Siemens Drager medical Carina, Instructions For Use Manual, Page: 11 / 144

Instructions for Use Carina SW 3.n
11
For Your Safety and That of Your Patients
Note on EMC/ESD risk for the device function
General information on electromagnetic compatibil-
ity (EMC) pursuant to international EMC standard
IEC 60601-1-2:
Electromedical devices are subject to special pre-
cautionary measures concerning electromagnetic
compatibility (EMC) and must be installed and put
into operation in accordance with the EMC informa-
tion provided on page 120.
Portable, mobile RF communications equipment
can affect medical electrical equipment.
Adequate monitoring of ventilation
The patient monitoring system integrated into
Carina monitors the following parameters:
– Airway pressure P
aw
– Inspiratory minute volume MVi
– Delivered minute volume MV (without leakage
compensation)
– Apnoea time T
apn
– Inspiratory tidal volume VTi (not in SPN-CPAP)
– Delivered tidal volume VT (without leakage
compensation) (not in SPN-CPAP)
– PEEP
– Mean pressure P
mean
– Frequency f
– I:E
Changes in these parameters can be caused by:
– acute change in the condition of the patient
– adjusting and handling errors
– device errors
– failure of power and gas supplies
If there is a fault in the integrated patient monitoring
system use separate measuring equipment.
CAUTION
Only use the device in well ventilated rooms to
prevent over heating of the device.
CAUTION
Do not expose the device to direct sunlight to pre-
vent over heating of the device.
WARNING
Only operate Carina with an inlet filter (HEPA)
to prevent infection and dusting patient.
WARNING
If inspiratory oxygen concentration differs
from ambient air concentration, monitoring of
inspiratory oxygen concentration with adjust-
able high and low alarm limits is needed. Con-
nect external monitor to hose system in
accordance with ISO 21647.
Otherwise no alarm will be activated if actual
inspiratory oxygen concentration differs from
set oxygen concentration.
WARNING
Patients depending on ventilation need either
monitoring of expiratory tidal volume, or mon-
itoring of expiratory minute volume, or moni-
toring of endtidal expiratory CO
2
concentration. Connect appropriate external
monitor to hose system.
Otherwise no alarm will be activated, if
patient's ventilation deteriorates.
CAUTION
Due to Carina's limited monitoring functionality
(no internal monitoring of expiratory minute vol-
ume), Carina is not always able to detect a dis-
connection of the hose system or pilot line!
Especially in cases when low PEEP values and
filters with high resistance are used. Use only fil-
ters listed in the separate accessories list, or con-
nect appropriate external monitor!
WARNING
In the case of patients who require a high O
2
concentration ensure that there is an emer-
gency supply of oxygen available, e.g. in O
2
cylinders.
WARNING
Do not operate a defibrillator while supplying
oxygen. Fire hazard!