm

User Manual

Page 48 of 95

made out of polyurethane

5350039

5350039 XL

Active plate without
temperature sensor (180
cm long)

(Optional)
Maximum length cable 200
cm

5100013 Hygienic protective cover

made out of polyurethane
with conductor gel for
active plate.

5100060 Hygienic protective cover

without conductor gel for
active plate.

5350033

5350033 XL

5350034

5350034 XL

5350035

5350035 XL

5350036

5350036 XL

Straight resistive electrode
holder (180 cm)

(Optional)
Maximum length cable 200
cm

Straight capacitive
electrode holder (180 cm)

(Optional)
Maximum length cable 200
cm.

90º resistive electrode
holder (180 cm)

(Optional)
Maximum length cable 200
cm.

90º capacitive electrode
holder (180 cm)

(Optional)
Maximum length cable 200
cm.

User Manual

Page 49 of 95

5100029 Resistive electrode 33mm

5100031 Resistive electrode 53mm

5100032 Resistive electrode 65mm

5100025 Capacitive electrode 33mm

5100027 Capacitive electrode 53mm

5100028 Capacitive electrode 65mm

5111028 Elastic strap 80 cm

5111030 Elastic strap 60 cm

5111029 Elastic strap 40 cm

User Manual

Page 50 of 95

5350040 Intracavitary accessory MJS

Max. cable length 200 cm

5100135 Vaginal rectal probe

membranes for Intracavitary
accessory MJS

500 units per box

5100157 Gel for vaginal and rectal

use steril, in format of
unidose

Individual unit 20 ml

5310002

Product of Cleaning of
accessories, for Capenergy
devices.

5100040 Device base.

5100104 Accessory tray adaptable to

device base.

User Manual

Page 51 of 95

350200 User Manual CAPENERGY

DEVICES

5100147 Isolation transformer of

700VA
For C400 y C300

5100148 Isolation transformer of

450VA
For C50, C100, C200 and

C500

Table 6.1. Accessories of Diathermy Capenergy devices.

(OPTIONAL – NOT SUPPLIED WITH THE DEVICE)

5350002 Technical box to transport of

Capeneregy devices with
internal flocking.

Models C-50 to C-200

5350003 Technical box to transport of

Capeneregy devices with
internal flocking.

Models C-300 to C-400

Table 6.2. Solutions of movility to the transport of

Diathermy Capenergy devices.

User Manual

Page 52 of 95

Chapter 7

Clinical application

In chapter 7, you will be explained how to perform treatments with the
CAPENERGY devices and how to apply the electrodes and plates in
function of the different pathologies.

CAPENERGY devices must be operated by qualified personnel and the
working methods and protocols described in this manual need to be
observed. In case of doubt we recommend you consult with the
manufacturer and / or medical advisor those symptoms not described in the
manual.

Warning

7.1 GETTING STARTED

What follows next forms part of basic knowledge and can be applied generally:

1. Take the device out of its packaging and verify no damages occurred during

transport. In case you detect any, do not use the device and notify of the damage as
described in the warranty conditions.

2. Before connecting the device to the network (230V~), make sure the power point has

been equipped with an earth wire.

3. Connect the mains cord to its corresponding connector in the back of the device and

insert the plug into the socket of the isolation transformer, then connect the isolation
transformer with his mains cord to the wall socket..

4. Start up the device by means of the switch located in the back of the device. As soon

as the device starts up, all the power outputs automatically set to ‘0’.

5. Before activating the device’s outputs connect the cable of the manual electrode to

the connector of the active output or connect the active plate to its corresponding
output. An electrode and an active plate cannot be connected at the same time to the
same connector.

6. Connect the cable of the passive plate to its corresponding connector.

7. Repeat the previous steps for all the electrodes or plates you wish to use during the

treatment.

User Manual

Page 53 of 95

8. Before starting the treatment, apply the previously cleaned passive plate(s) to the

client’s skin. Apply a small amount of vehicle cream if necessary.

9. According to the type of treatment, apply a small amount of vehicle cream to the

manual electrode or the active automatic plate.

7.2 SECURITY AND MAINTENANCE WARNINGS

The following matters have already been commented upon in the Safety Chapter but
those related to the application will be further detailed hereafter:

General matters

 The device must be connected to a power point that has been equipped with an earth

wire.

 This device cannot be connected to other devices.
 Always disconnect all the accessories that are not going to be used.
 Do not use the device in the absence an operator who can assist the client.
 The device’s casing must be cleaned using a damp cloth and very little neutral

detergent.

 The environmental temperature cannot exceed the interval indicated in the user’s

manual in order to assure the correct functioning of the device. Using the device at a
temperature inferior or superior to the indicated interval, may affect the technical
reliability of the device.

 In case that the patient has used any kind of adhesive bandage, it is important to

retire any rest of adhesive before the application of the plates.. Failure to comply with
this observance may cause burns.

Active plates / Passive plates

 Always apply the plates with the power output set to zero
 For reasons of hygiene, the active plates come with a washable cover. These covers

should be cleaned with water and soap after each treatment and they should be
replaced when they start to wear down. Complete cleaning after each treatment using
an class IIa disinfectant.

User Manual

Page 54 of 95

 Make sure the accessories and protective sleeves of the active plates are in a good

state. Worn down or damaged surfaces affect the functionality of the device and the
efficiency of the treatment and may cause damage to the device.

 After each treatment, the active plates should be disinfected with a class IIa

disinfectant.

 The passive plate must be placed in direct contact with the skin without using a

vehicle cream on the same surface. The active and passive plate should be
separated by at least 4 centimeters in order to avoid excessive temperature
increases.

 All the plates that will be used during the treatment have to be applied to the patient

before activating the outputs. Only after applying all the plates, you may activate the
outputs. Do not under any circumstance invert the order of these procedures.

 The plates should be handled by qualified personnel, with adequate knowledge of the

device and its use. Special attention should be paid to the positioning of the plates:
as much surface as possible should be in contact with the patient’s skin.

 Apply always first the passive plate (metal) and only then the active plate (isolated).
 After the treatment has come to an end, first remove the active plate and only then

the passive plate.

 The power of each channel can be regulated independently from the others, by

pressing “” and “”. The power level of each output is indicated by its
corresponding led bar. Power output can be regulated when the outputs are
deactivated or activated.

 When the cycle of the timer comes to an end and after a stop to deactivate the

outputs, the plates may be removed. First the active one and then the passive one.
The same procedure should be followed to move the plate or change their position on
the patient’s body.

