Apex Digital DOMUS 2+ User manual

Alternating Pressure Redistribution System
Sistema De Redistribución De Presión Alterna
Sistema De Redistribuição De pressão Alternada
Système De Redistribution à Pression Alternée
Alternierendes Druckumverteilungssystem
Alternerend Druksysteem
Sistema Di Ridistribuzione A Pressione Alternata
Model No.: 9P-046520 Please read the manual before use.

English
User’s manual ................................................................P. 1
Español
Manual de Instrucciones............................................... P.16
Português
Instruções de Utilização................................................ P.32
Français
Instructions d'utilisation ...............................................P.48
Deutsch
Gebrauchsanleitung ...................................................... P.63
Nederlands
Gebruikershandleiding..................................................P.78
Italiano
Manuale di istruzioni ....................................................P.93

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IMPORTANT SAFEGUARDS
SAVE THESE INSTRUCTIONS
READ ALL INSTRUCTIONS BEFORE USING
DANGER - To reduce the risk of electrocution:
1. Always unplug this product immediately after using.
2. Do not use while bathing.
3. Do not place or store this product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug immediately.
WARNING - To reduce the risk of burns, electrocution, fire, or injury to persons:
1. Evaluate patients for entrapment risk according to protocol and monitor patients
appropriately.
2. This system is not for use with patients who have a spinal cord injury.
3. Close supervision is necessary when this product is used on or near children.
Electrical burns or choking accident may result from a child swallowing a small part
detached from the device.
4. Use this product only for its intended use as described in this manual. Do not use
attachments not recommended by the manufacturer
5. Never operate this product if it has a damaged cord or plug, if it is not working
properly, or if it has been dropped, damaged, or dropped into water. Return the
product to a service center for examination and repair.
6. Keep the cord away from heated surfaces.
7. Never block the air openings of this product or place it on a soft surface, such as a
bed or couch, where their openings may be blocked. Keep the air openings free of lint,
hairs, and other similar particles.
8. Never drop or insert any object into any opening or hose.
9. Do not modify this equipment without authorization of the manufacturer.
10. The covers have passed skin sensitization and skin irritation test. However, If you
suspect that you may have had or are having an allergic reaction, please consult a
physician immediately.
11. Do not leave long lengths of tubing around the top of your bed. It could lead to
strangulation.
CAUTION –
1. If there is a possibility of electro-magnetic interference with mobile phones, please
increase the distance (3.3m) between devices or turn off the mobile phone.
NOTE - Indicate some tips.
CAUTION - Indicate correct operating or maintenance procedures in order to prevent
damage to or destruction of the equipment or other property
WARNING - Calls attention to a potential danger that requires correct procedures or
practices in order to prevent personal injury.

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SYMBOLS
Authorized representative in the European community
Catalog, reorder or reference number
Manufacturer
Complies with standards protecting against electric shock for type BF equipment.
Attention, you should read the accompanying information carefully!
Attention –Observe proper Disposal of Electrical & Electronic Equipment (WEEE):
This product should be handed over to an appropriate collection point for the recy-
cling of electrical and electronic equipment. For more detailed information about the
recycling of this product, please contact your local city office, household waste
disposal service or the retail store where you purchased this product.
Consult operating instructions for use
IP2X
Protected against solid foreign objects of 12,5 mm and greater; No protection
against vertically falling water drops
Class II
Temperature limitation/temperature range
Do Not Iron
Tumble Dry, Normal, Low Heat
Do Not Tumble Dry
Do Not Bleach
Do Not Dry Clean
Machine wash, regular / normal, 60 degrees C (140 degrees F)
KEEP THIS MANUAL FOR REFERENCE

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1. INTRODUCTION
This manual should be used for initial set up of the system and for reference purposes.
1.1 General Information
The system is a high quality and affordable mattress system suitable for treatment and
prevention of pressure ulcers.
The system has been tested and successfully approved to the following standards:
EN 60601-1 EN 60601-1-2
EN 55011 Class B EN 61000-3-2 Class A
EN 61000-3-3 IEC 61000-4-2
IEC 61000-4-3 IEC 61000-4-4
IEC 61000-4-5 IEC 61000-4-6
IEC 61000-4-8 IEC 61000-4-11
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the
EN60601-1-2:2007. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates uses and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to other devices, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
Consult the manufacturer or field service technician for help.
1.2 Intended Use
This product is intended to:
to help and reduce the incidence of pressure ulcers while optimizing patient comfort.
for long term home care of patients suffering from pressure ulcers.
for pain management as prescribed by a physician.
The product can only be operated by personnels who are qualified to perform general nursing
procedures and has received adequate training in knowledge of prevention and treatment of
pressure ulcer.
NOTE - Equipment not suitable for use in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.

