Drive MQ3200 Le manuel du propriétaire

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Modèle: MQ3200

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View SpO2 Deluxe Pulse Oximeter

MQ3200

ENGLISH

Instructions to User

Dear Users, thank you very much for purchasing our product.

This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices

and harmonized standards. The Manual is written for the current Pulse Oximeter. In case of modications and soft-

ware upgrades, the information contained in this document is subject to change without notice.

The Manual describes, in accordance with the Pulse Oximeter’s features and requirements, main structure, functions,

specications, correct methods for transportation, installation, usage, operation, repair, maintenance and storage, etc.

as well as the safety procedures to protect both the user and equipment. Refer to the respective chapters for details.

Please read the Manual very carefully before using this equipment. These instructions describe the operating proce-

dures to be followed strictly, failure to follow these instructions cm cause measuring abnormality, equipment damage

and personal injury. The manufacturer is NOT responsible for the safety, reliability and performance issues and any

monitoring abnormality, personal injury and equipment damage due to user’s negligence of the operation instructions.

The manufacturer’s warranty service does not cover such faults.

Owing to the forthcoming renovation, the specic products you received may not be totally in accordance with the

description of this User Manual. The expected service life of this device is 3 years.

This device is intended for sports or aviation use only.

Individuals who need a pulse oximeter due to a medical

condition should contact their physician.

WARNING:

M The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for

the microcircnlation barrier user. It is recommended that the sensor should not be applied to the

Deluxe FingertipPulse Oximeter

USER MANUAL

REV2.4.27.17

same nger for over 2 hours.

M For the individual user, there should be a more prudent inspecting in the placing process. The

device can not be clipped on the edema and tender tissue.

M The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and

the maintenance man, can not stare at the light.

M User can not use enamel or other makeup.

M User’s ngernail can not be too long.

M Please peruse the relative content about the user restrictions and caution.

M This device is not intended for treatment.

1 Safety

1.1 Instructions for Safe Operations

 Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect

user’s safety and monitoring performance about cables and transducers. It is recommended that the device

should be inspected once a week at least. When there is obvious damage, stop using the monitor.

 Necessary maintenance must be performed by qualied service engineers ONLY. Users are not permitted to

maintain it by themselves.

 The oximeter cannot be used together with devices not specied in User’s Manual.Only the accessory that

appointed or recommendatory by manufacture can be used with this device.

 This product is calibrated before leaving factory.

1.2 Warnings

 Explosive hazard-DO NOT use the oximeter in environment with ammable gas such as ignitable anesthetic

agents.

 DO NOT use the oximeter while the user measured by MRI and CT.

  Caution: This product contains natural rubber latex which may cause allergic reactions.

  The disposal of scrap instrument and its accessories and packings (including batteries, plastic bags, foams and

paper boxes) should follow the local laws and regulations.

 Please check the packing before use to make sure the device and accessories are totally in accordance with the

packing list, or else the device may have the possibility of working abnormally.

Please don’t measure this device with function test paper for the device’s related information.

1.3 Attentions

 Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and

moisture.

If the oximeter gets wet, please stop operating it.

 When it is carried from cold environment to warm or humid environment, please do not use it immediately.

DO NOT operate keys on front panel with sharp materials.

 High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to User Manual in

the relative chapter for instructions of cleaning and disinfection.

 Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with medical

alcohol by soft material. Do not spray any liquid on the device directly.

 When cleaning the device with water, the temperature should be lower than 60°C.

 As to the ngers which are too thin or too cold, it would probably affect the normal measure of the users’ SpO

and pulse rate, please clip the thick nger such as thumb and middle nger deeply enough into the probe.

 Do not use the device on infant or neonatal user.

 The product is suitable for children above four years old and adults (Weight should be between 15kg to 110kg).

 The device may not work for all users. If you are unable to achieve stable readings, discontinue use.

 The update period of data is less than 5 seconds, which is changeable according to different individual pulse rate.

 The waveform is normalized. Please read the measured value when the waveform on screen is equably and

steady-going. Here this measured value is optimal value. And the waveform at the moment is the standard one.

 If some abnormal conditions appear on the screen during test process, pull out the nger and reinsert to restore

normal use.

 The device has normal useful life for three years since the rst electried use.