 When the device is used in automatic treatment mode (active and passive plates

applied to the patient’s body), the operator has to gradually increase the power until
the desired level has been reached. Only after verifying the patient’s level of
sensitivity and tolerance to the endogenous heat that is being produced and after
connecting the security control, the treatment can continue without the operator being
present. We nevertheless recommend you regularly check the patient’s tolerance and
heat sensitivity during the treatment.

 When applying the fore-mentioned automatic treatments, the safety control must be

placed within the client’s reach.

 The non-compliance of these safety norms may cause the passive plate (metal)

burning the patient’s skin when the device is functioning.

User Manual

Page 55 of 95

 The plates or non-insulated electrodes (resistive) cannot enter into contact with the

central unit’s casing or any other conductive material when the outputs of the device
are activated. This precaution will avoid other surfaces from being exposed to the
same power as the device’s output and thusly reduces the risk of electrocuting
patients and operators.

Manual electrodes

 When manipulating electrodes during the treatment, always first set the power

regulator to zero.

 After each treatment the manual electrodes should be disinfected with a class IIa

disinfectant..

 Before cleaning the electrodes, the operator should turn off the device.
 When using the manual electrode, make sure that:

- You have deactivated the outputs before applying the return element.

- The electrode is being used with as much contact surface as possible.

- When performing a resistive application, pay specific attention to the energy

being delivered by the device.

 It is important to maintain the accessories with care. Please avoid them from bumping

or falling. Damaged accessories are a risk for the patient’s health and safety if applied
during a treatment.

 During the application of the manual electrode, an excess of vehicle cream or

cosmetics may build up on the electrodes surface. This may generate a voltaic arc
causing the current to concentrate in that area and wearing down the electrode. In
case of a built-up it is therefore recommended you lower the power to cero and then
wipe off the excess product. You may then continue the treatment.

Intracavitary eletrode

 Under no pretext should be used the intracavitary accessory with conductive gel

between the body of intracavitary and the vaginal-rectal probes. The use of the gel
should be exclusively external to the vaginal-rectal probes, when appropriate, as a
coupling medium.

 The vaginal-rectal probes approved by the manufacturer is of prescriptive use for

performing intracavitary treatments, to ensure the health and safety, and to guarantee
the correct coupling, being prohibited the use of any other type of condom, echo
sounder, or similar product.

User Manual

Page 56 of 95

Coupling creams

 The coupling product serves to facilitate the electrical coupling and lubricate the

treated area to facilitate the displacement of the capacitive and resistive active
electrodes.

 The recommended conductor product by the manufacturer to lubricate and facilitate

the movement of the electrodes is a emulsifier cream with moisturizing and emollient
properties, preferably free of parabens, with a proportional composition containing
natural oils, antioxidants extracts, and polar fatty factor.

 You can neither use as a conductor product any cream whose composition

percentage is higher in water than oil, nor gels. You cannot either use any cosmetic
product which has been previously validated by the manufacturer

 We do not recommend the use of products that contain cryogenic substances such

as menthol, camphor or similar. The same goes for carbon-based conductor gels: the
product base should by fat-soluble.. .

 Do not use corrosive products such as glycolic acid.
 You cannot use abrasive, thermogenic, cryogenic or anesthetic substances
 You cannot use any substance which is identified to be aggressive for accesories,

due to the risk of electrode breakage.

7.3 POSSIBLE TREATMENT MODES

The multi-purpose design of the different CAPENERGY devices allows using different
combinations of manual electrodes and / or capacitive plates during one single
treatment.

In order to do so, you have to select the treatment you wish to perform:

I. Do you wish to work with one (1) automatic electrode (plate)

II. Do you wish to work with two (2) automatic electrodes (plates)
III. Do you wish to work with three (3) automatic electrodes (plates)
IV. Do you wish to work with four (4) automatic electrodes (plates)

V. Do you wish to work with one (1) insulated manual electrode (capacitive electrode

holder)

VI. Do you wish to work with one (1) automatic electrode (plate) and one (1) insulated

manual electrode (capacitive electrode holder)

User Manual

Page 57 of 95

VII. Do you wish to work with two(2) automatic electrodes (plates) and one (1)

insulated manual electrode (capacitive electrode holder)

VIII. Do you wish to work with three (3) automatic electrodes (plates) and one (1)

insulated manual electrode (capacitive electrode holder)

IX. Do you wish to work with one (1) non-insulated manual electrode (resistive

electrode holder)

X. Do you wish to work with one (1) automatic electrode (plate) and one (1) non-

insulated manual electrode (resistive electrode holder)

XI. Do you wish to work with two (2) automatic electrodes (plates) and one (1) non-

insulated manual electrode (resistive electrode holder))

XII. Do you wish to work with three (3) automatic electrodes (plates) and one (1) non-

insulated manual electrode (resistive electrode holder)

XIII. Do you wish to work with one (1) insulated manual electrode (capacitive electrode

holder) and one(1) non-insulated manual electrode (resistive electrode holder)

 Before pressing the start button located at the back of the device:

1) When using any type of manual electrode holder: place the electrode on
the skin surface of the area you are going to treat.

2) When using automatic active plates: place the active plates on the
treatment area and make sure the contact between the plate and the skin is
ideal by means of elastic bandages, If you are going to use the automatic
plates without an operator being present, connect the safety control holder
which allows the patient to stop the treatment at any time.

 Place the passive plate(s) on the area(s) that will receive the return current.
 Program the treatment time and press the START button.
 Adjust the power until the client perceives the generated heat level as pleasant.
 At the end of the treatment, an acoustic signal will be heard. Press the STOP button

and set the power regulator to 0.

 Remove the plates.
 Clean the plates and/or the manual electrodes used during the treatment.

User Manual

Page 58 of 95

The C 400 allows working in all of the previously explained treatment modes, combining
manual and automatic techniques in one single session or working in automatic mode or
manual mode only. This means the operator can perform:

 Automatic treatments with active / passive plates.
 Manual treatments with an insulated (capacitive) electrode
 Manual treatments with a non-insulated (resistive) electrode
 Combined CAP-RES manual treatments
 Combined manual and automatic treatments

The intelligent connectors recognize the accessories connected to each output which
allows the operator to easily adapt to its use and to display a great versatility.

The number of outputs is what makes this device into multi-purpose unit, enabling the
treatment of multiple pathologies or even multiple patients in one single session.

