Beurer PO 30 Gerätebeschreibung Seite 2

Indication
The pulse oximeter is particularly suitable for at-risk patients and people with
cardiovascular diseases or respiratory diseases. The pulse oximeter is also suitable
for people who show symptoms of decreased oxygen saturation (e.g. shortness
of breath, increased heart rate, weakness, nervousness or outbreaks of sweating).
Clinical benefits
Users can quickly and easily determine their oxygen saturation value through the
device and detect a decreased oxygen saturation value.
Contraindication
 WARNING
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 small children or babies.
- on fingers with anatomical changes, oedemas, scars or burns.
- on large fingers that do not fit into the device easily (fingertip: width approx.
> 20 mm, thickness approx. > 15 mm).
- on fingers that are too small, as with small children for example (width approx.
< 10 mm, thickness approx. < 5 mm).
- on patients who are not steady at the site of application (e.g. trembling).
Undesirable side e ects
• Finger injuries such as chemical or thermal burns, skin tanning, pressure erosion,
sensory loss, gangrene
• 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
value is recorded as too low.
• Low accuracy of SpO measurement in critically ill patients: inherent potential
2
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.
 WARNING
• Check to ensure that the package contains all the parts that should be included
in the delivery.
• Check the pulse oximeter regularly before use to ensure that there is no visible
damage to the device and the batteries are still su ciently charged. If you have
any doubts, do not use the device and contact Beurer Customer Services or an
authorised retailer.
• Do not use any additional parts that are not recommended by the manufacturer
or o ered as equipment.
• 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 warranty. For repairs, please contact
Beurer Customer Services or an authorised retailer.
General warnings
• 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 medical results.
• 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 situation.
• Do not look directly inside the housing during the measurement. The red light
and the invisible infra-red 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 su ocation).
• 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.
easurement deviations may occur if the skin is strongly pigmented.
• M
• Do NOT use the pulse oximeter
- during an MRI or CT scan.
- whilst transporting a patient other than within a medical establishment.
- whilst taking a blood pressure measurement on the same arm using a cu .
- 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.
General precautions
NOTICE
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 fingernail 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 be impaired.
• In the case of carbon monoxide poisoning, the pulse oximeter displays a
measurement value that is too high.
• To avoid falsifying the measurement, 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 su er from jaundice or take medication
for vascular contraction, may experience incorrect or falsified 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 for 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 be falsified 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, and moisture as well as extreme
temperatures and explosive materials.
• 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 before using the device.
• The data averaging and signal processing results in a delay in updating the SpO
values. If the data 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.
Fluke INDEX-2LFE simulator, Fluke Index ProSim 8 simulator. Please refer to the
manual for detailed operating steps.
• Functional testers cannot be used to assess the accuracy of a pulse oximeter.
Notes on handling batteries
 WARNING
• Risk of explosion! Risk of fire! Failure to comply with the following points
can result in personal injury or cause overheating, leakage, venting, breakage,
explosion, or fire on the battery.
• This device contains non-rechargeable batteries which must not be charged.
• Do not throw batteries into a fire.
• Never charge, forcibly discharge, heat, disassemble, open, crush, deform,
encapsulate, or modify batteries.
• Never short-circuit batteries or battery compartment contacts.
• Protect the batteries from direct sunlight, rain, heat, and water.
• 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.
• Dispose of defective and discharged batteries immediately and properly (see
chapter on disposal).
• Do not use modified or damaged batteries.
• Always select the correct battery type.
• Always insert the batteries correctly, taking into account the polarity (+ / -).
• Never mix batteries of di erent manufacturers, capacities (new and used), size,
or type within a device.
• If a battery has leaked, put on protective gloves and clean the battery
compartment with a dry cloth.
• If fluid from a battery comes into contact with your skin or eyes, wash the
a ected areas with water and seek medical assistance.
• Choking hazard! Keep batteries out of the reach of children. Seek medical
attention immediately if swallowed. Swallowing them may cause burns, severe
internal injuries, and death.
• Never allow children to replace batteries without adult supervision.
 CAUTION
• Store batteries in a well-ventilated, dry, and cool place in a non-conductive
container in which the batteries cannot be short-circuited to each other or by
other metal objects.
• Keep batteries clean and dry.
• Keep batteries away from water.
• If the device is not going to be used for a long period of time, remove the
batteries from the battery compartment.
NOTICE
Do not use rechargeable batteries.
USAGE
Function button
The function button on the pulse oximeter has the following functions:
• Switch-on function: to switch on the pulse oximeter, press and hold the function
button.
• Brightness function: to adjust the display brightness, press and hold the function
button during operation.
