bei, dass tragbare und mobile HF-Kommunikationseinrichtungen dieses Gerät beeinflussen kön-
nen. Genauere Angaben können Sie unter der angegebenen Kundenservice-Adresse anfordern.
• Wir bestätigen hiermit, dass dieses Produkt der europäischen RED Richtlinie
2014/53/EU entspricht. Die CE-Konformitätserklärung zu diesem Produkt finden
Sie unter: www.beurer.com/web/we-landingpages/de/cedeclarationofconformity.
Hinweise zu elektromagnetischer Verträglichkeit
• Das Gerät ist für den Betrieb in allen Umgebungen geeignet, die in dieser Gebrauchsanweisung
aufgeführt sind, einschließlich der häuslichen Umgebung.
• Das Gerät kann in der Gegenwart von elektromagnetischen Störgrößen unter Umständen nur in
eingeschränktem Maße nutzbar sein. Infolgedessen können z.B. Fehlermeldungen oder ein Ausfall
des Displays/Gerätes auftreten.
• Die Verwendung dieses Gerätes unmittelbar neben anderen Geräten oder mit anderen Geräten in
gestapelter Form sollte vermieden werden, da dies eine fehlerhafte Betriebsweise zur Folge haben
könnte. Wenn eine Verwendung in der vorgeschriebenen Art dennoch notwendig ist, sollten dieses
Gerät und die anderen Geräte beobachtet werden, um sich davon zu überzeugen, dass sie ord-
• Die Verwendung von anderem Zubehör, als jenem, welches der Hersteller dieses Gerätes festgelegt
oder bereitgestellt hat, kann erhöhte elektromagnetische Störaussendungen oder eine geminderte
elektromagnetische Störfestigkeit des Gerätes zur Folge haben und zu einer fehlerhaften Betriebs-
• Halten Sie tragbare RF-Kommunikationsgeräte (einschließlich Peripherie wie Antennenkabel oder
externe Antennen) mindestens 30cm fern von allen Geräteteilen, inklusive allen im Lieferumfang
• Eine Nichtbeachtung kann zu einer Minderung der Leistungsmerkmale des Gerätes führen.
Nähere Informationen zur Garantie und den Garantiebedingungen finden Sie im mitgelieferten Garantie-
Hinweis zur Meldung von Vorfällen
Für Anwender / Patienten in der Europäischen Union und identischen Regulierungssystemen (Verord-
nung für Medizinprodukte MDR (EU) 2017/745) gilt: Sollte sich während oder aufgrund der Anwendung
des Produktes ein schwerer Zwischenfall ereignen, melden Sie dies dem Hersteller und/oder seinem
Bevollmächtigten sowie der jeweiligen nationalen Behörde des Mitgliedsstaates, in welchem sich der
Anwender/Patient befindet.
Irrtum und Änderungen vorbehalten
600.95_PO13Kids_2024-02-07_01_IM_BEU_MDR_DE_EN
Check that the exterior of the cardboard delivery packaging is intact and make sure that all contents are
included in the delivery. Before use, ensure that there is no visible damage to the device or accessories
and that all packaging material has been removed. If you have any doubts, do not use the device and
contact your retailer or the specified Customer Services address.
Pulse oximeter, 2 x 1.5 V AAA batteries, lanyard, belt bag, screwdriver, instructions for use
The following symbols are used on the device, in these instructions for use, on the packaging and on
the type plate for the device:
Indicates a potentially impending danger. If it is not avoided, there is a risk of death or serious
Indicates a potentially impending danger. If it is not avoided, slight or minor injuries may result.
Indicates a potentially harmful situation. If it is not avoided, the device or something in its vicinity
Note on important information
Read the instructions before starting
work and/or operating devices or
The electronic device must not be
disposed of with household waste
Do not dispose of batteries
containing harmful substances
Manufacturer Date of manufacture
This product satisfies the
requirements of the applicable
European and national directives.