EXAMPLE OF A MULTIPLE COMBINATION (Automatic + manual treatment)

User Manual

Page 59 of 95

MODUS OPERANDI AND USE (example) :

The patient will be lying on a couch in the supine or prone position, depending on the
treatment to be done. The operator will remain standing close to the area to be treated,
manipulating the corresponding accessory for each treatment and with easy access to
CAPENERGY device

As a general recommendation, before treating a patient and/or defining the treatment
protocol to follow, based on the pathology that has to be treated the operator should be
sure of how to approach the client’s pathology and what kind of treatment to apply:

 Automatic treatment
 Manual treatment with only 1 electrode
 Manual treatment with 2 electrodes
 Combined (automatic and manual)

The (patented) intelligent connect recognizes all different types of accessories and
identifies them on the screen, including the intracavitary accessory which can be
connected to all of the outputs.

1. Following the chosen approach, the operator will place the passive return plates on
the patient’s corresponding body areas, observing the following procedure:

 Output 1 – Place the active plate on the treatment area and assure a perfect

contact between the plate and the skin by using the elastic bandages. When
using the automatic plate without the presence of an operator, the safety
control should be connected so the client can stop the treatment whenever he
wants to.

 Output 2 – Repeat the previous procedure.
 Output 3 – Place the active plate on the area that will receive the return

current and place the manual (capacitive or resistive) electrode on the
treatment area, making sure there is a perfect contact between the passive
plate and the skin and applying vehicle cream to more swiftly move the
electrode throughout the treatment.

 Output 4 – Repeat the previous procedure.


2. The next step will be to determine the working mode::

 Basic mode (power-driven)
 Free treatment (power or temperature-driven)
 Guided treatment (By indication / temperature-driven)

Through the menu options, the desired power can be selected (more information in
Chapter 4 – Indications for Use)

User Manual

Page 60 of 95

3. To start the treatment, push the START/STOP button, after establishing the
estimated treatment time.

Increase / Decrease of the

treatment duration

Start/stop button

Screen indicator

4. The power has to be regulated in such a way the client perceives the generated heat
as pleasant and the frequency adjusted according to the area or pathology to be
treated.

Frequency may vary throughout

the treatment.

Each Output is independent

The power has to be adapted

manually in such a way the

client perceives the generated

heat as pleasant.

Screen indicator

5. At the end of the treatment an acoustic signal will be heard and on the screen the
word STOP will appear:

Screen indicator

User Manual

Page 61 of 95

6. Once the treatment has come to an end, the passive plates will be removed (this
should only be done after the device has been turned off and without brusquely
pulling from the cables as this could damage the plates).

7. You can now proceed to cleaning the plates and/or manual electrodes used during
the treatment.

8. When accessories are changed in the course of a treatment, the device will turn down
automatically as a safety measure. Accessories should be changed with the device
on hold.

Press the start/stop button to

change accessories in the course

of a treatment

Screen indicating the device is on

hold.

User Manual

Page 62 of 95

7.4 IMPORTANT PARAMETERS FOR USING CAPENERGY

a) Manual CAPACITIVE operating mode

Temperature

The sensation of heat generated inside the body depends of various factors and may
be perceived by the client as ranging from lukewarmness to intense endogenous
heat. The following should be taking into account when using manual capacitive
electrodes:

- Diameter of the electrode: At a same power, those electrodes with a larger

diameter will increase their temperature more gradually. Use them with the
protective hygienic membrane.

N.B.: It is correct to always choose the largest electrode available in function of
the area that needs to be treated as long as it correctly adapts to the skin’s
surface.

- Movement velocity: At a same power, the faster you move the electrode, lesser

will be the sensation of heath perceived by the patient.
N.B.: CAPENERGY devices can be used by applying a motionless electrode on

the treatment area or by applying the electrode in circular or linear movements,
according to the treatment surface and the power you wish to transmit.

Application pressure of the electrode

It is very important that the largest part of the electrode’s surface or the whole of it
remains in contact with the patient’s skin. This can be achieved by applying a discrete
pressure and following possible curvatures and irregularities of the treated areas,
continuously adapting to the latter. Correctly choosing the most adequate diameter
will be most helpful in this matter. A correct pressure is, without any doubt, important
to identify specific areas, core pain points or possible muscle contractions of the
middle superficial plane.

The electrode holder has been studied in detail in order to minimize the operator’s
efforts and to make the treatment more pleasant for the patient (deep tissue
massage, as if it were an extension of the operator’s hands.

N.B.: There are some exceptions where it is necessary to remain adhered to the skin
without exercising any specific pressure: this is the case with bruises, and phlebitis
and acute phlobosis in general.

User Manual

Page 63 of 95

Type of tissue treated

The temperature perceived by the client in the manual capacitive mode depends
either on the parameters described before or on the type of the tissue located
immediately below the area where the electrodes are applied. The richer the deep
tissues are in liquids and electrolytes, the faster and the more marked the
temperature increase will be in equality of all the other parameters.

CAPENERGY devices is an instrument which, by means of a displacement current of
internal charges, can cause an increase of the endogenous temperature in function of
previously determined parameters. On the other hand, there are clinical situations
where it is not indicated to provoke such thermic increase. The analgesic, anti­inflammatory and regenerative effect is present nevertheless, even when the internal
temperature is not increased.

b) Manual operating mode with direct coupling (RESISTIVE)

‘Direct coupling’ or RESISTIVE mode refers to the application of CIM with metal non
insulated electrodes (without an interposed dielectric). The activating mechanism of
this accessory, determined by the inversion of the current’s polarity, produces a faster
and more intense temperature increase in tissues that are not rich in water and
electrolytes (bone tissue and adipose tissue to be precise).

This application mode seems thus more indicated in combination with the capacitive
manual option for those pathologies that affect the fore-mentioned tissues.

Differences between the resistive and manual capacitive operating
mode

- DIRECTIONALITY: Given that the active electrode is not insulated, a smaller

concentration is produced in the area immediately below the active electrode that
takes on a directional aspect and is transported by the passive electrode (return
plate). Consequently, a displacement current of the charges is produced and a
temperature increase is generated inside the body. In other words, the main
difference resides in the special attention paid to the positioning of the return
electrode, which directs the impulses generated by the active electrode. For
example, when treating a lumbosciatic syndrome caused by a L-5 S-1 discopathy
with pain irradiation towards the heel, the return plate will be placed underneath
the foot, while the active plate will be applied in the lumbosacral area.

