Beurer PO 30 Manual

DEVICE DESCRIPTION

1. Lanyard holder
2. Function button
3. Finger opening
4. Oxygen saturation (value in percent)
5. Pulse rate (value in beats per minute)
6. Pulse wave (plethysmographic wave)
7. Pulse bar
8. Battery level indicator

USAGE

Inserting the batteries

1. Open the battery compartment
   
2. Insert batteries with correct polarity
   
3. Close the battery compartment
   

Attaching lanyard

Initial use

1. Place your finger in the opening and hold it steady
   
2. Press the function button and do not move during the measurement
   
3. Measured values appear
   

Pulse oximeter switches o a few seconds after the person withdraws their finger.

Read these instructions for use carefully. Observe the warnings and safety notes. Keep these instructions for use for future reference. Make the instructions for use accessible to other users. If the device is passed on, provide the instructions for use to the next user as well.

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 specified Customer Services address.
Pulse oximeter, 2x 1.5 AAA batteries, lanyard, belt bag, instructions for use

SIGNS AND SYMBOLS

The following symbols are used on the device, in these instructions for use, on the packaging and on the type plate for the device:

Indicates a potentially impending danger. If it is not avoided, there is a risk of death or serious injury.

Indicates a potentially impending danger. If it is not avoided, slight or minor injuries may result.

NOTICE
Indicates a potentially harmful situation. If it is not avoided, the device or something in its vicinity may be damaged.

Product information
Note on important information

Observe the instructions
Read the instructions before starting work and/or operating devices or machines

The electronic device must not be disposed of with household waste

Do not dispose of batteries containing hazardous substances with household waste

Manufacturer

Date of manufacture

CE labelling
This product satisfies the requirements of the applicable European and national directives.

Separate the packaging elements and dispose of them in accordance with local regulations.

Marking to identify the packaging material. A = Material code, B = Materi- A al number: 1-7 = Plastics, 20-22 = Paper and cardboard

Separate the product and packaging elements and dispose of them in accordance with local regulations.

Device protected against foreign objects ≥ 12.5 mm and against water IP22 dripping at an angle UDI

Unique Device Identifier (UDI) for unique product identification

Batch code

Item number

Serial number

Medical device

Type number

Type BF applied part

Temperature limit

Humidity limitation

atmospheric pressure limitation

Alarm suppression

INTENDED USE

Purpose

The pulse oximeter is used for the non-invasive measurement of arterial oxygen saturation (SpO₂) and heart rate (pulse rate) at home and in hospitals (not in AP and APG-class rooms). This device is not suitable for long-term measurement.

Target group

The pulse oximeter is suitable for people with and without pre-existing conditions who wish to measure their arterial oxygen saturation (SpO₂) and heart rate (pulse rate). This also includes athletes and healthy people who exercise at high altitude (e.g. mountaineers, skiers or amateur pilots). It is designed for those users with a fingertip 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 at-risk patients and people with cardiovascular diseases, respiratory diseases or sleep apnoea. The pulse oximeter is also suitable for people who show symptoms of decreased oxygen saturation (e.g. shortness of breath, increased heart rate, weakness, nervousness or outbreaks of sweating).

Clinical benefits

Users can quickly and easily determine their oxygen saturation value through the device and detect a decreased oxygen saturation value.

Contraindication

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.
• on fingers with anatomical changes, oedemas, scars or burns.
• on large fingers that do not fit into the device easily (fingertip: width approx. > 20 mm, thickness approx. > 15 mm).
• 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).

Undesirable side effects

• Finger injuries such as chemical or thermal burns, skin tanning, pressure erosion, sensory loss, gangrene
• Causes of these complications may include: pressure ischaemia, prolonged use, probe overheating, probe misuse, short circuit
• Possible measurement deviations if the finger is damaged. In this case, the SpO₂ value is recorded as too low.
• Low accuracy of SpO₂ measurement in critically ill patients: inherent potential error of 3–4% in measurements performed on these patients.

USAGE

Function button

The function button on the pulse oximeter has the following functions:

• Switch-on function: to switch on the pulse oximeter, press and hold the function button.
• Brightness function: to adjust the display brightness, press and hold the function button during operation.

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.

EVALUATING MEASUREMENT RESULTS

The following table for evaluating your measurements does NOT apply to people with certain pre-existing conditions (e.g. asthma, cardiac insufficiency, 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.

Source: following "Windisch W et al. European consensus-based (S2k) Guideline: Non-Invasive and Invasive Home Mechanical Ventilation for Treatment of Chronic Respiratory Failure, Update 2017; Pneumologie 2017; 71: 722795"

Decline in oxygen saturation depending on altitude

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, cardiac insufficiency, respiratory diseases, etc.). People with preexisting conditions may already show signs of illness (e.g. hypoxia) at lower altitudes.

Source: Hackett PH, Roach RC: High-Altitude Medicine. In: Auerbach PS (ed): Wilderness Medicine, 3rd edition; Mosby, St. Louis, MO 1995; 1-37.

MAINTENANCE/CLEANING

Do not use high pressure or ethylene oxide sterilisation on the pulse oximeter! The device is not suitable for sterilisation. 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 of the pulse oximeter 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 in order to prevent possible leaking.