Separate the packaging elements
and dispose of them in accordance
Marking to identify the packaging
A = material abbreviation,
B = material number: 1–7 = plastics,
20–22 = paper and cardboard
Separate the product and packaging
elements and dispose of them in
accordance with local regulations.
Device protected against foreign
objects ≥12.5 mm and against water
Serial number Medical device
Temperature limit Humidity limitation
PR bpm Pulse rate (beats per minute) %SpO2
Arterial oxygen saturation of
Alarm suppression Type number
Batch designation Importer
United Kingdom Conformity
Unique device identifier (UDI)
Identifier for unique product
The pulse oximeter is used for the non-invasive measurement of arterial oxygen saturation (SpO
heart rate (pulse rate) at home and in hospitals (not in AP and APG-class rooms). This device is not
suitable for long-term measurement.
The pulse oximeter is suitable for people aged one and over, with and without pre-existing conditions,
who require their arterial oxygen saturation (SpO
) and heart rate (pulse rate) to be measured. It is
designed for children weighing between 10 and 40 kg, whose fingertips are 7–11 mm wide and at least
30 mm long, and who have no contraindications. Persons under 12 years of age must be supervised
The minimum age for using the device depends on the child’s weight and finger size. For this reason, the
point at which the device can start to be used may vary (it may be reached earlier or later).
The pulse oximeter is particularly suitable for at-risk patients and children with cardiovascular diseases,
respiratory diseases or sleep apnoea. The pulse oximeter is also suitable for children who show
symptoms of decreased oxygen saturation (e.g. shortness of breath, increased heart rate, weakness,
nervousness or outbreaks of sweating).
The pulse oximeter oers the possibility of quickly and easily determining the oxygen saturation value
as well as straightforwardly identifying a reduced oxygen saturation value.
Do NOT use the pulse oximeter
- if you are allergic to rubber products.
- if the device or the finger you are using is damp.
- on fingers with anatomical changes, oedemas, scars or burns.
- on large fingers that do not fit into the device easily (fingertip: width approx. >11 mm).
- on fingers that are too slim or short (width approx. <7 mm, length approx. <30 mm).
- on patients who are not steady at the site of application (e.g. trembling).
• Finger injuries such as chemical or thermal burns, skin tanning, pressure erosion, sensory loss,
• Causes of these complications may include: pressure ischaemia, prolonged use, probe overheating,
probe misuse, short circuit
• Possible measurement deviations if the finger is damaged. In this case, the SpO
Read these instructions for use carefully. Follow the warnings and safety notes.
Keep these instructions for use for future reference. Make the instructions for
use accessible to other users. If the device is passed on, provide the instructions
for use to the next user as well.
measurement in critically ill patients: inherent potential error of 3–4% in
measurements performed on these patients.
WARNINGS AND SAFETY NOTES
Read these instructions for use carefully! Failure to observe the following information may result in
personal injury or material damage.
• Check to ensure that the package contains all the parts that should be included in delivery.
• Check the pulse oximeter regularly before use to ensure that there is no visible damage to the
device. If you have any doubts, do not use the device and contact Beurer Customer Services or an
• Do not use any additional parts that are not recommended by the manufacturer or oered as
• Under no circumstances should you open or repair the device yourself, as faultless functionality
could no longer be guaranteed thereafter. Failure to comply with this instruction will void the
guarantee. For repairs, please contact Beurer Customer Services or an authorised retailer.
• If the battery indicator on the display shows a low battery level, the batteries must be replaced.
• Using the pulse oximeter for long periods may cause pain for people with circulatory disorders.
Therefore, do not use the pulse oximeter for longer than 2 hours on one finger.
• The pulse oximeter displays an instantaneous measurement but cannot be used for continuous
monitoring. The device is calibrated to indicate functional oxygen saturation.
• The pulse oximeter does not have an alarm function and is therefore not suitable for evaluating
• Do not self-diagnose or self-medicate on the basis of the measurements without consulting your
doctor. In particular, do not start taking any new medication or change the type and/or dosage of
any existing medication without prior approval.
