Bionet Cardio7, Руководство по эксплуатации

Страница: 9 / 171

V 1.31
2021. 05 9 / 171 Doc. # : BN-OP-C7
WARNING:
OPERATOR — Medical technical equipment such as this system must be used only by
qualified and trained personnel.
WARNING:
SHOCK HAZARD — Improper use of this device presents a shock hazard. Strictly observe
the following guidelines. Failure to do so may endanger the lives of the patient, user,
and bystanders.
When disconnecting the device from the power line, remove the plug from the wall
outlet before disconnecting the cable from the device; otherwise, there is a risk of
coming into contact with line voltage by inadvertently introducing metal parts in the
sockets of the power cord.
Additional equipment connected to medical electrical equipment must comply with
the respective IEC or ISO standards (e.g. IEC 60950 for data processing
equipment).Furthermore all configurations shall comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3 Ed. of IEC 60601-1,
respectively). Anybody connecting additional equipment to medical electrical
equipment configures a medical system and is therefore responsible that the system
complies with the requirements for medical electrical systems.
Attention is drawn to the fact that local laws take priority over the above-mentioned
requirements.
If in doubt, consult your local representative or the technical service department.
WARNING:
SITE REQUIREMENTS — Improper placement of the device and/or accessories may result
in a hazard to the patient, operator, or bystanders.
Do not route cables in a way that they may present a stumbling hazard.
For safety reasons, all connectors for patient cables and lead-wires are designed to
prevent inadvertent disconnection, should someone pull on them.
For devices installed above the patient, adequate precautions must be taken to
prevent them from dropping on the patient.
WARNING:
TREADMILLS — Avoid rapid changes in treadmill speed and/or grade during a stress test.
CAUTION:
PROPER LEADWIRE CONNECTION — Improper connection will cause inaccuracies in the
ECG.
Trace each individual lead-wire from its acquisition module label to the colored
connector and then to the proper electrode to ensure that it is matched to the correct
label location.
CAUTION:
ACCESSORIES (SUPPLIES) — Parts and accessories used must meet the requirements of
the applicable IEC 60601 series safety standards and essential performance standards,
and/or the system configuration must meet the requirements of the IEC 60601
– 1 – 1
medical electrical systems standards.
Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper
operation.
CAUTION:
ACCESSORIES (EQUIPMENT) — The use of accessory equipment that does not comply
with the equivalent safety requirements of this equipment may lead to a reduced level
of safety of the resulting system.
Consideration relating to the choice of equipment shall include:
•Use of the accessory in the patient vicinity, and Evidence that the safety
certification of the accessory has been performed in accordance with the
appropriate IEC 60601
– 1 and/or IEC 60601 – 1 – 1harmonized national standard.