For Your Safety And That Of Your Patients - Dräger Tropic plus Instrucciones De Uso

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 device.
Strictly observe these instructions for use
WARNING
Any use of the medical device requires full understanding
and strict observation of all sections of these Instructions
for Use. The medical device must only be used for the pur-
pose specified under "Intended use" on page 20. Strictly
observe all WARNING and CAUTION statements throughout
these 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.
Maintenance
CAUTION
Risk of medical device failure and of patient injury
The medical device must be inspected and serviced regu-
larly by service personnel.
If the above is not complied with, medical device failure and
patient injury may occur. Observe chapter "Maintenance".
Dräger recommends that a service contract is obtained with
DrägerService and that all repairs are performed by
DrägerService. For maintenance Dräger recommends the
use of authentic Dräger repair parts.
Accessories
WARNING
Only the accessories indicated on the order list have been
tested and approved for use with the medical device.
Therefore, it is strongly recommended that only these
accessories are used in conjunction with the medical
device. Otherwise, the correct functioning of the medical
device may be compromised.
Connection to other devices
Device combinations (Dräger devices + Dräger devices or Dräger
devices + third-party devices) approved by Dräger (see instruc-
tions for use of the individual devices) meet the requirements of
the following standards:
– IEC 60601-1 (2nd or 3rd 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 electrical
systems
Instructions for Use Tropic plus
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety and essential perfor-
mance
Collateral standard: Electromagnetic compatibility – Require-
ments and tests
If a device combination is not approved by Dräger, proper opera-
tion of the devices can be compromised.
The operator must ensure that the device combination meets the
applicable standards.
Strictly observe instructions for use and assembly instructions of
all connected devices.
Product-specific safety information
WARNING
Risk of malfunction
Impermissible modifications to the medical device lead to mal-
function.
This medical device may not be modified without permission
from its manufacturer.
Patient safety
The design of the medical device, the accompanying documenta-
tion, and the labeling on the medical device are based on the
assumption that the purchase and the use of the medical device
are restricted to professionals, and that certain inherent character-
istics of the medical device are known to the user. Instructions and
WARNING and CAUTION statements are therefore largely limited
to the specifics of the Dräger medical device.
These Instructions for Use do not contain references to various
hazards which are obvious to professionals who operate this med-
ical device as well as references to the consequences of medical
device misuse, and to potentially adverse effects in patients with
different underlying diseases. Medical device modification or mis-
use can be dangerous.
Information on electromagnetic compatibility
General information on electromagnetic compatibility (EMC)
according to international EMC standard IEC 60601-1-2:2007:
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 on page 30.
Portable and mobile radio frequency communication equipment
can affect medical electrical equipment.
English
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