STORAGE

NOTICE
Store the pulse oximeter in a dry place. If the humidity is too high it may shorten the service life of the pulse oximeter or damage it.

WHAT IF THERE ARE PROBLEMS?

TECHNICAL DATA

Model	PO 30
Measurement method	Non-invasive measurement of arterial oxygen saturation of haemoglobin and pulse rate in finger
Measurement range	SpO2 – 100%, Pulse 30 – 250 beats/minute
Accuracy	SpO2 7 – 100%, ± 2%, Pulse ≤99 bpm ± 2 bpm, ≥100bpm ± 2%
Dimensions	L 61 mm x W 36 mm x H 32 mm
Weight	Approx. 58 g (including batteries)
Sensor to measure SpO2	Red light (wavelength 660 nm), optical output power <6.65 mW; infrared (wavelength 880 nm), optical output power < 6.75 mW; silicon receiver diode This information can be particularly useful for clinicians
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
Power supply	2 x 1.5 V AAA batteries
Battery life	2 AAA batteries last for approx. 2.5 years of operation at 3 measurements per day (60 seconds each)
Expected service life of the device	Information on the service life of the product can be found on the homepage
Classification	IP22, application part, type BF
Display	TFT

The serial number is located on the device or in the battery compartment.
Technical specifications are subject to change without notification to allow for updates.

Notes on electromagnetic compatibility

NOTICE

• 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. However, if it is necessary to use the device in such a manner, this device as well as the other devices must be monitored to ensure they are working properly.
• The use of accessories other than those specified 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 included in delivery.
• Failure to comply with the above can impair the performance of the device.

WARNINGS AND SAFETY NOTES

Read these instructions for use carefully! Failure to observe the following information may result in personal injury or material damage.

• 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. If you have any doubts, 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 with this instruction will void the warranty. For repairs, please contact Beurer Customer Services or an authorised retailer.

General warnings

• 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 2 hours on one finger.
• The pulse oximeter displays an instantaneous measurement but cannot be used for continuous monitoring. The device is calibrated to indicate functional oxygen saturation.
• 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.
• 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 clarified immediately by a doctor. This can be a life-threatening situation.
• 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. Supervise children around the device to ensure they do not play with it.
• Keep packaging material away from children (risk of suffocation!).
• 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.
• Measurement deviations may occur if the skin is strongly pigmented.
• Do NOT use the pulse oximeter- during an MRI or CT scan.
  • whilst transporting a patient other than within a medical establishment.
  • 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.
  • near flammable or explosive gas mixtures.
  • in hospitals in AP and APG-class rooms.

General precautions

NOTICE
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 fingernail 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 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.
• If an electronic surgical device or defibrillator is used, the functioning of the pulse oximeter may be impaired.
• 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. 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.
• The measurement may be falsified in patients with an arterial catheter, hypotension, severe vascular constriction, anaemia or hypothermia.
• Use the device under the respective permissible operating and storage conditions.
• Protect the pulse oximeter from dust, shocks, and moisture as well as extreme temperatures and explosive materials.
• Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio systems or mobile telephones.
• Ensure the device is at room temperature before taking a measurement. If the device has been stored close to the maximum or minimum storage and transport temperatures and is then moved into an environment with a temperature of 20°C, it is recommended that you wait approx. 4 hours before using the device.
• The data averaging and signal processing results in a delay in updating the SpO₂ values. If the data update period is less than 30 seconds, the time to obtain the dynamic average values will be extended due to signal degradation, low perfusion or other faults.
• Functional testers can be used to check if the device is functioning normally, e.g. Fluke INDEX-2LFE simulator, Fluke Index ProSim 8 simulator. Please refer to the manual for detailed operating steps.

Notes on handling batteries

• Always insert the batteries correctly, taking into account the polarity (+ / -). Keep batteries clean and dry and away from water. Always select the correct battery type.
• Never short-circuit batteries and battery compartment contacts.
• Never charge, forcibly discharge, heat, disassemble, deform, encapsulate or modify batteries.
• Never weld or solder on batteries.
• Never mix batteries of different manufacturers, capacities (new and used), size and type within a device.
• Risk of explosion! Failure to comply with the points mentioned above can result in personal injury, overheating, leakage, venting, breakage, explosion or fire.
• If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth.
• If your skin or eyes come into contact with battery fluid, rinse the affected areas with water and seek medical assistance.
• Choking hazard! Keep batteries out of the reach of children. Seek medical attention immediately if swallowed. Swallowing batteries may cause severe internal burns and death.
• Never allow children to replace batteries without adult supervision.

• Store batteries away from metal objects in a well-ventilated, dry and cool place.
• Never expose batteries to direct sunlight or rain.
• Exposure of batteries to an environment with extremely high temperatures or a low air pressure may result in explosion or leakage of flammable liquids and gases.
• Remove batteries from the device if it is not going to be used for a long period of time. Do not use the product if the battery compartment lid no longer closes properly.
• Dispose of discharged batteries immediately and properly. Never dispose of batteries in fire or hot ovens.

NOTICE

• When disposing of batteries, keep batteries with different electrochemical systems separate.

Documents / Resources

Download manual

Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

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