 The lanyard attached to the product is made from Non-allergy material, if particular group are sensitive to the

lanyard, stop using it. In addition, pay attention to the use of the lanyard, do not wear it around the neck avoiding

cause harm to the user.

 The instrument has a visible low-voltage indicator, please change the batteries when the voltage is low.

 The instrument dose not have low-voltage alarm function. Do not use the device in situations where alarms are

required.

 Batteries must be removed if the device is going to be stored for more than one month, or else batteries may

leak.

 A exible circuit connects the two parts of the device. Do not twist or pull on the connection.

2 Overview

The pulse oxygen saturation is the percentage of HbO, in the total Hb in the blood, so-called the 0, concentration in

the blood. It is an important bio-parameter for the respiration. For the purpose of measuring the SpO

, more easily

and accurately, our company developed the Pulse Oximeter. At the same time, the device can measure the pulse rate

simultaneously.

The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It

is only necessary for user to put one of his ngers into a ngertip photoelectric sensor for diagnosis, and a display

screen will directly show measured value of Sp0.

2.1 Classication:

Class II b(MDD93/42/EEC IX Rule 10) Class II (U.S.FDA)

2.2 Features

Operation of the product is simple and convenient.

 The product is small in volume, light in weight (total weight is about 50g including batteries) and

convenient in carrying.

 Power consumption of the product is low and the two originally equipped AAA batteries can be operat-

ed continuously for 20 hours.

The product will automatically be powered off when no signal is in the product within 5 seconds.

2.3 Major Applications and Scope of Application

The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through nger, and indi-

cate the pulse intensity by the bar-display. The product is suitable for use in with sporting and elavation activities.

The product is not suitable for use in continuous supervision for user.

The problem of overrating would emerge when the is suffering from toxicosis which caused by

carbon monoxide, the device is not recommended to be used under this circumstance.

2.4 Environment Requirements

Storage Environment Operating Environment

a) Temperature: -40°C--,60°C a) Temperature: 10°C-40°C

b) Relative humidity ≥95% b) Relative Humidity: ≥75%

c) Atmospheric pressure :500hPa-1060hPa c) Atmospheric pressure: 700hPa-1060hPa

3 Principle and Caution

3.1 Principle of Measurement

Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Lambert

Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (11b) and Oxyhemoglobin

(HbO,) in glow & near-infrared zones. Operation principle of the instrument is: Photoelectric Oxyhemoglobin

Inspection Technology is adopted in accordance with Capacity Pulse Scanning & Recording Technology, so that two

beams of different wavelength of lights can be focused onto human nail tip through perspective clamp nger-type

sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will

be shown on screen through treatment in electronic circuits and microprocessor.

3.2 Caution

1. The nger should be placed properly (see the attached illustration of this manual ,Figure 5), or else it may cause

inaccurate measurement.

2. The SpO

, sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a

position there between.

3. The SpO

, sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiv-

ing intravenous injection.

4. Make sure the optical path is free from any optical obstacles like rubberized fabric.

5. Excessive ambient light may affect the measuring result. It includes uorescent lamp, dual ruby light, infrared

heater, direct sunlight and etc.

6. Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.

7. User can not use enamel or other makeup.

3.3 User Restrictions

1. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood ow of subject is required. For

a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular con-

tracting drug, the SpO

, waveform (PLETH) will decrease. In this case, the measurement will be more sensitive

to interference.

2. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid

indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and

some with icteros problem, the Sp0a determination by this monitor may be inaccurate.

3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for

serious error of SpO

, measure.

4. As the SpO

, value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some users with

serious anemia may also report good SpO

, measurement

4 Technical Specications

1. Display Format: OLED Display;

Spl; Measuring Range: 0% - 100%;

Pulse Rate Measuring Range: 30 bpm - 250 bpm;

Pulse Wave Display: columniation display and the waveform display.

2. Power Requirements: 2 .1.5V AAA alkaline battery(or using the rechargeable battery instead), adaptable

range: 2.6V-3.6V.

3. Power Consumption: Smaller than 30mA.

4. Resolution: 1% for SpO

, and 1 bpm for Pulse Rate.

5. Measurement Accuracy: ±2% in stage of 70%-100% Sp0,, and meaningless when stage being smaller than

70%. ±2 bpm or-,2% (select larger) for Pulse Rate.

6. Measurement Performance in Weak Filling Condition: SpO

, and pulse rate can be shown correctly

when pulse-lling ratio is 0.4%. SpO

, error is ±-4%, pulse rate error is ±2 bpm or +2% (select larger).

