Safety Information For Dräger Minimodule - EDAN iM50 User Manual

Patient monitor
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Patient Monitor User Manual
1
The ISA analyzers should be securely mounted in order to avoid the risk of damage to
the ISA.
2
Do not operate the ISA sidestream gas analyzer outside the specified operating
environment.
3
(US Only) Caution: Federal law restricts this device to sale by or on the order of a
physician. For professional use. See instructions for use for full prescribing
information, including indications, contraindications, warnings, precautions and
adverse events.
19.2.3 Safety Information for Dräger Minimodule
1
Dräger Minimodule is intended to be used by trained and authorized health care
professionals only.
2
Dräger Minimodule must not be used in areas where combustible or explosive gas
mixtures are likely to occur.
3
Modifications to the module may lead to malfunctions.
4
It's recommended to use accessories approved by Dräger. If other, incompatible
accessories are used, there is a risk of patient injury due to module failure.
5
Do not use the module near magnetic resonance imagers (MRI, NMR, NMI).
6
During warm-up, reported values may not be accurate.
7
If the gas sensors are not ready for operation, the patient will not be adequately
monitored. Before using the medical device, ensure a suitable substitute monitoring.
8
Misdiagnosis or misinterpretation of the measured values or other parameters can
endanger the patient. Do not make therapeutic decisions based solely on individual
measured values and monitoring parameters. Therapeutic decisions must be made
solely by qualified users.
9
When using three anesthetic agents, the oxygen measurement may be inaccurate.
Only use two agents at a time.
10
The use of authentic Dräger sample lines is strongly recommended, as other sample
lines with an incorrect length and/or diameter may lead to erroneous agent
concentration readings and waveforms or water trap/sample line alarms.
11
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
WARNING
- 170 -
Monitoring AG

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