User Manual

Page 64 of 95

- TEMPERATURE INCREASE: The power should be increased gradually from the

minimum up to the point where the patient notices a pleasant and bearable
temperature which can be perceived in the active or passive electrode or in both
at the same time, in function of the tissues located in between the two electrodes
and the penetrated diameter (at a same power, those areas with an smaller
diameter will heat up more, for instance, the wrist or the ankle). If the patient
during the treatment warns about an increase of the pain he feels, the power must
be lowered until this sensation disappears.

- MOUVEMENT: Differently from the capacitive mode, when using direct coupling

in most cases the electrode will be used in a fixed position or with subtle
movements in circles slightly larger than the diameter of the electrode that is being
used. The power has to be adjusted constantly to make sure the temperature
perceived by the client is pleasant at all times.

- ADHERENCE: It is important you always use electrodes that adhere perfectly to

the patient’s skin. Be careful not to touch the patient with the brim of the
electrode’s circumference.

IT IS IMPERATIVE TO AVOID THE RESISTIVE
ELECTRODE FROM ENTERING IN DIRECT

Warning

CONTACT WITH THE PASSIVE PLATE OF THE
WORKING DEVICE.

Direct contact will produce technical damages in the
device.

c)

Automatic operating mode with CAPACITIVE PLATE

Using the larger (200 cm2) capacitive automatic electrodes (active plates) offers
great advantages and allows to treat, without the need of an operator being
present, larger body areas. Each working channel (max. 4) works autonomously
and consists of a so called active plate and passive reception plate.

User Manual

Page 65 of 95

Given the dimensions of the surface that can be treated, in spite of it being
insulated electrodes an ionic displacement current is generated capable of
creating a situation similar to that of the resistive operating mode.

In other words, as we’ve indicated before, in this case it also important to carefully
position the two electrodes in order to get the most out of the directionality of the
impulses created inside the organism.

The fundamental difference of the direct coupling consists in the careful evaluation
of the tissues located between the two electrodes: if the distance between them is
relevant and the tissues in between are mostly resistive, the electric field will
encounter obstacles that can interfere with the results. In that case it will be
necessary to reduce the distance between the active and passive electrode of the
same channel.

Let’s retake once more the example of the lumbosciatic syndrome L-5 S-1. If the
patient is overweight, the active plate has to be placed on the lumbosacral area
and the passive one along the nerve, for instance on the rear part of the thigh. If
the patient has a normal weight and even has a certain muscle tone (liquid rich
tissue), we can proceed in a way similar to direct coupling, placing the active plate
on the lumbosacral area and the passive plate against the foot sole.

The level of power applied should be assessed in function of the pathology that is
being treated and whether or not an increase of the internal temperature needs to
be obtained. The protocol will indicate the most appropriate parameters.

SUMMARY

1) Double working mode with operator

a. Capacitive mode
b. Direct coupling (resistive) mode

2) Operator free working mode (automatic)

a. Capacitive automatic plate with passive return plate.

3) Very versatile thanks to the fact that each channel can work autonomously and can
be used in all the treatment modes previously described.

User Manual

Page 66 of 95

7.5 WORKING PROTOCOL FOR THE CAPENERGY DEVICES

Application with capacitive manual electrodes

The experience gathered by various operators (doctors and therapists) working on
thousands of patients all over the world, has allowed us to develop easy, secure and
efficient treatment protocols that deliver fast results.

APPLIED PARAMETERS
Position of the

electrode

Movement of the
electrode

Temperature: No matter what problem is being treated, the temperature

Application time The electrode should remain on each of the treatment

On those points indicated for the pathology that is being
treated

Fixed and slightly rotating, covering an area slightly larger
than the diameter of the electrode.

generated has to be bearable. The patient has to perceive
a pleasant sensation of lukewarmness.

points for 5 to 10 minutes, depending on the amount of
points considered and the total duration of the session.
There are no counter-indications so the operator may
prolong the treatment time of the considered areas as long
as he sees fit.

Position of the
passive electrode

It is best to always position the passive plate close to the
treated problem area.

SUMMARY

The ideal way to use CAPENERGY devices is combining manual/automatic modes. It is
particularly recommended to start the session by treating the trigger points during a
couple of minutes in manual capacitive mode and then continuing with the automatic
plates.

User Manual

Page 67 of 95

7.6 CAPENERGY APPLICATION FREQUENCY

CAPENERGY devices can choose between three working frequencies, facilitating the
impedance matching between the equipment and the circuit formed between the
electrodes and the body. Available frequencies: 0.8 MHz, 1.0 MHz and 1.2 MHz

The column LED of therapy informs, in real time, about the power absorbed by the body,
helping the operator to select the optimal frequency that maximizes the power transfer.

When the column of LEDs of therapy achieves 100%, it indicates that it has reached the
possible maximum power transfer.

User Manual

Page 68 of 95

7.7 THERAPEUTICAL TREATMENT APPLICATIONS

 Pathologies of the muscles or articulations, fissures, orthopedics, physiotherapy

or sports medicine

- Non irradiated spine pathologies

- Lumbosacral spine with irridiations

- Lumbosciatic DX L1-L2

- Lumbosciatic DX L4-L5

- Knee pathologies

- Ankle and foot pathologies

- Cervical brachialgia

- Scapulohumeral Periarthritis

- Epicondilytis- epicondylitis

- Pathologies of the hand

 Phlebological pathologies
 Aesthetics Medicine and Surgery
 Cystocele, cystitis, pelvic pain, etc…in uro-ginecology
 Veterinary physiotherapy (under the supervision of a certified veterinarian)

Consult scientific publications, monographic therapeutic guides and documentation on
diathermy in medical treatments.

Feel free to ask us for further information, we will happily provide you.

User Manual

Page 69 of 95

LEGEND:

AP

PP

=

RADIATED PATHOLOGIES



Nuchal Cefalea







–

Lumbalgias

Application time:

Sensation perceived by the patient:

Lower the potency when the patient

N.B: CIM vehicles products. We advise

-

-

alopathics

(essential oils, fytotherapeuticals,

oxicologicals) to apply on the cleand

-

free skin before performing the

treatment.

EXAMPLES OF APPLICATIONS: PHYSIOTHERAPY

AP1

PP2

PP1

AP2

APPLICATION SCHEME FOR NON

-

SITUATED IN THE RAQUIS

Cervical artrosis
Cervical spinal distorsion
Dorsalgias

-

Hieralgias

Treatment mode

Nº applications: from 3 to 10

20 minuts

Advised potency: low/average

non intense warmth

Re gulation during therapy:

reports an excessive temperature.

using miorelaxing products and/or anti
inflammatory alopathics or non

homot
and grease

=

Active Plate

Passive Plate

User Manual

Page 70 of 95

EXAMPLES OF APPLICATIONS URO-GYNECOLOGY

(Cystocele, cystitis, annal fissures, pelvic pain, etc, ..)