• If oxygen saturation is known to be chronically diminished, it requires monitoring using the
pulse oximeter under medical supervision. An acutely low oxygen saturation (with or without
accompanying symptoms) must be clarified immediately by a doctor. This can be a life-threatening
• Do not look directly inside the housing during the measurement. The red light and the invisible
infrared light in the pulse oximeter are harmful to your eyes.
• This device is not intended for use by people (including children) with restricted physical, sensory
or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a
person who has responsibility for their safety or they receive instructions from this person on how
to use the device. Supervise children around the device to ensure they do not play with it.
• Keep packaging material away from children (risk of suocation).
• The displays for the pulse wave and pulse bar do not allow the strength of the pulse or circulation
to be evaluated at the measurement site. Rather, they are exclusively used to display the current
visual signal variation at the measurement site and do not enable reliable diagnostics for the pulse.
• Measurement deviations may occur if the skin is strongly pigmented.
• Do NOT use the pulse oximeter
- during an MRI or CT scan.
- whilst transporting a patient other than within a medical establishment.
- on a finger or arm that is being subjected to pressure (e.g. blood pressure measurement using
- on fingers that have nail varnish on, are dirty or have a plaster or other dressing on them.
- near flammable or explosive gas mixtures.
- in hospitals in AP and APG-class rooms.
Non-observance of the following instructions can lead to incorrect or failed measurements.
• There must not be any nail varnish, artificial nails or other cosmetics on the finger to be measured.
• Ensure that the finger nail on the finger to be measured is short enough that the fingertip covers the
sensor elements in the housing.
• Keep your hand, finger and body still during the measurement.
• For people with cardiac arrhythmia, the measurement values of SpO and the heart rate may be
incorrect or the measurement may not be possible at all.
• If an electronic surgical device or defibrillator is used, the functioning of the pulse oximeter may
• In the case of carbon monoxide poisoning, the pulse oximeter displays a measurement value that
• To avoid incorrect measurements, there should not be any strong light sources (e.g. fluorescent
lamps or direct sunlight) in the immediate vicinity of the pulse oximeter.
• People with low blood pressure, who suer from jaundice or take medication for vascular
contraction, may experience faulty or incorrect measurements.
• Incorrect measurements are likely for patients who have been administered medical dye in the
past or for those who have abnormal haemoglobin levels. This applies in particular in cases of
carbon monoxide poisoning and methaemoglobin poisoning, which can occur, for example, from
the administration of local anaesthetics or from an existing methaemoglobin reductase deficiency.
• The measurement may fail in patients with an arterial catheter, hypotension, severe vascular
constriction, anaemia or hypothermia.
• Use the device under the respective permissible operating and storage conditions.
• Protect the pulse oximeter from dust, shocks, moisture, extreme temperatures and explosive
• Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio
systems or mobile telephones.
• Ensure the device is at room temperature before taking a measurement. If the device has been
stored close to the maximum or minimum storage and transport temperatures and is then moved
into an environment with a temperature of 20°C, it is recommended that you wait approx. 4 hours
• The data averaging and signal processing cause a delay in updating the SpO
update period is less than 30 seconds, the time to obtain the dynamic average values will be
extended due to signal degradation, low perfusion or other faults.
• Functional testers can be used to check if the device is functioning normally, e.g. the Fluke INDEX-
2LFE Simulator or Fluke Index ProSim 8 Simulator. Please refer to the manual for detailed operating
• Functional testers cannot be used to assess the accuracy of a pulse oximeter.
Notes on handling batteries
• Always insert the batteries correctly, taking into account the polarity (+ / -). Keep batteries clean
and dry and away from water. Always select the correct battery type.
• Never short-circuit batteries and battery compartment contacts.
• Never charge, forcibly discharge, heat, disassemble, deform, encapsulate or modify batteries.
• Never weld or solder on batteries.
