Руководство Medisana PM 100 Пульсоксиметр

Руководство

This product must not be disposed of together with domestic waste. All users are obliged to

hand in all electrical or electronic devices, regardless of whether or not they contain toxic

substances, at a municipal or commercial collection point so that they can be disposed of

in an environmentally acceptable manner. Please remove the batteries before disposing of

the device. Do not dispose of old batteries with your household waste, but at a battery

Electromagnetic compatibility - Guidance and manufacturer‘s declaration

Effective: 19-Jul-2014

Electromagnetic emissions

The Pulse Oximeter is intended for use in the electromagnetic environment specied below. The

customer or the user of the device should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment

– guidance

RF emissions Group 1

CISPR11

RF emissions Class B

CISPR11

Harmonic emissions

Not applicable

nach IEC 61000-3-2

Voltage uctuations /

icker emissions Not applicable

IEC 61000-3-3

Electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specied below. The

customer or the user of the device should assure that it is used in such an environment.

Immunity IEC 60601- Compliance Electromagnetic environment

test test level level – guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

Power frequency

(50/60 Hz)

magnetic eld

IEC 61000-4-8

Electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specied below. The

customer or the user of the device should assure that it is used in such an environment.

Immunity IEC 60601- Compliance Electromagnetic environment

test test level level – guidance

Radiated RF

IEC 61000-4-3

The Pulse Oximeter is suitable for use in all

establishments, including domestic establish-

ments and those directly connected to the

public lowvoltage power supply network

that supplies buildings used for domestic

purposes.

The Pulse Oximeter uses RF energy only for

its internal function.

Therefore, its RF emissions are very low and

are not likely to cause any interference in

nearby electronic equipment.

± 6 kV

contact

± 8 kV air

± 6 kV

contact

± 8 kV air

Floors should be wood, concrete or ceramic tile.

If oors are covered with synthetic material, the

relative humidity should be at least 30 %.

3 A/m 3 A/m

Power frequency magnetic elds should

be at levels characteristic of a typical

location in a typical commercial or hospital

environment.

3 V/m

80 MHz to

2,5 GHz

3 V/m

Portable and mobile RF communications

equipment should be used no closer to any

part of the thermometer, including cables,

than the recommended separation distance

calculated from the equation applicable to

the frequency of the transmitter.

Recommended separation distance:

d=1.2 √P

d=1.2 √P 80 MHz to 800 MHz

d=2.3 √P 800 MHz to 2,5 GHz

Technical specications

Name and model :

Display system :

Power supply :

Measuring range :

Accuracy :

Display resolution :

Response time :

Life cycle :

Automatic switch-off :

Operating conditions :

Storage conditions :

Dimensions :

Weight :

Article number :

EAN number :

The current version of this instruction manual can be found under

www.medisana.com

Warranty and repair terms

Please contact your dealer or the service centre in case of a claim under the warranty. If you have

to return the unit, please enclose a copy of your receipt and state what the defect is.

The following warranty terms apply:

1. The warranty period for MEDISANA products is three years 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. Defects in material or workmanship will be removed free of charge within the warranty period.

3. Repairs under warranty do not extend the warranty period either for the unit or for the

replacement parts.

4. The following is excluded under the warranty:

a. All damage which has arisen due to improper treatment, e.g. non-observance of the user

instructions.

b. All damage which is due to repairs or tampering by the customer or unauthorised third

parties.

c. Damage which has arisen during transport from the manufacturer to the consumer or during

transport to the service centre.

d. Accessories which are subject to normal wear and tear.

5. 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.

MEDISANA AG, Jagenbergstr. 19, 41468 NEUSS, GERMANY.

E-Mail: [email protected], Internet: www.medisana.com

The service centre address is shown on the attached leaet.

Recommended separation distances between portable and mobile

RF communications equipment and the

Pulse Oximeter

The Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the device can help prevent electro-

magnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the device as recommended below, according to

the maximum output power of the communications equipment.