ON A WOMAN
INTRACAVITARY ELECTRODE POINTING FORWARDS AND PLATE ON THE

ABDOMEN

Intracavitary application:

Intracavitary accessory pointing forwards. Return plate on the abdomen..

Extracavitary application:

The same application can be done with plates in automatic mode: active plate on the
sacro and return passive plate on the abdomen.

User Manual

Page 71 of 95

IDENTIFICATION OF THE MARKINGS

C XXX

533XXXX Identification of the reference of the device

20XX-00X-00XX Identification of the serial number of the

230V~ / 50Hz / 800 W

Electrical specifications

Class I BF

Electrical classification of the device

Capenergy Medical S.L

Av. Mare de Deu de Montserrat,41
Pasaje 1º derecha
08970 Sant Joan Despí

Barcelona – España

www.capenergy.com
[email protected]

MADE IN SPAIN

(*) Consult table with model specifications. The 800W power output corresponds to a C 400 model.

Identification of the model of the device

generated by WINGEST
device composed of :

 Production date
 Production order
 Number of the produced unit

This number allows tracking sold devices
as well as their identification

(*)

Applicable symbols

2x 5x20mm 250V~ T3,15 A

Fuses

EN 60601-1

Applicable regulation

Identifier of the CE marking and

number of the notified body

REV: 2014-12-B

Label design review, composed of::

• Year of approval of the label
design

• Month of approval of the label
design

• Applicable version

Appendix A

User Manual

Page 72 of 95

MEANING OF THE SYMBOLS

Symbol representing the MANUFACTURER. This symbol is accompanied by

XXXX

the name and address of the manufacturer

Symbol representing the reference of the product according to the
CATALOGUE

Symbol representing the SERIAL NUMBER

Symbol representing the BF TYPE

CE symbol with the intervention of a Notified Body

Symbol for CONSULT INSTRUCTIONS FOR USE

RAEE symbol

FUSE symbol

Symbol for ALTERNATING CURRENT

Symbol for MEDICAL DEVICE THAT APPLIES ELECTROMAGNETIC RF
ENERGY FOR TREATMENT OR DIAGNOSE

Symbol for HOT SURFACE WARNING

Symbol for HAZARDOUS VOLTAGE

User Manual

Page 73 of 95

Appendix B

CERTIFICATE OF DELIVERY AND INSTALLATION

User Manual

Page 74 of 95

CERTIFICATE OF DELIVERY AND INSTALLATION

The undersigned _______________________________________, has been qualified and
entitled to act in name and respresentation of the company Capenergy Medical, S.L, with VAT B­62171731, and central offices in Sant Joan Despí (Barcelona), Avda. Mare de Déu de
Montserrat, 41, for the emission of the certificate of installation for the following device:

Model ________________ Serial number __________ Date of production ___________

And DECLARES

 Having verified all standard accessories and they are in a correct state.
 Having installed the device according to the manufacturer’s instructions.
 Having received the user manual in the ________________ language.
 Having instructed all personnel responsible for using the device.
 Having verified the total absence of defects and the correct functioning of the device.
 Having verified the correct functionality of the safety control.
 Having verified that the user does not have any reservation or objection regarding the

delivered good and that he therefore accepts it unconditionally.

The operations have been performed in presence of ____________________________,
employee selected by medical center______________________located in
_______________________________ at the following address
______________________________________________Email: ____________________
as the person responsible for the use of the device.
The present declaration is issued for the agreed upon use and according to the approved laws.

Date,___ of ____________,

The installation
tecnic

.........................................

1 Three (3) copies of this certificate are issued:one for the client, one for the distributor and a third one has to be filled in and sent
to the manufacturer CAPENERGY MÉDICAL,S.L. within 7 days after the installation of the device.

............................

The client

Stamp and signature

.........................

REG.7.2-01-01

User Manual

Page 75 of 95

CLINICAL CASUISTRY DOCUMENT

CLINICAL CASUISTRY

Management document

DETAILS FOR IDENTIFICATION OF THE STUDY
Contact person
Trade name
(Fiscal) Identification nº
Address / City

Appendix C

Telephone E-mail

Model
Serial number

TITLE OF THE STUDY / INVESTIGATION

Starting date End date
INTRODUCTION

ANAMNESIS

User Manual

Page 76 of 95

MATERIAL AND METHOD

1. City :

2. Criteria for inclusion :

3. Criteria for exclusion

4. Control Group : SI NO

TREATMENT PROTOCOLE

RESULTS

User Manual

Page 77 of 95

SIDE EFFECTS ASSOCIATED WITH THE TREATMENT

Skin irritation Others :
Curative crisis Others :
Burns Others:

DISCUSSION / CONCLUSIONS

OTHER COMMENTS / COMPLEMENTARY CONTRIBUTIONS:

ISSUED DOCUMENTS (in attachment)

Informed consent
Ultrasound scan, X-ray
CD archive / electronic format

User Manual

Page 78 of 95

Patient Evaluation File
Lab examinations
Others

BIBLIOGRAPHY

Confirmation of sending by the

professional

Confirmation of reception by Capenergy

Medical

Date / Stamp / Signature

Date / Stamp / Signature

Associated Nº Nº of Study

Send by e-mail to [email protected] or by Fax : [phone]

This fac-simile has to be filled out and sent to:

CAPENERGY MEDICAL, SL
Avda. Mare de Deu de Montserrat, 41 - Pasaje 1º Derecha
08970 Sant Joan Despí (Barcelona) - España
Tel.: + 34 (93) 477.43.48 / Fax: + 34 (93) 568 752
[email protected]

You may also take a picture of the filled out form with your Smartphone and send it by Whatsapp
[phone].

In order to contribute to the recollection of clinical data necessary for the permanent scientific
validation of the device, CAPENERGY MEDICAL, SL has the authorization to use the received
information, treating sensitive data with due respect and observing the established privacy
norms.

In case CAPENERGY MEDICAL, SL considers it convenient to reveal and/or publish these data,
it is hereby authorized to do so.

