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For your safety and that of your patients
General safety information
The following WARNING and CAUTION statements apply to gen-
eral operation of the medical device.
WARNING and CAUTION statements specific to subsystems or
particular features of the medical device appear in the respective
sections of these instructions for use or in the instructions for use
of another product being used with this medical device.
Strictly follow these instructions for use
WARNING
Risk of incorrect operation and of incorrect use
Any use of the medical device requires full understanding
and strict observation of all sections of this supplement
and the relevant instructions for use. The medical device
must only be used for the purpose specified under
"Intended use".
Strictly observe all WARNING and CAUTION statements
throughout this supplement and the relevant instructions
for use and all statements on medical device labels. Failure
to observe these safety information statements constitutes
a use of the medical device that is inconsistent with its
intended use.
Service
WARNING
Risk of medical device failure and of patient injury
The medical device must be inspected and serviced regu-
larly by service personnel. Repair and complex mainte-
nance carried out on the medical device must be performed
by specialized service personnel.
If the above is not complied with, medical device failure and
patient injury may occur. Observe chapter "Service".
Monitoring
WARNING
Risk due to gas measurement failure
If the gas measurement fails, the patient can no longer be
adequately monitored.
Ensure corresponding substitute monitoring
WARNING
Do not make therapeutic decisions based solely on individ-
ually measured values and parameters. Therapeutic deci-
sions must be made solely by the user. For further
information see "User groups" on page 3.
Accessories
WARNING
Risk due to incompatible accessories
The use of faulty or incompatible accessories may compro-
mise the functional integrity of the product. Personal injury
and property damage may occur as a consequence.
–
Use only compatible accessories. The accessories that
are compatible with this product are listed in the list of
accessories supplied with the product.
–
Use only accessories that are in good working order.
4
WARNING
Risk of operating errors and incorrect use
Strictly observe the instructions for use of all accessories.
Connecting to other devices
WARNING
Risk of electric shock and of device failure
Any connected devices or device combinations not com-
plying with the requirements mentioned in these instruc-
tions for use can compromise the correct functioning of the
medical device and lead to an electric shock. Before oper-
ating the medical device, strictly comply with the instruc-
tions for use of all connected devices or device
combinations.
WARNING
Risk of electric shock
Connecting devices to the RS232 or MEDIBUS interfaces
can lead to an increased leakage current. If the protective
ground of one of these devices fails, the leakage current
may rise above the permissible values. Only connect with
the approval of the respective device manufacturer. Have
the leakage current checked by service personnel.
If the permissible value is exceeded, disconnect the
devices from the RS232 or MEDIBUS interface.
WARNING
Risk of operating errors and incorrect use
Strictly observe assembly instructions and instructions for
use for each connected device.
WARNING
Risk of electric shock
Electrical connections to equipment not listed in these
instructions for use or these assembly instructions must
only be made when approved by each respective manufac-
turer.
Alternatively the operating organization must ensure that
the device combination complies with the applicable edi-
tions of the relevant standards for medical devices.
WARNING
Risk of device failure
The use of faulty or incompatible cabling and mounting
equipment may compromise the functional integrity of the
product. Personal injury and property damage may occur
as a consequence.
–
Use only compatible cables and mounting equipment.
The accessories that are compatible with this product
are listed in the list of accessories supplied with the
product.
–
Use only accessories that are in good working order.
WARNING
Risk of device failure
Usage of this equipment adjacent or stacked with other
equipment should be avoided. It could result in improper
operation.
If such use is necessary, this device and the other equip-
ment should be observed to verify that they are operating
normally.
Supplement Scio Four modules
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