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2. PRODUCT DESCRIPTION
Unpack the box to check for any damage which may have occurred during shipment. If
there are damages, please contact your dealer immediately.
2.1 Pump and Mattress System
1. CPR*
2. Pump unit
3. Mattress unit
4. Quick Connector
2.2 Pump Unit
Front
1. Quick Connector Slot
2. Display Panel
3. Quick Connector with Cap
Rear
4. Power Cord
5. Clip Hanger
6. Fuses
7. Filter

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2.3 FRONT PANEL
1. Pressure Adjustment Knob
The pressure adjustment knob controls the air pressure output. When turning
clockwise, the output pressure will be increased. On the other hand, when turning
counter-clockwise, the output air pressure will be decreased.
NOTE: You can also check if the pressure is suitable for the patient by sliding one
hand beneath the air cells at the level of the patient's buttocks. The air cells
will alternately inflate and deflate. You should feel slight contact with the
buttocks when the air cells beneath the buttocks deflate.
2. Low Pressure Indicator
When the mattress is initializing, the Low Pressure LED will illuminate until the
appropriate pressure is reached (according to the Pressure Adjustment Knob); this is
normal. Otherwise, the Low Pressure LED is a warning, indicating that the pressure
in mattress is unusually low. Check to ensure all connections are secured and correctly
installed as per the installation instructions.
3. Normal Pressure Indicator
When the green LED illuminates, the pressure inside of air mattress has reached the
desired pressure setting (preset on the Pressure Adjustment Knob).
4. Main Power Switch
To turn on/off the pump unit with illuminated green light.

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3. INSTALLATION
3.1 Pump & Mattress Installation
Several installation tips are listed below:
1. Place the mattress on top of the bed frame.
Fasten the Nylon Straps to secure the mat-
tress to bed frame if available.
Warning- The overlay mattress must
be applied on the underly-
ing mattress
2. Clip the plastic hanger on the back of pump
in a bottom-to-top direction and hang the
pump onto bed rail (foot-end) or place the
pump on a flat surface.
3. Connect quick connector from air mattress
to the pump unit. When a "click" is felt or
heard, the connection is completed and
secured.
NOTE- Check and ensure the air
hoses are not kinked or
tucked under mattress.
Warning- After installation, the extra length of the power cord, if any, should be
neatly arranged to avoid any tripping accidents. The EQUIPMENT
should be firmly placed at position where users/doctors can easily
access.

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4. Plug the power cord into electrical outlet.
NOTE- 1. Make sure the pump unit
is suitable for the local
power voltage.
2. The plug is also served as
the disconnect device. Do
not position the equipment
so that it is difficult to
operate the disconnecting
device.
CAUTION- The pump can only be
applied to the mattress
recommended by the
manufacturer. Do not
use it for any other pur-
pose. (applied part: air
mattress)
5. Then turn the main power switch to ON
position which located on the display panel.

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4. OPERATION
NOTE - Always read the operating instruction before use.
4.1 General operation
1. Switch on the main power switch on
the display panel.
2. The pump unit is beginning to deliver
air into mattress. Turn the comfort
knob clock-wise to increase firmness.
(i.e. pressure)
3. The low pressure indicator (yellow
LED) will light up when the mattress
is not yet fully inflated.
4. When the appropriate pressure is
reached, the low pressure indicator
(yellow LED) will go off and normal
pressure indicator (green LED) will
light up automatically.
NOTE- Each time when mattress is firstly inflated, it is recommended that the
pressure knob be set to "Firm" for the quickest inflation. User can then
adjust air mattress to the desired softness afterward.
4.2 CPR (only available for some models)
When there is an emergency to perform CPR on
the patient, quickly pull the CPR valves to re-
lease air from mattress. The CPR valves are
located at the head-end, right-hand-side of the
mattress. The quick connector on the pump unit
can be disconnected for even faster deflation.