7. Resistance to surrounding light: The deviation between the value measured in the condition of man-made

light or indoor natural light and that of darkroom is less than ±1%.

8. It is equipped with a function switch. The Oximeter can be powered off in case no nger is the Oximeter within

5 seconds.

9. Optical Sensor

Red light (wavelength is 660nm, 6.65mW)

Infrared (wavelength is 880nm, 6.75mW)

5 Accessories

One lanyard;  Carry Pouch

Two batteries (optional);

One User Manual.

6 Installation

6.1 View of the Front Panel

6.2 Battery

Step 1. Refer to Figure 3. and insert the two

AAA size batteries properly in the right direction.

Step 2. Replace the cover.

Please take care when you insert the batteries for the

improper insertion may damage the device.

Figure 6

6.3 Mounting the lanyard

Step 1. Put the end of the lanyard through the hole.

Step 2. Put another end of the lanyard through the

rst one and then tighten it.

7 Operation Guide

7.1 Insert the two batteries properly to the direction, and then replace the cover.

7.2 Open the clip as shown in Figure 5.

7.3 Let the user’s nger put into the rubber cushions of the clip

(make sure the nger is in the right position), and then clip the nger.

7.4 Press the switch button once on front panel.

7.5 Do not shake the nger and keep the user at ease during the process.

Meanwhile, human body is not recommended in movement status.

7.6 Get the information directly from screen display.

7.7 The button has three functions.When the device is powered off, the button will turn the unit on.

When the device is powered on, pressing the button shortly will open the menu. When the device is power on,

pressing and holding the button will cycle the screen views. (see Figure 7)

Fingernails and the luminescent tube should be on the same side.

7.8 PI value display

When the device is powered off, long press the button can change

direction of the screen. when it enters the PI screen, you can read the PL

value. (see Figure 6)

Menu Operations

Click = short press the power button and press = prolonged push the power

button (1sec)

Press the power button with a prolonged push (1 second) to enter the Setting Menu Interface (see Figure 7). The

user can setup the following parameters in the Settings Menu -Turn on alarm, turn on pulse sound, alarm high-low

Figure 7

Pulse on

Alarm on

Alarm Set

Exit

Figure 8

Alarm Set

Pulse Alarm

Alarm Set

Exit

Figure 9

Dir UP

High 120

Low 030

Exit

limits. Please note in the Settings Menu, press and hold the button to select a

menu option.

Alarm setting

On the main menu interface, click the power button to select “Alarm Set”, Press

the power button (l sec) to enter the alarm setting interface as shown in Figure 8:

Adjusting the high and low limits of alarms.

On the alarm setting interface, Click the power button to select “Pulse Alarm”

or “Sp02 Alarm”, then Press the button (l sec) to enter Pulse Alarm setting

interface or Sp02 Alarm setting interface as shown in Figure 9. Click the power button to select “Dir”, then Press the

button to choose Up or Down (this will be the place to change value of the high-low limits of Sp02 and pulse rate).

To raise the Sp02 and pulse rate limit, choose “Dir” as

`Up’, then Click the power button to select high limit

(High) or low limit (Low), Press the power button and

hold to adjust the selected limit to the desired higher

value and release the power button once the higher limit

has been reached. To lower the Sp02 and pulse rate lim-

it, choose “Dir” as ‘Down’, then Click the power button

to select high limit (High) or low limit (Low). Press the

power button and hold to adjust the selected limit to the

desired lower value and release the power button once the lower limit has been reached.

8 Reparing and Maintenance

Please change the batteries when the low-voltage displayed on the screen.

 Please clean the surface of the device before using. Wipe the device with medical alcohol rst, and then let it dry

in air or clean it by dry clean fabric.

Using the medical alcohol to disinfect the product after use, prevent from cross infection for next time use.

Please take out the batteries if the oximeter is not in use for a long time.

 The best storage environment of the device is - 40°C to 60°C ambient temperature and not higher than 95%

relative humidity

High-pressure sterilization cannot be used on the device.

Do not immerse the device in liquid.

It is recommended that the device should be kept in a dry environment. Humidity may reduce

the useful life of the device, or even damage it.

