Ce Mark For Medical Devices - MIR Spirodoc User Manual

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Battery type and power
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Name and address of the manufacturer
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Mark of conformity with the directive 93/42 CEE
1.4.2

CE mark for medical devices

This product is certified to conform to the
requirements of the 93/42/CEE medical devices
0476
directive.
1.4.3 Electrical safety symbol
In accordance with IEC 60601-1, this product and
its component parts are of type BF and therefore
protected against the dangers of direct and indirect
contact with electricity.
1.4.4 Warning symbol for the RS232 serial port
For connection to other devices such as PC or
printer. Use only the serial cable supplied by
the manufacturer and observe the safety
regulations of IEC 60601-1-1.
1.5 Product description
spirodoc is a simple to operate precise pocket spirometer and pulse oxymeter (weight only 100g). It is able to measure
the most important functional respiratory parameters and to monitor the oxygen saturation and pulse rate. It makes a
quality control check on the test carried out.
spirodoc is intended for any doctor, from a family doctor to a specialist, requiring a small and compact instrument able to
make full spirometry and oximetry tests.
To make a meaningful interpretation of the measured spirometry parameters, the measured parameters must be
compared to the so-called " normal " or " predicted " values which are calculated from the anthropometric data of the
subject. The predicted values represent an average taken from a healthy population.
spirodoc gives a simple traffic light summary of the spirometric test interpretation. This test interpretation is based on the
ATS (American Thoracic Society) standards of 5 levels of obstruction, 5 levels of restriction and one of normal
spirometry. The instrument thus gives a valid support to the doctor to make a functional diagnosis.
The sensor for flow and volume measurement is a turbine sensor based on the infrared interruption principle. This
measurement principle guarantees accuracy and reproducibility of the measurement without the requirement of constant
calibration. disinfection is simple as the only requirement is to withdraw the turbine tube and to immerse it in a cold
detergent solution.
The sensor for pulse oxymetry is placed on the finger of the patient. The sensor contains two light emitting diodes
(LEDs), one in the visible red spectrum and the other in the infrared spectrum. The beams of light pass through the
tissues to a photodetector. During passage through the tissues some light is absorbed by the blood and by soft tissues,
depending on the concentration of haemoglobin. The amount of light absorbed at each light frequency depends on the
degree of oxygenation of haemoglobin within the tissues
This measurement principle guarantees accuracy and reproducibility of the measurement without the requirement of
constant calibration.
The sensor can be disinfected with isopropyl alcohol.
The power supply is a 3V battery and the battery life is in the region of two years, depending on the use.
1.6 Method of test interpretation
Following every FVC test (forced expiration) the instrument makes a quality control check to verify the validity of the test
made and to compare the principal measured parameters FEV1, FEV1% and FVC with the respective normal (predicted)
value.
It also calculates a series of indices as per the following criteria:
index % = measured value / normal (or best) value x 100
The colours code of the functional interpretation is as follows:
spirodoc user manual code 980165 Rev 4.5 page 7 of 27