Oxygen - Heart rate monitor Medel - Free user manual and instructions

USER MANUAL Oxygen Medel

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medel®

PO01

SOMMARIO

ITALIANO 2

ENGLISH....21

DEUTSCH.... 43

FRANÇAIS....59

ESPANOL.....77

PORTUGUÊS...... 95

POLSKI.... 113

TURKÇE...... 131

ROMANA....148

166.

CE 0483

White medical pressure meter with digital display showing blood pressure value of 198.65 (no visible text or symbols on device body)

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ITALIANO

Gentile cliente,

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3. Introduzione

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12. Smaltimento

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ENGLISH

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 pressure, 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 Medel team

1. Included in delivery

1x Oxygen PO 01 pulse oximeter, 2x 1.5 V AAA batteries, 1x Lanyard, 1x Belt bag, 1x These instructions for use

2. Intended use

Only use the Medel Oxygen PO 01 pulse oximeter on humans to measure the arterial oxygen saturation ( SpO_2 ) 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).

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3. Getting to know your device

The Medel Oxygen PO 01 pulse oximeter provides a non-invasive measurement of the arterial oxygen saturation (SpO _2 ) and the heart rate (pulse rate). 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 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:

WARNINGWarning instruction indicating a risk of injury or damage to health

Manufacturer

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	IMPORTANTSafety note regarding potential for damage to the device/accessories		Application part, type BF
	NoteNote on important information	SN	Serial number
	Observe the instructions for use	0483	The CE labelling certifies that the product complies with the essential requirements of Directive 93/42/EEC on medical products.
%SpO2	Arterial oxygen saturation of haemoglobin (in percent)		Date of manufacture
PR bpm	Pulse rate (beats per minute)		Alarm suppression
	Disposal in accordance with EC Directive WEEE (Waste Electrical and Electronic Equipment)	IP 22	Device protected against foreign objects ≥ 12.5 mm and against falling drops of water

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Do not dispose of batteries containing hazardous substances with household waste.

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 Medel 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 Medel customer services or an authorised retailer.

Do NOT use the pulse oximeter

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• 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 >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.

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• 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 SpO_2 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 measuring result, there should not be any strong light sources (e.g. fluorescent lamps or direct sunlight) in the immediate vicinity of the pulse oxi-

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meter.

• 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.
• Protect the pulse oximeter from dust, shocks, moisture, extreme temperatures and explosive materials.

6. Unit description

Lanyard holder Function button Finger opening

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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

1. Slide the battery compartment lid open.

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	2. Place the two batteries supplied in the pulse oximeter as shown. Ensure that the correct battery polarity is observed.
	3. Close the battery compartment lid again.

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 lanyard through the holder as shown.

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2. Draw the other end of the lanyard through the loop at the narrow end and tighten.

8. Operation

	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 oximeter begins its measurement. Do not move during the measurement.
	3. Your measurement values will appear on the screen after a few seconds.

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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 operation.
• Brightness function: To select your desired display brightness, hold down the function button for slightly longer during operation.

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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 condition, always consult your doctor to evaluate your measurements.

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 altitudes.

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SpO2(oxygen saturation) measurement in %	Classification/measures to be taken
99-94 Normal range
94-90	Decreased range: visit to the doctor recommended
< 90	Critical rangeSeek medical attention urgently

Altitude	Expected SpO2value (oxygen saturation) in %	Impact on human body
1500-2500 m	>90	No altitude sickness (normally)
2500-3500 m	~90	Altitude sickness, acclimatisation recommended
3500-5800 m	<90	Very frequent altitude sickness, acclimatisation absolutely essential
5800-7500 m	<80	Severe hypoxia, only limited 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.

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10. 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.

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^ and 60^ .

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.

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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 cadmium, Hg = Battery contains mercury.

13. What if there are problems?

Problem Possible cause Solution
The pulse oximeter is not displaying measurement values	The batteries in the pulse oximeter are empty.	Replace the batteries.
	Batteries not inserted correctly.	Reinsert the batteries. If after rein- serting the batteries correctly there are still no measurement values dis- played, contact customer services.

