140 Instructions for use | Atlan A100 (XL), A300 (XL), A350 (XL) SW 2.1n
Operation
Device malfunction during operation
Device malfunctions can compromise the correct therapy functionality of the device.
As a result, the patient could be put at risk.
► Only operate the device under the constant supervision of users.
► Always keep a manual resuscitator ready.
A cyber attack can occur as a result of a connected service laptop.
► Do not connect a service laptop during operation.
Displays and therapy decisions
The status display serves as an information source for the airway pressure in the
internal breathing system and for the fresh-gas flow (only with mechanically
controlled gas mixer with electronic flow measurement).
► In the following cases, use the display on the airway pressure gauge and the
total flow tube as the information source for therapy:
– The status display has failed.
– The values on the status display do not match the values on the total flow
tube.
The following situations could result in misdiagnoses, which could put the patient at
risk:
– Measured values are misinterpreted.
– Measured values are incorrectly or inaccurately displayed.
– The accuracy of the measurements of flow and volume may be impaired if the
breathing system warmer is switched off.
– The parameter under consideration is not meaningful (e.g., MV×CO
2,
O
2 uptake, anesthetic agent uptake)
► Do not make therapeutic decisions based solely on individual measured values
and parameters.
► Only use the trend curve for the MV×CO
2 and O2 uptake parameters as a basis
for therapeutic decisions.
► Therapeutic decisions must be made solely by the user. For further information
see: "User group requirements", page 11.
► Do not use the virtual flow tubes of the electronically controlled gas mixer alone
when making therapeutic decisions.
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