Beurer PO 60 Gebrauchsanweisung Seite 2

PO 60
Pulse oximeter
Please read these instructions for use carefully and keep them
for later use, make them accessible to other users, and observe
the information they contain.
Dear customer,
Thank you for choosing a product from our range. Our name is synonymous with 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.
With kind regards,
Your Beurer team
1. Included in delivery
Check that the exterior of the cardboard delivery packaging is intact and make sure that all contents
are present. 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 specied Customer Services address.
1x PO 60 pulse oximeter, 2x 1.5 V AAA batteries, 1x lanyard, 1x belt bag, 1x these instructions for use
2. Signs and symbols
The following symbols are used on the device, in these instructions for use, on the packaging and on the
device's type plate:
WARNING Disposal in accordance with the Waste
Warning notice indicating a risk of Electrical and Electronic Equipment EC
injury or damage to health Directive – WEEE
IMPORTANT Do not dispose of batteries containing
Safety note indicating possible harmful substances with household
damage to the device/accessory waste
Note
Manufacturer
Note on important information
Observe the instructions for use Application part, type BF
Arterial oxygen saturation of
%SpO₂ Serial number
haemoglobin (in percent)
This product satises the requirements
PR bpm Pulse rate (beats per minute) of the applicable European and national
directives.
0483
Storage/Transport
Permissible storage temperature
Alarm suppression
and humidity
Device protected against foreign
Operating
Permissible operating temperature
IP 22 objects ≥ 12.5 mm and against water
and humidity
dripping at an angle
Dispose of packaging in an
21
Medical device
environmentally friendly manner
PAP
Unique device identier (UDI)
UDI
Identier for unique product Batch designation
identication
Item number
3. Intended use
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 diering wavelengths, which strike the nger inserted inside the
housing.
Purpose
The pulse oximeter is used for the non-invasive measurement of arterial oxygen saturation (SpO
rate (pulse rate) at home and in hospitals. This unit is not suitable for long-term measurement.
Target group
The pulse oximeter is suitable for people who have a need for its diagnostic function. It is designed for those
users with a ngertip width of approx. 10–20 mm and a thickness of approx. 5–15 mm and who have no
contraindications.
Indication
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). The pulse oximeter is also suitable for people without pre-existing conditions who want to measure
their oxygen saturation or who show symptoms of low oxygen saturation.
Clinical benets
Users can quickly and easily determine their oxygen saturation value through the device and detect a
decreased oxygen saturation value. People with a low oxygen saturation value frequently 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. An acutely low oxygen saturation (with or without accompanying
symptoms) must be claried immediately by a doctor. This can be a life-threatening situation.
4. Warnings and safety notes
Read these instructions for use carefully! Failure to observe the following information may result in personal
injury or material damage.
Contraindication:
Do NOT use the pulse oximeter
• if you are allergic to rubber products,
• if the device or the nger 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 cu,
• on ngers with nail varnish or which are dirty or have a plaster or other dressing on them,
• large ngers that do not t into the device easily (ngertip: width approx. > 20 mm,
thickness approx. > 15 mm),
• ngers that are too small, as with small children for example (width approx. < 10 mm,
thickness approx. < 5 mm),
• ngers with anatomical changes, oedemas, scars, or burns,
• on patients who cannot keep still at the site of application (e.g. trembling).
General warnings
• 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 because perfect function can 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.
• 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 approx. 2 hours on one nger.
• 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 can be used by children over the age of 8 and by people with reduced physical, sensory
or mental skills or a lack of experience or knowledge, provided that they are supervised or have been
instructed on how to use the device safely and are aware of the consequent risks of use.
• Children must not play with the device.
• 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.
• Do NOT use the pulse oximeter in close proximity to ammable or explosive gas mixtures.
General precautions
Non-observance of the following instructions can lead to incorrect or failed measurements.
• There must not be any nail varnish, articial nails, or other cosmetics on the nger to be measured.