Rated maximum

output power

of transmitter

W

0.01 0.1167 0.2334

0.1 0.3689 0.7378

1 1.1667 2.3334

10 3.6893 7.3786

100

11.6667 23.3334

For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in metres (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 80 MHz and 800 MHz, 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 reection from structures, objects and

people.

Separation distance according to frequency of transmitter

m

80 MHz to 800 MHz

d=1.2 √P

800 MHz to 2.5 GHz

d=2.3 √P

MEDISANA Pulse Oximeter PM 100

Digital display (OLED)

3 V , 2 batteries (type LR03, AAA) 1,5V 600 mAh

SpO

2

: 70 % - 99 %, Pulse: 30 - 235 beats / min.

SpO

2

: ± 2 %, Pulse: (30 - 99) = ± 2; (100 - 235) = ± 2 %

SpO

2

: 1 %, Pulse: 1 beat / min.

ø 12,4 seconds

approx. 5 years (if used for 15 measurements à 10 minutes per day)

After approx. 8 seconds

+5°C - +40°C, max. 80 % rel. humidity, pressure 86 kPa - 106 kPa

-20°C - +55°C, max. 93 % rel. humidity, pressure 86 kPa - 106 kPa

approx. 58 x 34 x 35 mm

approx. 53 g

79455

40 15588 79455 1

In accordance with our policy of continual product improvement, we reserve the right

to make technical and optical changes without notice.

0297

GB Instruction manual Pulse Oximeter PM 100

Thank you very much for your condence in us and congratulations on your purchase!

You have acquired a MEDISANA quality product with your purchase. To ensure the best results and

long-term satisfaction with your MEDISANA Pulse Oximeter PM 100, we recommend that you read

the following operating and maintenance instructions carefully.

IMPORTANT INFORMATION!

RETAIN FOR FUTURE USE!

Read the instruction manual carefully before using this device, especially the

safety instructions, and keep the instruction manual for future use.

Should you give this device to another person, it is vital that you also pass on

these instructions for use.

Explanation of symbols

This instruction manual belongs to this device. It contains important

information about starting up and operation. Read the instruction

manual thoroughly. Non-observance of these instructions can result

in serious injury or damage to the device.

WARNING

These warning notes must be observed to prevent any injury to the

user.

CAUTION

These notes must be observed to prevent any damage to the

device.

NOTE

These notes give you useful additional information on the installation

or operation.

The degree of protection against dripping water

Classication: Type BF applied part No SpO

2

alarm

Lot number Storage conditions

Manufacturer Serial number

Date of manufacture

IPX1

ASSIGNED PURPOSE

The Pulse Oximeter PM 100 is a portable non-invasive device intended for spot-

checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of

adult and pediatric patients. It is not suitable for continuous monitoring.

SAFETY INFORMATION

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Pulse oximeters are sensitive to motion artefacts. Therefore keep hands still while taking a reading.

Pulse Oximeters require sufcient blood ow to obtain proper readings. If your hands are cold or

you have poor circulation, warm your hands by rubbing them together or use another method befo-

re attempting to obtain a reading. A tourniquet, blood pressure cuff or other blood ow hindrances

may also result in inaccurate readings.

Fingernail polish or acrylic nails obstruct the light transmission and may also result in in-

accurate readings.

Your nger and the pulse oximeter must be clean for proper reading.

If a reading is different to obtain, switch to another nger or to the other hand.

Inaccurate measurement results may also caused by:

- dysfunctional hemoglobin or low hemoglobin

- the use of intravascular dyes

- high ambient light

- excessive patient movement

- high-frequency electrosurgical interference and debrillators

- venous pulsations

0297

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3

4

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SAFETY NOTES FOR BATTERIES

•

•

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Items supplied and packaging

Please check rst of all that the device is complete and is not damaged in any way. If in doubt, do

not use it and contact the service centre. The following parts are included:

• 1 MEDISANA Pulse Oximeter PM 100

• 2 Batteries (type AAA) 1,5V

• 1 Lanyard

• 1 Instruction manual

The packaging can be reused or recycled. Please dispose properly of any packaging material no

longer required. If you notice any transport damage during unpacking, please contact your dealer

without delay.

