Philips Children's Respiration Monitor Mode D'emploi

About the "Children's Respiration Monitor"
The "Children's Respiration Monitor" system comprises of an
accelerometer based device, with a belt to attach the device to the child.
There are two variants, Community health worker model called CHW and a
Professional Health worker model called PHW. This Philips product has to
be used and operated only in accordance with the safety procedures and
operating instructions provided in this "Instructions for Use," and for the
purposes for which it is designed. This product is intended for the below
mentioned purposes. However, nothing stated in this "Instructions For Use"
reduces the responsibilities of the operator for sound clinical judgment and
use of the best clinical procedures.
Intended Use
The "Children's Respiration Monitor" measures the respiration rate in
children under five years old and automatically classify fast breathing rate
according to the IMCI guidelines set by the "World Health Organization".
This device is to be used by health workers at the community level in low-
resource settings, clinical officers, nurses, midwives, clinicians (Professional
Health Workers) at primary or secondary care facilities.
This device is neither intended to provide automated treatment decisions,
nor to be used as a substitute for professional healthcare judgment. All
patient medical diagnosis and treatment has to be performed under the
supervision and oversight of an appropriate healthcare professional.
Conventions Used in this Guide
This guide uses the following conventions
I
"CAUTION" to be mandatorily exercised.
P Applicable only to Professional Health Worker model (PHW).
C Applicable only to Community Health Worker model (CHW).
Safety Summary
Symbols Marked on the Device and Packaging
Symbol Description
The Legal manufacturing address is next to this symbol.
Input DC voltage rating.
Indicates the need for separate collection for electrical and
electronic equipment in compliance with the Waste
Electrical and Electronic Equipment (WEEE) directive.
Date of manufacture.
For Medical Device directive.
0086
See the Children's Respiration Monitor
"Instructions for Use".
Type B Applied Part.
Dust-protected, Protected against splashing water.
The number next to this symbol is the serial number.
Pxxxxxx Serial number for PHW.
Cxxxxxx Serial number for CHW.
Important Safety Information
I
This Device has to be used by trained and authorized
personnel only.
I
This system should only be used on FULL TERM babies
(i.e. babies completed 37 weeks of gestation).
I
The system shall not be used on Children wearing any supportive
device at the area of the chest/belly.
I
The system does not need direct skin contact for measurement, the
user is recommended to attach directly on cloth. If used without a
cloth use on intact skin only.
I
Use only the belt supplied with the system, use of any other belt is
not allowed.
I
Be cautious while attaching the Belt to ensure that no injuries are
caused to the child.
I
Ensure that the belt is not too tightly attached to
the child.
I
Do not connect the Charging Cable to the device when it is attached
to the child.
I
Charge the PHW device to full before first use. Always charge the
device to full battery state for correct battery indication and
functioning.
I
Do not leave the system unattended while not
in use.
I
Ensure the system is not exposed to unhygienic
conditions.
I
The device or the belt should not be sterilized in any sterilizer
equipment.
I
The concerned device user is responsible for proper disposal of the
device past their expected life span or when no longer be used for
its intended purpose, dispose in accordance with applicable
waste disposal laws and local regulations.
Getting Started
1. On/Off Button.
2. LCD Display.
3. OK Button.
4. USB Port P.
5. Select Button.
6. LED Indicator.
Frequently used functions
– Attach the device to the child using the belt (Refer to the
"Quick Reference Guide" (QRG), Fig- 1).
– Power "ON" the Device (Refer to the QRG Fig- 2).
– Select an Age Group (Refer to the QRG Fig-3).
– Start a Measurement (Refer to the QRG Fig-4)
– Power "OFF" the Device (Refer to the QRG Fig-2).
– Charge the Device P (Refer to the QRG for a pictorial representation).
Download the Data P Refer to this Link
–
( http://www.philips.com/a-w/about/sustainability/healthy-
people/supporting-communities/fabric-of-africa/programs/
childrens-automated-respiratory-monitor.html ) under Tools and
Resources to find the detailed instructions.
Instructions for Disinfection
1. Turn off the device before disinfection.
2. Wipe the patient contact surface of the device and the belt (as shown
below) before every use with a clean cloth moistened with 70%
Isopropyl alcohol.
Routine Cleaning Instructions
1. Turn off the device before cleaning.
2. Wipe the external surfaces of the device and the belt with a cloth
dampened in mild soap solution or water.
Troubleshooting Guide
– If the unit does not power up after repeated attempts, and you just see a
blank screen, contact your local Philips representative.
– "- - -"
Displayed at end of measurement indicates that either
there was excess motion or loosely attached belt. Ensure that the
measurement conditions are followed for accurate results.