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The pulse oximeter is displaying measurement 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 measurements: Width between 10 and 22 mmThickness 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. Oxygen PO 01

Measurement method Non-invasive measurement of arterial oxygen saturation of haemoglobin and pulse rate in finger

Measurement range SpO_2 0 - 100% ,

Pulse 0 - 254 beats /minute

Accuracy SpO_2 70 - 100%, ± 2%,

Pulse 30-250 bpm, ± 2 beats /minute

Dimensions L 61 mm x W 36 mm x H 32 mm

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Weight Approx. 57 g (including batteries)

Sensor to measure SpO_2 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 2x1.5V 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 compatibility. 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 80601-2-61 standard (Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use)

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Guidance and manufacture's declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS

Guidance and manufacture's declaration -electromagnetic emission
The PO01 Pulse Oximeter is tended for use in the electromagnetic environment specified below. The customer of the user of the PO01 Pulse Oximeter should assure that it issued in such an environment.
Emission test compliance Electromagnetic environment-guidance
RF emissionsCISPR 11	Group 1 The PO01 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 emissionsCISPR 11	Class B The PO01 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 emissionsIEC 61000-3-2	Not appli-cable
Voltage fluctuations/flicker emissionIEC 61000-3-3	Not appli-cable

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Guidance and manufacture's declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture's declaration-electromagnetic immunity
The PO01 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of PO01 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/m80MHz to 2.5GHz	3V/m	Portable and mobile RF communication equipment should be used no closer to any part of the PO01 Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.recommended separation distance d = [ 3.5E_1 ] 80MHz to 800MHz d = [ 7E_1 ] 800MHz to 2.5GHz

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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 structures, 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 PO01 Pulse Oximeter is used exceeds the applicable RF compliance level above, the PO01 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 PO01 Pulse Oximeter.

^b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.

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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 PO01 Pulse Oximeter
The PO01 Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PO01 Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PO01Pulse 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 d = [ 3.5E_1 ]	d = [ 3.5E_1 ]	2.5GHz d = [ 7E_1 ]

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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 estimated 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 structures, objects and people.

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DEUTSCH

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(Fingerspitze: Breite ca. > 20 mm, Dicke ca. >15 mm)

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Lanyard holder Function button Finger opening

Displaybeschreibung

%SpO₂ PRbpm 1 98 65

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7. Inbetriebnahme

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FRANÇAIS

Chère cliente, cher client,

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7. Mise en service

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7.2 Fixer la lanière

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10. Nettoyage/entretien

ATTENTION :

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12. Élimination

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ESPAÑOL

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4. Símbolos

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7.2 Ajustar la correa

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Medidas L 61 mm x A 36 mm x A 32 mm

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PORTUGUÊS

Estimado(a) cliente:

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7.1 Colocar as pilhas

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7.2 Fixar a correia de pendurar

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

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12. Eliminação

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POLSKI

Szanowna Klientko, szanowny Kliencie!

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6. Opis urządzenia

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7. Uruchomienie

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Color palette bar with grayscale shades from black to white (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

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

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

odpadów.

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

TÜRKÇE

Sayın müşterimiz,

Color swatch bar with grayscale gradient from black to white (no text or symbols)

3. Ürün özellikleri

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

lidir.

Color swatch bar with grayscale gradient from black to white (no text or symbols)

6. Cihaz açıklaması

Color palette bar with grayscale gradient from black to white (no text or symbols)

7. Çalıştırma

Color palette bar with grayscale shades from black to white (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

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

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

ROMÂNA

Color swatch bar with grayscale gradient from black to white (no text or symbols)

3. Prezentare

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color palette bar with grayscale gradient from black to white (no text or symbols)

Color palette bar with grayscale shades and a grid of squares (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

9. Evaluarea rezultatelor

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

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

160

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

Color palette bar with grayscale shades and a row of solid color swatches (no text or symbols)

Color palette bar with grayscale shades from black to white (no text or symbols)

Two horizontal color swatches: black and gray with white borders, each containing a distinct color block (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color palette bar with grayscale swatches (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

4.شرح الرموز

Two horizontal color swatches: black, gray, white with squares, and yellow, magenta, blue, dark blue, green, red, black, yellow, pink, cyan (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

1. وصف الجهاز
   

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

.7. التشفيل

7.1 retirement巴黎

Color swatch bar with grayscale gradient from black to white (no text or symbols)

الزر الوظيفي

Color palette bar with grayscale gradient from black to white (no text or symbols)

1. الاستعمال

Color swatch bar with grayscale gradient from black to white (no text or symbols)

1. التنظيف / Psيانة

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)

Color swatch bar with grayscale gradient from black to white (no text or symbols)