8 EN MEDUMAT Standard
2
WM 68071 05/2021
2 Safety
2 Safety
The instructions for use form part of the device. If the instructions
for use and the following safety information are not fully complied
with, the treatment may fail or be compromised. This could cause
severe or life-threatening injuries to the patient, user or bystanders.
Fully comply with the instructions for use.
Keep the instructions for use with the device so that they can
be accessed at any time.
Only use the device as defined by the intended purpose
(see "2.1 Intended purpose", page 8).
Do not use the device in the event of contraindications.
Follow the instructions for use for the components and
accessories.
Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent
authority of the Member State.
2.1 Intended purpose
MEDUMAT Standard
2
is an emergency and transport ventilator
with functions for the monitoring of respiratory values. The device
can be used for invasive and non-invasive ventilation via the
patient's nose, mouth or trachea. In the case of volume-controlled
ventilation, tidal volumes of 50 ml or more are possible. Smaller
tidal volumes are also possible in the case of pressure-controlled
ventilation.
2.1.1 Patient groups
MEDUMAT Standard
2
is used in the treatment of infants, children
and adults weighing 3 kg or more where spontaneous breathing
has failed or is inadequate.
2.1.2 User
Qualified medical personnel (e.g., paramedics, emergency
physicians).
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