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Beurer GmbH • Söflinger Straße 218 • 89077 Ulm, Germany
PO 40
www.beurer.com • www.beurer-healthguide.com
Pulse oximeter
Dear customer,
Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure,
body temperature, pulse, gentle therapy, massage, beauty, baby and air. Please read these instructions for use carefully and keep them for later use, be sure to make them
accessible to other users and observe the information they contain.
With kind regards,
Your Beurer team
1. Included in delivery
1x PO 40 pulse oximeter, 2x 1,5 V AAA batteries, 1x lanyard, 1x belt bag, 1x these instructions for use
2. Intended use
Only use the Beurer PO 40 pulse oximeter on humans to measure the arterial oxygen saturation (SpO₂) of haemoglobin, the heart rate (PRbpm) and the perfusion index (PI).
The pulse oximeter is suitable for private use (at home) as well as for use in the medical sector (hospitals, medical establishments).
3. Getting to know your instrument
The Beurer PO 40 pulse oximeter provides a non-invasive measurement of the arterial oxygen saturation (SpO
(PI). Oxygen saturation indicates the percentage of haemoglobin in arterial blood that is loaded with oxygen. Therefore it is an important parameter for assessing the
respiratory function. To take a measurement, the pulse oximeter uses two rays of light with differing wavelengths, which strike the finger inserted inside the housing. A low
oxygen saturation value generally indicates underlying illnesses (respiratory diseases, asthma, heart failure etc.).
People with a low oxygen saturation value are more likely to experience the following symptoms: shortness of breath, increased heart rate, weakness, nervousness and out-
breaks of sweating. If oxygen saturation is known to be chronically diminished, it requires monitoring using the pulse oximeter under medical supervision. If you have acutely
diminished oxygen saturation, with or without the accompanying symptoms, you must consult a doctor immediately as it could lead to a life-threatening situation. The pulse
oximeter is particularly suitable for patients at risk such as people with heart disease or asthma, but also for athletes and healthy people who exercise at high altitude (e.g.
mountaineers, skiers or amateur pilots).
Features of the pulse oximeter
• Easy to use and to take with you (ideal for on the go)
• Compact, lightweight design
• Two-colour OLED display, readings for oxygen saturation (SpO
), pulse rate (PRbpm) and perfusion index (PI) are shown
2
• Adjustable display brightness (1 to 10)
• 7 display formats/low battery indicator/automatic switch-off after 8 seconds if no signal is received
4. Signs and symbols
The following symbols are used in these instructions for use, on the packaging and on the type plate for the device:
WARNING
Warning instruction indicating a risk of injury or damage
to health
IMPORTANT
Safety note regarding potential for damage to the device/
accessories
Note
Note on important information
Observe the instructions for use
%SpO₂
Arterial oxygen saturation of haemoglobin (in percent)
PR bpm
Pulse rate (beats per minute)
Storage
Permissible storage temperature and humidity
Operating
Permissible operating temperature and humidity
5. Warnings and safety notes
Non-observance of the following information may result in personal injury or material damage. Store these instructions for use and make them accessible to other users.
Make sure you include these instructions for use when handing over the device to third parties.
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 sufficiently charged. In case of doubt, 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 offered 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 will result in
voiding of the warranty. For repairs, please contact Beurer customer services or an authorised retailer.
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.
− during an MRI or CT scan.
− while transporting a patient other than within a medical establishment.
− whilst taking a blood pressure measurement on the same arm using a cuff.
− on fingers that have nail varnish on, are dirty or have a plaster or other dressing on them.
− on large fingers that do not fit into the device easily (fingertip: width approx. > 20 mm, thickness approx. >15 mm).
− on fingers with anatomical changes, oedemas, scars or burns.
− on fingers that are too small, as with small children for example (width approx. < 10 mm, thickness < 5 mm).
− on patients who are not steady at the site of application (e.g. trembling).
− near flammable or explosive gas mixtures.
• Using the device for long periods may cause pain for people with circulatory disorders. Therefore do not use the pulse oximeter for longer than 30 minutes on one
finger. This is essential to ensure correct sensor orientation and to safeguard the integrity of the skin.
• The pulse oximeter displays an instantaneous measurement but cannot be used for continuous monitoring.
• 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.
• 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. Children should be
supervised around the device to ensure they do not play with it.
• The displays for the pulse wave and pulse bar allows 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.
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 element in the housing.
• If the person moves while the measurement is being taken. Keep your hand, finger and body steady during the measurement.
• For people with cardiac arrhythmia, the oxygen saturation level (SpO₂) readings and the heart rate (PRbpm) 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 cases of carbon monoxide poisoning, the pulse oximeter displays a measurement value that is too high.
• To avoid falsifying the measuring result, 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 suffer 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.
