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 tempera-
ture, 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 35 pulse oximeter, 2x 1.5 V LR03 AAA batteries, 1x Lanyard, 1x Belt bag, 1x these
instructions for use
2. Intended use
Only use the Beurer PO 35 pulse oximeter on humans to measure the arterial oxygen saturation
(SpO₂) of haemoglobin and the heart rate (pulse rate). 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 device
The Beurer PO 35 pulse oximeter provides a non-invasive measurement of the arterial oxygen
saturation (SpO
2
) and the heart rate (pulse rate). 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.
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 (Hb)
and Oxyhemoglobin (O
2
) 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 finger-type sensor. Then measured signal can be ob-
tained by a photosensitive element, information acquired through which will be shown on screen
through treatment in electronic circuits and microprocessor.
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 outbreaks 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).
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
Manufacturer
IMPORTANT
Safety note regarding potential
for damage to the device/ac-
cessories
Storage
Permissible storage temperature
and humidity
Note
Note on important information
Operating
Permissible operating temperature
and humidity
Permissible ambient pressure
Application part, type BF
Observe the instructions for
use
Serial number
%SpO₂
Arterial oxygen saturation of
haemoglobin (in percent)
The CE labelling certifies that the
product complies with the es-
sential requirements of Directive
93/42/EEC on medical products.
PR bpm
Pulse rate (beats per minute)
Disposal in accordance with EC
Directive WEEE (Waste Electri-
cal and Electronic Equipment)
Alarm suppression
Do not dispose of batteries
containing hazardous sub-
stances with household waste.
IP 22
Device protected against foreign
objects ≥ 12.5 mm and against
falling drops of water
21
PAP
Dispose of packaging in an
environmentally friendly manner
European Authorized
Representative
+
Positive battery contact
-
Negative battery contact
Stand-by
Manufacture Date
5. Warnings and safety notes
Read these instructions for use carefully. 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 deliv-
ery.
•
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 function-
ality 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.
− 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 > 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 approx. 2 hours on one finger.
•
The pulse oximeter displays a current measurement but cannot be used for continuous
monitoring.
•
The pulse oximeter does not have an alarm function and is therefore not suitable for evaluat-
ing 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 invis-
ible 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.
•
Neither of 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 diagnos-
tics 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.
•
Keep your hand, finger and body steady during the measurement.
•
For people with cardiac arrhythmia, the measurement values of SpO₂ and the heart rate may
be incorrect or the measurement may not be possible at all.
•
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.
• Protect the pulse oximeter from dust, shocks, moisture, extreme temperatures and explosive
materials.
Notes on handling batteries
•
If your skin or eyes come into contact with battery fluid, flush out the affected areas with
water and seek medical assistance.
•
Choking hazard!
Small children may swallow and choke on batteries. Store the batteries
out of the reach of small children.
•
Observe the plus (+) and minus (-) polarity signs.
•
If a battery has leaked, put on protective gloves and clean the battery compartment with a dry
cloth.
•
Protect the batteries from excessive heat.
•
Risk of explosion!
Never throw batteries into a fire.
•
Do not charge or short-circuit batteries.
•
If the device is not to be used for a long period, take the batteries out of the battery compart-
ment.
•
Use identical or equivalent battery types only.
•
Always replace all batteries at the same time.
•
Do not use rechargeable batteries.
•
Do not disassemble, split or crush the batteries.
6. Unit description
Display description
1
2
3
4
5
98
65
%SpO
2
PRbpm
1. Oxygen saturation (value in percent)
2. Pulse rate (value in beats per minute)
3. Pulse wave (plethysmographic wave)
4. Pulse bar
5. Battery level indicator
7. Initial use
7.1 Inserting the batteries
1
. Slide the battery compart-
ment lid open.
2
. Place the two batter-
ies supplied in the pulse
oximeter as shown. Ensure
that the correct battery
polarity is observed.
3
. Close the battery compart-
ment lid again.
7.2 Attaching the lanyard
To transport the pulse oximeter more easily you can attach a lanyard to the device.
1
. Insert the narrow end of the lanyard
through the holder as shown.
2
. Draw the other end of the lanyard through
the loop at the narrow end and tighten.
8. Operation
98
65
%SpO
2
PRbpm
1
. Insert one finger into the
finger opening of the pulse
oximeter as shown and
hold it steady.
2. Press the function button.
The pulse oximeter begins
its measurement. Do not
move during the measure-
ment.
3. Your measurement values
will appear on the screen
after a few seconds.
Note
When you remove your finger from the pulse oximeter, the device will automatically switch off
after approx. five seconds.
Function button
The function button on the pulse oximeter has two functions in total:
•
Switch-on function
: When the pulse oximeter is switched off you can hold down the func-
tion button briefly to switch it on.
•
Brightness function:
To select your desired display brightness, hold down the function but-
ton for slightly longer during operation.
Note:
The display orients automatically (vertical format, horizontal format). This ensures that the val-
ues are easy to read on the display at all times, regardless of how you hold the pulse oximeter.
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, 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.
SpO₂ measurement
(oxygen saturation) in %
Classification/measures to be taken
99-94
Normal range
93-90
Decreased range: visit to the doctor recommended
< 90
Critical range: Seek medical attention urgently
Source: Adapted to “Windisch W et al. Guidelines for Non-Invasive and Invasive Home Mechanical Ventila-
tion for Treatment of Chronic Respiratory Failure Update 2017; Pneumologie 2017; 71: 722795”
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 people 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.
Altitude
Expected SpO₂ value
(oxygen saturation) in %
Impact on human body
1500-2500 m
> 90
No altitude sickness (normally)
2500-3500 m
~ 90
Altitude sickness, acclimatisation recom-
mended
3500-5800 m
< 90
Very frequent altitude sickness, acclimati-
sation absolutely essential
5800-7500 m
< 80
Severe hypoxia, only limited length of 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.
