Duronic OX01R User manual

OX01R - Pulse Oximeter
PLEASE READ ALL THE INSTRUCTIONS BEFORE USE

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English Manual
Manuel d’utilisation en français
Gebrauchsanleitung auf Deutsch
Manual de Instrucciones en Español
Manuale D’istruzioni In Italiano
Instrukcja obsługi. Polski
Gebruikershandleiding Nederlands
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Contents

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English Manual

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Safety Information
Thank you for purchasing the Duronic OX01R Pulse Oximeter.
This Manual is written and compiled in accordance with the council directive
MDD 93/42/EEC for medical devices and harmonized standards. In case
of modications and software upgrades, the information contained in this
document is subject to change without notice.
Please read this User Manual carefully before using this product and retain for
future reference.
Warning
• Explosive hazard---DO NOT use the oximeter in environment with
inammable gas, for example anaesthetic mixture with air/oxygen or
where there is nitrous oxide. These are highly ammable.
• DO NOT use the oximeter while the user is being scanned by MRI and CT.
Instructions for Safe Use
• Check the main unit and all accessories periodically to make sure
that there is no visible damage that may affect patient’s safety. If used
regularly, it is recommended that the device should be inspected once a
week at least. When there is obvious damage, stop using the monitor.
• You must not attempt to repair or disassemble the oximeter yourself. If the
device requires repair, please contact the Duronic Customer Care Team.
• The oximeter cannot be used together with devices not specied in User
Manual. The only accessories (if any) that can be used with this device are
those recommended by manufacturer.
• This oximeter is calibrated before leaving factory.

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• This device is not suitable for anyone who is allergic to rubber.
• You may feel discomfort or pain if using the device continuously. It is
recommended that the sensor should not be applied to the same nger for
over 2 hours at a time.
• The infrared light emitted from the device is harmful to the eyes, so the
user and anyone using the device should not stare at the light.
Attentions
• Please check the packs contents before use to make sure the device and
accessories are totally in accordance with the list in section 4. If you are
missing any parts, please contact Duronic directly for assistance.
• Keep the oximeter away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
• Enamel or Acrylic ngernail polish or other ngernail applications may
distort and/or produce inaccurate readings. Please remove them before
use.
• This device is not intended for treatment.
• If the oximeter gets wet, stop using it immediately.
• When it is carried from a cold environment to a warm or humid
environment, please do not use it straight away.
• Do not expose to high temperature or clean with high pressure steam as
this will damage the oximeter. Please read the cleaning and disinfection
instructions in this user manual for advice on how to clean it safely and
effectively.
• Do not submerge the oximeter in water or any other liquid. When it needs
cleaning, please wipe its surface with medical alcohol with a soft cloth. Do
not spray any liquid on the device directly.
• Do not use this device on young infants or newborn babies.
• This oximeter is suitable for children above four years old and adults

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(weight should be between 15kg to 110kg).
• The device may not work for all patients. 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 an individual’s pulse rate.
• The oximeter does not have low-battery alarm function, it only shows the
low-battery symbol on the digital display. Please change the battery when
the energy has run out.
• Batteries must be removed if the device is going to be stored for more than
one month, or else batteries may expire and leak.
• The disposal of the oximeter, its accessories and/or packaging (including
battery, plastic bags, foams and paper boxes) should be done so
responsibly following the local council/district refuse and recycling
regulations.
About the OX01R
What Does it Do
The OX01R oximeter measures two things: oxygen saturation and pulse rate.
• Oxygen saturation is the percentage of oxyhaemoglobin (HbO2) in blood.
HbO2is a combination of haemoglobin (Hb) and oxygen molecules (O2),
that is present in all human blood and is an important physiological factor
involved in respiration and circulation. The oxygen saturation of arterial
blood in the average human body is around 98%. Measuring oxygen
saturation is an important indicator of the amount of oxygen in the body. If
there is not enough oxygen it can affect the normal function of the body in
many ways and result in a condition called hypoxia.
In general, the normal levels of oxygen saturation should not be lower than
94%; if a measurement of 94% or less has been obtained, it means an
insufcient supply of oxygen has been detected and proper medical advice
should be sought from a qualied doctor.

