Operation With Other Devices; Maintenance; General Notes Regarding The Unit - Schiller FRED easy User Manual

1 Safety Notes
1.6

Operation with other Devices

Page 8
1.6 Operation with other Devices
 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
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.
1.7

Maintenance

 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.
1.8

General Notes Regarding the Unit

A defibrillation can fail with certain disease patterns.
FRED easy
symbol can affect the