– Appearing on the screen indicates that the accelerometer is faulty,
contact your local Philips representative.
– This icon indicates that the battery is low please charge the device
in case of PHW, order a new device in case of CHW.
– If the "RED LED" on the device appeared and the unit powered down
while turning on, this is due to excess temperature. Allow the unit to cool
and try powering ON after 30 minutes. If the issue persists, contact your
local Philips representative. If the RED LED appeared after power ON or
while initiating a measurement, it is due to critically low battery. Charge
the device to full in case of PHW. Order a new device in case of CHW.
Technical Specification
Meter Type: Breathing Rate Measurement.
Principle: Uses a 3D accelerometer with advanced signal processing to measure
the specific abdominal motions related to breathing.
Display: Liquid Crystal Display.
Accuracy: ±2 Breaths per minute when measured under the
recommended conditions.
Measurement Range: 10 to 150 Breaths per minute.
Completed Measurement: Beep sound and LED indication.
Mode of Operation: Non-Continuous.
Type of Protection: Class II (while charging Mode) P.
Degree of Protection: Type B Applied Part.
Power Specifications for Charging Adapter P: Input Voltage:
100-240V@50/60 Hz, Output Voltage: 5VDC Output Current: > 0.5A.
Battery Type: Alkaline for CHW C and Rechargeable NiMH for PHW P.
Battery Life: 2000 measurements over two year usage C,
4380 measurements over three years of usage with 200 measurements
per full charge cycle P.
Automatic Shut-off: Approximately after Two minutes of inactivity.
Memory: 300 measurement records P.
Degree of Ingress Protection: IP54 rated.
Operating Conditions: 0 °C to 40 °C; 10% to 90% RH.
Atm Pressure (Operating / Storage): 700 hPa – 1060 hPa.
Storage Conditions (Packaged): -20 °C to 50 °C; 10% to 95% RH.
Dimensions (approx.): 65 x 65 x 28 mm (without belt).
Weight (approx.): 95 gms including belt.
Safety Compliance: IEC 60601-1 Ed3.1, IEC 60601-1-2 Ed 3,
IEC 60601-1-11 Ed1.
Guidance and Manufacturer's Declaration, according to IEC 60601-1-2:2007.
Do not use mobile RF communication equipment, which generate strong
electrical or electromagnetic fields, near the medical device. The user can
help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF equipment (transmitters) and the
Children's Respiration Monitor as recommended below.
Rated maximum output power of
Transmitter
0.01 Watt
0.1 Watt
1 Watt
10 Watt
100 Watt
The CE mark on the product denotes compliance with all applicable EU
Directives. Note that the Notified Body number does not apply to RoHS
Directive (restriction of the use of certain hazardous substances in
electrical and electronic equipment).
REACH Requirements
REACH requires Philips Healthcare (PH) to provide chemical content
information for Substances of Very High Concern (SVHC) if they are
present above 0.1% of the product weight. Components within electric and
electronic equipment may contain phthalates above the threshold (e.g.bis
(2-ethylhexylphthalate), CAS nr.: 117-81-7). The SVHC list is updated on a
regular basis. Please refer to the following Philips REACH website for the most
up-to-date list of products containing SVHC above the threshold:
http://www.philips.com/about/sustainability/reach.page
www.philips.com/healthcare
healthcare@philips.com
EC REP
0086
Philips Medical Systems Nederland B.V.
Veenpluis 4-6 5684 PC Best, The Netherlands
Manufactured by
Philips India Limited, Plot No.B-79, MIDC, Phase - II,Chakan, Taluka-Khed
Village-Savardari, District: Pune - 410501, Maharashtra, India
4598 010 77026 / August 2017
Acerca del "Monitor de respiración para niños"
El sistema "Monitor de respiración para niños" consta de un dispositivo basado
en un acelerómetro con un cinturón para sujetar el dispositivo al niño. Hay dos
tipos: el modelo de trabajador sanitario extrahospitalario, llamado CHW por sus
siglas en inglés, y el modelo de trabajador sanitario profesional, llamado PHW
por sus siglas en inglés. Este producto de Philips debe utilizarse y ponerse en
funcionamiento de acuerdo con los procedimientos de seguridad e
instrucciones de funcionamiento incluidos en estas "Instrucciones de uso".
Este producto está diseñado para los fines que se mencionan a continuación.
No obstante, el contenido de estas "Instrucciones de uso" no exime de
responsabilidad al operador en cuanto al uso de los procedimientos analíticos
y clínicos adecuados.