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• Pulse rate is the number of pulse beats per minute. In general, the pulse
rate of every person should be between 60-100 beats per minute. If you
are concerned about your pulse being too fast or slow, consult a qualied
doctor for advice.
TIP: Talk to your doctor before using a home device like the OX01R so that
you understand how to interpret the results.
How Does it Work?
Pulse Oximeter uses light to work out oxygen saturation. Light is emitted
from one side of the device which goes across the pulse oximeter probe
and reaches light detector on the other side. When a nger is placed in the
oximeter between the source of light and the detector, the light has to try and
pass through the nger and through the blood cells. By measuring how much
light reaches the light detector on the other side, the pulse oximeter knows
how much light has been absorbed by the haemoglobin (Hb) in the blood. The
more Hb in the nger there is, the more light absorbed.
Application of the OX01R Oximeter
The OX01R Pulse Oximeter is a non-invasive device intended for the spot-
check of oxygen saturation of arterial haemoglobin (SpO2) and the pulse rate
of adult and paediatric patients. With a clear digital display, this device is easy
to use and comes with a lanyard to carry it with you should you wish.
The oximeter method can be used in a wide range of situations, for instance,
family care at home, in hospitals, for social medical care organisations and
for sports. While the OX01R can be used before and after sports, it is not
recommended to be used during sports activities.
Note: this device is not suitable for use in continuous supervision
patients.

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Features
• Simple design and convenient to use.
• Quick accurate measurements every time.
• The OX01R is small in size, lightweight and portable (total weight is about
50g including batteries).
• Low power consumption so batteries last longer.
• The oximeter will automatically turn off when not in use for over 16
seconds.
• Comes with handy carry pouch for easy storage and a lanyard for
transportation.
Key of Symbols
Symbol Description
Type BF applied part.
Caution: Please see this manual.
%SpO2Symbol of oxygen saturation.
bpmPR Symbol of pulse rate.
No SpO2alarms.
Consult the instructions for use.
When end users abandon this product, they must send the
product to the collection place for recycling.
IP22 The degree of protection against harmful ingress of water
and particulate matter.

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Operating Guide
Installing the Batteries
Step 1. Remove the battery cover and
insert the two AAA size batteries in the
correct position as demonstrated.
Step 2. Replace the cover ensuring it is
locked in place
Box Contents
• 1x storage bag
• 1x lanyard
• 2x AAA batteries
Digital Display
View of the Front Panel
1. Low-voltage display
2. Measured value of pulse rate
3. Measured value of oxygen
saturation
4. Pulse rate bargraph display
5. Power switch
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Take care when you insert the batteries as improper insertion may
damage insertion may damage the device.

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Attaching the Lanyard
Step 1. Insert the loop of the lanyard into
one of the holes and push the loop in until
it comes out of the other hole.
Step 2. Thread the lanyard strap through
the loop and pull tight to secure in place.
How to Take a Measurement
Only use the oximeter when you are sitting or standing comfortably. You will
not get an accurate reading if you are under exertion or have been doing any
vigorous activity beforehand or during use of the device.
1. Insert the two batteries properly and
then replace the cover.
2. Open the clip by pinching it open.
3. Place your nger nail-side up into the
device resting it on the rubber pads
inside. Make sure your nger is fully
inserted, ensuring the end of the nger
touches the end of the space inside and that the nger’s rst digit covers
the sensor.
4. Close the clip around the nger
5. Press the button on front panel once.
6. Do not shake the nger and stay at ease during the process.
7. The oximeter will instantly give you a reading providing you with your
current statistics on the display screen.

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Maintenance and Cleaning
• Change the batteries when the low-battery symbol appears on the screen.
• To clean the device, wipe with damp (well wrung) cloth. Then leave to air
dry or dry with a clean dry cloth.
• Medical alcohol can be used in place of water if you wish to disinfect the
product after use and prevent cross infection.
• If you plan to not use the oximeter for a long period of time, remove the
batteries before storing.
Warning:
High-pressure, high-temperature or gas sterilization cannot be used
on the device.
Do not immerse the device in water or any other liquid.
It is recommended that the device should be kept in a dry
environment. Humidity may reduce the life of the device, or even
damage it.

