1 Safety Notes
1.4 Contraindication for use
Page 8
Art. no.: 2.511279 Rev. d
FRED
®
easyport
®
plus
1.4 Contraindication for use
1.5 Responsibility of the User
AED mode
The defibrillator must not be used when the person:
– is responsive
– is breathing normally
– has pulse
Manual defibrillation mode
– Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity
(PEA), such as idioventricular or ventricular escape rhythms, and in the treat-
ment of asystole.
CPR feedback
The CPR feedback option is contraindicated for use on neonatal and pediatric
patients under 8 years and <
25 kg.
CPR feedback option is contraindicated when manual CPR is contraindicated.
Other contraindications
Do not use the device in or near magnetic resonance imaging equipment (MRI).
Danger of explosion! — The device must not be used in areas where there is
any danger of explosion. There might be a danger of explosion in areas where
flammable products (petrol), flammable anaesthetic agents or products for skin
cleaning/disinfection are in use, or where the ambient air's oxygen concentration
is higher than 25 %.
The device is not designed for sterile use.
The device is not for use in or near magnetic resonance imaging equipment.
.
Regulations on who is allowed to use devices like the
FRED easyport plus and which training is required, are country-specific. In any
case, legal regulations have to be observed.
Before using the device, a SCHILLER representative must perform a
presentation on the device's operation and safety measures, if it is required by
the local regulations.
Interpretation suggested by the device must be examined with respect to the
patient's overall clinical condition and the quality of the recorded data.
Damaged or missing components must be replaced immediately.
The device must be stored in a place inaccessible to children.
Properly dispose of the packaging material and make sure it is out of children's
reach.
The FRED easyport plus is an emergency device and must be ready for
operation at any time and in all situations. Make sure that:
– the device is always equipped with a sufficiently charged battery
– you always keep a new spare battery on hand
– an empty battery must not be reused and must be disposed of immediately
– a set of adult electrodes is pre-connected and a spare set of electrodes must be
stored with the device
– the maintenance intervals are observed see 7 Maintenance.
If any serious incident has occurred in relation to the device it should be reported
to the manufacturer and the competent authority of the Member State in which
the user and/or patient is established.
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