9 Troubleshooting

Trouble Possible Reason Solution

The SpO

and Pulse Rate can not

bedisplayed normally

1. The nger is not properly positioned.

2. The user’s SpO

, is too low to be detected.

1. Place the nger properly and try again.

2. Try again; Go to a hospital for a diagnosis if

you are sure the device works all right

The SpO2 and Pulse Rate are

not be displayed stably

1. The nger is not placed inside deep enough.

2. The nger is shaking or the user is moving.

1. Place the nger properly and try again.

2. Let the user keep calm

The device can not be turned on

1. The batteries are drained or ahnost drained.

2. The batteries are not inserted properly.

3. The malfunction of the device.

1. Change batteries.

2. Reinstall batteries.

3. Please contact the local service center.

The display is off suddenly

1. The device will power off automatically when it

e no signal within 5 seconds.

2. The batteries are almost drained.

1. Normal.

2. Change batteries.

10 Key Symbols

Symbol Description

Type BF

Warning — See User Manual

The pulse oxygen saturation (%)

Pulse rate (bpm)

The battery voltage indication is decient (change the battery in time avoiding the inexact measure)

1. No nger inserted 2. An indicator of signal inadequacy

Battery positive electrode

Battery cathode

1. Power switch 2. Change direction of the screen 3. Menu selection

Serial number

Alarm inhibit

WEEE (2002/96/EC)

Ingress of liquids ranks

11 Function Specication

Display Information Display Mode

The Pulse Oxygen Saturation (SpO2) OLED

Pulse Rate (PR) OLED

Pulse Intensity (bar-graph) OLED bar-graph display

Pulse wave OLED

SPO2 Specication

Measuring range 0%~100%, (the resolutionis 1%)

Accuracy 70%-100%; ±2% ,Below 70% unspecied.

Optical Sensor Red light (wavelength is 660mn) Infrared (wavelength is 880nm)

Pulse Parameter Specication

Measuring range 30bpm-250bpm (the resolution is 1 bpm)

Accuracy ±2bpm or- ±2% select larger

Pulse Intensity Display Mode

Range Continuous bar-graph display, the higher display indicate the stronger pulse.

Battery Requirement

1.5V (AAA size) alkaline batteries x 2 or rechargeable battery

Battery Useful Life

Two batteries can work continually for 20 to 30 hours

Dimensions and Weight

Dimensions 61(L) x 36(W) x 32(H) mm

Weight About 57g (with the batteries)

Appendix

Guidance and manufacture’s declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration —electromagnetic emission

The MQ3200 Pulse Oximeter is tended for me in the electromagnetic environment specied below. The customer of the

user of the MQ3200 Pulse Oximeter should assure that it isused in such an environment.

Emission test Compliance Electromagnetic environment-guidance

RF emissions CISPR 11 Group 1

The MQ3200 Pulse Oximeter uses RF energy only for their 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 MQ3200 Pulse Oximeter is suitable for use in all estab-

lishments,including domestic establishments and those directly

connected to the public low-voltage power supply network that

supplies buildings used for domestic purposes.

Harmonic emissions IEC

61000-3-2

Not applicable

Voltage uctuations/ icker

emission IEC 61000-3-3

Not applicable

Guidance and manufacture’s declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration-electromagnetic immunity

The MQ3200 Pulse Oximeter is intended for use in the electromagnetic environment specified specified below.

The the user of MQ3200 Pulse Oximeter should assure that it is used in such an environment.

Immunity test IEC60601 test level Compliance level Electromagnetic environment-guidance

Electrostatic dis-

charge (ESD) IEC

61000-4-2

±6KV contact

±8KV air

±6KV contact

±8KV air

Floors should be wood, concrete or ceramic tile.

If oor are covered with synthetic material, the

relative humidity should be at least 30%.

Power frequency

(5 0Hz) magnetic

eld IEC 61000-4-8

3A/m 3A/m Power frequency magnetic elds should be at

levels characteristic of a typical location in a

typical commercial or hospital environment

Guidance and manufacture’s declaration-electromagnetic immunity for

EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration-electromagnetic immunity

The MQ3200 Pulse Oximeter is intended for use in the electromagnetic environment specied below. The customer or

the user of MQ3200 Pulse Oximeter should assure that it is used in such an environment.

