Lutech Datalys V650, User Manual

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The host equipment should be equipped with an appropriate alarm system to remind the
user of circumstances which may cause death or serious damages to the patient‟s health.

Every corresponding alarm message in IRMA state abstract fields must be implemented in
the host equipment.

The IRMA probe is not designed to be contactable to the patient.

Incorrect probe zeroing will result in false gas readings.

The IRMA probe is designed for being used by authorized or trained medical personnel.

The IRMA probe is not designed shall not be used in an inflammable anesthetic gas.

A disposable IRMA airway adapter shall not be used repeatedly. Repeatedly using a
disposable adapter will cause cross infection.

Used disposable airway adapters should be disposed according to local medical waste
stipulations.

Only oxygen sensors made by PHASEIN can be used. Oxygen exhausted oxygen sensors
should be disposed according to local battery disposal stipulations.

Never try to open the oxygen sensor device. The oxygen sensor in the IRMA probe is a
disposable product, containing corrosive electrolytes and lead.

The IRMA probe is designed only as an auxiliary means for patient evaluation. It must be
used together with other vital sign and symptom evaluation equipment.

Never place the IRMA airway adapter somewhere between the trachea catheter and the
elbow; otherwise it may result in the adapter window being clogged by the patient‟s
secretions and operating errors.

In order to prevent secretions and moisture from aggregating at the window and the
oxygen sensor port, always place the IRMA probe at a vertical position and let the LED
face upwards.

Never use the IRMA airway adapter together with a quantitative spraying agent or spray;
otherwise it may affect the light traveling of the airway adapter window.

If an IRMA OR (without the automatic anesthetic gas identification function) user select a
wrong anesthetic gas, it will result in false anesthetic gas readings.

If the IRMA OR (without the automatic anesthetic gas identification function) is applied to
a mixed gas containing several anesthetic gases, it will result in false anesthetic gas
readings.

Mobile and radio frequency communication equipment will affect measurement. You