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EN
Novidion GmbH
Fuggerstr. 30 • 51149 Köln
Tel.: +49 (0) 2203 / 9885 200
Fax: +49 (0) 2203 / 9885 206
www.pulox.de • Mail: [email protected]
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter.
This manual contains the instructions necessary to operate the product safely and in accordance with its
function and intended use. Observance of this manual is a prerequisite for proper product performance
and correct operation and ensures patient and operator safety.
Read this manual carefully before using the fingertip pulse oximeter.
This product is a reusable medical device. The using life is 2 years.
1. Safety
1.1 Contraindications
Do not use oximeter in a magnetic resonance (MR or CT) environment.
1.2 Warning
Keep the oximeter away from young children. Small parts such as the battery door, battery and lanyard
may trigger choking hazards.
1.3 Caution
Do not use the oximeter in the present of flammable anesthetics.
The oximeter needs to be used according to information provided in the user manual.
The equipment is NOT intended for neonate and infant.
Do not use damaged oximeter which may affect measurement performance.
Do not place the oximeter on the same hand/arm when using a blood pressure cuff or monitor.
Do not use the oximeter for more than 5 minutes without relocating the device to another finger.
Do not place the oximeter on edema or fragile tissues.
Do not use the oximeter as the only basis for making medical decision, it is intended only to be used
as additional information that you can give to your licensed health care professional.
Do not use the oximeter in high frequency environment such as electrosurgical equipment.
Do not place the oximeter in liquid.
Follow local disposal and recycling laws for the oximeter and its components, including the battery.
Do not stare into the light (infrared is invisible) which is emitted from the oximeter, it is harmful to
the eyes.
For clinical limitations and contraindications, please carefully review the medical literature.
The equipment is just an auxiliary equipment for clinical diagnosis. The physiological data displayed
on the equipment are for reference only and can not be directly used for diagnostic interpretation.
Not suitable for the users with arrhythmia/heart failure/low perfusion (PI<0.3)/finger trembling.
Not suitable for the users with large finger size or exceeding pulse oximeter’s finger measurement
cavity size.
Please don’t use the thumb and tail finger for measurement.
Discomfort or pain may appear if using the equipment ceaselessly, especially for microcirculation
barrier patients, it is recommended that the equipment should not be used on the same finger more
than 5 minutes.
The oximeter is designed to measure the percentage of arterial oxygen saturation of functional
hemoglobin.
Any of the following conditions may reduce the performance of the oximeter :
-
Flicking or very bright light
-
Moisture in the oximeter
-
Patient younger than 2 years old
-
Weak pulse quality (low perfusion)
-
Venous pulsations
-
Low hemoglobin
-
Cardiogreen and other intravascular dyes
-
Carboxyhemoglobin
-
Methemoglobin