Retain For Future Use; Safety Information - Medisana Pulsoximeter PM 150 Gebrauchsanweisung

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❷
❸
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Instruction manual 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 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
IP22
The degree of protection against ingress of dust and water
Classification: Type BF applied part No SpO alarm
2
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
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 att-
empting 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 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.
• 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 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 child-
ren! Risk of suffocation!
Device and controls
❶ Battery compartment lid ❷ LED Screen
❸ Start-button ❹ 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
user.
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
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:
Bluetooth
Pulse frequency
Pulse signal strength
Oxygen saturation in %
5. Remove your finger. The Pulse Oximeter will power off automatically after approx. 8 seconds.
What does the measured result mean?
The oxygen saturation (SpO ) of the blood is a term referring to the concentration of oxygen attached
2
to human hemoglobin. The normal value lies between 90 and 96 % SpO
) through
2
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 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 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: SpO and / or pulse frequency values are not displayed resp. are not displayed correctly.
2
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 sym-
bol) "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
Effective: 19-Jul-2014
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
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions nach IEC 61000-
Not applicable
3-2
Voltage fluctuations / flicker emissions
Not applicable
IEC 61000-3-3
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
Electrostatic
± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
®
will also be activated
Power frequency
(50/60 Hz)
3 A/m
magnetic field
IEC 61000-4-8
Electromagnetic immunity
®
symbol
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.
IEC 60601 - test
Immunity Test Compliance level
level
. A too low value may be an
2
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz
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
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
Rated maximum output
power of transmitter
W
0.01
0.1
1
10
100
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 environment - guidance Electromagnetic propagation is affected by absorption and reflection from structures, objects and people
Technical specifications
The Pulse Oximeter uses RF energy only for its
Name and model:
internal function. Therefore, its RF emissions
Group 1
are very low and are not likely to cause any
Display system:
interference in nearby electronic equipment.
Power supply:
Group 1 The Pulse Oximeter is suitable for use in all
Measuring range:
establishments, including domestic establish-
Accuracy:
ments and those directly connected to the public
lowvoltage power supply network
Display resolution:
that supplies buildings used for domestic
purposes.
Response time:
Bluetooth ® specifications:
Automatic switch-off:
Operating conditions:
Compliance level Electromagnetic environment - guidance
Storage conditions:
Floors should be wood, concrete or ceramic
Dimensions:
± 6 kV contact tile. If floors are covered with synthetic
± 8 kV air material, the relative humidity should be at
Weight:
least 30 %.
Article number:
Power frequency magnetic fields should EAN number:
be at levels characteristic of a typical
3 A/m
Compatible Smartphones:
location in a typical commercial or hospital
environment.
0297
In accordance with our policy of continual product improvement, we reserve the right to make
The current version of this instruction manual can be found under
Electromagnetic environment - guidance
Warranty and repair terms
Portable and mobile RF communications
equipment should be used no closer to any Please contact your dealer or the service centre in case of a claim under the warranty. If you have to return
part of the thermometer, including cables, the unit, please enclose a copy of your receipt and state what the defect is.
The following warranty terms apply:
than the recommended separation distance
calculated from the equation applicable to the
1. The warranty period for MEDISANA products is three years from date of purchase. In case of
frequency of the transmitter.
a warranty claim, the date of purchase has to be proven by means of the sales receipt or
Recommended separation distance:
invoice.
d=1.2 √P
2. Defects in material or workmanship will be removed free of charge within the warranty period.
d=1.2 √P 80 MHz to 800 MHz
3. Repairs under warranty do not extend the warranty period either for the unit or for the
3 V/m d=2.3 √P 800 MHz to 2,5 GHz
replacement parts.
where P is the maximum output power
4. The following is excluded under the warranty:
rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer a. All damage which has arisen due to improper treatment, e.g. non-observance of the user
and d is the recommended separation
instructions.
distance in metres (m). Field strengths
b. All damage which is due to repairs or tampering by the customer or unauthorised third
from fixed RF transmitters, as determi-
parties.
ned by an electromagnetic site survey ,
a
c. Damage which has arisen during transport from the manufacturer to the consumer or during
should be less than the compliance level
in each frequency range . Interference
transport to the service centre.
b
may occur in the vicinity of equipment
d. Accessories which are subject to normal wear and tear.
marked with the following symbol:
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: info@medisana.de, Internet: www.medisana.com
The service centre address is shown on the attached leaflet.
Pulse Oximeter
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
80 MHz to 800 MHz 800 MHz to 2.5 GHz
d=1.2 √P d=2.3 √P
0.1167 0.2334
0.3689 0.7378
1.667 2.3334
3.6893 7.3786
11.6667 23.3334
MEDISANA Pulse Oximeter PM 150
Digitale Anzeige (LED)
1,5 V= , 1 battery (type LR03, AAA)
SpO : 70 % - 99 %, Pulse: 30 - 235 beats / min.
2
SpO : ± 2 %, Pulse: (30 - 99) = ± 2; (100 - 235) = ± 2 %
2
SpO : 1 %, Pulse: 1 beat / min.
2
ø 12,4 seconds
Max. range = 10 m; frequency: 2400 - 2483,5 MHz, version: 4.0
After approx. 8 seconds
+5°C - +40°C, 15 % - 93 % rel. humidity, pressure 86 kPa - 106 kPa
-25°C - +70°C, 15 % - 93 % rel. humidity, pressure 86 kPa - 106 kPa
approx. 76 x 56 x 31 mm
approx. 55 g
79457
40 15588 79457 5
iOS: iPhone 4S and newer, iPad 3 und newer.
Android: Devices supporting Google Android version 4.3 and
Bluetooth ® 4.0.
technical and optical changes without notice.
www.medisana.com