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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 suffi ciently 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 off 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 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 fi 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 cuff .
− on fi ngers that have nail varnish on, are dirty or have a plaster or other dressing on them.
− on large fi ngers that do not fi t into the device easily (fi ngertip: width approx. > 20 mm, thickness approx. >15 mm).
− on fi ngers with anatomical changes, oedemas, scars or burns.
− on fi ngers 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 fl ammable 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 fi 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 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, artifi cial nails or other cosmetics on the fi nger to be measured.
• Ensure that the fi nger nail on the fi nger to be measured is short enough that the fi ngertip covers the sensor elements in the housing.
• Keep your hand, fi nger 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. fl uorescent lamps or direct sunlight) in the immediate vicinity of the pulse
oximeter.
• People with low blood pressure, who suff er from jaundice or take medication for vascular contraction, may experience incorrect or falsifi 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 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 defi ciency.
• 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 fl uid, rinse the aff ected 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 fi re.
• 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 com-
2. Insert the two supplied
3. Close the
partment lid open.
batteries into the pulse
oximeter battery compart-
ment following the correct
polarity as shown.
8. Operation
1. Insert one fi nger into the fi nger 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.
Note
When you remove your fi nger from the pulse oximeter, the device will automatically switch off after approx. 10 seconds.
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 hold down the function button briefl y to switch it on.
• Data transfer plus synchronisation of time and date: When the pulse oximeter is switched off you can hold down the function button (for at least 5 seconds) to
transfer the data to the app.
• Display function: To select your desired display format (vertical format, horizontal format), hold down the function button briefl y during operation.
• Brightness function: To select your desired display brightness, hold down the function button for slightly longer during operation.
9. System requirements for the app „beurer HealthManager"
- iOS from 8.0, Androit
TM
from 4.4
®
- from Bluetooth
4.0
10. Transfer of measured values via Bluetooth
It is also possible to transfer the measured values saved on the device to your smartphone via Bluetooth
You will need the „beurer HealthManager" app for this. This is available for free in the Apple App Store and from Google Play.
Proceed as follows to transfer values:
• Activate Bluetooth
®
in your smartphone settings and open the app.
• With the device switched off , hold down the function button for 5 seconds. "SYNC" will fl ash on the display.
• The device now attempts to connect to the app for approx. 10 seconds.
• "SYNC" stops fl ashing as soon as a connection is established.
• All measurement data in the memory is automatically transferred to the app. The device will then switch off automatically.
- 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-
Classifi cation/measures to be taken
tion) measurement in %
99-94
Normal range
Decreased range:
93-90
Visit to the doctor recommended
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 fl 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. 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 batteries in the pulse oximeter are empty.
The pulse oximeter is not displaying measure-
ment values.
Batteries not inserted correctly.
Insuffi cient circulation in the measurement fi nger.
The pulse oximeter is displaying measure-
Measurement fi nger is too large or too small.
ment interruptions or high measurement value
jumps.
Finger, hand or body is moving.
Cardiac arrhythmia.
Display description
1
2
1. Oxygen saturation (value in percent)
2. Pulse rate (value in beats per minute)
%SpO
PRbpm
2
98
3. Pulse wave (plethysmographic wave)
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.
1. Insert the narrow end of the
2. Draw the other end of the
battery com-
lanyard through the holder as
lanyard through the loop at the
partment cover
shown.
narrow end and tighten.
again.
%SpO
2
PRbpm
98
65
3. Your measurement values will appear on the
screen after a few seconds.
®
low energy technology
®
low energy technology.
Decline in oxygen saturation depending on altitude
Note
The following table informs you of the eff ects of various altitudes on oxygen satura-
tion 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.
Expected SpO₂ value
Altitude
(oxygen saturation)
Impact on human body
in %
1500-2500 m
> 90
No altitude sickness (normally)
Altitude sickness, acclimatisa-
2500-3000 m
~90
tion recommended
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
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 fi nger, hand and body still during the
measurement.
Seek medical attention.
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 Inc.
Android is a trademark of Google Inc.
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 via Bluetooth
wireless techno-
®
logy
The serial number is located on the device or in the battery compartment.
Technical information is subject to change without notifi cation to allow for updates.
• This device complies with European Standard EN60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibility. Please note that
portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated Customer Services address or found at
the end of the instructions for use.
