MEDISANA Pulse Oximeter PM 150 Instruction Manual

MEDISANA Pulse Oximeter PM 150

Thank you very much for your confidence 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.

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

ASSIGNED PURPOSE

This devices is intended to measure the oxygen saturation of human blood (in % SpO2) 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 sufficient blood flow 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 attempting to obtain a reading. A tourniquet, blood pressure cuff or other blood flow 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 finger and the pulse oximeter must be clean for proper reading. • If a reading is different to obtain, switch to another finger 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 defibrillators
  • 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 fingernails
  • 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 conjunction 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.

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 fire! 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 first 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 children! Risk of suffocation!

Device and controls

1. Battery compartment lid
2. LED Screen
3. Start-button
4. Rubber opening for finger (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 fingers 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 finger 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 finger. The Pulse Oximeter will power off automatically after approx. 8 seconds.

FAQ

• What does the measured result mean?
  The oxygen saturation (SpO2) of the blood is a term referring to the concentration of oxygen attached to human hemoglobin. The normal value lies between 95 and 100 % SpO2. A too low value may be an indication for existing diseases like e.g. cardiac defect, problems of the circulatory system, asthma or specific 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 confirm 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 synchronisation 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 find 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 configurated on the receiving device).

Troubleshooting

• Error: SpO2 and / or pulse frequency values are not displayed resp. are not displayed correctly.
  Remedying: Place on of your fingers 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.

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 certified in accordance with EC Guidelines and carries the CE symbol (conformity symbol) “CE 0297”. The specifications 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

Electromagnetic emissions

The Pulse Oximeter is intended for use in the electromagnetic environment specified 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 fluctuations / flicker emissions IEC 61000-3-3| Not applicable
Electromagnetic emissions

The Pulse Oximeter is intended for use in the electromagnetic environment specified 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 fluctuations / flicker emissions IEC 61000-3-3| Not applicable
Electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specified 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 fixed RF transmitters, as determi- ned by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. 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 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 mea- sured field 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, field strengths should be less than 3 V/m.

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 reflection from structures, objects and people

Technical specifications

• 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:
  • SpO2: 70 % – 99 %,
  • Pulse: 30 – 235 beats / min.
• Accuracy:
  • SpO2: ± 2 %,
  • Pulse: (30 – 99) = ± 2; (100 – 235) = ± 2 %
• Display resolution: SpO2: 1 %, Pulse: 1 beat / min.
• Response time: ø 12,4 seconds
• Bluetooth® specifications: 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:
  • 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:
   • All damage which has arisen due to improper treatment, e.g. non-observance of the user instructions.
   • All damage which is due to repairs or tampering by the customer or unauthorised third parties.
   • Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre.
   •  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.

ABOUT COMPANY

• medisana GmbH, Carl-Schurz-Str. 2, 41460 NEUSS, GERMANY.
• E-Mail: info@medisana.de,
• Internet: www.medisana.com
  The service centre address is shown on the attached leaflet.

References

• local.Se
• VitaDock Online | VitaDock Online
• Home page medisana – Your health in good hands
• Startseite medisana – Deine Gesundheit in guten Händen
• VitaDock Online | VitaDock Online

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