Ref : Sistema ISO 13485 - REG.7.3-03-03

User Manual

Page 79 of 95

Appendix D

NOTIFICATION OF BREAKDOWN

User Manual

Page 80 of 95

NOTIFICATION OF BREAKDOWN

BY THE CLIENT

DETAILS FOR IDENTIFICATION
Contact person
Trade name
(Fiscal) Identification nº
Address / City
Telephone
Model
Date of purchase Sold by

DETECTED BREAKDOWN or ANOMALY

E-mail
Serial number

Shipment confirmation Confirmation of reception

Date / Stamp / Signature

TAS ID nº

Send by e-mail to [email protected] or by Fax : [phone]

User Manual

Page 81 of 95

Date / Stamp / Signature

Appendix E

Warnings concerning Logistics and Transport

The following warnings should be taken into consideration when receiving a
CAPENERGY device in order to be able to activate the legal warranty and / or proceed
to lodge the corresponding complaint to the transport agency in case the device has
suffered damages during its shipment:

1. Upon reception of the CAPENERGY device please check if the package received is
in perfect state. If not, please contact the provider / transport agency by telephone or
by writing in order to lodge the corresponding complaint. This has to be done within
48 hours after the reception. The same procedure should be observed when installing

HOW TO ACTIVATE THE WARRANTY

the device.

2. When receiving the shipment, please write the following on the delivery note: ‘Goods
received, pending inspection’, to make sure you have time to check the entire device
during its installation.

3. Within 7 working days after the reception of the device, it is mandatory to send the
manufacturer a copy of the ‘Certificate of Installation and Delivery’, in order to activate
the legal warranty.

4. If the manufacturer does not receive copy of the ‘Certificate of Installation and
Reception’, any intervention of the technical service will be charged to the client.

5. The original ‘Certificate of Installation and Delivery’ (not a copy) has to be signed and
sent to the following address:

CAPENERGY MEDICAL, SL
Avda. Mare de Deu de Montserrat, 41 - Pasaje 1º Derecha
08970 Sant Joan Despí (Barcelona) - España

6. In case technical assistance under warranty is required, before shipping the device to
the manufacturer, please carefully read the indications and prescription on how to do
this. UNDER NO CIRCUMSTANCES WILL THE MANUFACTURER ACCEPT
DEVICES THAT DO NOT INCLUDE THE CORRESPONDING ACCESSORIES
(electrodes, active and passive plates, etc… as corresponding to the CAPENERGY
model at hand)

7. The ‘Breakdown Notification’ form should be sent along with the device and the
accessories to identify the device. Make a photocopy of the corresponding appendix
of this User manual, fill it in by hand and sign it, in order to proceed to the repair of
the device.

8. In case you send the device through a transport agency, please pack the device with
care (we recommend you keep the original wooden box) and send it sealed on a
pallet exclusively. The device travels at the client’s risk and expenses. Make sure the
sender’s details are clearly identified as well as the destination. Once you’ve signed
the pickup note, please send a copy of it to us by email so we can track the parcel
and make sure it does not get lost or delayed.

User Manual

Page 82 of 95

Appendix F

REGARDING ELECTROMAGNETIC

COMPATIBILITY (CEM)

The equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and
C500, require special precautions regarding CEM and need to be installed an used
according to the CEM information provided in this user manual.

Guidance and manufacturer’s declaration – electromagnetic emissions

The equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and C500 are
intended for use in the electromagnetic environment specified below. The customer or the user the
CAPENERGY product range: C400, C300, C200, C100, C50 and C500 should assure that it is used
in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions
CISPR 11

RF emissions
CISPR 11
Harmonic emission
IEC 61000-3-2
Voltage fluctuations/ flickers
emissions

IEC 61000-3-3

Table J-1. Electromagnetic emissions

GROUP 2 The equipments of the CAPENERGY product

range : C400, C300, C200, C100, C50 and
C500 must emit electromagnetic energy in order
to perform its intended function. Nearby
electronic equipment may be affected..

Class A
Class A
Complies

The equipments of the CAPENERGY product
range : C400, C300, C200, C100, C50 and
C500 is suitable for use in all establishments
other than domestic, and may be used in
domestic establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes, provided the following
warning is heeded:

Warning: This equipment/system is intended
for use by healthcare professionals only. This
equipment/ system may cause radio
interference or may disrupt the operation of
nearby equipment. It such as re-orienting or
relocating the equipments of the
CAPENERGY product range : C400, C300,
C200, C100, C50 and C500 or shielding the
location.

User Manual

Page 83 of 95

Guidance and manufacturer’s declaration – electromagnetic immunity

The equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and C500 are
intended for use in the electromagnetic environment specified below. The customer or the user of the
equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and C500 should
assure that it is used in such an environment.

Immunity test IEC 60601

test level

Electrostatic discharge
(ESD)
IEC 61000-4-2

Electrical fast
transient/burst

IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short

interruptions and voltage
variations on power
supply input-lines

IEC 61000-4-11

Power frequency
(50/60 Hz)
Magnetic field

IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.

±6 kV contact
±8 kV air

±2 kV for power
supply lines

±1 kV for input/output
lines
±1 kV line(s) to
line(s)

±2 kV line(s) to earth
<5% UT
(>95% dip in UT )
for 0,5 cycle

40% UT
(60% dip in UT )
for 5 cycles

70% UT
(30% dip in UT )
for 25 cycles

<5% UT
(>95% dip in UT )
for 5 s

3 A/m 3 A/m Power frequency magnetic

Compliance level Electromagnetic

environment - guidance

±6 kV contact
±8 kV air

±2 kV for power
supply lines

±1 kV for power
inputs/outputs
±1 kV line to line

±2 kV line to earth
<5% UT

(>95% dip in UT )
for 0,5 cycle

40% UT
(60% dip in UT )
for 5 cycles

70% UT
(30% dip in UT )
for 25 cycles

<5% UT
(>95% dip in UT )
for 5 s

Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%
Mains power quality should
be that of a typical
commercial or hospital
environment.

Mains power quality should
be that of a typical
commercial or hospital
environment.
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the equipments of the
CAPENERGY product
range: C400, C300, C200,
C100, C50 and C500
requires continued
operation during power
mains interruptions, it is
recommended that the
equipments of the
CAPENERGY product
range: C400, C300, C200,
C100, C50 and C500 be
powered from an
uninterruptible power supply
or battery

fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.

Table J-2. Electromagnetic immunity

User Manual

Page 84 of 95

Guidance and manufacturer’s declaration – electromagnetic immunity

The equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and C500 are intended for
use in the electromagnetic environment specified below. The customer or the user of the equipments of the
CAPENERGY product range: C400, C300, C200, C100, C50 and C500 should assure that it is used in such an
enviroment.