Immunity

test

IEC60601

test level

Compliance

level

Electromagnetic environment -guidance

Radiated

IEC

61000-4-3

3V/m

80MHz to

2.5GHz

3V/m

Portable and mobile RF communication equipment should be used no

closer to any part of the MQ3200 Pulse Oximeter, including cables,

than the recommended separation distance calculated from the equation

applicable to the frequency of the transmitter.

recommended separation distance

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 xed RF transmitters, as determined by an electro-

magnetic site survey ‘should be less than the compliance level in each

frequency range .b

Interference may occur in the vicinity of equipment

marked with the following symbol:

NOTE

At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection 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, AM and FM radio

broadcast and TV broadcastcannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromag-

netic site survey should be considered. If the measured eld strength in the location in which The MQ3200 Pulse Oximeter is used exceeds the applicable RF compliance

level above, the MQ3200 Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such

as reorienting or relocating the MQ3200 Pulse Oximeter.

b Over the frequency range 150 KHz to 80 MHz, eld strengths should be less than 3V/m.

Recommended separation distances between portable and mobile RF communications equipment and

the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that not LIFE-SUPPORTING

Recommended separation distances between

portable and mobile RF communications equipment and the MQ3200 Pulse Oximeter

The MQ3200 Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF distur-

bances are controlled. The customer or the user of the MQ3200 Pulse Oximeter can help prevent electromagnetic

interference by maintaining a minimum distance between portable and mobile RF communications equipment

(transmitters) and the MQ3200 Pulse Oximeter 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)

150KHz to 800MHz 80MHz to 800MHz 800MHz to 2.5GHz

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distanced in me-

ters (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

At 80MHz and 800MHz, 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.

Warranty

Your Drive brand product is warranted to be free of defects in materials and workmanship for two years from the

original purchase date.

The device was built to exacting standards and carefully inspected prior to shipment. This two year Limited

Liability warranty is an expression of our condence in the materials and workmanship of our products and our

assurance to the consumer of years of dependable service. In the event of a defect covered by this warranty, we will

at option, repair or replace the device.

This warranty does not cover device failure due to owner misuse or negligence, or normal wear and tear. If you have

questions about your Drive device, or this warranty, please contact an authorized Drive Medical provider.

MQ3200

Manufactured for :

Drive Medical Design & Manufacturing

99 Seaview Boulevard

Port Washington, NY 11050

Phone: 1-877-224-0946 File No:2.782.028(MQP)TSS/1.2

Fax: 516-998-4601 Release Date: December 2016

1.4.01.33.581

www.drivemedical.com

MQ3200

Oxímetro de pulso táctil de lujo

MANUAL DEL USUARIO

ESPAÑOL

Instrucciones para el usuario

Estimados usuarios, muchas gracias por comprar nuestro producto.

Este manual se escribe y compila en cumplimento con la directiva MMD93/42/EEC del consejo para dispositivos

médico y normas armonizadas. El manual se escribe para el Oxímetro del pulso actual. En caso de modicaciones y

actualizaciones de software, la información incluida en este documento está sujeto a cambio sin previo aviso.

El manual describe, en conformidad con las funciones y requisitos del oxímetro del pulso, la estructura principal,

funciones, especicaciones, métodos correctos de transporte, instalación, uso, operación, reparación, mantenimiento

y almacenaje, etc., al igual que procedimientos de seguridad para proteger tanto al usuario como al equipo. Consul-

tar los capítulos respectivos para detalles.

Leer el manual cuidadosamente antes de usar este equipo. Estas instrucciones describen los procedimientos de

operación a seguir estrictamente, cuando no se siguen estas instrucciones se pueden ocasionar anormalidades en las

mediciones, daños al equipo y lesiones personales. El fabricante NO es responsable por la seguridad, conabilidad y

cuestiones de rendimiento ni ninguna anormalidad en el monitoreo, lesiones personales y daños al equipo debido a

la negligencia del usuario en cuanto a las instrucciones de operación. El servicio de garantía del fabricante no cubre

dichas fallas.

Debido a la próxima renovación, puede que los productos especícos que recibió no estén en total armonía con la

descripción en este manual del usuario. Lo lamentamos sinceramente. La vida útil esperada de este dispositivo es

de 3 años.

ADVERTENCIA:

M Puede presentarse una sensación incomoda o dolorosa si el dispositivo se usa constantemente,

especialmente para usuarios con barreras de microcirculación. Se recomienda que no se aplique

el sensor al mismo dedo por más de 2 horas.