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Troubleshooting
Problem Possible Reason Solution
The SpO2and Pulse
Rate is not displaying
normally
a.The nger is not
properly positioned.
b.The patient’s SpO2is
too low to be detected.
a.Place the nger
properly and try again.
b.Try again; If you are
sure that the device
is working well, seek
medical help for a
diagnosis.
The SpO2and Pulse
Rate are not displayed
stably
a.The nger is not
placed inside deep
enough.
b.The nger is shaking
or the patient is moving.
a.Place the nger
properly and try again.
b.Calm the patient and
then try again.
The device cannot be
turned on
a.Low battery or no
battery.
b.The batteries are not
inserted properly.
c.The malfunction of the
device.
a.Change batteries.
b.Check batteries are
installed correctly.
c.Contact Duronic.
The display has turned
off suddenly
a.The device will power
off automatically when
there is no signal within
16 seconds.
b.The batteries are
almost drained.
a.Normal.
b.Change batteries.
Authorized European Representative: Wellkang Ltd
Manufactured by: Shenzhen Jumper Medical
Equipment Co. Ltd
Distributed by: SHINEMART Ltd.

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Technical Specication
Display Information Display Mode
Display Format LED display
The Pulse Oxygen Saturation (SpO2) Digital
Pulse Rate (PR) Digital
Pulse Intensity (bar-graph) Digital bar-graph display
SpO2 Parameter Specication
Measuring range 35%-100% (the resolution is 1%).
Accuracy 70%-100%;±2%, Below 70% unspecied.
Pulse Parameter Specication
Measuring range 25bpm-250bpm (the resolution is 1 bpm)
Accuracy ±2bpm
Pulse Intensity
Range Continuous bar-graph display, the higher
display indicates the stronger pulse.
Alert conditions
SpO2Less than 94%
PR Less than 50bpm or more than 130bpm
Battery Requirement
2 X 1.5V (AAA size) alkaline battery
Power Consumption
Smaller than 35 mA.
Battery Useful Life
Two batteries can work continually for 24 hours
Power off
The Oximeter can be powered off in case no nger is the Oximeter within 16
seconds.
Optical Sensor
Red light (wavelength is 660nm)
Infrared (wavelength is 905nm)
Dimensions and Weight
Dimensions 62.2 (L)X37.0 (W)X33.1(H) mm
Weight About 28g (without batteries)

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Appendix: Electromagnetism Compatibility
Guidance and manufacture’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The Duronic OX01R is intended for use in the electromagnetic environment specied
below. The customer or the user of the OX01R should assure that it is used in such
anenvironment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The OX01R 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 emission
CISPR 11
Class B The OX01R is suitable for use in all
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Device Specications
Classication:
Class II b (MDD 93/42/EEC IX Rule 10)
Class II (U.S.FDA)
Environment Requirements
Operation Temperature: 5°C-40°C
Storage Temperature: -10°C-50°C
Ambient Humidity: 15%-80% RH, no condensation in operation
10%-93% RH, no condensation in storage
Atmospheric Pressure: 70 kPa to 106 kPa, in operation
50kPa–106 kPa, in storage

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Warranty
1 Year Guarantee from Shine-Mart Ltd, Trademark owners of Duronic Products.
NOTE: THESE STATEMENTS DO NOT AFFECT YOUR STATUTORY RIGHTS AS A
CONSUMER
This product has been manufactured under the strictest or quality control procedures, and
using the highest quality of materials, to ensure excellent performance and reliability. It will
give very good and long lasting service, provided it is properly used and maintained. The
product is guaranteed for 1 years from the date of original purchase. If any defect arises due
to a faulty materials or poor workmanship, the faulty product must be returned to the original
place of purchase. Refund or replacement is at the discretion of that company.
Duronic Products are offered with a 1 year guarantee under the following conditions:
1. The product must be returned to the retailer with original proof of purchase.
2. The product must be installed and used in accordance with the instructions
contained in this operating manual.
3. It must be used only for domestic purposes.
4. It does not cover wear and tear, malicious damage, misuse, neglect,
inexpert repairs or consumable parts.
5. Shine-Mart Ltd has no responsibilities for accidental or consequential loss or damage.
6. Shine-Mart Ltd are not liable to carry out any type of servicing work,
under the guarantee
7. Valid in the UK only
This product is tted with CE:1363 plug and fuse
Imported by Shine-Mart Ltd, RM3 8SB
Information on waste Disposal for Consumers of
Electrical & Electronic Equipment.
This mark on a product and/or accompanying documents indicates that when it
is to be disposed of, it must be treated as Waste
Electrical & Electronic Equipment, (WEEE).
Any WEEE marked products must not be mixed with general household waste,
but kept separate for the treatment, recovery and recycling of the materials used.
For proper treatment, recovery and recycling; please take all WEEE marked
waste to your Local Authority Civic waste site,
where it will be accepted free of charge.
If customers dispose of Waste Electrical & Electronic Equipment correctly, they
will be helping to save valuable resources and preventing any potential negative
effects upon human health and the environment, of any hazardous materials that
the waste may contain.