• This device complies with EU Directive 93/42/EEC concerning medical devices, the Medizinproduktegesetz (German Medical Devices Act) and the DIN EN ISO
80601-2-61 standard (Medical electrical equipment − Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medi-
cal use).
• We hereby guarantee that this product complies with the European R&TTE Directive 1999/5/EEC.
Please contact the specified service address to obtain more detailed information such as the CE conformity declaration.
Guidance and manufacture's declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS
The PO60 Pulse Oximeter is tended for use in the electromagnetic environment specifi ed below. The customer of the user of the PO60 Pulse Oximeter should
assure that it issued in such an environment.
Emission test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fl uctuations/ fl icker emission
IEC 61000-3-3
Guidance and manufacture's declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS
The PO60 Pulse Oximeter is intended for use in the electromagnetic environment specifi ed specifi ed below. The user of PO60 Pulse Oximeter should assure that it
is used in such an environment.
Immunity test
Electrostatic discharge (ESD) IEC 61000-4-2
Power frequency (50Hz) magnetic fi eld
IEC 61000-4-8
Guidance and manufacture's declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are
The PO60 Pulse Oximeter is intended for use in the electromagnetic environment specifi ed below. The customer or the user of PO60 Pulse Oximeter should assure
that it is used in such an environment.
Immunity test
IEC60601 test level
Radiated RF
3V/m
ICE 61000-4-3
80MHz to 2.5GHz
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aff ected by absorption and refl ection from structures,
objects and people.
Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
a
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an elec-
tromagnetic site survey should be considered. If the measured fi eld strength in the location in which The PO60 Pulse Oximeter is used exceeds the applicable
RF compliance level above, the PO60 Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the PO60 Pulse Oximeter.
b
Over the frequency range 150 KHz to 80 MHz, fi eld strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF communications equipment and the
EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that not LIFE-SUPPORTING
The PO60 Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user
of the PO60 Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi-
cations equipment (transmitters) and the PO60 Pulse Oximeter as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of transmitter
(W)
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be estimated using the equa-
tion applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aff ected by absorption and refl ection from structures, objects and
people.
Solution
„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.
Device is still switched on.
PO 60
Non-invasive measurement of arterial oxygen saturation of haemoglobin and pulse rate in finger
SpO₂ 0 – 100%,
pulse 0 – 254 beats/minute
SpO₂ 70 – 100%, ± 2%,
pulse 30 – 250 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,
®
2.4 GHz frequency band,
Compatible with Bluetooth 4.0 smartphones/tablets
List of supported smartphones/tablets
Guidance and manufacture's declaration –electromagnetic emission
compliance
Electromagnetic environment-guidance
Group 1
The PO60 Pulse Oximeter uses RF energy only for their internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference in nearby electro-
nic equipment.
Class B
The PO60 Pulse Oximeter is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Not applicable
Not applicable
Guidance and manufacture's declaration-electromagnetic immunity
IEC60601 test level
Compliance level
±6KV contact
±6KV contact
±8KV air
±8KV air
3 A/m
3 A/m
not LIFE-SUPPORTING
Guidance and manufacture's declaration-electromagnetic immunity
Compliance level
Electromagnetic environment -guidance
Portable and mobile RF communication equipment should be used no closer to any
part of the PO60 Pulse Oximeter, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.
recommended separation distance
3V/m
of the transmitter in watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fi xed RF transmitters, as determined by an electromagnetic site
survey,
a
should be less than the compliance level in each frequency range
Interference may occur in the vicinity of equipment marked with the following symbol:
Recommended separation distances between
portable and mobile RF communications equipment and the PO30 Pulse Oximeter
Separation distance according to frequency of transmitter (m)
150KHz to 80MHz
80MHz to 800MHz
0.12
0.12
0.37
0.37
1.17
1.17
3.69
3.69
11.67
11.67
Activate Bluetooth ® on the smartphone and start
the app.
Replace the batteries.
Wait until the device switches off .
Electromagnetic environment-guidance
Floors should be wood, concrete or ceramic tile. If
fl oor are covered with synthetic material, the relative
humidity should be at least 30%.
Power frequency magnetic fi elds should be at levels
characteristic of a typical location in a typical commer-
cial or hospital environment
Where P is the maximum output power rating
b
800MHz to 2.5GHz
0.23
0.74
2.33
7.38
23.33
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