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4.3 Transport
For transport purpose, interconnect Male
to Female part of the air hose connector.
When a "click" is felt or heard, the con-
nection is completed and secured; then
air from mattress is sealed off.
5. CLEANING
It is important to follow the cleaning procedures before using the equipment on human
bodies; otherwise, patients and/or doctors may have the possibility of getting infection.
Wipe the pump unit with a damp cloth and a mild detergent, and keep it away from dust. If
other detergent is used, choose one that will have no chemical effects on the surface of
the plastic case of the pump unit.
CAUTION- Do not immerse or soak pump unit.
Wipe down the mattress with warm water containing a mild detergent. The cover may
also be cleaned by using sodium hypochlorite diluted in water. All parts should be air
dried thoroughly before use.
Cover Material: Nylon/PU
Cover Material: Silver+ Nylon/PU
CAUTION- Do not use phenolic based product for cleaning.
CAUTION- Dry the mattress on SUNLESS capitalized area after cleaning.
6. STORAGE
1. To store the mattress, lay the mattress out flat and upsides down.
2. Roll from the head end towards the foot end with CPR valve open.
3. Foot-end strap can then be stretched around the rolled mattress to prevent unrolling.
NOTE- Do not fold, crease or stack the mattresses.Avoid direct sunshine.

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7. MAINTENANCE
7.1 General
1. Check main power cord and plug if there is abrasions or excessive wear.
2. Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes
are stubbed together correctly.
3. Check airflow from the quick connector. The airflow should alternate between each
connector every half-cycle time if it's in alternating mode.
4. Check the air hoses if there is kink or breaks. For replacement, please contact our
local dealers.
7.2 Fuse Replacement
1. Disconnect the plug form mains power when a
fuse is to be replaced.
2. Remove the cover of the fuse holder by means of
a screwdriver. (If necessary, un-clip the hanger
form the pump unit)
3. Insert a new fuse of the correct rating in, and re-
place the cover of the fuse holder back. The fuse
should be T1AL/250V type and VDE approved.
7.3 Air Filter Replacement
1. Open the air filter plate located at the back of
pump.
2. Suggest to check and replace air filter regularly
3. if environment is dirty.

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8. Troubleshooting
If your questions can't be answered with above information, please contact your local
agent directly. They might require a technician to take care of the problem.
Problem
Solution
Power is not ON
‧Check if the plug is connected to mains.
‧Check if there is any blown fuse.
Low pressure indicator is
ON
‧Check if the connection between quick connector to
pump unit is tightly secured.
‧Check if all tubing connections along mattress are
secured.
‧Check if the CPR valve is sealed.
‧Check if there are any air leakage on air cells.
Patient is bottoming out
‧Pressure setting might be inadequate for the patient,
adjust pressure to higher level and wait for a few
minutes.
Mattress form is loose
‧Check if all the snap buttons or straps of mattress are
all securely fastened.
‧Check if the mattress is fixed to the bed frame by
straps.
No air produced from some
air outlets of the air tube
connector
‧This is normal since there is alternating mode. Air
outlets take turns to produce air during their cycle
time.
9. EXPECTED SERVICE LIFE:
The products are intended to offer safe and reliable operation when use or installed according to
the instructions provided by Apex Medical. Apex Medical recommends that the system be
inspected and serviced by authorized technicians if there are any signs of wear or concerns with
device function and indication on products. Otherwise, service and inspection of the devices
generally should not be required.

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10. TECHNICAL DESCRIPTION
Item
Specification
Power Supply
(Note: Refer to the rating label on
the product)
AC230V 50/60 Hz,0.05A ( for 230V system )
Fuse Rating
T1AL, 250V
Cycle time
PM100B
Model: 9P-046520
8 min for 60 Hz / 9.6 min for 50 Hz
Dimension(LxWxH)
25 x 13.5 x 9.5 (cm) or 9.8" x 5.3" x 3.7"
Weight
1.8 Kg or 4.0 lb
Environment
Atmospheric
Pressure
700 hPa to 1013.25 hPa
Temperature
Operation:10 ºC to 40 ºC (50 ºF to 104 ºF )
Storage: -15 ºC to 50 ºC (5 ºF to 122 ºF)
Shipping: -15 ºC to 70 ºC (5 ºF to 158 ºF)
Humidity
Operation:10% to 90% non-condensing
Storage:10% to 90% non-condensing
Shipping:10% to 90% non-condensing
Classification
Class II, Type BF, IP2X ( for 230V system )
Applied Part: Air Mattress
Not suitable for use in the presence of a flammable
anesthetic mixture (No AP or APG protection)
Mattress
Speification
Model
Domus 2+
Dimension (LxWxH)
200x80x10.2 (cm) or 78.7" x 31.5" x 4"
Weight
3.8 kg or 8.4 lb
NOTE-
1. The specification is also suitable for other areas operating with same power
supply.
2. Consult the distributor or EU representative for other technical documents.
3. The manufacturer reserves the right to modify the specifications without notice.

