Beurer PO 60 Gebrauchsanweisung Seite 2

PO 60
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 pres-
sure, 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 60 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 60 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 60 pulse oximeter provides a non-invasive measurement of the arterial oxygen saturation (SpO
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
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
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
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 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.
− 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 approx. < 5 mm).
− on patients who are not steady at the site of application (e.g. trembling).
− near flammable or explosive gas mixtures.
• 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 finger.
• 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 knowl-
edge, 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. Super-
vise children around the device to ensure they do not play with it.
• 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.
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 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 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 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 ap-
plies in particular for cases of carbon monoxide poisoning and methaemoglobin poisoning, which can occur for example from the administration of local anaesthet-
ics 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, rinse 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 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 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.
• Do not disassemble, open or crush the batteries.
6. Unit description
Function button
5
Finger opening
4
Lanyard holder
7. Initial use
7.1 Inserting the batteries
1. Slide the battery 2. Insert the two supplied batteries
compartment lid into the pulse oximeter battery
open. compartment following the cor-
rect polarity as shown.
8. Operation
1. Insert one finger into the finger opening of the 2. Press the function button. The pulse oximeter
pulse oximeter as shown and hold it steady. begins its measurement. Do not move during the
measurement.
Function button
The function button on the pulse oximeter has four functions in total:
• Switch-on function: When the pulse oximeter is switched off you can press the function button briefly to switch it on.
• Activating and deactivating Bluetooth ® :
– Briefly 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
the display.
– Briefly 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 off the pulse oximeter, wait for 10 seconds. The pulse oximeter switches itself off automatically.
• Transferring measurements to the app and synchronising time and date: See point 10 „Transferring measurements using Bluetooth
• 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 ensures that the values are easy to read on the display at all times, regardless of how you
hold the pulse oximeter.
Beurer GmbH • Söflinger Straße 218 • 89077 Ulm, Germany
www.beurer.com • www.beurer-gesundheitsratgeber.com
www.beurer-healthguide.com
ENGLISH
) and the heart rate (pulse rate). Oxygen saturation
2
Disposal in accordance with the Waste Electrical and Electronic Equip-
ment EC Directive – WEEE
Do not dispose of batteries containing hazardous substances with
household waste.
Manufacturer
Application part, type BF
Serial number
The CE labelling certifies that the product complies with the essential
requirements of Directive 93/42/EEC on medical products.
0483
Alarm suppression
Device protected against foreign objects ≥12.5 mm and against water
IP 22
dripping at an angle
Display description
1 2
1. Oxygen saturation (value in percent)
2. Pulse rate (value in beats per minute)
%SpO PRbpm
2
3. Pulse wave (plethysmographic wave)
98
65
4. Pulse bar
5. Battery level indicator
3
7.2 Attaching the lanyard
To transport the pulse oximeter more easily you can attach a lanyard
to the device.
3. Close the battery 1. Insert the narrow end of the 2. Draw the other end of the
compartment cover lanyard through the holder as
again. shown.
%SpO 2 PRbpm
98 65
3. Your measurement values will appear on the
screen after a few seconds.
settings. „ON" or „OFF" will appear in
®
® .
9. System requirements for the app „beurer HealthManager"
- iOS from 10.0, Android from 5.0
TM
- from Bluetooth 4.0
®
10. Transfer of measured values via Bluetooth
Note
Note: Bluetooth must be activated (ON) if you wish to transfer data.
®
The „beurer HealthManager" app must be activated if you wish to transfer data.
Each time data is transferred, the time and date are synchronised with the smartphone. To save all of your measurements with the correct date, we recommend con-
necting your PO 60 to your smartphone before taking the first measurement.
To transfer the measurements to your smartphone via Bluetooth
ger" 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, and at the same time, an input field appears on the smartphone in which 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
oximeter (ON). You must also ensure that the „beurer HealthManager" app is open on your smartphone.
• Option 1: When the pulse oximeter is switched off, press and hold the function button for 5 seconds. „SYNC" will flash on the display. The device will now attempt
to connect to the app for approx. 10 seconds. „SYNC" stops flashing 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 off automatically.