The display orients automatically (vertical format, horizontal format). This
ensures that the values are easy to read on the display at all times, regardless
of how you hold the pulse oximeter.
EVALUATING MEASUREMENT RESULTS
 CAUTION
The following table for evaluating your measurements does NOT apply to people
with certain pre-existing conditions (e.g. asthma, cardiac insu ciency, respiratory
diseases) or whilst staying at altitudes above 1500 metres. If you have a pre-exist-
ing condition, always consult your doctor to evaluate your measurements.
SpO (oxygen saturation)
Classification/measures to be taken
measurement in %
99–94 Normal range
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 e ects of various altitudes on oxygen
saturation value and its impact on the human body. The following table
2
does NOT apply to people with certain pre-existing conditions (e.g. asthma,
cardiac insu ciency, respiratory diseases, etc.). People with pre-existing
conditions may already show signs of illness (e.g. hypoxia) at lower
altitudes.
Expected SpO value
Altitude (oxygen saturation) Impact on human body
in %
1500–2500 m > 90 No altitude sickness (normally)
Altitude sickness, acclimatisation
2500–3500 m ~ 90
recommended
Very frequent altitude sickness,
3500–5800 m < 90
acclimatisation absolutely essential
Severe hypoxia, only limited length of
5800–7500 m < 80
stay possible
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.
MAINTENANCE/CLEANING
 CAUTION
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 a low battery status appears on the display of the pulse oximeter, change the
batteries.
• 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.
• If a low battery status appears on the display of the pulse oximeter, charge the
batteries.
STORAGE
NOTICE
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.
DISPOSAL
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 for waste disposal.
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
Measurement The measured SpO is too Do the measurement again. If
values are low (< 70%). the problem occurs repeatedly
not correctly and the device is functioning
displayed properly, seek medical advice as
a matter of urgency.
There is a strong light Remove pulse oximeter from the
source (e.g. fluorescent vicinity of these light sources.
lamp or direct sunlight) in
the vicinity.
The batteries in the pulse
Replace the batteries.
The pulse
oximeter are empty.
oximeter does
not display Batteries are not inserted
Reinsert the batteries.
correctly.
any readings
or cannot be
The pulse oximeter is Contact the retailer or Customer
switched on.
faulty. Services.
Insu cient circulation in Pay attention to the warnings
the measurement finger. and safety notes!
The pulse
oximeter is Fingertip must have the following
displaying
measurements: Width between
Measurement finger is too
measurement 10 and 20 mm
large or too small.
interruptions
Thickness between 5 and 15
or high
mm.
measurement
Finger, hand or body is Keep your finger, hand and body
value jumps.
moving. still during the measurement.
Cardiac arrhythmia. Seek medical attention.
TECHNICAL DATA
Model PO 30
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%,
Pulse ≤99 bpm ± 2 bpm, ≥100bpm ± 2%
Dimensions L 61 mm x W 36 mm x H 32 mm
2
Weight Approx. 58 g (including 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;
silicon receiver diode
This information can be particularly useful for clinicians
Permissible operating
+10 to +40, ≤ 75% relative humidity,
conditions
700 – 1060 hPa ambient pressure
Permissible storage -40°C to +60°C, ≤ 95% relative humidity
conditions
Power supply
2 x 1.5 V AAA batteries
Battery life 2 AAA batteries last for approx. 2.5 years of operation at
3 measurements per day (60 seconds each)
Expected service life of Information on the service life of the product can be
the device found on the homepage
Classification IP22, application part, type BF
Display TFT
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 conforms to the European standard EN 60601-1-2 (Group 1, Class
B, in accordance with CISPR 11, IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-8)
and is subject to particular precautions with regard to electromagnetic compa-
tibility. Please note that portable and mobile HF communication systems may
interfere with this device. For more details, please contact our Customer Servi-
ces 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:
https://www.beurer.com/conformity
Notification of incidents
For users/patients in the European Union and identical regulation systems, 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.
Notes on electromagnetic compatibility
NOTICE
• The device is suitable for use in all environments listed in these instructions for
use, including domestic environments.
• The use of the device may be limited 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. However, if it is necessary to use
the device in such a manner, this device as well as the other devices must be
monitored to ensure they are working properly.
• 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 30 cm away from all device
parts, including all cables included in delivery.
• Failure to comply with the above can impair the performance of the device.
WARRANTY/SERVICE
Further information on the warranty and warranty conditions can be found in the
warranty leaflet supplied.
Subject to errors and changes
Beurer GmbH • Söflinger Str. 218 • 89077 Ulm • Germany
www.beurer.com • www.beurer-healthguide.com
www.beurer-gesundheitsratgeber.com