Immunity test IEC 60601 test

level

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
of 150 kHz to 80 MHz

3 V/m
of 80 MHz to 2,5 GHz

Compliance

level

3 V

3 V/m
The laboratory
limit is 1GHz

Electromagnetic environment ­guidance

Portable and mobile RF communications
equipment should be used no closer to
any part of the equipments of the
CAPENERGY product range: C400,
C300, C200, C100, C50 and C500,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter

Recommended separation distance

d=1.2

d= 1.2

d=2.3
where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:

P

P

80 MHz to 800 MHz

P

800 MHz to 2,5 GHz

NOTE 1 At 80 MHz and 800 MHz, the highest frequency range applies
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones
and land mobile radios, amateur radio, AMF and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and
C500 are used exceeds the applicable RF compliance level above, the equipments of the CAPENERGY
product range: C400, C300, C200, C100, C50 and C500 should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or

b

relocating the equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and C500.
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3V/m.

Table J-3. Electromagnetic immunity. Radiated emissions.

User Manual

Page 85 of 95

Following the results of the radiated immunity tests, if the device suffers radiated
electromagnetic disturbance, the normal functioning can be interrupted and a non­authorized accessory change alarm will be displayed. In this case, the user only needs to
deactivate the alarm by pressing the OK button, make sure the electromagnetic
disturbance has disappeared and resume the treatment by selecting the corresponding
treatment parameters.

Recommend separation distances between

portable and mobile RF communication and the equipment and the equipments of the

CAPENERGY product range: C400, C300, C200, C100, C50 and C500.

Rated maximum

output power

transmitter

W

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and persons.

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

d=1,2

P

80 MHz to 800 MHz

d=1,2

P

800 MHz to 2,5 GHz

d=2,3

P

Table J-4

and the equipments of the CAPENERGY product range: C400, C300, C200, C100, C50 and C500.

Recommend separation distances between portable and mobile RF communication equipment

User Manual

Page 86 of 95

Apéndice G

CAPENERGY EQUIPMENT FAMILY

The CIM equipment range consist of 6 different models. In the following section you will
find the characteristics and equipment of each of the different models.

User Manual

Page 87 of 95

C 400

Ref 5330004
Device with 4 work channels: automatic and manual for individual or simultaneous use of

capacitive and/or resistive electrodes.

Units Description Ref Equipment

1 Device C 400 5330004 Standard
1 User Manual 350200 Standard
2 Mains cord 080224 Standard
1 Safety control 5350070 Standard
4 Active plates with temperatura sensor 5350037 Standard
4 Passive plates 5350038 Standard
4 Hygienic protective gel covers 5100013 Standard
4 Hygienic protective covers without gel 5100060 Standard
1 Straight resistive electrode holder 5350033 Standard
1 Straight capacitive electrode holder 5350034 Standard
1 Capacitive electrode 33 mm 5100025 Standard
1 Capacitive electrode 53 mm 5100027 Standard
1 Capacitive electrode 65 mm 5100028 Standard
1 Resistive electrode 33 mm 5100029 Standard
1 Resistive electrode 53 mm 5100031 Standard
1 Resistive electrode 65 mm 5100032 Standard
8 Elastic bandage 80 cm 5100028 Standard
8 Elastic bandage 60 cm 5100030 Standard
8 Elastic bandage 40 cm 5100029 Standard
1 Isolation transformer of 700VA 5100147 Standard

1 90º capacitive electrode holder 5350035 Optional
1 90º resistive electrode holder 5350036 Optional
1 Capacitive electrode 65 mm 5100028 Optional
1 Resistive electrode 65 mm 5100032 Optional
4 Active plates WITHOUT temperature sensor 5350039 Optional

UPGRADE TO C 500 : YES
1 Intracavitary accessory MJS 5350040 Upgrade
1 Box vaginal/rectal probe covers intracavitary

accessory MJS (144 unids x caja)

5100131 Upgrade

User Manual

Page 88 of 95

C 300

Ref 5330003
Device with 3 work channels: automatic and manual for individual or simultaneous use of

capacitive and/or resistive electrodes

Units Description Ref Equipment

1 Device C 300 5330003 Standard
1 User Manual 350200 Standard
2 Mains cord 080224 Standard
1 Safety control 5350070 Standard
3 Active plates with temperature sensor 5350037 Standard
3 Passive plates 5350038 Standard
3 Hygienic protective gel covers 5100013 Standard
3 Hygienic protective covers without gel 5100060 Standard
1 Straight resistive electrode holder 5350033 Standard
1 Straight capacitive electrode holder 5350034 Standard
1 Capacitive electrode 33 mm 5100025 Standard
1 Capacitive electrode 53 mm 5100027 Standard
1 Capacitive electrode 65 mm 5100028 Standard
1 Resistive electrode 33 mm 5100029 Standard
1 Resistive electrode 53 mm 5100031 Standard
1 Resistive electrode 65 mm 5100032 Standard
6 Elastic bandage 80 cm 5100028 Standard
6 Elastic bandage 60 cm 5100030 Standard
6 Elastic bandage 40 cm 5100029 Standard
1 Isolation transformer of 700VA 5100147 Standard

1 90º capacitive electrode holder 5350035 Optional
1 90º resistive electrode holder 5350036 Optional
1 Capacitive electrode de 65 mm 5100028 Optional
1 Resistive electrode65 mm 5100032 Optional
3 Active plates WITHOUT temperature sensor 5350039 Optional

UPGRADE TO C 500 : YES
1 Intracavitary accessory MJS 5350040 Upgrade
1 Box vaginal/rectal probe covers for intracavitary

accessory MJS (144 un. x box)

5100131 Upgrade

User Manual

Page 89 of 95

C 200

Ref 5330002
Device with 2 work channels: automatic and manual for individual or simultaneous use of

capacitive and/or resistive electrodes

Units Description Ref Equipment

1 Device C 200 5330002 Standard
1 User Manual 350200 Standard
2 Mains cord 080224 Standard
1 Safety control 5350070 Standard
2 Active plates with temperature sensor 5350037 Standard
2 Passive plates 5350038 Standard
2 Hygienic protective gel covers 5100013 Standard
2 Hygienic protective covers without gel 5100060 Standard
1 Straight resistive electrode holder 5350033 Standard
1 Straight capacitive electrode holder 5350034 Standard
1 Capacitive electrode 33 mm 5100025 Standard
1 Capacitive electrode 53 mm 5100027 Standard
1 Capacitive electrode 65 mm 5100028 Standard
1 Resistive electrode 33 mm 5100029 Standard
1 Resistive electrode 53 mm 5100031 Standard
1 Resistive electrode 65 mm 5100032 Standard
4 Elastic bandage 80 cm 5100028 Standard
4 Elastic bandage 60 cm 5100030 Standard
4 Elastic bandage 40 cm 5100029 Standard
1 Isolation transformer of 450VA 5100148 Standard

1 90º capacitive electrode holder 5350035 Optional
1 90º resistive electrode holder 5350036 Optional
1 Capacitive electrode 65 mm 5100028 Optional
1 Resistive electrode 65 mm 5100032 Optional
2 Active plates WITHOUT temperature sensor 5350039 Optional

UPGRADE TO C 500 : YES
1 Intracavitary accessory MJS 5350040 Upgrade
1 Box vaginal/rectal probe covers for intracavitary

accessory MJS (144 un. x box)

5100131 Upgrade

User Manual

Page 90 of 95

C 100

Ref 5330001
Device with 1 work channel: automatic or manual capacitive or resistive.

