Dräger Scio Four, Manual, Page: 4 / 258

English
4 Supplement Scio Four modules
Maintenance
Accessories
Connecting to other devices
Device combinations approved by Dräger meet the requirements
of the following standards:
– IEC 60601-1 (3rd edition)
Medical electrical equipment
Part 1: General requirements for basic safety and essential
performance
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety and essential
performance
Collateral standard: Electromagnetic compatibility –
Requirements and tests
– IEC 60601-1 (2nd edition)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-1
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for medical elec-
trical systems
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety and essential
performance Collateral standard: Electromagnetic com-
patibility - Requirements and tests
– IEC 60601-1-4
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical medical sys-
tems
If Dräger devices are connected to other Dräger devices or third-
party devices and the resulting combination is not approved by
Dräger, the correct functioning of the devices may be compro-
mised. The operating organization is responsible for ensuring that
the resulting system meets the requirements of the applicable
standards.
Information on electromagnetic compatibility
General information on electromagnetic compatibility (EMC)
according to international EMC standard IEC 60601-1-2:
Medical electrical equipment is subject to special precautionary
measures concerning electromagnetic compatibility (EMC) and
must be installed and put into operation in accordance with the
EMC information provided in the instructions for use of the patient
monitor.
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 "Maintenance".
Dräger strongly recommends that a service contract is
obtained with DrägerService and that all repairs are per-
formed by DrägerService. For maintenance Dräger recom-
mends the use of authentic Dräger repair parts.
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of accessories
listed in the current list of accessories. If other, incompati-
ble accessories are used, there is a risk of patient injury due
to medical device failure.
Dräger recommends that the medical device is only used
together with accessories listed in the current list of acces-
sories.
WARNING
Risk of operating errors and incorrect use
Strictly observe the instructions for use of all accessories.
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 device failure
Electromagnetic fields e.g., those generated by radio fre-
quency communication equipment such as mobile phones,
high-frequency electrical surgery equipment, defibrillators
or shortwave therapy devices can disrupt the function of
the medical device.
Only operate radio frequency devices at a sufficient safety
clearance.