• Option 2: After measurements are taken, the data will automatically be sent to the app. „SYNC" will flash on the display. The device will now attempt to connect to
the app for approx. 10 seconds. „SYNC" stops flashing 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 off automatically. If Bluetooth
- Bluetooth is activated automatically.
®
- The „beurer HealthManager" app must be activated to allow data transfers.
- Each time data is transferred, the time and date are synchronised with the smartphone.
11. Evaluating measurement results
WARNING
The following table for evaluating your measurements does NOT ap-
ply 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 (oxygen satura-
tion) measurement in %
99-94
93-90
12. Maintenance/cleaning
IMPORTANT:
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 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.
13. 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.
14. Disposal
• The empty, completely flat 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. 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.
15. What if there are problems?
Problem
The pulse oximeter is not displaying measure-
ment values.
The pulse oximeter is displaying measure-
ment interruptions or high measurement value
jumps.
No data transfer possible for measured values.
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.
16. Technical data
Model No.
Measurement method
Measurement range
Accuracy
Dimensions
Weight
Sensor to measure SpO2
Permissible operating conditions
Permissible storage and transport conditions
Power supply
Battery life
Classification
Data transfer
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 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.
• 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 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 dis-
play/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,
lanyard through the loop at the
including all cables included in delivery. Failure to comply with the above can impair the performance of the device.
narrow end and tighten.
• 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
a. improper treatment, e.g. nonobservance of the user instructions.
b. repairs or tampering by the customer or unauthorised third parties.
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.
® low energy technology".
®
low energy technology
® , proceed as follows: Activate Bluetooth
is deactivated (OFF), the message OFF will appear after you have taken the measurement.
®
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 al-
titudes.
Classification/measures to be taken Altitude
Normal range 1500-2500 m
Decreased range:
2500-3000 m
Visit to the doctor recommended
Source: Hackett PH, Roach RC: High-Altitude Medicine. In: Auerbach PS (ed): Wilder-
ness Medicine, 3rd edition; Mosby, St.Louis, MO 1995; 1-37.
Possible cause
The batteries in the pulse oximeter are empty.
Batteries not inserted correctly.
Insufficient circulation in the measurement finger.
Measurement finger is too large or too small.
Finger, hand or body is moving.
Cardiac arrhythmia.
„beurer HealthManager" app is not activated or Blue-
tooth is switched off in the smartphone settings.
®
The batteries in the pulse oximeter are too low or are
empty.
Bluetooth is not activated (OFF) at the device.
®
PO 60
Non-invasive measurement of arterial oxygen saturation of haemoglobin and pulse rate in finger
SpO2 0 – 100%,
pulse 30 – 254 beats/minute
SpO2 70 – 100%, ± 2%,
pulse 30 – 254 bpm, ± 2 beats/minute
L 58.5 mm x W 31 mm x H 32 mm
Approx. 27 g (without batteries)
Red light (wave length 660 nm); infra-red (wave length 905 nm); silicon receiver diode
+10°C to +40°C, ≤ 75% relative humidity, 700 – 1060 hPa ambient pressure
-40°C to +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 (each of 60 seconds).
IP22, application part, type BF
The pulse oximeter uses Bluetooth low energy technology,
®
2402 MHz – 2480 MHz frequency band
Max. 2.87 dBm transmission power,
Compatible with Bluetooth 4.0 smartphones/tablets
®
List of supported smartphones/tablets
® in your smartphone settings, open the „beurer HealthMana-
® must be activated on your smartphone and on the pulse
Expected SpO2 value
(oxygen saturation) Impact on human body
in %
> 90 No altitude sickness (normally)
Altitude sickness, acclimatisation
~90
recommended
Solution
Replace the batteries.
Reinsert the batteries. If after reinserting the batter-
ies correctly there are still no measurement values
displayed, contact customer services.
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.
Activate Bluetooth ® on the smartphone and start
the app.
Replace the batteries.
Activate Bluetooth ® on the device by following the
instruction of section 8 (ON).
Subject to errors and changes
454.20-PO60_2019-01-31_02_IM1a_BEU_DE-EN