Supplement Scio Four modules 5
English
Using the MEDIBUS protocol
Storing the instructions for use
Product-specific safety information
Essential performance
The essential performance consists in:
– Accuracy of gas measurement
If the accuracy of gas measurement is not fulfilled, the device
transmits status information with the purpose of generating a tech-
nical alarm on the patient monitor.
Application
Intended use
The Scio Four module samples gas from the breathing gas of
pediatric patients and adults. It continuously measures the con-
centration of CO
2, N2O, and anesthetic agents (Halothane, Isoflu-
rane, Enflurane, Sevoflurane, and Desflurane) in the breathing
gas as well as the O
2 concentration (optional). All measured val-
ues as well as derived values are communicated to a patient mon-
itor.
Environment of use
The gas analyzer is designed for use inside professional health-
care facilities in rooms in which therapeutic or diagnostic interven-
tions are carried out.
WARNING
Risk due to electromagnetic disturbance
Wireless communication devices (e.g., cellular phones) and
medical electrical equipment (e.g., defibrillators, electro-
surgical devices) emit electromagnetic radiation. When
such devices are operated too close to this device or its
cables, the functional integrity of this device may be com-
promised by electromagnetic disturbances. As a result, the
patient could be put at risk.
– Maintain a distance of at least 0.3 m (1.0 ft) between this
device and wireless communication devices, to ensure
that the essential performance of this device is fulfilled.
– Maintain an adequate distance between this device and
other medical electrical equipment.
WARNING
Risk of patient injury
Data transmitted over the MEDIBUS interface is not
intended for a distributed alarm system (in the sense of
remote monitoring) according to the applicable standards
("Relevant standards" on page 18). They are for information
only and must not be used as the sole basis for diagnostic
or therapeutic decisions.
Carry out further diagnostic measures.
CAUTION
Risk of incorrect use
Instructions for use must be kept accessible to the user.
WARNING
Risk of fire
To avoid a fire hazard, do not introduce drugs or other sub-
stances based on flammable solvents, such as alcohol, into
the device and do not use explosive anesthetic agents such
as ether or cyclopropane or spray them into the device. If
highly flammable substances are used for disinfection, ade-
quate ventilation is required.
WARNING
Risk of malfunction
Modifications to the medical device may lead to malfunc-
tions.
WARNING
Risk of patient injury
Electrical connections to equipment not listed in these
instructions for use or these assembly instructions must
only be made when approved by each respective manufac-
turer.
WARNING
Risk of insufficient oxygen supply
The sample flow diverted by the gas monitor may reduce
the breathing system volume in case of low-flow anesthe-
sia.
Compensate either by increasing the fresh-gas flow of the
anesthesia machine accordingly or by returning the sample
gas to the breathing system.
In some anesthesia systems the sample flow may influence
the measurement of the expiratory minute volume.
WARNING
Risk due to inaccurate gas measurement values
The use of authentic Dräger sample lines is strongly recom-
mended, as other sample lines with an incorrect length
and/or diameter may lead to erroneous agent concentration
readings and waveforms or watertrap/sample line alarms.
Never use standard pressure-sensor tubing or IV lines
(PVC) because it absorbs anesthetic agents, which are
released later (degassing) resulting in erroneous agent
concentration readings.
CAUTION
Risk of gas measurement failure
To prevent damage to the gas measurement, especially during
cleaning and disinfection, always keep the water trap installed.
WARNING
Risk of explosion or fire
This medical device must not be used in areas where oxy-
gen concentrations exceed 25 %, or where combustible or
explosive gas mixtures are likely to occur.
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