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Manuel d’utilisation en français

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Avertissements
•
Merci pour votre achat de l’Oxymètre de Pouls (ou Saturomètre) OX01R.
Ce manuel est écrit et compilé en accord avec la directive du Conseil MDD
93/42/EEC pour les équipements médicaux et les normes harmonisées.
Dans le cas de modifications ou mises-à-jour du software, les informations
contenues dans ce document sont susceptibles de changer sans
notifications.
Veuillez lire ce manuel attentivement avant d’utiliser le produit et gardez-le
pour référence future.
Informations de sécurité
Danger d’explosion --- N’utilisez PAS l’oxymètre dans un environnement
contenant des gaz inflammables, par exemple des mixtures anesthésiques
avec de l’air/oxygène ou des endroits où il y a du protoxyde d’azote. Ceux-ci
sont hautement inflammables.
• N’utilisez PAS l’oxymètre lorsque l’utilisateur est en train de passer une
IRM ou une TDM.
•
Instructions pour une utilisation sûre
Contrôlez l’unité principale et les accessoires de façon périodique afin de
vous assurer qu’il n’y ait pas de dommages visibles qui pourraient affecter la
sécurité du patient. Si vous l’utilisez régulièrement, il est recommandé
d’inspecter l’appareil au moins une fois par semaine. Lorsqu’il y a des
dommages apparents, arrêtez d’utiliser le moniteur.
• N’essayez pas de réparer ou de désassembler le saturomètre vous-même.
Si l’appareil requiert des réparations, Veuillez contacter l’Equipe de Service
Client de Duronic.
• L’oxymètre ne peut pas être utilisé avec des appareils non spécifiés dans ce
manuel. Les seuls accessoires (s’il y en a) pouvant être utilisés avec ce
moniteur sont ceux recommandés par le fabriquant.
• L’oxymètre est calibré avant de quitter l’usine.

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• Cet appareil n’est pas approprié pour les personnes souffrant d’allergies au
caoutchouc.
• Vous pourriez ressentir une gêne ou de la douleur si vous utilisez l’appareil
continuellement. Il est recommandé de ne pas poser le capteur sur le même
doigt pour plus de 2 heures.
• La lumière infrarouge émise par l’appareil est néfaste pour les yeux, donc
l’utilisateur ou toute personne utilisant l’appareil ne devrait pas regarder la
lumière.
Attention
• Avant l’utilisation, veuillez vous assurer que ce paquet contient l’appareil et
les accessoires tels qu’ils sont référencés dans la liste de la section 4. S’il
manque quelque chose, veuillez contacter Duronic directement.
• Gardez l’oxymètre à distance de la poussière, des vibrations, des
substances corrosives, des matériaux explosifs, des températures élevées et
de l’humidité.
• Le vernis à ongle, les ongles en acrylique ou toutes autres applications sur
les ongles peuvent fausser et/ou produire des lectures inexactes. Veuillez les
enlever avant l’utilisation.
• Cet appareil n’est pas conçu pour soigner.
• Si l’oxymètre est mouillé, arrêtez son utilisation immédiatement.
• Lorsqu’il est transporté d’un endroit froid à un environnement chaud ou
humide, veuillez ne pas l’utiliser directement.
• Ne l’exposez pas à des fortes températures et ne le nettoyez pas avec de la
vapeur car cela pourrait endommager l’oxymètre. Veuillez lire les instructions
de nettoyage et désinfection contenues dans ce manuel afin de le nettoyer
sûrement et effectivement.
• Ne submergez pas l’oxymètre sous l’eau ou tout autre liquide. Lorsqu’il
nécessite d’être nettoyé, veuillez essuyer ca surface avec de l’alcool médical
et un tissu doux. Ne pulvérisez pas de liquide directement sur l’appareil.
• N’utilisez pas cet appareil sur des enfants en bas âge ou des nouveau-nés.