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SCOMBA-1.1
SpiroCare Operation Manual
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:
CONNECTION TO MAINS — This is class I equipment.
The mains plug must be connected to an appropriate power supply.
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.
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.
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
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