Beurer PO 30 - Handbuch (Seite 2)

− 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 evaluating medical results.
• Do not self-diagnose or self-medicate on the basis of the measurements without consulting your doctor. In particular, do not start taking any
new medication or change the type and/or dosage of any existing medication without prior approval.
• Do not look directly inside the housing during the measurement. The red light and the invisible infra-red light in the pulse oximeter are harmful
to your eyes.
• This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or
a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person
on how to use the device. Children should be supervised around the device to ensure they do not play with it.
• 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 diagnostics for the
pulse.
Non-observance of the following instructions can lead to incorrect or failed measurements.
• There must not be any nail varnish, artificial nails or other cosmetics on the finger to be measured.
• Ensure that the finger nail on the finger to be measured is short enough that the fingertip covers the sensor element in the housing.
• 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 pos-
sible 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 haemo-
globin 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.
6. unit description display description
Function button
Lanyard
holder
Finger opening
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 7.2 Attaching the lanyard
To transport the pulse oximeter more easily (e.g. whilst on the
move) you can attach a lanyard to the device.
1 . Slide the battery
compartment lid
open.
2 . Place the two batteries
supplied in the pulse
oximeter as shown.
Ensure that the cor-
rect battery polarity is
observed.
3 . Close the
battery com-
partment lid
again.
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 %SpO2 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 oxime-
ter begins its measurement. Do not move
during the measurement.
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 a three functions in total:
• switch-on function: When the pulse oximeter is switched off you can hold down the function button briefly to switch it on.
• display function: To select your desired display format (vertical format, horizontal format), hold down the function button briefly during opera-
tion.
• Brightness function: To select your desired display brightness, hold down the function button for slightly longer during operation.
9. evaluating measurement results
WARNING
The following table for evaluating your measurements does
NOT apply to people with certain pre-existing conditions (e.g.
asthma, heart failure, respiratory diseases) or whilst staying at
altitudes above 1500 metres. If you have a pre-existing condi-
tion, always consult your doctor to evaluate your measure-
ments.
decline in oxygen saturation depending on altitude
Note
The following table informs you of the effects of various altitudes on oxy-
gen 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.
spO₂ (oxygen satura-
tion) measurement
in %
classification/measures to be
taken
Altitude
expected spO₂
value (oxygen satu-
ration) in %
Impact on human body
99-94 Normal range 1500-2500 m > 90
No altitude sickness
(normally)
94-90
Decreased range:
visit to the doctor recommended
2500-3500 m ~90
Altitude sickness, acclima-
tisation recommended
< 90
Critical range
Seek medical attention urgently
3500-5800 m <90
Very frequent altitude
sickness, acclimatisation
absolutely essential
5800-7500 m <80
Severe hypoxia, only lim-
ited 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 batteries 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
Please dispose of the device in accordance with EC Directive – WEEE (Waste Electrical and Electronic Equipment).
If you have any queries, please contact the appropriate local authorities.
The empty, completely flat batteries should be disposed of through specially designated collection boxes, recycling points or electronics
retailers. You are legally required to dispose of the batteries.
Note: the codes below are printed on batteries containing harmful substances: Pb = Battery contains lead, Cd = Battery contains cad-
mium, Hg = Battery contains mercury.
13. What if there are problems?
Problem Possible cause solution
The pulse oximeter is not displaying meas-
urement 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 measure-
ment values displayed, contact customer
services.
The pulse oximeter is displaying measure-
ment 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 measure-
ments: 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 no. PO 30
Measurement method Non-invasive measurement of arterial oxygen saturation of haemoglobin and pulse rate in finger
Measurement range SpO₂ 0 – 100%,
Pulse 0 – 254 beats /minute
Accuracy SpO₂ 70 – 100%, ± 2%,
Pulse 30-250 bpm, ± 2 beats /minute
Dimensions L 61 mm x W 36 mm x H 32 mm
Weight Approx. 57 g (including batteries)
Sensor to measure SpO₂ Red light (wave length 660 nm); infra-red (wave length 905 nm); silicon receiver diode
Permissible operating conditions +10 °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 measurements per day (each of 60 seconds).
Classification IP22, application part, type BF
Technical information is subject to change without notification to allow for updates.
•
This device complies with European Standard EN60601-1-2 and is subject to particular precautions with regard to electromagnetic compatibil-
ity. Please note that portable and mobile HF communication systems may interfere with this unit. More details can be requested from the stated
Customer Service address or found at the end of the instructions for use.
• This device complies with the EU Directive 93/42/EC concerning medical devices, the Medizinproduktegesetz (German Medical Devices Act)
and the DIN EN ISO 9919 standard (Medical electrical equipment – Particular requirements for the basic safety and essential performance of
pulse oximeter equipment for medical use)
Mat. Nr
. 750.802-0114 Irr
tum und Änderungen vorbehalt
en
Guidance and manufacture’s declaration-electromagnetic emission
for all eQuIPMeNt and sYsteMs
Guidance and manufacture’s declaration –electromagnetic emission
The PO30 Pulse Oximeter is tended for use in the electromagnetic environment specified below. The customer of the user of the PO30
Pulse Oximeter should assure that it issued in such an environment.
emission test
compliance electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1 The PO30 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 electronic equipment.
RF emissions
CISPR 11
Class B The PO30 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. Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emission
IEC 61000-3-3
Not applicable
Guidance and manufacture’s declaration-electromagnetic immunity
for all eQuIPMeNt and sYsteMs
Guidance and manufacture’s declaration-electromagnetic immunity
The PO30 Pulse Oximeter is intended for use in the electromagnetic environment specified specified below. The user of PO30 Pulse Oxi-
meter should assure that it is used in such an environment.
Immunity test
Iec60601 test level compliance level electromagnetic environ-
ment-guidance
Electrostatic discharge (ESD) IEC 61000-
4-2
±6KV contact
±8KV air
±6KV contact
±8KV air
Floors should be wood, con-
crete or ceramic tile. If floor are
covered with synthetic material,
the relative humidity should be
at least 30%.
Power frequency (50Hz) magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels cha-
racteristic of a typical location
in a typical commercial or
hospital environment
Guidance and manufacture’s declaration-electromagnetic immunity
for eQuIPMeNt and sYsteMs that are not LIFe-suPPORtING
Guidance and manufacture’s declaration-electromagnetic immunity
The PO30 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of PO30 Pulse
Oximeter should assure that it is used in such an environment.
Immunity test
Iec60601 test level compliance
level
electromagnetic environment -guidance
Radiated RF
ICE 61000-4-3
3V/m
80MHz to 2.5GHz 3V/m
Portable and mobile RF communication equipment should be used
no closer to any part of the PO30 Pulse Oximeter, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
recommended separation distance
Where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, a should be less than the compliance
level in each frequency range b
Interference may occur in the vicinity of equipment marked with the
following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from struc-
tures,
objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which The PO30 Pulse Oximeter is used exceeds the applicable RF compliance level above, the PO30 Pulse Oximeter should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorien-
ting or relocating the PO30 Pulse Oximeter.
b Over the frequency range 150 KHz to 80 MHz, field 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
Recommended separation distances between
portable and mobile RF communications equipment and the PO30 Pulse Oximeter
The PO30 Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the PO30 Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance bet-
ween portable and mobile RF communications equipment (transmitters) and the PO30Pulse Oximeter as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
separation distance according to frequency of transmitter
(m)
150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters (m) can be esti-
mated using the equation 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 affected by absorption and reflection from struc-
tures,
objects and people.