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Appendix A: EMC Information
Guidance and Manufacturer’s Declaration- Electromagnetic Emissions:
This device is intended for use in the electromagnetic environment specified below. The user of
this device should make sure it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment-Guidance
RF emissions
CISPR 11
Group1
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment
RF emissions
CISPR 11
Class B
The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network
Harmonic emissions
IEC61000-3-2
Class A
Voltage fluctuations /
Flicker emissions
IEC61000-3-3
Complies
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of
this device should make sure it is used in such an environment.
Immunity Test
IEC60601 test
level
Compliance
Electromagnetic
Environment-Guidance
Electrostatic Discharge (ESD)
IEC61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast transient/ burst
IEC61000-4-4
±2kV for power supply
line
±1kV for input/out line
±2kV for power supply
line
±1kV for input/out line
Mains power quality should be that
of atypical commercial or hospital
environment
Surge
IEC61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to
line(s)
Mains power quality should be that
of atypical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC61000-4-11
<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 sec
<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 sec
Mains power quality should be that
of atypical commercial or hospital
environment. If the user of this
device requires continued operation
during power mains interruptions, it
is recommended that the device be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60Hz) magnetic field
IEC61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
atypical location in a typical
commercial or hospital
environment.
NOTE: UTis the a.c. mains voltage prior to the application of the test level

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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of
this device should make sure it is used in such an environment.
Immunity Test
IEC60601 test level
Compliance
Electromagnetic Environment-Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms150 kHz to
80 MHz outside
ISM bandsa
3 V/m 80 MHz to
2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of this device,
including cables, than there commended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Pd 2.1
150kHz to 80MHz
Pd 2.1
150kHz to 80MHz
Pd 3.2
80 MHz to 2.5G MHz
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).b
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site surveyc, should be less than
the compliance level in each frequency ranged.
Interference may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, 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 people.
a)The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795
MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b)The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80
MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is
used in calculating the recommended separation distance for transmitters in these frequency ranges.
c) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM 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 the device is used exceeds
the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the device.
d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended separation distances between portable and mobile RF
communications equipment and this device:
This device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and this device as recommended below,
according to the maximum output power of the communications equipment
Rated maximum output
power
of transmitter
W
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
Pd 2.1
80 MHz to 800 MHz
Pd 2.1
800 MHz to 2,5 GHz
Pd 3.2
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 people.

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MEDIDAS DE SEGURIDAD IMPORTANTES
CONSERVAR ESTAS INSTRUCCIONES
LEER TODAS LAS INSTRUCCIONES ANTES DEL USO
PELIGRO - Para reducir el riesgo de electrocución:
1. Desconectar siempre el producto inmediatamente después de usarlo.
2. No lo utilice durante el baño.
3. No coloque o almacene este producto donde pueda caerse o ser introducido en una bañera o
lavabo.
4. No lo coloque ni lo sumerja en agua u otro líquido.
5. No intente recoger el equipo si se ha caído al agua. Desconéctelo inmediatamente.
AVISO - Para reducir el riesgo de quemaduras, electrocución, incendio, o daños a personas:
1. Evaluar el riesgo de atrapamiento de los pacientes de acuerdo con el protocolo y supervisarlos
adecuadamente.
2. Este sistema no debe ser utilizado en pacientes que presentan lesiones en la médula espinal.
3. Cuando se utilice este producto en o cerca de niños hay que mantenerlo estrechamente
vigilado. Se podrían producir quemaduras eléctricas o un accidente por asfixia si un niño se
tragara una pieza pequeña desprendida del aparato.
4. Utilice este producto sólo para el uso indicado en este manual. No utilice accesorios no
recomendados por el fabricante.
5. No haga funcionar este producto si tiene un cable o enchufe estropeados, si no funciona
normalmente o si se ha caído o dañado o se ha sumergido en el agua. Devuelva el producto a
un centro de servicio técnico para su examen y reparación.
6. Mantenga alejado el cable de cualquier superficie caliente.
7. No bloquear nunca las entradas o salidas de aire de este producto ni lo coloque sobre una
superficie mullida como una cama o un sofá ya que podrían bloquearse igualmente. Mantener
las entradas y salidas de aire libres de pelusas, pelos y otras partículas similares.
8. No introduzca ni deje entrar objetos extraños en las entradas o salidas de aire o en los
conductos
9. No modificar este equipo sin la autorización del fabricante.
10. Las fundas han superado una prueba de sensibilización e irritación de la piel. No obstante, si
sospecha que ha tenido o está teniendo una reacción alérgica, consulte inmediatamente con el
médico.
11. No deje largos tramos de tubo en la parte superior de la cama. Podrían provocar la
estrangulación.
PRECAUCIÓ N –
1. Si existiera la posibilidad de interferencia electromagnética con teléfonos móviles, incremente
la distancia (3,3 m) entre dispositivos o apague el teléfono móvil.
SIGNIFICADO DE LAS LLAMADAS NOTA, PRECAUCIÓ N Y AVISO
NOTA –Proporciona consejos prácticos.
PRECAUCIÓ N:Indica los procedimientos para un correcto funcionamiento o mantenimiento con el
fin de evitar daños o la destrucción del equipo o de otros bienes.