M Para los usuarios individuales se debe de contar con una inspección más prudente en el proceso de

colocación. El dispositivo no se debe acoplar en el edema o tejido delicado.

M La luz (el infrarrojo es invisible) emitida desde el dispositivo es perjudicial a los ojos, así que el

usuario y el personal de mantenimiento no deben mirar jamente a la luz.

M El usuario no debe usar esmalte para uñas ni maquillaje.

M Las uñas del usuario no debe estar muy largas.

M Usar de acuerdo al contenido relacionado con las restricciones y precauciones clínicas.

M Este dispositivo no está previsto para tratamiento.

1 Seguridad

1.1 Instrucciones para operaciones seguras

 Revisar la unidad principal y todos los accesorios con regularidad para asegurarse de que no existan daños visi-

bles que puedan afectar la seguridad del usuario y los cables y transductores para el monitoreo del rendimiento.

Se recomienda inspeccionar el dispositivo como mínimo una vez por semana. Cuando se presenten daños obvios

dejar de usar el monitor.

 El servicio de mantenimiento necesario SOLO debe realizarlo personal calicado. Los usuarios no tienen permit-

ido realizar el mantenimiento ellos mismos.

 El oxímetro no se puede usar junto con dispositivos no especicados en el manual del usuario. Solo se pueden usar

accesorios indicados o recomendados por el fabricante con este dispositivo.

 Este producto se calibra antes de salir de la fábrica.

1.2 Advertencias

 Peligro de explosión -NO usar el oxímetro en un medio ambiente con gas inamable como lo son agentes

anestésicos inamables.

 NO usar el oxímetro mientras el usuario recibe imágenes por resonancia magnética y tomografía computarizada.

 Cuidado: Este producto contiene látex de caucho natural que puede causar reacciones alérgicas.

  La eliminación de desechos, accesorios y empaques del instrumentos (incluyendo baterías, bolsas de plástico,

hule espuma y cajas de papel) deben seguir las leyes y normas locales.

 Consultar el empaque antes de su uso y asegurarse de que el dispositivo y los accesorios concuerden totalmente

con la lista de embalaje, de no ser así existe la posibilidad de un funcionamiento anormal.

No medir este dispositivo con el papel de prueba de función para la información relacionada con el dispositivo.

1.3 Cuidado

 Mantener el oxímetro alejado del polvo, vibración, sustancias corrosivas, materiales explosivos, altas temperatu-

ras y humedad.

Si el oxímetro se moja detener su funcionamiento.

No usar inmediatamente después de transportarlo desde ambientes fríos a ambientes cálidos o húmedos.

NO poner en funcionamiento las teclas del panel frontal con objetos losos.

 No se permite desinfectar el oxímetro con vapor a alta temperatura y alta presión. Consultar el manual del

usuario en el capítulo correspondiente para ver las instrucciones de limpieza y desinfección.

 No sumergir el oxímetro en líquidos. Cuando sea necesaria la limpieza, limpiar la supercie con alcohol médico

y un material suave. No rociar ningún líquido directamente sobre el dispositivo.

 Al limpiar el dispositivo con agua, la temperatura no debe ser menor de 60°C.

 Cuando se trata de dedos muy delgados o muy fríos esto probablemente afecta la medida normal del SpO de los

usuarios y la frecuencia cardíaca, así que coloque el dedo más grueso como el dedo pulgar y el dedo anular lo

más profundo posible dentro de la sonda.

 No usar el dispositivo en infantes o usuarios neonatales.

 El producto es adecuado para menores mayores de 4 años de edad y adultos (el peso deberá estar entre 15 kg a

110 kg).

 Puede que el dispositivo no funcione para todos los usuarios. Si no logra obtener lecturas estables descontinúe su

uso.

 El periodo de actualización de datos es menos de 5 segundos, esto cambia de acuerdo a las diferentes frecuencias

cardíacas individuales.

 La forma de onda es normalizada. Leer el valor medido cuando la forma de onda en la pantalla es igual y con-

stante. Aquí es donde el valor medido es el valor óptimo y la forma de onda en el momento es la estándar.

 Si se presentan condiciones anormales en la pantalla durante el proceso de prueba, sacar el dedo y volver a

introducirlo para restablecer el uso normal.

 El dispositivo tiene un ciclo de vida útil de tres años a partir de su primer uso.

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