Device and controls

1

OLED Screen

2

Start-button

3

Opening for nger

4

Battery compartment lid (on rear side of the device)

Insert / change battery

Insertion: You must insert the batteries provided before you can use your unit. The lid of the battery

compartment

4

is located on the backside of the unit. Open it, remove it and insert the 2 x AAA

type 1.5 V batteries supplied. Ensure correct polarity when inserting (as marked inside the battery

compartment). Close the battery compartment.

Removal: Replace the batteries when the battery exchange symbol appears in the display.

If nothing is displayed the batteries are completely empty and need to be replaced immediately.

Use

1.

2.

3.

4.

5.

6.

What does the measured result mean?

The oxygen saturation (SpO

2

) of the blood is a term referring to the concentration of oxygen at-

tached to human hemoglobin. The normal value lies between 90 and 96 % SpO

2

. A too low value

may be an indication for existing diseases like e.g. cardiac defect, problems of the circulatory sys-

tem, asthma or specic diseases of the lung. A too high value may be caused by a too fast and too

deep breathing, what bears the danger of a too low blood carbon dioxide level. The value measured

with this device is not suitable in any way to make or conrm a diagnosis - contact your doctor under

all circumstances to get a correct diagnosis.

- placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intra-

vascular line

- patients suffering from hypotension, severe vasoconstriction, severe anemia, or hypothermia

- cardiac arrest or shock

- false ngernails

- circulatory disorder

The Pulse Oximeter will not alert you if your readings are out of normal range.

Explosion hazard: Do not use the Pulse Oximeter in an explosive atmosphere.

The device is not suitable for continuous blood oxygen monitoring.

In order to ensure correct sensor alignment and skin integrity, the maximum application time at a

single site for our device should be less than 4 fours.

Operation of the Pulse Oximeter may be affected by the use of an electrosurgical unit (ESU).

Do not use the Pulse Oximeter in an MRI or CT environment.

The Pulse Oximeter is intended only as an adjunct in patient assessment. It must be used in con-

junction with other methods of assessing clinical signs and symptoms advised by a professional

physician.

The device is not intended for sterilization or for cleaning with liquids.

This equipment is not intended for use during patient transport outside the healthcare facility.

This equipment should not be used adjacent to or stacked with other equipment.

The device must not be used with accessories, detachable parts and other materials not described

in the instructions for use.

Please do not attempt to repair the unit yourself in the event of malfunctions. Stop using the device

and conact the service centre.

The materials that contact with the patient’s skin have been tested to be in tolerance. In case you

should detect skin irritations etc., stop using the device and contact a doctor.

The swallowing of small parts like packaging bag, battery, battery cover and so on may cause

suffocation.

WARNING

Please ensure that the polythene packing is kept away from the

reach of children! Risk of suffocation!

Do not disassemble batteries!

Never leave any low battery in the battery compartment since it may leak and cause damage to

the unit!

Increased risk of leakage! Avoid contact with skin, eyes and mucous membranes!

If battery acid comes in contact with any of these parts, rinse the affected area with copious

amounts of fresh water and seek medical attention immediately!

If a battery has been swallowed, seek medical attention immediately!

Insert the batteries correctly, observing the polarity!

Keep batteries out of children‘s reach!

Do not attempt to recharge batteries! There is a danger of explosion!

Do not short circuit! There is a danger of explosion!

Do not throw into a re! There is a danger of explosion!

Do not throw used batteries into the household refuse; put them in a hazardous waste container or

take them to a battery collection point, at the shop where they were purchased

Oxygen

saturation in %

Pulse frequency

Pulse Signal Start-button

Open the nger opening by pressing the left upper and lower parts of the device together.