• Never mix batteries of dierent manufacturers, capacities (new and used), size and type within a
• Risk of explosion! Failure to comply with the points mentioned above can result in personal injury,
overheating, leakage, venting, breakage, explosion or fire.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• If your skin or eyes come into contact with battery fluid, rinse the aected areas with water and
• Choking hazard! Keep batteries out of the reach of children. Seek medical attention immediately if
swallowed. Swallowing them may cause severe internal burns and death.
• Never allow children to replace batteries without adult supervision.
• Store batteries away from metal objects in a well-ventilated, dry and cool place.
• Never expose batteries to direct sunlight or rain.
• Exposure of batteries to an environment with extremely high temperatures or an extremely low air
pressure may result in explosion or leakage of flammable liquids and gases.
• Remove batteries from the device if it is not going to be used for a long period of time. Do not use
the product if the battery compartment lid no longer closes properly.
• Dispose of discharged batteries immediately and properly. Never dispose of batteries in fire or hot
• When disposing of batteries, keep batteries with dierent electrochemical systems separate.
The function button on the pulse oximeter has the following functions:
• Switch-on function: to switch on the pulse oximeter, press the function button.
• Brightness function: to adjust the display brightness, press and hold the function button during
operation. There are five dierent brightness levels to choose from.
The display is oriented automatically (portrait, landscape). This ensures that the values are easy to
read on the display at all times, regardless of how you hold the pulse oximeter.
The following table for evaluating your measurements does NOT apply to people with certain pre-
existing conditions (e.g. asthma, cardiac insuciency, respiratory diseases) or whilst staying at
altitudes above 1500 metres. If you have a pre-existing condition, always consult your doctor to
evaluate your measurements.
Classification/measures to be taken
93–90 Decreased range: visit to the doctor recommended
<90 Critical range: seek medical attention urgently
Source: following “Windisch W et al. European consensus-based (S2k) Guideline: Non-Invasive and
Invasive Home Mechanical Ventilation for Treatment of Chronic Respiratory Failure, Update 2017;
Pneumologie 2017; 71: 722795”
Decline in oxygen saturation depending on altitude
The following table informs you of the eects of various altitudes on oxygen saturation value
and its impact on the human body. The following table does NOT apply to people with certain
pre-existing conditions (e.g. asthma, cardiac insuciency, respiratory diseases, etc.). People
with pre-existing conditions may already show signs of illness (e.g. hypoxia) at lower altitudes.
Expected SpO2 value (oxygen
1500–2500 m >90 No altitude sickness (normally)
Altitude sickness, acclimatisation
Very frequent altitude sickness,
acclimatisation absolutely essential
Severe hypoxia, individual can only stay at
7500–8850 m <70 Immediate, acute danger to life
Source: Hackett PH, Roach RC: High-Altitude Medicine. In: Auerbach PS (ed): Wilderness Medicine,
3rd edition; Mosby, St.Louis, MO 1995; 1-37.
Do not use high-pressure or ethylene oxide sterilisation on the pulse oximeter! The device is not suitable
for sterilisation. Under no circumstances should you hold the pulse oximeter under water, as this can
cause liquid to enter and damage the pulse oximeter.
• Clean the housing and the interior rubber surface of the pulse oximeter with a soft cloth dampened
with medical alcohol after each use.
• If you are not going to use the pulse oximeter for more than one month, remove both batteries from
the device in order to prevent possible leaking.
Store the pulse oximeter in a dry place. If the humidity is too high it may shorten the service life of the
pulse oximeter or damage it.
For environmental reasons, do not dispose of the device in household waste at the end of
its service life. Dispose of the device at a suitable local collection or recycling point in your
country. Dispose of the device in accordance with EC Directive Waste Electrical and Electronic
Equipment (WEEE). If you have any questions, please contact the local authorities responsible
Batteries must not be disposed of in the household waste. They may contain poisonous heavy metals
and are subject to special refuse treatment.
