medisana PM 100 Fingertip Pulse Oximeter Instruction Manual

1. OLED screen
2. Start-button| 3. Opening for finger
4 Battery compartment lid (on rear side of the device)
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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.

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 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.
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| 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.
| Protection Rating regarding foreign objects and drops of water
| Classification: Type BF applied part
| No SpO2 alarm
| LOT number
| Storage conditions
| Serial number
| Manufacturer
| Date of manufacture

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 inaccurate 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 measurement 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.
• 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 autoclavable and 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.
• In case of an unstable signal the measurement values may be faulty. Do not use these values as reference 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
• 2 Batteries (type AAA) 1.5V
• 1 Lanyard
• 1 Instruction manual

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 dealer immediately.

WARNING – Please ensure that the polythene packing is kept away from the reach of children! Risk of suffocation!

Insert/change batteries
Insertion: You must insert 2 batteries 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. 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 3 on the right side of the device and release the upper and lower parts.

3. Press the Start-button 2. The OLED-screen will switch on immediately.

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:
   

5. By repeatedly pressing the Start-button 2 you may switch between 7 different display modes (showing the already explained values in different view modes) and change the displayed parameters from SpO2 and PR (Pulse frequency) to SpO2 and PI (Perfusion index).

6. Remove your finger. The Pulse Oximeter will power off automatically after approx. 8 seconds.

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. 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 amplitude). 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. SpO2 and / or pulse frequency values are not displayed resp. are not displayed correctly.
Remedying: Place on of your fingers completely into the finger opening 3 on the backside of the device. 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 2. If the device still 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. 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.

Technical specifications

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:| medisana Pulse Oximeter PM 100
Digital display (OLED)
3 V , 2 batteries (type LR03, AAA) 1.5V
SpO2 : 70-100%, Pulse: 30 – 250 beats / min.., PI: 0.3%-20%
SpO2 : ± 2 %, Pulse: (30 – 99) : ± 2; (100 – 250) : ± 2 %
SpO2 : 1 %, Pulse: 1 beat / min.
ø 8 seconds
approx. 5 years (if used for 15 measurements à 10 minutes per day)
After approx. 8 seconds in absence of any signal
+5°C – +40°C, 15% – 93% rel. humidity without condensation, pressure 70 – 106 kPa
-25°C – +70°C, max. 93 % rel. humidity without condensation, pressure 70 – 106 kPa
approx. 57 x 32 x 35 mm
approx. 32 g
79455
40 15588 79455 1
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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 GmbH, Jagenbergstr. 19, 41468 NEUSS, GERMANY.
The service centre address is shown on the attached leaflet.

References

• Home page medisana – Your health in good hands

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