10. Maintenance/cleaning
IMPORTANT:
D
o not use high-pressure sterilisation on the pulse oximeter!
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 batter-
ies from the device to avoid possible leaking.
11. Storage
IMPORTANT:
Store the pulse oximeter in a dry place (relative humidity ≤ 95 %). 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 -40 °C and 60 °C.
12. Disposal
For environmental reasons, do not dispose of the device in the household waste at the
end of its useful life. Dispose of the unit at a suitable local collection or recycling point.
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 responsi-
ble for waste disposal.
The empty, completely flat batteries must be disposed of through specially designated collec-
tion boxes, recycling points or electronics retailers. You are legally required to dispose of the
batteries.
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
Possible cause
Solution
The pulse oximeter
is not displaying
measurement
values.
The batteries in the pulse
oximeter are empty.
Replace the batteries.
Batteries not inserted
correctly.
Reinsert the batteries. If after reinserting
the batteries correctly there are still no
measurement values displayed, contact
customer services.
The pulse oximeter
is displaying
measurement
interruptions or
high measurement
value jumps.
Insufficient circulation in
the measurement finger.
Observe the warnings and safety notes
in chapter 5.
Measurement finger is too
large or too small.
Fingertip must have the following meas-
urements: Width between 10 and 22 mm
Thickness between 5 and 15 mm
Finger, hand or body is
moving.
Keep your finger, hand and body still
during the measurement.
Cardiac arrhythmia
Seek medical attention.
14. Technical Data
Model
PO 35
Type
CMS50D
Measurement method
Non-invasive measurement of arterial oxygen saturation of haemo-
globin and pulse rate in finger
Measurement range
SpO₂ 0 – 100 %,
Pulse
30 – 250
beats /minute
Accuracy
SpO₂ 70 – 100 %, ± 2 %,
Pulse 30 – 250 bpm, ± 2 beats /minute
Dimensions
L 59,3 mm x W 34 mm x H 34 mm
Weight
Approx. 54,5 g (including batteries)
Sensor to measure SpO₂
Red light (wave length 660 nm);
infra-red (wave length 880 nm);
silicon receiver diode
Permissible operating cond10 °C to +40 °C,
<
75 % relative humidity,
700 –1060 hPa ambient pressure
Permissible storage conditions
-40 °C to +60 °C, ≤
95 % relative humidity,
500 –1060 hPa ambient pressure
Power supply
2 x 1.5 V
AAA batteries
Battery life
2 AAA batteries last for approx. 2 years of operation at 3 measure-
ments per day (each of 60 seconds).
Classification
IP22, application part type BF
Display
TFT
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 ac-
cordance 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 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 the EU Directive 93/42/EEC concerning medical devices, the
Medizinproduktegesetz (German Medical Devices Act) and the DIN EN ISO 80601-2-61
standard (Medical electrical equipment – Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use)
Notes on electromagnetic compatibility
•
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. If, however, it is necessary to use the 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 in-
cluded 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
Beurer GmbH, Söflinger Straße 218, 89077 Ulm, Germany (hereinafter referred to as “Beurer”)
provides a warranty for this product, subject to the requirements below and to the extent
described as follows.
The warranty conditions below shall not affect the seller’s statutory warranty obligations
which ensue from the sales agreement with the buyer.
The warranty shall apply without prejudice to any mandatory statutory provisions on
liability.
Beurer guarantees the perfect functionality and completeness of this product.
The worldwide warranty period is 5 years, commencing from the purchase of the new, unused
product from the seller.
The warranty only applies to products purchased by the buyer as a consumer and used exclu-
sively for personal purposes in the context of domestic use.
German law shall apply.
During the warranty period, should this product prove to be incomplete or defective in function-
ality in accordance with the following provisions, Beurer shall carry out a repair or a replace-
ment delivery free of charge, in accordance with these warranty conditions.
If the buyer wishes to make a warranty claim, they should approach their local retailer in
the first instance: see the attached “International Service” list of service addresses.
The buyer will then receive further information about the processing of the warranty claim, e.g.
where they can send the product and what documentation is required.
A warranty claim shall only be considered if the buyer can provide Beurer, or an authorised
Beurer partner, with
- a copy of the invoice/purchase receipt, and
- the original product.
The following are explicitly excluded from this warranty:
- deterioration due to normal use or consumption of the product;
- accessories supplied with this product which are worn out or used up through proper use
(e.g. batteries, rechargeable batteries, cuffs, seals, electrodes, light sources, attachments and
nebuliser accessories);
- products that are used, cleaned, stored or maintained improperly and/or contrary to the
provisions of the instructions for use, as well as products that have been opened, repaired or
modified by the buyer or by a service centre not authorised by Beurer;
- damage that arises during transport between manufacturer and customer, or between service
centre and customer;
- products purchased as seconds or as used goods;
- consequential damage arising from a fault in this product (however, in this case, claims may
exist arising from product liability or other compulsory statutory liability provisions).
Repairs or an exchange in full do not extend the warranty period under any circumstances.
Subject to errors and changes
Function button
Lanyard
holder
Finger opening
454.31_PO35_2020-02-26_02_IM1a_BEU_DE-EN
ENGLISH
Distributed by: Beurer GmbH, Söflinger Str. 218, 89077 Ulm, Germany
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, 20537 Hamburg, Germany
Contec Medical Systems Co., Ltd.
112 Qinhuang West Str. E&T Development Zone, Qinhuangdao, Hebei, PRC
Pulse oximeter
PO 35