Bionet Cardio7, Operation Manual

Page: 8 / 171

V 1.31
2021. 05 8 / 171 Doc. # : BN-OP-C7
Safety Messages
The following messages apply to the product as a whole. Specific messages may also
appear elsewhere in the manual.
WARNING:
ACCIDENTAL SPILLS — If liquids enter a device, take the device out of service and have
it checked by a service technician before it is used again.
To avoid electric shock or device malfunction, liquids must not be allowed to enter the
device.
WARNING:
BATTERY OPERATION — If the integrity of the electrical ground is in doubt, operate the
unit from its battery.
WARNING:
CABLES — To avoid possible strangulation, route all cables away from the patient's
throat.
WARNING:
CONNECTION TO MAINS — This is class I equipment.
The mains plug must be connected to an appropriate power supply.
WARNING:
DEFIBRILLATOR PRECAUTIONS — Do not come into contact with patients during
defibrillation.
Otherwise, serious injury or death could result.
Patient signal inputs labeled with the CF symbols with paddles are protected against
damage resulting from defibrillation voltages.
To ensure proper defibrillation protection, use only the recommended cables and lead-
wires.
Proper placement of defibrillator paddles in relation to the electrodes is required to
ensure successful defibrillation.
WARNING:
ELECTRODES — Polarizing electrodes (stainless steel or silver constructed) may cause the
electrodes to retain a residual charge after defibrillation. A residual charge will block
acquisition of the ECG signal.
Whenever patient defibrillation is a possibility, use non-polarizing electrodes (silver or
silver chloride construction) for ECG monitoring.
WARNING:
MAGNETIC AND ELECTRICAL INTERFERENCE — Magnetic and electrical fields are
capable of interfering with the proper performance of the device.
For this reason, make sure that all external devices operated in the vicinity of the device
comply with the relevant EMC requirements. X-ray equipment or MRI devices are
possible sources of interference as they may emit higher levels of electromagnetic
radiation.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
WARNING:
EXPLOSION HAZARD — Do NOT use in the presence of flammable anesthetics vapors or
liquids.
WARNING:
INTERPRETATION HAZARD — Computerized interpretation is only significant when used in
conjunction with clinical findings.
A qualified physician must verify all computer-generated diagnoses.