• Ensure that the nger nail on the nger to be measured is short enough that the ngertip covers the sensor
elements in the housing.
• Keep your hand, nger, and body still 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 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. uorescent 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 falsied 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 deciency.
• Protect the pulse oximeter from dust, shocks, and moisture as well as extreme temperatures and explosive
materials.
Measures for handling batteries
• If your skin or eyes come into contact with battery uid, rinse the aected areas with water and
seek medical assistance.
• Choking hazard! Small children can swallow and choke on batteries. Therefore, batteries should
be stored out of the reach of small children.
• Risk of explosion! Do not throw batteries into a re.
• If a battery has leaked, put on protective gloves, and clean the battery compartment with a dry
cloth.
• Do not disassemble, open or crush the batteries.
• Observe the plus (+) and minus (-) polarity signs.
• Protect the batteries from excessive heat.
• Do not charge or short-circuit batteries.
• If the device is not to be used for a relatively long period, take the batteries out of the battery
compartment.
• Use identical or equivalent battery types only.
• Always replace all batteries at the same time.
• Do not use rechargeable batteries!
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.
Beurer GmbH • Söinger Straße 218 • 89077 Ulm, Germany
www.beurer.com • www.beurer-gesundheitsratgeber.com
www.beurer-healthguide.com
ENGLISH
• The use of accessories other than those specied 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.
• Failure to comply with the above can impair the performance of the device.
5. Device description
Function button
Finger opening
Lanyard holder
Display description
1 2
1. Oxygen saturation (value in percent)
2. Pulse rate (value in beats per minute)
3. Pulse wave (plethysmographic wave)
5 %SpO PRbpm
2
4. Pulse bar
98
65
5. Battery indicator
4
3
6. Initial use
6.1 Inserting the batteries
1. Slide the battery compartment 2. Insert the two supplied
lid open. batteries into the pulse
oximeter battery compartment
following the correct polarity
as shown.
6.2 Attach 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 2. Draw the other end of the lanyard through the
clasp as shown. loop at the narrow end and tighten.
6.3 System requirements for "beurer HealthManager Pro" and
"beurer HealthManager" apps
- iOS 12.0 and above, Android TM 8.0 and above
- Bluetooth ® 4.0 and above
) and heart
7. Usage
2
1. Insert one nger into the nger opening of the
pulse oximeter as shown. Hold your nger still.
2. Press the function button. The pulse oximeter
starts to measure. Do not move during the
measurement.
3. Your measurement values will appear on the
display after a few seconds.
%SpO 2 PRbpm
98 65
Function button
The function button on the pulse oximeter has four functions in total:
• Switch-on function: When the pulse oximeter is switched o, you can press the function button briey to
switch it on.
• Activate and deactivate Bluetooth ® :
- Briey press the function button to switch on the pulse oximeter.
- After switching on the pulse oximeter, press and hold the function button for 5 seconds, in order to
access the Bluetooth ® setting. "ON" or "OFF" will appear in the display.
- Briey press the function button in order to activate (ON) or deactivate (OFF) Bluetooth
- To return to the measurement, press and hold the function button for 5 seconds.
- To switch o the pulse oximeter, wait for 10 seconds. The pulse oximeter switches itself o automatically.
• Transferring measurements to the app and synchronising time and date: See 7.1 "Transfer of the
measured values via Bluetooth ® low energy technology".
• Brightness function: To select your desired display brightness, hold down the function button for slightly
longer during operation.
Note
The display orients automatically (vertical format, horizontal format). This means that you can easily read the
values on the display at any time no matter how you hold the pulse oximeter.
7.1 Transfer of the measured values via Bluetooth ®
Note
Bluetooth ® must be activated (ON) if you wish to transfer data.
The "beurer HealthManager Pro"/"beurer HealthManager" app must be activated for transfer.
• Each time data is transferred, the time and date are synchronised with your smartphone. In order to save
all of your measurements with the correct date, we recommend connecting your PO 60 to your smartphone
before taking the rst measurement.