The codes below are printed on batteries containing harmful substances:
Pb = battery contains lead
Cd = battery contains cadmium
Hg = battery contains mercury
WHAT IF THERE ARE PROBLEMS?
Problem Possible cause Solution
taken has not been inserted
Insert the finger in the pulse oximeter again.
Do the measurement again. If the problem
occurs repeatedly and the device is
functioning properly, seek medical advice
lamp or direct sunlight) in
Remove pulse oximeter from the vicinity of
The batteries in the pulse
Batteries are not inserted
The pulse oximeter is faulty. Contact your retailer or Customer Services.
Insucient circulation in the
Pay attention to the warnings and safety
Fingertip must have the following
measurements: 7–11 mm wide, min. 30mm
Keep your finger, hand and body still during
Cardiac arrhythmia Seek medical attention.
Measurement method Non-invasive measurement of arterial oxygen saturation of
haemoglobin and pulse rate in finger
Measurement range SpO 0–100%,
Pulse 30–250 beats/minute
Accuracy SpO 70–100%, ± 2%, below 70% unspecified
Pulse ≤99 bpm +/- 2 bpm, ≥100 bpm +/- 2%
Dimensions L 59 mm x W 37 mm x H 35 mm
Weight Approx. 27 g (without batteries)
Sensor to measure SpO Red light (wavelength 660 nm), optical output power < 6.65 mW;
infrared (wavelength 905 nm), optical output power < 6.75 mW;
This information can be particularly useful for clinicians
+10°C to +40°C, ≤ 75% relative humidity,
700–1060hPa ambient pressure
-40°C to +60°C, ≤ 95% relative humidity
Battery life 2 AAA batteries last for approx. 2.5 years of operation at
3measurements per day (60 seconds each)
Information on the product’s service life can be found on the website
Classification IP22, applied part, type BF
The serial number is located on the device or in the battery compartment.
Technical specifications are subject to change without notification to allow for updates.
• This device complies with the European standard EN 60601-1-2 (Group 1, Class B, in compliance
with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8) and is subject to special
precautionary measures with regard to electromagnetic compatibility. Please note that portable and
mobile HF communication systems may interfere with this device. For more details, please contact
our Customer Services at the address indicated.
• We hereby confirm that this product complies with the European RED Directive
2014/53/EU. The CE Declaration of Conformity for this product can be found at:
www.beurer.com/web/we-landingpages/de/cedeclarationofconformity.php
Notes on electromagnetic compatibility
• The device is suitable for use in all environments listed in these instructions for use, including
• The device may not be fully usable in the presence of electromagnetic disturbances. This could
result in issues such as error messages or the failure of the display/device.
• Avoid using this device directly next to other devices or stacked on top of other devices, as this
could lead to faulty operation. If, however, it is necessary to use the device in the manner outlined
above, this device as well as the other devices must be monitored to ensure they are working
• The use of accessories other than those specified or provided by the manufacturer of this device
can lead to an increase in electromagnetic emissions or a decrease in the device’s electromagnetic
immunity; this can result in faulty operation.
• Keep portable RF communication devices (including peripheral equipment, such as antenna cables
or external antennas) at least 30cm away from all device parts, including all cables included in
• Failure to comply with the above could impair the performance of the device.
More information on the guarantee and guarantee conditions can be found in the guarantee leaflet
For users/patients in the European Union and identical regulatory systems (EU Medical Device
Regulation (MDR) 2017/745), the following applies: if a major incident occurs during or through use
of the product, notify the manufacturer and/or their representative of this as well as the respective
national authority of the member state in which the user/patient is located.
Subject to errors and changes
UK Importer: Beurer UK Ltd., Suite 16, Stonecross Place, Stonecross Lane North, WA3 2SH
Beurer GmbH • Söflinger Str. 218 • 89077 Ulm, Germany
www.beurer.com • www.beurer-healthguide.com •
www.beurer-gesundheitsratgeber.com