Units Description Ref Equipment

1 Device C 100 5330001 Standard
1 User Manual 350200 Standard
2 Mains cord 080224 Standard
1 Safety control 5350070 Standard
1 Active plate with temperature sensor 5350037 Standard
1 Passive plate 5350038 Standard
1 Hygienic protective gel covers 5100013 Standard
1 Hygienic protective covers without gel 5100060 Standard
1 Straight resistive electrode holder 5350033 Standard
1 Straight capacitive electrode holder 5350034 Standard
1 Capacitive electrode 33 mm 5100025 Standard
1 Capacitive electrode 53 mm 5100027 Standard
1 Capacitive electrode 65 mm 5100028 Standard
1 Resistive electrode 33 mm 5100029 Standard
1 Resistive electrode 53 mm 5100031 Standard
1 Resistive electrode 65 mm 5100032 Standard
2 Elastic bandage 80 cm 5100028 Standard
2 Elastic bandage 60 cm 5100030 Standard
2 Elastic bandage 40 cm 5100029 Standard
1 Isolation transformer of 450VA 5100148 Standard

1 90º capacitive electrode holder 5350035 Optional
1 90º resistive electrode holder 5350036 Optional
1 Capacitive electrode 65 mm 5100028 Optional
1 Resistive electrode 65 mm 5100032 Optional
1 Active plates WITHOUT temperature sensor 5350039 Optional

UPGRADE TO C 500 : YES
1 Intracavitary accessory MJS 5350040 Upgrade
1 Box vaginal/rectal probe covers for intracavitary

accessory MJS (144 un. x box)

5100131 Upgrade

User Manual

Page 91 of 95

C 50

Ref. 5330050
Exclusively manual devie with 1 capacitive or resistive work channel

Units Description Ref Equipment

1 Device C 50 5330050 Standard
1 User Manual 350200 Standard
2 Mains cord 080224 Standard
1 Safety control 5350070 Standard
1 Passive plate 5350038 Standard
1 Straight resistive electrode holder 5350033 Standard
1 Straight capacitive electrode holder 5350034 Standard
1 Capacitive electrode 33 mm 5100025 Standard
1 Capacitive electrode 53 mm 5100027 Standard
1 Capacitive electrode 65 mm 5100028 Standard
1 Resistive electrode 33 mm 5100029 Standard
1 Resistive electrode 53 mm 5100031 Standard
1 Resistive electrode 65 mm 5100032 Standard
2 Elastic bandage 80 cm 5100028 Standard
2 Elastic bandage 60 cm 5100030 Standard
2 Elastic bandage 40 cm 5100029 Standard
1 Isolation transformer of 450VA 5100148 Standard

1 90º capacitive electrode holder 5350035 Optional
1 90º resistive electrode holder 5350036 Optional

UPGRADE TO C 500 : NO

User Manual

Page 92 of 95

C 500

Ref 5330005
Device designed specifically for URO-GINECOLOGICALtreatments, with 1 intracavitary

manual electrode (1 work channel)

Units Description Ref Equipment

1 Device C 500 5330005 Standard
1 User Manual 350200 Standard
2 Mains cord 080224 Standard
1 Safety control 5350070 Standard
1 Intracavitary accessory MJS 5350040 Standard
1 Box vaginal/rectal probe covers for intracavitary

accessory MJS (144 unids x caja)
1 Passive plate 5350038 Standard
2 Elastic bandage 80 cm 5100028 Standard
2 Elastic bandage 60 cm 5100030 Standard
2 Elastic bandage 40 cm 5100029 Standard
1 Isolation transformer of 450VA 5100148 Standard

UPGRADE TO C 100 : YES

5100131 Standard

User Manual

Page 93 of 95

Appendix H

INTELLECTUAL PROPERTY

INTELLECTUAL PROPERTY RIGHTS

CAPENERGY MEDICAL, SL is the exclusive owner of all graphic material, pictures,
logotypes, publications or press communications spread over the internet in
representation of the commercial brand CAPENERGY and holds the exploitation rights
on the fore-mentioned information, as well as the contents of this USER AND
MAINTENANCE MANUAL.

Updated information regarding new products is available on the official CAPENERGY
website and can be consulted in printed or telematic version for its incorporation in
articles, press notes or publications in which the author explicitly mentions CAPENERGY
and reflects the contents in a reliable and unmodified way.

UNDER NO CIRCUMSTANCES MAY THE CONTENTS OF THIS USER AND
MAINTENANCE MANUAL BE DISCLOSED. THEY ARE EXCLUSIVELY FOR THE USE
OF CIM USERS THAT OWN A PROFESSIONAL CAPENERGY DEVICE.

Under no circumstances may this information be modified or used in a way that harmful
to CAPENERGY, who will have the right to claim damages caused by the inappropriate
use of its intellectual property by third parties.

Should you wish to use any of the information for publication, please contact
CAPENERY MEDICAL by writing. The board of directors will then decide according to its
criteria whether or not to grant the corresponding authorization.

As the owner of the intellectual property, CAPENERGY reserves all the rights to
undertake legal action aimed at the legitimate defense of its own contents..

For further information, please consult the website http://www.capenergy.com

User Manual

Page 94 of 95

CAPENERGY MEDICAL S. L.U

Av. Mare de Déu de Montserrat, 41 - Pasaje 1º Derecha

Polígono Industrial Font Santa

08970 Sant Joan Despí (Barcelona)

España (SPAIN)

Tel. : + 34 (93) 477.43.48
Fax : + 34 (93) 477.42.90

[email protected]

www.capenergy.com

User Manual

Page 95 of 95