• In order to transfer the measurements to your smartphone via Bluetooth
Activate Bluetooth ® in the settings of your smartphone, open the "beurer HealthManager Pro"/ "beurer
HealthManager" app, and follow the instructions. In the settings menu of the app, select and connect the
PO 60. A randomly generated six-digit PIN code is displayed on the pulse oximeter. At the same time, an
input eld appears on the smartphone. Here you must enter this six-digit PIN code.
There are two ways in which you can synchronise data with your smartphone. In both instances,
Bluetooth ® must be activated on your smartphone and on the pulse oximeter (ON). In addition, the "beurer
HealthManager Pro"/"beurer HealthManager" app must be opened on the smartphone.
• Version 1: When the pulse oximeter is switched o, press and hold the function button for 5 seconds.
"SYNC" will ash on the display. The device will now attempt to connect to the app for approx.
10 seconds. "SYNC" stops ashing as soon as a connection is established. All measurement data in the
memory is automatically transferred to the app. The pulse oximeter will then switch o automatically.
• Version 2: After measurements are taken, the data will automatically be sent to the app. "SYNC" will ash
on the display. The device will now attempt to connect to the app for approx. 10 seconds. "SYNC" stops
ashing as soon as a connection is established. All measurement data in the memory is automatically
transferred to the app. The pulse oximeter will then switch o automatically. If Bluetooth
(OFF), the message OFF will appear after you have taken the measurement.
- Bluetooth ® is activated automatically.
- The "beurer HealthManager Pro"/"beurer HealthManager" app must be activated for transfer.
- Each time data is transferred, the time and date are synchronised with the smartphone.
7.2 Evaluate measurement results
WARNING
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-existing condition, always consult your doctor to evaluate your measurements.
SpO₂ measurement (oxygen saturation) in %
99–94
93–90
< 90
Source: "Windisch W et al. European consensus-based (S2k) Guideline: Non-Invasive and Invasive Home
Mechanical Ventilation for Treatment of Chronic Respiratory Failure, Update 2017; pneumology 2017; 71:
722795"
Decline in oxygen saturation depending on altitude
Note
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 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.
Altitude
1500–2500 m
2500–3000 m
Source: Hackett PH, Roach RC: High-Altitude Medicine. In: Auerbach PS (ed): Wilderness Medicine, 3rd
edition; Mosby, St.Louis, MO 1995; 1–37.
8. Cleaning and maintenance
ATTENTION:
Do 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 with a soft, damp cloth after each use.
• After each use, clean the rubberised inner surface of the pulse oximeter with a soft cloth moistened with
medical alcohol (e.g. Sagrotan Hygiene Spray, Bacillol AF, Gigasept FF new, or Helipur Plus N). The
eectiveness of the cleansing can be found in the manufacturer's instructions of the respective medical
alcohol.
• 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.
9. What if there are problems?
Problem
The batteries in the pulse oximeter
are empty.
The pulse oximeter
is not displaying
measurement values
Batteries not inserted correctly.
Insucient circulation in the
measurement nger.
The pulse oximeter
is displaying
Measurement nger is too large or
measurement
too small.
interruptions or high
measurement value
jumps
Finger, hand or body is moving.
3. Close the battery compartment
Cardiac arrhythmia.
lid again.
"beurer HealthManager Pro"/"beurer
HealthManager" app is not activated
or Bluetooth
smartphone settings.
No data transfer
possible for measured The batteries in the pulse oximeter
values are too low or are empty.
Bluetooth
device (OFF).
The word mark Bluetooth ® and accompanying logo are registered trademarks of Bluetooth SIG, Inc. Any and
all use of these marks by Beurer GmbH is done so under licence. Other trademarks and trade names are the
property of the relevant holder.
Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store
is a service mark of Apple Inc., registered in the U.S. and other countries.
Google Play and the Google Play logo are trademarks of Google LLC.
