1 Safety Notes
1.6 Operation with other Devices
Page 8
Art. no.: 0-48-0013 Rev. m
FRED easy
1.6 Operation with other Devices
1.7 Maintenance
1.8 General Notes Regarding the Unit
Accessory equipment connected to the analogue and digital interfaces must be
certified according to the respective IEC standards (e.g. IEC/EN 60950 for data
processing equipment and IEC/EN 60601-1 for medical equipment). Further-
more, all configurations shall comply with the valid version of the system standard
IEC/EN 60601-1-1. Everybody who connects additional equipment to the signal
input part or signal output part configures a medical system and is therefore re-
sponsible that the system complies with the requirements of the valid version of
the system standard IEC/EN 60601-1-1. If in doubt, consult the technical service
department or your local representative.
Magnetic and electrical fields from X-ray or tomographic devices, portable radio
equipment, HF radios and devices labelled with the symbol can affect the
operation of this device (see section 8.4) . Avoid using such devices or keep a
sufficient distance from them.
A 16.7 Hz filter allows to operate the FRED easy in the vicinity of a mains network
with a frequency of 16.7 Hz (railway lines in some countries).
FRED easy® is not intended to be operated while using high-frequency surgical
devices.
Interference with other devices - The charging of energy and the release of the
defibrillation impulse can disturb other devices. Check these devices before their
further use.
Sensors and devices that are not defibrillation-proof must be disconnected from
the patient before a shock is triggered.
If the patient has an implanted pacemaker, be sure not to position the electrodes
directly on top of it.
Danger of electric shock! Do not open the device. No serviceable parts inside.
Refer servicing to qualified personnel only.
Before cleaning, switch the unit off and remove the battery.
Do not use high-temperature sterilisation processes (such as autoclaving). Do
not use E-beam or gamma radiation sterilisation.
Do not use aggressive or abrasive cleaners.
Do not, under any circumstances, immerse the device or cable assemblies in liq-
uid.
To ensure patient safety, the accuracy of displayed values and interference-free
operation, only use original SCHILLER accessories. The user is responsible for
the use of third-party accessories. The warranty does not cover damage result-
ing from the use of accessories or consumables other than those marketed by
SCHILLER.
A defibrillation can fail with certain disease patterns.
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