Uso previsto
El "Monitor de respiración para niños" mide la frecuencia de la respiración
en niños menores de cinco años y clasifi a automáticamente la frecuencia
respiratoria rápida de acuerdo con las directrices AIEPI (Atención Integrada
a las Enfermedades Prevalentes de la Infancia) fijadas por la Organización
Mundial de la Salud. Este dispositivo está concebido para ser utilizado por
parte de trabajadores sanitarios a nivel extrahospitalario en entornos con
pocos recursos, auxiliares médicos, personal de enfermería, matronas,
profesionales clínicos (trabajadores sanitarios profesionales) en centros de
atención primaria o en centros de atención especializada.
Este dispositivo no está diseñado para ofrecer decisiones de tratamiento
automatizadas ni para ser utilizado como sustituto de un juicio clínico
profesional. Todo diagnóstico y tratamiento médico del paciente debe
realizarse bajo la supervisión y responsabilidad de un profesional sanitario
adecuado.
Convenciones utilizadas en esta guía
Esta guía utiliza las siguientes convenciones
I
"PRECAUCIÓN" que debe cumplirse obligatoriamente.
P Aplicable solo al modelo de trabajador sanitario profesional (PHW).
C
Aplicable solo al modelo de trabajador sanitario extrahospitalario
(CHW).
Resumen de seguridad
Símbolos marcados en el dispositivo y el embalaje
Símbolo
0086
Pxxxxxx
Cxxxxxx
Información importante sobre seguridad
I
Este dispositivo debe utilizarse exclusivamente por personal
autorizado y convenientemente entrenado.
I
Este sistema solo debe usarse en bebés NACIDOS A TÉRMINO
(es decir, los bebés que han completado 37 semanas de gestación).
I
El sistema no debe usarse con niños que lleven un dispositivo de
Minimum Safe
apoyo en la zona del pecho/abdomen.
Distance
I
El sistema no requiere contacto directo con la piel para realizar la
0.23 meter
medición; se recomienda que el usuario lo coloque directamente en
0.73 meter
un paño. Si se usa sin un paño, colóquelo solo sobre piel sana.
I
2.3 meter
Utilice únicamente el cinturón suministrado con el sistema. No se
permite el uso de ningún otro cinturón.
7.3 meter
I
Tenga cuidado cuando coloque el cinturón para garantizar que no se
23 meter
provocan lesiones al niño.
I
Asegúrese de que el cinturón no se ha colocado demasiado
apretado al niño.
I
No conecte el cable de carga al dispositivo cuando esté colocado en
el niño.
I
Cargue el dispositivo PHW por completo antes de usarlo por primera
vez. Cargue siempre el dispositivo por completo para el correcto
funcionamiento e indicación de la batería.
I
No deje el sistema desatendido mientras no se está utilizando.
I
Asegúrese de que el sistema no está expuesto a condiciones poco
higiénicas.
I
Ni el dispositivo ni el cinturón deben esterilizarse en un equipo
esterilizador.
I
El usuario del dispositivo es responsable de eliminar adecuadamente
el dispositivo después de su vida útil prevista o cuando ya no se
utilice para su fin previsto y debe desecharlo de acuerdo con las
leyes y normativas locales aplicables sobre el desecho de residuos.
Primeros pasos
1. Botón de encendido/apagado.
2. Pantalla LCD..
3. Botón de OK.
4. Puerto USB P.
5. Botón de selección.
6. Indicador LED.
Funciones utilizadas con frecuencia
– Colocar el dispositivo al niño con el cinturón (consulte la "Guía de
referencia rápida" (GRR), Fig. 1).
– Encender el dispositivo pulsando el botón de encendido/apagado
(consulte la GRR, Fig. 2).
– Seleccionar un grupo de edad (consulte la GRR, Fig. 3).
– Iniciar la medición (consulte la GRR, Fig. 4).
– Apagar el dispositivo pulsando el botón de encendido/apagado
(consulte la GRR, Fig. 2).
– Cargar el dispositivo P (consulte la GRR para obtener una
representación gráfica).
Descripción
La dirección de fabricación legal se encuentra junto a este
símbolo.
Tensión nominal de entrada de CC.
Indica la necesidad de recogida por separado de aparatos
eléctricos y electrónicos en cumplimiento de la directiva
sobre residuos de aparatos eléctricos y electrónicos (RAEE).
Fecha de fabricación.
Para la directiva sobre productos sanitarios.
Consulte las "Instrucciones de uso" del Monitor de
respiración para niños.
Parte aplicable de tipo B.
Con protección frente al polvo; con protección frente a
salpicaduras de agua.
El número que aparece junto a este símbolo es el número
de serie.
Número de serie del PHW.
Número de serie del CHW.