Android is a trademark of Google LLC.
10. Disposal
• The empty, completely at batteries must be disposed of through specially designated
collection 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
For environmental reasons, do not dispose of the device in the household waste at the end of its
useful 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 – WEEE (Waste Electrical and Electronic
Equipment). If you have any questions, please contact the local authorities responsible for waste
disposal.
11. Technical specifications
Type
Measurement method
Measurement range
Accuracy
Dimensions
Weight
Sensor to measure SpO₂
Permissible operating conditions 10–40°C, ≤ 75% relative humidity, 700–1060 hPa ambient pressure
Permissible storage and trans-
port conditions
Power supply
® .
Battery life
Classication
Data transfer
The serial number is located on the device or in the battery compartment.
Technical information is subject to change without notication to allow for updates.
low energy technology
• This device complies with European standards EN60601-1 and EN60601-1-2 (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.
• The device complies with Regulation (EU) 2017/745 of the European Parliament and of the Council for
medical devices as well as the respective national regulations and the standard DIN EN ISO 80601-2-61
(Medical electrical equipment – Particular requirements for basic safety and essential performance of pulse
oximeter equipment).
® , proceed as follows:
• We hereby conrm 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.
12. Warranty/service
Beurer GmbH, Söinger 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 aect 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.
® is deactivated
The warranty only applies to products purchased by the buyer as a consumer and used exclusively 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 functionality in
accordance with the following provisions, Beurer shall carry out a repair or a replacement 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 rst
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
Classication/measures to be taken
– a copy of the invoice/purchase receipt, and
– the original product.
Normal range
Decreased range: The following are explicitly excluded from this warranty:
Visit to the doctor recommended – 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,
Critical range:
rechargeable batteries, cus, seals, electrodes, light sources, attachments and nebuliser accessories);
Seek medical attention urgently
– 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 modied 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.
Notication of incidents
For users/patients in the European Union and identical regulation systems (EU Medical Device Regulation
(MDR) 2017/745), the following applies: If during or through use of the product a major incident occurs, 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.
Expected SpO₂ value (oxygen
Consequences for humans
saturation) in %
>90 No altitude sickness (normally)
Altitude sickness, acclimatisation
~90
recommended
Possible cause Solution
Replace the batteries.
Reinsert the batteries. If after reinserting
the batteries correctly there are still no
measurement values displayed, contact
customer services.
Observe the chapter "Warning information
and safety notes".
Fingertip must have the following
measurements:
Width between 10 and 20 mm.
Thickness between 5 and 15 mm.
Keep your nger, hand and body still
during the measurement.
Seek medical attention.
Activate Bluetooth ® on your smartphone
® is switched o in the and start the app.
Replace the batteries.
Switch on Bluetooth ® on the device as
® not activated on the
described in the "Application" chapter
(ON).
PO 60
Non-invasive measurement of arterial oxygen saturation of haemoglobin
and pulse rate in nger
SpO₂0–100%,
Pulse30–250 beats/minute
SpO₂70–100%, ± 2%,
Pulse30–250 bpm, ± 2 beats/minute or ±2%
L 58.5 mm × W 31 mm × H 32 mm
Approx. 27 g (without batteries)
Red light (wave length 660 nm); infra-red (wave length 905 nm); silicon re-
ceiver diode
−40–60°C, ≤ 95% relative humidity, 500 –1060 hPa ambient pressure
2 x 1.5V AAA batteries
2 AAA batteries last for approx. 2 years of operation at 3 measurements
per day (60 seconds each).
IP22, application part, type BF
The pulse oximeter uses Bluetooth ® low energy technology
2402–2480 MHz frequency band,
Max. 2.87 dBm transmission power,
Compatible with Bluetooth ® 4.0 smartphones/tablets
List of supported smartphones/tablets
Subject to errors and changes
454.20_PO60_2021-05-19_05_IM1a_BEU_MDR_DE-EN