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SCOMBA-1.1
SpiroCare Operation Manual
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.
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.
To ensure patient safety, use only parts and accessories manufactured or
recommended by bionet.
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 60601–1–1 harmonized national standard.
CAUTION:
BATTERY POWER — If a device equipped with an optional battery pack will not be used
or connected to the power line for a period of over six months, remove the battery.
CAUTION:
BEFORE INSTALLATION — Compatibility is critical to safe and effective use of this device.
Please contact your local sales or service representative prior to installation to verify
equipment compatibility.
CAUTION:
DISPOSABLES — Disposable devices are intended for single use only. They should not be
reused as performance may degrade or contamination could occur.
CAUTION:
DISPOSAL — At the end of its service life, the product described in this manual, as well
as its accessories, must be disposed of in compliance with local, state, or federal
guidelines regulating the disposal of such products.
If you have questions concerning the disposal of the product, please contact bionet or
its representative.
CAUTION:
EQUIPMENT DAMAGE — Devices intended for emergency application must not be
exposed to low temperatures during storage and transport to avoid moisture
condensation at the application site.
Wait until all moisture has vaporized before using the device.
CAUTION:
ELECTRIC SHOCK — To reduce the risk of electric shock, do not remove cover or back.
Refer servicing to qualified personnel.
CAUTION:
OPERATOR — Medical technical equipment such as this electrocardiograph system
must only be used by persons who have received adequate training in the use of such
equipment and who are capable of applying it properly.
CAUTION:
SUPERVISED USE — This equipment is intended for use under the direct supervision of a
licensed health care practioner.
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