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AVISO - Llama la atención sobre algún posible peligro que requiera un procedimiento o
prácticas de uso correctos con el fin de evitar daños personales
SÍMBOLOS
Representante autorizado para la comunidad europea.
Número de catálogo, repetición de pedido o referencia
Fabricante
Cumple con las normas de protección contra descargas eléctricas para equipos de
tipo BF.
Atención, debería leer atentamente la información adjunta.
Atención –Respete las normas de eliminación correcta de los Equipos Eléctricos y
Electrónicos (WEEE):
Este producto debe ser entregado en un centro de recogida adecuado para el
reciclaje de equipos eléctricos y electrónicos. Para una información más detallada
sobre el reciclaje de este producto, por favor contacte con la oficina municipal, el
servicio de recogida de residuos domésticos o el comercio donde adquirió este
producto.
Consulte las instrucciones de funcionamiento.
IP2X
Protegido contra objetos extraños sólidos de 12,5 mm y superiores; Sin protección
contra gotas de agua que caigan verticalmente
Clase II
Limitación de temperatura / margen de temperatura
No planchar
Secar en secadora, normal, baja temperatura
No secar en secadora
No utilizar lejía
No limpiar en seco
Lavar a máquina, regular / normal, 60 grados C
GUARDAR ESTE MANUAL PARA SU CONSULTA

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1. INTRODUCCIÓ N
Este manual debe ser utilizado para una instalación inicial y como referencia posterior.
1.1 INFORMACIÓ N GENERAL
Se trata de un sistema de colchón de alta calidad y precio económico adecuado para el
tratamiento y la prevención de escaras.
El sistema ha sido comprobado y homologado positivamente de acuerdo con las
siguientes normas:
EN 60601-1 EN 60601-1-2
EN 55011 Clase B EN 61000-3-2 Clase A
EN 61000-3-3 IEC 61000-4-2
IEC 61000-4-3 IEC 61000-4-4
IEC 61000-4-5 IEC 61000-4-6
IEC 61000-4-8 IEC 61000-4-11
Advertencia sobre compatibilidad electromagnética
Este equipo ha sido sometido a prueba y se ha encontrado que respeta los límites para
aparatos médicos según la norma EN60601-1-2:2007. Estos límites han sido establecidos para
proporcionar una protección adecuada contra interferencias perjudiciales en una instalación
médica típica. Este equipo genera, utiliza y puede irradiar energía de radiofrecuencia y si no se
instala y utiliza de acuerdo con las instrucciones, puede provocar interferencias perjudiciales
en otros aparatos cercanos. Sin embargo, no hay garantía de que no se produzcan
interferencias en una instalación particular. Si este equipo produjera interferencias perjudiciales
en otros aparatos, lo cual puede determinarse apagando y encendiendo el equipo, el usuario
puede tratar de corregirlas mediante alguna de estas medidas:
Reorientar o recolocar el aparato receptor.
Aumentar la separación entre aparatos.
Conectar el equipo a una toma de corriente en un circuito diferente del resto de aparatos.
Consultar con el fabricante o el servicio técnico para recibir más asesoramiento.
1.2 Uso indicado
Este producto ha sido diseñado para:
Aliviar y reducir la formación de escaras aumentando al mismo tiempo la comodidad del
paciente.
El cuidado domiciliario de larga duración de pacientes con escaras.
El tratamiento del dolor prescrito por un médico.
Este producto sólo puede ser manipulado por personal cualificado para realizar procedimientos
generales de enfermería y que haya recibido una formación adecuada en la prevención y
tratamiento de escaras o úlceras de presión.
NOTA - Este equipo no está indicado para el uso en presencia de una mezcla
anestésica inflamable de aire o con oxígeno u óxido nitroso.