Not For Use In Areas Of Explosion Hazard; Connected Devices; Device Combinations; Patient Safety - Dräger Carina Instructions For Use Manual

Not for use in areas of explosion hazard

WARNING
Risk of fire
The medical device is not approved for use in
areas where oxygen concentrations above
25 Vol% or combustible or explosive gas mix-
tures are likely to occur.

Connected devices

WARNING
Risk of electric shock and of device malfunc-
tion
Electrical connections to equipment not listed
in these instructions for use or these assem-
bly instructions must only be made when ap-
proved by each respective manufacturer.
Before operating the medical device, strictly
comply with the instructions for use of all con-
nected devices or device combinations.

Device combinations

This device can be operated in combination with
other Dräger devices or with devices from third-
party manufacturers. Observe the accompanying
documents for the individual devices.
If a device combination is not approved by Dräger,
the safety and correct functioning of the individual
devices may be compromised. The owner must en-
sure that the device combination complies with the
applicable editions of the relevant standards for
medical devices.
Device combinations that are approved by Dräger
meet the requirements of the following standards:
– IEC 60601-1, 2nd edition (general require-
ments for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic compatibil-
ity)
– IEC 60601-1-4 (software-controlled func-
tions)
– IEC 60601-1-8 (alarm systems)
Instructions for use Carina SW 3.2n
For your safety and that of your patients

Patient safety

The design of the medical device, the accompany-
ing documentation, and the labeling on the medical
device are based on the assumption that the pur-
chase and the use of the medical device are re-
stricted to persons familiar with the most important
inherent characteristics of the medical device.
Instructions and WARNING and CAUTION state-
ments are therefore largely limited to the specifics
of the Dräger medical device.
The instructions for use do not contain any informa-
tion on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with dif-
ferent underlying diseases
Medical device modification or misuse can be dan-
gerous.
CAUTION
Risk of patient injury
Do not make therapeutic decisions based solely
on individual measured values and monitoring pa-
rameters.

Patient monitoring

The user of the medical device is responsible for
choosing a suitable patient monitoring system that
provides appropriate information on medical device
performance and patient condition.
Patient safety may be achieved by a wide variety of
means ranging from electronic surveillance of med-
ical device performance and patient condition to
simple, direct observation of clinical signs.
The responsibility for selecting the best level of pa-
tient monitoring lies solely with the user of the med-
ical device.
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