Safety Information - Medisana PM 100 Mode D'emploi

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Instruction manual Pulse Oximeter PM 100
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 informa-
tion 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 ob-
served 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 addi-
tional information on the installa-
tion or operation.
Protection Rating regarding for-
IP22
eign objects and drops of water

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 inaccura-
te 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.
• To ensure a correct sensor alignment and skin integrity, the maximum application time on a single measu-
0297
rement place should be less than half an hour.
• 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.
OLED screen
1 • 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.
2 Start-button
• The Pulse Oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction
3 Opening for finger
with other methods of assessing clinical signs and symptoms advised by a professional physician.
Battery compartment lid (on rear
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• The device is not autoclavable and is not intended for sterilization or for cleaning with liquids.
side of the device)
• 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
ASSIGNED PURPOSE
instructions for use.
The Pulse Oximeter PM 100 is a por-
• Please do not attempt to repair the unit yourself in the event of malfunctions. Stop using the device and
table non-invasive device intended for
conact the service centre.
spot-checking of oxygen saturation of
• The materials that contact with the patient's skin have been tested to be in tolerance. In case you should
arterial hemoglobin (SpO ) and pulse
detect skin irritations etc., stop using the device and contact a doctor.
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rate of adult and pediatric patients. It
• The swallowing of small parts like packaging bag, battery, battery cover and so on may cause suffocation.
is not suitable for continuous monito-
• In case of an unstable signal the measurement values may be faulty. Do not use these values as reference
ring.
values.
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. Do not short circuit. 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 100
Classification: Type BF applied
• 1 Lanyard
part
Packaging is reusable or can be returned to the raw material cycle. Please dispose of any packaging material
that is no longer required properly. If you notice any transport damage when unpacking, please contact your
No SpO alarm
dealer immediately.
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WARNING - Please ensure that the polythene packing is kept away from the reach of
children! Risk of suffocation!
LOT number
Insert / change batteries
Insertion: You must insert 2 batteries before you can use your unit. The lid of the battery compartment
Storage conditions 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 com-
partment.
Serial number
Removal: Replace the batteries when the battery exchange symbol
displayed the batteries are completely empty and need to be replaced immediately.
Manufacturer Use
1. Open the finger opening by pressing the left upper and lower parts of the device together.
2. Place your finger as far as possible into the opening
Date of manufacture upper and lower parts.
3. Press the Start-button
4. Keep your finger 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:
saturation in %
5. By repeatedly pressing the Start-button
the already explained values in different view modes) and change the displayed parameters from SpO
and PR (Pulse frequency) to SpO
6. Remove your finger. The Pulse Oximeter will power off automatically after approx. 8 seconds.
• 2 Batteries (type AAA) 1.5V
• 1 Instruction manual
appears in the display. If nothing is
3 on the right side of the device and release the
2 . The OLED-screen will switch on immediately.
Battery exchange symbol Pulse frequency Error Perfusion index
Oxygen
Pulse signal Start-button
2 you may switch between 7 different display modes (showing
and PI (Perfusion index).
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What does the measured result mean?
The oxygen saturation (SpO ) of the blood is a term referring to the concentration of oxygen attached to hu-
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man hemoglobin. The normal value lies between 95 and 100 % SpO
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. PI indicates the perfusion index, which is a measure for the pulse
strength. The results lie in between 0.02% (very weak pulse amplitude) and 20% (very strong pulse ampli-
tude). 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.
Adjustment of the display brightness
The medisana Pulse Oximeter PM 100 offers the possibility to adjust the brightness of the display 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: „?" appears on the display. SpO and / or pulse frequency values are not displayed resp. are not
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displayed correctly.
Remedying: Place on of your fingers completely into the finger opening
Use a new battery. Do not move or speak during the measurement and avoid bright surrounding light. 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
cannot be switched on, contact the service centre.
Error: „Error 7" appears on the display.
Remedying: The OLED 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
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. Plea-
se 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 concer-
ning medical devices" are met. Electromagnetic compatibility: The device complies with the EN 60601-1-2
standard for electromagnetic compatibility.
Technical specifications
is
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Name and model: medisana Pulse Oximeter PM 100
Display system: Digital display (OLED)
Power supply: 3 V , 2 batteries (type LR03, AAA) 1.5V
Measuring range: SpO : 70-100%, Pulse: 30 - 250 beats / min.., PI: 0.3%-20%
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Accuracy: SpO : ± 2 %, Pulse: (30 - 99) : ± 2; (100 - 250) : ± 2 %
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Display resolution: SpO : 1 %, Pulse: 1 beat / min.
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Response time: ø 8 seconds
Life cycle : approx. 5 years (if used for 15 measurements à 10 minutes per day)
Automatic switch-off: After approx. 8 seconds in absence of any signal
Operating conditions: +5°C - +40°C, 15% - 93% rel. humidity without condensation,
pressure 70 - 106 kPa
Storage conditions: -25°C - +70°C, max. 93 % rel. humidity without condensation,
pressure 70 - 106 kPa
Dimensions: approx. 57 x 32 x 35 mm
Weight: approx. 32 g
Article number: 79455
EAN number: 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.
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.
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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 GmbH, Jagenbergstr. 19, 41468 NEUSS, GERMANY.
The service centre address is shown on the attached leaflet.
. A too low value may be an indication
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on the backside of the device.
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. If the device still
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