MX-7711-02
1. General information and warnings
As outlined in the user manuals the Flow family systems are intended for use:
in administrating anesthesia while controlling the entire ventilation of patients with no
ability to breathe, as well as in supporting patients with a limited ability to breathe.
by healthcare professionals, trained in the administration of anesthesia
on neonate to adult patient populations.
hospital environments, except MRI environments.
When not in operation, the systems are designed for in-hospital transport.
The following information is being provided as a guidance. Using the anesthesia device outside of
the intended use as specified in the user manual and as noted above (e.g. long-term ventilation) is
considered off-label use. If the user (health care provider) decides to use the anesthesia device
off-label, he/she is responsible to make this determination and so at his/her own (liability) risk. The
risk benefit assessment has to be made by the responsible health care provider based on the
circumstances. Please also be aware that this information is only intended for the duration of the
COVID-19 emergency.
Maquet Critical Care AB is providing the following information for a better understanding of how the
anesthesia device functions so that the health care provider can make the decisions on how to
proceed when using a Flow-i, Flow-c and Flow-e anesthesia system for use in the ICU as a
ventilator only.
Please be specifically aware of the following:
- The devices are specified for a usage during surgical or diagnostic interventions under
constant supervision of a trained user. It is therefore important that the personnel using the
anesthesia device is familiar and well trained of the user interface, the controls and the
alarms of the machine or that the user is supervised by someone who is. This has to be
determined by the health care provider based on the situation on the site.
- Certain patients are susceptible to malignant hyperthermia and it is therefore important to
prepare the anesthesia device prior to treating such patients. Make sure to follow the
instructions in the Cleaning and Maintenance Manual (for US - MCV00011319_REVA).
- The User manual states that a resuscitator always must be available at the anesthesia
device to mitigate if any mal-functioning of the device should occur that disturbs the oxygen
intake of the patient.
- The anesthesia device is designed with alarms that are constantly supervised by the user
and safety measures that are dependent on user presence. The healthcare provider must
be aware of this and take appropriate actions so that it is always possible to react on
alarms perform safety measures.
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