Bruksanvisning Medisana PM 150 Pulsoximeter

Bruksanvisning

IMPORTANT INFORMATION!

RETAIN FOR FUTURE USE!

Read the instruction manual carefully before using this device, especially the safety instruc-

tions, 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 instruc-

tions 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.

IP22

The degree of protection against ingress of dust and water

Classication: Type BF applied part

No SpO

2

alarm

Lot number Storage conditions

Manufacturer Serial number

Date of manufacture

ASSIGNED PURPOSE

This devices is intended to measure the oxygen saturation of human blood (in % SpO

2

) through

a photoelectric sensor and to measure the pulse rate. The measured values may be transferred

via Bluetooth

®

to compatible smartphones resp. VitaDock+

®

app.

SAFETY INFORMATION

• 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 before att-

empting 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 inaccu-

rate 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

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

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, the maximum duration of use must

not exceed 30 minutes.

• 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 conjunc-

tion 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.

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 electromagnetic 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

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

0.01 0.1167 0.2334

0.1 0.3689 0.7378

1 1.667 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

Technical specications

Name and model: MEDISANA Pulse Oximeter PM 150

Display system: Digitale Anzeige (LED)

Power supply: 1,5 V= , 1 battery (type LR03, AAA)

Measuring range: SpO

2

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

Accuracy: SpO

2

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

Display resolution: SpO

2

: 1 %, Pulse: 1 beat / min.

Response time: ø 12,4 seconds

Bluetooth

®

specications: Max. range = 10 m; frequency: 2400 - 2483,5 MHz, version: 4.0

Automatic switch-off: After approx. 8 seconds

Operating conditions: +5°C - +40°C, 15 % - 93 % rel. humidity, pressure 86 kPa - 106 kPa

Storage conditions: -25°C - +70°C, 15 % - 93 % rel. humidity, pressure 86 kPa - 106 kPa

Dimensions: approx. 76 x 56 x 31 mm

Weight: approx. 55 g

Article number: 79457

EAN number: 40 15588 79457 5

Compatible Smartphones:

0297

iOS: iPhone 4S and newer, iPad 3 und newer.

Android: Devices supporting Google Android version 4.3 and

Bluetooth

®

4.0.

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

technical and optical changes without notice.

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.

0297

❶

❷

❸

❹

Cleaning and maintenance

Remove the battery 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

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 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 sym-

bol) “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 electromagnetic compatibility.

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 CISPR 11 Group 1

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.

RF emissions CISPR 11 Group 1 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.

Harmonic emissions nach IEC 61000-

3-2

Not applicable

Voltage uctuations / icker emissions

IEC 61000-3-3

Not applicable

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 Test IEC 60601 - test level Compliance level Electromagnetic environment - guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 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 %.

Power frequency

(50/60 Hz)

magnetic eld

IEC 61000-4-8

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.

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 Test

IEC 60601 - test

level

Compliance level Electromagnetic environment - guidance

Radiated RF

IEC 61000-4-3

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

where P is the maximum output power

rating of the transmitter in watts (W) ac-

cording to the transmitter manufacturer

and d is the recommended separation

distance in metres (m). Field strengths

from xed RF transmitters, as determi-

ned 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 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 mea

-

sured 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.

• 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 suffoca-

tion.

SAFETY NOTES FOR BATTERIES

• 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!

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 150

• 1 Battery (type AAA) 1,5V

• 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.

WARNING

Please ensure that the polythene packing is kept away from the reach of child-

ren! Risk of suffocation!

Device and controls

❶

Battery compartment lid

❷

LED Screen

❸

Start-button

❹

Rubber opening for nger (on rear side of the device)

Insert / change battery

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

compartment

❶

is located on the backside of the unit. Open it, remove it and insert the 1 AAA type 1.5

V battery supplied. Ensure correct polarity when inserting (as marked inside the battery compartment).

Close the battery compartment.

Removal: Replace the battery if “Por Lo“ appears in the display. If nothing is displayed the battery is

completely empty and need to be replaced immediately.

Use

1. Place one of your ngers into the rubber opening

❹

on the back side of the device.

2. Press Start-button

❸

. The LED screen immediately swichtes on. Bluetooth

®

will also be activated

shortly afterwards.

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

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

LED screen:

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

What does the measured result mean?

The oxygen saturation (SpO

2

) of the blood is a term referring to the concentration of oxygen attached

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 system, 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.

Transfer via Bluetooth

®

to VitaDock+

®

app

The MEDISANA Pulse Oximeter PM 150 offers the possibility to transfer your measured values via

Bluetooth

®

to the VitaDock+

®

app. The VitaDock+

®

app allow the evaluation, storage and synchronisa-

tion of your data between multiple iOS- and Android-devices to have access to it anytime and anywhere.

You may share your results with your friends or your doctor. Therefore you need a free user account,

which you can create on the website www.vitadock.com. For Android or iOS mobile devices, you may

download the respective apps. You will nd a detailed instruction for how to install and use the software

on the mentioned website. After each measurement an automatic transfer of the values will take place

(provided that Bluetooth

®

is activated and congurated on the receiving 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 rubber opening

❹

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

❸

. 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 battery. A mechanical or electronical error may be present, which cannot be

eradicated by replacement of the battery. 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 battery, contact the service centre.

Pulse frequency

Bluetooth

®

symbol

Pulse signal strength

Oxygen saturation in %

GB Instruction manual Pulse Oximeter PM 150

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 150, we recommend that you read

the following operating and maintenance instructions carefully.

Betyg

Mer om denna bruksanvisning

Vi förstår att det är trevligt att ha en pappersbruksanvisning för din Medisana PM 150 Pulsoximeter. Du kan alltid ladda ner bruksanvisningen från vår hemsida och skriva ut den själv. Om du vill ha en originalbruksanvisning rekommenderar vi att du kontaktar Medisana. De kanske kan tillhandahålla en originalbruksanvisning. Letar du efter bruksanvisningen för din Medisana PM 150 Pulsoximeter på ett annat språk? Välj ditt föredragna språk på vår hemsida och sök efter modellnumret för att se om vi har det tillgängligt.

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