• Protect the pulse oximeter from dust, shocks, moisture, extreme temperatures and explosive materials.
6. Unit description
Device
Function button
Lanyard holder
Finger opening
Display formats (7 different formats)
7.
Initial use
7.1 Inserting the batteries
1. Slide the battery
compartment lid
open.
7.2 Attaching the lanyard
To transport the pulse oximeter more easily (e.g. whilst on the move) you can attach a lanyard to the device.
1. Insert the narrow end of the
lanyard through the holder as
shown.
8. Operation
1. Insert one finger
into the finger
opening of the
pulse oximeter
as shown and
hold it steady.
Note
?
• If the
, symbol appears on the display this indicates that the measurement signal is unstable, and the readings shown are invalid.
ENGLISH
), the heart rate (pulse rate) (PRbpm) and the perfusion index
2
Manufacturer
Application part, type BF
Do not dispose of batteries containing hazardous substances with
household waste.
The CE labelling certifies that the product complies with the essen-
tial requirements of Directive 93/42/EEC on medical products.
0483
Serial number
Alarm suppression
Device protected against foreign objects ≥ 12.5 mm and against
IP22
falling drops of water
Disposal in accordance with the Waste Electrical and Electronic
Equipment EC Directive – WEEE
Display
1
2
3
5
4
6
2. Insert the two sup-
plied batteries into
the pulse oximeter
battery compart-
ment following the
correct polarity as
shown.
2. Draw the other end of the lanyard through the
loop at the narrow end and tighten.
2. Press the function
button. The pulse
%SpO
PRbpm
98
2
65
oximeter begins
its measurement.
%SpO
PRbpm
98
2
65
Do not move
during the meas-
urement.
• When you remove your finger from the pulse oximeter, the device will automatically switch off after approx. 8 seconds.
• To select your desired display format, hold down the function button briefly during operation.
• To select your desired display brightness, hold down the function button for slightly longer during operation.
9. Evaluating measurement results
WARNING
The following table for evaluating your measurements does NOT apply to
people with certain pre-existing conditions (e.g. asthma, heart failure, res-
piratory diseases) or whilst staying at altitudes above 1500 metres. If you
have a pre-existing condition, always consult your doctor to evaluate your
measurements.
SpO₂ (oxygen saturation)
measurement in %
99-94
93-90
< 90
Evaluating perfusion index
The perfusion index (PI) may lie between 0.3% and 20%, and varies
depending on the patient, measurement location and state of health. A very
low PI value can impair the measurement.
10. Maintenance/cleaning
IMPORTANT:
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 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 to avoid possible leaking.
11. Storage
IMPORTANT:
Store the pulse oximeter in a dry place (relative humidity ≤93 %). If the humidity is too high it may shorten the service life of the pulse oximeter or damage it. Store the pulse
oximeter in a place where the ambient temperature is between -25°C and 70°C.
12. Disposal
Please dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local
authorities responsible for waste disposal.
The empty, completely flat batteries should be disposed of through specially designated collection boxes,
recycling points or electronics retailers. You are legally required to dispose of the batteries.
Note: The codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cadmium,
Hg = Battery contains mercury.
13. What if there are problems?
Problem
"Finger out" appears on the display
Measurement values are not correctly displayed
The pulse oximeter is displaying measurement
interruptions or high measurement value jumps
Problem
Pulse oximeter will not switch on.
Indicator light goes out suddenly
"Error 3" appears on the display
"Error 4" appears on the display
"Error 6" appears on the display
"Error 7" appears on the display
14. Technical data
Model no.
Measurement method
Measurement range
Accuracy
Dimensions
Weight
Sensor to measure SpO₂
Permissible operating conditions
Permissible storage conditions
Power supply
Battery life
Classification
The serial number is located on the device or in the battery compartment.
Technical information is subject to change without notification to allow for updates.
• This device conforms with the European standards EN60601-1 and EN60601-1-2 (In accordance with CISPR, IEC 61000-4-2, IEC 61000-4-3 and IEC 61000-4-8) and is
subject to particular precautions 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.
• This device complies with EU Directive 93/42/EEC concerning medical devices, the Medizinproduktegesetz (German Medical Devices Act) and the DIN EN ISO 80601-2-
1. Oxygen saturation (value in
61 standard (Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use).
percent)
2. Inaccurate measurement
Notes on electromagnetic compatibility
3. Pulse rate (value in beats
per minute)
WARNING
4. Pulse bar
• The device is suitable for use in all environments listed in these instructions for use, including domestic environments.
5. Perfusion index (value in
• 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/
percent)
device.
6. Pulse wave (plethysmo-
• 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
graphic wave)
device in the manner stated, this device as well as the other devices must be monitored to ensure they are working properly.