Place your nger as far as possible into the opening

3

on the right side of the device and release

the upper and lower parts.

Press the Start-button

2

. The OLED-screen will switch on immediately.

Keep your nger resp. your whole body still for the reading.

After a short time, the values for the pulse frequency and the blood oxygen saturation appear on

the OLED screen:

By repeatedly pressing the Start-button

2

you may switch between 6 different display modes

(showing the already explained values in different view modes).

Remove your nger. The Pulse Oximeter will power off automatically after approx. 8 seconds.

Adjustement of the display brightness

The MEDISANA Pulse Oximeter PM 100 offers the possibility to adjust the brightness of the dis-

play in 10 steps. To do so, press and hold the Start-button

2

(device must be switched on), until

the desired brightness level is reached. The current brightness level is displayed on the upper right

screen area (e.g. Br 1, Br 2, Br 3, Br 4 etc.). The factory setting is level 4 (Br 4).

Using the Lanyard

A Lanyard is included in the scope of delivery of the MEDISANA

Pulse Oximeter PM 100. You may attach it to the device by

threading the thinner end of the lanyard through the hanging hole

on the left side of the device.

Troubleshooting

Error: SpO

2

and / or pulse frequency values are not displayed resp. are not displayed correctly.

Remedying: Place on of your ngers completely into the nger opening

3

on the backside of the

device. Use a new battery. Do not move or speak during the measurement. If still no correct values

can be measured, contact the service centre.

Error: The device cannot be switched on.

Remedying: Remove the old battery and insert a new one. Press the START-button

2

. If the

device still cannot be switched on, contact the service centre.

Error: „Error 3“ or „Error 4“ appear on the display.

Remedying: Replace the batteries. A mechanical or electronical error may be present, which can-

not be eradicated by replacement of the batteries. Contact the service centre.

Error: „Error 6“ or „Error 7“ appear on the display.

Remedying: The LED screen is defective or another technical error is present. Does the error

message still appear even after you have exchanged the batteries, contact the service centre.

Cleaning and maintenance

Remove the batteries before cleaning. Never use strong detergents or hard brushes. Clean the unit

with a soft cloth, moistened with isopropyl alcohol. Do not let water enter the unit. After cleaning,

only use the unit when it is completely dry.

Disposal

collection station at a recycling site or in a shop. Consult your municipal authority or your dealer for

information about disposal.

Directives / Norms

This device is certied in accordance with EC Guidelines and carries the CE symbol (conformity

symbol) “CE 0297”. The specications of EU Guideline “93/42/EEC of the Council Directive dated

14 June 1993 concerning medical devices” are met.

Electromagnetic compatibility: The device complies with the EN 60601-1-2 standard for elec-

tromagnetic compatibility.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reection from structures, objects and people.

a. Field strengths from xed 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 xed RF transmitters, an

electromagnetic site survey should be considered. If the measured eld strength in the location in which the

device is used exceeds the applicable RF compliance level above, the device should be observed to verify

normal operation. If abnormal performance is observed, additional measures may be necessary, such as

reorienting or relocating the device.

b. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

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 metres

(m). Field strengths from xed RF transmit-

ters, as determined by an electromagnetic

site survey

a

, should be less than the compli-

ance level in each frequency range

b

. Interfe-

rence may occur in the vicinity of equipment

marked with the following symbol:

Рейтинг

Подробнее об этом руководстве

Мы понимаем, что приятно иметь бумажное руководство для вашего Medisana PM 100 Пульсоксиметр. Вы всегда можете скачать инструкцию с нашего сайта и распечатать самостоятельно. Если вы хотите получить оригинальное руководство, мы рекомендуем вам связаться с Medisana. Возможно, они смогут предоставить оригинальное руководство. Вы ищете руководство для вашего Medisana PM 100 Пульсоксиметр на другом языке? Выберите предпочитаемый язык на нашей домашней странице и найдите номер модели, чтобы узнать, есть ли она у нас в наличии.

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