• The use of accessories other than those specifed 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.
• Failure to comply with the above can impair the performance of the device.
15. Warranty/service
In case of a claim under the warranty please contact your local dealer or the local representation which is mentioned in the list "service international".
In case of returning the unit please add a copy of your receipt and a short report of the defect.
The following warranty terms shall apply:
1. The warranty period for BEURER products is either 5 years or- if longer- the country specifc warranty period from date of Purchase.
In case of a warranty claim, the date of purchase has to be proven by means of the sales receipt or invoice.
2. Repairs (complete unit or parts of the unit) do not extend the warranty period.
3. The warranty shall not be valid for damages because of
3. Close the battery
a. improper treatment, e.g. nonobservance of the user instructions.
compartment
b. repairs or tampering by the customer or unauthorised third parties.
cover again.
c. transport from the manufacturer to the consumer or during transport to the service centre.
d. The warranty shall not be valid for accessories which are subject to normal wear and tear (cuff, batteries etc.).
4. Liability for direct or indirect consequential losses caused by the unit are excluded even if the damage to the unit is accepted as a warranty claim.
3. Your measurement
values will appear on
the screen after a few
seconds.
Decline in oxygen saturation depending on altitude
Note
The following table informs you of the effects of various altitudes on oxygen saturation
value and its impact on the human body. The following table does NOT apply to peo-
ple with certain pre-existing conditions (e.g. asthma, heart failure, respiratory diseases
etc.). People with pre-existing conditions can show signs of illness (e.g. hypoxia) at
lower altitudes.
Classification/measures to be taken
Altitude
Normal range
1500-2500 m
Decreased range:
2500-3500 m
Visit to the doctor recommended
Critical range:
3500-5800 m
Seek medical attention urgently
5800-7500 m
7500-8850 m
Source: Hackett PH, Roach RC: High-Altitude Medicine. In: Auerbach PS
(ed): Wilderness Medicine, 3rd edition; Mosby, St.Louis, MO 1995; 1-37.
Possible cause
The finger on which the measurement is being taken has not
been inserted properly in the pulse oximeter
The measured SpO₂ is too low (<70%)
There is a strong light source (e.g. fluorescent lamp or direct
sunlight) in the vicinity
Insufficient circulation in the measurement finger
Measurement finger is too large or too small
Finger, hand or body is moving
Cardiac arrhythmia
Possible cause
Batteries are flat
The batteries have not been inserted correctly
The pulse oximeter is faulty.
The pulse oximeter switches off automatically after 8 seconds
if it is not receiving a signal
Batteries are flat
The red light receiving LED is faulty
The infrared light receiving LED is faulty
The display is faulty.
The receiving LEDs are faulty
PO 40
Non-invasive measurement of arterial oxygen saturation of haemoglobin, pulse rate and perfusion index in finger.
SpO₂ (oxygen saturation): 70 - 100%, pulse: 30 - 250 beats/minute
PI: 0.3 - 20 %
SpO₂ (oxygen saturation): 70 - 100%, ± 2%, pulse: 30 - 250 bpm, ± 2 beats/minute
PI: 0.3% - 1%; ±0.2 digits; >1.1% ± 20%
L 58.4 mm x W 33.5 mm x H 37 mm
Approx. 57 g (including batteries)
Red light (wave length 660 nm); infra-red (wave length 905 nm); silicon receiver diode
+5 °C to +40 °C, ≤15 - 93 % relative humidity, 86 - 106 kPa ambient pressure
-25 °C to +70 °C, ≤93 % relative humidity, 86 - 106 kPa ambient pressure
2 x 1.5V
AAA batteries
2 AAA alkaline batteries last for approx. 2 years of operation at 1 measurements per day (each of 60 seconds).
IP22, application part, type BF
Expected SpO₂ value (oxy-
Impact on human body
gen saturation) in %
> 90
No altitude sickness (normally)
~90
Altitude sickness, acclimatisa-
tion recommended
<90
Very frequent altitude sickness,
acclimatisation absolutely
essential
<80
Severe hypoxia, only limited
length of stay possible
<70
Immediate, acute danger to life
Solution
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 as a matter of urgency
Remove pulse oximeter from the vicinity of these
light sources
Observe the warnings and safety notes in section 5
Fingertip must have the following measurements:
Width between 10 and 20 mm
Thickness between 5 and 15 mm
Keep your finger, hand and body still during the
measurement.
Seek medical attention
Solution
Replace the batteries
Reinsert the batteries
Contact the retailer or Customer Services
Switch the pulse oximeter on again using the ON/
OFF button.
Replace the batteries
Contact the retailer or Customer Services
Contact the retailer or Customer Services
Contact the retailer or Customer Services
Contact the retailer or Customer Services
Subject to errors and changes
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